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1
Dunya News

WHO declares polio vaccination mandatory for Pakistanis travelling abroad
       
 

WHO declares Pakistan as one of the dangerous countries failing to control spread of polio virus.

 
ISLAMABAD (Dunya News) – World Health Organisation (WHO) on Monday imposed travel ban on Pakistan due to failure to control polio virus. Dunya News has obtained copy of the WHO report.
According to the WHO report, it will be mandatory for any Pakistani travelling abroad to get polio vaccination.
The recommendation further says that any Pakistan travelling abroad would be bound to submit polio vaccination certificate four weeks before his departure while one time polio vaccination would be valid for one year.
The decision was made on the recommendations of International Health Regulations Committee.
Meanwhile, WHO also imposed travel restrictions on the citizens of other countries including Cameroon and Syria.
Earlier, the government reportedly decided to declare polio vaccination mandatory for Pakistanis traveling abroad owing to the growing polio cases.
According to sources, the federal government was taking preemptive measure on emergency basis to avoid any hindrance in international travel of Pakistani citizens.
Reportedly, Health Minister Saira Afzal Tarrar had expressed concerns over the situation and called an emergency session summoning all provincial health ministers in the coming week.
The session was likely to approve the policy of mandatory polio vaccination for Pakistanis traveling abroad.
As per the new policy, all Pakistani airports would be equipped with special anti-polio counters to facilitate with the vaccination.
World Health Organization’s International Health Regulation Committee reviewed polio situation in at least 10 countries including Pakistan in an emergency session.

http://dunyanews.tv/index.php/en/Pakistan/221032-WHO-declares-polio-vaccination-mandatory-for-Pakis

2
Medical News & General Information / selling spurious drugs
« on: April 27, 2014, 05:28:36 PM »
LAHORE: The Federal Investigation Agency (FIA) has identified more than 450 drug stores selling spurious drugs in the provincial capital, according to a report of the agency available with The Express Tribune.
  The drugs include medicine manufactured by local and multinational pharmaceutical companies including life-saving drugs. Along with the FIA report, the names of the spurious drugs and the medical stores selling them have been shared with the provincial health authorities, including the Punjab health minister and the provincial health secretary, FIA Punjab Director Dr Usman Anwar said.
The Punjab chapter of the FIA had launched an operation in early April after several complaints were made about the sale of substandard medicine in Lahore. Over the last two weeks, the FIA identified and raided 10 establishments which engaged in the manufacture, bulk supply and distribution of spurious drugs to hundreds of drug stores in Lahore. The record confiscated at the 10 establishments jointly raided by the FIA personnel and drug inspectors of the Health Department included invoices documenting the sale of spurious drugs to more than 450 drug stores in Lahore. In random checks, the adulterated medicines supplied by the 10 establishments were recovered from the cited drug stores.
Pulling together
The schedule of offences that the FIA covers includes spurious drugs. However, the agency can only proceed against spurious drugs in coordination with the Health Department. Before initiating the crackdown, the FIA had held meetings with officials of the Health Department, the Quality Control Board, the drug testing laboratory and the pharmaceutical association, and requested their assistance. All four had agreed to support the action, according to FIA officials.
The FIA report said that the medicine found during raids included fake drugs in forged packing, unregistered drugs, drugs sold without manufacturer’s warranty, expired medicine which had been repacked, drugs stolen from government or armed forces institutions, homeopathic or herbal products containing allopathic ingredients and drugs smuggled into Pakistan.
A taste of their own medicine
FIA Punjab Director Dr Usman Anwar said one of the arrested men had fainted in FIA’s custody. “He was taken to Sir Ganga Ram Hospital where he regained consciousness just as a nurse was about to administer a Risek injection to him. You should have seen him beg and plead with the nurses and doctors not to give him the injection. He had no compunction in stating that Risek was one of the fake injections that he manufactured and distributed in Lahore,” said the FIA Punjab chief.
Action by FIA
During the 10 raids the FIA arrested 13 accused and recovered millions of tablets and injections from factories and distribution networks. A factory in Kot Abdul Malik, another on Bund Road, distribution networks in Johar Town and BOR Society, pharmacies in Samanabad and two stores at Medicine Market were raided. Two establishments dealing in medicine stolen from armed forces and other government hospitals were raided in Tajpura Scheme and Islampura.
Obstacles
The FIA report highlighted various obstacles during the operation against spurious drugs due to the complex procedure, particularly regarding constitution of teams to raid drug establishments. The FIA could not conduct a raid without the area drug inspector accompanying its team. After a successful raid, permission from the Quality Control Board was mandatory before a case could be registered. After the FIA completed its investigation and submitted the report to the relevant drug inspector, the drug inspectors had to again send this report to the Quality Control Board for permission to prosecute.
Published in The Express Tribune, April 27th, 2014.


http://tribune.com.pk/story/700743/bad-medicine-over-450-pharmacies-selling-spurious-drugs-in-lahore/

3
ٱلۡحَمۡدُ لِلَّهِ رَبِّ ٱلۡعَٰلَمِينَ
خاص تعریف اللہ تعالٰی کے لیے ہے جو تمام جہانوں کا رب ہے
حمد
تعریف بوجوہِ انعامات و صفاتِ موصوف ۔
رب

عالمین

4
بسمِ ٱللَّهِ ٱلرَّحۡمَٰنِ ٱلرَّحِيم
شروع اللہ کے نام سے جورحمٰن اور رحیم ہے
رَحِمَ  رَحَمَ  رُحُم مَرحَم
Mercy, Compassion, Favor, Pardon.
رَحِم
Womb, Uterus. Place of origin and early growth for young
Hadith Qudusi
اناالرّحمٰن و انتِ الرَحِم شققتُ اسمکِ من اسمی فمن وصَلکِ وصلتُہُ و من قطعکِ قطَعتُہُ
    I am Rahman and you are Rahim,I have derived your name from mine therefore who makes you close I will make him close and who sever you I will sever him
رَحمَ
Relation
وَصَلَ رَحِمَہُ
To make tie of relationship strong with kind behaviour
قَطَعَ رَحِمَہُ 

To sever tie of relationship with unkind behaviour
رحمت
یہ وہ عطیہ ہے جو کسی کی ظاہری و باطنی کمی پوری کرے۔ اور جسے بلا قیمت دیا جائے۔ اس میں سامانِ نشو نما، و سامانِ حفاظت دونوں شامل ہیں۔ دراصل رحمِ مادر رحمت کا مفہوم جاننے کی بہترین مثال ہے جو انسان کو ایک خاص مدت تک سامان،نشو نما اور حفاظت مہیا کرتی ہے بلا کسی معاوضہ کے اور نہایت نرمی اور قربت  اور چار سو گھیراو کے ساتھ ۔
الرحمٰن
وہ صفت جس کے تحت مخصوص حالات و ضروریات میں رحمت کا پر جوش نزول ہوتا ہے۔
الرحیم
ملسل رحمت کی وہ صفت جس پر کائینات کا دارومدار ہے

5
National Health Accounts Pakistan 2011-12 This report provides the fourth round of National Health Accounts (NHA) for Pakistan, compiled by the Pakistan Bureau of Statistics (PBS). Its reference year is 2011-12. The third round was released in July, 2013 for 2009-10. The fifth round with reference year 2013-14 is un-der preparation.


Download

6
Pharmaceutical / PHARMACY ACT 1967
« on: April 17, 2014, 03:13:05 PM »
 PHARMACY ACT 1967 
(XI OF 1967)

(As Amended Upto   8th  February 1973).

    An act to establish Pharmacy Councils to regulate the practice of Pharmacy.

     WHEREAS it is expedient to establish Pharmacy Councils to regulate the practice of pharmacy and to provide to matters connected therewith and incidental thereto;

     AND WHEREAS the national interest of Pakistan in relation to the achievement of uniformity within the meaning of clause (2) of Article 131 of the Constitution requires Central legislation in the matter;

     It is hereby enacted as follows:

1. Short title, extent and commencement.
(1) This Act may be called the Pharmacy Act, 1967.
(2) It extends to the whole of Pakistan.
(3) It shall come into force at once.

2. Definitions.
In this Act, unless there is anything repugnant in the subject or context,
(a) `approved' means approved under section 18 or, as the case may be, section 19;
(b) `Central Council' means the Pharmacy Council of Pakistan established under section 3;
(c) `Council' means a Pharmacy Council established under section 3;
(d) `Medical Institution' means an institution whose medical qualifications are recognized under the Medical Council Ordinance, 1962 (XXXII of 1962);
(e) `Pakistan Pharmacists Association' means the association registered under the Societies Registration Act 1860 (XXI of 1860) and known at the commencement of the Pharmacy (Amendment) Act, 1973 by that name;
(f) `Pharmacist' means a person who is registered under section 24 in register A and Register B.
(g) `Pharmacy Institution' means an institution whose qualifications of Pharmacy are recognized under this Act; and
(h) `Provincial Council' means the Pharmacy Council of a Province established under section 3.

3. Establishment of Pharmacy Councils. Within a period of one year from the commencement of this Act:

(a)  The Central Government shall, by notification in the official Gazette, establish a Central Pharmacy Council to be known by the name of the Pharmacy Council of Pakistan; and
(b)  Each provincial Government shall in like manner, establish a provincial Pharmacy Council to be known by the name of the province concerned.

(2) Each of the Pharmacy Councils established under sub section (1) shall be a body corporate having perpetual succession and common seal, with power, among others, to acquire, hold and dispose off property, and shall by its name sue and be sued.

4. Composition of Central Council.  (1) The Central Council shall, subject to the provisions of sub section (2), consist of the following members, namely:

(a)  The Director General of Health, Government of Pakistan, ex-officio, who shall, unless the Central Government appoints any other officer to be the President, also be the President of the Council;

(b)  The officer, if any, appointed under clause (a) to be the President of the Council;

(c)  Eight persons to be nominated by the Federal Government out of whom one from each province shall be nominated in consultation with the provincial Government concerned, one shall be a teacher of Pharmaceutics and one a teacher of Pharmaceutical Chemistry;

(d)  One person from each province, to be nominated by the Federal Government so far as may be in consultation with the provincial Council concerned;

(e)  One person, to be nominated by the Federal Government in consultation with the Pakistan Pharmacists Association; and

(f) The Drugs Controller, Government of Pakistan; and

(2) The Central Government may by notification in the official Gazette, increase or decrease the number of persons to be nominated by it under clause (c) of sub section (1).

     Provided that the decrease in the number of members shall not affect the continuance in office of, and the performance of functions by, any member until the expiry of his term.

5. Composition of the Provincial Council.  (1) A Provincial Council shall, subject to the provisions of sub section (2), consist of the following members namely:

(a) the Secretaries to the Provincial Governments in the Health Department, ex
officio, who shall, unless the Provincial Government appoints any other officer to be the President, also be the President of the respective Council; and

(b) the officers, if any, appointed under clause (a) to be the President of the Council;

(c) five persons to be nominated by the Provincial Government, of whom one shall be an officer of that Government; and

(d) One person to be nominated by the provincial Branch of the Pakistan Pharmacists Association

6.Disqualification for membership:  A person, other than a professor of a medical institution of a pharmacy institution or an officer of the Provincial Government nominated under Clause(c) of sub section (1) of Section 5, shall not be eligible for nomination as a member of the council unless he is a pharmacist registered in Register A;
     Provided that, for the purpose of the constitution of the first Council after the Commencement of the Pharmacy (Amendment) Act, 1973, a person who is qualified to be registered as a pharmacist under this Act shall be eligible for such nomination.

7. Publication of names.  The Central Government shall publish in the official Gazette the names or the official titles of the members of the Council.

8. Term of office.  (1) Subject to provision of subsection (2), a member other than an ex- officio member shall hold office for a period of three years commencing on the day on which he assumes office and shall be eligible for re-nomination.

     Provided that notwithstanding the expiry of his term a member shall continue to function until his successor assumes office.

(2)  Where the Central Government or, as the case may be, the Provincial Government, upon recommendation of a majority of the members of the Council, is satisfied that a member of the Council is negligent in the discharge of his duties or is guilty of any unprofessional or dishonorable conduct or is otherwise not competent to perform the function of a member, it may, by notification in the official Gazette, remove such member; and upon the publication of such notification the seat of the member shall become vacant.

9. Filling of casual vacancy.  A casual vacancy in the office of a member shall be filled for the remainder of term of such member not being less than six months, by nominating another person in his place, in the same manner in which such a member was nominated.

10.  Vacancy, etc., not to invalidate the proceedings of a Council.  No act or proceedings of a Council shall be valid merely on the ground of the existence of any vacancy in, or any defect in the composition of, the Council.

11. Election of Vice- President. (1) A Council shall every year elect one of its members to be the vice President of the Council and the Vice-President so elected shall hold office for a period of one year and shall be eligible for re-election:

     Provided that a Vice-President shall, not with-standing the expiry of his term, continue to function until his successor is elected.

     (2) The Vice-President shall perform such functions as may be entrusted to him by the Council and, in the absence of the President also the, functions of the President.

12.  Committees of a Council.  (1) A Council may constitute  such committees as it deems fit for the purpose of advising and assisting it in the performance of its functions.

(2) A committee constituted under sub-section (1) may co-opt as its member any person whose assistance or advice it may consider necessary for the efficient performance of its functions.

13. Meetings of Council.  (1) A Council shall meet at such time and place, and a meeting of Council shall be summoned and conducted in such manner, as may be laid down by its bye
laws.


Provided that, until such bye-laws are made, the President of the Council may, by notice addressed to each member summon and conduct a meeting at such time and place and in such manner as he may deem expedient.

(2) The President and, in his absence, the Vice-President shall preside at every meeting of the Council and, in the absence of both the President and the Vice-President, the members present shall elect one amongst them to preside.

(3) The quorum for a meeting of the Council shall be one third of the total numbers a fraction being counted as one.     

14.  Annual Report. As soon as may be after the close of every year, the Central Council shall submit to the Central Government an annual report giving an account of its proceedings together with a statement of moneys received and expenses incurred by it during that year.

15. Appointment of Secretary, officers and staff of the Council.  (1)  A council shall, with the approval in the case of the Central Council of the Central Government and in the case of a Provincial Council of the Provincial Government, appoint a Secretary from amongst persons eligible for registration as pharmacists in Register "A" on such terms and conditions as it may deem fit.

(2) The Council may also appoint such officers and staff as may be necessary for the efficient performance of its functions.

16. Finances. (1) The funds of the Central Council shall consist of such moneys as may be placed at its disposal by the Central Government.

(2) The funds of a Provincial Council shall consist of the fees received by it under this Act and of such moneys as may be placed at its disposal by the Provincial Government.
     
17. Functions of the Central Council. (1) The functions of the Central Council shall be
(a)    to approve examinations in pharmacy for the purpose of qualifying persons for registration as pharmacists;

(b)    to prescribe the subjects in which approved examinations shall be held;

(c)    to approve the courses of study and practical training in pharmacy for the purpose of admission to approved examination;

(d)    to prescribe the conditions and procedure for admission of candidates to an approved examination;

(e)    to lay down the standard of teaching to be maintained by institutions conducting the approved courses of study;

(f)    to prescribe the equipment and facilities to be made available to the students;


(g)    to recognise degree or diplomas in pharmacy for the purpose of registration as pharmacists;

(h)    to cause inspection of institutions which conduct any courses of study in pharmacy and of the teachings imparted and examinations held by them; and

(i)    to do such other acts and things as it may be empowered or required to do by or under this Act.

(2) The Central Council, with the previous approval of the Central Government, may, by notification in the official Gazette, make regulations for the purposes of sub-section (1).

18. Approval of examinations. (1) Any institution or authority, including a Provincial Council, which holds an examination in pharmacy, may apply to the Central Council for approval of the examination for the purpose of qualifying a person for registration as a pharmacist under this Act.

(2)  The Central Council, if it is satisfied after such inquiry as it may think fit that the examination for the approval of which an application has been made under sub-section (1) is in conformity with this Act and the regulations, shall approve the examination and, by notification in the official Gazette, declare it to be an approved examination for the purpose of qualifying a person for registration as a pharmacist under this Act.

19. Approval of courses of study.-(1) Any institution or authority which conducts a course of study in pharmacy may apply to the Central Council for approval of such course of study for the purpose of admission to an approved examination.

(2) The Central Council, if is satisfied after such inquiry as it may think fit that the course of study for  the approval of which an application has been made under sub-section (1) is in conformity with this Act and the regulations, shall submit the application together with its recommendation to the Central Government and shall, upon the approval of the course of study by the Central Government, declare it, by notification in the official Gazette, to be an approved course of study for the purpose of admission to an approved examination.

20. Furnishing of information.- Every institution or authority which applies for the approval of an examination under section 18 or of a course of study under section 19, or holds an approved examination, or conducts an approved course of study, shall furnish to the Central Council such information as the Council may, from time to time, require relating to-

(a)    the course of study conducted and training given;
(b)    the examination held;
(c)    the ages at which the students may undergo the course of study;
(d)    the equipment and facilities provided for the students; and
(e)    matters generally pertinent to the course of study, training and examinations and standard of teaching.

21. Inspectors.- (1) The Central Council may appoint such Inspectors for the inspection of institutions as it may consider necessary.

(2) An Inspector appointed under sub-section (1) may, if he is so authorised in writing by the President of the Council,-

(a)    inspect any institution which holds an approved examination or conducts an approved course of study and may attend any such examination held by such institution;

(b)    inspect any institution which has applied for the approval of the examination held, or course of study conducted, by it and attend any examination held by such institution.

(3) An Inspector who attends any examination shall not interfere with the conduct thereof but shall submit to the Central Council a report on the sufficiency or otherwise of such examination and on any other matter in regard to which the Central Council may require him to report.

22. Withdrawal of approval. (1) Where, upon a report by an Inspector, it appears to the Central Council that an approved course of study or an approved examination does not continue to be in  conformity with this Act and the regulation, the Central Council shall give notice to the institution or authority concerned calling upon it to explain in writing why the approval of its course of  study or examination should not be withdrawn.

(2) The institution or authority to whom a notice has been given under sub-section (1) shall, within sixty days from the receipt of such notice, comply with the notice and may also make such representation to the Central Council, through the Provincial Government, as it may wish to make.
 
(3)  The Central Council, after considering the explanation given and any representation made under sub-section (2) and any observations on the representation which the Provincial government may think fit to make, may, by notification in the official Gazette declare that its approval of the course of study or examination conducted or held by the institution or authority concerned shall stand withdrawn with affect from such date as may be specified therein; and every such declaration shall state that the course of study or examination conducted or held by such institution or authority shall be deemed to be approved only when completed or passed, as the case may be, before the date so specified.

23. Functions of a Provincial Council.- The functions of a Provincial Council shall be-

(a)    to prepare and maintain registers of pharmacists and apprentices in pharmacy;
(b)    to register pharmacists and grant certificates of registration.
(c)    to conduct examinations for the purpose of registration as pharmacists; and                     
(d)     to do such other acts and things as it may be empowered or required to do by this Act.

24. Preparation and maintenance of Registers.- (1) The Provincial Council shall prepare or cause to be prepared and maintained the following Registers of Pharmacists and apprentices for the Province, namely:-

(a)    Register A - in which shall be registered the persons specified in clause (a) of sub-section (1) of section 25;

(b)    Register B - in which shall be registered the persons specified in clauses (b) and (c) of the said sub-section; and

(c)    Register C - in which shall be registered the apprentices in pharmacy;

Provided  that the Provincial Council may, with the previous approval of the Provincial Government, discontinue the registration of apprentices in pharmacy and may, with like approval re-open such registration after it has been discontinued and shall, upon such discontinuance or re-opening, publish in the official gazette a notice there of specifying the date of such discontinuance or re-opening.

(2) Every Register prepared and maintained under sub-section (1) shall include the following particulars relating to a person registered, namely;
    (a) full name;
    (b) residential address;
    (c) professional address;
    (d) father's name;
    (e) date and place of birth;
    (f) nationality;
    (g) qualification;       
      (h) date on which registered; and
    (i) such other particulars as may be prescribed by bye-laws.

25. Qualifications for registration as a pharmacist or as an apprentice in pharmacy.-(1) The following persons shall, subject to the provision of sub-section (3), be qualified for registration as pharmacists under this Act, namely;

(a) persons who hold a degree in pharmacy conferred by a University or an institution affiliated thereto, where the degree is recognised by the Central Council;

(b) persons who hold a diploma in pharmacy granted by any institution recognised by the Central Council; and

(c) persons who pass the examination in pharmacy held by a Provincial Council.
 
(1-a)  Subject  to the provisions of sub-section (3) during the period of one year from the commencement of the Pharmacy (Amendment) Act 1973, a person who was on the 19th day of June, 1972 to be deemed to be qualified for registration as a Pharmacist shall be deemed to be so qualified; and

(2) The following persons shall, subject to the provisions of sub-section (3) be qualified to be registered as an apprentice in Pharmacy, namely:
 
(i) an inspector of Drugs and a government Analyst appointed under the Drugs Act, 1940 (XXIII of 1940), if not otherwise eligible for registration;

(ii) a person certified by a Government Hospital to be a qualified compounder and dispenser;

(iii) a person who has been taken as a student or apprentice in Pharmacy by, and produces a certificate to that effect from, a Pharmacist registered in Register "A" and approved for the purpose, by notification in the official Gazette, by the Provincial Government, and
     
(iv) a person who is a qualified person within the meaning of rule 65 of the West Pakistan Drugs Rules 1958, if not otherwise eligible for registration.
 
(3) No person shall be qualified for registration as a Pharmacist or as an apprentice in pharmacy-

(a) if he is of unsound mind and stands so declared by a court; or

(b) if he has been convicted by a court of any offence which in the opinion of the Provincial Council involves moral turpitude.

26. Procedure for registration. (1) As soon as may be after the opening of the Registers under section 24, the Provincial Council shall, by notification in the official Gazette, invite applications from persons desirous of being registered as pharmacists or as apprentices in pharmacy.

(2) An application for registration shall contain such particulars and be made in such form as may be specified by the Provincial Council and shall be accompanied be such fee as may be prescribed  by the bye-laws.

(3) The Provincial Council shall examine every application received by it and, if it is satisfied that the applicant is qualified for registration under section 25, direct the entry of the name of the applicant in the appropriate Register.
 
(4) The Provincial Council shall, if it rejects the application of any person, inform the applicant in writing of such rejection within ninety days from the date of receipt of the application, and the applicant may within sixty days of the receipt of the information appeal against such rejection to the Provincial Government whose decision shall be final.

(5) Failure to inform the applicant of the rejection within the period specified in sub-section (4) shall be treated as acceptance of the application for registration.     

27. Certificate of registration. (1) The Provincial Council shall issue a certificate of registration to a person who has been registered under section 26.
 
(2) A certificate of registration issued under sub-section (1) shall bear a number and the official seal of the Council and be signed by its President and the Secretary and shall contain the following, namely;-

(a) a passport size photograph of the person registered
(b) the full signature of the person registered; and
(c) an endorsement of any mark of identification of the person registered.

(3) A copy of the certificate with all the particulars specified in sub-section (2) shall be kept in the official record of the Council,

(4) A person to whom a certificate of registration has been issued may, if the original is lost, defaced or mutilated or for any other reason, obtain a duplicate thereof on payment of the same fee as was paid for the original.

28. Revocation of certificate.-(1) The Provincial Council may, after giving the person concerned an opportunity to make representation and of being heard, revoke the certificate of registration issued to him, if such person-

(a) incurs any disqualification specified in sub-section (3) of section 25; or
 
(b) contravenes any of the provisions of the Poisons Act, 1919 (XII of 1919), the Dangerous Drugs Act, 1930 (II of 1930) the Drugs Act 1940 (XXIII of 1940), or this Act or of the rules made under any of those Acts; or
 
(c) fails or neglects to comply with any directive in respect of the profession of a pharmacist with the Central Government or the Provincial government may, from time to time, issue; or

(d) is guilty of such professional misconduct as may be laid down by the Provincial Council in this behalf.

(2) Where any certificate of registration is revoked under sub-section (1), the name of the person whose certificate has been so revoked shall, after he has been given a notice in writing of such revocation, be struck off the register in which his name was entered and his registration shall thereupon stand cancelled.

(3) The Provincial Council may, of its own motion. and shall, upon an application made in this behalf within thirty days of the receipt of the notice under sub-section (2) by the person concerned review its decision to revoke a certificate of registration; and the decision of the Council upon such review shall be final.

29. Examination for registration as pharmacists. (1) For the purpose of registration as pharmacists, the Provincial Council shall, after giving notice in this behalf hold examinations twice in every year.

(2) An examination under sub-section (1) shall be held at such place in a province as the Provincial Council may decide.

(3) Notice of an examination shall be published for a continuous period of not less than one week in at least one newspaper in English and one newspaper in the local language, each having wide circulation in the Province.

(4) Every application for admission to an examination shall be made in such manner and in such form as may be specified by the Provincial Council and shall be accompanied by-

(a) such fee as may be prescribed by the bye-lews;
(b) a certificate of good moral character from a respectable person; and
(c) such other papers or particulars as may be required by the Provincial Council.
 

30. Qualification for admission to an examination.-An applicant for admission to an examination under section 29,-

(a) shall not be below seventeen years of age on the date fixed for the examination;
 
(b) must have passed the matriculation examination or an equivalent Higher Secondary or Senior Cambridge examination with general science as one of the subject; and

(c) must have been registered as an apprentice in pharmacy for a period of not less than two years before the date fixed for the examination.

Provided that clause (c) shall not apply during  any period during which registration of apprentices in pharmacy remains discontinued under the proviso to sub-section (1) of section 24 and the period of two years thereafter:

Provided further that, notwithstanding anything contained in this  Act, it shall not be necessary for any apprentice in Pharmacy to attend any regular classes or to complete any number of days or lectures at any institution for the purpose of being qualified to be admitted to an examination under section 29.
 
31. Prohibition of practice without registration.- (1) Subject to the provisions  of sub-section (4), no person shall, after the expiry of five years from the commencement of this Act or such later date as the Central Government may, by notification in the official Gazette, specify in this behalf, practice as a pharmacist unless he is a registered pharmacist and displays his certificate of registration in a conspicuous place within the premises in which he so practices.

(2) Whoever employ any pharmacist for the purpose of any business in pharmacy shall cause the certificate of registration of the pharmacist so employed to be displayed in a conspicuous place within the premises in which such business is carried on

(3) Whoever contravenes the provisions of sub-section (1) or sub-section (2) shall be punishable with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.

(4) Nothing in sub-section (1) shall apply to-

(a) a registered medical practitioner as defined in the Medical Council Ordinance, 1962 (XXXII of 1962), or a person authorized to prescribe antibiotic and dangerous drugs under the Allopathic System (Prevention of Misuse) Ordinance, 1962 (LXV of 1962), who dispenses medicine to his own patients or serves his own prescriptions;

(b) a person who deals in non-poisonous household remedies in original and un-opened container at any store or place or prepares non-poisonous household remedies in accordance with  the rules made under/Drugs Act, 1940 (XXIII of 1940),

(c) a person who manufactures, sells or distributes drugs and medicines which fall exclusively under the unani, ayurvedic, biochemic or homoepathic system of medicine;
(d) a person engaged as a health or veterinary technician in a Government hospital or institution;

(e) a foreign pharmacist who is engaged, with the approval of the Central Council, for the purposes of consultation, advice or instruction, and

(f) an apprentice in Pharmacy, during the period of four years from the commencement of the Pharmacy (Amendment) Act, 1973 or during such further period as the Federal Government may, be notification in the official Gazette, specify in this behalf.

32. Cognizance of offences, etc. No court  shall take cognizance of an offence under this Act except upon a complaint in writing made by an Inspector appointed under the Drugs Act 1940 (XXIII of 1940), or an officer specially empowered in this behalf by the Provincial Government.


33. Indemnity.- No suit, prosecution or other legal proceeding shall lie against any person for any-thing which is in good faith done or intended to be done under this Act.

34. Power to make bye-laws. (1) A Council may with the previous approval, in the case of the Central Council of the Central Government and in the case of Provincial Council of the Provincial Government, make bye-laws for carrying out the purposes of this Act.

(2) In particular and without prejudice to the generality of the foregoing power, such bye laws may provide for all or any of the following matters, namely:

(a) the procedure for the meetings of the Council and of its committees;
(b) the management of the property of the Council;
(c) maintenance and audit of the accounts of the Council;
(d) the procedure for election of the Vice-President;
(e) the powers and duties of the President., Vice-President and other members of the Council;
(f) the terms and conditions of the service of the Secretary and other officers and staff of the Council;
(g) fees to be prescribed under this Act; and
(h) such other matters as are required by this Act to be provided for by bye-laws or are considered necessary for the efficient performance of the functions of the Council.

(3) Until such time as the bye-laws are made, the President of the Council may issue such instructions as he may consider necessary to regulate all or any of the matters specified in sub-section (2); and any such instructions shall stand rescinded upon the making of bye-laws by the Council.

Saving.- Nothing in this Act shall be deemed to affect the registration of any person who registered under the said Act immediately before the commencement of this Act.       


 

7
Pharmaceutical / The Drugs (Research) Rules, 1978
« on: April 17, 2014, 03:08:29 PM »
The Drugs (Research) Rules, 1978


S.R.O. 1047(I)/78, dated 15th July, 1978: In exercise of the powers conferred by Section 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal Government is pleased to make the following rules, the same having been previously published as required by sub-section (3) of the said section, namely :--

1. Short title and commencement: (1.) These rules May be called the Drugs (Research) Rules, 1978.
(2) They shall come into force at once,

2. Definitions: In these rules, unless there is anything repugnant in the subject or context,--
(a) "Committee" means the Committee of Experts constituted under rule 8;
(aa) "form" means form appended to these rules;
(b) "Fund" means the Central Research Fund maintained by the Federal Government under sub-rule (14) of rule 19 of the Drugs (Licensing, Registering and Advertising), Rules, 1976, [...];
(c) "investigator" means a person engaged in the investigation, research, development or evaluation of a drug on his own initiative or under the sponsorship of any other person or an institution;
(d) "recipient" means a person or an institution who or which receives aid from the Fund [...]; and
(e) "sponsor" means a person, firm, an establishment or institution promoting research on a drug.

3. Utilisation of Fund: The Federal Government may utilise the Fund for conducting research, development .or evaluation of a drug either itself or through a search institution working under its control or disburse it among investigators or institutions for such purposes subject to such conditions as may be specified.

4. Research in drugs: The research in drugs shall be conducted at such place or places and by such person or persons as may be approved by the Federal Government and shall be categorised as under :--
(i) other than clinical trials; and
(ii) clinical trials.

5. Application for grant of aid: (1) An application for the grant of aid from the Fund for conducting research on a drug on aspects other than the clinical trials and for clinical trials shall be made in Form 'A' and Form 'B', respectively, land addressed to the Secretary of the Committee [...].

(2) The Federal Government may, before granting any aid from the Fund, cause inspection of the premises concerned end technical evaluation of the project by the Committee or any expert appointed by it for this purpose.

(3) The Federal Government may, after obtaining the advice of the Committee and subject to such conditions as it may specify in this behalf, grant such aid from the Fund to a person or an institution as it may deem fit.

6. Conditions for conducting research on aspects of other than clinical trials: (1) The research on any aspect of drugs other than clinical trial shall be conducted under the supervision of an investigator who possesses post-graduate qualification and experience in the relevant field and has sufficient background knowledge. to conduct scientific investigation.

(2) The recipient shall, at regular intervals not exceeding six months, submit the progress report to the Federal Government in respect of the investigation being conducted.

(3) No change of an investigator or in the plan for investigation shall be made without prior approval of the Federal Government.

(4) The recipient shall allow an expert or a panel of experts authorised by the Federal Government to visit the premises at which the research is being conducted and to see that the Fund is being utilised in accordance with the approved plan.

7. Conditions for research in clinical trials: (1) In addition to the conditions laid down in rule 6, research in drugs on aspect of clinical trials shall be conducted in the following stages :--

(i) Stage 1 of investigation on human beings shall consist of studies to determine single and short term multiple dosing for tolerance, side effects, toxicity, metabolism, preferred routes of administration, safe dosage range and other pharmacological actions of the drug:

Provided that these studies shall be conducted under carefully controlled circumstances on comparatively small number of subjects to prevent any serious deleterious effect on health.

(ii) Stage II of investigation shall consist of studies to determine safety and effectiveness including an effective dose range, the common side effects of the drug on both clinical and laboratory parameters and where possible the level of drug in biological fluds in relation to therapeutic response:

Provided that these studies shall be undertaken if studies in Stage I of investigation demonstrate satisfactory results and shall involve initial and limited use of the drug in the treatment or prevention of the disease for which the drug is intended and shall be administered to carefully supervised patients:

Provided further that the Federal Government may require additional pharmacological studies to be conducted concurrently on animals to indicate safety for stage II of the investigation.

(iii) Stage III of investigation shall consist of studies under controlled conditions in order to expand knowledge of potential use and hazards and shall be undertaken if the data obtained in stages I and II provide reasonable assurance of safety and effectiveness or suggest that the drug may have a potential value of conducting several trials outweighing its hazards:

Provided that these studies shall be carefully monitored and all possible precautions shall be taken to prevent unnecessary exposure of the patient to the risk.

(2) If at any stage there appears to be an unwarranted hazard in the continuation of the ongoing clinical trials, the sponsor and recipient may be asked by the Federal Government to modify or discontinue clinical trials until further pre-clinical work has been done and the investigator conducting such research shall discontinue further tests under intimation to the sponsor and the recipient in writing, a copy of which be sent to the Federal Government.

(3) Studies on children shall not be undertaken unless there is a possibility of benefit to them and adequate studies of safety and efficacy are available in adults.

(4) When any dangerous or adverse effects are observed, emergency reports shall be sent immediately by the recipient to the Federal Government so that the other investigators are informed and the studies are stopped if the hazard so warrants.

(5) The consent for use of all investigational new drugs in clinical trials for stages I and II shall be obtained in writing by the investigator but for stage III it is the responsibility of the investigator to take into consideration the physical and mental state of the patient to decide when it is necessary or preferable to obtain consent other than in writing and if written consent is not obtained, the investigator, must obtain oral consent and record the fact in the medical record of the person receiving the drug.

(6) The recipient shall keep the record of his studies carefully in respect of every drug, retain it for at least ten years after registration of that drug and produce it before the Federal Government whenever required.

8. Committee of Experts on Drug Research: (1) The Federal. Government shall set up a Committee of Experts on Drug Research to determine the priorities, to give directions in drug research, to evaluate the applications received for the grant and make allocations from the .Fund and to take or propose such actions and measures as may be necessary for ensuring effective and proper use of the Fund:

(1) The Federal Government shall constitute a Committee of Experts to advise it on the utilisation of the Fund and for such other purposes as may be necessary for the proper utilisation of the Fund.

(2) The Committee shall consist of the following members namely :--

(a) Director-General Health who shall be its ex-officio Chairman.
(b) Executive Director, National Institute of Health, Islamabad.
(c) Chairman of the Pharmacy Department who shall hold office for three years by rotation. Chairman, Pharmacy Department, Peshawar University shall be the member for the first term.
(d) Chairman of the Pakistan Council of Scientific and industrial Research or his nominee who may be directly responsible for drugs research activities in the Council.
(e) Chairman of the Pakistan Medical Research Council, or his. nominee who may be directly responsible for drugs research activities in the Council.
(f) A Dean of the Pharmacy Faculty who shall hold office for three years by rotation. Dean of the Pharmacy Faculty, University of Karachi, shall be the member for the first term.
(g) A Professor of Pharmacology who shall hold office for three years by rotation. Professor of Pharmacology Allama Iqbal Medical College, Lahore, shall be the member for the first term.
(h) One representative of the Pakistan Pharmaceutical Manufacturers' Association (PPMA) who may be well-versed with the subject and actively engaged in the planning or conducting of research on drugs.
(i) Drugs Controller or Deputy Drugs Controller, Health. Division, Islamabad.

(3) The Federal Government may appoint a Secretary of the Committee from amongst its members.

9. Withdrawal of Fund and termination of an investigation: (1) The Federal Government may, at any stage of an investigation, withdraw the aid from the recipient and direct him and the sponsor to terminate a clinical trial under any of the following conditions, namely :-

(i) evidence of significant hazard;
(ii) convincing evidence that the drug is ineffective;
(iii) submission of false data;
(iv} omission of material information pertaining to safety got efficiency of the drug;
(v) unsatisfactory manufacturing practices;
(vi) failure to conduct the investigation in accordance with plan submitted and approved by the Federal Government;
(vii) commerciatization of the drug before completing clinical trial;
(viii) failure to report serious or potentially serious adverse reaction;
(ix) failure to meet the requirement of patient's consent; and
(x) evidence of misuse of the Fund:

Provided that the Federal Government may, before withdrawing the aid, require the recipient and the sponsor of any drug to comply with any of the above conditions which he has failed to comply within a specified period and may, after it is satisfied that the said conditions have been compiled with, allow resumption of the investigation.
FORM 'A'
[See rule 5 (1)]
Application for grant of aid for conducting research in drugs other than clinical trials
1. Name and address of the applicant.
2. Name and address of the sponsor if he is other than the applicant.
3. Title of Research project.
4. Financial implications of the project.
(i) Total Financial implications.
(ii) Present investment.
(iii) Other sources of finance. if any
(iv) Amount required from the Drugs Research Fund and details of its proposed utilisation.
5. Details of the Research project as follows :--
(i) Purpose.
(ii) Outline.
(iii) Progress already made (if any).
(iv) Comprehensive future Plan.
(v) Benefits.

6. Bio-data of all investigators including Incharge of the Research project giving the name. qualifications with years and experience.
FORM 'B'
[See rule S (l)]

Application for grant of aid for conducting clinical trials
1. Name and address of the applicant.
2. Name and address of the sponsor if he is other than applicant.
3. Title of Research project.
4. Financial implications of the project:
(i) Total Financial implications.
(ii) Present Investment.
(iii) Other sources of finance, if any.
(iv) Amount required from the Central Research Fund and details of its proposed utilisation.

5. Enclose herewith--
(i) outline of the Research Project, its purpose, benefits, description of the comprehensive plans. and progress already made, if any :

(ii) information and data about the drug to be investigated including its exact composition, chemistry. pharmacology, toxicity, conditions for use in man, and pharmacy with special reference to the method of manufacture and quality control to show that adequate standards exist and a meaningful assessment can be made of the safety of the material for use in man (copies of all informational material to be supplied to the investigator should be enclosed);

 

8
Pharmaceutical / CURRENT GOOD MANUFACTURING PRACTICES
« on: April 17, 2014, 12:40:03 PM »
 CURRENT GOOD MANUFACTURING PRACTICES

 NOTIFIED ON MAY 15, 1998 UNDER DRUGS ACT 1976 AND
 DRUGS (LICENSING, REGISTERING AND ADVERTISING) RULES 1976.
 
 PUBLISHED BY:
 MINISTRY OF HEALTH,
 GOVERNMENT OF PAKISTAN
 ISLAMABAD
 
 No.F.9-19/96-Lic.
 Government of Pakistan
 Ministry of Health
 *****
 Islamabad, the  15th May 1998
 S.R.O. 470(I)/98, - In  exercise of the powers conferred by section 43   of the Drugs Act, 1976(XXXI of  1976), the Federal Government of   Pakistan to direct that the following further amendments shall be made   in the Drugs (Licensing, shall be made in the Drugs  (Licensing ,   Registering and Advertising) Rules , 1976, the same having been    previously published as required by sub-section (3) of the said section,   namely  :-
 In the aforesaid Rules-
 I. For rule 2 the following shall be substituted, namely :-
 2. Definitions In these rules, unless there is anything repugnant in the    subject or context:-
 (a) “active pharmaceutical ingredient” means a substance   pharmacologically active  compound (ingredient);
 (b) “airlock” means an enclose space with two or more doors, which is    interposed between two or more rooms of differing classes of cleanliness   for  the purpose of controlling the airflow between those rooms when   they need to be  entered and an airlock is designed for and used by   either people or goods;
 (c) “authorized person responsible for the release of batches of product   for  sale:
 (d) “basic manufacture” means manufacturer of a drug from basic raw   material to  a product which is ready for use as a staring material for   the formulation of a  finished drug or for repacking and such   manufacture may involve chemical ,  bio-chemical, photochemical, microbial or such other processes or a combination  of any of such processes;
 (e) “batch (or lot)” means a defined quantity of starting material,   packaging  material, or finished product processed in a single process   or series of  processes so that it could be expected to be homogeneous,   in the case of  continuous manufacture the batch must correspond to   complete to be homogeneous,  in the case of continuous manufacture the   batch must correspond to a defined  fraction of the production ,   characterized by its intended homogeneity, and to complete certain   stages of manufacture it may sometimes be necessary to divide  a batch   into a number of sub-batches, which are later brought to form a final    homogeneous batch;
 (f) “batch number (or lot number)” means a distinctive combination of   numbers  and or letters which specifically identifies a batch on the   labels , the batch  to be trace and revived.
 (g) “batch numbering system” means a standard operating procedure   describing  the details of the batch numbering;
 (h) “batch records” means all documents associated with the manufacture   of a  batch of bulk product or finished product showing a history of   each batch of  product and of all circumstances pertinent to the quality   of the final product;
 (i) “biological agents” means micro-organisms, including genetically   engineered  microorganisms, cell cultured and endoparasites, whether   pathogenic or not ;
 (j) “biological agents” means micro-organisms, including genetically   engineered  micro organisms, cell culture and end parasites, including   final packing;
 (k) “calibration” means the set of operations that established, under   specified  conditions, the relationship between values indicated by an   instruments or  meaning system for especially weighing, recording, and   controlling, or the  values relationship between values indicated by an   instrument or measuring  system for especially weighing, recording, and   controlling, or the values  represented by a material measure, and the   corresponding known values of a  reference standard and the limits for   acceptance of the results;
 (l) “Clean area” means an area with defined environments control of   particulate  and microbial contamination, constructed and used in such a   way as to reduce  and or eliminate introduction, generation, and   retention of contaminants within  the area ;
 (m) “compounding” means scientific combination of two or more   ingredients with  a view to make a finished;
 (n) “consignment or delivery” means the quantity of starting material,   or of a  drug product, made by one manufacturer and supplied at one time   in response to  a particular request or order, a consignment may   comprise one or more packages  or containers and may include material   belonging to more than one batch;
 (o) “critical process” means a process that may cause variation in the   quality  of the pharmaceutical product;
 (p) “cross-contamination” means of a starting material, intermediate   product,  or finished product with another starting martial or drug   during production;
 (q) “finished product” means a product that has undergone al stags of    production, including packaging in its final container and labeling;
 (r) “Form” means a form set forth in Schedule A;
 (s) “formulation” means all operations involved in converting a drug   into a  final pharmaceutical dosage form ready for use as a finished   drug including  compounding, processing, formulating, filling, packing,   finishing, labeling,  and other like processes;
 (t) “good manufacturing practices for pharmaceutical products” means   part of  quality assurance which:-
 (u) “half-finished product” means any material or mixture of materials   that has  to undergo further manufacture;
 (v) “in-process control” means checks performed during production in   order to  monitor and if necessary to adjust the process to ensure that   the product  conforms to its specifications and control of the environment or equipment may  also be regarded as a part of in-process control;
 (w) “intermediate product” means partly processed material that must   undergo  further manufacturing steps before it becomes a bulk product;
 (x) “large-volume parenteral” means sterile solutions intended for parenteral  application with a volume of more than 100 ml one container   of the finished  dosage form;
 (y) “manufacturer” means all operations of production , quality control,    release, storage and the related controls;
 (z) “manufacturer” means a company that carries out at least one step of    manufacturer;
 (aa) “manufacturer authorization” means a document, issued by the Drug    Registration Board set up under the Drugs Act, 1976, as a certificate of   drug  registration;
 (ab)“master formula” means a document or set of documents specifying the    starting materials with their quantities and the packaging materials ,   together  with a description of the procedures and precautions required   to produce a  specified quantity of a finished product as well as the   processing  instructions, including the in-process controls;
 (ac) “master record” means a documents or set of documents that as a   basis for  the batch documentation (blank batch record);
 (ad) “new drug” means drug that has not been commonly sold or distributed to  the public in Pakistan and is introduced for the first time;
 (ae) “Ordinance” means  the Drug s Ordinance, 1976(IV of 1976)
 (af) “Packing” means  all operations, including filling and labeling   which a bulk drug has to undergo  in order to become a finished product;
 Note : Sterile filling  would not normally be regarded as part of packaging, the bulk product being the  filled , but not the finally packaged, primary container.
 (ag) “Packing material”  means any a material, including printed material, employed in the packing of a  pharmaceutical product, excluding any outer packaging used for transportation  or shipment and packaging material are referred to as primary or secondary  according to   whether or not they are intended to be in direct contact with the product;
 (ah) “Pharmaceutical product” means any drug intended for human use or    veterinary use presented in its finished dosage form or as a starting   material  for use in such a dosage form;
 (ai) “Processing instruction or procedures” means as defined include   (ab) of  this section;
 (aj) “production” means all operations involved in the preparation of a    pharmaceutical product;
 (ak) “Purity” means the degree to which other chemical or biological   entities  are present in any substance;
 (al) “quality assurance” means the totality of the arrangements made   with the  object of ensuring that pharmaceutical products are of the   quality required for  their intended use and so incorporates good manufacturing practices , Quality  Control and other factors including design and development and good laboratory  practices;
 (am) “quality control” means the part of good manufacturing practices   concerted  with sampling, specifications, and necessary and relevant   tests are actually  carried out and that materials are not released for   use, nor finished products  released procedures which ensure that the   necessary and relevant tests are  actually carried out and that   materials are not released for use , nor finished  products released for   sale or supply until their quality has been judged to be satisfactory   and it is involved in all decision concerning the quality of the    product;
 (an) “quarantine” means status of starting or packing materials, intermediates,  or bulk or finished products isolated physically or by other effective means  while a decisions concerning the quality of the product;
 (ao) “ reconciliation” means a comparison, making due allowance for   normal  variation between the amount of product or used and the amount   actually  produced or used and the amount actually produced or used;
 (ap) “recovering or blending” means the introduction of all or part of   previous  batches or of redistilled solvents and similar prints of the   requires quality  into and the batch at defined stage of manufacture;
 (aq) “repacking “ means all operations involved in the transfer of a   drug from  a larger container or packing into smaller xontanes or pickings including  filling, packing and labeling with a view to make it   ready for retail sale or  wholesale, but does not includes any compounding , or processing with a view to  formulate it in any dosage form;
 “Retail Sale” means a sale other than wholesale.
 (as)”reprocessing” means the reworking of all or part of a barh of product of  an unacceptable quality from a refined sage of production so   that its quality  may be rendered acceptable by one or more additional   operators;
 (at)“returned product” means finished product sent back to the   manufacturer or  distributor.
 (au) “schedule” means schedule to these rules:
 (av) “semi-basic manufacture means manufacture from an intermediate   substance  of a drug to be used as starting material for the formulation   of a finished  drug or to be used for repacking;
 (aw) “specification” means the requirements with which the products or    materials udder or obtained during manufacture must confirm as specified   in the  Drugs (Specification) Rules, 1978;
 (ax) “standard operating procedure” means an authorized written procedure  including instructions for performing operations not necessarily specific to a  given product or material but of amore general nature such as control sampling  and inspection, and certain standard operating procedures may be used to  supplement specific master batch production documentation;
 (ay) “Starting material” means any substance used in the production of    pharmaceutical product but excluding packing materials;
 (az) “system” means a regulated pattern of interacting activities and    techniques which are united to form an organized whole;
 (ba) “validation” means the documents fact of proving that any procedure    process, equipment, material, activity or system works correctly and   actually  leads to the expected results ; and
 (bb) “wholesale” means sale to a person who purchases for the purpose of    selling again and includes sale to a hospital or dispensary, or to   medical,  educational or research institute.
 
