Drugs (Licensing, Registering and Advertising) Rules 1976

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DRUGS (LICENSING, REGISTERING AND ADVERTISING) RULES, 1976

[Gazette of Pakistan, Extraordinary, Part II, 14th February 1976]

S.R.O. 145(1)/76.‑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

*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.

  1. Definitions.‑In theserules, unless there is anything repugnant in then subject or context‑

(a)"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 for‑

mulation of a finished drug or for repacking and such manufacture may involve chemical, bio‑chemical, phytochemical, microbial or such other processes or a combination of any of such processes;

(b) "compounding" means scientific combination of two or more in gredients with a view to make a finished drug;

(c) "finished drug" means a drug which is in the finished form and is made and labelled ready for use, whether after or without dilution;

(d)"form" means a form set forth in Schedule A.

(e)"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;

(f) "half‑finished product" means any material or mixture of materials thathas to undergo further manufacture;

(g) "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;

(h)"Ordinance" means the Drugs Ordinance. 1976 (IV of 1976);

(t) "purity" means the degree to which other chemical or biological entities are present in any substance;

(j) "quality control" means all measures employed fto ensure the uniform output of batches of drugs that conform to the required specifications of identity, strength, purity and other characteristics;

(k) "quarantine" means the status of a material :that is set apart and thatt g not available for use until released by the quality control department for ibis purpose;

(1) "repacking" means all operations involved in the transfer of a drug prom a larger container or packing into smaller containers or packings includ ing filling, packing and labelling with a view to make it ready for retail sale or wholesale, but does not include any compounding, or processing with a view to formulate it in any dosage form;

(m)"retail sale" means a sale other than wholesale;

(n)"Schedule" means a schedule to these rules;

(o) "semi‑basic manufacture" means manufacture, from an intermediate substance of a drug to be used as a starting material for the formulation of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking;

(p) "starting material" means all substances, whether active or inactive or whether they remain unchanged or become altered, that are employed in the manufacture of drugs; and

(q) "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 manufacturedrugs.‑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 drugsare manu factured 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 3shall be made in Form 1 to the Central Licensing Board addressed 2o it Secretary.

(2) An application under sub‑rule (1) shall be accompanied by a fee of‑

*(a)*rupees two thousand and five hundred for the grant of a licence to manufacture by way of basic manufacture or repacking *and rupees one thousand for its renewal; and

(b) rupees five thousand for the grant of a licence to manufacture by way of semi‑basic manufacture or formulation and rapes two thousand and five hundred for its renewal:

Provided that the application for renewal of the licence is made before the expiry of the validity of the licence.

(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 applica tion for the grant of a licence.

(4) A fee of rupees one hundred shall ba piid 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.

  1. Duration of a licence to manufacture drugs.‑Alicence issued under this Chapter shall, unless earlier suspended or cancelled, be in force for a period of two years from the date of issue and may thereafter be renewed for periods of two years at a time:

Provided that if application for renewal is made before the expiry of the. period of validity of a licence, the licence shall continue in force until orders

are passed on such application.

7. Certificate of licence to manufacture.‑Alicence 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 Secretary, Health Department, Government of Sind, ex‑officio;

(c) the Secretary, Health Department, Government of the Punjab, exofficlo;

(d) one member who is well conversant with pharmaceutical or medical profession to be nominated by the Government of the North‑West Frontier Province;

(e) one member who is well conversant with pharmaceutical or medical profession to be nominated by the Government of Baluchistan; and

(f ) one member from the Drugs Administration. Government of Pakistan, to be nominated by the Federal Government, who shall also be its Secretary:

Provided that the members nominated under clauses (d) and *(e)*shall be persons who are not the members of the Appellate Board.

(2) The members of the Central Licensing Board other than its ex‑ofcfo members, shall hold office for three years but shall be eligible for re‑nomination.

(3) The Central Licensing Board may co‑opt any other person who is, expert in the pharmaceutical or medical profession for advice on any parti cular matter under consideration.

(4) The Central Licensing Board shall, for the performance of its func tions, meet at least once in three months.

(5) Meetings of the Central Licensing Board may be held at such times as the Board may deem fit or on the request of any of its members if there is an important matter for its consideration.

(6) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy m, or any defect in the constitution of, the Board.

(7) Subject to rule 14, the Central Licensing Board may appoint a licens ing authority or authorities for such purpose as it may deem fit.

*(8)*The Chairman and the Secretary of the Central Licensing Board shall, after the Board has approved the issuance of a licence, sign the licence.

(9) The Central Licensing Board may authorise the Chairman to exercise all or any of its powers or to perform all or any of its functions.

(10) The Central Licensing Board may appoint its sub‑committee or a panel of experts or Inspectors to inspect the premises of a manufacturer of drugs on behalf of the Board and report to it.

*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 a 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 manu facture 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 standardizing, if necessary, and analysing sub stances 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‑committee or panel of experts or 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 rejec tion of an application under sub‑rule (4).

(6) If after the expiry of three months but within six months of the rejec tion 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 (4), such application shall be treated as a fresh application and full fee shall have to be deposited.

  1. Special provisions regarding grant of a licence.‑(1) Where a manu facturer 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 suspensions of licences.‑(1)*If a licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, 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 suspend, 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 applicationbeing 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.

14. Licensingauthority.‑For the purpose of section 18 of the Ordinance, ,the Secretary to the Government of a 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 renewed, 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 in tended use. in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of conta mination.

*(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 Depart went and maintain separate staff, premises and adequate laboratory equip ment 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 manu facturing units and its incharge shall be a whole time employee of the manu facturer and shall possess a degree in pharmacy, or a degree in science with chemistry, cr 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 the 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;

(iii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personal, where required;

*(iv)*hygienic garments shall be worn by all staff in processing and packag ing area.

(v) high standard of personal 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 periodi cal check up thereafter at least once a year;

(iii) facilities for vaccination and inocculation against the enteric or any other epidemic group of diseases; and

(iv) adequate precautions for safeguarding the health of the workers, including measures to avoid industrial accidents or diseases.

  1. Conditions for the grant or renewal of licence to manufacture drugs by way offormulation.‑Before a licence to manufacture drugs by way of for mulation 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 i 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).

(c) The manufacture shall be conducted under the active directions an

personal supervision of competent technical staff consisting 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 Ordi nance and has at least twelve months of practical experience in the manu facture of drugs; or

(ti) 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 know ledge of pharmacy which, in the opinion of the CentralLicensing Board, is adequate for the purpose; or

(iii) any foreign qualification the quality and content of the training of which are comparable with those prescribed 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 manu facture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision of 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 pro ducts which are intended to be produced

Provided further that the Central Licensing Board may, in the case of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non‑chemical contraceptives, plaster of paris, surgical dressings or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit the manufacture of the drug under the active direction and personal supervision of competent staff who although not having any of the qualifications included in sub‑clauses (i), (ii) and (iii) 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 Depart ment 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.

(e) The Quality Control Department shall be independent of the manu facturing unit and its incharge shall be whole time employee of the manu facturer 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.

  1. Licence to manufacture drugs by way of repacking.‑(1) Alicence 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.

  1. Conditions for the grant or renewal of a licence to manufacture drugs by way ofrepacking.‑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 condi tions and under the 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.

  1. Conditions of licence to manufacture by way of basic manufacture, semi‑basic manufacture, formulation and repacking of drugs.‑(1) Alicence to manufacture by way of basic, semi‑basic manufacture, formulation or re packing of drugs shall be subject to the conditions stated therein, 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 licensed premises and shall be pro duced at the request of any member of the Central Licensing Board or of a 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 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 defects 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 subrule

(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 and 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 or 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 infor mation 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 a licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture.

(14) The licencee shall contribute one per cent. of his total turnover towards the Central Research Fund to be maintained by the Federal Govern ment for the purpose of research and development of new drugs or evaluation of drugs

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.

20. Additional conditions of licence to manufacture drugs by way of formulation.‑A licence to manufacture drugs by was of formulation shall, is addition to the conditions laid down in rule 19, the subject to the following further conditions, namely

(a) The licensee shall comply with the requirements and conditions in respect of good practices in the manufacture and quality control of drugs as specified in Schedule B‑II.