 11. In rule 16:-
 A. in clause(a) for the Schedule B the following shall be substituted,   namely:-
 SCHEDULE-B
 
 CONTENTS
 SECTION-I
 Premises
 1. Location and Surroundings
 1.1 Location
 1.2 Surroundings
 
 2. Building Layout And Its Pre-Approval
  3. Building Design And Construction (General)
  3.1 General
 3.2 Services
 3.3 Protection Against Insects etc
 3.4 Surfaces
 
 4. Storage Area
  4.1 Capacity
 4.2 Design
 4.3 Bays
 4.4 Quarantine
 4.5 Sampling
 4.6 Rejected Material
 4.7 Special Material
 4.8 Packaging Material
 4.9 Weighing Area
 
 5. Production Department
  5.1 General Facilities
 5.2 Dedicated Facilities for Production
 5.3 General Requirements for Production
 (i) Layout
 (ii) Adequacy
 (iii) Surfaces
 (iv) Services
 (v) Drains
 (vi) Environmental Controls
 (vii) Packaging
 (viii) Light
 
 6. Ancillary Area
  6.1 Rest Rooms
 6.2 Changing Rooms
 6.3 Workshop
 6.4 Animal House
 
 SECTION-2EQUIPMENT FOR PRODUCTION 
 2.1 General
 2.2 Layout
 2.3 Construction
 2.4 Piping
 2.5 Tanks
 2.6 Filters
 2.7 Cleaning Equipment
 2.8 Defective Equipment
 
 SECTION-3QUALITY CONTROL DEPARTMENT
  3.1 General
 3.2 Laboratories
 3.3 Areas
 3.4 Facilities
 (i) Equipment
 (ii) Others
 (iii) Written Procedures
 (iv) Validation
 (v) Storage
 
 SCHEDULE-BCONTITIONS FOR GRANT OF A LICENSE TO  MANUFACTURE DRUGS   BY WAY OF FORMUATION
 SECTION-1
 Premises
 1. Location and surroundings.
 1.1 Location : The premises shall be located preferably in an industrial   area  and in any case not in any congested residential or commercial   area.
 1.2 Surroundings : Premises shall be situated in an environment that,   when  considered together with measures to protect the manufacturing   processes,  presents minimum risk of causing any contamination of   materials or products. It  shall be away from filthy surroundings and   shall not be adjacent to an open  sewerage, drain, public lavatory or   any factory which products. It shall be  away from filthy surroundings   and shall be adjacent to an open sewerage, drain, public lavatory or   any factory which products a disagreeable or obnoxious odor  or fumes or   large quantities of soot, dust or smoke which may contaminate the drugs    being manufactured or adversely affect their quality. Existing units   shall keep  the surroundings under their control to be clean.
 1.3 Size: The size of the plot shall be less than 2000 square yards.
 2. Building layout and its pre-approval .The building shall be of adequate size  and suitable design and construction in view of the need   for drugs to be  manufactured and to suit the operations to be carries   out. The site and layout  plan of building shall be not approval from   the central Licensing Board or person  authorized by it in this behalf   before starting construction of the building  and any minor subsequent   change in the layout plan will be communicated as and when made with a   revised updated layout plan at the time of renewal of Drug    Manufacturing License.
 3. Building, design and construction (General) .
 3.1 General : The layout and design shall aim at minimization the risk   of  errors, facilitate good sanitation and permit effective cleaning and   maintained  in order to avoid cross contamination , build-up of dust or   dirt, and in  general , any adverse effect on the quality of products.
 3.2 Services: Electrical supply, lighting, temperature and humidity   controls  and ventilation shall be appropriate and such that they do not   adversely  effect, directly or indirectly either the pharmaceutical   products during their  manufacture and storage, or the accurate   functioning of equipment.
 
 SECTION-4DOCUMENTATION
  4.1 General
 4.2 Specifications & Testing Procedures
 (i) Reference Books
 (ii) Testing Procedures
 (iii) Specifications
 4.3 Specifications for Starting and Packing Materials
 4.4 Specifications For Starting and Packaging Materials
 4.5 Mater Formula
 4.6 Packing Instructions
 4.7 Standard Operating Procedures (SOPs) and Records
 4.8 S.O. Ps for Testing
 4.9 S.O.Ps for Sanitation
 4.10 S.O.Ps Miscellaneous
 4.11 Labels
 4.12 Batch Processing records
 
 SECTION-5SANITAON AND HYGIENE
  5.1 Sanitation
 5.2 Hygiene
 
 3.4 Surfaces : In arrears where raw materials, in-process materials or   drugs  are exposed, the following general condition shall apply to the   extent  necessary prevent contamination, namely :-
 (i) floors, walls, and ceilings/permit easy cleaning, brick , cement   blocks,  and other porous materials are sealed;
 (ii) floors, walls, ceilings, and other surfaces are hard, smooth, and   free of  sharp corners where extraneous material can collect;
 (iii) joints are sealed between walls, ceilings and floors;
 (iv) pipes, light fittings, ventilation points and other services do not   create  surfaces that can not be cleaned; and
 (v) screened and trapped floor drains are provided if required.
 4. Storage areas.
 4.1 Capacity: Storage area shall be properly defined of sufficient   capacity to  allow orderly storage of virus categories of materials and   products in  quarantine, and released, rejected, returned ,or recalled   products.
 4.2 Design: Storage areas shall be designed or adapted to ensue good   storage  conditions. In particular, they shall be clean and dry ,   suitably lit and  maintained within acceptable temperature limits which   should be commensurate  with storage requirements of the drugs. Where   special storage conditions are  required (e.g., controlled temperature   and humidity) these shall be provided, checked, and monitored.
 4.3 Bays: Receiving and dispatch bays shall protect materials and   products from  the weather, Reception areas shall be designed and equipped to allow containers  of incoming materials to be cleaned if necessary before storage.
 4.4 Quarantine: Well defined quarantine area shall be provided for the   incoming  materials, in process materials and finished drugs. Where   quarantine status is  ensured by storage in separate areas, these areas   shall be clearly marked and  their access restricted to authorized   personnel. Any system replacing the physician quarantine shall be given   equivalent security.
 4.5 Sampling: These shall normally be a separate sampling area for   starting  materials. If sampling is to be performed in the storage area,   it shall be  provided for the storage of rejected, recalled, or   returned materials, or  products.
 4.6 Rejected Materials: Segregation in a separate area shall be provided   for  the storage of rejected, recalled, or returned materials or   products.
 4.7 Special Materials : Highly active materials, narcotics, other   dangerous  drugs, and substances presenting special risks of abuse ,   fire or explosion  shall be stored in safe an secure areas.
 4.8 Packaging Materials : Printed packing materials are considered   critical to  the conformity of the pharmaceutical product to its   labeling, and special  attention shall paid to safe and secure storage   of these materials .
 4.9 Weighing Area : The weighing of starting materials on the basis of    estimation of yield shall be carried out in separate weighing areas   designed  for that use with provisions for dust control. Separate   provisions shall be  made for materials posing high risks of   contamination, like steroids and  antibiotics especially penicillin.
 5. Production Department.
 5.1 General Facilities : A Production Department shall be provide which   shall  have all necessary facilities including:-
 (i) adequate number of appropriately qualified and trained technical   personnel;
 (ii) adequate and properly planned areas;
 (iii) suitable equipment, instruments and containers for manufacture   including  their validation where necessary;
 (iv) Clearly defined manufacturing processes shown to be capable of    consistently manufacturing pharmaceutical products of the required   quality and  complying with their specifications;
 (v) validated critical steps of manufacturing processes;
 (vi) Procedure and instructions for working approval by the Quality   Control  Department;
 (vii) suitable storage places for in process materials;
 (viii) adequate number of technically trained and skilled personnel and    equipment for in-process controls;
 (ix) skilled operations trained to carry out procedures correctly, the   record  of training should be available; and
 (x) appropriate air handling system to avoid contamination and cross    contamination.
 5.2 Dedicated facilities for production.
 Dedicated and self-contained facilities for the production of particular   drugs  shall be provide in addition to the general facilities such as   highly  sanitizing materials (e.g., penicillin) or biological   preparations (e.g., love  microorganisms) or cytotoxic substances or   radiopharmaceutical or veterinary  immunological preparations or sterile   products or for that matter such other  highly active pharmaceutical   products, antibiotics, hormones as may be identifies by the Central   Licensing Board at any stage in order to minimize the  risk of a serious   medical hazard due to cross contamination. Veterinary  products   containing ingredients similar to those used for human health and of    the same quality can be manufactured in the same premises use for   manufactured  of pharmaceutical products, however, simultaneously human   drugs shall not be  manufactured. Non-pharmaceutical products, technical   poisons, such as  pesticides shall not be manufactured.   Non-Pharmaceutical products , however ,  simultaneously human drugs   shall not be manufactured in the same premises  already use for the   manufacture of pharmaceutical products. In exceptional  cases of   emergency, the principle of campaign working in the same facilities  may   be allowed by the Central Licensing Board provided that specific    precautions are taken and the necessary validations are made.
 5.3 General  requirements for production areas.
 (i) Layout: The production area shall be laid out in such a way as to   allow the  production to take place in areas connected in a logical   order corresponding to  the sequence of the operations and to the   requisite cleanliness levels.
 (ii) Adequacy : The adequacy of the working and in process storage space   shall  permit the orderly and logical placement of equipment and   materials so as to  minimize the risk of confusion between different   pharmaceutical products or  their components, to avoid cross   contamination, and to minimize the risk of  omission error or working   application of any of the manufacturing or control  steps.
 (iii) Surfaces : Starting and primary packaging materials and intermediate or  bulk products are exposed to the environment, interior   surfaces (walls, floors,  and ceilings) shall be smooth and free from   cracks and open joints shall not  shed particulate matter, and shall   permit easy effective cleaning and , if  inaccessible, disinfection.
 (iv) Services : Pipe work, light fittings, ventilation points and other    services shall be designed and sided to avoid the creation of recesses   that are  difficult to clean. As far as possible, for maintenance   purposes, they shall be  accessible from outside the manufacturing   areas.
 (v) Drains : Drains shall be of adequate size and equipped to prevent    back-flow. Open. Channels shall be avoided.
 (vi) Environmental Controls : Production areas shall be effectively   ventilated,  with air-control facilities (including control of   temperature and, where  necessary, humidity and filtration ) appropriate   to the products handled to the  operations undertaken, and to the   external environment. These areas shall be  regulatory monitored during   production and non-production periods to ensure compliance with design   specifications.
 (vi) Packaging : Area (s) for the packing of pharmaceutical products   shall be  specifically designed and laid out so as to avoid mix-ups or   cross  contamination.
 (vii) Light :Production areas shall be well lit, particularly where   visual  on-line controls are carried out.
 
 6. Ancillary areas.
 6.1 Rest rooms : Rest and refreshment rooms shall be separate from other   areas.
 6.2 Changing rooms : Facilities shall be provided for changing and   storing  clothes and for washing and toilet purposes which shall be   easily accessible  and appropriate for the number of users. Toilets   shall not communicate directly  with production or storage areas.
 6.3 Workshop : Maintenance workshop shall perfectly be separated from    production areas. Whenever parts and tools are stored in the production   area,  they shall be kept in rooms or lockers reserved for that use.
 6.4 Animal houses :Animal houses shall be well isolated from other   areas, with  separate entrance (animal access) and air-handing facilities.
 
 
 SECTION – 2EQUIPMENT FOR PRODUCTION 
 2.1 General: The all  necessary equipment shall be provided which shall   be so designed, constructed,  located installed and maintained as to   suit the operation to be carried out,  and the layout and design of   equipment must aim to minimize the risk of errors  and permit effective   cleaning and maintenance in order to avoid cross-contamination,   build-up of dust or dirt, and, in general, any adverse  effect on the   quality of products.
 2.2 Layout: The  equipment shall be so laid that: -
 (a) Permits it to  function in accordance with its intended use. Parts   in contact with raw  material, in-process materials, or drugs are   accessible to cleaning or are  removable;
 (b) Permits cleaning of adjacent areas and does not interfere with other    processing operations, and it also minimizes circulation of personnel   and  optimizes flow of material;
 (c) Prevents the contamination of drugs by other drugs, by dust, and by   foreign  material such as rust, lubricant, and particles coming from the   equipment; and
 (d) The base of immovable equipment is adequately sealed along points of    contact with their floor.
 
 2.3 Construction: The equipment shall be so constructed that it does not   add  extraneous material to the drug and for that;
 
 (a) the surfaces that come in contact with raw materials, in-process   materials,  or drugs are smooth and are made of material that is   non-toxic, corrosion  resistant, non-reactive to the drug being   manufactured, and capable of with  standing repeated cleaning or sanitizing;
 
 (b) The design is such that the possibility of a lubricant or other   maintenance  material contaminating the drug is minimum;
 (c) wooden equipment  and equipment made of material that is prone to   shed particles or to harbor  bacteria do not come in contact or   contaminate raw material, in- process  materials, or drugs; and
 
 (d) Chain drives and transmission gears are enclosed or properly   covered.
 2.4 Pining: All service  piping and devices shall be clearly labeled to   indicate the contents and, where  applicable, the direction of flow and   special attention is paid to the  provision of non-interchangeable   connection or adopter for dangerous gases and liquids.
 2.5 Tanks: Tanks used in processing liquids and ointments are equipped   with  fittings that can be dismantled and cleaned and are provided with   appropriate  covers.
 2.6 Filters: Filter  assemblies are designed for easy dismantling.
 2.7 Cleaning equipment:  Washing and cleaning equipment shall be   provided which shall not be a source of  contamination.
 2.8 Defective equipment:  Defective equipment shall, if possible, be   removed form production and quality  control areas, at least, be clearly   labeled as defective.
 
 SECTION – 3QUALITY CONTROL DEPARTMENT
  3.1 General: The  Quality Control Department shall be independent with   adequate number of trained  personnel and under the authority of a   person who shall be a full time  employee.
 3.2 Laboratories:  Adequate laboratory facilities shall be provided with   necessary equipment and  instrument, glassware, chemicals, reagents   etc. suited to testing procedures of  drugs to be manufactured.
 3.3 Area: The quality  control laboratories shall have adequate areas   which shall : -
 (i) Be separated from  production areas, and the areas where biological,   microbiological or  radioisotope test methods are employed shall be   separated from each other;
 (ii) Be designed to  suit the operations to be carried out in them and   sufficient space shall be  given to avoid mix-ups and cross-contamination;
 (iii) be so designed so  that it takes into account the suitability of   construction materials, fume  prevention and ventilation and separate   air handling units and other  requirements shall be provided for   biological, microbiological, sterility  testing and radioisotope   laboratories;
 
 (iv) have separate room for highly sensitive instruments to protect   these  against electrical interference, vibrations, contact with   excessive moisture  and other external factors or where there is need to   isolate the instrument;  and
 (v) Have appropriate  facilities to store samples and records.
  3.4 Facilities: The  quality   control laboratory shall have;
 (i) Satisfactory  equipment required for test and analysis of drugs intended to be manufactured,  protocols for test and analysis of drugs to be manufactured including their  validation where necessary;
 (ii) have adequate  other facilities and approved procedures for sampling, inspecting and testing  starting materials, packaging materials, intermediate, bulk, and finished  products, and where applicable for monitoring environmental conditions for good manufacturing practice purposes;
 (iii) Written  procedures specifically: -
 (a) Validation of  methods of manufacture and   quality control testing;
 
 (b) Validation of equipment and instruments and   cleaning procedures;
 (c) Stability testing  of the active   pharmaceutical substances and the finished drugs; and
 (d) Determining the  shelf life of both raw   materials and finished drugs.
 
 (vi) Validations studies conducted for important equipment or instruments,  methods of manufacture and quality control and cleaning procedures in  accordance with predefined protocols. A written report summarizing results and  conclusions shall be available.
 
 (vii) Separate facilities for the bulk storage of   volatile and inflammable  materials.
 
 SECTION – 4DOCUMENTATION
  4.1 General: The documents  shall: -
 (i) be designed and  prepared, complying with the   relevant parts of the drug registration approvals.
 (ii) be approved,  signed, and dated by   appropriate authorized persons and shall not be changed  without   authorization.
 
 (iii) have unambiguous contents and shall clearly state the title, nature, and  purpose, and they shall be laid out in an orderly fashion and be easy to check,  reproduced documents shall be clear and legible.
 4.2 Specifications and  Testing Procedures:   Following document shall be available:-
 (i) Reference Bodies:  Pharmacopoeias, reference standards, reference spectra, and other reference  materials, where necessary.
 (ii) Testing  Procedures: Validated testing procedures in the context of available facilities  and equipment.
 (iii) Specifications:  Appropriately authorized   and dated specifications, including tests on identity,  content, purity, and quality, for starting and packaging material and finished products; and where appropriate, for intermediate or bulk products. Specifications for water, solvents, and reagents (e.g. acids and bases) used in  production shall also be included.
 4.3 Specifications for  Starting and Packaging Materials: Specifications for starting and primary or  printed packaging materials shall include, if applicable: -
 (i) the designated name  (if applicable, the International Non-proprietary Name) and internal code  reference;
 (ii) the reference, if  any, to a pharmacopoeia   monograph;
 (iii) qualitative and  quantitative requirements   with acceptance limits; and
 (iv) packaging material  shall conform to specifications, with emphasis placed on the compatibility of  the material with the drug product it contains.
 4.4 Specifications for  Finished Products:
 Specification for finished products shall include:   -
 (i) the designated name  of the product and the   code reference where applicable;
 (ii) the designated  name(s) of the active ingredient(s) (if applicable, the International  Non-proprietary Name)
 (iii) the label claim  or the reference to the   formula.
 (iv) a description of  the dosage form;
 (v) directions for  sampling and testing or a   reference to procedures;
 (vi) the qualitative  and quantitative   requirements with acceptance limits;
 (vii) the storage  conditions and precautions   where applicable; and
 (viii) the shelf –  life.
 4.5 Master formula: A  formally authorized master formula shall exist for each product and batch size  to be manufactured, which shall include;
 (i) the name of the  product, with a product   reference code relating to its specifications;
 (ii) a description of  the dosage form, strength   of the product, and batch size; specifications;
 (iii) a list of all  starting materials to be used (If applicable, with the International  Non-proprietary Name), with the amount of each described, using the designated  name and a reference that is unique to that material (mention shall be made of  any substance   that may disappear in the course of processing) and a reference  number   that may disappear in the course of processing) and a reference number    or code number to its quality control testing.
 (iv) a statement of the expected final yield with the acceptance limits, and of  relevant intermediate yields where applicable;
 (v) a statement of the processing location and the   principal equipment to be  used;
 (vi) detailed step-wise processing instructions (e.g. checks on materials,  pretreatment, sequence for adding materials, mixing times, temperatures);
 (vii) the instructions for any in-process controls   with their limits;
 (viii) where necessary, the requirements for   storage of the products, including  the container, the labeling, and any special storage conditions; and
 (ix) any special precautions to be observed.
 4.6 Packaging  Instructions: Formally authorized packaging instructions shall exist for each  product, pack size, and type which shall normally include, or made reference to
 (i) the name of the  product;
 (ii) a description of its pharmaceutical for,   strength and method of  application where applicable;
 (iii) the pack size expressed in terms of the number, weight, or volume of the  product in the final container;
 (iv) a complete list of all the packaging   materials required for a standard  batch size, including quantities,   sizes, and types, with the code or reference  number relating to the specifications for each packaging materials;
 (v) where appropriate, an example or reproduction   of the relevant printed  packaging materials and specimens, indicating where the batch number and expiry  date of the product have been marked;
 (vi) special precautions to be observed, including   a careful examination of the  packaging area and equipment in order to ascertain the line clearance before  operations being;
 (vii) a description of the packaging operations, including any significant  subsidiary operations, and equipment to be used; and
 (viii) details of in-process controls with   instructions for sampling and  acceptance limits.
 4.7 Standard Operating  Procedures and Records.   There shall be standard operating procedures for : -
 (i) the receipt of each  delivery of starting   material and primary and printed packaging material;
 (ii) the international labeling, quarantine, and storage of starting materials,  packaging materials, and other materials, as appropriate;
 (iii) each instrument and piece of equipment.   These shall be placed in close  proximity to the equipment;
 (iv) sampling, which specify the person(s) authorized to take samples, and the  sampling instructions shall included;
 (a) the method of  sampling and the sampling plan;
 (b) the equipment to be used;
 (c) any precautions to be observed to avoid contamination of the material or  any deterioration in its quality;
 (d) the amount of sample to be taken;
 (e) instructions for any required sub-division of   the samples;
 (f) the type of sample container to be used, and whether they are for aseptic  sampling or for normal sampling; and
 (g) any specific precautions to be observed, especially in regard to the  sampling of sterile or noxious material;
 (v) describing the  details of the batch (lot) numbering system, with the objective of ensuring  that each batch of intermediate, bulk, or finished product is identified with a  specific batch number;
 (vi) for batch numbering that are applied to the processing stage and to the  respective packaging stage shall be related to each other;
 (vii) for batch numbering shall assure that the   same batch numbers will not be  repeatedly used; this applies also to reprocessing.
 4.8 There shall be  written procedures for testing materials and products at different stage of  manufacture, describing the methods and equipment to be used. The tests  performed shall be recorded and shall include: -
 (a) name of the  material or drug and, where   applicable, dosage form;
 (b) batch number and, where appropriate, the   manufacturer and /or supplier;
 (c) references to the relevant specifications and   testing procedures;
 (d) test results, including observations and   calculations, and reference to any  specifications (limits);
 (e) dates of testing;
 (f) initials of the persons who performed the   testing;
 (g) initials of the persons who verified the   testing and the calculations.  Where appropriate;
 (h) a clear statement of release or rejection and   the dated signature of the  designated responsible person.
 4.9 There shall be  written procedures assigning responsibility for sanitation and describing in  sufficient detail the cleaning schedules, methods, equipment, and materials to  be used and facilities to be cleared and such written procedures shall be followed.
 4.10 Written standard operating procedures and the associated records of  actions taken shall be available, for: -
 (a) equipment assembly  and validation;
 (b) analytical apparatus and calibration;
 (c) maintenance, cleaning and sanitization;
 (d) personnel matters including qualifications,   training, clothing, hygiene;
 (e) environmental monitoring;
 (f) pest control;
 (g) complaints;
 (h) recalls;
 (i) returns;
 4.11 Labels:
 4.11.1 Labels firmly  affixed or security attached to containers, equipment or working areas shall be  clear and unambiguous and shall indicate the status like “quarantined”  “accepted” “rejected” “clean”, etc.
 
 4.11.2 All finished drugs shall be labeled in accordance with the approval of  Registration Board and with at least the following information: -
 a) the name of the  drug;
 b) a list of the active ingredients, showing the amount of each present, and a  statement of the net contents, e.g. number of dosage units, weight or volume;
 c) the batch number assigned by the manufacturer;
 d) the expiry date;
 e) any special storage conditions or handling   precautions that my be necessary;
 f) direction for use, and warnings and precautions   that may be necessary; and
 g) the name and address of the manufacturer or the company or the person  responsible for placing the drug on the market.
 4.11.3 The label or  accompanying document of reference standards shall indicate concentration, date  of manufacture, expiry date, date the closure is first opened and storage  conditions, where appropriate.
 4.12 Batch Processing Records:
 4.12.1 A Batch  Processing Record shall be maintained for each batch processed. It shall be  based on the relevant portions of the approved Master Formula and Processing  Instructions.
 4.12.2 Before starting any processing a check   shall be performed and recorded  that the equipment and work station are clear of previous products, documents  or materials not required for the planned process, and that equipment is clean  and suitable for use.
 4.12.3 During processing, the following   information shall be recorded and,  after completion, the record shall   be dated and signed in agreement by the  person responsible for the   processing operations:
 a) the name of the  drug;
 b) the number of the batch being manufactured;
 c) dates and time of commencement of significant   intermediate stage and of  completion of production;
 d) initials of the operator of different   significant steps of production and  where appropriate, of the person   who checked each of these operations (e.g.  weighing);
 e) the batch number and / or analytical control number as well as the  quantities of each starting material actually weighed (including the batch  number and amount of any recovered or reprocessed material added);
 f) any relevant processing operation or event and   major equipment used;
 g) a record of the in-process controls and the initials of the person(s)  carrying them out, and the results obtained;
 h) the amount of drug obtained at different stages of manufacture (yield)  explaining any significant deviations fro the expected yield;
 i) notes on special problems including details,   with signed authorization, for  nay deviation from the Master Formula.
 
 SECTION – 5SANITATION AND HYGIENE
  5.1 Sanitation: A written sanitation program shall be   available which  will include instructions on the sanitary production   of drugs and the handling  of materials used in the production of drugs   and, in particular, indicating the  following cleaning procedures for   the premised and the equipment used in the  production of drug, namely: -
 (i) cleaning  requirements applicable to all production areas of the plant, with emphasis on  manufacturing areas that require special attention;
 (ii) cleaning requirements applicable to   processing equipment;
 (iii) cleaning intervals;
 (iv) cleaning materials, their concentration, and   the equipment to bused;
 (v) responsibilities of outside contractors, if   any;
 (vi) disposal procedures for waste material and   debris;
 (vii) pest control measures;
 (viii) precautions required to prevent   contamination of a drug when  rodenticides, insecticides, and fumigation   agents are used;
 (ix) microbial and environmental monitoring procedures and limits in areas  where susceptible products are manufactured; and
 (x) the personnel responsible for carrying out   cleaning procedures.
 5.2. Hygiene:
 5.2.1 Minimum  requirements of health, hygienic behavior and clothing for personnel shall be  available in writing in order to ensure the clean and sanitary production of  the drug.
 5.2.2 No person who is affected with or is a   carrier of a disease in a  communicable for, or has an open lesion on   any exposed surface of the body  shall be employed for areas where a   drug during any stage of its production is  exposed.
 5.2.3 Minimum requirements of health shall be   available in in writing and shall  provide for : -
 (j) pre-employment  medical examination;
 (ii) assessment of an employee’s health prior to return to his place of  employment following illness involving a communicable disease;
 (iii) action to be taken in the event of a   positive diagnosis or a case  suspected of being hazardous to consumers   of the products; and
 (iv) routine supervisory check system of   employees.
 5.2.4 The hygiene  program shall clearly define clothing requirements and hygiene procedures for  company personnel and visitors including the following : -
 (i) Where a potential  for the contamination of a raw material, in-process material, or drug exists,  individuals shall wear clean clothing and protective covering.
 (ii) Eating, smoking, or any unhygienic practice   shall not be permitted in  production areas.
 (iii) Requirements concerning personal hygiene,   with emphasis on hand hygiene.
 (iv) Requirements concerning cosmetics and jewelry   worn by employees.
 B in clause (c), in  sub-clause (i) : -
 
 (a) for the words “ twelve months” the words   “three years” shall be  substituted; and
 (b) for the word “drug” the words “type of drugs   to be manufactured” shall be  substituted; and
 C in clause (e), for  the words “sufficient experience in testing of drugs” the words “three years  experience in testing of types of drugs intended to be manufactured” shall be substituted;
 
 III. in rule 20, in clause (a), for the “Schedule B II” the following new  Schedule B II shall be substituted, namely : -
 
 SCHEDULE B-II
 GOOD MANUFACTURING PRACTICES (GMPS) FOR  LICENSE TO   MANUFACTURE BY WAY OF FROMULATION
 CONTENTS
 PART – I
 GENERAL CONDITIONS 
 SECTION – I                  1 Responsibility of  licensee for drugs fitness   for use
 SECTION – 2                   2. Quality assurance system
 SECTION – 3                    3. Quality control
 3.1 Quality Control  Department
 3.2 Basic requirements
 3.3 Control procedures.
 3.1 General
 3.3.2 Sampling
 3.3.3 Test requirement for starting and packaging   materials
 3.3.4 Test requirement for in-process controls
 3.3.5 Test Requirement for Finished Products
 3.3.6 Production record/batch review
 3.3.7 Stability studies
 3.4 Self inspection
 3.4.1 General
 3.4.2 Items for self inspection
 3.4.3 Self inspection team
 3.4.4 Frequency of self inspection
 3.4.5 Self inspection report
 3.5 Quality Audit
 3.5.1 Audit by independent specialist
 3.5.2 Supplier’s audits
 3.5 Complaints
 3.6.1 Review of complaints
 3.6.2 Person authorized
 3.6.3 Written procedures
 3.6.4 Recording defects and investigation
 3.6.5 Investigation
 3.6.6 Follow-up action
 3.6.7 Recording measures
 3.6.8 Review for Reviewing Problem
 3.7 Product recalls
 3.7.1 System
 3.7.2 Authorized person
 3.7.3 Written procedures
 3.7.4 Recall with promptness
 3.7.5 Distribution records
 3.7.6 Recording and progress
 3.7.7 Evaluation
 3.7.8 Storage of recalled drugs
 3.7.9 All concerned to be informed
 SECTION – 4                    4. Personnel
 4.1 General
 4.2 Written duties
 4.3 GMP awareness
 4.4 Prohibition of unauthorized person
 4.5 Duties of Heads of Departments
 4.6 Duties of Production Incharges
 4.7 Duties of Quality Control Incharges
 4.8 Training
 4.8.1 Written programme
 4.8.2 Training appropriate to duties
 4.8.3 Specific training
 4.8.4 Understanding concepts
 4.8.5 Visitor and untrained personnel discouraged
 4.9 Personal hygiene
 4.9.1 Health examination
 4.9.2 Practices in personal hygiene
 4.9.3 Illnesses
 4.9.4 Reporting health problems
 4.9.5 Avoiding direct contact with materials
 4.9.6 Appropriate clothing and covering
 4.9.7 Foods and drinks prohibited
 SECTION – 5GOOD PRACTICES IN MANUFACTURING PROCESSING                 5.1 General  responsibility of licensee
 SECTION – 6MATERIALS                    6.1 Material general
 6.1.1 Quarantine
 6.1.2 Appropriate storage
 6.2 Starting materials
 6.2.1 Purchase
 6.2.2 Purchase from producer or established   supplier
 6.2.3 Checking of containers
 6.2.4 Damaged container
 6.2.5 Delivery from different batches
 6.2.6 Labeling
 6.2.7 Identity of contents
 6.2.8 Released materials to be used
 6.2.9 Correct dispensing
 6.2.10 Checking
 6.2.11 Labeling
 6.3 Packaging materials
 6.3.1 Purchase
 6.3.2 Printed materials
 6.3.3 Reference numbers
 6.3.4 Obsolete materials
 6.3.5 Checking before delivery
 6.4 Intermediate and bulk products
 6.4.1 Storage
 6.4.2 Handling
 6.5 Finished pharmaceutical products
 6.5.1 Quarantine
 6.5.2 Release
 6.6 Rejected and recovered materials
 6.6.1 Storage and disposal
 6.6.2 Reprocessing
 6.6.3 Batch recovers
 6.6.4 Additional testing of reprocessed material
 6.7 Recalled and returned products
 6.7.1 Recalled products
 6.7.2 Returned goods
 6.8 Reagents and culture media
 6.9 Reference standards
 6.9.1 Testing prepared reference standard
 6.9.2 Use
 6.9.3 Working standards
 6.9.4 Storage
 6.10 Waste materials
 6.10.1 Storage
 6.10.2 Disposal
 6.11 Miscellaneous
 SECTION – 7
 7.1 Processing operations
 7.1.1 General
 7.1.2 Material handling
 7.1.3 Avoiding deviation
 7.1.4 Yield checks
 7.1.5 Avoiding mix-ups
 7.1.6 Labeling
 7.1.7 Unauthorized entry prohibited
 7.1.8 In price controls
 7.2 Prevention of cross-contamination and   bacterial
 Contamination in production
 7.2.1 Precautions against dust
 7.2.2 Measures against contamination
 7.2.3 Cross contamination checks
 7.2.4 Microbiological monitory
 7.3 Processing operations intermediate and bulk
 Products
 7.3.1 Pre-Processing cleanliness checks
 7.3.2 In-process controls
 7.3.3 Defective equipment
 7.3.4 Cleaning containers
 7.3.5 Yield deviations
 7.3.6 Product pipelines
 7.3.7 Water pipes
 7.3.8 Equipment calibration
 7.3.9 Repair or maintenance
  7.4 Packaging  operations
 7.4.1 Avoiding mix-ups
 7.4.2 Pre-packaging checks
 7.4.3 Labeling packaging line
 7.4.4 Process continuity
 7.4.5 Printing operation checks
 7.4.6 Label verification
 7.4.7 Resistant printing on labels
 7.4.8 On-line packaging checks
 7.4.9 Product re-introduction on packaging line
 7.4.10 Discrepancies to be investigated
 7.4.11 Destruction of un-used packaging materials

 SECTION – 8
 
Sanitation and hygiene
 
SECTION – 9
 
Validation
 9.1 General
 9.2 Process validation
 9.2.1 Validation of critical processes
 9.2.2 Validation of new master formula
 9.2.3 Validation of equipment or materials
 
 SECTION – 10
 
                  10.1 Documents
 10.1.1 Maintenance of documents
 10.1.2 Recording actions
 10.1.3 Documentation system
 10.1.4 Status identification
 10.1.5 Product labeling
 10.1.6 Reference standards identification
 10.1.7 Specification approvals
 10.1.8 Revision of specification
 10.1.9 Packaging material specification
 10.1.10 Starting material re-assay
 10.2 Specification for intermediate and bulk products
 10.3 Batch processing records
 10.3.1 General
 10.3.2 Checking work station
 10.3.3 Recording process operation
 10.4 Batch packaging  records
 10.4.1 General
 10.4.2 Pre-packaging line checks
 10.4.3 Recording packaging Operation
 10.4.4 Recording packaging batch numbers
 10.4.5 Analytical records
 10.4.6 Finished product release procedure
 10.4.7 Recording batch distribution
 10.4.8 Standard operating procedures
 10.4.9 Equipment logbooks
 10.4.10 Equipment utilization records
 
PART – II
 ADDITIONAL CONDITIONS FRO MANUFACTURE  OF STERILE PRODUCT
 SECTION -1
 
                  General
 1.1 Air Classification System for manufacture of sterile products
 Manufacture of sterile  preparations
 2.1 manufacturing operations
 2.2 Terminally sterilized products
 2.3 Products sterilized by filtration
 2.4 Products manufactured under aseptic conditions
 3 Personnel
 3.1 General
 3.2 Personnel training
 3.3 Entry restricted
 3.4 Hygiene and cleanliness
 3.5 Use of protective garments
 3.6 Clothing requirements
 3.7 Protective garments in grade B room
 3.8 Washing of clothing
 3.9 Prohibitions
 
SECTION – 2
 
                  4 Maintenance of clean area
 4.1 General
 4.2 Airlock system
 4.3 Air supply system
 4.4 Maintenance of equipment
 4.5 Water supply
 
SECTION – 3
 
                  5 Equipment maintenance
 5.1 Documentation
 
SECTION – 4
 
                  6 Sanitation
 6.1 Procedure
 6.2 Use of disinfectants and detergents
 6.3 Fumigation
 6.4 Monitoring of clean areas
 
SECTION – 5
 
                  7 Processing
 7.1 Precautions against contamination
 7.2 Preparation of live organisms
 7.3 Simulation of aseptic operations validation
 7.4 Monitoring water supply sources
 7.5 Activities in clean areas kept minimum
 7.6 Care of stating materials
 7.7 Care against fibers
 7.8 Care after final cleaning of materials
 7.9 Interval between operations to be minimal
 7.10 Sterilization of gases used
 7.11 Disburden to be minimal
 7.12 Asepsis of articles in clean areas
 7.13 New processes to be validated
 
SECTION – 6
 
                  8 Sterilization
 8.1 General
 8.2 Validation
 8.3 Suitability of process
 8.4 Care for biological indicates
 8.5 Sterilized non-sterilized products
 9 Sterilization by heat
 9.1 Recording sterilization cycle
 9.2 Sufficient time allowed to reach required temperature
 9.3 Precautions drugging cooling
 10 Sterilization by moist heat
 10.1 General
 10.2 Wrapping materials
 11 Sterilization by dry heat
 12 Sterilization by radiation
 12.1 General
 12.2 Outside contractor
 12.3 Measurement of radiation
 12.4 Validation
 12.5 Handling procedures
 13 Sterilization by ethylene oxide
 13.1 General
 13.2 Ensure contact between gas and microbial cells
 13.3 Equilibrium with humidity and temperature
 13.4 Monitoring each cycle
 13.5 Biological indicators
 13.6 Record maintenance
 13.7 Validation
 14 Filtration of pharmaceutical products that can not
 Be sterilized in the final container
 14.1 General
 14.2 Using double filter layer
 14.3 Eliminate fibers
 14.4 Checking integrity of filters
 14.5 Frequency of use of filter
 14.6 Filter safety
 15 Finishing of sterile products
 15.1 General
 15.2 Use of vacuum
 15.3 Inspection of containers
 16 Quality control
 16.1 Sterility testing
 16.2 Sterility test as the last measures
 16.3 Monitoring end toxin
 SCHEDULE –II
  GOOD MANUFACTURING  PRACTICES (GMPS) FOR LICENSE TO
 MANUFACTURE BY WAY OF FROMULATION
  PART – I
 GENERAL CONDITIONS  SECTION – 1 
 1. Responsibility of licensee  for drug’s fitness for use.
 The licensee shall  assume the responsibility for the quality of the   furs manufactured by it to  ensure that they are fit for their intended   use, comply with the requirements  of the Ordinance and rules made there   under and do not place patients at risk  due to inadequate safety,   quality or efficacy. To achieve the quality objective  reliably, there   shall be a comprehensively designed and correctly implemented  system of   quality assurance incorporating good manufacturing practices nod    quality control. It shall be fully documented and its effectiveness   monitored.  All parts of the quality assurance system shall be   adequately staff with  competent personnel and shall have suitable and   sufficient premises, equipment,  and facilities.
 
 SECTION – 2
 
 2. Quality assurance system.
 The licensee shall have a system of quality assurance appropriate to   the  manufacture of drugs which shall ensure that: -
 (a) drugs are designed  and developed in a way that takes into account   the requirements of good  manufacturing practices and other associated   codes as may be notified form time  to time;
 (b) production and control operations are clearly specified in a   written form  and good manufacturing practices requirements are adopted   and followed;
 (c) managerial responsibilities are clearly specified in job   description;
 (d) arrangements are made for the manufacture, supply, and use of the   correct  starting and packaging materials;
 (e) all necessary controls on starting materials, intermediate   products, and  bulk products and other in process controls, calibrations   and validations are  carried out;
 (f) the finished products are correctly processed and checked,   according to the  defined procedures;
 (g) finished drugs are not sold or supplied before the authorized   person(s) has  certified that each production batch has been produced   and controlled in  accordance with the requirements of the good   manufacturing practices and the  relevant rules made under the Ordinance   relevant to the production, control and  release of drugs as well as of   conditions of registration;
 (h) satisfactory arrangements exist to store in appropriate storage   conditions;
 (i) there is a procedure for self inspection and or quality audit at    appropriate intervals that regularly reviews the effectiveness and    applicability of the quality assurance system and that such a procedure   is  followed; and
 (j) a system exist in the form of written Standard Operating   Procedures  according to which complaints about marketed products are   examined, the causes  of quality defects investigated, and appropriate   measure taken in respect of  the defective products and to prevent   recurrence and that system is followed.
 
 SECTION – 3
 
 3. Quality control.
 3.1. Quality control  department: The licensee shall maintain and   satisfactory run its quality  control department which is independent of   other departments and under the  authority of a person with the   required qualifications and experience and with  adequate facilities to   ensure that all the quality control arrangements are effectively and   reliably carried out.
 3.2. Basic requirements: The basic requirements to be met for quality   control  shall be as follows: -
 (a) During the period of validity of license, adequate facilities,   trained  personnel and approved procedures are available for sampling,   inspecting, and  testing stating materials, packaging materials, and   intermediate, bulk, and  finished products, and where appropriate for   monitoring environmental  conditions for good manufacturing practices   purposes;
 (b) Samples of starting materials, packaging materials, intermediate   products,  bulk products and finished products are taken by methods and   personnel approved  of by the quality control department;
 (c) Test methods are validated;
 (d) Records are made manually and or by recording instruments   demonstrating  that all the required sampling, inspecting, and testing   procedures have  actually been carried out and that any deviation has   been fully recorded and  investigated;
 (e) The finished products contain ingredients complying with the   qualitative  and authorization, the ingredients shall be of the required   purity, in their  proper container, and correctly labeled;
 (f) Record are made of the results of inspecting and testing materials   and  intermediate, buck, and finished precuts against specification and   product  documentation and an assessment of deviations from specified   procedures;
 (g) No batch of product is released for sale prior to certification by   the  authorized person(s) that it is in accordance with the   requirements of the  rules;
 (h) Sufficient samples of starting materials and products are retained   to  permit future examination of the product if necessary and the   retained product  is kept in its final pack unless the pack is   exceptionally large; and
 (i) All quality control procedures are established, validated and   implemented;  the reference standard for substances are evaluated,   maintained, and stored,  correct labeling of containers of materials and   product is ensured; the  stability of the active pharmaceutical   ingredients and products is monitored,  complaints related to the   quality of the product are investigated and environmental monitoring is   conducted. All these operations shall be carried  out in accordance   with written procedures and where necessary, recorded,  provided that   the Central Licensing Board may allow other arrangements if it is    considered so necessary for an effective quality control system of the    licensee.
 3.3 Control Procedures.
 3.3.1 General: All tests and analysis and analysis conducted shall be   in  accordance with the instructions given in the relevant written test   procedures.  The result shall be checked by the supervisor before the   material or product is  released or rejected.
 3.3.2 Sampling: The samples shall: -
 (a) be representative of the batches of material from which they are   taken and  in accordance with approved written procedure;
 (b) be taken in a manner so as to avoid contamination or other adverse   effects  on quality, and the containers that have been sampled shall be   marked  accordingly and carefully resealed after sampling;
 (c) be taken with care to guard against contamination or mix-up of, or   by, the  material being sampled, all sampling equipment that comes into   contact with the  material shall be clean, and some particularly   hazardous or potent materials  may require special precautions;
 (d) be taken with equipment which shall be cleaned and, if necessary,    sterilized before and after each use and stored separately from other    laboratory equipment; and
 (e) bear a label indication: -
 (i) the name of the sampled material;
 (ii) the batch or lot number;
 (iii) identify the container from which the sample has been taken
 (iv) the signature of the person who has taken the sample; and
 (v) the date of sampling.
 3.3.3 Testing requirement for starting and packaging materials.
 (i) Test before use: Before releasing a starting or packaging material   for use,  the quality control manager shall ensure that the materials   have been tested  for conformity with specifications for identity,   strength, purity, and other  quality parameters.
 (ii) Identity from each container: An identity test shall be conducted   on a  sample from each container of starting material.
 (iii) Examination of each batch: Each batch (lot) of printed packaging    materials shall be examined following receipt.
 3.3.4 Test requirement  for in-process controls.
 Records of testing: In-process control records shall be maintained and   form a  par------ of the batch records.
 