(b) The licensee shall record in Schedule B‑III the particulars of manu facture 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 froth 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) ofrule 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 is 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.

*21. Licence to manufacture drugs for experimental purposes.‑(l)*If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manu facture, 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 (t) shall be counter‑signed 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 purposes.‑A licence issued under rule 2 t shall be subject to the folio ping conditions, namely

(a) The 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 not‑cc, the premises where the drugs are manufactured and to satisfy himself that the manufacture is being conduced for experimental purposes.

(c) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made.

*23. Labelling of drugs manufactured for experimental purposes.‑(1)*Any drug 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 ofthe 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 the following members, namely :‑

(a) The Director‑General, Health, Government of Pakistan, who shall be its ex‑officio Chairman ;

(b) one Professor ofClinical subject to be nominated by the Federal Government ;

(c) one Professor of Pharmacology to be nominated by the Federal Government ;

(d) one Deputy Director‑General, Health, Government of Pakistan, or one Pharmacist, to be nominated by the Federal Government ;

*(e)*one Pharmaceutical Chemist to be nominated by the Federal Govern ment ;

(f) one Medical Specialist from the Army Medical Corps, to be nomi nated by the Federal Government ;

*(g)*one person from the Drugs Administration, Government of Pakistan, to be nominated by the Federal Government who shall be its Secretary.

(2) The members of the Registration Board shall hold office for three years but shall be eligible for renomination.

(3) The Registration Board shall, for the performance of its functions, meet as and when required to do so by the Federal Government.

(4) No act or proceeding of the Registration Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of 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 certificates of Registration.

(6) The Registration Board may authorise the Chairman to exercise any of its powers or to perform any of its functions.

25. Powers of RegistrationBoard.‑The members of the Registration 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.

  1. *Application for registration of drugs and fees thereof.‑(1)*An appli cation for registration of a drug shall be made in form 5 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 a fee of‑

(a) rupees one thousand for the registration of a 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.

(4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate of 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 certifi cate 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 a certificate of registration.‑A certificateof registration under this chapter, shall, unless earlier suspended or cancelled, be in force for a period of five years from the date of issue and may thereafter be renewed for periods not exceeding five years at a time

Provided that if application for renewal is made before the expiry of the period of validity of a certificate, the certificate shall continue in force until orders are passed on such application:

Provided further that, if in the opinion of the Registration Board it is necessary so to do in the interest of public health, it may provisionally register a new drug for a period of two years.

28. Certificate of registration.‑Acertificate 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 Board may, before issuing a licence, cause the premises in which the manufacture is proposed to be conducted to be ins pected 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 pre mises and the plant and appliances, inspect the process of manufacture intended to b.‑ 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 be 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 the 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, 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 shall, 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) the packing size(s) and retail price of the 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 estab lished 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 purposes 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, it may, after providing an opportunity of being heard to the applicant, 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 of 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‑indications, side effects, the dosage and cau tions, 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 a 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 indentor or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of the drug in Pakistan,

(8) 1n 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 manu facturer or reported to him by any person concerning that drug ;

(b) reports from the scientific literature or the bibliography there from that are available to him concerning that drug ;

(c) experience, 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 produce its expected pharmacologi cal activity.

(9) The following information shall be supplied to the Registration Board‑

(a) on request, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f ) ofsub‑rule (8) ; and

(b) immediately upon reciept by him, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f ) ofsub‑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 informa tion contemplated by paragraphs (g),(h) and (i) of sub‑rule (8).

CHAPTER 4‑ADVERTISING of Dauos, ETc.

  1. 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 or a tractment 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.

(2) A drug may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through academic scientific research journals which are registered with the Federal Government on the recommendation of the Committee on Advertising and are meant for circulation exclusively amongst the members ofthe medical, pharmaceutical and allied professions.

(3) Advertisements under sub‑rule (2) shall be subject to the following conditions, namely

(i) All claims shall be made in accordance with those approved for registration of that drug.

(ii) Where the usual information on indications and dosage is provided, the advertisement material shall contain information on contra‑indications, side effects and outer necessary precautions as may be applicable.