 3.3.5 Test requirements for finished products:
 (i) Testing each batch: For each batch of drug product, there shall be   an appropriate  laboratory determination of satisfactory conformity to   its finished product  specifications prior to release.
 (ii) Rejection of failed products: Products failing to meet the   established  specifications or any other relevant quality criteria may   be revalidated and  shall be rejected if they do not qualify   revalidation protocols.
 (iii) Reprocessing: Reprocessing may be performed, if feasible, but   the  reprocessed product shall meet all specifications and other quality   criteria  prior to its acceptance and release.
 3.3.6 Production record and batch review.
 (i) Review of Records: Production and control records shall be   reviewed and any  divergence or failure of a batch to meet its   specifications shall be thoroughly  investigated, the investigation   shall, if necessary, extend to other batches of  the same product and   other products that may have been associated with the specific failure   or discrepancy, and a written record of the investigation  shall be made   and shall include the conculsio0n and details of follow-up  action.
 (ii) Retention of  Samples: Retention samples from each batch of   finished product shall be kept  for at least one year after the expiry   date. Finished products shall usually be  kept in their final packaging   and stored under the recommended conditions. If exceptionally large   packages are produced, smaller samples might be stored in  appropriate   container. Samples of active starting materials shall be retained  for   five years. Other starting materials (other than solvents, gases, and    water) shall be retained for minimum of two years if their stability   allows;  Retention samples of materials and products shall be of a size   sufficient to  permit at least tow full re-examinations.
 3.3.7 Stability studies:
 (i) The quality control department shall: -
 (a) evaluate the quality and stability of finished pharmaceutical   products and,  of starting materials and intermediate products; and
 (b) establish expiry dates and shelf-life specifications on the basis   of  stability tests related to storage conditions.
 (ii) A written program for ongoing stability determination shall be   developed  and implemented to include elements such as: -
 (a) a complete description of the drug involved in the study;
 (b) the complete testing parameters and methods describing all tests   for potency,  purity, and physical characteristics and documented   evidence that these test  indicate stability.
 (c) Provision for the inclusion of a sufficient number of batches;
 (d) The testing of each drug;
 (e) Provision for special storage conditions;
 (f) Provision for adequate sample retention; and
 (g) A summary of all the data generated, including the evaluation and   the  conclusions of the study.
 (iii) Stability of the finished product shall be evaluated and   documented prior  to marketing and following and significant changes in   the processes, equipment,  primary packaging materials, etc.
 3.4 Self-inspection:
 3.4.1 General: The  licensee shall conduct repeated self inspection   with a view to evaluate its own  compliance with good manufacturing   practices in all aspects of production and  quality control; The self   inspection program shall be designed to detect any shortcomings in the   implementation of good manufacturing practices and to  recommend the   necessary corrective actions; Self inspections shall be performed    routinely, and may be, in addition, performed on special occasions, e.g.   in the  case of product recalls or repeated rejections or when an   inspection by the  Central Licensing Board is required; The team   responsible for self inspection  shall consist of personnel who can   evaluate the implementation of good  manufacturing practices   objectively; all recommendations for corrective action shall be   implemented; The procedure for self-inspection shall be documented,  and   there shall be an effective follow-up program.
 3.4.2 Items for self inspection: Written instructions for self   inspection shall  be established to provide a minimum and uniform   standard of requirements and  shall include questionnaires on good   manufacturing practices requirements  covering at least the following   items, namely;
 (a) personnel;
 (b) premises including personnel facilities;
 (c) maintenance of buildings and equipment;
 (d) storage of starting materials and finished products;
 (e) equipment;
 (f) production and in-process controls;
 (g) quality control;
 (h) documentation;
 (i) sanitation and hygiene;
 (j) validation and verification programs;
 (k) calibration of instruments or measurement systems;
 (l) recall procedures;
 (m) complaints management;
 (n) labels control; and
 (o) results of previous self-inspections and any corrective steps   taken.
 3.4.3 Self-inspection team: Management shall appoint a self-inspection   team of  members from inside or outside the company who are expert in   the field of  inspection and familiar with good manufacturing practices.
 3.4.4 Frequency of self-inspection: The frequency at which   self-inspections are  conducted may depend on company requirements but   it shall be at least once  every year.
 3.4.5 Self-inspection report: A report shall be made at the completion   of  self-inspection which shall include: -
 (a) self-inspection results;
 (b) evaluation and conclusion; and
 (c) recommended corrective actions.
 
 3.4.6 Follow-up actions: The company management shall evaluate both   the  self-inspection report and the corrective actions as are necessary.
 3.5 Quality audit:
 3.5.1 Audit by independent specialist: It may be useful to supplement    self-inspection with a quality audit which consists of an examination   and  assessment of all or part of a quality system with the specific   purpose of  improving it; a quality audit is usually conducted by   outside or independent  specialists or a tem a designated by the   management for this purpose; such  audits may also be extended to   suppliers and contractors.
 3.5.2 Supplier’s audits: The quality control department shall have   responsibility  together with other relevant departments for approving   suppliers who can  reliably supply starting and packaging materials that   meet established  specifications.
 3.6 Complaints:
 3.6.1 Review of complaints: All complaints and other information   concerning  potentially defective products must be carefully reviewed   according to written  procedures.
 3.6.2 Person authorized: A person responsible for handling the   complaints and  deciding the measures to be taken shall be designated,   together with sufficient  supporting staff to assist him and if this   person is different from the  authorized person, the latter shall be   made aware of any complaint,  investigation, or recall.
 3.6.3 Written procedures: There shall be written procedures describing   the  action to be taken including the need to consider a recall, in the   case of a  complaint concerning a possible product defect.
 3.6.4 Recording defects and investigation: Any complaint concerning a   product  defect shall be recorded with all the original details and   thoroughly  investigated; The person responsible for quality control   shall normally be  involved in the study of such problems.
 3.6.5 Investigation: If a product defect is discovered or suspected in   a batch,  consideration shall be given to whether other batches shall   be checked in order  to determine whether they are also affected; in   particular, other batches that  may contain reprocessed product from the   defective batch shall be investigated.
 3.6.6 Follow up action: Where necessary, appropriate follow-up action,   possibly  including product recall, shall be taken after investigation   and evaluation of  the compliant.
 3.6.7 Recording measures: All the decisions and measures taken as a   result of a  complaint shall be recorded and referenced to the   corresponding batch record.
 3.6.8 Review for recurring problems: Complaint record shall be   regularly  reviewed for any indication of specific or recurring problems   that require  attention.
 3.7 Product recalls.
 3.7.1 System: There shall be a system to promptly and effectively   recall from  the market the products known or suspected to be defective.
 3.7.2 Authorized person: A person responsible for the execution and    coordination of recalls shall be designated, as well as sufficient staff   to  handle all aspects of the recalls with the appropriate degree of   urgency; this  person shall normally be independent of the sales and   marketing organization;  if this person is different from the authorized   person the latter shall be jade aware of any recall operation.
 3.7.3 Written procedures: There shall be established written   procedures,  regularly checked and updated for the organization of any   recall activity.  Recall operations shall be capable of being initiated   promptly at least down to  the level of the health institutions and all   sale channels including whole sale  and where possible retail sale and a   public notice if required.
 3.7.4 Recall with promptness: All competent authorities to whom a   given product  may have been distributed shall be promptly informed of   any intention to recall  the product because it is, or was suspected of   being, defective.
 3.7.5 Distribution records: The distribution records shall be readily   available  to the person(s) responsible for recalls, and they shall   contain sufficient  information on wholesalers and directly supplied   customers(including, for  exported products, those who have received   samples for clinical tests and  medical samples) to permit and effective   recall.
 3.7.6 Recording of progress: The progress of the recall process shall   be  recorded and a final report issued, including a reconciliation   between the  delivered and recovered quantities of the products.
 3.7.7 Evaluation: The effectiveness of the arrangements for recalls   shall be  evaluated from time to time.
 3.7.8 Storage of recalled drugs: An instruction shall be included to   store  recalled products in a secure segregated area while their fate is   decide.
 3.7.9 All concerned to be informed: The Central Licensing and   Registration  Boards and other concerned government authorities shall be   immediately informed  if it is intended to recall product(s) or if a   product has been recalled.  Effective system shall be maintained to   inform the doctors, pharmacists and  public of the recalled products.
 
 SECTION - 4 Personnel 
 4.1 General: The  licensee shall provide: -
 (a) sufficient qualified personnel to fulfill all its responsibilities   required  under these rules; and
 (b) organization chart.
 4.2 Written duties: All responsible staff shall have their specific   duties  recorded in written descriptions and adequate authority to carry   out their  responsibilities. There shall be no gaps or unexplained   overlaps in the  responsibilities of personnel concerned with the   application of good  manufacturing practices. Individual   responsibilities shall be clearly  understood by the individuals   concerned;
 4.3 Good manufacturing practices awareness: All personnel shall be   aware of the  principles of good manufacturing practices that affect   them and receive initial  and continuing training, including hygiene   instructions, relevant to their  needs.
 4.4 Prohibition of unauthorized persons: Steps shall be taken to   prevent  unauthorized people from entering production, storage, and   quality control  areas, and personnel who do not work in these areas   shall not use them as a  passageway.
 4.5 Duties of heads of departments: The heads of the production and   quality  control departments may have shared, or jointly exercised the   following  responsibilities relating to quality, namely: -
 (a) the authorization of written procedures and other documents,   including  amendments;
 (b) the monitoring and control of the manufacturing environment;
 (c) plant hygiene;
 (d) process validation and calibration of analytical apparatus;
 (e) training, including the application and principles of quality   assurance;
 (f) the approval and monitoring of suppliers of materials;
 (g) the approval and monitoring of contract manufacturers;
 (h) the designation and monitoring of storage conditions for materials   and  product;
 (i) the retention of records;
 (j) the monitoring of compliance with good manufacturing practices    requirements;
 (k) the inspection, investigation, and taking of samples in order to   monitor  factors that may affect product quality.
 4.6 Duties of production in charge: The head of the production   department may  have the following responsibilities, namely: -
 (a) to ensure that products are produced and stored according to the    appropriate documentation in order to obtain the required quality;
 (b) to approve the instructions relating to production operations   including the  in process controls, and to ensure their strict   implementation;
 (c) to ensure that the production records are evaluated and signed by a    designated person before they are made available to the quality   control  department;
 (d) to check the maintenance of the department, premises, and   equipment;
 (e) to ensure that the appropriate process validations and   calibrations of  control equipment are performed and recorded and the   reports made available;  and
 (f) to ensure that the required initial and continuing training of   production  personnel is carried out and adapted according to need.
 4.7 Training:
 4.8.1 Written programmed: The training shall be provided in accordance   with a  written program for all the personnel whose duties required   them to work in the  production areas, as the case may be, in the   control laboratories (including  the technical, maintenance, and   cleaning personnel), and for other personnel  whose activities could   affect the quality of the product.
 4.8.2 Training appropriate to duties: Besides basic training on the   theory and  practice of good manufacturing practices, newly recruited   personnel shall  receive training appropriate to the duties assigned to   them, continuing  training shall also be given, and its practical   effectiveness shall be  periodically assessed, training programs shall   be available, approved by the  head of either production or quality   control, as appropriate, and training  records shall be kept.
 4.8.3 Specific training: Personnel working in areas where   contamination is a  hazard, such as clean areas or areas where highly   active, toxic, infectious, or  sensitizing materials are handled, shall   be given specific training.
 4.8.4 Understanding concepts: The concept of quality assurance and all   the  measures capable of improving its understanding and implementation   shall be  fully discussed during the training sessions.
 4.8.5 Visitors or untrained personnel discouraged: Visitors or   untrained  personnel shall be discouraged entry into the production and   quality control  areas.
 4.9 Personal hygiene:
 4.9.1 Health examination: All personnel, prior to and during   employment, as may  be appropriate, shall undergo health examinations   and personnel conducting  visual inspections shall also undergo periodic   eye examinations.
 4.9.2 Practices in personal hygiene: All personnel shall be trained in   the practices  of personal hygiene, a high level of personal hygiene   shall be observed by all  those concerned with manufacturing processes,   personnel shall be instructed  particularly to wash their hands before   entering productions areas, and signs  to this effect shall be pasted   and instructions observed.
 4.9.3 Illnesses: Any person shown at any time to have an apparent   illness or  open lesions that may adversely affect the quality of   products shall not be  allowed to handle starting materials, packaging   materials, in process  materials, or drug products until the condition   is no longer judge to be a  risk.
 4.9.4 Reporting health problem: All employees shall be instructed and    encouraged to report to their immediate supervisor any conditions,   relating to  plant, equipment, or personnel, that they consider may   adversely affect the  products.]
 4.9.5 Avoiding direct contact with materials: Direct contact shall be   avoided  between the operator’s hands and starting materials, primary   packaging  materials, and intermediate or bulk product.
 4.9.6 Appropriate clothings and covering: To ensure protection of the   product  form contamination, personnel shall wear clean body coverings   appropriate to  the duties they perform, including appropriate hair   covering, and used clothes,  if re-usable, shall be stored in separate   closed containers until properly laundered and, if necessary,   disinfected or sterilized.
 4.9.7 Foods and drinks prohibited: Smoking eating, drinking, chewing,   and  keeping plants, food, drink smoking material, and personal   medicines shall not  be permitted in production, laboratory, and storage   areas or in any other areas  where they might adversely influence   product quality.
 
 
 SECTION – 5GOOD PRACTICES IN MANUFACTURING PROCESSING. 5.1 General responsibility of licensee: The licensee shall follow Good   Manufacturing Practices in production  of drugs under which it shall be   ensured that: -
 (a) all manufacturing processes which shall be defined are   systematically  reviewed in the light of experience, and shown to be   capable of consistently  manufacturing pharmaceutical products of the   required quality that comply with  their specifications;
 (b) critical steps of manufacturing processes and any significant   changes made  to the processes are validated;
 (c) all necessary facilities are continued to be made available,   including:-
 (i) appropriately qualified and trained personnel;
 (ii) adequate premises and space;
 (iii) suitable equipment and services;
 (iv) correct materials, containers, and labels;
 (v) approved procedures and instructions;
 (vi) suitable storage and transport; and
 (vii) adequate personnel, laboratories, and equipment of in-process   controls  under the responsibility of the             
production management.
 (d) instructions and procedures are written in clear and unambiguous language,  specifically applicable to the facilities provided and followed in letter and  spirit;
 (e) operators receive training and refresher courses at regular intervals to  carry out procedures correctly, and records of such training are maintained;
 (f) records are made, manually and or by recording instruments, during manufacture to show that all the steps required by the defined procedures and  instructions have in fact been taken and that the quantity and quality of the  product are as expected, and any significant deviations are fully recorded and  investigated;
 (g) records covering manufacture and distribution, which enable the complete  history of a batch to be traced, are retained in a comprehensible and  accessible form;
 (h) the proper storage and distribution of the products minimizes any   risk to  their quality; and
 (i) the written system to recall any batch of product from sale or   supply is  followed whenever a recall is necessitated.
 
 SECTION – 6MATERIALS
  Material general:
 6.1.1 Quarantine: All incoming materials and finished products shall   be  quarantined immediately after receipt or processing, until they are   released  for use or distribution.
 6.1.2 Appropriate storage: All materials and product shall be stored   under the  appropriate conditions established by the manufacturer and in   an orderly manner  to permit batch segregation and stock rotation by a   first-in, first-out rule.
 Starting materials:
 6.2.1 Purchase: The purchase of starting materials is an important   operation  that must involve staff who have a particular and thorough   knowledge of the  products and suppliers and a pharmacist with some   experience of production may  be preferred.
 6.2.2 Purchase from producer or established suppliers: Starting   materials shall  be purchased directly from the producer or only from   established suppliers.
 6.2.3 Checking of Containers: For each consignment, the containers   shall be  checked for integrity of package and seal and for correspondence between the  order, the delivery note, and the supplier’s   labels, and, containers shall be  cleaned where necessary and labeled,   if required, with the prescribed data.
 6.2.4 Damaged container: Damage to containers and any other problem   that might  adversely affect the quality of a materials shall be   recorded and reported to  the quality control department and investigated.
 6.2.5 Delivery from different batches: If a delivery of material is   made up of  different batches, each batch shall be considered as   separate for sampling,  testing, and release.
 6.2.6 Labeling: Starting materials in the storage area shall be   appropriately  labeled, and labels shall bear at least the following   information, namely: -
 (a) the designated name of the product and the internal code reference   where  applicable;
 (b) the batch number(s) given by the supplier and on receipt by the   manufacture,  if any;
 (c) where appropriate, the status of the contents such as on   quarantine, on  test, released, rejected, returned, and recalled; and,
 (d) where appropriate, and expiry date or a date beyond which   retesting is  necessary. When fully computerized storage systems are   used appropriate system  shall be developed for the identification of   above referred information.
 6.2.7 Identity of contents: There shall be appropriate procedures or   measures  to ensure the identity of the contents of each container of   starting material,  and bulk containers from which samples have been   drawn shall be identified.
 6.2.8 Released materials to be used: Only starting materials released   by the  quality control department and with in their shelf-life shall be   used.
 6.2.9 Correct dispensing: Starting materials shall be dispensed only   by  designated persons, following a written procedure to ensure that the   correct  materials are accurately weighed or measured in to clean and   properly labeled  containers.
 6.2.10 Checking: Each dispensed material and its weight or volume   shall be  independently checked and the check recorded.
 6.2.11 Labeling: Materials dispensed for each batch of the final   product shall  be kept together and conspicuously labeled as such.
 6.3 Packaging materials:
 6.3.1 Purchase: The purchase, handling and control of primary and   printed  packaging materials shall be as for starting materials.
 6.3.2 Printed materials: Particular attention shall be paid to printed    packaging materials which shall be stored in secure conditions so as   to exclude  the possibility of unauthorized access, cut labels and other   printed materials  shall be stored and transported in separate closed   containers so as to avoid  mix-ups and packaging materials shall be   issued for use only by designated personnel following an approved and   documented procedure.
 6.3.3 Reference numbers: Each delivery or batch of printed or primary   packaging  material shall be given a specific reference number or   identification mark.
 6.3.4 Obsolete materials: Outdated or obsolete primary packaging   material or  printed packaging material shall be destroyed and its   disposal be recorded.
 6.3.5 Checking before delivery: All products and packaging materials   to be used  shall be checked on delivery to the packaging department for   quantity, identity,  and conformity with the packaging instructions.
 6.4 Intermediate and bulk products:
 6.4.1 Storage: Intermediate and bulk products shall be kept under   appropriate  conditions.
 6.4.2 Handling: Intermediate and bulk products purchased as such shall   be handled  on receipt as though they were starting materials.
 6.5 Finished pharmaceutical products:
 6.5.1 Quarantine: Finished pharmaceutical products shall be held in   quarantine  until their final release, and thereafter they shall be   stored as usable stock  under conditions established by the manufacturer.
 6.5.2 Release: The evaluation of finished products and the   documentation  necessary for release of a product for sale, as per requirement of these rules,  shall be followed.
 6.6 Rejected and recovered materials:
 6.6.1 Storage and disposal: Rejected materials and products shall be   clearly  marked as such and stored separately in restricted areas, and   they shall either  be returned to the suppliers or, where appropriate,   reprocessed or destroyed,  and then action shall be approved by   authorized personnel and recorded.
 6.6.2 Reprocessing: The reprocessing of rejected products shall be   exceptional,  it is permitted only if the quality of the final product   is not affected, if  the specifications are met, and if it is done in   accordance with a defined and  authorized procedure after evaluation of   the risks involved and record shall be kept of the reprocessing and a   reprocessed batch shall be given a new batch  number.
 6.6.3 Batch recovery: The introduction of all or part of earlier   batches,  conforming to the required quality, in to a batch of the same   product at a  defined stage of manufacture shall be authorized   beforehand, this recovery  shall be carried out in accordance with a   defined procedure after evaluation of  the risks involved, including any   possible effect on shelf-life and the recovery shall be recorded.
 6.6.4 Additional  testing of reprocessed materials: The need for   additional testing of any  finished product that has been reprocessed ,   or into which a recovered product  has been incorporated, shall be   considered by the quality control department.
 6.7 Recalled and returned products:
 6.7.1 Recalled products: Recalled products shall be identified,   clearly marked  as such and stored separately in a secure area until a   decision is taken on  their fate.
 6.7.2 Returned goods; Products returned from the market shall be   destroyed  unless it is certain that their quality is satisfactory, they   may be considered  for resale, relabelling, or bulking with a   subsequent batch only after they have  been critically assessed by the   quality control department in accordance with a written procedure. The   nature of the product, any special storage conditions if  requires, its   condition and history, and the time elapsed since it was issued  shall   be taken into account in this assessment, where any doubt arises over   the  quality of the product, it shall not be considered suitable for   reissue or  re-use, although basic chemical reprocessing to recover the   active ingredient  may be possible, and any action taken shall be   appropriately recorded.
 6.8 Reagents and culture media:
 6.8.1 All reagents and culture medial shall be recorded upon receipt   or  preparation.
 6.8.2 Reagents made up in the laboratory shall be prepared according   to written  procedures and appropriately labeled, the label shall   indicate the  concentration, standardization factor, shelf-life, the   date when  re-standardization is due, and the storage conditions and the   label shall be  signed and dated by the person preparing the reagent.
 6.8.3 Both positive and negative controls shall be applied to verify   the  suitability of culture media, and the size of the inoculum used in   positive  controls shall be appropriate to the sensitivity required.
 6.9 Reference standards:
 6.9.1 Testing of prepared reference standard: Reference standards may   be  available in the form of official reference standards and reference   standards  prepared by the producer shall be tested, released, and then   stored in the same  way as official standards, and they shall be kept   under the responsibility of a designated person in a secured area.
 6.9.2 Use: Official reference standards shall be used only for the   purposed  described in the appropriate testing method submitted for   registration  purposes.
 6.9.3 Working standards: Secondary or working standards may be   established by  the application of a appropriate tests and checks at   regular intervals to  ensure standardization, and all in-house reference   standards shall be based on  official reference standards, when   available.
 6.9.4 Storage: All reference standards shall be stored and used in a   manner  that will not adversely affect their quality.
 6.10 Waste materials:
 6.10.1 Storage: Provision shall be made for the proper and safe   storage of  waste materials awaiting disposal, and toxic substances and   flammable  --------------- shall be stored in suitably designed and   separate enclosed  cupboat---------
 6.10.2 Disposal: Waste material shall not be allowed to accumulate,   and  -----------collected in suitable receptacles for removal to   collection points  --------------- buildings and disposed of safely and   in a sanitary manner at  regular and -------------intervals.
 6.10.3 Effluent Control: There shall be a effluent control system.
 6.11 Miscellaneous: Rodenticides, insecticides, fumigating agents, and    sanitizing-----shall not be permitted to contaminate equipment,   starting  materials, packaging-------in-process materials, or finished   products.
 
 SECTION – 7
  7.1 Processing  operations:
 7.1.1 General: Productions operations must follow clearly defined   procedures  with the objective of obtaining products of the requisite   quality.
 7.1.2 Material  handling: All handling of materials and products such   as receipt and  quarantine, sampling, storage, labeling, dispensing,   processing, packaging, and  distribution shall be done in accordance   with written procedures or  instructions and, where necessary, recorded.
 7.1.3 Avoiding deviation: Any deviation from instructions or   procedures shall  be avoided as far as possible and if deviations occur,   they shall be approved  in writing by a designated person, with the   involvement of the quality control  department.
 7.1.4 Yield checks: Check on yields and re-conciliation of quantities   shall be  carried out as necessary to ensure that yields are within   acceptable limits.
 7.1.5 Avoiding mix-ups: Operations on different products shall not be   carried  out simultaneously or consecutively in the same room unless   there is no risk of  mix-up or cross contamination.
 7.1.6 Labeling: At all times during processing, all materials, bulk   containers,  major items of equipment, and where appropriate the rooms   used shall be labeled  or otherwise identified with an indication of the   product or material being  processed and its strength, where   applicable, and the batch number, and where applicable this indication   shall also mention the stage of production.
 7.1.7 Unauthorized entry prohibited: Access to the production premises   shall be  restricted to authorized personnel.
 7.1.8 Inprocess controls: In-process controls are mostly performed   within the  production area and they shall not carry any risk for the   quality of the  product.
 7.2 Prevention of cross-contamination and bacterial contamination in    production:
 7.2.1 Precautions against dust: When dry materials and products are   used in  production, special precautions shall be taken to prevent the   generation and  dissemination of dust. This applies particularly to the   handling of highly  active or sensitizing materials.
 7.2.2 Measures against contamination: Contamination of a starting   material or  of a product by another material or product shall also be   avoided and  similarly, cross-contamination shall be avoided by   appropriate technical or  organizational measures, as may be necessary   by production segregated areas,  namely: -
 (a) conducting production in segregated areas;
 (b) providing appropriate airlock, pressure differentials and dust   extraction;
 (c) minimizing the risk of contamination caused by re-circulation or   re-entry  of untreated or insufficiently treated air;
 (d) wearing and keeping protective clothing in areas where products   with  special risk of cross-contamination are processed;
 (e) using, cleaning and decontamination procedures of known   effectiveness, as  in-effective cleaning of equipment is a common source   of cross-contamination;
 (f) encourage using a “closed system” of production;
 (g) testing for residues where necessary;
 (h) using cleanliness status labels on equipment, showing the name of   the  previous product.
 7.2.3 Cross contamination checks: Measures to prevent cross-contamination and  their effectiveness shall be checked periodically according to standard  operating procedures.
 7.2.4 microbiological monitoring: Production areas where susceptible   products  are processed shall undergo periodic microbiological   monitoring and the bio  burden shall be kept within the specified   limits.
 7.3 Processing operations intermediate and bulk products:
 7.3.1 Pre-processing and cleanliness checks: Before any processing   operation is  started, steps shall be taken to ensure that the work area   and equipment are  clean and free from any starting materials,   products, product residues, labels,  or documents not required for the   current operation.
 7.3.2 Inprocess controls: Necessary in-process controls and   environmental  controls shall be carried out and recorded.
 7.3.3 Defective equipment: Means shall be instituted for indicating   failures of  equipment or of services, such as water or gas, to   equipment. Defective  equipment shall be withdrawn from use until the   defect has been rectified.
 7.3.4 Cleaning containers: Containers for filling shall be cleaned   before  filling and attention shall be given to avoiding and removing   any contaminants  such as glass fragments and metal particles.   Production equipment shall be  cleaned according to detailed written   procedures and stored only under clean  and dry conditions.
 7.3.5 Yield deviations: Any significant deviation from the expected   yield shall  be recorded and investigated.
 7.3.6 Product pipelines: Checks shall be carried out to ensure that   pipelines  and other pieces of equipment used for the transportation of   products form one  area to another are connected in a correct manner.
 7.3.7 Water pipes: Pipes used for conveying distilled or deionizer   water and,  where appropriate, other water-pipes shall be sanitized   according to written  procedures that detail the action and limits for   microbiological contamination  and the measures to be taken.
 7.3.8 Equipment calibration: Measuring, weighing, recording control   equipment  and instruments shall be serviced and calibrated at   pre-specified interclass  and records maintained. To ensures   satisfactory functioning instruments shall  be checked daily or prior to   use for performing analytical tests and the date  of calibration and   the date when re-calibration is due shall be clearly indicated.
 7.3.9 Repair and maintenance: Repair and maintenance operations shall   not  present any hazard to the quality of the products.
 7.4 Packaging operations:
 7.4.1 Avoiding mix-ups: When the program for packaging operations is   being set  up particular attention shall be given to minimizing the risk   of cross contamination,  mix-ups, or substitutions, and different   products shall not be packaged in  close proximity unless there is   physical segregation or these of electronic surveillance.
 7.4.2 Pre-packaging checks: Before packaging operations are begun,   steps shall  be taken to ensure that the work area, packaging lines,   printing machines, and  other equipment are clean and free from any   products, materials, or documents  previously used and not required for   the current operation, and the line  clearance shall be performed   according to an appropriate checklist and  recorded.
 7.4.3 Labeling of packaging line: The name and batch number of the   product  being handled shall be displayed at each packaging station or   line.
 7.4.4 Process continuity: Normally, filling and sealing shall be   followed as  quickly as possible by labeling, and if labeling is   delayed, appropriate  procedures shall be applied to ensure that no   mix-up or mislabeling can occur.
 7.4.5 Printing operation checks: The correct performance of any   printing, code  numbers or expiry dates, done separately or in the   course of the packaging.
 shall be checked and recorded, and attention shall be paid to printing   by hand  which shall be rechecked at regular intervals.
 7.4.6 Label verification: Special care shall be taken when cut labels   are used  and when overprinting is carried out off-line and in   hand-packaging operations,  roll-feed labels are normally preferable to   cut labels in helping to avoid  mix-up. On-line verification of all   labels by automated electronic means can be helpful in preventing   mix-up, but checks shall be made to ensure that electronic code   readers, label counters, or similar devices are operation  correctly.
 7.4.7 Fast colour printing on labels: Printed and embossed information   on  packaging materials shall be distinct and resistant to fading or   erasing .
 7.4.8 On-Line packaging checks: On-line control of the product during   packaging  shall include at least check on: -
 (a) the general appearance of the packages;
 (b) whether the packages are complete;
 (c) whether the correct products and packaging materials are used;
 (d) whether any overprinting is correct;
 (e) the correct functioning of line monitors and
 (f) sample taken from the packaging line shall not be returned unless    inspection is done in close the packaging proximity of line.
 7.4.9 Product re-introduction on packaging line: Products that have   been  involved in an unusual event during packaging shall be   re-introduced into the  process only after special inspection,   investigation, and approval by  authorized personnel and a detailed   record shall be kept of this operation.
 7.4.10 Discrepancies to be investigated; Any significant or unusual   discrepancy  observed during reconciliation of the amount of bulk   product and printed  packaging materials and the number of units   produced shall be investigated and  satisfactorily accounted for before   release.
 7.4.11 Destruction of un-used packaging materials: Upon completion of a    packaging operation, unused batch-coded packaging materials shall be   destroyed  and the destruction recorded, and a documented procedure   shall be followed if  encoded printed materials are returned to stock.
 
 SECTION – 8
  8. Sanitation and  hygiene:
 General: A high level of sanitation and hygiene shall be practiced in   every  aspect of the manufacture of drug products, the scope of   sanitation hygiene  covers personnel, premises, equipment and apparatus,   production materials and  containers, products for cleaning and   disinfection, and anything that could  become a source of contamination   to the product, and potential sources of  contamination shall be   eliminated through and integrated comprehensive program  of sanitation   and hygiene. (For sanitation and hygiene please also refer to  Section   59 Schedule B-I and Section 4.9 of Schedule.
 
 SECTION – 9 
 Validation:
 9.1 General: Validation studies shall be conducted in accordance with    pre-defined protocols. A written report summarizing recorded results   and  conclusions shall be prepared and stored. Processes and procedures   shall be  established on the basis of a validation study and undergo   periodic  re-validation to ensure that they remain capable of achieving   the intended  results, and particular attention shall be accorded to the   validation of  processing, testing, and cleaning procedures.
 9.2 Process validation to be performed as per written procedures:
 9.2.1 Validation of critical processes: Critical processes shall be   validated,  prospectively or retrospectively.
 9.2.2 Validation of new master formula: When any new master formula or   method  of preparation is adopted, steps shall be taken to demonstrate   its suitability  for routine processing, and, the defined process, using   the materials and  equipment specified, shall be shown to yield a   product consistently of the  required quality.
 9.2.3 Validation of equipment and materials: Significant amendments to   the  manufacturing process, including any change in equipment or   materials that may  affect product quality and or the re-producibility   of the process shall be  validated.
 SECTION -10Documents
                  10.1.1 Maintenance of documents: Documents, as required under these   rules,  shall be meticulously maintained and regularly reviewed and kept   up to date, and when a document has been revised, a system shall exist   to prevent inadvertent use of the superseded version.
 10.1.2 Records of action: Records shall be made or completed when any   action is  taken and in such a way that all significant activities   concerning the  manufacture of pharmaceutical products are traceable.   The batch record shall be  retained for at least on year after the   expiry date of the finished product.
 10.1.3 Documentation systems: Data may be recorded by electronic data    processing systems or by photographic or other reliable means. Master   formulae  and detailed standard operating procedures relating to the   system in use shall  be available and the accuracy of the records shall   be checked and if  documentation is handled by electronic   data-processing methods, only authorized persons shall be able to enter   or modify data in the computer, and there shall  be a record of changes   and deletion; access shall be restricted by passwords or  other means   and the entry of critical data shall be independently checked and  data   shall also be readily available.
 10.1.4 Status identification: Labels applied to containers, equipment,   or  premises shall be unambiguous and in the company’s agreed format.   the labels of  different colors to indicate the status such as   “quarantined”, “accepted”,  “rejected”, or “clear” may also be used in   addition to the wording.
 10.1.5 Product labeling: All finished products shall be labeled in   accordance  with the Drug (Labeling and Packing) Rules 1986
 10.1.6 Reference standard identification: For reference standards, the   label or  accompanying documents shall indicate concentration, date of   manufacture,  expiry date, and storage conditions, where appropriate.
 10.1.7 Specification approvals: Each specifications shall be approved   and  maintained by the quality control unit.
 10.1.8 Revision of specification: Periodic revisions of the   specifications may  be necessary to comply with new edition of the national pharmacopoeia or other  official compendia or the Drugs (Specifications) Rules 1978.
 10.1.9 Packaging material specification: Packaging material shall   conform to  specification, with emphasis placed on the compatibility of   the material with  the drug product it contains.
 10.1.10 Starting material re-assay: Documents describing testing   procedures  shall state the required frequency for re-assaying each   starting material, as  determined by its stability.
 10.2 Specifications for Intermediate and bulk products:
 Specification for intermediate and bulk products shall be available if   these  are purchased or dispatched, or if data obtained from   intermediate products are  used in the evaluation of the finished   product, and the specifications shall be  similar to specifications for   starting materials or for finished products.
 10.3 Batch processing records:
 10.3.1 General: A batch processing record shall be kept for each batch    processed based on the relevant parts of the currently approved master   formula,  and the method of preparation of such records shall be   designed to avoid  transcription errors.
 10.3.2 Checking work station: Before any processing beings, a check   shall be  made that the equipment and work station are clear of previous   products,  documents, or materials not required for the planed process,   and that the  equipment is clean and suitable for use, and this check   shall be recorded.
 10.3.3 Recording process operation: During processing, the following    information shall be recorded at the time each action is taken, and   after  completion the record shall be dated and signed by the person   responsible for  the processing operations, namely: -
 (a) the name of the product;
 (b) the number of the batch being manufactured;
 (c) date and time of commencement of significant intermediate stages,   and of  completion of production;
 (d) the name of the person responsible for each stage of production;
 (e) the initials of the operator(s) of different significant steps of    production and, where appropriate, of the person(s) who checked each of   these  operations (e.g. weighing);
 (f) the batch number and or analytical control number and the quantity   of each  starting material actually weighed including the batch number   and amount of any  recovered or reprocessed material added;
 (g) any relevant processing operation or event and the major equipment   used;
 (h) the in-process controls performed, the initials of the person(s)   carrying  them out, and the result obtained;
 (i) the amount of product obtained at different and pertinent stage of   manufacture  (yield,) together with comments or explanations for   significant deviations from  the expected yield; and
 (j) notes on special problems including details, with signed   authorization for  nay deviation from the master formula.
 10.4 Batch packaging records:
 10.4.1 General: A batch packaging record shall be kept for each batch   or part  batch processed based on the relevant parts of the packaging   instruction, and  the method of preparing such records shall be designed   to avoid transcription  errors.
 10.4.2 Pre-packaging line check: Before any packaging operation   beings, checks  shall be made that the equipment and work station are   clear of previous  products, document s or material not required for the   planned packaging  operations, and that equipment is clean and suitable   for use. These checks  shall be recorded.
 10.4.3 Recording of packaging operation: The following information   shall be  recorded at the time each action is taken, and the date and   the person  responsible shall be clearly identified by signature or   electronic password  namely: -
 
 (a) the name of the product, the batch number, and the quantity of   bulk product  to be packed, as well as the batch number and the planned   quantity of finished  product obtained, the quantity actually obtained,   and the reconciliation;
 (b) the date(s) and time(s) of the packaging operations;
 (c) the name of the responsible person carrying out the packaging   operation;
 (d) the initials of the operator s of the different significant steps;
 (e) the checks made for identity and conformity with the packaging   instruction,  including the results of in-process controls;
 (f) details of the packaging operations carried out, including   references to  equipment and the packaging lines used, and, when   necessary, the instructions  for keeping the product un-packed or a   record of returning product that has not  been packaged to the storage   area;
 (g) whenever possible, samples of the printed packaging materials   used,  including specimens bearing the batch number, expiry date, and   any additional  overprinting;
 (h) notes on any special problems, including details of any deviation   from the  packaging instructions, with written authorization by an   appropriate person;  and
 (i) the quantities and reference number or identification of all   printed  packaging materials and bulk product issued, used, destroyed,   or returned to  stock and the quantities of product obtained to permit   an adequate  reconciliation.
 10.4.4 Recording batch numbers: Batch-number allocation shall be   immediately  recorded in a logbook, and the record shall included date   of allocation,  product identity, and size of batch.
 10.4.5 Analytical records: Analysis records shall include at least the    following, namely: -
 (a) the name of the material or product and, where applicable, dosage   form;
 (b) the batch number and, where appropriate, the manufacturer and or   supplier;
 (c) references to the relevant specifications and testing procedures;
 (d) test results, including observations and calculations, and   reference to any
 specifications (limits);
 (e) dates of testing;
 (f) the initials of the persons who performed the testing;
 (g) the initials of the persons who verified the testing and the   calculations,  where
 appropriate; and
 (h) a clear statement of release or rejection (or other status   decision) and  the dated
 signature of the designated responsible person.
 10.4.6 Finished product release procedure: Written release and   rejection  procedures shall be available for materials and products, and   in particular for  the release for sale of the finished product by an   authorized person.
 10.4.7 Recording batch distribution: Records shall be maintained of   the  distribution of each batch of a product in order to facilitate the   recall of  the batch if necessary.
 10.4.8 Standard operating procedures: Standard operating procedures   and associated  records of actions taken or, where appropriate,   conclusions reached shall be  available at the premises for : -
 (a) equipment assembly and validation;
 (b) analytical apparatus and calibration;
 (c) maintenance, cleaning, and sanitization;
 (d) personnel matters including qualification, training, clothing, and   hygiene;
 (e) environmental monitoring;
 (f) pest control;
 (g) complaints;
 (h) recalls; and
 (i) returns.
 10.4.9 Equipment logbooks: Logbooks shall be kept with major and   critical  equipment as identified by the licensee and shall record, as   appropriate, any  validations, calibrations, maintenance, cleaning, or   repair operations  including dates and the identity of the people who   carried out these  operations.
 10.4.10 Equipment utilization record: The use of major and critical   equipment  and the areas where products have been processed shall be   appropriately  recorded in chronological order.
 
 
 
 PART – II
 ADDITIONAL CONDITONS FOR MANUFACTURE OF STERILE PRODUCTS. 
 In additional to the  general conditions manufacture of drugs by way   of formulation as described in  Part – II of this Schedule, the   following additional conditions shall be  followed for the manufacture   of sterile products.
 
 SECTION – 1
 1. General
 1.1 The production of sterile preparations shall be carried out in   clean areas,  entry to which shall be through airlocks for personnel   and/or for goods. Clean  areas shall be maintained to an appropriate   standard of cleanliness and  supplied with air that has passed through   filters of an appropriate efficiency.
 1.2 The various operations of component preparation (such as   containers and  closures), product preparation, filling, and sterilization shall be carried out  in separate areas within the clean area.
 1.3 Clean areas for the production of sterile products are classified   according  to the required characteristics of the ark in grades A,B,C,   and D as given in  the table
 TABLE
 Air classification system for manufacture of sterile products
 Maximum number of  Maximum number
 particles permitted per m3 of viable micro-organisms
 permitted per m3
 Grade 0.05µm >5µm
 A 3500 none less than 1
 (Laminar-airflow
 workstation)
 B 3500 none 5
 C 350 000 2 000 100
 D 3 500 000 20 000 500
 
 Notes:-
 • Laminar-airflow systems shall provide a homogeneous air speed about    0.30±20%m/s for vertical flow and about 0.45±20%m/s for horizontal flow   but  precise air speeds will depend on the type of equipment.
 • In order to reach the B,C, and D air grades, the number of air   changes shall  generally be higher than 20 per hour in a room with a   good airflow pattern and  appropriate HEPA (high efficiency particulate   air) filters.
 • Low values for contaminants are reliable only when a large number of   air  samples are taken.
 • The guidance given for the maximum permitted number of particles   corresponds  approximately to the United States Federal Standard 209E as   follows: Class 100  (grades A and B), Class 10 000 (grade C), and Class   100 000 (Grade D).
 It may not always be  possible to demonstrate conformity with   particular air standards at the point  of fill when filling is in   progress, owing to the generation of particles or  droplets from the   product itself.
 1.4 Area Grades: Area  grades must be selected by the manufacturer on   the basis of validation runs  e.g., sterile media fills as identified   below.
 
 2. Manufacture of sterile preparations
 2.1 Manufacturing Operations Classifications are here divided into   three  categories:
 (a) Terminally sterilized products: those in which the preparation is   sealed in  its final container and terminally sterilized;
 (b) Products sterilized filtration: the preparation is sterilized by    filtration;
 (c) Products manufactured under aseptic conditions: those in which the    preparation can be sterilized neither by filtration nor terminally and    consequently must be produced from sterile starting materials in an   aseptic  way.
 2.2 Terminally sterilized products: Solutions shall generally be   prepared in  grade C environment in order to give low microbial and   particulate counts,  suitable for immediate filtration and   sterilization. Solution preparation could  be allowed in a grad D environment if additional measures are taken to minimize contamination,   such as the use closed vessels. For parenteral, filling shall be  done   in a laminar-airflow workstation (grade A) in grade C environment. The    preparation of other sterile products, e.g., ointments, creams,   suspensions,  and emulsion, and filling of containers shall generally be   done in a grade C  environment before terminal sterilization.
 2.3 Products sterilized by filtration: The handling of starting   materials and  the preparation of solutions shall be done in grade C   environment. These  activities could be allowed in a grade D environment   if additional measures are  taken to minimize contamination, such as   the use of closed vessels prior to  filtration. After sterile   filtration, the product must be handled and dispensed into containers   under aseptic conditions in a grade A or B area with a grade B  or C   background respectively.
 2.4 Products manufactured under aseptic conditions: The handling of   starting  materials and all further processing shall be done in a grade A   or B area with  a grade B or C background respectively.
 