(4) A drug may be advertised through press without reference to the Federal Government if it is merely intended to inform the public of the avail ability or the price of such drug, subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires.

(5) A drug 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 too general claims, such as "effective in all cases" or "effective against all com plaints" or superlatives shall be avoided.

(8) Advertisement of a drug to the public shall include such information on any risks and other precautions as may be necessary for the protection of public health.

(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 substance or any remedy, treatment or offer for 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 ofdrugs.‑Samples of drugs may be provided to the physi cians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words "Physi cian's Sample Not for Sale".

33. Expenditure on advertisement.‑No personshall spend more than five per cent. of his turnover on advertisement, sampling and other promo tional activities in respect of drugs.

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.

SCHEDULE A

[See rule 2(e)]

FORM 1

[Seerule 5(1)]

APPLICATIONFOR GRANT/RENEWAL OF A LICENSE TO

MANUFACTURE BY WAY OF BASIC MANUFACTURE/

SEMI‑BASIC MANUFACTURE/FORMULATION/REPACKING

I/We . ......... ......... ......... .......... .... ......... ......... .. ...... of .. ... ......... ... ...... ... ... ... ... ...... hereby apply for the grant/renewal of a licence to manufacture by way of ...... .......................................... on premises situated at

  1. The undermentioned drug(s) or class(es) of drugs are intended to be manufactured

(1) Class(es) of drugs.

(2) Dosage form(s) of drugs.

(3) Name of the drug(s).

  1. I enclose herewith

(i) Details of the firm as per pro formaenclosed.

(It) Details of the premises including layout plan of the factory.

(M) Details of the section wise equipment and machinery for manufacture specifying type and capacity for each as well as total capacity of every section.

(iv) Names and qualification of the technical staff for supervising manu facturing processes and Quality Control Department.

  1. The premises and plant

will be ready for inspection on

are ready for inspection.

Dated.............................................................................................. Signed

Name and address of the

Signatory

Place....................................... "

Note.‑Strike off which is not applicable.

PRO FORMA 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

Turnover based Profit after Year Investment on income Administrative Profit actual payment

tax expenses before of tax (returns) (if any)

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 premesis

The licence permits the manufacture of

  1. 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 two years from the date of issue unless earlier suspended or cancelled.

(li) The licence authorises the sale by way of wholesale dealing and storage for sale by the licencee of the products manufactured under this licence, subject to the conditions applicable to licenses for sale.

(N) Name of the approved expert staff.

Date of Issue..............................

Secretary, Chairman,

Central Licensing Board (Seal) Central Licensing Board.

FORM 3

[Seerule 21(1)]

APPLICATION FOR LICENCE TO MANUFACTURE

DRUGS) 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 t‑

Signature ...........................

Name................................

Address.............................

Countersigned by .............

FORM 4

[Seerule 21 (3)j

LICENCE TO MANUFACTURE DRUGS) FOR EXPERI MENTAL PURPOSES

Mr./Messrs ................ ............ ....................... . ................................... .. is/are; hereby; licence to manufacture the drug(s) specified below for experi mental purposes at ..... or at such other place(s) at the Central Licensing Board may from time to time permit.

  1. 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 maybe subsequently prescribed or specified by the Central Licensing Board in this behalf.

  2. 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 I Licensing Authority.

FORM 5

[Seerule 26(1)]

APPLICATION FORM FOR REGISTRATION OF A

DRUG

I/We .....................................................................of .... .............. ........................ hereby apply for registration of the drug namely ....................................... details of which are enclosed herewith.

Signed... .....................

Date........................

Place........................

ENCLOSURE OF THE APPLICATION FOR REGISTRA TION OF A DRUG

(State where inapplicable or not yet possible)

  1. Name and address of the applicant and his status whether manufacturer,

importer, manufacturer's agent, indentor or other.

  1. Name and address of the manufacturer of the drug.

  2. Whether the drug is to be manufactured in Pakistan or to be imported.

  3. Name and address of the indentor and the manufacturer's authorised agent in case of imported drug.

  4. Name of the drug.

(a) Proprietary name (if any).

(b) International non‑proprietary name, of pharmacological monograph name or scientific or any other name descriptive of the true nature of the drug.