 3. Personnel
 3.1 General: Only the minimum number of personnel required shall be   present in  clean areas, and it is particularly, important during   aseptic processes.  Inspections and control shall be conducted from   outside the areas as far as  possible.
 3.2 Personnel training: All personnel, including those concerned with   cleaning  and maintenance, employed in such areas shall receive regular   training for disciplines  relevant to the correct manufacture of sterile   products, including reference to  hygiene and to the basic elements of   microbiology. When outside staff who have not received such training   (e.g, building or maintenance contractors) need to  be brought in,   particular care shall be taken over their supervision.
 3.3 Entry restricted: Staff who have been engaged in the processing of    animal-tissue materials or of cultures of microorganisms other than   those used  in the current manufacturing process shall not enter   sterile-product areas  unless rigorous and clearly defined   decontamination procedures have been  followed.
 3.4 Hygiene and cleanliness: High standards of personal hygiene and   cleanliness  are essential and personnel involved in the manufacture of   sterile preparations  shall be instructed to report apparent illness or   open lesion. Periodic health  checks for such conditions are desirable,   and actions to be taken about  personnel who could be introducing undue   microbiological hazard shall be  decided by a designated competent   person.
 3.5 Use of protective garments: Outdoor clothing shall not be brought   into the  clean areas, personnel entering the changing rooms shall   already be clad in  standard factory protective garments and changing   and washing shall follow a  written procedure.
 3.6 Clothing requirements: The clothing and its quality shall be   appropriate  for the process in such a way so as to protect the product   from contamination.
 3.7 Protective garments in grade B room: For every worker in a grade B   room, clean  sterilized protective garments shall be provided at each   work session, or at  least once a day if monitoring results justify it,   the goes shall be regularly dis-infected during operations, masks and   gloves shall be changed at least at  every working session, and the use   of disposable clothing may be followed where  possible.
 3.8 Washing of clothing: Clothing used in clean areas shall be washed   or  cleaned in such a way that it does not gather additional particulate    contaminants that can later be shed. Separate laundry facilities for   such  clothing are desirable. If fibers are damaged by inappropriate   cleaning or  sterilization there may be an increased risk of shedding   particles. Washing and  sterilization operations shall follow standard   operating procedures.
 3.9 Prohibitions: Wrist-watches and jewelry shall not be worn in clean   areas,  and cosmetics that can shed particles shall not be used,   clothing shall be  appropriate to the air grade of the area where the   personnel will be working,  and the description of clothing required for   each grade is given below:
 
 Grade D: The hair and, where appropriate, beard shall be covered,   protective  clothing and appropriate shoes or long shoes shall be worn,   and appropriate  measures shall be taken to avoid any contamination   coming from outside the  clean area.
 Grade C: The hair and,  where appropriate, beard shall be covered, a   single or two-piece trouser suit,  gathered at the wrists and with a   high neck and appropriate shoes or overshoes,  shall be worn, and the   clothing shall shed virtually no fibers or particulate  matter.
 Grade B: Headgear shall  totally enclose the hair and, where   appropriate, beard it shall be tucked into  the neck of the suit; a face   mask shall be worn to prevent the shedding of  droplets; sterilized   non-powdered rubber or plastic gloves and sterilized or disinfected   footwear shall be worn; trouser-bottoms shall be tucked inside the    footwear and garment sleeves into the gloves, and the protective   clothing shall  shed virtually no fibers or particulate matter and shall   retain particles shed  by the body.
 
 SECTION – 2                  4 Maintenance of clean  area:
 4.1 General: Each manufacturing operation requires an appropriate air    cleanliness level in order to minimize the risks of particulate or   microbial  contamination of the product or materials being handled   Section 1.3 gives the  minimum air grades required for different   manufacturing operations. The  particulate and microbiological   conditions as prescribed shall be maintained in  the zone immediately   surrounding the product whenever the product is exposed to  the   environment. These conditions shall also be achieved throughout the    background environment if no personnel are present in the processing   area and  if the standards fall for any reason it shall be possible to   recover the conditions  after a short “clean-up” period. The utilization   of absolute-barrier technology  and automated systems to minimize human   interventions in processing areas can produce significant advantages   in ensuring the sterility of manufactured  products, and when such   techniques are used the recommendations relating to air  quality an   monitoring, still apply, with appropriate interpretations of the  terms   “workstation” and environment.
 4.2 Airlock system: The entry to the sterile production areas shall be   through  airlocks for personal and/or for materials. Airlock doors   shall not be opened  simultaneously, and an interlocking system and a   visual and/or audible warning  system where appropriate shall be   operated to prevent the opening of more than  one door at a time.
 4.3 Air supply system: A filtered air supply system of appropriate   efficiency  shall maintain a positive pressure relative to surrounding   area under all  operational conditions and flush the area effectively.   More over particular  attention shall be paid to the protection of the   zone of great risk that is,  the immediate environment to which the   product and the cleaned components in contact with it are exposed, and   the various recommendations regarding air  supplies and pressure   differentials may need to be modified if it become  necessary to contain   materials such as pathogenic, highly toxic, radioactive,  or live viral   or bacterial materials. Decontamination facilities and the  treatment   of air leaving a clean area may be necessary for some operations.
 4.4 Maintenance of equipment: When equipment maintenance is carried   out within  the clean area, clean instruments and tools shall be used,   and the area shall  be cleaned and dis-infected, where appropriate,   before processing recommences,  if the required standards of cleanliness   and/or asepsis have not been  maintained during the maintenance work.
 4.5 Water supply: Water treatment plants shall not be operated beyond   their  designed capacity and water shall be produced, stored and   distributed in manner  that prevents microbial growth for example by   constant circulation at 90ºC or  at temperature validated to keep   microbial count of water within the limit.
 
 
 SECTION – 3
 
 5. Equipment maintenance:
 5.1 Documentation: All equipment, including sterilizers, air-filtration  systems, and water-treatment systems including stills, shall be subject to  planed maintenance, validation and monitoring, and   its approved use, following  maintenance work, shall be documented.
 
 SECTION – 4 
 
 6. Sanitation
 6.1 Procedure: The sanitation of clean areas is particularly   important, they  shall be cleaned frequently and thoroughly in   accordance with a written program  approved by the quality control   department; where disinfectants are used, more  than one type shall be   employed with periodic alterations, the monitoring shall  be regularly   undertaken in order to detect the emergence of resistant strains  of   microorganism, and in view of its limited effectiveness, ultraviolet   light  shall not be used as a substitute for chemical disinfection.
 6.2 Use of disinfectants and detergents: Disinfectants and detergents   shall be  monitored for microbial contamination. Dilutions hall be kept   in previously  cleaned container and shall not be stored for long   periods unless sterilized,  and partly emptied containers shall not be   topped up.
 6.3 Fumigation: Fumigation of clean areas may be useful for reducing    microbiological contamination in inaccessible places, if required
 6.4 Monitoring of clean areas: Clean areas shall be monitored at   planned  intervals during operations by means of microbial counts of air   and surface,  where aseptic operations are performed, monitoring shall   be frequent to ensure  that the environment is within specifications,   the results of monitoring shall be considered when batches are assessed   for approval, air particulate quality  shall also be evaluated on a   regular basis, and additional monitoring is  sometimes desirable even   when there are no production operations such as after  validation of   systems, cleaning, and fumigation.
 SECTION – 5                  7. Processing:
 7.1 Precautions against contamination: Precautions to minimized   contamination  shall be taken during all processing stages including the   stage before  sterilization.
 7.2 Preparations of live organisms: Preparations containing live    microbiological organisms shall not be made or containers filled in   areas used  for the processing of other pharmaceutical products except   for validation  purposes however, vaccines of dead organisms or of   bacterial extracts may be  dispensed into containers after validated   inactivation and validated cleaning procedures in the same premises as   other sterile pharmaceutical products.
 7.3 Simulation of aseptic operations validation: The use of nutrient   media that  support microbial growth in trials to simulate aseptic   operations, sterile  media fills and broth fills, is a valuable part of   overall validation of an  aseptic process, and such trials shall have   the following characteristics,  namely: -
 (a) they shall simulate as closely as possible actual operations,   taking into  account such factors as complexity of operations, number of   personnel working,  and length of time;
 (b) the medium or media selected shall be capable of growing a wide   spectrum of  microorganisms, including those that would be expected to   be found in the  filling environment, and
 (c) they shall include a sufficient number of units of production to   give a  high degree of assurance that low levels of contamination, if   present, would be  detected,
 Note:- It is recommended that at least 3000 units of production be   included in  each broth-fill trial. The target shall be zero growth and   anything above 0.1%  of units contaminated shall be considered   unacceptable. Any contamination shall  be investigated. Broth fills   shall be repeated at regular intervals, and  whenever a significant   alteration in the product, premises, equipment or  process warrants   revalidation. Care shall be taken that validations do not harm  the   processes.
 7.4 Monitoring water supply sources: Water sources, water-treatment   equipment  and treated water shall be monitored regularly for chemicals,   biological  contamination and contamination with endotoxins to ensure   that the water  complies with the specifications appropriate to its use.   Records shall be  maintained of the results of the monitoring and of   any action.
 7.5 Activities in clean areas kept minimum: Activities in clean areas,    especially when aseptic operations are in progress, shall be kept to a   minimum  and the movement of personnel shall be controlled and   methodical to avoid  excessive shedding of particles and organisms due   to over-vigorous activity,  and the ambient temperature and humidity   shall not be uncomfortably high  because of the nature of the garments   worn.
 7.6 Care of starting materials: Micro-biological contamination   (bioburden) of  starting materials shall be minimal which shall be   monitored before  sterilization, and specifications shall included   requirements for  microbiological quality when the need for this has   been indicated by  monitoring.
 7.7 Care against  fibers: The presence of containers and materials   liable to generate fibers  shall be minimized in clean areas and avoided   completely while aseptic work is  in progress.
 7.8 Care after final cleaning of materials: Components, bulk-product   containers  and equipment shall be handled after the final cleaning   process in such a way  that they are not recontaminated, and the stage   of processing of components, bulk-product containers, and equipment   shall be properly identified.
 7.9 Interval between operations to be minimal: The interval between   the washing  and drying and the sterilization of components,   bulk-product containers, and  equipment, as well as between   sterilization and use, shall be as short as  possible and subject to a   time-limit appropriate to the validated storage conditions, similarly   the time between the start of the preparation of solution  and its   sterilization or filtration through a bacteria-retaining filter shall    be as short as possible, and maximum permissible time shall be set for   each  product that takes into account its composition and the prescribed   method of  storage.
 7.10 Sterilization of gases used: Any gas that is used to purge a   solution on  blanket a product shall pass through a sterilization   filter.
 7.11 Bioburden to be minimal: The microbiological contamination of   products  (bioburden) shall be minimal prior to sterilization, there   shall be a working  limit on contamination immediately before   sterilization that is related to the  efficiency of the method to be   used and the risk of pyrogens, all solutions, in particular   large-volume parenteral, shall be passed through a micro-organism    retaining filter, if possible immediately before the filling processes,   and  where aqueous solutions are held in sealed vessels, any   pressure-release  outlets shall be protected such as by hydrophobic   microbial air filter.
 7.12 Asepsis of articles in clean areas: Components, bulk-product   containers,  equipment and any other articles required in a clean area,   where aseptic work  is in progress, shall be sterilized and, wherever   possible, passed into the  area through double-ended sterilizers sealed   into the wall, and other  procedures that achieve the same end of not   introducing contamination, such as  triple wrapping, may be acceptable   in some circumstances.
 7.13 New processes to be validated: The efficacy of any new processing    procedure shall be validated and the validation shall be repeated at   regular  intervals thereafter or when any significant change is made in   the process or  equipment.
 
 SECTION – 6 
 
 8. Sterilization:
 8.1 General: Sterilization can be achieved by moist or dry heat, by   ethylene oxide  or other suitable gaseous sterilizing agent, by   filtration with subsequent  aseptic filling of sterile final containers,   or by irradiation with ionizing  radiation but not with ultraviolet   radiation unless the process is thoroughly  validated, each method has   its particular applications and limitations, and where possible and   practicable heat sterilization is the method of choice.
 8.2 Validation: All sterilization processes must be validated and   particular  attention shall be given when the adopted sterilization   method is not in  accordance with pharmacopoeial or other national   standards or when it is used  for a preparation that is not a simple   aqueous or oily solution.
 8.3 Suitability of process: Before any sterilization process is   adopted, its  suitability for the product and its efficacy in achieving   the desired  sterilizing conditions in all parts of each type of load to   be processed shall  be demonstrated and this work shall be repeated at   scheduled intervals, at  least annually, and whenever significant   modifications have been made to the  equipment, and records shall be   kept of the results.
 8.4 Care for biological indicators: Biological indicators shall be   considered  only as and additional method for monitoring the   sterilization, and if they are  used, strict precautions shall be taken   to avoid transferring microbial contamination from them.
 8.5 Sterilized not sterilized product differentiation: There shall be a   clear  means of differentiating products that have not been sterilized   from those that  have and each basket, tray, or other carrier of   products or components shall be  clearly labeled with the name of the   material, its batch number and an  indication of whether or not it has   been sterilized, and indicators such as autoclave tape may be used,   where appropriate, to indicate whether or not a  batch, or sub-batch,   has passed through a sterilization process, but they do  not give a   reliable indication that the lot is, in fact, sterilize.
 9. Sterilization by heat:
 9.1 Recording sterilization cycle: Each heat sterilization cycle shall   be  recorded by appropriate equipment with suitable accuracy and   precision such as  time and temperature chart with a suitably large   scale, the temperature shall  be recorded from a probe at the coolest   part of the load or loaded chamber having  been determined during the   validation. The temperature shall preferably be checked against a   second independent temperature probe located at the same  position, the   chart, or a photocopy of it, shall form part of the batch record,  and   chemical or biological indicators may also be used but shall not take   the  place of physical controls.
 9.2 Sufficient time allowed to reach required temperature: Sufficient   time must  be allowed for the whole of the load to reach the required   temperature before  measurement of the sterilizing time is started and   this time must be determined  for each type of load to be processed.
 9.3 Precautions during cooling: After the high-temperature phase of a   heat  sterilization cycle, precautions shall be taken against   contamination of a sterilized  load during cooling, and any cooling   fluid or gas in contact with the product shall be sterilized, unless it   can be shown that any leaking container would  not be approved for use.
 10. Sterilization by moist heat:
 10.1 General: Sterilization by moist heat is suitable only for   water-wettable  materials and aqueous solutions, both temperature and   pressure shall be used to  monitor the process, the temperature recorder   shall normally be independent of  the temperature regulator and there   shall be an independent temperature  indicator, the reading from which   is routinely checked against the chart recorder during the   steri8lization period, for sterilizers fitted with a drain  at the   bottom of the chamber, it may also be necessary to record the    temperature at this position, throughout the sterilization period, and   there  shall be regular leak tests on the chamber when a vacuum phase is   part of the  cycle.
 10.2 Wrapping materials: The items to be sterilized, other than   products in  sealed containers, shall be wrapped in a material that   allows removal of air  and penetration of steam but prevents   recontamination after sterilization and  all parts of the load shall be   in contact with water or saturated steam at the required temperature   for the required time.
 10.3 Care shall be taken to ensure that steam used for sterilization   is of  suitable quality and does not contain additives at a level that   could cause  contamination of the product or equipment.
 11. Sterilization by dry heat:
 The process used for sterilization by dry heat shall include air   circulation  within the chamber and the maintenance of a positive   pressure to prevent the  entry of non-sterile air, if air is supplied,   it shall be passed through a  microorganism-retaining filter, and where   this process of sterilization by dry  heat is also intended to remove   pyrogens, challenge tests using endotoxins  would be required as part of   the validation.
 12. Sterilization by radiation:
 12.1 General: Radiation sterilization is used mainly for the   sterilization of  heat-sensitive materials and products, many pharmaceutical products and some  packaging materials are radiation-sensitive, so this method is permissible only  when the absence of deleterious effect on the product has been confirmed experimentally, and ultraviolet irradiation is not acceptable method for terminal sterilization.
 12.2 Outside contractor: If radiation sterilizations is carried out by   an  outside contractor, the manufacturer has the responsibility of   ensuring that  the requirements of section 12.1 are met and that the   sterilization process is  validated and the responsibilities of the   radiation plant operator, such as the  right dose, shall also be   specified.
 
 12.3 Measurement of radiation: During the sterilization procedure the   radiation  dose shall be measured and for this purpose, dosimeters that   are independent of  dose rate shall be used giving a quantitative   measurement of the dose received  by the product itself, dosimeters   shall be inserted in the load in sufficient  number and close enough   together to ensure that there is always dosimeter in  the chamber: where   plastic dosimeters are used, they shall be used within the  time-limit   of their calibration, Biological indicators may be used only as an    additional control. Radiation – sensitive colour discs may be used to    differentiate between packages that have been subjected to irradiation   and  those that have not they are not indicators of successful   sterilization. The  information obtained shall constitute part of the   batch record, and the total  radiation dose shall be administered within   a predetermined time span.
 12.4 Validation: Validation procedures shall ensure that consideration   is given  to the effect of variations in the density to the packages.
 12.5 Handling procedures: Handling procedures shall prevent any mix-up   between  irradiated and non-irradiated materials. Each package shall   carry a  radiation-sensitive indicator to show whether or not it has   been subjected to  radiation treatment.
 
 13 Sterilization by ethylene oxide:
 13.1 General: Various gases and fumigants may be used for   sterilization,  ethylene oxide shall be used only when no other method   is practicable. During  process validation it shall be shown that the   gas has no damaging effect on the  product and that the conditions and   time allowed for degassing are such as to  reduce any residual gas and   re-action products to defined acceptable limits for the type of product   or material, and these limits shall be incorporated into  the   specifications.
 13.2 Ensure contact between gas and microbial cells: Direct contact   between gas  and microbial cells is essential, precautions shall be   taken to avoid the  presence of organisms likely to be enclosed in   material such as crystals or  dried protein, and the nature and quantity   of packaging materials can  significantly affect the process.
 13.3 Equilibrium with humidity and temperature: Before exposure to the   gas,  materials shall be brought into equilibrium with the humidity and   temperature  required by the process. The time required for this shall   be balanced against  the opposing need to minimize the time before   sterilization.
 13.4 Monitoring each cycle: Each sterilization cycle shall be   monitored with  suitable biological indicators, using the appropriate   number of test pieces  distributed throughout the load, and the   information so obtained shall form  part of the batch record.
 13.5 Biological indicators: Biological indicators shall be stored and   used  according to the manufacturer’s instructions and their performance   checked by  positive controls.
 13.6 Record maintenance: For each sterilization cycle, records shall   be made of  the time taken to complete the cycle of the pressure,   temperature, and humidity  within the chamber during the process and of   the gas concentration, the  pressure and temperature shall be recorded   throughout the cycle on a chart and  the records shall form part of the   batch record.
 13.7 Validation: After sterilization, the load shall be stored in a   controlled  manner under ventilated conditions to allow residual gas and   re-action products  to fall to the defined level, and this process   shall be validated.
 14 Filtration of pharmaceutical products that cannot be sterilized in   the final  container.
 14.1 General: Whenever possible, products shall be sterilized in the   final  container preferably by heat sterilization. Certain solutions and   liquids that  cannot be sterilized in the final container can be   filtered through a sterile  filter of nominal pore size 0.22um or less,   or with at least equivalent microorganism-retaining properties into a   previously sterilized container, such  filter can remove bacteria and   moulds, but not all viruses or mycoplasmas.
 14.2 Using double filter layer: Owing to the potential additional   risks of the  filtration method as compared with other sterilization   processes, a double  filter layer or second filtration via a further   sterilized  microorganism-retaining filter immediately prior to filling   may be advisable  and the final sterile filtration shall be carried out   as close as possible to  the filling point.
 14.3 Eliminate fibres: Filters that shed fibers shall not be used and   the use  of asbestos-containing filters shall be absolutely excluded.
 14.4 Checking integrity of filters: The integrity of the filter shall   be  checked by an appropriate method such as a bubble point test   immediately after  each use, it may also be useful to test the filter in   this way before use, the  time taken to filter a known volume of bulk   solution and the pressure  difference to be used across the filter shall   be determined during validation  and any significant differences from   this shall be noted and investigated.  Results of these checks shall be   recorded in the batch record.
 14.5 Frequency of use of filter: The same filter shall not be used for   more  than one working day unless such use has been validated.
 14.6 Filter safety: The filter shall not affect the product by removal   of  ingredients from it or by release of substances into it.
 15 Finishing of sterile products:
 15.1 General: Containers shall be closed by appropriately validated   methods,  and same shall be checked for integrity according to   appropriate procedures.
 15.2 Use of vacuum: Containers sealed under vacuum shall be  sampled   and the same tested for maintenance of that vacuum after and    appropriate pre-determined period.
 15.3 Inspection of containers: Filled containers of parenteral   products shall  be inspected individually, when inspection is done   visually it shall be done  under suitable and controlled conditions of   illumination and background,  operators doing the inspection shall pass   regular eyesight checks, with  spectacles if worn, and be allowed   frequent breaks from inspection, and where  other methods of inspection   are used, the process shall be validated and the  performance of the   equipment checked at intervals.
 
 SECTION – 7                  16. Quality control:
 16.1 Sterility testing: Samples taken for sterility testing shall be    representative of the whole of the batch but shall, in particular,   include  samples taken from parts of the batch considered to be most at   risk of  contamination, such as: -
 (a) for products that have been filled aseptically, samples shall   include  containers filled at the beginning and end of the batch and   after any  significant interruption of work; and
 (b) for products that have been heat sterilized in their final   containers, and  samples can be taken form any part of the load.
 16.2 Sterility test as the last measures: The sterility test applied   to the  finished product shall be regarded only as the last in a series   of control  measures by which sterility is assured and can be   interpreted only in  conjunction with the environmental and batch   processing records.
 16.3 Monitoring endotoxins: For injectable products, consideration   shall be  given to monitoring the water and the intermediate and   finished product for  endotoxins, using and established pharmacopoeial   method that has been validated  for each type of product, for large   –volume infusion solutions, such monitoring of water or intermediates   shall always be done, in addition to any test  required by the marketing   authorization on the finished product, and when a  sample fails a test,   the causes of failure shall be investigated and remedial  action taken   where necessary.
 Saving: This Schedule  B-II shall come into force with effect form the   date as may be notified by the  Federal Government and till such time   Schedule B-II as already provided in the  Rules shall remain in-force.
 After rule 20 the following new rule shall be inserted, namely: -
 “20A. Contract Manufacture. Manufacture or analysis on contract is   permissible  on behalf of a licensee or of a pharmaceutical company   whose products are  registered for import in Pakistan for sale subject   to the conditions laid down  in Schedule G”, as a special case and for   genuine reasons as approved by the Registration Board.
 SCHEDULE ‘G’
 1. Contract production and analysis:
 1.1 Contract of manufacture shall be undertaken only by a manufacturer   who  holds a valid drug manufacturing license, and the contract   acceptor shall/have  adequate facilities, knowledge, experience and   competent personnel to  satisfactorily carry out the work ordered by the   contract giver.
 1.2 General: Contract production and analysis shall be correctly   defined,  agreed and controlled in order to avoid misunderstandings that   could result in  a drug or work or analysis of unsatisfactory quality. A   written contract  between the contract giver and the contract acceptor   shall clearly establish  the duties of each party and state the way in   which the authorized person shall exercise his full responsibility in   releasing each batch of product for sale or  issuing the certificate of   analysis, and a copy of such a contract shall be  supplied to the   Central Licensing Board also.
 1.3 All arrangements for contract manufacture and analysis, including   any  proposed changes in technical or other arrangements, shall be in   accordance  with the registration of the drug concerned.
 1.4 There shall be a written contract covering the manufacture and or   analysis  arranged under contract and any technical arrangements made in   connection with  it.
 1.5 The contract shall permit the contract giver to audit the   facilities of the  contract acceptor.
 1.6 In the case of contract analysis, the final approval for release   must be  given by the authorized person(s).
 2. Contract Giver
 2.1 The contract giver shall be responsible for assessing the   competence of the  contract acceptor in successfully carrying out the   work or tests required and  for ensuring by means of the contract that   the principles of good manufacturing  practices are followed.
 2.2 The contract giver shall provide the contract acceptor with all   the  information necessary to carry out the contracted operations   correctly in  accordance with the registration and any other legal   requirement’s and the  contract giver shall ensure that the contract   acceptor is fully aware of any  problem associated with the product,   work, or tests that might pose a hazard to premises, equipment,   personnel, other material or other products.
 2.3 The contract giver shall ensure that all processed products and   material  delivered by the contract acceptor to comply with their   specifications or that the  product has been released by the authorized   person(s)
 3. Contract acceptor:
 3.1 The contract acceptor shall not pass to a third party any of the   work  entrusted to him or her under the contract without the written   consent of the  contract giver and prior evaluation and approval by the   arrangements of the  Central Licensing Board, and arrangements made   between the contract acceptor  and any third party shall ensure that the   manufacturing and analytical information is made available in the same   way as between the original contract  giver and contract acceptor.
 3.2 The contract acceptor shall refrain from any activity that may   adversely  affect the quality of the product manufactured and or   analyzed for the contract  giver.
 4. The contract:
 4.1 A contract shall be drawn up between the contract giver and the   contract  acceptor that specifies their respective responsibilities   relating to the  manufacture and control of the product, and technical   aspects of the contract  shall be drawn up by competent persons suitably   knowledgeable in pharmaceutical technology, analysis, and good   manufacturing practices. All arrangements for  production and analysis   must be in accordance with the registration and agreed  by both parties.
 4.2 The contract shall specify the way in which the authorized person   releasing  the batch for sale ensures that each batch has been   manufactured in, and  checked for, compliance with the requirements of   the marketing authorization.
 4.3 The contract shall describe clearly who is responsible for   purchasing, testing,  and releasing material and for undertaking   production and quality controls,  including in process controls, and who   has responsibility for sampling and  analysis, and in the case of   contract analysis, the contract shall state  whether or not the contract   acceptor shall take samples at the premises of the manufacture.
 4.4 Manufacturing, analytical distribution records and reference   samples shall  be kept by, or be available to, the contract giver, and   any records relevant to  assessing the quality of a product in the event   of complaints or a suspected  defect shall be accessible and specified   in the defect or recall procedures of  the contract giver.
 4.5 The contract shall describe the handling of stating material   intermediate  and bulk products and finished products if they are   rejected and it shall also  describe the processing of information if   the contract analysis shows that the  tested product must be rejected.           

9
Pharmaceutical / The Drugs (Labeling and Packing) Rules, 1986
« on: April 17, 2014, 12:24:07 PM »
The Drugs (Labeling and Packing) Rules, 1986


1. Short title and commencement : (1) These rules may be called the Drugs (Labeling and Packing) Rules. 1986.
 
2. They shall come into force on the expiration of the period of one year beginning with their publication in the official Gazette.

3. Definitions :- In these rules, unless there is anything repugnant in the subject or context;

(a) International non-proprietary name means the name of drug as recommended by the World Health Organization or such other name as may be notified by the federal Government in the official gazette;
(b) Pharmacopoeial means a publication mentioned in sub-clause (ii) of clause (2) of section (3) of drugs Act, 1976 (XXXI of 1976).
(c) Pharmacopoeial name “means the name of a drug as mentioned in the pharmacopoeia”.
(d) “Schedule” means a schedule to these rules; and
(e) “Registered Medical Practitioners” means a Medical Practitioner registered or provincially registered under the medical and Dental Council Ordinance, 1962(XXXII of 1962).

(3) Manner of Labeling : The following particulars shall appear either in print or in writing in inedible ink in a conspicuous manner on a label of the innermost container of drug and also on the in which such container is packed namely :
( a) The registered name of the drug;
(b) If the registered name is a proprietary name, then immediately following the registered name, the international non-proprietary name, and if no such non-proprietary name is known the Pharmacopoeial name or any other name, if any, approved by the registration board for this purpose in conspicuous manner;
(c) The international non-proprietary name of the pharmacopoeial name of the generic name, and if no such name is known the chemical name of each active ingredient of a drug with weight. Added by SRC 1122 (i) 86 dated 23-12-1986


Manual of Drug Laws

Or measures in metric system, or the number of units of activity as the cause may be, expressed :


(i) In the case of oral liquid preparations in terms of contents per specified volume, the volume being indicated in militaries;
(ii) In the case of liquid parenteral preparations ready for administration in terms of militaries or percentage by volume or dose. Provided that in the case of a preparation contained in ampoule, it shall be sufficient if the ingredients are shown on the label or wrapper affixed to any package in which such ampoule is issued for sale.
(iii) In the case of drugs in solid form intended for parenteral administration in terms of weight or unitage per milligram or gram or per container.
(iv) In the case of tablets, capsules pill or other units as the case may be; and
(v) In the case of other preparations in terms of percentage by weight or volume or unitage per gram or milliliter as the case may be;
(d) The name and principal place of business of the manufacturer
(e) The drug manufacturing license number.
(f) The drug registration number.
(g) The date of expiry.
(h) Urdu version of the following namely;
(i) Name of drug
(ii) dosage; and
(iii) Instructions;
(i) The distinctive batch number date of manufacture and the maximum retail price;

Provided that in the case of a drug packed in a strip of paper or blister or foil or contained in an ampoule of a capacity of not more that two milliliter or in an ampoule containing a sterile suture or ligature and such strip foil blister or ampoule is placed in other package and also in the case of printed collapsible tubes it shall be sufficient to give the information on the outer packing containing such strips, foils, blister or ampoule.

Provided further that the registration board may allow relaxation of any of these conditions.

4. Labelling of Drugs for internal use :- The label of container of a drug meant for internal use, except a Drug contained in a strip or foil or blister or collapsible tube shall in additions to the particulars required to be given under rule 3, bear in a conspicuous manner.

(i) If it contains a substance specified in the schedule the words “to be sold on prescription of a registered medical practitioner only” and ;
(ii) If it contains not less then three percent by volume and alcohol a statement giving the quantity of alcohol in terms of average percentage by volume of absolute alcohol in the finished product.

5. Labelling of Drugs of external use only :-The label of a container of ointment, cream, liniment, lotion, antiseptic or any drug for external application shall in
addition to the particular required to be given under rule 3, bear in a conspicuous manner :
(i) The words “For external use only “ and;

6. Labelling of physician’s sample :-The label of a container of every drug intended for distribution to the medical profession as free sample shall in addition to the particulars required to be given under these rules bear the words “Physician sample not for Sale” which shall be over printed or stamped.
Provided that if the drug is packed in a strip of paper or blister or foil or contained in an ampoule of a capacity of not more than three milliliters or in a collapsible tube, it shall be to label the outer packing only with the said words.

7. Labelling of Drugs for Government supply :-T he label of a container of every drug intended for the supply to any Government agency including an utonomous body or a semi-Government Agency shall. While complying with the other labelling requirements of these rules, bear the words or mark reading “Government supply” or such other words or mark as may be required by the agency concerned.

8. Labelling of Drugs for Veterinary use:-The label of a container of drug for veterinary use shall bear in a conspicuous manner the words “ For veterinary use only” 9. Outer transparent wrapper not to require labeling :-Nothing in these rules shall be deemed to require the labeling of any transport cover, wrapper, case, or other covering used solely for the purpose of packing, transport or delivery of a drug.

10. Labelling of Non-Sterile Surgical ligature and suture :-Every container of and every wrapper enclosing a surgical ligature or suture, other than a ligature or suture certified to be sterile and fit for surgical use without further sterilization., shall bear a label or which shall be printed or written in a conspicuous manner in indelible red ink the word “ Non-Sterile Surgical ligature/suture, Not to be used for operations upon human body unless properly sterilized”.

11. Use of letters to indicate specifications :-Subject to these rules the letters “P.P”, “Ph.I”, “Eur.P”, “B.P”, “B.P.C” and “U.S.N.F”. shall be printed or written in indelible ink on the label to indicate so that the drug is manufactured in accordance with the specifications set out in the Pakistan Pharmacopoeia, international Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, British Pharmacopoeia, British Pharmaceuticals Codex or the United States National Formulary, as the case may be.

12. Packing of finished drugs :- Each finished drugs ready for use shall be packed in containers intended for retail sale to a hospital dispensary, clinic, or any other such institutions.

13. Labelling of Drugs manufactured for export :- Noting contained in rules 3 to 12 shall apply to a drug manufactured for export the label on the package or container of which has has bee adopted to meet the specific requirements of the country to which the drug is exported. The label on the package or container of such drug shall bear the following particulars at a conspicuous place on the innermost container in which the container is packed namely :
(i) The Name of the drug
(ii) The name and principle place of business of the manufacturer and ;
(iii) Batch number of the drug date of manufacture and the date of expiry.

Provided that in the case of a drug packed in strips of paper or foils or blister or contained in ampoules of a capacity of not more than two milliliters or in printed
collapsible tubes, except for expiry date it shall be sufficient if these particulars are given on the outer packing containing such strips, foil, blister, ampoules or tubes.

14. Exemption :-These rules should not be applicable in respect of a drug made up ready for treatment, whether after or without dilution and is supplied by a person licensed to sell drugs on the prescription a registered medical practitioner. Provided that the label bears the following particulars namely :


(i) The name and the address of the suppliers of the drug;
(ii) The name of the patient;
(iii) The number representing the serial number of the entries in the prescription register.
(iv) If the drug is for internal use the dosage
(v) If the drug is for external use and does not contains a substance specified in the schedule the words, “For external use only” and;
(vi) If he drug is for external use and contains a substance specified in the schedule the words “Poison for external use only”

THE SCHEDULE
TO BE SOLD BY A RETAILER ON THE PRESCRIPTION OF
REGISTERED MEDICAL PRACTITIONERS.


1. C.N.C. stimulants
2. Drugs affecting Uterine motility.
3. Drugs inhibiting hormonal production.
4. Hormones and other steroidal preparation excluding preparations for external and topical use.
5. Narcotic drugs as per single convention on Narcotic drugs 1961.
6. Psychotropic substances, 1971.

10
Pharmaceutical / Drugs (Specifications) Rules, 1978
« on: April 17, 2014, 12:02:34 PM »
Notification S.R.O. 1080 (1)/78: In exercise of the powers conferred by Section 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal Govern moist is pleased to make the following rules, the same having been previously published as required by sub-section (3) of the said section, .namely :--
1. Short title and commencement: (1) These rules may bc called the Drugs (Specifications) Rules, 1978.
 
 (2) They shall come into force at once.
2. Specifications: The specifications for the classes of drugs specified in column 1 of the schedule shall be those specified against those drugs in column 2 of the schedule.
 SCHEDULE
 Specifications for Drugs
 
SCHEDULE
 Specifications for Drugs
Class of drugSpecifications to be compiled with
1. Drugs bearing reference on the lebelling to any of the publications specified under sub-clause t (ii) of clause (z) of Section 3.Specifications given in the publication referred to on the labelling.
2. Drugs included in the recent editions of any of the following publications but not bearing any reference to such publication :- (a) the international Pharmacopoeia or such other specifications as published by the World Health Organisation,
 (b) the European Pharmacopoeia,
 (c) the United States Pharmacopoeia,
 (d) the British Pharmacopoeia,
 (e) the British Pharmaceutical Codex.
 (f) the United States .National Formulary.
Specifications as approved by the Registration Board for this purpose and if no such approval is available the specifications given in the said publications in the same order of preference as given in column 1.
3. Veterinary drugsSpecifications as approved by the Registration Board for this purpose and if no such approval is available, the specification given in the current edition of British Veterinary Codex and, if a drug is not included in the current edition and is included in an earlier edition the specification proscribed in that edition.
4. Drugs other than those falling under serial number 1, 2 or 3 above.Specifications as approved by the Registration Board for specification are available the ingredients and their quantities displayed in the labelling which shall be tested and analysed by the Government Analyst or the Federal Drug Laboratory or such other laboratory as may have been specified to be the laboratory for the purpose of sub-section (5) of section 22.
5. Ophthalmic preparationsIn addition to the requirements, if any, set out above, ophthalmic preparations shall meet the following requirement:-
 A-Ophthalmic Solutions and Suspensions;
 Ophthalmic solutions and suspensions shall--
(a) be sterile except in case of those ophthalmic solutions and suspensions which are not specifically required to comply with the test for 'Sterility' in the Pharmacopocia;
(b) contain one or more suitable substances as preservatives to prevent the growth of micro-organisms
 Provided that solutions in used surgery shall not have any preservative and be packed in single dose containers;
(c). be free from foreign matter:
(d) be contained in bottles made of either neutral glass or soda glass specially treated to reduce the amount of alkali released when in contact with aqueous liquids or in suitable plastic containers which would not in any way be incompatible with the solution and the droppers to be supplied with the containers shall be made of neutral glass or of suitable plastic material and when supplied separately shall be packed in sterile cellophane or other suitable packings; and
B-- Ophthalmic Ointment Ophthalmic Ointment shall--
(a) be sterile;
 (b) be free from foreign matter.

11
Drugs (Licensing, Registering and Advertising) LR&A Rules, 1976.



S.R.O. 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :--

 CHAPTER I - PRELIMINARY

 1. Short title and commencement: .(1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976.
 (2) They shall come into force at once.
 
 2. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:--
 
 (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient);
 
 (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods;
 
 (c) "authorized person" means a person responsible for the release of batches of product for sale;
 
 (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes;
 
 (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch;
 
 (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived.
 
 (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering;
 
 (h) "batch records" means all documents associated with the manufacture of a batch of bulk product or finished product showing a history of each batch of product and of all circumstances pertinent to the quality of the final product;
 
 (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not;
 
 (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging;
 
 (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring;
 
 (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area;
 
 (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug;
 
 (n) "consignment or delivery" means the quantity of starting material or of a drug product, made by one manufacturer and supplied one time in response to a particular request or order, a consignment may comprise one or more packages or containers and may include material belonging to more than one batch;
 
 (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product;
 
 (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production;
 
 (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling;
 
 (r) "Form" means a form set forth in Schedule A;
 
 (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes;
 
 (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:--
 (i) ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use are as required by the marketing authorization or product specification; and
 (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products;
 
 (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture;
 
 (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control;
 
 (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product;
 
 (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form;
 
 (y) "manufacture" means all operations of production, quality control, release, storage and the related controls;
 
 (z) "manufacturer" means a company that carries out at least one step of manufacture;
 
 (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration;
 
 (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls;
 
 (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record);
 
 (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time;
 
 (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976);
 
 (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product;
 
 Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container.
 
 (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product;
 
 (ah) "pharmaceutical product" means any drug intended for human use or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form;
 
 (ai) "processing instructions or procedures" means a defined in clause (ab) of this section;
 
 (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product;
 
 (ak) "purity" means the degree to which other chemical or biological entities are present in any substance;
 
 (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices;
 
 (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product;
 
 (an) "quarantine" means status of starting or packaging materials intermediate, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing;
 
 (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used;
 
 (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture;
 
 (aq) "repacking" means all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labeling with a view to make it ready for retail sale or wholesale, but does not includes any compounding, or processing with a view to formulate it in any dosage form;
 
 (ar) "retail sale" means a sale other than wholesale;
 
 (as) "reprocessing" means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operations;
 
 (at) "returned product" means finished product sent back to the manufacturer or distributor;
 
 (au) "Schedule" means Schedule to these rules;
 
 (av) "semi-basic manufacture" means manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking;
 
 (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978;
 
 (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation;
 
 (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials;
 
 (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole;
 
 (ba) "validation" means the documented act of proving that any procedure, process, equipment, material, activity or system works correctly and actually leads to the expected result; and
 
 (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute.
 
 CHAPTER II
 MANUFACTURE OF DRUGS FOR SALE
 3. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :--
 (i) licence to manufacture by way of basic manufacture.
 (ii) licence to manufacture by way of semi-basic manufacture;
 (iii) licence to manufacture by way of formulation;
 (iv) licence to manufacture by way of repacking; and
 (v) licence to manufacture for experimental purposes.
 
 4. Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises.
 
 5. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary.
 
 (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F.
 
 Proviso: Added vide S.R.O. 536(1)/93 dated 23rd June 1993. Omitted vide S.R.O. 277 (1)/96 dated 2 lst April 1996.
 
 (3) If the application for renewal of the licence is made after the expiry of the period of the validity of the licence, it shall be treated as a fresh application for the grant of a licence.
 
 (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. Such copy of the licence shall bear the words "DUPLICATE COPY".
 
 (5) Any fee deposited under sub-rule (2) Shall in no case be refunded.
 
 6. Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time:
 
 Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years.
 
 Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled.
 
 7. Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2.
 
 . 8. Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :--
 
 (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman;
 (b) the Director, Health Services of, each Provincial Government;
 (c) two pharmacologists, to be nominated by the Federal Government.
 (d) one pharmacist, to be nominated by the Federal Government;
 (e) one medical specialist from the Army Medical Corps. to be nominated by the Federal Government.
 (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government;
 (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary;
 (h) one representative, not below the status of an officer of BPS- 19 [.....], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and
 (i) one representative of the Central Board of Revenue, not below the status of an officer of B-20, to be nominated by the Federal Government;
 (j) Cost Accountant of the Ministry of Health;
 (k) One physician, to be nominated by the Federal Government;
 (j) One Surgeon, to be nominated by the Federal Government. or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. and
 (m) one expert in veterinary medicine to be nominated by the Federal Government.
 
 (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board.
 
 (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination.
 
 (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration.
 
 (5) The meetings of the Central Licensing Board may be held at such time as the Board may deem fit and, on the request of any of its members, the Chairman may at any time call a meeting if there is any important matter for its consideration.
 
 (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting.
 
 (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership.
 
 (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period.
 
 (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time.
 
 (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board.
 
 (10) The chairman and the Secretary of the Central Licensing Board shall, after the Board has approved the issuance of a licence sign the licence.
 
 (11) Subject to rule 14, the Central Licensing Board may appoint a licensing authority or authorities for such purpose as it may deem fit.
 
 9. Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30.
 
 (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector -
 
 Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector.
 
 10. Procedure of Central Licensing Board: (1) The Central Licensing Board may, before issuing a licence, cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspector or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standarizing, if necessary, and analysing substances to be manufactured and enquire into the professional qualifications of the technical staff employed.
 
 (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection.
 
 (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2.
 
 (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued.
 
 (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4).
 
 (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application.
 
 (7) In case an application for licence to manufacture is made after the expiry of six months from the date of rejection of an application under sub-rule (1), such application shall be treated as a fresh application and full fee shall have to be deposited.
 
 11. Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf.
 
 (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products.
 
 (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences.
 
 12. Cancellation or suspension of licences: (1) If licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, or fails to deposit the requisite amount of the Central Research Fund due from him, the Central Licensing Board may, by an order in writing stating the reasons thereof, cancel a licence or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates.
 
 (2) The Central Licensing Board shall, before cancelling or suspending a licence under sub-rule (1), provide an opportunity of being heard to the licensee.
 
 (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence.
 
 (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be.
 
 13. Renewal of a licence: On application being made for renewal, the Central Licensing Board may cause an inspection to be made, and if satisfied that the conditions of the licence and the rules are and will continue to be observed, shall issue a certificate of renewal or otherwise reject the application and inform the licencee accordingly.
 
 14. Licensing authority: For the purpose of Section 18 of the Ordinance the Secretary to the Government of Province in the Health Department shall be the licensing authority for that Province.
 
 15. Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :--
 
 (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination.
 
 (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations;
 
 (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured.
 
 (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture.
 
 (e) The Quality Control Department shall be independent of the manufacturing units and its incharge shall be a whole-time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry, or a degree in medicine, microbiology, pharmacology, or bacteriology from a university in Pakistan or any other institution recognised by the Federal Government for the purposes of Ordinance, as the Central Licensing Board may deem fit for any particular unit; and shall be independent of the incharge of the manufacture (Production Units).
 
 (f) the applicant shall ensure that--
 
 (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin;
 (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area;
 (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required;
 (iv) hygienic garments shall be worn by all staff in processing and packaging areas;
 (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and
 (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. open lesions or skin infection shall be engaged in production areas.
 
 (g) The applicant shall provide--
 (i) adequate facilities for first aid;
 (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year;
 (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and
 (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases.
 
 Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and
 
 16. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :--
 
 (a) The factory premises shall comply with the conditions specified in Schedule B.
 (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1.
 
 (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A.
 
 (c) The manufacture shall be conducted under the 'active directions and personal supervisions of competent technical staff conisting of at least one person who is a whole-time employee and who has--
 
 (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or
 
 (ii) a degree in science with chemistry or pharmaceutical chemistry as the principal subject who, for the time being is working as incharge of a licensed pharmaceutical manufacturing unit, has not less than ten years practical experience in the manufacture of drugs intended to be manufactured knowledge of pharmacy which, in the opinion of the Central Licensing Board is adequate for the purposes; or
 
 (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced:
 
 Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, […..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced.
 
 (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture.
 
 Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule.
 
 (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs:
 
 Provided that in the case of drugs specified in Schedule C, the Central Licensing Board may allow the applicant to make arrangements with some other institution approved by the Central Licensing Board for such tests to be regularly carried out on his behalf by that institution.
 
 17. Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D.
 
 (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify.
 
 18. Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :--
 
 (a) adequate space and equipment shall be provided;
 (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16;
 (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked.
 
 19. Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence.
 
 (2) The licence shall be kept on the licenced premises and shall be produced at the request of any member of the Central Licensing Board or of Provincial Quality Control Board or an Inspector.
 
 (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board.
 
 (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent.
 
 (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities.
 (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance.
 
 (7) The licensee shall comply with the provisions of the Ordinance and the rules and with such further requirements, if any, as may be specified in any rule subsequently made-in this behalf or any other condition that may be imposed at the time of grant of a licence in the special circumstances of each case.
 
 (8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis.
 
 (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed.
 
 (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied.
 
 (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be.
 
 (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board.
 