  1. Name under which the drug is proposed to be sold.

  2. Dosage form of the drug *e.g.*tablet, syrup, injection, etc.

  3. Composition of the drug.

A list of ingredients of the drug given by their non‑proprietary or scienti fic or pharmacological monograph name or any other name or descriptive title by which it can be readily identified. These should be stated in the manner in which they will be included on the product labels and literature and should include their exact quantities stated as per unit dose or, if it is not practicable, as a percentage of total formulation..

9. Proposed dosage:

(a) for adults..

(B) children by age group.

(c) infants.

*(d)*special groups.

  1. Main pharmacological group to which the drug belongs.

  2. Pharmacological and clinical data :‑

A statement of all representations to be made for the labellings and pro

motion of the drug respecting‑

(a) recommended clinical use and the claims to be made for the drug.

(b) contra‑indications.

**RULES,**1876

(c) toxicity of the side effects.

(d) any directions for use to be included in the labelling ; warning and precautions in use ; symptoms of overdosage should be given along with the treatment including antidotes where required.

*(e)*proposed route of administration.

12. Pharmaceutical Data.

*la)*Manufacturing Data

(i) Description of the plant and equipment to be used in the manu facture of the drug ; Please indicate (a) total installed capacity, *(b)*capacity utilised for any other purpose indicating details thereof and (c) capacity intended to be utilised for the manufacture of the drug requiring registration.

(ii) Expected average yearly production of the drug for the next 3 years.

(iii) Description of the method of manufacture (while only an outline of the general method is required, detailed information should be furnished on those aspects of the method which are of particular significance with regard to the nature of the product including the quality control checks to be made at each stage of process).

(iv) Name, qualifications and designation in the factory of the person under whose direct supervision and control the drug shall be manufactured.

*(b)*Quality Control Data

(i) Description of the equipment to be used for the quality control of the ingredients of the drug and the finished products.

(ii) Specifications of each ingredient (both active and non‑active) to be used in the manufacture of the dosage form : When the substance will comply with the specifications of any of the documents mentioned under the Ordinance or the Rules e. g. P. P., Ph. 1. U. S. P., B. P., B. P. C., etc. or if specifications are already approved for the same product by the Registration Board, a reference to the same would be sufficient for the purpose.

(iii) The in‑process controls carried out during the course of manufacture of the dosage form.

(iv) Specifications of the finished product‑

*(a)*internal factory specifications : those upon which the Quality Control Department shall decide for release of the product for marketing; and

(b) those with which the product must comply throughout its total spec ified period.

(v) Description of analytical control procedures for the finished drug.

(vi) Name, qualifications and designation of the person who will be the incharge responsible for the quality control for the drug.

(c) Bio‑availability studies

Reports of the in‑vitro and in‑vivo tests carried out on the drug to de termine the bio‑availability of the active constituents) of the drug from the proposed dosage form.

(d) Stability studies

Report of the studies to demonstrate the stability of the finished product so as to comply with its required specifications throughout the stated shelf. life under normal or specified storage conditions.

*(e)*Sources of the active constituents of the drugs.

Where possible and specifically in case of all patent and proprietary pro ducts the usual source of the raw‑meterial should be indicated.

(f) Proposed shelf‑life of the drug.

(g) Type of the containers to be used in marketing the product and any directions to be given for storage or transport.

13. Labelling :

A draft of every label and leaflets to be used for labelling of the drug giving the precise details that are to appear on these should be furnished.

14. Method of retail sale or supply

State whether the drug is proposed to be made available through‑

*(a)*general sale ;

(b) pharmacies‑

(i) for over the counter ;

(ii) on prescription only ;

(c) other methods ; give details. _

15. Method of sales promotion

State whether it is intended to promote the drug through medical pro fession as a prescription item. If so, state the quantity of the samples to be distributed to the medical profession, if any.

16. Pricing

*(a)*State proposed pack‑size and proposed pricing data on each pack, giving in particular in respect of each unit/pack, as for local products‑

(i) the rate and cost of each component of the raw and packing material ;

(ii) ex‑factory cost ;

(iii) details of all other charges ;

(iv) trade price

(v) retail price ;

(b) for imported drug‑,

(1) F. O. B. price ;

(il) C & F. price ;

(N) other expenses (give details).

(iv) retail price.

17. Justification

Justification for application including comparative study in relation to its efficacy, safety and price with other therapeutically equivalent or nearly equivalent products in the market.

18. Samples of the drug

Sufficient quantity of samples of the drug in the finished form in which it is proposed to be sold, for the purpose of examination, test and analysts. The Registration Board may also require such examples of the components of the drugs as it tray deem fit for the purposes of the drug

19. Patent number

If the drug is patented under the Patents and Designs Act, *1911,*the name of the ingredients so patented, the patent number, date of grant of patent, date of expiry of patent and the date of validity of patent.

20. Certificate regarding sale and good manufacturing practices in the country of origin:

If a drug is being or to be imported, a certificate on the enclosed form from the Health Authority of the country of export of that drug to the effect that the drug is being manufactured by the firm for sale in accordance with the good practices in the manufacture and quality control of drugs and in a premises approved or licensed for the manufacture of that drug by the compe tent authority.

21. Certificate of registration in the country of origin in U.K. and U.S.A.:

In the case of a product of a foreign firm, whether that firm is based in Pakistan or not, the certificate of registration and documentation on regis tration including material as approved in respect of indication, contra indica tion, side effects and details of other condition3 subject to which the approval has been granted for registration :‑

*(a)*in the country of origin of that firm ; and

*(b)*in U. K and U. S. A., if these are not the countries of or origin and the drug has been introduced in these or in any one of these countries.

22. Additional information for anew drug:

For anew drug, the following additional information shall be furnished :‑

*(a)*Chemistry and pharmacy of the new substance, its name, full description, method of manufacture, its impurities, development chemistry, specifica tion and stability studies;

(b) based on pre‑clinical, pharmaco‑dynamic, pbarmacokinetic, acute and chronic toxicity, carcinogenic or chronic long term toxicity and teratogenic studies clinical pharmacology and clinical trial studies

(t) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended ;

(Ii) substantial evidence of the clinical efficacy of the new drug for the purpose and under the conditions of use recommended.

This information shall he supported by reprints from journals of interna tional repute ;

(c) A statement of the names and qualifications of all the investigators to whom the new drug had been given for the purposes of clinical trials in Pakistan and copies of their reports ; and

(d) Date to be furnished under clauses (a) and *(b)*shall as far as possible include information on the following stages of investigation of that drug, namely :‑

Chemical and pharmaceutical investigations

Stage I Isolation and purification of active molecule with development chemistry.

Stage II Incorporation with acceptable formulations for required routes of administration on a pilot scheme basis,

Stage III Design and confirmation of tests for analysis, including those in formulations and body fluids.

Stage IV Identification and study of metabolites and of related sub. stance and impurities.

Stage V Demonstration of stability and conditions thereof.

Stage VI Full scale production with confirmation of previous stages.

Animal investigations

Stage I Fundamental Pharmacology for evidence of activity and of lack of activity in different systems and species.

Stage II Standard toxicity studies in animals, and initial metabolic studies.

Stage III Special studies in relevant species, long‑term design studies, specialized metabolic work, completion of appropriate investi gations.

Investigations in human beings (clinical pharmacology)

Stage I The initial study of single and short‑term multiple dosing for tolerance, side effects and where possible the relation of these to levels of drug in the biological system, and the metabolism of the drug. This stage is usually carried out in normal subjects.

Stage It The initial and limited use of the drug in patients suffering from the condition for which the drug is intended for treatment, its purpose is the establishment of an effective dose‑range, the more common side effects of the drug on both clinical and laboratory parameters and where possible, a study of the levels of drug in biological fluids in relation to therapeutic response.

Stage III An extention of the use of the drug to include several trials (usually controlled) in patients, in order to expand knowledge of potential use and hazards.

Stage IV Widespread trials often under varying conditions.

Stage V Special trials in which patient may be suffering from certain complications, which may alter the behaviour of the drug in the body.

Stage VI Monitored and limited release of the drug with records of use and effects.