 (13) No drug manufactured under licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture.
 (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution.
 
 (14) The Licensee shall , by the 30th June and the 31st December each year, Whichever is immediately after the annual financial closing of the company. contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978:
 
 Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly.
 Explanation: In this sub-rule, "profit" means gross profit before payment of income tax or other tax.
 
 (14-A) The contributions made towards the Central 'Research Fund under sub-rule (14) shall be kept in such bank as the Federal Government may specify and shall be utilised in accordance with the Drugs (Research) Rules, 1978.
 (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund;
 
 20. Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :--
 
 (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II.
 
 (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture.
 
 (c) The licensee shall either in his own laboratory or, where so authorised under the proviso to clause (e) of rule 16, in any other laboratory approved by the Central Licensing Board, test each batch of the raw materials used by him for the manufacture of drugs and also each batch of the final drug, shall maintain records showing the particulars in respect of such tests as specified in Schedule B-III and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture.
 
 20A. Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board.
 
 SCHEDULE ‘G’
 1. Contract production and analysis
 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver.
 
 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. A written contract between the contract giver and the contract acceptor shall clearly establish the duties of each party had state the way in which the authorized person shall exercise his full responsibility in releasing each batch of product for sale or issuing the certificate of analysis and a copy of such a contract shall be supplied to the Central Licensing Board also.
 
 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned.
 
 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it.
 
 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor.
 
 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s).
 
 2. Contract Giver
 2.1 The contract giver shall be responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of good manufacturing practices are followed.
 
 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products.
 
 2.3 The contract giver shall ensure that all processed products and materials delivered by the contract acceptor to comply with their specifications or that the product has been released by the authorised person(s).
 
 3. Contract acceptor
 3.1 The contract acceptor shall not pass to a third party any of the work entrusted to him or her under the contract without the written consent of the contract giver and prior evaluation and approval by the arrangements of the Central Licensing Board, and arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor.
 
 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver.
 
 4. The contract
 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties.
 
 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization.
 
 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer.
 
 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver.
 
 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected.
 
 21. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary.
 
 (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. or the director or manager of the firm or company by which, the drug will be manufactured.
 
 (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4.
 
 22. Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :--
 
 (a) That licensee shall use the drugs manufactured under the licence exclusively for experimental purposes and shall carry on the manufacture and experimental work at the place specified in the licence.
 
 (b) The licensee shall allow a member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that the manufacture is being conducted for experimental purposes.
 
 (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made.
 
 23. Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured.
 
 (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured.
 
 CHAPTER 3
 REGISTRATION OF DRUGS
 24. Registration Board: (1) The Registration Board shall consist of such members, including the
 Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8.
 
 (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act.
 
 (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board.
 
 (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board.
 
 (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration.
 
 (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply.
 
 25. Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30.
 
 26. Application for registration of drugs and fees thereof: (1) An application for registration of a drug shall be made in Form 5 or 5-A in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug.
 
 (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug.
 (3) An application under sub-rule (1) shall be accompanied by fee or--
 (a) rupees one thousand for the registration of new drug;
 (b) rupees five hundred for the registration of any other drug; and
 (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug:
 
 Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration.
 
 (3-A) Application for renewal of registration of a drug shall be made in Form 5-B.
 (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F.
 (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug.
 (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy".
 (6) Any fee deposited under sub-rule (3)shall in no case be refunded.
 
 27. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time.
 
 Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years :
 
 Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [....] drug for period of two years.
 
 28. Certificate of registration: A certificate of registration of drug shall be issued in Form 6.
 
 29. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report.
 
 (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed.
 
 (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection.
 
 (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.'
 
 (5) The Registration Board may, while registering a drug under sub-rule (4), approve the details as supplied by the applicant or approve them with amendments as it may deem fit in respect of the following particulars, namely :--
 
 (a) the name under which the drug may be sold;
 (b) the labelling;
 (c) the statement of all the representations to be made for the promotion of the drug in respect of--
 (i) the claims to be made for the drug;
 (ii) the route of administration;
 (iii) the dosage;
 (iv) the contra-indications, the side effects and precautions if any; and
 
 (d) Omitted by S.R.O. 551(1)//93, dated 3. 7. 1993.
 
 (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug.
 
 (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions:
 
 Provided that under special circumstances to be recorded in writing, the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration.
 
 (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features.
 
 (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration.
 
 (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ .]..., reject the application for registration and inform the applicant of the reasons for such rejection in writing.
 
 (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26.
 
 30. Conditions or registration of drug: (1) The relevant provisions of the Ordinance and the rules in respect of the registered drug, shall be complied with.
 
 (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered:
 
 Provided that deviations from any such information may be made only after obtaining prior approval of the Registration Board.
 
 (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion.
 
 (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market.
 
 (5) The manufacture of any drug shall not, without the prior approval of the Registration Board, be discontinued for period which may result in its shortage:
 
 Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board.
 
 (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year.
 
 (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan.
 
 (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and
 
 (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding--
 
 (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning
 that drug;
 (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug;
 (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug;
 (d) any substitution of another substance for that drug or any mixing of another substance with that drug;
 (e) any error in the labelling of that drug;
 (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug;
 (g) any failure of one or more distributed batches of that drug to meet the required specifications;
 (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and
 (i) any unusual failure of that drug to product it expected pharmacological activity.
 
 (9) The following information shall be supplied to the Registration Board--
 (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of
 sub-rule (8); and
 (b) immediately upon receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f) of sub-rule (8); and
 (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8).
 
 (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and--
 
 (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time;
 
 (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc;
 
 (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware.
 
 (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G.
 
 (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug, and
 
 CHAPTER IV
 ADVERTISING OF DRUGS, Etc.
 31. Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made:
 
 Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved.
 
 (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement.
 
 (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and
 
 (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only.
 
 (2) A drug or any substance referred to in clause (ii) of Sec. 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions •
 
 Provided that:
 (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and
 (ii) the Federal Government may, after giving an opportunity of being heard, prohibit the publication of any advertisement in any such journal as it is found to violate any of the conditions specified under sub-rule (1).
 
 (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :--
 (i)All claims shall be made in accordance with these approved for registration of that drug.
 (ii) Where the usual information on indications and dosage is provided, that advertisement material shall contain information on contra-indications, side effects and other necessary precautions as may be applicable.
 
 (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires.
 
 (5) A drug or any substance referred to in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied professions through a documentary film.
 
 (6) No advertisement under this rule shall contain any direct or indirect comparison in any way with any other drug or substance or remedy for any disease for the purpose of attracting customers or with a view to discredit other such product.
 
 (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided.
 
 (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12.
 
 (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health.
 
 (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2).
 
 (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request".
 
 32. Sampling of drugs: Samples of drugs may be provided to the physicians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words "Physicians Sample Not for Sale".
 
 33. Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs,
 
 Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule.
 
 34. Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance.
 
 35. Retailer's discount: The retailers discount shall be 15% of the maximum retail price.
 
 SCHEDULE A
 [See rule 2 (e)]
 Form 1
 [See rule 5 (/)]
 APPLICATION FORM GRANT OF A LICENCE TO MANUFACTURE BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BASIC MANUFACTURE/REPACKING
 I/We ...........of .........hereby apply for the grant of a licence to manufacture by way of........................on premises situated at ...................
 
 2. The drug(s) or class(es) of drugs intended to be manufactured :-
 (1) Class(es) of drugs.
 (2) Dosage form(s) of drugs.
 (3) Name of the drug(s).
 
 3. I enclose :-
 
 (i) Particulars regarding the legal status of the applicant (i.e. in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors).
 
 (ii) Details of the premises including layout plan of the factory.
 
 (iii) Details of the section-wise equipment and machinery for manufacture and quality control.
 
 (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments.
 
 4. The premises and plan will be ready for inspectionon or are ready for inspection.
 Dated.................. Signed……………………
 Place.................... Name, designation and address ........................
 
 -----------------------
 PROFORMA
 DETAILS OF THE FIRM
 Name of the Company ...................Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.)
 Name(s) of Proprietor(s)/Director(s)/Partner(s).
 Date of Establishment.
 Initial investment (and details of equity shares).
 Present investment (and details of equity shares).
 Profit and loss statement as per audited accounts for the last five years :
 Year
 Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit
 Calculated Paid investment Turnover
 
 Note: Copies of balance sheets to be enclosed with the application for renewal only"; and
 
 (6) in. Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely:
 
 Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture.
 ----------------
 FORM 1-A
 [See rule (5(I)]
 APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING
 I/We ............................ of ........................ hereby apply for the renewal of a licence to manufacture by way of on premises situated at ....................................
 
 2. The drug(s) or class(es)of drugs intended to be continued to be manufactured:-
 (i) Class(es) of drugs.
 (ii) Dossage form(s) of drugs.
 (iii) Name of the drug(s) registered/approved.
 
 3. There have been/have not been any change in respect of
 (i) Name of the proprietor/directors/partner(s)
 (ii) Details of the premises including layout plan of the factory.
 (iii) Details of the section-wise equipment and machinery for manufacture and quality control.
 (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments
 
 4. Statement of the Central Research Fund.
 
 Attested copies of the last two income tax assessment orders of the Income Tax Department attached.
 Following statement, as per audited accounts/based on Income Tax Return for the last five years:-
 Year Investment Turn-over
 CRF due C R F paid as per Col. 41 2 3 4 5
 Date Signed………………………….
 Place Name, designation and address of the signatory .......................
 Note:-Strike off which is not applicable
 ----------------------
 FORM 2
 [See rule 7] GOVERNMENT OF PAKISTAN
 Licence to Manufacture
 is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:-
 
 2. This licence permits the manufacture of
 
 3. This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:-
 
 (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled.
 
 (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale.
 
 (iii) Name of the approved expert staff.
 .......................................
 ....................................... .......................................
 .......................................
 Date of issue .................
 Secretary, Central Licensing Board. (Seal) Chairman, Central Licensing Board.
 
 FORM 2A
 (See rules 19 and 30)
 Warranty under Section 23(I)(i) of the Drugs Act, 1976
 I...................being a person resident in Pakistan, carrying on business at (full address) .................. under the name of.....................(and being an importer/indenter/authorised agent of ..................), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76.
 Dated (Signed)
 1. Name(s)• of the drug(s):
 (i)
 (ii) Batch number(s)
 
 2. Description of bill of sale, invoice, bill of lading or other document (if any).
 Signed ..............................
 ------------------------
 FORM 3
 [See rule 21(I)]
 APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES.
 I/We ............... of ........... hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .......................... and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976.
 
 1. Name and quantity of drug(s) to be manufactured for the said purposes:.
 Signature............................
 Name ..............................
 Address ...........................
 Countersigned by .......................
 
 FORM 4
 [See rule 21(3)]
 LICENCE TO MANUFACTURE DRUG(S)
 FOR EXPERIMENTAL PURPOSES
 Mr./Messrs .................... of .................. is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at ........................... :. or at such other place(s) at the. Central Licensing Board may from time to time permit.
 
 2. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf.
 
 3. This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:-
 
 Name of drugs with quantity to be manufactured.
 Date:.................
 Place:................. Licensing Authority.
 
 FORM 5
 [See rule 26(I)]
 APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE
 I/we.........................of ................hereby apply for registration of the drug namely ..................details of which are enclosed.
 Date .......................
 Place ......................
 ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG
 1. Name and address of the manufacturer •
 
 2, Name of drug •
 (a) Generic/international non-proprietary name:
 (b) Proprietory name, if any:
 
 3 Name under which drug is proposed to be sold
 
 4. Dosage from of the drug:
 
 5. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation :
 
 6. Proposed dosage :
 (a) for adults.
 (b) children by age group.
 (c) infant
 (d) special groups.
 
 7. Main Pharmacological group to which the drug belongs:
 
 8. Pharmacological and clinical data :
 (a) recommended clinical use and the claims to be made for the drug.
 (b) contra-indications.
 (c) toxicity or the side-effects.
 (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required.
 
 9. Proposed route of administration.
 
 10. Description of the method of manufacture and quality control with details of the equipment.
 
 11. Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed).
 
 12. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan).
 
 13. Stability Summary :
 (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used
 
 (b) Shelf-life when stored under expected or directed storage conditions.
 
 (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package..
 
 (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. (Such observations should be utilized for appropriate labelled storage conditions or warning statements).
 
 (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental).
 
 14. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted.
 
 15. Pack size (s) and proposed maximum retail price with the following details:-
 (i) Cost per retail pack of each active and non-active. Ingredients :
 (ii) Cost of each packing material.
 (iii) Cost of direct labour,
 
 16. Justification : (Only in case of a new entity).
 
 17. Patent number, if any, with date and its date of expiry.
 
 18. In case of a new drug (entity) not yet registered in Pakistan :
 (i) enclose certificate of registration and Free Sale from any of the following countries:
 Japan, USA and European Company Member countries.
 
 (ii) Any other relevant information that may be required by the Board for consideration of this application.
 FORM -5(A)
 [See rule 26 (1)]
 APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG
 I/We ........................of ..........................hereby apply for registration of the drug, namely....................details of which are enclosed.
 Date .......................
 Place ...................... Signed...........................
 
 ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG
 1. Name, address and status of the applicant:
 2. Name and address of the manufacturer:
 3. Name of the drug:
 (a) Generic international non-proprietory name:
 (b) Proprietory name, if any:
 
 4. Name of drug, under which it is proposed to be sod:
 5. Dosage form of the drug:
 6. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation:
 7. Proposed dosage:
 (a) for adults.
 (b) children by age group.
 (c) infants.
 (d) special groups,
 
 8. Main Pharmacological group to which the drug belongs:
 
 9. Proposed route of administration:
 
 10. Pharmacological and clinical data :
 (a) recommended clinical use and the claim to be made for the drug.
 (b) contra-indications.
 (c) toxicity or the side-effects.
 (d) any directions for. use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required.
 
 11. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed):
 
 12. Bio-availability studies:
 
 13. Stability studies :
 
 14. Proposed shelf life with storage conditions, if any :
 
 15 Type of container :
 
 16. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) :
 
 17. Proposed C and F and maximum retail price (in case of imported drug) :
 
 18. Justification :
 
 19. Certificate regarding sale and G.M.P. in the country of origin (in English and in Form 5 (c) :
 
 20. Certificate of registration by F.D.A. of USA. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. and Denmark.
 
 21. Patent number, if any, with date and its date of expiry :
 
 22. Undertaking to manufacture drug locally within two years. If it is not possible, the reasons therefor.
 FORM-5B
 [See rule 26(3A)]
 APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS
 I/We .................... of ................. hereby apply for renewal of registration of the drug, namely .................details of which are as follows •
 
 1. Name and address of the manufacturer:
 2. Name and address of the agent or indentor in case of imported drug -
 3. Whether the drug is registered for local manufacture or import •
 4. Name of the registered drug, with its registration number and date or initial ,registration and last renewal '
 5. Changes, if any, in information furnished at the time of initial registration or last renewal
 6. If withdrawn from the market anywhere •
 (i) Country.
 (ii) Reasons thereof.
 Place..................... Signature ..................
 Date....................... Name, and address of the signatory ............................
 FORM-5C
 TO WHOM IT MAY CONCERN CERTIFICATE OF DRUGS REGISTERED UNDER
 THE DRUGS ACT, 1976
 Name and dosage form of product .........................................
 Name and amount of each active ingredient .............................................................................................
 
 Manufacturer and or when applicable the person responsible for Placing the Product on the market ............................ Address(es)......................................................................
 
 It is certified :
 * This product has been authorised to be place of the market for use in this country.
 *Number of Registration and date of issue if plicable.
 *This product has not been authorised to be placed on the market for use in this country for the following reason-
 ...
 ...
 ..................................................................................
 ........................................
 
 It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported.
 (Signature of designated authority (Place and date)
 FORM 6
 [See rules 28 and 29(4)]
 GOVERNMENT OF PAKISTAN
 CERTIFICATE OF REGISTRATION
 Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:-
 Name of Drug(s).
 Name of Manufacturer.
 Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only).
 
 2. This registration shall be valid for a period of five years unless earlier suspended or cancelled.
 
 3. This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure.
 Date of Registration Secretary Registration Board (Seal) Chairman. Registration Board
 
 FORM 7
 [See rule 30(6)]
 STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE
 Name of drug. _________________________
 Pharmacological group _________________________
 Name of the Firm. _________________________
 Address. _________________________
 For the quarter ending. _________________________
 Pack size. No. of Pack Total quantity in terms of individual units e.g., total No. of tablets, injections tubes litres etc.
 1 2 3
 VALUE (in Rs.) Details of Disposal
 On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. Value of raw materials used (Active & inactive) (in Rs.)
 4 5 6 7
 Total.
 
 
 SCHEDULE B
 
 CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION
 
 SECTION-I
 PREMISES
 1. Location and Surroundings .
 1.1 Location
 1.2 Surroundings
 2. Building Layout And Its Pre-Approval3. Building Design And Construction (General)
 3.1 General
 3.2 Services
 3.3 Protection Against Insects etc.
 3.4 Surfaces
 4. Storage Areas
 4.1 Capacity
 4.2 Design
 4.3 Bays
 4.4 Quarantine
 4.5 Sampling
 4.6 Rejected Materials
 4.7 Special Materials
 4.8 Packaging Materials
 4.9 Weighing Area
 5. Production Department
 5.1 General Facilities
 5.2 Dedicated Facilities for Production
 5.3 General Requirements for Production Areas
 (i) Layout
 (ii) Adequacy
 (iii) Surfaces
 (iv) Services
 (v) Drains
 (vi) Environmental Controls
 (vii) Packaging
 (viii) Light
 6. Ancillary Areas
 6.1 Rest Rooms
 6.2 Changing Rooms
 6.3 Workshops
 6.4 Animal House
 
 SECTION--2
 EQUIPMENT FOR PRODUCTION
 2.1 General
 2.2 Layout
 2.3 Construction
 2.4 Piping
 2.5 Tanks
 2.6 Filters
 2.7 Cleaning Equipment
 2.8 Defective Equipment
 
 SECTION--3
 QUALITY CONTROL DEPARTMENT
 3.1 General
 3.2 Laboratories
 3.3 Areas
 3.4 Facilities
 (i) Equipment
 (ii) Others
 (iii) Written Procedures
 (iv) Validation
 (v) Storage
 
 SECTION--4
 DOCUMENTATION
 4.1 General
 4.2 Specification & Testing Procedures
 (i) Reference Books
 (ii) Testing Procedures
 (iii) Specifications
 4.3 Specifications for Starting and Packaging Materials
 4.4 Specifications for Finished Products
 4.5 Master Formula
 4.6 Packaging Instructions
 4.7 Standard Operating Procedures (SOPs) and Records
 4.8 S.O.Ps for Testing
 4.9 S.O.Ps for Sanitation
 4.10 S.O.Ps Miscellaneous
 4.11 Labels
 4.12 Batch processing records
 
 SECTION--5
 SANITATION AND HYGIENE
 5.1 Sanitation
 5.2 Hygiene
 
 SCHEDULE B-I
 [See rule 16 (6) (b)]
 
 REQUIREMENTS OF PLANT AND EQUIPMENT
 (A) The following equipment is required for the manufacture of drugs for external appliances or suspense:
 (1) Mixing tanks where applicable:
 (2) Kettles, steam, gas or electrically heated.
 (3) A suitable power driven mixer.
 (4) Storage tanks or pots.
 (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable.
 (6) A triple-roller mill or an ointment mill, where applicable.
 (7) Liquid filling equipment.
 (8) Jar or tube filling equipment, where applicable.
 Area of minimum of 200 square feet is required for the basic installation.
 
 (B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :--
 (1) Mixing and storage tanks.
 (2) Mixer.
 (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter.
 (4) Water still or Deioniser.
 (5) Various liquid measures and weighing scale.
 An area of maximum 300 square feet is required for the basic installations.
 
 (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms,
 (i) Granulating Section;
 (ii) Tableting Section;
 (iii) Coating Section.
 The following equipment is required in each of the three sections :-
 
 1. Granulating Section: (1) Disintegrator, where applicable.
 (2) Power Mixer or granulation mixer with stainless steel cabinet
 (3} Granular
 (4) Oven thermostatically controlled.
 
 2. Tableting Section:
 (1) Tablet machine, single punch or rotary.
 (2) Pill machine, where applicable.
 (3) Punch and dyes storages cabinet.
 
 The Tableting Section shall be free from dust and floating particles. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles.
 
 3. Coating Section:
 (1) Jacketed kettle, or equivalent steam, gas or dect£1cally heated for preparing solution.
 (2) Coating pan.
 (3) Polishing pan, where applicable,
 {4) Heater and exhaust system, where applicable.
 
 The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation.
 
 A total area of not less than 900 square feet for the three Sections is required for basic installations.
 
 The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. The granulation, tableting and packing shall be done in this room.
 
 (D) The following equipment is required for the manufacture of Powders :--
 (1) Disintegrator, where applicable.
 (2) Mixer.
 (3) Sifter or sieve.
 (4) Stainless steel vessels and scoops of suitable material,
 (5) Filling equipment,
 
 In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation.
 
 If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules.
 
 (E) The following equipment is required for filling of Hard Gelatin Capsules:-
 
 (1) Mixing and blending equipment.
 
 (2) Capsule filling units.
 An area of minimum of 200 square feet is required for the basic installations. The room shall be air-conditioned and also dehumidified wherever necessary.
 
 (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool
 (1) Rolling machine.
 (2) Trimming machine.
 (3) Cutting equipment.
 (4) Folding and pressing machine for gauze.
 (5) Mixing tanks for processing medicated dressings.
 (6) Hot air drying ovens.
 (7) Steam steriliser or dry heat steriliser.
 
 An area of minimum of 300 square feet is required for the basic installations. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided.
 
 (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :-
 
 (1) Hot air oven electrically heated with thermostatic control.
 (2) Kettle, gas or electrically heated with suitable mixing arrangement.
 (3) Colloid mill or homogeniser.
 (4) Tube filling equipment.
 (5) Mixing and storage tanks of stainless steel or of other suitable material.
 (6) Sintered glass funnel, seitz filter or filter candle.
 (7) Liquid filling equipment.
 (8) Autoclave.
 
 An area of minimum of 250 square feet is required for the basic installation. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. The room shall be further dehumidified if preparations containing antibiotics are manufactured.
 
 (H) The following equipment is required for the manufacture of Pessaries and Suppositories :-
 (1) Mixing and pouring equipment.
 (2) Moulding equipment.
 An area of minimum of 200, square feet required far the basic installation,
 
 In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :--
 (1) Mixer.
 (2) Granulator.
 (3) Drier.
 (4) Compressing machine.
 (5) Pessary and tablet counter.
 
 (I) The following equipment is required for the manufacture of inhalers end Vitrallae:
 (1) Mixing equipment.
 (2) Graduated delivery equipment for measurement of the medicament.
 (3) Sealing equipment,
 An area of minimum of 200 square feet is required for the basic installations.
 
 (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals
 (1) Sifter.
 (2) Stainless steel scoops end vessels.
 (3) Weighing and measuring equipment.
 (4) Filling equipment.
 An area of minimum of 300 square feet is required for basic packing operations. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided.
 
 (K) Requirements for the manufacture of Parenteral Preparations: The whole process of the manufacture of parenteral preparations may be divided into the following separate operations:
 
 (a) Preparations of the container: This includes, cutting. washing, drying sterilisation of ampoules or vials prior to
 (b) Preparation of solution: This includes preparation and filteration of solution.
 (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials.
 (d) Sterilisation.
 (e) Testing,
 The following basic hygienic requirement shall be complied with
 
 (1) Strict sanitation shall be maintained throughout the entire plant in order to prevent contamination and to keep out pyrogens, Masks end overalls shall be worn wherever necessary.
 
 (2) The preparation room where the solution ate prepared shall be of such a nature that may be kept scrupulously clean. This room shall be air-conditioned.
 
 (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. prevent, the entry of air from outside. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed.
 
 (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted.
 
 (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin
 
 (6) Finished products shall be stored in a suitable separate place.
 
 The following equipment required :-
 
 Manufacturing Area :
 (1) Storage equipment for ampoules and vials
 (2) Ampoule washing and drying equipment.
 (3) Dust proof storage Cabinets.
 (4) Water still.
 (5) Mixing and preparation tanks or other containers. The tanks or containers shall be made of either glass or such material which will not react with the liquid
 (6) Filtering equipments such as filter press or sintered glass funnel.
 (7) Autoclave,
 (8) Hot Air Steriliser,
 
 Filling and Sealing Room:
 (9) Benches for filling and sealing.
 (10) Filling and sealing unit
 
 Aseptic Filling and sealing room:
 (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters,
 (12} Filling and. sealing unit,
 
 General Room:
 (13) Inspection table with draft and light background
 (14) Leak tasting equipment.
 (15) Labelling and packing benches,
 (16) Storage equipment including cold storage and refrigerators, if necessary
 
 Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case:
 
 Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record,
 
 Note//: This Schedule gives equipment and space required for certain categories of drugs only. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. The Central Licensing Board shall, in respect of such categories of drugs, have the discretion to examine the adequacy or otherwise of factory premises, space, plant, machinery and other requirements having regard to the nature and extent of the manufacture to carry out necessary modifications in them and, on the modification. having been made, approve of the manufacture of such categories of drugs. Any drug so permitted to be manufactured by the Central Licensing. Board shall be deemed to be an additional category of drug for the purpose of this Schedule.
 
 SCHEDULE B I-A.
 [See rule 16 (bb)-7]
 CONDITIONS OF FACTORY PREMISES
 1. Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding.
 
 2. (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. Sufficient water must be available for fire-fighting.
 (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material.
 (c) Doors; Doors must be fire resistant preferably with self-closing system,
 (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. There should be no drains at all in plants and in warehouse. If drains are absolutely necessary they must not contract directly with waterways or public sewers,
 (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. Local exhaust system must be effective,.
 
 3. Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided.
 
 Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. Safety instructions should be strategically displayed in local language. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory.
 
 4. Medical Services: There must be pre-employment medical; , examination for all staff members whether working permanently or on contract basis. When organophosphates or carbamates are handled, pre-exposure baseline blood cholinesterase level must be determined for all operational staff. Staff regularly engaged in formulation and packing procedures and maintenances must have their cholinesterase levels checked regularly and detailed records must be kept. The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert.
 
 "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :--
 
 (i) A decease of more than 20% in blood cholinesterase activity,. from the pre-exposure value indicates that the cause should be investigated.
 
 (ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates.
 
 Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value.
 
 SCHEDULE B-II
 GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO
 MANUFACTURE BY WAY OF FORMULATION
 
 CONTENTS
 
 PART-I
 
 GENERAL CONDITIONS
 
 SECTION-1
 1.1 Responsibility of licensee for drugs fitness for use.
 
 SECTION-2
 2. Quality assurance system.
 
 SECTION-3
 3. Quality control.
 3.1 Quality Control Department
 3.2 Basic requirements
 3.3 Control procedures
 3.3.1 General
 3.3.2 Sampling
 3.3.3 Test requirement for starting and packaging materials
 3.3.4 Test requirement for in-process controls
 3.3.5 Test Requirement for Finished Products
 3.3.6 Production record/batch review
 3.3.7 Stability studies
 3.4 Self inspection
 3.4.1 General
 3.4.2 Items for self inspection
 3.4.3 Self inspection team
 3.4.4 Frequency of self inspection
 3.4.5 Self inspection report
 3.4.6 Follow-up Action
 3.5 Quality Audit
 3.5.1 Audit by independent specialist
 3.5.2 Supplier’s audits
 3.6 Complaints
 3.6.1 Review of complaints
 3.6.2 Person authorized
 3.6.3 Written procedures
 3.6.4 Recording defects and investigation
 3.6.5 Investigations
 3.6.6 Follow-up action
 3.6.7 Recording measures
 3.6.8 Review for Reviewing Problem
 3.7 Product recalls
 3.7.1 System
 3.7.2 Authorized procedures
 3.7.3 Written procedures
 3.7.4 Recall with promptness
 3.7.5 Distribution records
 3.7.6 Recording and progress
 3.7.7 Evaluation
 3.7.8 Storage of recalled drugs
 3.7.9 All concerned to be informed
 
 SECTION--4
 4. Personnel
 4.1 General
 4.2 Written duties
 4.3 GMP awareness
 4.4 Prohibition of unauthorized person
 4.5 Duties of Heads of Departments
 4.6 Duties of Production Incharges
 4.7 Duties of Quality Control Incharges
 4.8 Training
 4.8.1 Written programme
 4.8.2 Training appropriate to duties
 4.8.3 Specific training
 4.8.4 Understanding concepts
 4.8.5 Visitor and untrained personnel discouraged
 4.9 Personal hygiene
 4.9.1 Health examination
 4.9.2 Practices in personal hygiene
 4.9.3 Illness
 4.9.4 Reporting health problems
 4.9.5 Avoiding direct contact with materials
 4.9.6 Appropriate clothing and covering
 4.9.7 Foods and drinks prohibited
 
 SECTION -- 5
 GOOD PRACTICES IN MANUFACTURING PROCESSING
 5.1 General responsibility of licensee
 
 SECTION--6
 MATERIALS
 6.1 Material, general
 6.1.1 Quarantine
 6.1.2 Appropriate storage
 6.2 Starting materials
 6.2.1 Purchase
 6.2.2 Purchase from producer or established supplier
 6.2.3 Checking of containers
 6.2.4 Damaged container
 6.2.5 Delivery from different batches
 6.2.6 Labelling
 6.2.7 Identity of contents
 6.2.8 Released materials to be used
 6.2.9 Correct dispensing
 6.2.10 Checking
 6.2.11 Labelling
 6.3 Packaging materials
 6.3.1 Purchase
 6.3.2 Printed materials
 6.3.3 Reference numbers
 6.3.4 Obsolete materials
 6.3.5 Checking before delivery
 6.4 Intermediate and bulk products
 6.4.1 Storage
 6.4.2 Handling
 6.5 Finished Pharmaceutical Products
 6.5.1 Quarantine
 6.5.2 Release
 6.6 Rejected and recovered materials
 6.6.1 Storage and disposal
 6.6.2 Reprocessing
 6.6.3 Batch recovers
 6.6.4 Additional testing of reprocessed materials
 6.7 Recalled and returned products
 6.7.1 Recalled products
 6.7.2 Returned goods
 6.8 Reagents and culture media
 6.9 Reference standards
 6.9.1 Testing prepared reference standard
 6.9.2 Use
 6.9.3 Working standards
 6.9.4 Storage
 6.10 Waste materials
 6.10.1 Storage
 6.10.2 Disposal
 6.11 Miscellaneous
 
 SECTION -- 7
 7.1 Processing operations
 7.1.1 General
 7.1.2 Material handling
 7.1.3 Avoiding deviation
 7.1.4 Yield checks
 7.1.5 Avoiding mix-ups
 7.1.6 Labelling
 7.1.7 Unauthorized entry prohibited
 7.1.8 In price controls
 7.2 Prevention of cross-contamination and bacterial contamination in production
 7.2.1 Precautions against dust
 7.2.2 Measures against contamination
 7.2.3 Cross contamination checks
 7.2.4 Microbiological monitory
 7.3 Processing operations intermediate and bulk products
 7.3.1 Pre-Processing cleanliness checks
 7.3.2 In-process controls
 7.3.3 Defective equipment
 7.3.4 Cleaning containers
 7.3.5 Yield deviations
 7.3.6 Product pipelines
 7.3.7 Water pipes
 7.3.8 Equipment calibration
 7.3.9 Repair or maintenance
 7.4 Packaging operations
 7.4.1 Avoiding mix-ups
 7.4.2 Pre-packaging checks
 7.4.3 Labeling packaging line
 7.4.4 Process continuity
 7.4.5 Printing operation checks
 7.4.6 Label verification
 7.4.7 Resistant printing on labels
 7.4.8 On-line packaging checks
 7.4.9 Product re-introduction on packaging line
 7.4.10 Discrepancies to be investigated
 7.4.11 Destruction of un-used packaging materials
 
 SECTION -- 8
 8. Sanitation and hygiene
 
 SECTION -- 9
 9. Validation
 9.1 General
 9.2 Process validation
 9.2.1 Validation of critical processes
 9.2.2 Validation of new master formula
 9.2.3 Validation of equipment if materials
 
 SECTION -- 10
 10.1 Documents
 10.1.1 Maintenance of documents
 10.1.2 Recording actions
 10.1.3 Documentation system
 10.1.4 Status identification
 10.1.5 Product labelling
 10.1.6 Reference standards identification
 10.1.7 Specification approvals
 10.1.8 Revision of specification
 10.1.9 Packaging material specification
 10.1.10 Starting material re-assay
 10.2 Specification for intermediate and bulk products
 10.3 Batch processing records
 10.3.1 General
 10.3.2 Checking work station
 10.3.3 Recording process operation
 10.4 Batch packaging records
 10.4.1 General
 10.4.2 Pre-packaging line checks
 10.4.3 Recording packaging operation
 10.4.4 Recording batch numbers
 10.4.5 Analytical records
 10.4.6 Finished product release procedure
 10.4.7 Recording batch distribution
 10.4.8 Standard operating procedures
 10.4.9 Equipment logbooks
 10.4.10 Equipment utilization record
 
 PART-II
 
 ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT
 SECTION -1
 1. General
 Air Classification system for manufacture of sterile products
 2. Manufacture of sterile preparations
 2.1 Manufacturing operations
 2.2 Terminally sterilized products
 2.3 Products sterilized by filtration
 2.4 Products manufactured under aseptic conditions
 3. Personnel
 General
 Personnel training
 Entry restricted
 Hygiene and cleanliness
 Use of protective garments
 Clothing requirements
 Protective garments in grade B room
 Washing of clothing
 Prohibitions
 
 SECTION--2
 4. Maintenance of clean area
 General
 Airlock system
 Air supply system
 Maintenance of equipment
 Water supply
 
 SECTION -- 3
 5. Equipment maintenance
 Documentation
 
 SECTION -- 4
 6. Sanitation
 Procedure
 Use of disinfectants and detergents
 Fumigation
 Monitoring of clean areas
 
 SECTION -- 5
 7. Processing
 Precautions against contamination
 Preparation of live organisms
 Simulation of aseptic operations validation
 Monitoring water supply of sources
 Activities in clean areas kept minimum
 Care of starting materials
 Care against fibers
 Care after final cleaning of materials
 Interval between operations to be minimal
 Sterilization of gases used
 Bioburden to be minimal
 Asepsis of articles in clean areas
 New processes to be validated
 
 SECTION -- 6
 8. Sterilization
 General
 Validation
 Suitability of process
 Care for biological indicators
 Sterilized non-sterilizer products differentiation
 9. Sterilization by heat
 Recording sterilization cycle
 Sufficient time allowed to reach required temperature
 Precautions during cooling
 10. Sterilization by moist heat
 General
 Wrapping materials
 11. Sterilization by dry heat
 12. Sterilization by radiation
 General
 Outside contractor
 Measurement of radiation
 Validation
 Handling procedures
 13. Sterilization by ethylene oxide
 General
 Ensure contact between gas and microbial cells
 Equilibrium with humidity and temperature
 Monitoring each cycle
 Biological indicators
 Record maintenance
 Validation
 14. Filtration of pharmaceutical products that cannot be sterilized in the final container
 General
 Using double filter layer
 Eliminate fibers
 Checking integrity of filters
 Frequency of use of filter
 Filter safety
 15. Finishing of sterile products
 General
 Use of vacuum
 Inspection of containers
 
 SECTION -- 7
 16. Quality control
 Sterility testing
 Sterility test as the last measures
 Monitoring endotoxin
 
 
 SCHEDULE B-III
 [See rule 20 (b)]
 PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS
 A. Substances Parenteral preparation in general:
 1. Serial Number.
 2. Name of the drug.
 3, Batch Size,
 4. Batch number.
 5. Date of commencement of manufacture and date when manufecture was completed,
 6. Name of all ingredients, quantities required for the batch size, quantities actually used. (All weighings and measurements shall be checked initiated b¥ the competent person in the section).
 7. Control reference numbers in respect of raw materials used in formulation.
 8. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc.
 9. Date of granulation wherever applicable.
 10. Weight of granules.
 11. Date of compression in case of tablets/date of filling in case of capsules.
 12. Dates of coating wherever applicable.
 13. Records of test to be carried out in case of tablets as under
 (a) Average weight every thirty minutes.
 (b) Disintegration time as often as practicable.
 14. Records of readings taken to check weight variation in case of capsules,
 15. Reference to Analytical Report number stating whether of standard quality or otherwise.
 16, Records on the disposal of rejected batches and batches with-drawn from the market.
 17, Actual production and packing particulars indicating the size and quantity of finished packings,
 18. Date of release of finished packings for distribution or sale,
 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained,
 20. Signature of the expert staff responsible for the manufacture,
 
 B. Parenteral preparation:
 1. Serial Number,
 2. Name of the drug,
 3. Batch Size,
 4. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch),
 
 5. Date of commencement of manufacture and date of completion.
 
 6. Name of all ingredients, quantities required for the lot size, quantities actually used. (All weighings and measurements shall be checked and initialled by the competent person in the section).
 
 7. Control reference numbers in respect of raw materials used.
 8. PH of the solution wherever applicable.
 9. Date and methods of filtration.
 10. Sterility test reference on bulk batch wherever applicable. (If bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch.
 11. Date of filling.
 12. Records of tests employed :--
 (a) To ensure that sealed ampules are leak-proof,
 (b) To check the presence of foreign particles.
 (c) For pyrogens wherever applicable.
 
 13. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed.
 14. Number and size of containers filed and number rejected.
 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise.
 16. Records of the disposal of rejected batch and batches with-drawn from the market.
 17. Actual production and packing particulars.
 18. Date of release finished packings for distribution or sale.
 19. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained.
 20. Control reference numbers in respect of the lot of glass containers used for filling.
 21. Signature of the expert staff responsible for manufacture.
 
 II. RECORDS OF RAW MATERIALS
 Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks.
 
 III. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS
 A. Tablets and capsules:
 1. Analytical report number.
 2. Name of the sample.
 3. Date of receipt of sample,
 4. Batch number.
 5. Protocols of tests applied:
 (a) Description.
 (b) Identification.
 (c) Uniformity of weight.
 (d) Uniformity of diameter (if applicable).
 (e) Disintegration test (time in minutes).
 (f) Any other tests.
 (g) Results of assay.
 
 Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. 5 whenever necessary.
 6. Signature of the Analyst.
 7. Opinion and signature of the approved Analyst.
 
 B. Parenteral Preparations
 1. Analytical report number.
 2. Name of the sample.
 3. Batch number.
 4, Date of receipt of sample.
 5. Number of containers filled.
 6. Number of container packed
 7. Protocols of tests applied
 (a) Clarity,
 (b) PH wherever applicable,
 (c) Identification.
 (d) Volume in container,
 (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample.
 (f) Pyrogen test, wherever applicable.
 (g) Toxicity test, wherever applicable.
 (h) Any other teats.
 (i) Results of assay.
 
 Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. wherever necessary
 8. Signature of the Analyst.
 9, Opinion and signature of the approved Analyst Pyrogen Tests:-
 1. Test Report number.
 2. Name of the sample.
 3. Batch number.
 4. Number of rabbits used.
 5. Weight of each rabbit.
 6. Normal temperature of each rabbit.
 7. Mean initial temperature of each rabbit,
 8. Dose and volume of solution injected into each rabbit and time of injection.
 9. Temperature of each rabbit noted at suitable intervals,
 10. Maximum temperature.
 11. Response.
 12. Summed response,
 13. Signature of the Analyst,
 14. Opinion and signature of the approved Analyst
 
 Toxicity Test:
 1. Test Report number.
 2. Name of the Sample
 3, Batch number
 4. Number of mice used and weight of each mouse, Strength and volume of the drug injected,
 6, Date of injection,
 7. Results and remarks,
 8. Signature of Analyst,
 9. Opinion and signature of the approved Analyst.
 
 C. For other drugs:
 1.Analytical report number
 2. Name of the sample
 3. Batch number.
 4, Date of receipt of sample
 5. Protocols of tests applied:
 (a) Description.
 (b) Identification.
 (c) Any other tests
 (d). Results of assay.
 
 Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 5 wherever necessary.
 
 6. Signature of the Analyst.
 7. Opinion and signature of the approved Analyst.
 
 D. Raw materials:
 1. Serial number
 2. Name of the material
 3. Name of the manufacturer/supplier.
 4. Quantity received.
 5. Invoice/Challan number and date.
 6. Protocols of tests applied.
 Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. 6 wherever necessary.
 E. Container, packing material, etc.:
 1. Serial number.
 2. Name of the item.
 3. Name of the manufacturer/supplier.
 4. Quantity received.
 5. Invoice/Challan number and date.
 6, Results of tests applied.
 
 Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. 6 wherever necessary.
 
 7. Remarks.
 8. Signature of the examiner.
 
 Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule.
 
 Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with.
 
 Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case.
 
 
 SCHEDULE C
 [See rule 16(c) (iii) and (e)]
 1. Sera.
 2. Solution of serum proteins intended for injunction.
 3. Vaccines.
 4. Toxins.
 5. Antigen.
 6. Antitoxins.
 7. Insulin.
 8. Pituitary (Posterior Lobe) Extract.
 9. Sterilized surgical lignature and sterilized surgical suture.
 10. Bacteriophages.
 
 SCHEDULE D
 [See rule 17(1)]
 DRUGS FOR REPACKING
 1. Alniminium Hydroxide Gel Dried.
 2. Ammonium Bicarbonate.
 3. Ammonium Chloride.
 4. Ammonium Carbonate.
 5. Benzoic Acid.
 6. Bismuth Carbonate.
 7. Bismuth Subnitrate.
 8. Boric Acid.
 9. Borax.
 10. Caffein and its Salts.
 11. Calamine.
 12. Calcium Carbonate.
 13. Calcium Lactate.
 14. Calcium Gluconate.
 15. Calcium Hydroxide.
 16. Castor Oil.
 17. Cetrimide Powder.
 18. Chloral Hydrate.
 19. Ephedrine Hadrochloride.
 20. Ephedrine Sulphate.
 21. Ferrous Sulphate.
 22. Ferric Ammonium Citrate.
 23. Gentian Violet.
 24. Glycerin.
 25. Iodine.
 26. Ichthammol.
 27. Kaolin.
 28. Liquid Paraffin Heavy.
 29. Magnesium Carbonate.
 30. Magnesium Hydroxide.
 31. Magnesium Sulphate.
 32. Methylene Blue.
 33. Magnesium Trisilicate.
 34. Methyl Salicylate.
 35. Phenothlazine (B. VET. C.).
 36. Pix Carb.
 37. Potassium Acetate.
 38. Potassium Bromide.
 39. Potassium Bicarb.
 40. Potassium Chloride.
 41. Potassium Citrate.
 42. Potassium Iodine.
 43. Potassium Permanganate.
 44. Procaine Hydro-Chloride.
 45. Pulv Gentian.
 46. Resorcin.
 47. Salicylic Acid.
 48. Sentonin.
 49. Sena.
 50. Sodium Benzoate.
 51. Sodium Bicarbonate.
 52. Sodium Chloride.
 53. Sodium Bromide.
 54. Sodium Carbonate.
 55. Sodium Citrate.
 56. Sodium Iodide.
 57. Sodium Metabisuphite.
 58. Sodium Potassium Tartrate.
 59. Sodium Salicylate.
 60. Sodium Sulphate.
 61. Sodium Thiosulphate.
 62. Soft yellow Paraffin.
 63. Sulphonilamide Powder (B. VET. C).
 64. Sulphur Precipitated.
 65. Sulphur Sublime.
 66. Tannic Acid.
 67. Zinc Oxide.
 68. Zinc Sulphate.
 SCHEDULE D-I
 [See rule (31)1]
 Household remedies including--
 
 Analgesics:
 Aspirin and Paracetamol in tablets and liquid forms.
 (2) Analgesic Balms/Plasters.
 (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics.
 (4) Antidandruff preparations.
 (5) Dental preparations.
 (6) Antacid and carminatives:
 Compound Effervescent Salts, [--] , Milk of Magnesia.
 (7)
 (8) Contraceptives.
 (9) Miscellaneous.
 Fish Liver Oil and its equivalents.
 
 SCHEDULE E
 [See rule 31 (10)]
 DISEASES, ADVERTISEMENT FOR TREATMENT OF
 WHICH IS PROHIBITED
 1. [Omitted vide S.R.O. 871(I)/78, dated 8th July, 1978.]
 2. [Omitted vide S.R.O. 871(I)/78, dated 8th July, 1978.]
 3. Venereal diseases.
 4. Sexual importance.
 5. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts.
 6. Bright’s disease, cataract, glaucoma, epilepsy, [...] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness.
 7. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities.
 8. Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs).
 9. Gripe Waters.
 10. Cough Preparations.
 
 
 SCHEDULE F
 [See rule 5 (2)]
 1. DRUG MANUFACTURING LICENCE FEE
 (a) For the grant of licence:
 Type of licence Fee
 By way of basic Rs. 10,000By way of semi-basic Rs. 10,000
 By way of formulation Rs. 25,000
 By way of repacking Rs. 15,000
 (b) For the renewal of licence
 
 (i) If the application for renewal if made before the expiry of period of validity of licence.
 Type of licence Fee
 By way of basic Rs. 5000By way of semi-basic Rs. 5,000
 By way of formulation Rs. 12,500
 By way of repacking Rs. 7,500
 (ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity:
 Type of licence Fee
 By way of basic Rs. 10,000By way of semi-basic Rs. 10,000
 By way of formulation Rs. 25,000
 By way of repacking Rs. 15,000
 II. DRUG REGISTRATION FEE
 [See rule 26 (3)]
 (A) For the grant of Registration Rs. 5,000
 (B) For the renewal of Registration
 (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 2,500
 (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate
 Rs. 5,000
 III. FEE FOR ADVERTISEMENT
 [See rule 31 (1A) and (1B)]
 Application fee for Advertisement. Rs. 1,000 per advertisement
 
 
 
 
 
 SCHEDULE G
 [See rule 30 (11)]
 ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION
 1. Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.
 
 (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. The word "safe" shall not be used with respect to promotion unless properly qualified. Comparison of products shall be factual, fair and capable of substantiation. Promotional material shall not be designed so as to disguise its real nature.
 
 (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs.
 
 2. Advertisements in any form made to physicians and health-related professionals.-(1) The wording and illustrations in advertisements to physicians and related health professionals shall be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. The text shall be fully legible.
 
 (2). While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:-
 (a) The generic name(s) of the active ingredient(s);
 (b) the content of active ingredient(s) per dosage form or regimen;
 (c) the generic name(s) of other ingredient(s) known to cause problem(s)
 (d) the approved therapeutic uses;
 (e) dosage form or regimen;
 (f) side-effects and major adverse drug reactions;
 (g) precautions, contra-indications and warnings;
 (h) major interactions;
 (i) the name and address of manufacturer or distributor; [--]
 (j) reference to appropriate scientific literature ; and
 (k) Price of the drug, ; and
 
 (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information.
 
 3. Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. While advertisements shall take account of people’s legitimate desire for information regarding their health they shall not take undue advantage of people’s concern about their own health. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug.
 
 (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. Language which brings about fear or distress shall not be used.
 
 (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:-
 (a) The generic name(s) of the active ingredient(s);
 (b) major indication(s) for use; (S.R.O. 1362(I)/96-28.11.96).
 (c) major precautions, contra-indications and warnings, if any; and
 (d) name of manufacturer or distributor.
 
 4. Information on price to the consumer shall be accurately and honestly portrayed.
 
 4. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers shall be responsible for the basic and continuing training of their representatives. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. criteria.
 
 (2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents.
 
 (3) Employers shall be responsible for the statements and activities of their medical, representatives. Medical representative shall not offer inducements to prescribers and dispensers. Prescribers and dispenses shall not solicit such inducements. In order to avoid over-promotion, the main part of the volume of sales they generate.
 
 5. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request.
 
 6. Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes.
 
 7. Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. The invitation letter should accurately reflect the presentations and discussions to be held. Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level.
 
 8. Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible.
 
 (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion.
 
 (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority.
 
 9. Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule.
 
 10. Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. If package inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this Schedule. The wording of the pcakge inserts or leaflets, if prepared specially for patients, shall be in lay language subject to the condition that the medical and scientific content is properly reflected.
 
 (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule.
 
 [No. F. 8-1/90--AU (Vol-11.)]
 DR. F.R.Y. FAZLI,
 Deputy Director General (Pharmacy)/Drugs Controller.
 (S.R.O. 1362(I)/96 28.11.1997)
 
 

12
Pharmaceutical / Drug Regulatory Authority Pakistan DRAP ACT 2012
« on: April 17, 2014, 11:51:39 AM »
WHEREAS it is expedient to establish a Drug Regulatory Authority of Pakistan to provide for effective coordination and enforcement of the Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods;

AND WHEREAS it is expedient to regulate manufacture, import, export, storage, distribution and sale of therapeutic goods;

AND WHEREAS the Provincial Assemblies of Khyber Paktunkhwa, Punjab and Sindh have passed resolution under Article 144 of the Constitution of the Islamic Republic of Pakistan to the effect that Majlis-e-Shoora (Parliament) may by law regulate the issue;

It is hereby enacted as follows:-
   Chapter I
 
 
 PRELIMINARY
 
 1. Short title, extent and commencement. - (1) This Act may be called the Drug Regulatory Authority of Pakistan Act, 2012.
 
 (2) It extends to the whole of Pakistan.
 
 (3) It shall come into force at once.
 
 2. Definitions. - In this Act, unless there is anything repugnant in the subject or context,-
 (i) “Act” means the Drugs Act, 1976 (XXXI of 1976);
 
 (ii) “alternative medicine” means a product used exclusively in Homeopathic, Unani, Ayurvedic, Biochemic, Chinese or other traditional system of treatment;
 
 (iii) “Appellate Board” means an Appellate Board constituted under section 12 for the disposal of appeals against the decisions of the Licensing Board or the Registration Board or Pricing Committee;
 
 (iv) “Authority” means the Drug Regulatory Authority of Pakistan established under section 3;
 
 (v) “biologicals” means biological drugs as defined in Schedule-I;
 
 
 (vi) “Board” means the Policy Board of the Authority constituted under section 9;
 
 (vii) “CEO” means the Chief Executive Officer of the Authority appointed under section 5;
 
 (viii) “Chairperson” means the Chairperson of the Board;
 
 (ix) “civil servant” means a civil servant as defined in the Civil Servants Act, 1973 (LXXI of 1973);
 
 (x) “decision” includes an order, determination or direction of the Authority or the Board made in accordance with laws, rules and regulations;
 
 (xi) “Director” means director of a department of the Authority;
 
 (xii) “drug” means drug as defined in Schedule-I;
 
 (xiii) “fee” means fee prescribed by the Board for any service;
 
 (xiv) “Fund” means the Drug Regulatory Authority of Pakistan Fund created under section 19;
 
 (xv) “health and OTC Products (non-drugs)” include probiotics and disinfectant, nutritional products, food supplements, baby milk and foods, medicated cosmetics, medicated soaps and medicated shampoos;
 
 (xvi) “Inspector” means the Inspector appointed under the Act as specified in Schedule-V;
 
 (xvii) “Licensing Board” means a Licensing Board constituted under clause (u) of section 7 to regulate the grant of licences for the manufacture of therapeutic goods;
 
 (xviii) “medical device” means medical devices as specified in Schedule-I;
 
 (xix) “medicated cosmetics” means cosmetics containing drugs as specified in Schedule-I;
 
 (xx) “member” means a member of the Board;
 
 (xxi) “OTC” mean over-the-counter non-prescription products;
 
 (xxii) “penalty” means penalty as specified in Schedule III;
 
 (xxiii) “person” means any individual or any legal entity;
 
 (xxiv) “Pension Endowment Fund” means an endowment fund separate from the Fund of the Authority dedicated only for the payment of pension benefits to Authority’s employees;
 
 (xxv) “pharmaceutical field” means regulation, manufacturing, quality control, quality assurance, research, academia, import, export and pharmacy services in drugs;
 
 (xxvi) “pharmacy services” means services rendered by a pharmacist in pharmaceutical care, selection, posology, counseling, dispensing, use, administration, prescription monitoring, pharmacoepidemiology, therapeutic goods information and poison control, pharmacovigillance, pharmacoeconomics, storage, sales, procurement, forecasting, supply chain management, distribution, drug utilization evaluation, drug utilization review, formulary based drug utilization and managing therapeutic goods at all levels including pharmacy, clinic, medical store, hospital or medical institution;
 
 (xxvii) “pharmaceutical evaluation” means the assessment of a detailed pharmaceutical dossier submitted for the registration of a therapeutic good;
 
 (xxviii) “pharmaceutical dossier” means a set of documents as specified in Schedule-I;
 
 (xxix) “prescribed” means prescribed by rules or regulations under this Act;
 
 (xxx) “prohibitions” means prohibitions as specified in Schedule-II;
 
 (xxxi) “regulations” means the regulations made under this Act;
 
 (xxxii) “Registration Board” means a Registration Board constituted under clause (u) of section 7 to regulate the grant of registration to therapeutic goods;
 
 (xxxiii) “rules” means the rules made under this Act;
 
 (xxxiv) “Secretary” means Secretary of the Board;
 
 (xxxv) “Schedule” means Schedule to this Act; and
 
 (xxxvi) “therapeutic goods” includes drugs or alternative medicine or medical devices or biologicals or other related products as may be notified by the Authority.
 
 Chapter II
 
 AUTHORITY AND BOARD
 
 3. Establishment of the Authority.- (1) As soon as may be, after the commencement of this Act, the Federal Government shall, by notification in the official Gazette, establish an Authority to be known as the Drug Regulatory Authority of Pakistan, to carry out the purposes of this Act.
 
 (2) The Authority shall be a body corporate having perpetual succession and a common seal and may sue and be sued in its own name and, subject to and for the purposes of this Act, may enter into contracts and may acquire, purchase, take, hold and enjoy moveable and immovable property of every description and may convey, assign, surrender, yield-up, charge, mortgage, demise, reassign, transfer or otherwise dispose of or deal with, any moveable or immovable property or any interest vested in it.
 
 (3) The Authority shall be an autonomous body under the administrative control of the Federal Government with its headquarters at Islamabad.
 
 (4) The Authority may set up its establishments including sub-offices and laboratories at Provincial capitals and such other places, as it may deem necessary from time to time. The existing Federal Drugs Control Administration and the sub-offices set up in all Provinces and laboratories called the Central Drugs Laboratory, Karachi, the National Control Laboratory for Biologicals, Islamabad and the Federal Drug Surveillance Laboratory, Islamabad shall, upon the commencement of this Act, become part of the Authority.
 
 (5) The common seal of the Authority shall be kept in the custody of the Chief Executive Officer or such other person as may be prescribed by regulations and documents required or permitted to be executed under the common seal shall be specified and authenticated in such manner as may be prescribed by regulations.
 
 4. Composition of the Authority.- (1) The Authority shall consist of a full time Chief Executive Officer (CEO) and thirteen Directors who shall be appointed by the Federal Government on the of recommendation of Board, whose qualifications, terms and conditions shall be such as may be prescribed. The Directors shall be designated as,-
 
 (a) Director Pharmaceutical Evaluations and Registration.- He shall be incharge of the Division of pharmaceutical evaluations and registration which shall be responsible for the evaluation, assessment and registration of pharmaceuticals drugs for human beings, animals and to perform other functions connected therewith and assigned by the Board;
 
 (b) Director Drug Licensing.- He shall be the incharge of the Division of drug licensing which shall be responsible for the licensing of the drugs manufacturing facilities and perform other functions connected therewith;
 
 (c) Director Quality Assurance and Laboratory Testing.- He shall be incharge of the Division of quality assurance and laboratory testing which shall be responsible for enforcement of current good manufacturing practices under the Act and for testing or research of drugs and to perform other functions connected therewith. The Division shall also perform the functions related to post-marketing surveillance and shall be responsible for the evaluation, coordination and monitoring of safety, efficacy and quality of registered drugs and inactive materials including the clinical and toxicological study, drug recalls and withdrawls and to perform other functions connected therewith;
 
 (d) Director Medical Devices and Medicated Cosmetics.- He shall be incharge of the Division of medical devices and medicated cosmetics which shall be responsible for the assessment, enlistment or registration of medical devices and medicated cosmetics, medicated shampoos and medicated soaps for human beings, animals and to perform other functions connected therewith;
 
 (e) Director Biological Drugs.- He shall be incharge of the Division of biological evaluation and research which shall be responsible for the evaluation, assessment, registration and licensing of biologicals for human beings, animals and to perform other functions connected therewith including all the functions of national control authority for biologicals as required for the prequalification by World Health Organizations of locally manufactured human biological drugs;
 
 (f) Director Controlled Drugs.- He shall be incharge of the Division of controlled drugs which shall in consultation with the Federal Government be responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor chemicals and to perform other functions connected therewith;
 
 (g) Director Pharmacy Services.- He shall be incharge of the Division of pharmacy services which shall be responsible for the development and promotion of pharmacy services and to perform other functions connected therewith;
 
 (h) Director Health and OTC Products (non-drugs).- He shall be incharge of the Division of health and OTC products (non-drugs) which shall be responsible for the assessment, licensing and registration of alternative medicines such as Ayurvedic, Chinese, Unani and Homeopathy, enlistment or registration of nutritional products and food supplements for human beings, animals and to perform other functions connected therewith;

 (i) Director Costing and Pricing.- He shall be incharge of the Division of costing and pricing which shall be responsible for the costing and pricing of therapeutic goods and to perform other functions connected therewith;

 (j) Director Budget and Accounts.- He shall be incharge of the Division for budget and accounts which shall be responsible for budgetary and financial aspects of the Authority and other daily accounting matters connected therewith or ancillary thereto;
 
 (k) Director Administration, Human Resource and Logistics.- He shall be incharge of the Division for administration, human resource and logistics which shall be responsible for administration, recruitment, appointment, capacity building and development for the Authority and other matters connected therewith and ancillary thereto;
 
 (l) Director Legal Affairs.- He shall be incharge of the Division for legal affairs which shall be responsible for legal affairs of the Authority and other matters connected with Drug Court and other court cases therewith or ancillary thereto; and
 
 (m) Director Management Information Services.- He shall be incharge of the Division for management information services which shall be responsible for development of automation of functions using information technology for the Authority and other matters connected therewith and ancillary there to.
 
 (2) The Federal Government, on the recommendations of the Board, may increase or decrease the number of Divisions or Directors and prescribe their functions and the relevant experience, qualification, terms, mode and manner of appointment of Directors and related staff in each Division.
 
 5. Chief Executive Officer. - (1) The Federal Government may, on the recommendations of the Board, appoint a person as Chief Executive Officer who-
 
 (a) has a postgraduate degree in pharmacy or medicine with an age not less than forty-five years or more than fifty-six years, with a minimum of twenty years experience in management or pharmaceutical field or regulatory affairs, in public sector, or if no such person of aforesaid qualifications is available in the public sector, then a person possessing above qualifications and experience from the private sector;
 
 (b) the tenure of appointment of CEO shall be for a period of three years, extendable on the recommendation of the Board for one year only; and
 
 (c) the CEO shall exercise general control and supervision over the affairs of the Authority and shall ensure the provisions of the Act, the rules, and that the regulations, policies and directions of the Board are properly executed.
 
 (2) The CEO shall discharge such duties and perform such functions as are assigned to him by or under this Act or as may be prescribed by the Board and in particular shall-
 
 (a) keep in custody the records and seal of the Authority;
 
 (b) submit plan of work and budget estimates of the Authority for approval of the Board; and
 
 (c) submit to the Board, in accordance with the rules and regulations reports on the activities of the Authority.
 
 (3) The CEO shall also have the power to-
 
 (a) supervise the activities connected with the execution of programs for training, research, institutional consultancies and other services;
 
 (b) authorize expenditure provided for in the budget in accordance with the rules and regulations;
 
 (c) re-appropriate funds within the approved budget;
 
 (d) delegate his powers to appropriate levels of management subject to such conditions as he may deem fit;
 
 (e) issue notices of meetings of the Board and Appellate Board and to maintain proper record of the minutes and proceedings thereof;
 
 (f) execute deeds and documents on behalf of the Board; and
 
 (g) perform any other duty assigned to him by the Board.
 
 (4) The CEO shall not, except with the prior approval of the Board in each case or unless already approved in the budget duly itemized, allow expenditure on items of civil works or capital expenditure on office or laboratory equipment or automobiles.
 
 (5) The CEO may tender his resignation under his own hand.
 
 (6) In case of occurrence of vacancy of CEO the Federal Government is authorised to appoint any person having prescribed qualification as CEO for a period of three months or till the appointment of CEO, whichever is earlier.
 
 6. Meeting of the Authority.- (1) Save as hereinafter provided, the Authority shall regulate the procedure for its meetings.
 
 (2) The meetings of the Authority shall be convened by the CEO at any time on his own or as directed by the Policy Board on any matter requiring decision by the Authority.
 
 7. Powers and functions of the Authority.- The powers and functions of the Authority shall be to-
 
 (a) administer the laws specified in the Schedule-VI that apply to Federal Government and advise the Provincial Governments for the laws that are applicable to the Provinces;
 7
 (b) monitor the enforcement of laws specified in the Schedule-VI and collect relevant data and information;
 
 (c) issue guidelines and monitor the enforcement of-
 
 (i) licensing of the manufacture of therapeutic goods;
 (ii) registration of therapeutic goods;
 (iii) regulation for the advertisement;
 (iv) drug specifications and laboratory practices;
 (v) prosecution and appeals under this Act and the Drugs Act, 1976 (XXXI of 1976) relating to Federal subject;
 (vi) regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor substances (chemicals) in consultation with Federal Government;
 (vii) regulation for pricing and mechanism for fixation of prices of various therapeutic goods under its ambit;
 (viii) determining standards for biological manufacturing and testing;
 (ix) implementation of internationally recognized standards such as good laboratory practices, current good manufacturing practices, good distribution practices, cold chain management, bioequivalence studies, stability studies, anti-spurious codes, clinical trials, biosimilar evaluations, and endorsement and systematic implementation of World Health Organization, International Conference on Harmonizations and Food and Drug Administration guidelines etc.;
 (x) regulation, enforcement and monitoring of advertisement rule and ban on false advertisement;
 (xi) manufacturing of active pharmaceutical ingredients in all its forms; and
 (xii) use of central research fund;
 
 (d) coordinate, monitor or engage, in conjunction with other organizations, Provincial Governments and international agencies, in training, study or project related to therapeutic goods. The Authority may engage any individual or counsel to advise or work for managing national and international opportunities for training, education, seminars, conferences etc., with a view to improve capacity building;
 
 (e) facilitate advancement and up-gradation of the sector to meet international standards and also to promote manufacture and export of active pharmaceutical ingredients and therapeutic goods;
 
 (f) coordinate at policy level and provide policy guidance to the Provincial Governments in the performance of their functions with a purpose to bring uniformity;
 
 (g) facilitate the procurement and implementation of foreign aided technical assistance on therapeutic goods where such expertise does not exist but its existence would promote public good;
 
 (h) take steps for development and promotion of pharmacy services;
 
 (i) undertake awareness campaigns regarding prevention of diseases, patients’ rights, healthcare privileges etc., through media, seminars, publications and other available means of information technology;
 
 (j) issue guidelines and monitor proceedings and funding and accounts of health seminars, workshops and conferences;
 
 (k) advise the Federal Government on issues related to obligations and commitments related to therapeutic goods;
 
 (l) appoint such employees, consultants and experts as deemed necessary on prescribed terms and conditions including their salaries and remunerations with consultation and approval of the Board. Such recruitment, continuation and remuneration shall be based on merit and productivity;
 
 (m) prescribe rules for seniority, promotion, code of conduct and terms and conditions of service of its employees;
 
 (n) levy such charges or fees as may be prescribed for services and facilities provided by the Authority and its offices;
 
 (o) enter into contract for the supply of materials or for the execution of works as may be necessary for the discharge of any of its duties and functions;
 
 (p) prepare annual budget to be approved by the Board;
 
 (q) to monitor and regulate the marketing practices, so as to ensure rational use of drugs, and ethical criteria for promotion of therapeutic goods in line with international practices;
 
 (r) develop working manuals, guidelines, references, materials and procedures in order to improve the working environment of offices etc., set up under the Authority;
 
 (s) prescribe, regulate or implement measures and standards on matters related to or connected with the Authority;
 
 (t) develop, issue, adopt and enforce the standards and guidelines to ensure safety, efficacy and quality of therapeutic goods with rational use at reasonable price;
 
 (u) perform licensing, registration, pricing and appellate functions thereof;
 
 (v) coordinate with Provincial Governments and international agencies for smooth implementation of laws, capacity building and training of the regulatory staff;
 
 (w) develop standard operating procedures, manuals, guidelines for transparent working of offices and conduct quality audits for conformance of the same;
 
(x) establish system of cost recovery to ensure financial autonomy and efficient functioning of the authority without becoming burden on the Government; and
 
 (y) perform and carry out any other act, duty or function as may be assigned to it by the Policy Board and the Federal Government for furthering the provisions of this Act.
 
 8. Delegation of powers.- The Authority may with the approval of the Board, by general or special order in writing subject to such conditions or limitations, delegate any of its powers and functions to any of its officers as it may deem appropriate.
 
 9. Policy Board.- (1) The general direction, administration and monitoring of the Authority shall vest in the Policy Board which shall consist of fifteen members, namely:-
 
 (a) Secretary of the concerned Division (Federal Secretary BS-22) Chairperson
 (b) CEO Member
 (c) Representative of Ministry of Law and Justice not below BPS-20 Member
 (d) Secretary of the concerned Department, Government of the Balochistan Member
 (e) Secretary of the concerned Department, Government of the Sindh Member
 (f) Secretary of the concerned Department, Government of the Khyber Pakhtunkhwa Member
 (g) Secretary of the concerned Department, Government of the Punjab Member
 (h) Secretary of the concerned Department, Government of the Gilgit-Baltistan Member
 (i) Representative from Federally Administered Tribal Areas Member
 (j) Six experts from the public and private sector with equal representation from each Province, these members shall be from different specialties as defined in sub-section (3) below. Member
 
 (2) The CEO shall also be the Secretary of the Board. The Board shall look after and be responsible for the affairs of the Authority.
 
 (3) The Federal Government shall, by notification in the official Gazette, appoint six expert members, with representation from the Provinces, under clause (j) of sub-section (1) preferably one from each province having specialty in the fields of drug manufacturing, quality control, drug regulation, public health, pharmacy services, health finance, health economics, health management, pharmacology or biotechnology:
 
 Provided that unless earlier removed by the Federal Government the term of the expert member shall be two years and shall be eligible for one more similar term only. The expert member may resign his office by writing under his hand addressed to the Federal Government:
 
 Provided further that the expert member shall himself attend the meeting and shall not send a representative.
 
 (4) No act or proceeding of the Board shall be invalid by reason only of the existence of a vacancy in the constitution of the Board.
 
 (5) Notwithstanding the composition of the Board constituted by the Federal Government under sub-section (1), the Board may increase or decrease the number of its members and prescribe the qualifications and procedure for their appointment
 
 10. Meeting of the Policy Board.- (1) The meetings of the Board shall be convened by the Secretary of the Board with the prior approval of the Chairperson. In case of absence of the Chairperson, the members present may elect the Chairperson for that meeting.
 
 (2) The meetings of the Board shall be held twice a year or more as and when required. A special meeting may also be called at any time to deal with any urgent business.
 
 (3) Save as hereinafter provided, the Board shall make regulations for the conduct of its business.
 
 (4) A simple majority of the total membership shall constitute the quorum for a meeting of the Board and in case of equality of votes, the Chairperson or the person presiding over the meeting shall have a casting vote.
 
 (5) All decisions or determinations taken by the Board shall be recorded in writing.
 
 (6) The Board’s meeting shall be called by giving an advance notice of at least seven days.
 
 11. Functions of the Board.- (1) The Board shall have the following functions, namely:-
 
 (a) frame the policy and provide guidelines based on global and regional trends to the Authority and monitor the implementation and performance of the guidelines and of the functions of the Authority ensuring good governance and accountability;
 
 (b) monitor and supervise all the functions of the Authority;
 
 (c) approve the budget of the Authority; and
 
 (d) determine all fees and levies.
 
 12. Appellate Board and Committees of the Policy Board. - (1) The Board may constitute Appellate Board and Committees of experts as it considers necessary or expedient to assist it in the performance of its functions under this Act.
 
 (2) A Board and Committee constituted under sub-section (1) shall act in accordance with the regulations made by the Board.
 
 13. Invitation by Board.- The Board may invite any person to attend its meeting or deliberations including any meeting of the Appellate Board or its Committees constituted under section 12, for the purpose of advising it on any matter under discussion but such person shall have no right to vote at the meeting or deliberation.
 
 14. Appointment of officers and employees etc., of the Authority.- (1) The Authority, with approval of the Board, may create posts and appoint such officers, employees, experts and consultants, as it may consider necessary, for the performance of its functions in the prescribed manner. The criteria for recruitment and selection of employees and officers shall be determined by the Board according to the rules.
 
 (2) The age of superannuation for each employee shall be sixty years.
 
 (3) No person shall be appointed as the CEO or Director of the Authority unless he is a citizen of Pakistan.
 
 15. Integration of Federal Drugs Control Administration its sub-offices and Laboratories. - (1) Upon the commencement of this Act, the Drugs Control Administration, its sub-offices and its Laboratories hereinafter referred to as the said offices as referred in sub-section (4) of section 3 shall become part of the Authority.
 
 (2) All assets, rights, powers, authorities and privileges and all properties, movable and immovable, cash and bank balance, reserve funds, investment and all other interest rights in or arising out of such properties and all debts, liabilities and obligations of whatever kind of the said offices subsisting immediately before there integration shall stand transferred to and vest in the Authority.
 
 (3) All debts and obligations incurred or contracts entered into or rights acquired and all matters and things engaged to be done by, with or for the said offices before their integration, shall be deemed to have been incurred, entered into, acquired or engaged to be done by or for the Authority.
 
 (4) All suits and other legal proceedings instituted by or against the said offices before their integration shall be deemed to be suits and proceedings by or against the Authority and may be proceeded or otherwise dealt with accordingly.
 
 (5) Notwithstanding anything contained in any contract or agreement or in the conditions of services,-
 
 (a) every employee of the said offices under the Federal Government immediately after the commencement of this Act shall be required to exercise an irrevocable option either to continue in the present pay and service structure as a civil servant or to opt for absorption in the Authority within a period of thirty days from the date of commencement of this Act;
 
 (b) all employees who opt to be included in the Authority under its rules shall be governed by this Act and the terms and conditions so prescribed;
 
 (c) no health personnel who opts to be governed under this Act shall be entitled to any compensation because of such transfer; and
 
 (d) the terms and conditions of service of all officers and staff employed in the Drug Regulatory Agency of Pakistan under Ordinance (I of 2012) before the commencement of this Act shall not be varied to their disadvantage under the Authority.
 
 16. Experts, consultants and advisers not to be civil servants. - The experts, consultants, employees or advisers employed by the Authority shall be governed by the terms and conditions of their appointment and shall not be deemed to be civil servants within the meaning of Civil Servants Act, 1973 (LXXI of 1973).
 
 17. CEO and officers etc., to be public servants. - The CEO, officers, employees, experts and consultants of the Authority shall, when acting or purporting to act in pursuance of any of the provisions of this Act, be deemed to be public servants within the meaning of section 21 of the Pakistan Penal Code (Act XLV of 1860).
 
 18. Conflict of interest. – (1) No person shall be appointed as CEO, Director, consultant, adviser, officer or employee of the Authority if he or she has any financial or professional conflict of interest.
 
 (2) No person shall be member of the Board or Director if he has immediate family members (parent, child, sibling or spouse) as senior officials or owners of concerns dealing in therapeutic goods.
 
 Chapter III
 
 FUND, BUDGET AND ACCOUNTS
 
 19. Drug Regulatory Authority of Pakistan Fund.- (1) There shall be a fund to be known as the Drug Regulatory Authority of Pakistan Fund which shall vest in the Authority and shall be utilized by the Authority to meet its expenses and charges properly incurred in connection with the carrying out of its functions and duties assigned or transferred to it under this Act, including but not limited to the payment of salaries and other remuneration to the CEO, Director, members of the different Boards, employees, experts, consultants and advisers of the Authority.
 
 (2) The Drug Regulatory Authority Funds shall be financed from the following sources namely:-
 
 (a) grant-in-aid in terms of salaries and retirement benefits of the existing staff to be provided by the Federal Government;
 
 (b) donations and endowments;
 
 (c) grants and loans by the Federal Government or a Provincial Government;
 
 (d) loans and grants from the national and international agencies received by the Federal Government and Provincial Governments to finance the function of the Authority;
 
 (e) charges and fees collected by the Authority to recover the costs of regulated activities under this Act;
 
 (f) proceeds of any investments made by the Authority which are not required for immediate use. All investments to be made by the Authority shall be with the approval of the Board;
 
 (g) proceeds from any other service rendered by the Authority, including inspection services, foreign or local, or sale of any publication; and
 
 (h) Central Research Fund collected from the pharmaceutical industry.
 
 (3) At the end of each financial year, the balance sheet shall be prepared and any un-spent remaining amount and all other collections including Central Research Fund shall be securely invested only in Government schemes in order to achieve self-sufficiency of the Authority.
 
 4) A separate pension endowment fund shall be established for the payment of pensions of employees recruited in the Authority.
 
 20. Fees and other charges to be levied by the Authority.- (1) The Authority shall levy and collect such fees, in respect of any of its functions at such rates as may be determined, from time to time by the Authority, with the approval of the Policy Board, in accordance with rules.
 
 (2) The Central Research Fund fee shall be deposited in the non-lapsable sub-account of the Authority to be utilized as per existing rules.
 
 (3) The existing Central Research Fund kept with the Federal Government shall be transferred to the Authority immediately after the notification of establishment of the Authority.
 
 21. Budget.- (1) The Authority shall, in respect of each financial year, prepare on such date as may be prescribed a statement of the estimated receipts and expenditure, including the revised and estimated budgets, requirements of grant-in-aid from Federal Government and foreign exchange for the next financial year for consideration and approval of the Board. Any foreign exchange requirements within the overall annual approved budget by the Board shall be sent to Federal Government for appropriate provision and allocation.
 
 (2) It shall not be necessary for the Authority to take prior approval from the Government to spend money from its own generated funds and shall practice financial freedom as the Board deem fit for furtherance of its functions.
 
 22. Accounting and audit.- (1) The Authority may open its accounts with any scheduled bank or financial institution within the framework of the prescribed rules. The Authority may approach the Government, for the grant of initial funds in this respect.
 
 (2) The accounts of the Authority shall be maintained as a double entry system and in the manner prescribed by the Controller General of Accounts.
 
 (3) The Authority shall cause to be carried out audit of its accounts by one or more auditors registered as chartered accountants within the meaning of the Chartered Accountants Act, 1961 (X of 1961).
 
 (4) Notwithstanding the audit provided for in sub-section (3) the Auditor-General of Pakistan shall have the power to audit or cause to be audited the accounts of the Authority.
 
 (5) A copy of the audit report shall be sent to the Federal Government along with the comments of the Authority.
 
 (6) The Authority shall take the requisite steps for the rectification of any objection raised by the Auditor-General of Pakistan.
 
 Chapter IV
 
 RULES AND REGULATIONS
 
 23. Power to make rules.- The Authority may, with the approval of the Federal Government, by notification in the official Gazette, make rules for carrying out the purposes of this Act.
 
 24. Power to make regulations.- The Authority may, by notification in the official Gazette, with the approval of the Board, make regulations, for its internal working and terms and condition of employees not inconsistent with the provisions of the Act or the rules, for the carrying out of its functions under this Act.
 
 Chapter V
 
 MISCELLANEOUS
 
 25. Submission of annual reports and returns.- (1) Within three months of the conclusion of each financial year, the Authority shall submit an annual report to the Federal Government in respect of the activities of the Authority including the status of its existing programs, projects and further plans formulated in furtherance of its aims and objectives.
 
 (2) The Federal Government may require the Authority to furnish:
 
 (a) any return, statement, estimate, statistics or other information regarding any matter under the control of the Authority;
 
 (b) a report on any subject related to the Authority; and
 
 (c) a copy of any document in the custody of the Authority.
 
 
 (3) The Authority shall expeditiously comply with such directions.
 
 26. Power to call for information.- The Authority may call for any person, involved directly or indirectly, and reasonably believed to having such information in his control or possession which is required for carrying out the purposes of this Act. The person so called upon to provide such information shall do so within the period prescribed by the Authority and in case of failure to do so he shall be punished by imposition of such penalty which may not exceed one hundred thousand rupees.
 
 27. Offences, penalties etc.- (1) The offences shall be such as specified in Schedule-III
 
 (2) The prohibition specified in Schedule-II shall be punished in accordance with Schedule-III.
 
 28. Offences by companies etc.- Where the person guilty of an offence under this Act or the Drugs Act, 1976 (XXXI of 1976), is a company, corporation, firm or institution, every director, partner and employee of the company, corporation, firm or institution with whose knowledge or consent the offence was committed shall be guilty of the offence.
 
 29. Cognizance of offences. - Cognizance of offences shall be taken by the Inspector in the manner specified in Schedule-IV.
 
 30. Complaints.- (1) Any aggrieved person may file a written complaint with the Authority against contravention of any provision of this Act or any law specified in Schedule-VI.
 
 (2) The Authority shall, on receipt of a complaint, cause it to be investigated as may be prescribed and provide an opportunity to the complainant as well as the person against whom such complaint has been made. The Authority may, on completion of investigation, take any action as may be prescribed under this Act or as the case may be subject to the provisions of any law specified in the Schedule-VI.
 
 (3) The appeals against the decisions of the Authority shall be referred to the Board, which shall formulate an Appellate Board from among its members, who shall decide the case on merit.
 
 31. Confidential information.- (1) Except as provided under the regulations, no person shall communicate, or allow to be communicated, any record or information obtained under this Act to a person not legally entitled to that record or information or allows any person not legally entitled to that record or information to have access to any record obtained under this Act.
 
 (2) A person who knowingly receives records or information obtained under this Act shall hold the record or information subject to the same restrictions under sub-section (1) as apply to the person from whom the records or information were received.
 
 32. Act not to override other laws.- (1) The provisions of this Act shall be in addition to and not in derogation of the provisions made in the Drugs Act, 1976 (XXXI of 1976) and any other law for the time being in force.
 
 (2) In case of inconsistency between the provisions of this Act and any other law for the time being in force, the provisions of this Act shall prevail.
 
 33. Recovery of arrears.- All amounts due to the Authority may be recovered as arrears of land revenue.
 
 34. Indemnity.- No suit prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act or any rules or regulations made thereunder.
 
 35. Power to amend Schedule.- The Federal Government may, by notification in the official Gazette, amend the Schedule so as to add any entry thereto or modify or omit any entry therefrom on the recommendation of the Board.
 
 36. Removal of difficulties.- If any difficulty arises in giving effect to any of the provisions of this Act, the Federal Government may make such order by notification in the official Gazette, not inconsistent with the provisions of this Act, for the purpose of removing the difficulty.
 
 37. Employment under the Authority to be employment under the Federal Government.-Every employment under the Authority shall, for the purpose of Pakistan Essential Services (Maintenance) Act, 1952 (LIII of 1952), be deemed to be employment under Federal Government and the said Act shall have effect accordingly.
 
 38. Act X of 2012 not to apply to the Authority.- Nothing contained in the Industrial Relations Act, 2012 (X of 2012), shall apply to or in relation to the Authority or any of its officers and employees.
 
 39. Co-operation with international organizations.- The Authority may, subject to the prior approval of the Federal Government, co-operate with any foreign authority or international organization in the field of health on the terms and conditions of any program or agreement for co-operation to which such authority or organization is a party, or pursuant to any other international agreement made or after the commencement of this Act.
 
 40. Repeal and Savings.- (1) The Drug Regulatory Agency of Pakistan Ordinance, 2012 (I of 2012) is hereby repealed.
 
 (2) Notwithstanding the repeal of the Drug Regulatory Agency of Pakistan Ordinance, 2012 (I of 2012) by sub-section (1),-
 
 (a) any licence to manufacture or any registration or maximum retail price fixed for sale issued thereunder to any person, or for the revalidation of a licence or registration issued earlier under the Act, for which an application has been made to the Licensing Board, Registration Board and Drug Pricing Committee as the case may be within the specified time, shall continue to be valid;
 
 (b) any licence for import or export or sale of drugs issued thereunder to any person, shall, unless it expires earlier under the terms thereof, continue to be valid for such periods as the Federal Government, may by notification in the official Gazette, specify in this behalf.
 
 (3) All such actions of the Federal Government as mentioned in sub-section (2) since the 20th April, 2010 shall be deemed to have been validly made under this Act.
 
 41. Policy directive of Federal Government.- (1) The Federal Government may issue policy directives in accordance with the law and constitution to the Board in respect of any of its activities, powers and functions and whose compliance shall be binding on the Authority, within a stipulated time.
 
 (2) Notwithstanding anything contained in sub-section (1) if there is any difficulty in implementation of the directions and guidelines of the Policy Board or the Federal Government, the Authority shall refer the case back to the Federal Government for its review specifying reasons for non-implementation, within the stipulated time, whose decision in this respect shall be final.
 
 42. Winding up of Authority.- No provision of any law relating to winding up of bodies corporate shall apply to the Authority. The Authority shall only be wound up by the law to be enacted by the Parliament for winding up of the Authority.
 
SCHEDULE-I
 [see clauses (v), (xii),(xviii), (xix) and (xxviii) of section 2]
 
 1. BIOLOGICALS include-
 (1) biological drugs produced by biological systems and which require standardization by biological assays according to the relevant and updated recommendations of the World Health Organization published in Technical Report Series and Biological Standardization Report and includes,-
 
 (a) blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clotting Factors Tractions, Fibrinogens, Immunoglobulins;
 
 (b) immunological products including Antisera, Antitoxins, specific Immunoglobulins:
 
 (c) in vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, Coccidioidin, Allergens, Allergens Extracts, Antibodies conjugated with isotopes for imaging studies;
 
 (d) antigens, cytokines/antibodies/cells injected to elicit a biological response;
 
 (e) vaccines, including:
 (i) bacterial vaccines including live, killed whole cell, protein sub-unit, polysacchride or glyco-conjugate, toxin derivatives, and rDNA biotechnology developed;
 (ii) viral vaccines including live, inactivated, sub-unit, rDNA, conjugated;
 (iii) polyvalent combinations of vaccines containing combination of vaccines defined in e (i) and d(ii).
 (f) toxins and venoms including snake venoms, scorpion venoms etc;
 
 (g) immunostimulants of biological origin including BCG vaccine for immunotherapy;
 
 (h) biotechnology products which are primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology or other processes involving site specific genetic manipulation techniques;
 
 (i) human interferons, natural hormones, recombinant antibodies, monoclonal antibodies and derivatives gene therapy products.
 
 (2) “biological drugs (finished form)”, are biological drugs that are defined in sub-paragraph (1) above and are manufactured, packed by the manufacturer under his responsibility of quality assurance and is further released by the National Control Authority or the National Control Laboratory of the country of origin under the World Health Organization’s Lot Release system of evaluation.
 
 (3) “biological drugs (ready-to-fill form)”, are biological drugs that are defined in sub-paragraph (1) above but are manufactured at one site in the form of a “Ready-to-fill Bulk” but are transferred to another site for final filling, labeling, packaging and quality control of the finished form. No further formulation or dilution of the ready-to-fill bulk is allowed in this case of manufacture. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.
 
 (4) “biological drugs (concentrated form)”, are biological drugs that are defined in sub-paragraph (1) above that are manufactured at one site but are stored in the form of Concentrated-Bulk of the active ingredient at controlled temperatures. Such Concentrated-Bulk may be transferred to any other site under temperature controlled conditions for further dilution, stabilization, filling and packaging. The diluted and stabilized bulk requires its own set of quality control test and the final finished form of such biological drugs undergo another set of complete quality control tests. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.
 
 (5) “biological drugs (naked vials)”, are biologicals drugs that are defined in sub-paragraph (1) above that are manufactured and filled at one site but the final containers are neither labeled nor packed in cartons. These drugs are imported in unlabeled vials and are labeled and packed in carton locally. In such cases at least an identity test is required to confirm the positive identification of the required antigen. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.
 
 (6) Originator biological drugs means a biological drug which has been licensed by the national regulatory authorities on the basis of a full registration dossier, i.e. the approved indications for use were granted on the basis of full quality, efficacy and safety data:
 
 (a) reference biotherapeutic product (RBP) means an originator biological drug product that was licensed on the basis of a full registration dossier. It does not refer to measurement standards such as international, pharmacopoeial, or national standards or reference standards;
 
 (b) biosimilar biological drugs mean Similar Biotherapeutic Product (SBP) which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product;
 
 (c) similarity means absence of a relevant difference in the parameter of interest.
 
 (7) No human biological drug is allowed sale and use until a “Lot Release Certificate” from the Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has been obtained.
 
 ( 8) Pharmaceutical dossier includes a set of documents submitted by a person for the registration of a therapeutic good, containing complete information about-
 
 (a) master formula;
 
 (b) all ingredients both active pharmaceutical ingredients and inactive excipients added with their safety profile data;
 
 (c) complete manufacturing procedure of the drug, biological or medical device;
 
 (d) quality control steps and procedures at each level of raw material selection, in-process testing, finished drug testing, and stability testing;
 
 (e) clinical trial data and published reports about the safety and efficacy of the drug;
 
 (f) complete details of manufacturing plant and equipment, quality control laboratories and equipment;
 
 (g) ware-houses capacities and facilities; details of human resources available and the latest cGMP report shall also be part of this document set;
 
 (h) any other information required by the registration board for establishing the safety, efficacy, bioavailability, bioequivalence, or biosimilarity of the drug.
 
 2. DRUG includes-
 
 (a) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals, including substance used or prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic, Chinese or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed;
 
 (b) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solution;
 
 (c) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism as cause, carry or transmit disease in human beings or animals or for disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored;
 
 (d) such pesticides as may cause health hazard to the public;
 
 (e) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States, whether alone or in combination with any substance exclusively used in the Unani, Ayurvedic, Homoeopathic, Chinese or Biochemic system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (a), (b) and (c); and
 
 (f) any other substance which the Federal Government may by notification in the official Gazette, declare to be a drug for the purpose of this Act.
 
 3. MEDICAL DEVICES include,-
 
 (a) instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease; or
 
 (b) any other item which the Federal Government may, by notification in the official Gazette, declare as medical device;
 
 4. MEDICATED COSMETICS include,- Cosmetics containing drugs and are defined as articles containing active drug ingredients intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to human body or part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.
 
 Schedule II
 [see section 2(xxx)]
 PROHIBITIONS
 A. Import, manufacture and sale of therapeutic goods:
 
 (1) No person shall himself or by any other person on his behalf,-
 (a) export, import or manufacture for sale or sell any,-
 
 (i) spurious therapeutic good;
 (ii) counterfeit therapeutic good;
 (iii) misbranded therapeutic good;
 (iv) adulterated therapeutic good;
 (v) substandard therapeutic good;
 (vi) therapeutic good after its expiry date;
 (vii) therapeutic good which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceutical evaluation;
 (viii) therapeutic good which, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;
 (ix) drug if it is dangerous to health when used in the dosage or with the frequency, or for the duration specified, recommended or suggested in the labeling thereof; or
 (x) therapeutic good in contravention of any of the provisions of this Act or rules made thereunder;
 
 (b) manufacture for sale any therapeutic good except under, and in accordance with the condition of a license issued under this Act;
 
 (c) sell any therapeutic good except under, and in accordance with the conditions of a license issued under this Act;
 
(d) import or export any therapeutic good the import or export of which is prohibited by or under this Act;
 
 (e) import or export any therapeutic good drug for the import or export of which a license is required, except under, and in accordance with the conditions of, such license;
 
 (f) supply an incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;
 
 (g) peddle, hawk or offer for sale any therapeutic good in a park or public street or on a highway footpath or public transport or conveyance;
 
 (h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a therapeutic good but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a therapeutic good;
 
 (i) sell any therapeutic good without having warranty in the prescribed form bearing the name and batch number of the therapeutic good issued,-
 (i) in the case of a therapeutic good manufactured in Pakistan, by the manufacturer holding a valid license to manufacture therapeutic good and permission to manufacture that therapeutic good or by his authorized agent;
 (ii) in the case of an imported drug, by the manufacture or importer of that therapeutic good or if the therapeutic good is imported through an indenter by such indenter; and
 (iii) apply an incorrect batch number to a therapeutic good.
 
 (2) Nothing in paragraph (1) shall apply to the manufacture of small quantities of any therapeutic good for the purpose of clinical trial examination, test, analysis or personal use in small quantities.
 
 B. Control of advertisement:-
 No person shall himself or by any other person on his behalf advertise, except in accordance with such conditions as may be prescribed,-
 
 (a) any therapeutic good;
 
 (b) any substance used or prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic, Chinese or Biochemic system of treatment or any other substance or mixture of substances as may he prescribed;
 
 (c) any remedy, treatment or offer of a treatment for any disease.
 