FORM 6

[See rules 28 and 29(4)]

CERTIFICATE OF REGISTRATION

Certified that following drug(s) are hereby registered under the Drugs Ordinance Act, 1976 t‑

Name of Drug(s)

Name of Manufacturer ..................................................................

Name of Indentor/Manufacturer's agent/Importer (Incas.‑ of imported drugs only). ‑‑ ~~

  1. This registration shall be valid for a period of five years unless earlier suspended or cancelled.

  2. This registration is subject in the conditions specified in the Drugs Ordinance Act, 1976, and the rules thereunder and to the conditions specified in the enclosure. Date of Issue........................

Registration Board, (Seal) Registration Board.

FORM 7 ‑

. [Seerule 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 PACKS | TOTAL QUANTITY IN TERMS OF INDIVIDUAL UNITS , E.G. TOTAL NOS OF TABLETS, INJECTIONS TUBES, LITRES, ETC | ON TRADE PRICE | ON RETAIL PRICE | INDICATE WHETHER SUPPLIED THROUGH NORMAL DISTRIBUTION | BALUE OF RAW MATERIALS USED (ACTIVE AND INACTIVE) (IN RS) | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | | TOTAL |||||||

SCHEDULE B

[See rule 16(a)]

***Conditions of***Factory Premises

(1) Location and Surroundings.‑The factory shall be situated in a place which shall not be adjacent to an open sewage, drain, public avatory or any factory which produces a disagreeable or obnoxius odour of fumes or large quantities of soot, dust or smoke which may interfere or contaminate the drug being manufactured op adversely affect its quality. The factory shall be located in a sanitary place. remote, from filthy surroundings, preferably not in congested residential area.

(2) BuOdings.‑Buildings shall beof suitable size and construction to

facilitate adequate cleaning, maintenance and permit manufacture of drugs under hygienic conditions. The buildings shall‑

(a) be so designed and constructed as to prevent the entry of animals and insects. Interior surfaces, including walls, floors and ceilings, shall be smooth and free from cracks, shall not shed particulate matter and shall permit easy cleaning and, if necessary, disinfection. The building shall not be used for any purpose other than manufacturing purposes of the manufacturing firms. The staying place for watchmen shall also be separate from manufac turing area;

(b) provide adequate space for orderly placement of equipment and materials;

(c) provide adequate lighting, ventilation and precautions to minimise contamination by extraneous adulterants;

(d) provide suitable housing and space for the care of all laboratory ani mals where so required;

(e) provide for safe and sanitary disposal of sewage, trash and other refuse from the buildings;

(f ) provideareas which shall‑

(i) provide adequate space and shall be arranged and equipped in a manner to allow clean and orderly placement of stored materials and products and under cortrolled conditions of temperature and humidity, where so required in conformity with stability information, and goods shall be stored off the floor, where possible, to keep them clean dry and orderly

Provided that materials whose condition is not likely to be affected if stored in the open, may be so stored;

(ii) provide for suitable and effective separation of quarantined and other materials and products to minimize any risk of mix‑up; and

(Iii) provide separate areas for storage of ‑

(1) dangerous substances; and

(2) rejected and recalled materials and products.

(g) provide for special purpose, such as the manufacture of drugs that are intended to be sterile but cannot be sterilized in their final container, separate enclosed areas, specifically designed for the, purpose. These areas shall be entered through an air lock, essentially dust‑free and ventilated with an air supply through bacteria retaining filters giving a pressure higher than in adjacent areas. Surfaces shall be designed to facilitate cleuniag and disinfec tion, Routine microbe counts of the air in the areas described above shall be carried out regularly to ensure maintenance of aseptic conditions. The results of such counts shall be checked against established standards and adequate records of the counts shall be **maintained.**r

(h) provide for the manufacture of drugs that can be sterilised in their final container, the requirements given under clause (g) with the exception of mandatory sterilization of air supplies. The design of areas used for the purpose shall preclude the possibility of mixing up of the products intended for sterilization with products already sterilized.

(1) provide working benches, where required, for carrying out operations such as filling, labelling, packing, etc. Such benches shall be fitted with smooth, impervious toys capable of being washed.