 Explanation: For the purpose of this entry “Advertise” means to make any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of a therapeutic good, a substance or a mixture of substances, a remedy or a treatment except the display of sign boards for a clinic, a dispensary or a hospital or such other institution offering treatment.
 C. Control of samplings:-
 No person shall distribute or cause to be distributed any therapeutic good as a sample except in accordance with such conditions as may be prescribed.
 
 D. Control of printing of labeling:-
 No person shall print any label in respect of any therapeutic good which is required to be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-section (6) of section 7 of Act, or for a person who does not possess a license under that Act to manufacture that therapeutic good.
 
 Schedule III
 [see section 27]
 OFFENCE
 
 (1) Whoever himself or by any other person on his behalf,-
 
 (a) exports, imports, manufactures for sale or sells any spurious therapeutic good or any therapeutic good which is not registered;
 
 (b) manufactures for sale any therapeutic good without a license;
 
 (c) imports without license any therapeutic good for the import of which a license is required, shall be punishable with imprisonment for a term which shall not be less than three years or more than ten years and with fine which may extend to ten lakh rupees:
 
 Provided that the Drug Court may, for any special reasons to be recorded, award a sentence of imprisonment for a term of less than three years.
 
 (2) Whoever himself or by any other person on his behalf,-
 
 (a) imports, manufactures for sale or sells any counterfeit therapeutic good; or
 
 (b) gives to the purchaser a false warranty in respect of any therapeutic good sold by him that the therapeutic good does not in any way contravene the provisions of Schedule II and is not able to prove that, when he gave the warranty, he had good and sufficient reason to believe the same to be true; or
 
 (c) applies or permits to be applied to any therapeutic good sold, or stocked or exhibited for sale, by him, whether the container or a label or in any other manner, a warranty given in respect of any other therapeutic good; or
 
 (d) imports, manufactures for sales or sells any therapeutic good under a name other than the registered name; or
 
 (e) exports, imports, manufactures for sale or sells any therapeutic good with which any substance, which should not actually be its component, or has been mixed or packed it so as to reduce its quality or strength or for which any such substance has been substituted wholly or in part,
 shall be punishable with imprisonment for a term which may extend to seven years, or with fine which may extend to five lakh rupees or with both.
 
 (3) Obstruction of Inspector.- Whoever obstructs an Inspector in the exercise of any power conferred upon him by or under this Act, or disobeys the lawful authority of any Inspector, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one lakh rupees, or with both.
 
 (4) Contravention of rules.- Subject to the provisions of clause (1), (2) and (3), whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to one lakh rupees, or with both.
 
(5) Penalty for subsequent offence.- Whoever having been convicted of an offence under clause (1) of Schedule-III is convicted for a subsequent offence under that section shall be punishable with imprisonment for life or with imprisonment which shall not be less than five years and with fine which may extend to five hundred thousand rupees.
 
(6) Penalty for violating the prohibitions.- Whoever himself or by any other person on his behalf violates any prohibitions specified in Schedule-II shall be punished with imprisonment for a term up to five years and with fine up to five hundred thousand rupees.
 
 Schedule IV
 [see section 29 ]
 COGNIZANCE OF OFFENCES
 
 (1) Subject to the provisions of Schedule-V no prosecution shall be instituted under this Act except,-
 
 (a) by a Federal Inspector, where the prosecution is in respect of a contravention of clause (h) of paragraph (1) of heading A of Schedule-II or any of the provisions of this Act or the rules relating to the import or export of therapeutic goods or the manufacture for sale, or sale, of a therapeutic good which is not for the time being registered or for the manufacture for sale of which a license is not for the time being in force; or
 
 (b) by a Provincial Inspector:
 
 Provided that, where the public interest so requires, the Federal Inspector may, with the prior permission of the Registration Board or Licensing Board as the case may be, institute a prosecution for a contravention of any other provision of this Act and the Drugs Act, 1976 (XXXI of 1976).
 
 (2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of 1898):
 
 (a) an offence punishable under Schedule-III other than an offence mentioned in clause (1) of that Schedule shall be non-cognizable;
 
 (b) no Court other than a Drug Court established under the Drugs Act, 1976 (XXXI of 1976) shall try an offence punishable under this Act and the Drugs Act, 1976 (XXXI of 1976); and
 
 (c) nothing contained in this Schedule shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence punishable under this Act or the Drugs Act, 1976 (XXXI of 1976) or to require the transfer to a drug court of any case which may be pending in any court immediately before the establishment of Drug Court.
 
 Schedule V
 [see section 2(xvi)]
 POWERS OF INSPECTORS
 
 (1) Subject to the provisions of this Schedule and of any rules made in this behalf, an Inspector may, within the local limits for which he is appointed, and in any other area with the permission of the licensing Authority or Licensing Board as the case may be,-
 
 (a) inspect any premises where in any therapeutic good is manufactured, the plant and process of manufacture, the means employed for standardizing and testing the therapeutic goods and all relevant records and registers;
 
 (b) inspect any premises wherein any therapeutic good is sold or is stocked or exhibited for sale or is distributed, the storage arrangements and all relevant records and registers;
 
 (c) take samples of any therapeutic good which is being manufactured, or being sold or is stocked or exhibited for sale or is being distributed;
 
 (d) enter and search, with such assistance, if any, as he considers necessary, any building, vessel or place, in which he has reason to believe that an offence under this Act or any rules has been or is being committed or may continue to be committed;
 
 (e) call any person to be present as witness in the course of search or seizure or in connection with any other matter where the presence of witnesses is necessary;
 
 (f) seize such therapeutic good and all materials used in the manufacture thereof and any other articles, including registers cash memos, invoices and bills, which he has reason to believe may furnish evidence of the commission of an offence punishable under this Act or any rules;
 
 (g) require any person to appear before him at any reasonable time and place to give statement, assistance or information relating to or in connection with the investigation of any offence under this Act and the Drugs Act 1976 (XXXI of 1976) or the rules:
 
 Provided that the exemption under sections 132 and 133 of the Code of Civil Procedure, 1908 (Act V of 1908), shall be applicable to requisitions for attendance under this Schedule;
 
 (h) lock and seal any factory, laboratory, shop, building, store-hose or godown, or a part thereof, where any therapeutic good is or is being manufactured, stored, sold or exhibited for sale in contravention of any of the provisions of this Act, the Drugs Act 1976 or the rules;
 
 (i) forbid for a reasonable period, not exceeding four weeks or such further period, which shall not be more than three months, as the Inspector may, with the approval of the Provincial Quality Control Board, the Licensing Board, the Registration
 
 Board, as the case may be, specify, any person in charge of any premises from removing or dispensing of any therapeutic good, article or other thing likely to be used in evidence of the commission of an offence under this Act or the rules; and
 
 (j) exercise such other powers as may be necessary for carrying out the purposes of this Act or any rules:
 
 Provided that the powers under paragraph (f) to (j) shall be exercisable only by an Inspector specifically authorized in this behalf, by an order in writing, by the Government appointing him, subject to such conditions as may be specified in such order:
 
 Provided further that the power under paragraph (h) may be exercised by an Inspector not authorized as aforesaid where the contravention is of a provision which requires a license to be obtained for the manufacture, storage or sale of drug.
 
 (2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they are not inconsistent with the provisions of this Act and the Drugs Act, 1976 (XXXI of 1976), shall apply to searches and seizures made under this Act.
 
 PROCEDURE FOR INSPECTORS
 
 (1) Where an Inspector seizes any therapeutic good or any other article under this Schedule he shall tender a receipt therefore in the prescribed form.
 
 (2) Where an Inspector takes a sample of a therapeutic good for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divided the sample into four portions and effectively seal and suitable mark the same and permit such persons to add his own seal, if any, and mark to all or any of the portions so sealed and marked:
 
 Provided that, where the sample is taken from premises whereon the drug is being manufactured, it shall be necessary to divide the sample into three portions only:
 
 Provided further that, where the therapeutic good is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the therapeutic good be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them:
 Provided also that if the contents of one container are insufficient for the laboratory test and analysis, the Inspector may increase the number of the containers in order to make the sample sufficient for this purpose.
 
 (3) The Inspector shall return one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same within seven days as follows, namely:-
 
 (a) one portion of sample he shall send to the Government Analyst concerned for test and analysis;
 
 (b) the second he shall send to the Chairman, Provincial Quality Control Board or the Licensing Board or the Registration Board, as the case may be; and
 
 (c) the third, where taken, he shall send to the warrantor, if any, named under proviso to sub-section (3) of section 32 of the Drugs Act, 1976 (XXXI of 1976).
 
 (4) Where an Inspector seizes any therapeutic good containing any filthy or putrid substance, vermin, worm, rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such that it cannot or need not be divided, he shall effectively seal and suitably mark the same and permit the person from whom he seizes the therapeutic good to add his own seal, if any, and mark to it and shall produce the same before the Drug Court, or the Provincial Quality Control Board, or the Licensing Board or the Registration Board, as the case may be, before which proceedings are instituted or action is initiated in respect of the drug.
 
 (5) Where an Inspector takes any action under section this Schedule,-
 
 (a) he shall as soon as practicable ascertain whether or not the therapeutic good contravenes any of the provisions of this Act and, it is ascertained that the drug does not so contravene, he shall forthwith revoke the order passed under the said section or, as the case may be, take such action as may be necessary for the return of the stock seized and payment for the samples taken, under intimation to the Board concerned;
 
 (b) if he seizes the stock of the therapeutic good he shall, as soon as may be inform the Board concerned and take its order as to the custody thereof:
 
 Provided that where a Federal Inspector is not competent to take action under Schedule-IV, he shall as soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector for further action under this Act or The Drugs Act 1976.
 
 (6) The Provincial Inspector on finding any contravention of this Act or the Drugs Act 1976 (XXXI of 1976) shall, unless the Board otherwise directs, always refer the case to the Provincial Quality Control Board and seek orders as to the action to be taken in respect of such contraventions.
 
 (7) The Federal Inspector on finding any contravention of this Act or the Drugs Act 1976 (XXXI of 1976) for which he is authorized shall unless otherwise directed, always refer the case to the Licensing Board or the Registration Board or any other authority as may be specified for the purpose and seek any further orders as to the action to be taken in respect of such contravention.
 
 Schedule VI
 [see section 2 (i)]
 
 (1) The Drugs Act, 1976 (XXXI OF 1976).
 
 (2) Rules made under the Drugs Act, 1976 (XXXI OF 1976).
 _______________________
 
 
 Passed by the National Assembly on 16th October, 2012,
 and by the Senate on 17th October, 2012.
 
 
 
 
 Chairman
 Senate of Pakistan
 
 I assent to this Bill.
 
 
 President
 
 
 STATEMENT OF OBJECTS AND REASONS
 
 The Drug Regulatory Authority of Pakistan Bill, 2012 is proposed to bring harmony in inter-provincial trade and commerce of drugs and therapeutic goods to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods and medical devices and drugs research.
 
 2. The proposed provisions of the Bill shall undertake measures to ensure self sufficiency in the field of drugs, medicine and allied therapeutic goods to create conducive environment for manufacture, import and promotion of export etc.
 
 3. The Drug Regulatory Authority envisaged through this Bill shall advise Federal Government on the issues relating to obligations and commitments with international organizations related to therapeutic goods including drugs, medicine and medical devises, and develop ethical criteria on drug promotion marketing advertising and rational use of drugs including research and development.
 
 4. The Bill seeks to achieve the aforesaid objects.
 
 
 
 (DR. FIRDOUS ASHIQ AWAN)
 Minister for National Regulations and Services

13
 
THE DRUGS ACT
 (XXXI OF 1976
)
 
 [llth May, 1976]
 An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs
Preamble : Whereas it is expedient to regulate the import, export, manufacture, storage, distribution and sale of drugs:
 It is hereby enacted as follows:--
CHAPTER I
 
 Introductory
1. Short title, extent and commencement: (1) This Act may be called the Drugs Act, 1976.
 (2) It extends to the whole of Pakistan.
 (3) It shall come into force at once.

2. Application of other laws not barred: The provisions of this Act, shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (11 of 1930), and any other law for the time being in force.
3. Definitions: In this Act, unless there is anything repugnant in the subject or context,--
 (a) "adulterated drugs" means a durg--
 
 (i) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin, worm, rodent or insect; or
 (ii) which has been manufactured, packed, or held under unsanitary conditions whereby it [has] been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health; or
 (iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health; or
 (iv) which bears or contains as an ingredient a substance other than the prescribed substance; or
 (v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or in part;
 
 (b) "Appellate Board" means the Board constituted under Section 9;
 (c)"batch" means a quantity of any drug produced during a given cycle of manufacture;
 (d) "batch number" means a designation printed on the label of a drug that identifies the batch and permits the production history of the batch, including all stages of manufacture and control, to be traced and reviewed;
 (e) "Central Licensing Board" means a Board set up under Section 5;
 (f) "counterfeit drug" means a drug the label' or outerpacking of which is an imitation of, or resembles or so nearly resembles as to be calculated to deceive the label or outer-packing of a drug of another manufacture;
 (g) "drug" includes--
 (i) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals, not being a substance exclusively used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of treatment except those substances and in accordance with
 such conditions as may be prescribed;
 
 (ii) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatine capsules and antiseptic solutions;
 
 (iii) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism as cause, carry or transmit disease in human beings or animals or for disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored;
 
 (iv) such pesticides as may cause health hazard to the public;
 
 (v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) and (iii), and
 
 (vi) any other substance which the Federal Government may, by notification in the official Gazette, declare to 'be a "drug" for the purposes of this Act;
 
 (h) "expiry date" means the date stated on the label of a drug after which the drug is not expected to retain its claimed efficacy, safety, quality or potency or after which it is not permissible to sell the drug;
 (i) "expert" means a specialist through university education and experience in the relevant field;
 (j) "export", with its grammatical variations and cognate expressions, means to take out of Pakistan by sea, land or air;
 (k) "generic name" means the non-proprietary, scientific or official name of a drug as approved by the Federal Government;
 (l) "Government analysis" means a Federal Government Analyst or Provincial Government Analyst appointed under Section 16;
 (m) "import" with its grammatic31 variations and cognate expressions means to bring into Pakistan by sea, land or air;
 (n) "Inspector" means a Federal Inspector or a Provincial Inspector appointed under Section 17;
 (o) "label" means a display of written, printed or graphic matter upon the immediate container, or the outside container or wrapper of a drug package;
 "Labelling" means all labels and other written, printed or graphic matter accompanying any drug;
 (q) "licensing authority" means such authority as may be prescribed;
 (r) "manufacture", in relation to a drug, means all operations involved in the production of the drug, including processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labelling with a view to its storage, sale and distribution, but does not include the compounding and dispensing or the packing of any drug in the ordinary course of retail business or on a prescription of a registered medical practitioner or dentist or of a veterinarian and "to manufacture" shall be construed accordingly;
 (s) "misbranded drug" means a drug--
 
 (i) which is not labelled in the prescribed manner; or
 (ii) on the label or labelling of which any word, statement or other matter or information required by the rules to appear on the label or labelling is not prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices on the label or labelling) and in such terms as may render it likely to be read 'and understood by the ordinary individual under customary conditions of purchase and use; or
 (iii) which is not labelled with such directions for use and such warnings against use in indications where its use may be dangerous to health, or against unsafe dosage or duration of administration or application in such manner and form as are necessary for the protection of users or as may be prescribed; or
 (iv) the label or container of which, or anything accompanying which, bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or
 (v) which is so coloured, coated, powdered or polished that damage is concealed, or which is made to appear of better or greater therapeutic value than it really is; or
 (vi) which is manufactured according to the specifications of a particular pharmacopoeia or any other document as may be prescribed and the label does not bear the name of that pharmacopoeia or document;
 (t) "prescribed" means prescribed by rules;
 (u) "Provincial Quality Control Board" means a Board set up under Section 11;
 (v) "Registration Board" means a Board set up under Section 7;
 (w) "registered drug" means any drug registered under Section 7;
 (x) "rules' means rules made under this Act;
 (y) "Drug Court" means a Court established under Section 31;
 (z) "specifications" when applied to a drug mean--
 (i) such specifications as may be prescribed; or
 (ii) when the specifications are not prescribed, the specifications as contained in the most recent edition of any of the following publications, namely:-
 
 (1) the Pakistan Pharmacopoeia;
 (2) the International Pharmacopoeia;
 (3) the European Pharmacopoeia;
 (4) the United States Pharmacopoeia;
 (5) the British Pharmacopoeia;
 (6) the British Pharmaceutical Codex;
 (7) the United States National Formulary; and
 ( 8) such other publication as may be prescribed:
 Provided that, if the specifications do not appear in the most recent edition of any such publication, the specifications appearing in the next preceding edition of such publication in which the specifications appear shall apply; or
 
 (iii) if no specifications are either prescribed or contained in any of the publications referred to in sub-clause (ii), the specification approved for the purpose of registration under this Act;
 
 (z-a) "sell" means sell, offer for sale, expose for. sale, have in possession for sale and distribution and "to sell", "sold" or "sale" shall be construed accordingly;
 (z-b) "spurious drug" means a drug--
 
 (i) which purports to be a drug but does not contain the active ingredient of that drug; or
 (ii) which purports to be the product of a manufacturer, place or country of whom or of which it is not truly a product; or
 (iii) which is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or
 (iv) the label of which bears the name of an individual or company purporting to be its manufacturer or producer which individual or company is fictitious or does not exist;
 (z-c) "storage" means storage for sale and "to store" or "stored" shall be construed accordingly; and
 (zz) "sub-standard drug' means a drug which is not of specifications.

    
 
CHAPTER II
 
 Administration and Enforcement
4. Regulation and prohibition of import, etc., of drugs: (1) The Federal Government shall regulate the import and export. of drugs in the prescribed manner and for that purpose may make such orders and issue such directions to the importers and exporters as it may deem fit.
 
 (2) If in the opinion of the Federal Government the public interest so requires, the Federal Government may, by notification in the official Gazette,--
 (a) direct that a drug or a class of drugs specified in the notification, or drugs generally, shall not be imported or exported otherwise than under the authority of 'a license issued under this Act or except by an importer or exporter or through an indentor registered in accordance with the rules;
 (b) direct that a drug or class of drugs specified in the notification shall not be imported except by an agency of Government so specified; or
 (c) prohibit the import or export of any drug or class of drugs specified in the notification.

  [(3) Subject to sub-sections (1) & (2), only such drugs shall be imported which are on sale in the market of any of the Western European countries, USA, Japan, Australia or any other country as may be prescribed.]
5. Regulation of manufacture of drugs: (1) The grant of licenses to manufacture drugs shall be regulated in accordance with such conditions and procedure as may be prescribed, by a Central Licensing Board to be set up by the Federal Government and consisting of such representatives of the Federal Government and the Provincial Governments as may be prescribed.
 
 (2) The members of the Central Licensing Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
 
 
(3) The Central Licensing Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
 
 (4) Any member of the Central Licensing Board may, at any time, by writing under his hand addressed to the Federal Government, resign his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
 
 (5) Subject to sub-section (4), a member of the Central Licensing Board shall hold office for the prescribed period.

6. Regulation of sale of drugs : The Provincial Governments shall regulate the sale of drugs in the prescribed manner and may for that purpose make such orders, and issue such directions to the importers, manufacturers, stockists, retailers or other dealers of drugs, as they may deem fit.
  7. Registration of drugs : (1) The Federal Government shall cause all drugs to be registered in-accordance with such conditions and procedure as may be prescribed and for that purpose set up a Registration Board, consisting of such number of persons, possessing such qualifications, as may be prescribed.
 
 Explanation: In this section, "drugs" means drugs which are in the finished form ready for use.
 
 (2) The members of the Registration Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.

  (3) The Registration Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
 

 (4) Any member of the Registration Board may, at any time, by writing under his hand addressed to the Federal Government, resign .his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
 
 (5) Subject to sub-section (4), the members of the Registration Board shall hold office for the prescribed period.
 
 (6) The Federal Government shall, by notification in the official Gazette, fix the date after which no drug which is not registered shall be allowed to be exported, imported, manufactured, stored, distributed or sold.
 
 (7) A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy, safety, and quality, or as may be required by the Registration Board for the purpose of the evaluation of the drug.
 
 ( 8) Single-ingredient drugs shall be registered generally by their generic names while compound drugs shall be registered generally by their proprietary names.
 
 Explanation:In this sub-section,--
 (a) "single-ingredient drugs" means drugs containing one active ingredient;
 (b) "compound drugs" means drugs containing more than one active ingredient.
 
 
[(9) The registration of a drug shall be subject to such conditions as may be prescribed.]
  (10) Where the Registration Board registers a drug, it shall inform the person applying for its registration and the Provincial Governments of its having done so and of the conditions subject to which it has been registered.
 
 (11) If the Registration Board, on the basis of information received or an inquiry conducted by it, is of opinion that--
 
 (a) the registration of a drug was procured by fraud or misrepresentation; or
 (b) the circumstances in which a drug was registered no longer exist; or
 (c) there has been a violation of the conditions subject to which a drug was registered; or
 (d) it is necessary in the public interest so to do;
 the Registration Board may, after affording to the person on whose application the drug was registered an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration or specify any further conditions to which the registration shall be subject and inform such person and the Provincial Governments accordingly.
 
 (12) The Provincial Governments shall take all such steps as may be necessary to ensure compliance with the
 conditions subject to which a drug is registered and to prevent the manufacture or sale of a drug--.
 (a) which has not been registered; or
 (b) the registration of which has been cancelled or stands suspended.

8. Pakistan National Formulary: The Federal Government shall compile and publish in the official Gazette Pakistan National Formulary comprising all drugs allowed to be imported, manufactured or sold and such Formulary may be reviewed and modified from time to time.
 
 9. Appellate Board : (1) The: Federal Government shall, in accordance with the rules, constitute an Appellate Board for the disposal of appeals preferred by persons aggrieved by any decision of the Central Licensing Board or the Registration Board or the Licensing Authority or a Board or Authority to which the powers of the Federal Government under section 12 have been delegated under sub-section (3) of that section and for revision of any such decision on its own motion.
 
 (2) The Appellate Board shall consist of such representatives of the Federal Governments and the Provincial Governments, including a Chairman, as the Federal Government may from time to time appoint.
 
 (3) Subject to sub-section (4), the Chairman and other members of the Appellate.-Board shall hold office for the prescribed period.
 
 (4) The Chairman or any other member of the Appellate Board may, by writing under his hand addressed to the Federal Government, resign his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
 
 (5) The members of the Appellate Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
 
 (6) The Appellate Board may appoint experts for the purposes of detailed study of any specific matter before it.
 
 
(7) The Appellate Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
  [( 8) The Appellate Board shall meet at least every month and shall decide any appeal
  preferred to it within sixty days of receipt of appeal unless the Board is prevented from doing so for sufficient cases to be recorded.]
  [9A. Appeals to the Provincial Appellate Authority. - (1) Any person aggrieved by any decision of the licensing authority may prefer appeal to the Provincial Appellate Authority.
  (2) The Provincial Government shall constitute a Provincial Appellate Authority for the disposal of appeal preferred under sub-section (1) as my be prescribed.]
10. Expert Committees: (1) The Federal Government may constitute committees of experts on Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters as may be necessary for the purposes of this Act.
 
 (2) Each committee constituted under sub-section (1) shall consist of such members as the Federal Government may appoint from time to time and each such member shall hold office during the pleasure of the Federal Government.
 
 11. Provincial Quality Control Board: (1) Each Provincial Government shall set up a Provincial Quality Control Board consisting (3f such members, including a Chairman, as that Government may appoint from time to time.
 
 (2) The Chairman and other members of the Provincial Quality Control Board shall hold office during the pleasure of the Provincial Government, on such terms and conditions as that Government may determine.
 
 (3) 'The provincial Government shall appoint a person to be the Secretary of the Provincial Quality Control Board and provide the Board with such staff as the Provincial Government may consider necessary.
 
 
(4)The Provincial Quality Board shall, [with the approval of the Provincial Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
  (5) The following shall be the powers and functions of the Provincial Quality Control Board, namely:--
 
 (a) to inspect any premises where any drug is being or is to be, manufactured or sold and to recommend to the appropriate authority the cancellation or suspension of the licence to manufacture or sell drugs granted to any person who is found to be contravening, or to have contravened, any of the provisions of this Act, or the rules;
 
 (b) to scrutinize the reports of Provincial Inspectors in respect of contraventions of this Act and 'reports of the Government Analysts in respect of drugs Sent to them by the Provincial Inspectors for test and analysis and issue instructions to the Inspectors to the action to be taken on such reports:
 
 Provided that the Provincial Quality Control Board may specify the class of cases in which a Provincial Inspector may make a complaint to the Drug Court, or take any other action, without the specific instructions of the Board;
 
 (c) to exercise all the powers of an Inspector under this Act and the rules;
 
 (d) to advise the Provincial Government on ways and means to ensure quality control of drugs manufactured in the Province;

  [(e) to ascertain the names of such directors, partners and employees of the company, corporation, firms or institution who are prima facie responsible for the commission of any offence under this Act or the rules and allow an inspector to institute prosecution only against such persons;
  (f) to conduct annual validation of all instruments in the provincial drug testing laboratories and to recommend measures to upgrade such laboratories, if required;
  (g) identify and accredit on payment of fee other laboratories in the Province with suitable facilities and expertise;
  (h) to conduct training programs to update Government Analysts and for improving their knowledge according to latest analytical method and technology; and
  (i) to submit a monthly report of decisions and activities to the Federal Government. ]
  (6) The Provincial Quality Control Board may entrust any of its powers or functions under sub-section (5) to any one or more of its members.
[11A. Conflict of interest. - No person who is a member of the Appellate Board, Central Licensing Board, a Provincial Quality Board, the Registration Board or a member of Expert Committee shall be a member of the any other board or committee of which he is a member to avoid any conflict of interest.]
12. Power to fix maximum prices of drug, etc.: (1)
 The Federal Government may, by notification in the official Gazette,--
 
 (a)fix the maximum price at which any drug specified in the notification is to be sold; and
 (b) specify a certain percentage of the profits of manufacturers of drugs which shall be utilised, in accordance with the rules for purposes of research in drugs.
 
 (2) For the purpose of the exercise of its powers under sub-section (1), the Federal Government may require a manufacturer, stockist, importer, exporter, retailer or other dealer in drugs to furnish such relevant information as may be necessary.
 
 (3) The Federal Government may, by notification in the official Gazette, delegate any of its powers under this section .to any Board or other authority.
 
 13. Directions to Provincial Governments : The Federal Government may give such directions to a Provincial Government as may appear to the Federal Government to be necessary for carrying into execution in the Province of any of the provisions of this Act or of any rule or order made thereunder or for maintaining supplies of drugs of standard quality at reasonable prices or for the achievement of uniformity in respect of any matter in different parts of Pakistan.
 
 14. Federal Drugs Laboratory and institutes etc.: The Federal Government shall, as soon as may be, establish a Federal Drug Laboratory and may also set up such other institutes and drugs testing and research laboratories for the purposes of this Act as may be prescribed.
 
 15. Provincial Drugs Testing Laboratory : Each Provincial Government shall, as soon as may be, set up a Provincial Drugs Testing Laboratory for such purposes as may be prescribed.
 
 16. Government Analysts: The Federal Government or a Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be the Federal Government Analysts or, as the case may be, Provincial Government Analysts, for such areas and in respect of such drugs or classes of drugs as may be specified in the notification:
 
 Provided that no person who has any financial interest in the manufacture, import, export or sale of drugs shall be so appointed:
 
 Provided further that a person serving under the Federal Government or another Provincial Government shall not be so appointed without the previous consent of that Government.

17. Inspectors : The Federal Government or a Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Federal Inspectors, or, as the case may be, Provincial Inspectors for the purposes of this Act within such local limits as it may assign to them respectively:
 
 Provided that no person who has any financial interest in the manufacture, import, export or sale of any drug shall be appointed:
 
 Provided further that a person serving under the Federal Government or another Provincial Government shall not be .so appointed without the previous consent of such Government

  18. Powers of, Inspectors : (1) Subject to the provisions of section 19 and of any rules made in this behalf, an Inspector may, within the local limits for which he is appointed, and in any other area within the permission of the licensing authority,-
 
 (a) inspect any premises-wherein any drug is manufactured, the plant and process of manufacture, the means employed for standardising and testing the drugs and all relevant records and registers;
 
 (b) inspect any premises wherein any drug is sold or is stocked or exhibited for sale or is distributed, the storage arrangements and all relevant records and registers;
 
 (c) take samples of any drug which is being manufactured, or being sold or is stocked or exhibited for sale or is being distributed;
 
 (d) enter and search, with such assistance, if any, as he considers necessary, any building, vessel or place, in which he has reason to believe that an offence under this Act or any rules has been or is being committed or may continue to be committed;
 
 (e) call any person to be present as witness in the course of search or seizure or in connection with any other matter where the presence of witnesses is necessary;
 
 (f) seize such drug and all materials used in the manufacture thereof and any other articles, including registers, cash memos, invoices and bills, which he has reason to believe may furnish evidence of the commission of an offence punishable under this Act or any rules:

  [Provided that where the contravention is such which can be remedied, the stocks shall not be seized upon undertaking in writing of the person not to sell drug without remedying the defect, under intimation to the Board concerned]
 
 (g) require any person to appear before him at any reasonable time and place to give statement, assistance or information relating to or in connection with the investigation of an offence under this Act or the rules:
 
 Provided that the exemptions under Sections 132 and 133 of the Code of Civil Procedure, 1908 (Act V of 1908), shall be applicable to requisitions for attendance under this Clause;
 
 (h) lock and seal any factory, laboratory, shop, building, store-house or godown, or a part thereof, where any drug is or is being manufactured, stored, sold or exhibited for sale in contravention of any of the provisions of this Act or the rules;

  (i) forbid for a reasonable period, not exceeding [two] weeks or such further period, which shall not
  be more than three months, as the Inspector may, with. the approval of the Provincial Quality Control Board, the Central Licensing Board, the Registration Board, or the licensing authority, as the case may be, specify, any person in charge of any premises from removing or dispensing of any drug, article or other thing likely to be used in evidence of the commission of an offence under this Act or the rules; and
  (j) exercise such other powers as may be necessary for carrying out the purposes of this Act or any rules:
  Provided that the powers under causes (f) to (j) shall be exercisable only by an Inspector specifically authorised in this behalf, by an order in writing, by the Government appointing him, subject to such conditions as may be specified in such order.
 [omitted]
 
 (2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they are not inconsistent with the provisions of this Act, shall apply to searches and seizures made under this Act.

19. Procedure for Inspectors: Where an Inspector seizes any drug or any other article under section 18, he shall tender a receipt therefore in the prescribed form.
 
 (2) Where an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divide the sample into [five] portions and effectively seal and suitably mark the same and permit such persons to add his own seal, if any, and mark to all or any of the portions so sealed and marked:
 Provided that, where the sample is taken from premises whereon the drug is being manufactured, it shall be necessary to divide the sample into three portions only:
 
 Provided further that, where the drug is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them:
 
 Provided further that if the contents of one container are insufficient for the laboratory test and analysis, the Inspector may increase the number of the containers in order to make the sample sufficient for this purpose.
 
 (3) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same within seven days as follows :-
 
 (i) one portion of sample he shall send to the Government Analyst concerned for test and analysis;
 
 (ii)the second he shall send to the chairman, Provincial Quality Control Board or the Central Licensing Board or the Registration Board, as the case may be;
 
 (iii)the third, where taken, he shall send to the warrantor, if any, named under the proviso to sub-section (3) of Section 32; and

  [(iv) the fourth, where taken, he shall send to the person purporting to be its manufacturer or
  importer, as the case may be.] (4) Where an Inspector seizes any drug containing any filthy or putrid substance, vermin, worm, rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such that it cannot or need not be divided, he shall effectively seal and suitably mark the same and permit the person from whom he seizes the drug to add his own seal, if any, and mark to it and shall produce the same before the Drug Court or the Central Licensing Board or the Registration Board, as the case may be, before which proceedings are instituted or action is initiated in respect of the drug.
 
 (5) Where an Inspector takes any action under section 18,--
 
 (a) he shall as soon as practicable ascertain whether or not the drug contravenes any of the provisions of this Act and, it is ascertained that the drug does not so contravene, he shall forthwith revoke the order passed under the said section or, as the case may be, take such action as may be necessary for the return of the stock seized and payment for the samples taken, under intimation to the Board concerned;
 
 (b) if he seizes the stock of the drug he shall, as soon as may be inform the Board concerned and take its order as to the custody thereof:
 
 Provided that where a Federal Inspectors not competent to take action under section 30, he shall as soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector for further action under this Act.
 
 (6) The Provincial Inspector on finding any contravention of this Act shall, unless the Board otherwise directs, always refer the case to the Provincial Quality Control
 
 Board and seek orders as to the action to be taken in respect of such contravention.
 
 (7) The Federal Inspector on finding any contravention of this Act for which he is authorised shall, unless otherwise directed, always refer the case to the Central Licensing Board or the Registration Board or any other authority as may be specified for the purpose and seek any further orders as to the action to be taken in respect of such contravention.

20. Persons bound to disclose place where drugs are manufactured or kept: Every person for the time being in charge of any premises whereon any drug is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, disclose to the Inspector the place where the drug is being manufactured or is kept, as the case may be.
 
 21. Disclosure of the name of the manufacturer: Every person, not being the manufacturer of a drug or his agent for the distribution thereof, shall if so required by an Inspector, disclose to him the name, address and other particulars of the manufacturer or other person from whom he acquired the drug.
 
 22. Reports of .Government Analysts : (1) The Government Analyst to whom a sample of any drug has been submitted for test and analysis under sub-section (3) of section 19 shall deliver to the Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one copy thereof to the authority as may be prescribed.
 
 (2) The Government Analyst, as far as may be, shall submit the report referred to in sub-section (1) within sixty days of the receipt by him of the sample of the drug and, if he is not able to do so for reasons beyond his control, shall communicate the reasons to the Inspector in writing and shall endorse its copy to the
[Central Licensing Board or, as the case may be, the Registration Board or the Provincial Quality Control Board] who shall have the sample tested from the same or any other Government Analyst or a Government Drug Testing Laboratory or any other Laboratory and shall ensure the receipt of results of such test and analysis within a further period as may be prescribed and shall make the test report available to the Inspector for further action.
 (3) On receipt of the report, the Inspector shall--
 (a) deliver one copy thereof to the person from whom the sample was taken;
 (b) forward one copy to the warrantor, if any, named under the proviso to sub-section (3) of Section 32;

  (c) forward one copy to the [Central Licensing Board or, as the case may be, the Registration Board or the Provincial Quality Control Board] for its directions as to the action to be taken;and
 (d) retain the fourth copy for use in any prosecution or for any other purpose.
 
 (4) Notwithstanding anything contained in any other law for the time being in force, any document purporting to be a report signed by a Government analyst shall be admissible as evidence of the facts stated therein without formal proof and such evidence shall be conclusive unless the person from whom the sample was taken or the said warrantor has, within thirty days of the receipt of a copy of the report notified in writing to the Inspector or [
Provincial Quality Board or, as the case may be, the Central Licensing Board or the Registration Board or the Drug Court] before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.
 
 (5) Where a person has, under sub-section (4), notified his intention of adducing evidence in controversion of a Government Analyst's report, [
Provincial Quality Board or, as the case may be, the Central Licensing Board or the Registration Board or the Drug Court] may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug lying with the Board concerned under sub-section (3) of section 19 to be sent for test or analysis to the Federal Drug Laboratory or any other laboratory specified for the purpose by the Federal Government which shall make the test or analysis and report in writing signed by, or under the authority of the person for the time being incharge of the Federal Drug Laboratory, or, as the case may be, such other laboratory, the result thereof and such report shall be conclusive evidence of the facts stated therein.
  (6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory under sub-section (5) shall be paid by the complainant or accused as the Drug Court or the Board concerned shall direct.
CHAPTER III
 
 Prohibitions
23. Import, manufacture and sale of drug: (1) No person shall himself or by any other person on his behalf--
 (a) export, import or manufacture for sale or sell ·
 (i) any spurious drug;
 (ii) any counterfeit drug;
 (iii) any misbranded drug;
 (iv) any adulterated drug;
 (v) any substandard drug;
 (vi) any drug after its expiry date;
 (vii) any drug which is not registered or is not in
 accordance with the conditions of registration;
 (viii) any drug which, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate .any such disease or ailment, or to have any such other effect, as may be prescribed;
 (ix) any drug if it is dangerous to health when used in the dosage or with the frequency, or, for the duration specified, recommended or suggested in the labelling thereof; or
 (x) any drug in contravention of any of the provisions of this Act or any rule;
 
 (b) manufacture for sale any drug except under, and in accordance with the conditions of, a licence issued under this Act;
 
 (c) sell any drug except under, and in accordance with the conditions of, a licence issued under this Act;
 
 (d) import or export any drug the import or export of which is prohibited by or under this Act;
 
 (e) import or export any drug for the import or export of which a licence is required, except under, and in accordance with the conditions of, such licence;
 
 (f) supply an incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;
 
 (g) peddle, hawk or offer for sale any drug in a park or public street or on a highway, footpath or public transport or conveyance;
 
 (h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a drug but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a drug;
 
 (i) sell any drug without having a warranty in the prescribed form bearing the name and batch number of the drug issued,--
 
 (i) in the case of a drug manufactured in Pakistan, by the manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug or by his authorised agent;
 
 (ii) in the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is imported through an indentor by such indentor; and
 
 (j) apply an incorrect batch number to a drug.
 
 (2) Nothing in sub-section (1) shall apply to the manufacture or subject to prescribed conditions, of small quantities or any drug for the purpose of clinical trial examination, test, analysis or personal use.

24. Control of advertisement: No person shall himself or by any other person on his behalf advertise, except in accordance with such conditions as may be prescribed,--
 
 (i) any drug;
 
 (ii) any substance used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of treatment or any other substance or mixture of substances as may be prescribed;
 
 (iii) any remedy, treatment or offer of a treatment for any disease.
 
 Explanation: In this section, "advertise" means to make any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of a drug, a substance or a mixture of substances, a remedy or a 'treatment except the display of sign boards for a clinic, a dispensary or a hospital or such other institution offering treatment.

  25. Control of samplings: No person shall distribute or cause to be distributed any drug as a sample except in accordance with such conditions as may be prescribed.
 
 26. Control of printing of labelling: No person shall print any labelling in respect of any drug which is required to be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-section (6) of section 7 or for a person who does not possess a licence under this Act to manufacture that drug.

 
CHAPTER IV
 Offences, Penalties and Procedure
27. Penalties : (1) Whoever himself or by any other person on his behalf:
 (a) exports, imports, manufactures for sale or sells any spurious drug or any drug which is not registered;
 (b) manufactures for sale any drug without a licence; or
 (c) imports without licence any drug for the import of which a licence is required;
 
 shall be punishable with imprisonment for a term which shall not be less than three years or more than ten years and with fine which may extend to one lakh rupees:
 
 Provided that the Drug Court may, for any special reasons to be recorded, award a sentence of imprisonment for a term of less than three years.
 
 (2) Whoever himself or by any other person on his behalf--
 (a) imports, manufactures for sale or sells any counterfeit drugs; or
 
 (b) gives to the purchaser a false warranty in respect of any drug sold by him that the drug does not in any way contravene the provisions of Section 23 and is not able to prove that, when he gave the warranty, he had good and sufficient reason to believe the same to be true; or
 
 (c) applies or permits to be applied to any drug sold, or stocked or exhibited for sale, by him, whether on the container or a label or in any other manner, a warranty given in respect of any other drug, or
 
 (d) imports, manufactures for sales or sells any drug under a name other than the registered name; or
 
 (e) exports, imports, manufactures for sale or sells any drug with which any substance, which should not actually be its component, has been mixed or packed so as to reduce its quality or strength or for which any such substance has been substituted wholly or in part;
 
 shall be punishable with imprisonment for a term which may extend to seven years, [and with fine which may extend to one lakh rupees or with both.]
 
 (3) Whoever obstructs an Inspector in the exercise of any power conferred upon him by or under this Act, or disobeys the lawful authority of any Inspector, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to ten thousand rupees, or with both.
 
 (4) Subject to the provisions of sub-section (1), sub-section (2) and sub-section (3), whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to fifty thousand rupees, or with both.

28. Penalty for subsequent offence : (1) Whoever having been convicted of an offence under sub-section (1) of section 27 is convicted for a [subsequent offence] under that sub-section shall be punishable with imprisonment for life or with imprisonment which shall not be less than five years and with fine which may extend to two lakh rupees.
 
 (2) Whoever having been convicted of an offence under sub-section (4) of section 27 is convicted for a [subsequent offence] under that sub-section shall be punishable with imprisonment for a term which shall not be less than two years or more than ten years, or with fine which may extend to two lakh rupees, or with both.
 
 (3) Whoever having been convicted of an offence under sub-section (4) of section 27 is convicted for a [subsequent offence] under that sub-section shall be punishable with imprisonment for a term which may extend to seven years, or with fine which may extend to one lakh rupees, or with both.

  29. Forfeiture : (1) Where any person has been convicted under this Act, for contravening any such provisions of this Act or any rule as may be prescribed in this behalf, the Drug Court may order that the stock of drug or substance by means of or in relation to which the offence was committed or anything of a similar nature belonging to or in the possession of the accused or found with such drug or substance, and if such contravention is punishable under sub-section (1) of section 27, any implements used in manufacture or sale of such drug and any receptacles, packages or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances, used in carrying such drug, be forfeited to the Federal Government or, as the case may be, the Provincial Government and, upon such order being made, such .drug, substance, implements, receptacles, packages or coverings, animals, vehicles, vessels or conveyance may be disposed of as that Government may direct.
 
 (2) Without prejudice to the provisions of sub-section (1), where the Drug Court is satisfied on the application of an Inspector or otherwise, and after such inquiry as may be necessary that a drug contravenes the provisions of this Act, the Drug Court may order that such drug be forfeited to the Federal Government or, as the case may be, the Provincial Government and, upon such order being made, such drug may be destroyed or otherwise disposed of as that Government may direct.
 
 (3) An Inspector shall release any drug or article seized by him under this Act when he is satisfied that all the provisions of this Act and the rules with respect thereto have been complied with.

  30. Cognizance of offences: (1) Subject to the provisions of Section 19, no prosecution shall be instituted under this Chapter except--
 
 (a) by a Federal Inspector, where the prosecution is in respect of a contravention of clause (h) of sub-section (1) of section 23 or section 24 or any of the provisions of this Act or the rules relating to the import or export of drugs or the manufacture for sale, or sale, of a drug which is not for the time being registered or for the manufacture for sale of which a licence is not for the time being in force; or
 
 (b) by a Provincial Inspector:
 
 Provided that, where the public interest so requires, the Federal Inspector may, with the prior permission of the Federal Government, institute a prosecution for a contravention of any other provision of this Act.

  (2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of 1898),--
 (a) an offence punishable under this Chapter other than an offence mentioned in sub-section (1) of section 27, shall be non-cognizable, and
 (b) no Court other than a Drug Court shall try an offence punishable under this Chapter.
 
 (3) Nothing contained in this Chapter shall be deemed. to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence punishable under this Chapter or to require the transfer to a Drug Court of any case which may be pending in any Court immediately before the establishment of the Drug Court.

  31. Drug Courts : (1) The Federal Government may, by notification in the official Gazette, establish as many Drug Courts as it considers necessary and, where it establishes more than one Drug Court, shall specify in the notification the territorial limits within which, of the class of cases in respect of which, each one of them shall exercise jurisdiction under this Act.
 
 (2) A Drug Court shall consist of a person who is, or has been, or is qualified for appointment as, a Judge of a High Court, who shall be the Chairman, and two members being persons who, in the opinion of the Federal Government, are experts in the medical or pharmaceutical fields:

  [Provided that for deciding applications of bail the chairman any one member shall constitute full
  quorum of a Drug Court.]
 
 (3) A Drug Court shall sit at such place or places as the Federal Government may direct.
 (4) A Drug Court shall have all the powers conferred by the Code of Criminal Procedure, 1898 (Act V of 1898), on a Court of Session exercising original jurisdiction.
 (5) A Drug Court shall not merely by reason of a change in its composition, be bound to recall and rehear any witness who has given evidence, and may act on the evidence already recorded by or produced before it.
 (6) A Drug Court shall, in all matters with respect to which no procedure has been prescribed by this Act, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (Act V of 1898), for the trial of summons cases by Magistrates.
 (7) A person sentenced by a Drug Court may prefer an appeal to a Bench of the High Court consisting of not less than two Judges within thirty days of the judgment.
 ( 8) The provisions of Sections 5 and 12 of the Limitation Act, 1908 (IX of 1908), shall be applicable to an appeal referred to in sub-section (7).

32. Pleas: (1) Save as hereafter provided in this section, it shall be no defence in a prosecution under this Act to prove merely that the accused was ignorant of the nature, substance or quality of the drug in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.
 
 (2) A drug shall not be deemed to be misbranded or adulterated or sub-standard only by reason of the fact that there has been added thereto some innocuous substance or. ingredient because the same is required for the manufacture or preparation of the drug fit for carriage or consumption and not to increase the bulk, weight or measure of the drug or to conceal its inferior quality or other defect or there is a decomposed substance which is the result of a natural process of decomposition:
 
 Provided that such decomposition is not due to any negligence on the part of the manufacturer or the drug or the dealer thereof and that it does not render the drug injurious to health or does not make it substandard.
 
 (3) A person, not being the manufacturer of a drug or his agent for the distribution thereof, shall not be liable for a contravention of section 23 if he proves--
 
 (a) that he did not know, and could not with reasonable diligence have ascertained, that the drug in any way contravened the provision of this Act and that the drug while in his possession remained in the same state as when he acquired it; and
 
 (b) that he acquired the drug from a duly licensed manufacturer or his authorised agent or an importer or an indentor resident in Pakistan under a written warrant, in the prescribed form stating, in particular. the batch number of the drug and signed by such person that the drug does not in any way contravene the provisions of Section 23 and that the drug while in his possession was properly stored and remained in the same state as when he acquired it and that the drug has been manufactured by a manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug:
 
 Provided that a defence under clause (b) shall be open to a person only--
 
 (i) if he has, within seven days of the service on him of the summons, sent to the Inspector a copy of the warranty with a written notice stating that he intends to rely upon it and giving the name and address of the warrantor, and
 
 (ii) if he proves that he has, within the same period, sent written notice of such intention to the said warrantor.
 
 33. Application of law relating to customs and powers of officers of customs : (1) The law for the time being in force relating to customs and to goods the import of which is prohibited by or under the Customs Act, 1969 (IV of 1969), shall, subject to the provisions of section 27 of this Act, apply in respect of drugs the import of which is prohibited under this Act, and officers of customs and officers to whom any of the functions of an officer of customs have been entrusted under the said Act shall have the same powers in respect of such drugs as they have for the time being in respect of such goods as aforesaid.
 
 (2) Without prejudice to the provisions of sub-section (1), an officer of customs or a Federal Inspector or any other person as may be authorised by the Federal Government in this behalf may detain any imported package which he suspects to contain any drug the import of which is prohibited under this Act, and shall forthwith report such detention to the licensing authority and, if required by it, forward the package or samples of any suspected drug found therein to a laboratory specified by it.
 
 34. Offences by companies, etc.: Where the person guilty of an offence under this Act, is a company, corporation, firm or institution, every director, partner and employee of the company, corporation, firm or institution [with whose knowledge or consent the offence was committed shall be guilty of the offence]

35. Publication of offender's name: (1) If any person is convicted of an offence under this Act, it shall be lawful for the Drug Court to cause the offender's name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct.
 
 (2) The expenses of such publication shall be recoverable in the same manner as a fine is recoverable.
 
 36. Powers to exempt : Notwithstanding anything contained in this Act, the Federal Government may, if it is of opinion that the public interest so requires, at any time, of its own motion or on a representation made to it, by notification in the official Gazette, exempt any drug or class of drugs from the operation of any of the provisions of this Act, subject to such conditions, if any, and for such period, as may be specified in the notification.

  37. Inspectors to be public servants : Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Pakistan Penal Code (Act XLV of 1860), and shall be officially subordinate to such authority as the Government appointing him may specify in this behalf.
  38. Indemnity : Except as otherwise expressly provided in this Act, no suit, prosecution or other legal proceeding shall lie against Government or any other authority or person for anything which is in good faith done or intended to be done under this Act or any rule.
39. Finality of order, etc.: Save as otherwise expressly provided in this Act, every order passed or decision given by any Board, a Drug Court or any other authority under this Act shall be final and shall not be called in question by or before any Court or other authority.
  40. Publication of result of test or analysis, etc.: (1) It shall be lawful for the Federal Government to publish, in such manner as it may deem fit, the result of any test or analysis of any drug for public information and to pass such orders relating to the withdrawal of such drug from sale and its disposal as it may consider necessary.
 
 (2) The Federal Government may, if it considers it necessary in the public interest so to do, publish for public information, in such manner as it may deem fit, any information relating to a drug or to the use of a drug in specified circumstances.
 
 41. Cancellation or suspension of licences: Where any person has been found to have contravened any of the provisions of this Act, or the rules in respect of any drug and the contravention is of such a nature that the import, export, manufacture or sale of any drug by such person is, in the opinion of the licensing authority or the Central Licensing Board, likely to endanger public health, that authority may, after giving such person an opportunity of being heard, cancel the licence to import, export, manufacture or sell drugs issued to such person or suspend such licence for a specified period.
 
 42. Cancellation or suspension of registration of registered drugs: Where any person has been found to have contravened any of the provisions of this Act, or the rules in respect of any registered drug, the Registration Board may, after giving such person an opportunity of being heard, cancel the registration of such drug or suspend such registration for a specified period.

 
CHAPTER V
 
 Miscellaneous
43. Power of Federal Government to make rules: (1) Subiect to section 44, the Federal Government may, by notification in the official Gazette, make rules for carrying out the purposes of this Act.
 
 (2) In particular and without prejudice to the generality of the foregoing provision, such rules may-
 
 (a) prescribe the functions of the Federal Drug Laboratory and any other laboratory set up under section 14 or specified under section 22 or section 33 and the procedure for the submission to any such laboratory of samples of drugs for analysis or test, the forms of the laboratory's reports thereon and the fees payable in. respect of such reports and such other matters as may be necessary for any such laboratory to perform its functions;
 
 (b) prescribe specifications, including the strength, potency, purity, quality or other property, of any drug, and the methods of test or analysis to be employed in determining whether a drug is of required specifications:
 
 (c) prescribe the maximum proportion of any poisonous or other substance which may be added to or contained in any drug, or extracted or omitted therefrom; prohibit the import, manufacture, sale or stocking or exhibition for sale or distribution of any drug in which that proportion is exceeded and specify substances which shall be deemed to be poisonous;
 
 (d) specify the drugs or classes of drugs for the import or export of which a licence is required, the testing of such drugs, and prescribe the form and conditions of such licences, the authority empowered to issue the .same, and the fees payable therefor;
 (e) prescribe the places at which any specific drug or drugs may be imported, prohibit their import at any other place, and control their import through any specified agency;
 
 (f) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs sought to be imported, the procedure of officers, of customs in dealing with such evidence and the manner of storage at places of import of drugs detained pending admission;
 
 (g) prescribe the forms of licences for the manufacture for sale of drugs or any specified drugs or class of drugs, the form of application for such licences, the conditions subject to which such licence may be issued, the person under whose signature the same be issued and the fees payable therefor;
 
 (h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label' and container of any specified drug or class of drugs and prohibit the sale, stocking or exhibition for sale or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry date and prescribe the manner of disposal of such drug or class of drugs;
 
 (i) prescribe the conditions to be observed in the packing in bottles, packages and other containers of drugs and prohibit the sale, stocking or exhibition for sale or distribution of drugs packed in contravention of such conditions;
 
 (j) regulate the mode of packing and packaging, including its size, dimensions, fill and other specifications, the material used therefor and mode of labelling packed drugs and prescribe the matters which shall or shall not be included in such labels or on the leaflets accompanying the drugs;
 
 (k) require that the non-proprietary or chemical or accepted scientific name or the proprietary name of any specified drug or any ingredient thereof shall be displayed in the prescribed manner;
 
 (l) prescribe the requirements and conditions in respect of good practices in the manufacture and quality control of drugs;
 
 (m) prescribe conditions for distribution of samples for sales promotion of drugs; prescribe the procedure for introduction in Pakistan of a new drug;
 
 (o) prescribe terms and conditions of members of the Central Licensing Board and the Registration Board;
 
 (p) prescribe types of registration of drugs, the form of application for such registration, the conditions subject to which such registration may be granted, the manner of registration and post-registration and surveillance and deregistration of registered drugs and the fees payable therefor;
 
 (q) prescribe conditions for registration of indentors, importers, wholesalers and distributors within Pakistan and any establishment within any foreign country engaged in the manufacture for export of a drug and prescribe conditions providing effective and adequate means, by arrangement with the Government of such foreign country or otherwise, to enable the licensing authority or the Registration Board to determine from time to time whether drugs manufactured in such establishment, if imported or offered for import into Pakistan, shall be refused admission where the public interest so requires;
 
 (r) prescribe the form of warranty for manufactured drugs;
 
 (s) specify offences in relation to which the stock of drugs, articles or things shall be liable to forfeiture under this Act;
 
 (t) prescribe the qualifications, and regulate the procedure for exercise of powers and performance of functions, of Federal Inspectors;
 
 (u) prescribe the laboratories to which the Federal Inspectors shall submit samples of drugs taken for the purpose of test and analysis and the form and procedure for submitting the report of such test and analysis and the fee payable therefor, where so required;
 
 (v) prescribe measures for securing and maintaining supplies of drugs at reasonable prices, conditions to be met in respect of manufacture, production, pricing, keeping, movement and disposal of drugs and to fix prices, commissions, discount of the manufacturer, wholesaler, distributor, retailer or any other dealer of drugs, to control giving of bonus in cash or kind or in any other manner to any of the said parties and for collecting or calling for any information, statistics, records or books with a view to regulating the matters aforesaid;
 
 (w) specify drugs which may be advertised and the conditions subject to which such drugs may be advertised;
 
 (x) prescribe conditions subject to which small quantities of drugs may be imported or manufactured or exported for the purpose of examination, test or analysis, clinical trial or personal use; and
 
 (y) prescribe any other matter which is to be, or may be, prescribed by the Federal Government.
 
 (3) The power to make rules conferred by this section shall, except on the first occasion of the exercise thereof, be subject to the condition of previous publication.
 
 44. Power of the Provincial Government to make rules: (1) The Provincial Government may by notification in the official Gazette, make rules in respect of the following matters, namely :--
 (a) the establishment of laboratories for testing and analysing drugs;
 (b) the qualifications and the procedure, for exercise of powers and performance of functions of Provincial Inspectors;
 (c) the forms of reports to be given by Government Analysts and the manner of application for test or analysis and the fees payable therefor;
 (d) the conditions to regulate sale or storage or distribution of drugs or any specific drug or class of drugs;
 (e) the offences against this Act or any rule in relation to which the stock of drugs shall be liable to confiscation and destruction under this Act;
 (f) the forms of licences for the sale or distribution of drugs or any specified drug or class of drugs, the authority empowered to issue the same, the form of applications for such licences, the fees payable therefor and the condition subject to which such licerices may be issued;
 (g) the procedure to be followed by the Provincial Quality Control Board; and any other matter which is to be or may be, prescribed by the Provincial Government.
 
 (2) The power to make rules conferred by this section shall, except on the first occasion'of the exercise thereof, be subject to the condition of previous publication.
 
 45, Repeal and savings : [(1) The Drugs Act, 1940 (XXIII of 1940), the Drugs (Generic Names) Act, 1972 (XXIV of 1972), and the Drugs Ordinance, 1976 (IV of 1976), are hereby repealed.
 
 (2) Notwithstanding the repeal of the Drugs Act, 1940 (XlII of 1940), by sub-section (1),--
 
 (a) any licence to manufacture for sale issued thereunder to any person, for the revalidation of which an application has already been made to the Central Licensing Board within the date specified by the Federal Government shall continue to be valid until orders are passed by the said Board in this behalf;
 
 (b) any licence for import or export or sale of drugs issued thereunder to any person, shall, unless it expires earlier under the terms thereof, continue to be valid for such periods as the Federal Government, or as the case may be, the Provincial
 Government may by notification in the official Gazette, specify in this behalf:
 
 Provided that in case of drugs to be imported or exported licences may continue to be issued under the rules framed under the Drugs Act, 1940, till the rules under this Act are framed or, as the case may be, a date is fixed under sub-section (6) of section 7 in respect of drugs in the finished form ready for use.

  [ Ordinance No CXXVIII dated 15th Nov. 2002]
 

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Drug Regulatory Authority of Pakistan (DRAP)

Drug Regulatory Authority of Pakistan (DRAP)

Drug Regulatory Authority of Pakistan (DRAP) was established under DRAP Act, 2012 (Act No. XXI of 2012). DRAP  is  to provide effective coordination and enforcement of the Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods. DRAP is  an autonomous body under the administrative control of the Federal Government with its headquarters at Islamabad.DRAP is an Authority that is composed of a Chief Executive Officer and thirteen Directors, and a Policy Board that oversees the working of DRAP and gives Policy Guidelines. Presently DRAP is attached to the Ministry of National Regulations and Services. Ministry of National Regulations and Services has been renamed in May 2013 as: "Ministry of National Health Services, Regulations and Coordination"

Mission To ensure availability of quality therapeutic goods at affordable prices and to support public health.


 



Pharmacy Council of Pakistan

Pharmacy Council of Pakistan is a professional body responsible for the registration of pharmacists and promotion of pharmacy education in the country.
The  Pharmacy Council Pakistan (PCP) is the regulator established in terms of the Pharmacy Act, 1967 to regulate pharmacists, pharmacy support personnel and pharmacy premises in Pakistan. Our mandate is to protect, promote and maintain the health, safety and well being of patients and the public who use pharmaceutical services in Pakistan.

Punjab Pharmacy Council

Punjab Pharmacy Council, established under Pharmacy Act 1967 as amended in 1973, with the crystal clear objective to regulate the practice of pharmacy. The Secretary Health Government of the Punjab acts as President (Ex-officio) while the secretary, bears the office of Punjab Pharmacy Council to execute and exercise all the legislative functions (Section-23 of the Pharmacy Act, 1967) as;

· Registration & Renewal of Pharmacist (Register-A)

· Enrollment of Pharmacy Apprentices (Register-C) [Discontinued]

· Examination & Registration of Pharmacy Assistant (Register-B)

· Examination & Registration of Pharmacy Technician (Register-B)

· Prepare and maintain Registers of ;

· Graduate/Post Graduate Pharmacist

· Apprentices in Pharmacy

· Pharmacy Assistant & Pharmacy Technician

· Issuance of Good Standing Certificate.

· Verification of Certificate

· Publication of Text Books of Pharmacy for Pharmacy Assistant & Pharmacy Technician  as per the approved curriculum.

· On the Job Training of Pharmacists/Drug Inspectors.

· Refresher Course for Qualified Dispensers/Chemists.

· Inspect institutions (in coordination with Central Council) imparting pharmacy education to ensure standardized Education and Training.

· To do such other act & things as it may be empowered  or required to do by the Pharmacy Act, 1967.

 

 
Pakistan Pharmaceutical Manufacturers' Association

The Pharmaceutical Industry is a human Industry – an industry which caters to the health of public and is therefore of significant importance. As such, the Pakistan Pharmaceutical Manufacturers' Association came into existence on January 26, 1961 and the Government of Pakistan through the Ministry of Commerce registered PPMA as the only Representative body of the Pharmaceutical Industry in the Country. The Government issued a Licence to this effect under Section 26 of the Companies Act, 1913 on July 18, 1961 . The Association was formally incorporated under the Companies Act, 1913 by the Registrar of Joint Stock Companies.

At the time of establishment of PPMA there were only ten members throughout the country who are the founder members of the PPMA and it was through their efforts that this Association came into being. Now, today the Membership of the Association is 210 (Approximately), who possess the licence for manufacturing drugs granted by the Ministry of Health, Government of Pakistan against a total number of 350 units approximately.
The Pharmaceutical industry Comprises around 400 manufacturing units including over 350 national or Pakistani owned and licensed manufacturing unites and 25 licensed International subsidiaries of well known worldwide based Pharmaceutical Corporations.

PPMA feels strongly about the fact that all its members possess all requisite facilities necessary for the production of pharmaceuticals of quality and should comply with CGMP standards.

PMA has its head office located at KARACHI with two Regional office, viz. Punjab & NWFP Regional Office at Lahore and Sindh & Balochistan Regional Office at Karachi .

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This section is dedicated to develop an understanding regarding Pakistan's basic health issues and finding a road map to a practical and viable health policy through discussion among general population and the health professionals.

Objective: People to Propose Pakistan’s Health Policy

The structure and functional status of our health care services is far below that of today’s world standards. We need to understand the core health issues of our nation and through discussions and input from various quarters we need to formulate a proposal for health policy which could be implemented by our government at appropriate time to uplift the standards and quality of our health care services.

                     Better Health is mandatory for the progress of nation in all fields
 
Health Issues

Our Health issues are not the same as those of Americans or any other nation. We have to understand and pin point our own particular health issues.

Health Policy

Once we pinpoint our own health issues we can draft a proposal for a Health Policy which would be able to effectively address our core health issues.
 
How to implement

Once we have a consensus on our core health issues and policy then we can find means of convincing our government to implement those proposals.

 
Summary of Objectives.

    To impart an understanding of health care system to the public.
    To increase awareness among masses of our health issues.
    To figure out solutions for our health issues through debate among health professionals and general public.
    To find out the means of implementing better health care for Pakistan by influencing Government.

Simplify The Complex Health issue

To Solve any complex problem first simplify it. Presume our health system is a complex problem. Let us simplify it by raising few questions. A quest for the answers will lead us to the solution.

Premise :

1. Better Health is achievable at low expenses without foreign aid

2. A Health policy must address core health issues.

Questions Regarding Health Policy?

  • Who are our Current Health Policy Makers & What is our current health policy?
  • What should be the outline of our Realistic Health Policy?
  • Should main bulk of our health budget go to  secondary and tertiary health care ?
  • What are our main Health issues?
  • Is a common man aware of the Four tiers of Health care Systems?
  • Does he know where exactly to go when he falls sick?
  • What is our Current Health Care Delivery Apparatus?
Health Equation --> Preventive & Primary Health Care?   PHC = LHW   & Prevention = 0 Is Lady Health worker all what primary health care is about ? Is Prevention out of syllabus?

A little cost at preventive &  primary health care can save a lot at advanced care 

Primary Health Care

  • Does Sickness revolve only around delivery, infant care and family planning?
  • By providing the services of LHWs have we fulfilled our obligations of PHC?
  • What is the actual concept of Primary Health Care?
Family Medicine

  • Do we know what is Family Medicine?
  • Are we clear about the importance of the institution of a family physician?
  • Do we know how Family Medicine & Primary Health Care are intertwined?
Preventive Medicine We know the jargon
" Prevention is better than cure"
  • but do we really understand the value of preventive care?
  • Reactive or pro-active?
  • Should we wait for our enemy to strike us and then we will start preparing our defenses?
Damage Prevention and early damage control is always cheaper.   

What is Quackery

  • Do we allow any untrained person to fiddle with our expensive machines?
  • Is our body the cheapest household item so that we let the least trained people fiddle with it?
  • Do we know the role of quacks in spreading current epidemic of Viral Hepatitis?
  • Are we not going to stop health criminals commonly known as quacks?
Solution

Is govt not going to put the things right for us?  Should not the sufferers raise their voices now? Must they keep on suffering for ever? Key to solution is awareness of the problem. Become aware of your health issues. Become aware of Health care system. Learn to differentiate between authentic health care systems and fake ones. Promote Health Education.

Healthy Pakistan?  Our dreams have long been stolen. We must get them back. We must get out of despair. We need to act and act now. Our actions will change our tomorrow. We must not remain reactive alone. We need to become proactive.


Following is a general list of important and basic health issue of our public. If you want to add more please feel free to forward your suggestions.

  • We have a poorly organized health structure. We need to clearly define the four tier health care system and reorganize our health apparatus accordingly thus enhancing its credibility as well as functional capability.
  • Our health priorities are not properly defined. We work in a reactionary way in response to issues. That is why our health machinery is mainly controlled through a plethora of various programs instead of a general purpose & competent health provision system. We should clearly define our Health issues, Health priorities and Health policy.
  • We neither have insight nor physical existence of a properly functioning preventive health care system. Instead of an adhoc service we must have full time properly functioning public health departments at all levels.
  • We neither have insight nor physical existence of properly functioning Primary Health care facilities.  We lack experts in the field of Primary health care. The field of Family medicine needs to be properly highlighted, promoted and utilized by govt to the best of its advantage and to the advantage of public.
  • We like to spend more on secondary and tertiary care centers while neglecting primary and preventive care systems although by spending less on preventive & primary health care we can save a lot on secondary and tertiary level treatment.
  • Majority of our public belong to socioeconomic strata that cannot afford the costly medicines and treatment procedures. We must endeavor to reduce the cost of medicines and procedures. We should work around the system to accommodate everyone under health umbrella. We should quit the concept of free treatment. We should adopt the concept of affordable treatment for all.
  • Promotion of Research in Medical Field towards self reliance on production of pharmaceuticals and medical equipment is a must to reduce the cost of treatment.
  • There is a circulation of fake medicines, poor regulation & standardization of pharmaceuticals. More authenticity & Transparency needs to be imparted to pharmaceutical standardization, licensing and control procedures.
  • Quackery should be clearly defined and assumed to be a crime and therefore it should be stopped forthwith.
  • Our Public lacks health education. A national health education curriculum should be devised that should enable every citizen to know certain dos and don'ts regarding health. Public should also be made aware of legitimate / illegitimate and scientific /unscientific methods of treatment.
  • A gap exists between our medical training focus and our on ground health issues. Training structure & Curriculum of our medics/paramedics should be revised in the light of our own socioeconomic environments. Instead of blindly following books of foreign authors we should endeavor to prepare our own curriculum corresponding to our own needs through specially designated institutions/bodies by incorporating the services of existing bodies.
  • Demand and supply of health professionals for different services has not been properly worked out resulting in gross discrepancies at various health care giver levels. A statistical analysis in realistic terms of availability of health professionals in comparison to actual needs is needed and directed efforts are required to equate the availability of manpower to actual demand.
Health Care System; Tier wise approach.

We have to clearly define the functional tiers of health care   system i.e. Preventive, Primary, Secondary and tertiary level health care systems.  Proper functioning of each of the earlier tiers will result in tremendous decrease in work load and expenditure at the next level.

Preventive care
  • Central preventive research & policy making wings should be established at federal and provincial levels. These central wings will keep on evaluating the health priorities and prevalent disease patterns   and will thus formulate policies for intervention methodologies.
  • Implementing departments of preventive health should be restructured/established at District and Tehsil levels. These implementing organs will carry out their functions independently as well   as in coordination with staff of RHCs, BHUs  and LHWs.
Primary care
  • First level standardized treatment facility should be designed for   whole country and placed according to the pockets of population.
  • For rural level BHUs and RHCs already exist which only need a revision of their structure and functional capabilities.
  • For urban areas health units similar to BHCs should be created and   placed at different location to cater for public needs. This will not only save people from unnecessary travelling but also decrease the load   on bigger hospitals thereby increasing their efficiency and quality of service.
  • The basic health facilities should be well equipped in the light of modern development in health technology to provide good quality basic diagnostic as well as treatment facilities to the public near their doorstep.
Secondary care
  • Tehsil and district level hospitals along with multiple big city   small hospitals providing treatment facilities in different specialties for both outdoor as well as indoor cases. Their functional capabilities need to be assessed individually and rectified accordingly.
Tertiary care
  • Teaching hospitals in big cities providing state of art health facilities in different specialties are already working.  A thorough analysis will pinpoint the weaknesses which will be corrected accordingly.
  • A study is required to estimate the actual requirements of centers of excellence specialized in individual disorders like cardiac centers, burn centers, kidney centers, cancers hospitals etc. Any deficiencies in their structural or functional capabilities thus found could be addressed accordingly.
  • Through implementation of general policy recommendations as   discussed at other places in this document a significant improvement in functional capabilities of these health facilities is expected.
Prime Targets

keeping in mind the core health issues we have to clearly define the targets that we desire to achieve through a directional health policy. Once we have defined our targets we will be able to discuss ways to achieve them.

Please carefully read this provisional list of our health targets, debate them and add new targets to the list which you find important but missing in this list.

1. Implement and strengthen the four tier health care provision system.
2. Give special emphasis to the roles of properly structured and implemented preventive and primary health care facilities.
3. Provide health education for all through educational system and electronic media.
4. Judiciously use our budgetary resources for health services with a premise that small expenditure on preventive and primary care can save a huge sum at secondary and tertiary levels.
5. Switch the basic concept from free treatment to affordable quality treatment for all.
6. Enhance national capabilities of producing pharmaceuticals and medical equipments.
7. Promote genuine research in medical field for the good of our public.
8. Re-align the professional training structure of medics and paramedics to better serve our socio-economic fabric.
Health Priorities

Like defining our health targets we must also set our priorities right. To set the priorities right we mean to put the targets in right order so that the thing which matters most must be dealt with first.

  • We need to set the health priorities and goals in proper perspective according to our own socio-cultural circumstances for each of the health care tiers.
  • We have always witnessed an influence of VIP culture whether it comes to bureaucracy or politicians. The VIPs do not need preventive and primary health care systems. They need Specialists for each of their health issues. They need state of the art health facilities. It is commonly witnessed that during visits of higher officials the primary health care facilities and preventive health departments are skipped and only state of the art equipment dealing with tertiary health care facilities and concerned departments are highlighted. This pleases the visitors and brings good name to the hospital administrators. At the same time they effectively keep preventive and primary health care facilities hidden to conceal their pathetic state of affairs. It is for this reason that although we have an absent preventive and a crippled primary health care facility, we have an advanced secondary and tertiary health care apparatus.
  • For delivering quality health to all and to get the best results out of our limited health budget we must judiciously incorporate and invigorate the primary and preventive health facilities.
  • Fewer amounts spent at Preventive and primary levels will save huge expenditures at secondary and tertiary levels.
Setting straight our Quacks dominated Primary Health Care Sector   
  • Lady Health Worker Program is not the Primary health care as is touted by our government. We have to clear our minds that this is a short focus & limited mandate program. Actual requirements of primary health care are far more than this program and labeling LHW program as primary health care is either a big conceptual error or deliberate deception attempt. We must consider re invigoration of BHUs and RHCs as actual Primary health care organs. Institutions of similar capabilities must also be started in cities to provide 100% coverage to the population and at the same time to share the workload of larger hospitals in the cities.
  • How to make BHU work.
    • First of all we need to create a situation in which we can have   doctors willing to work and willingly work at BHUs. For that matter we will have to make their job socially respectable, professionally   satisfying and financially rewarding.
    • We need to define the service carrier structure of doctors as well   as staff. We must also make the mechanism of rewards and accountability   crystal clear. There should be no dead ends in the carrier ladder.   Anyone who wants to excel in his carrier at any time during his service   should struggle to fulfill the prerequisites. Primary health care along   with Preventive care should be clearly defined as specialties and given   appropriate service incentives through well defined service structure so   that people adopt these as carriers rather than as transit affair.
    • 2 years mandatory service at BHU should become part of a structured postgraduate training program.
    • The initial bond of service for doctors as well as medical technicians should be that of a short service without long term benefits. That bond will be renewed only if the person proves his worth through qualifying courses and service record. The availability of room   in organization will also be a consideration for extension of service   tenure thereby regularizing it
    • Appropriate recreational facilities should be provided in collaboration with rural uplift programs/ social action programs & tourism promoting organizations.
    • As a practical social uplift of the locality, setting up of the   residential colony of the members of village uplift committees in the   same premises along with BHU, cottage industry, school, business training programs and law enforcement unit can be considered with pros and cons.
    • The technical staff must be given similar incentives. Appropriate incentives will call in better lot for these services.
  • Revision of functional capabilities of BHU & therefore its staff   as well as equipment is long overdue. A basic health facility should be   mandated to provide certain basic diagnostic and treatment facilities.   Due to easy accessibility and lower cost of equipment and technology,   several diagnostic and therapeutic facilities must be incorporated in   our basic health units. These facilities should include:
    • Basic clinical laboratory tests.
    • X-ray facility
    • ECG facility.
    • Ultrasonography. (doctors should receive one month course in USG during their house job)
    • Minor surgical facilities.
Provision of above mentioned facilities at the basic health unit   levels will boast the functional capabilities as well as moral of staff   and dependent population to enormous degrees. The patients many a times   have to travel long distances just to get these basic investigations   done. They also spend huge amount of their hard earned cash on traveling expenses as well as in billings of private investigation   facilities. Provision of these facilities to public on the basis of cost   of material plus maintenance will benefit the public a great deal but   will put very little extra load on health budget. Due to availability of   these facilities at BHUs the doctors will feel greater confidence and professional satisfaction while working here.

 Community Medicine or Public Health  Remains the most Neglected Social service by Government   
  • We have totally forgotten at our national health policy level that “Prevention is better than cure”
  • We don’t have any properly functioning preventive health care   system. Instead of relying on adhoc ism  we must have full time properly   functioning public health departments at all levels.
  • At the central level the preventive health wing of health ministry   will carry out research in the disease prevalence and the possible   prevention methods for each of them. In the light of findings of its   research this central prevention wing should prepare its action plan to   control prevalent diseases/health hazards.
  • District/Tehsil preventive health departments will be the implementing units which will to carry out essential disease control procedures in the light of central preventive wing’s directions. These implementing organs will carry out their functions independently as well   as in coordination with staff of RHCs, BHUs  and LHW. One of the staff   members of BHUs could be a representative of district/tehsil preventive   health department having received additional training in desired   preventive tasks.
  • Staff for malaria control program or any other task related with   preventive health wherever present will be made part of the preventive   health structure and will be utilized in a bigger sphere of preventive   health thereby effectively utilizing their services.
  • The central research wing should be receptive to any useful input   from anyone down the ladder which can help in establishing methodologies   for controlling/eradicating certain prevalent diseases/health hazards.

   Training of health care professionals must focus on our sociocultural setup

   
  • We must redefine the training structure & curriculum of doctors   as well as paramedics according to our own social and health/disease   statistics.
  • Efforts are needed to pump in desired strength of health professionals in health delivery system to meet the goals of delivering quality health service. Any deficiencies can be met through creating additional training slots. The trainees at various levels provide a very   useful work force so we should never hesitate in opening additional   training slots whenever needed. Any surplus amount of trained   professionals can later be easily diverted to other countries and that   will generate handsome foreign exchange as compared to sending unskilled   labor.
  • We should abolish open merit system for girls and boys and revive   the previous quota system for girls. The government spends a significant   amount on the training of doctors but most of our Female doctors do not   continue their profession after marriage. Similarly female doctors do   not perform duties at BHUs which reduces the actual availability of   trained doctors especially for service at rural health facilities.   Resultant the amount spent on the training of such female doctors goes   down the drain. Only those girls should be admitted to govt medical   colleges who sign a bond to serve for a minimum of 5-7 years at   appropriate govt health facilities. If by training more male doctors we   get surplus doctors then we can facilitate their expatriation through   MOUs with different govts which will generate Foreign Exchange for us.
  • 2 years mandatory service at BHU should become part of a structured   postgraduate training program. Targets to be achieved and tasks to be   performed during the tenure must be clearly defined. Supervision of that   service tenure must be carried out at regular intervals through   specially designed methods for ensuring proper output of doctors during   that tenure. The doctor after 2 years experience at a BHU will become   eligible to appear in an intermediary module. Qualifying it in addition   to points attained through assessments during that service tenure will   entitle him for a one year training program at a teaching hospital. In   case of joining the specialty of Family medicine this whole tenure will   be counted towards total training requirement for specialization while   in case of joining other specialties this time period will only   partially be counted towards total training req of specialty provided   the doctor achieves certain targets related to his own specialty during   the tenure. After that the doctor will be eligible to appear for MCPS.   If desirous to go for fellow ship then he will need to enter another 2 year program at Teaching hospitals + BHU rotations (1 year each). The doctors thus trained will be given appropriate Promotion and salary incentives according to their professional competence.  The organization of training structure on these lines for primary health care specialists will provide us a work force of expert and dedicated professionals who can make our dreams of a quality primary health care facility for all come true. As a further incentive any doctor who gets an appointment in BHU will automatically become eligible to enter into the training program of CPSP from the same date after registering with   them. He will however have to clear FCPS-I within a particular time   frame to be eligible for appearing in next modules.
  • A plan for proper training of health technicians working at rural   health facilities is desirable. These people should get initial training   at some training centre for three months which will cover theoretical   aspects of basic nursing skills, human anatomy and physiology. Then they   will receive on job training at BHUs under supervision of doctor and   senior technicians for two years (One year at low salary and the second   year at raised salary). During that period they will be required to   prepare for basic exam. If they qualify the exam at that level then they   will be given the designation of regular short service technical staff   rather than trainee.  After qualifying that exam they will be given one   year on job training at a bigger hospital. The doctor will receive   credit for appropriately training nursing staff. These trainings will be   organized at district level and appointment of staff will be within   district. Survey of the existing health facilities will be carried out   so as to incorporate teaching classes within the buildings of already   existing hospitals etc so as to avoid extra unnecessary expenditures.    Any technician who is desirous to enter into a specialty will be able   to do so through entrance exams and service records instead of sifarish.
Cost vs Affordability of Health Care.
   Well planned efforts are required to reduce the cost of medicines and other health care facilities.
 
  • Abolishing the concept of free treatment. The concept of free   treatment for all in a welfare state seems to be a popular voice. Once   started none of our govts had the strength to revise it. This concept is   impractical and has several ills. We can easily see that this system is   mostly not working. In fact the concept of free medicines is one of the   causes of failure and bad reputation of our govt health facilities. It   is clearly not possible to provide free medicine to all the patients   reporting at govt hospitals under our current economic situations.
    • Whatever medicine is provided to the govt health facilities is   selectively utilized by the health authorities at their own discretion.   Others are routinely asked to purchase their own medicines. This creates   a sense of frustration among public who think that they are being   deceived.
    • Concept of free medicine prompts those people to report sick who do   not have a definite reason to do so. This puts unnecessary burden on the   govt health facilities.
    • Due to limited budget the govt health facilities always remain short   of staff as well as equipment. Similarly these facilities are always   short of budgets to carry out necessary building and equipment   maintenance. On the other hand the dependent population keeps on   increasing day by day. All these factors accumulate into a poor quality   and inefficient health service. This is a recipe of disaster. We have to   say goodbye to it one day, the earlier we do it the better it is.
  • Adopting affordable treatment for all.  We must replace the concept   of free treatment with that of affordable treatment for all. Let us look   into its feasibility and action plan.
    • The govt will provide staff for its health facilities.
    • The govt will purchase medicines out of a specially prepared   essential medicines list from the least cost bidder in open bids amongst   licensed pharmaceuticals. Those medicines will be marked and labeled   for govt hosp use only. The same will be provided to public on the   procurement cost basis without profit. At the same time govt should   establish its own production units for producing essential drugs.
    • Health facilities will charge patients a small token fee for each   visit which can be set somewhere between Rs 10 & Rs 100. All the   procedures whether diagnostic or therapeutic on each visit will be   provided to the public on a nominal cost. The cost of each procedure   would be calculated on the basis of cost of materials to the govt plus a   little percentage for maintenance of equipment, while cost of trained   staff will be out of govt pocket.
    • The Funds generated out of Medicines will be utilized to procure   more medicines and the funds generated through procedures will be used   to procure more material for procedures and maintenance of equipment.
    • The funds generated through token fee will be used to carry out the ongoing maintenance of health facilities.
    • Due to this model people with genuine reason will usually be reporting sick to govt health facilities.
    • As people will have to pay for the medicines so they will not like to stock these as bounties.
    • As govt will be eased out of its expenditures on medicines so it   will be able to direct its resources in employing more staff and   maintaining or upgrading structure and equipment of health facilities.   This will result in better quality and efficiency of health service.
    • As this model ensures presence of medicines in govt health   facilities round the clock so it will be a plus point in attracting   doctors towards rural health facilities because many of the doctors have   an argument that it is useless to serve in BHUs which don’t have any   medicines or equipment.
    • For those people who cannot afford even a token money a system of   zakat should be invoked and their payments should be tackled under zakat   heads.
    • Similarly Emergency cases will not be charged any amount beforehand.   They can be put into the categories of affording or zakat afterwards.
    • This is a technically feasible and highly practical model as   compared to the existing one. In the existing model we have assigned   impractical goals to the health care system as we are not giving them   the required budget to meet the goals. The reason of failure in our   current system is basically more related to unrealistic health policy   rather than the corruption or mismanagement of health care givers. The   currently proposed system ensures realistic tasks and availability of   proper resources, so only honest and dedicated implication is required.
Code of Conduct, charter of duties & accountability mechanisms for health professionals
  • A charter of duties for each and every member of health provision   facilities should be formulated after thorough deliberation.  The same   should be made easily accessible for public.
  • Code of conduct for each and every member of health provision facilities should be defined in clear terms.  The same should be made easily accessible for public.
  • Devising proper accountability mechanisms for the health staff and   strengthening it is mandatory to keep its efficiency at desired levels.   For establishing any effective accountability procedure it is a must to   remove political influence.
  • The objective is to enhance the functional capabilities of health   services along with uplifting their quality, while retaining the honor   of profession.       
 
 
 How to achieve a Peoples Friendly flourishing Pharmaceutical sector in Pakistan.   
  • Strategies should be adopted to curtail the very high profit margins   in pharmaceutical sector through introducing healthy competition   without affecting open market or quality of products.
  • Any deals with foreign pharmaceuticals/Legislation against public interest should be carefully revised.
  • A central drug research institution should be established. It should   bring within its jurisdiction the present redundant national drug   testing laboratories thus reinvigorating them. The same institute should   commence study of new drugs especially through testing the old traditional medicines. In this way any effective traditional medicines   would be properly identified and put into use.
  • Proper structuring and revision of policies regarding pharmaceuticals.
  • Efforts are needed to control circulation of fake medicines.
  • All pharmaceutical manufacturers, importers, exporters should be   properly licensed after thoroughly assessing their production units and   manufacturing standards. Only those companies who fulfill the desired   standards of production should be allowed to bring their products to   market.
  • A fool proof and crystal clear mechanism for assessment of pharmaceutical manufacturing, storage, transport and marketing must be established.
  • As drugs can freely circulate in different parts of country after   manufacturing at a particular location so their control must become a   federally administered subject.
  • A Federal government official Pharmaceutical website designed to   clearly provide all the pharmaceutical related information for health   sector as well as public must be made. A complete list of licensed   Pharmaceutical companies must be available there.  The website must also   contain pharmaceutical related laws, policies, production standards,   standards assessment system, procedure for getting license, and   complaint cell regarding any pharmaceutical malpractice that comes into   notice of any citizen.
  • The revision of standard assessments must be carried out annually by   a well paid, competent team of honest members whose identity is not   made public. Multiple teams thus created will be assigned different   regions annually on random selection basis. These revisions must be   accordingly published in the proposed website regularly.
  • The surprise checking teams will either be given legal powers or   they should include a magistrate so as to summarily deal with the offenders by imposing penalties ranging from confiscation of stocks to imposition of fines or imprisonment in case of case of criminal acts of   faltering medicines or knowingly supplying/Marketing faltered medicines.
  • Prohibition of unauthorized sale of medicines. A list of over the   counter medicines should be decided and freely circulated among pharmacies. Sale of any other medicines must only be through authorized prescriptions.
   
 Population Planning is must to achieve social & Economic uplift of Pakistan     
 
  • Reinvigorate the drive to control population explosion through following successful model of Bangladesh.
  • Religious and cultural hindrances to implementation of this program   should be addressed through proper deliberations and dialogues with   concerned quarters.
  • We have to assess and redefine the structure and functional capabilities of LHWs program. We must also look into the failure areas in availability/ provision of contraceptive devices/facilities to the general public through regular public surveys.

   General population of Pakistan relies heavily on the private sector to meet its needs of health care   
  • We must properly analyse the quantum as well as ethical and professional competency standards of our private health sector.
  • We must make a full audit of all the existing private practice outlets, properly register them and establish an efficient monitoring system.
  • We must also look into the possibilities of govt and private partnership possibilities.
  • A system of leasing out may also be considered but not at the cost of public agony.

   Medical and Surgical Equipment Manufacturing in Pakistan   
  • Local   industry related to medical fields i.e. medical equipment   /pharmaceuticals etc must be encouraged to enhance their production   through several incentives helping them to generate more income through   exports / tax incentives/ energy cost incentives, but at the same time   they should be duty bound to provide the same to local market at minimum   profit margins.
  • A special institution of Electro medical   research and production should be established which should carry out   feasibility studies regarding home production of various electro medical equipments. This institution should gradually first streamline and promote those local pvt electro medical manufacturers who are already doing certain activity on self initiative. The institution should motivate others in pvt sector to join the electro medical production grid. The institute should also establish capabilities of manufacturing electro medical equipment through its own enterprise of public pvt partnership.
Quackery   
   
  • We must abolish quackery in all forms.
  • We have got unanimity of opinion regarding crimes against personal   property and body but we are confused in case of crimes against personal   health.
  • Quackery should be clearly defined. Laws should be promulgated to   define authorized as well as unauthorized health care. Quackery and unauthorized health care giving should be penalized under law.
  • A doubting attitude like “this may work” at official level must now be stopped forthwith.
  • Only scientifically proven methods must be allowed practice.
  • Modern medicine is now EBM (Evidence based medicine). Today only those drugs/Medical Procedures which bring evidence of efficacy and safety are allowed.
  • Any traditional methods of treatment if claimed to be effective must   be brought before a central research institution to verify their validity. Only after getting proper evidence regarding their efficacy/safety those methods will be authorized.
  • There are numerous health hazards of inappropriate health practices   which include; injudicious use of medications causing organ damage as   well as creating resistance to multiple organisms in case of antibiotics, spread of infections though indiscriminate use of injections, delay in reaching appropriate diagnosis and thus appropriate treatment resulting in disease aggravation, creating misconceptions in   public regarding health issues for the sake of financial gains which in   turn create negative trends among public regarding health.
Public Health Education
   
   
  • Health Education: No mechanism exists to properly educate masses   about health related issues in a systematized manner. Any education   given so far is in context of a particular program with focus on   selective points like malaria control, population planning etc.
  • A mandatory health education curriculum for the masses should be   prepared which should be brief and to the point but still comprehensive   enough to cover a basic knowledge of health and disease, hygiene and   sanitation, common locally prevalent diseases, preventive health,   structure and responsibilities of health care system. This curriculum   should be taught to masses through electronic media as well as through   inclusion into educational syllabus.
  • People are confused regarding selection of health care facility due   to lack of proper education on the subject. Devising proper health care   system and thoroughly introducing it to public through media campaign   can make the public aware of scientific and non-scientific treatment   methods. People are intelligent enough to realize that they should use   the latest technological advancement for facilitating their day to day   needs, but when it comes to health they are still having so many   superstitions and misconceptions that they very frequently utilize   inappropriate, unproven and hazardous methods for their treatment.
  • There are many elements in our society which keep on enforcing as   well as propagating these false beliefs through propaganda for the sake   of monetary gains. It thus becomes a prime responsibility of state to   educate the masses regarding scientific/unscientific & legitimate/illegitimate systems of health care.
Institutionalized Medical Research to focus on Indigenous Health Issues of Pakistan   
  • We need to initiate and promote fruitful medical research with a special emphasis on solving our indigenous health related issues. New institutions need to built and existing institutions need to be strengthened.
  • CPSP is already stimulating the medical fraternity towards research.   It is required to realize that productive research is what we really   need. We need that kind of research which can be used to benefit our   public by revising treatment concepts, facilitating treatment procedures   or reducing treatment costs. Govt should also establish a central   medical research center which should not only itself carry out various   research projects but it should also facilitate other non governmental   bodies involved in medical research.
  • A Study into causative mechanisms of the commonly prevalent disease   patterns in our masses is required to reach effective plans for   addressing those. Mostly these stem from poor health education, social   stresses, unhygienic living environments, malnutrition and ill designed   physical activities.
Public Education Regarding Food and Nutrition Concepts and Quality Control of Supplies   
  • People should be educated in the concepts of balanced and healthy   diets and they must now be brought out of the spheres of outdated   concepts of cold and warm foods.
  • A healthy diet is mandatory for proper health. Provision of   unadulterated healthy food for all and sundry must be the prime objective of our government.
  • Laws in dealing with food and medicine adulteration if required must be promulgated at the earliest and implemented forcefully.
  • Adulteration in food is not only done by local offenders it has been   reported several times in media that several multinational companies   are involved in this practice especially in products like milk and other   packed food items. It has also been reported that several such   companies pick up their expired stocks from European countries and after   packing them in fresh packs with new expiry dates sell them in our   country. Such practice should be seriously looked into and dealt with   accordingly.
Mental Health is included in WHO Definition of Health     
   
  • Mental and psychological health of individuals is very much related to the socioeconomic environments.
  • Through efforts in economic uplift, provision of social amenities,   social justice, national security etc we can do a lot in reducing the   stresses. This will thus improve the psychological health of individuals   who will  become more energetic,   motivated and productive components of the society.
  • Health Education plays a vital role in understanding the stress generating phenomena and their management. With proper health education people can be motivated to participate in diffusing the tension and stress from the social atmosphere and thus making the community interactions healthy and ensuring a better mental health of individuals.

   

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