(a) in factories where operations involving the use of containers, such as bottles, vials, jars, ampoules, are conducted provide adequate arrangements, separated from the manufacturing operations for washing, cleaning and drying such containers with suitable equipment for the purpose. Sterlizing facilities where necessary shall also be provided.

SCHEDULE B‑1

[See rule 16(6)(b)]

REQUIREMENTS OF PLANT AND EQUIPMENT

(A) The following equipment is required for the manufacture drugs for external appliances or suspensions:‑

(1) Mixing tanks where applicable.

(2) Kettles, steam, gas or electrically heated.'

(3) A suitable power driven mixer.

(4) Storage tanks or posts.

(5) A colloid 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. Elixirs 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 minimum of 300 square feet is required for the basic in stallations.

(C) Equipment for the manufacture of Pips and Compressed Tablets in cluding Hypodermic Tablets. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms,

(a) Granulating Section;

(b) Tableting Section;

(c) Coating Section;

The following equipment is required in each of the three sections:‑

  1. Granulating Section i

(1) Disintegrator, where applicable.

(2) Power Mixer or granulation mixer with stainless steel cabinet parts.

(3) Granulator.

(4) Oven, thermostatically controlled.

  1. 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.

  1. Coating Section

(1) Jacketed kettle, or equivalent steam, gas or electrically 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 eva poration.

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 dono in this room.

(D) The following equipment is required for the manufacture of Powders:‑

(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 a tablet section where the powder or the granules can be manufactured provided that such granules or powder are not toxic, no separate equipment will be required for manufacture of such powder or 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 30(1 square feet is required for the basic installa tions. 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 sterile preparations for external use :‑

  1. Hot air oven electrically heated with thermostatic control.,

  2. Kettle, gas or electrically heated with suitable mixing arrangement.

  3. Colloid mill or ointment 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 candle.

  7. Liquid filling equipment.

  8. Autoclave.

An area of minimum of 250 square feet is required for the basic installa tions. The manufacture and filling shall be carried out in an 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 is required for the basic installa tions.

In case of pessaries manufactured by granulation and compression, if the licensee does not have a tablet section, a separate area of minimum of 300 square feet and the following equipment 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 and Vitrallae:‑

  1. Mixing equipment.

  2. Graduated delivery equipment for measurement of the medicament.

  3. Sealing equipment.

(J) The following equipment is required for the repacking installations of drugs and Pharmaceutical Chemicals:

  1. Shifter.

  2. Stainless steel scoops and 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 ofParenteral Preparations.‑The whole process of the manufacture of parenteral preparations may be divided into the following separate operations:‑

(a) Preparations ofthe container.‑This includes, cutting, washing, drying and sterilisation of ampoules or vials prior to filling.

(b) Preparation of solution.‑This includes preparation and filteration of solution.

(c) Riling and sealing.‑This includes filling and sealing of ampoules or filling and capping of vials.

(d) Sterilisation.

(e) Testing.

The following basic hygienic requirements shall be complied with:‑

(1) (1) Strict sanitation shall be maintained throughout the entire plant in

order to prevent contamination and to keep out pyrogens.. Masks and over

alls shall be worn wherever necessary.

(2) The preparation room where the solutions are 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 out side. The walls and floors shall be such as may permit their being sprayed and washed with an antiseptic solution. The tenches 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 drying.

(6) Finished products shall be stored in a ,suitable separate place.

The following equipment is required :‑

Manufacturing Area:

Storage equipment for ampoules and vials.

Ampoule washing and drying equipment.

  1. Dust proof storage cabinets.

  2. Water still.

  3. Mixing and preparation tanks or other containers. The tanks or containers shall be made of either glass or such material which will not reactwith the liquid.

  4. Filtering equipments such as filter press or sintered glass funnel..

  5. Autoclave.

  6. Hot Air Steriliser.

Filling and Sealing Room:

  1. Benches for filling and sealing.

  2. Filling and sealing unit.

Aseptic Filling and Sealing Room:

  1. Bacteriological filters such as Seitz filter, candles or sintered glass filters.

  2. Filling and sealing unit.

General Room:

  1. Inspection table with dark and light background.

  2. Leak testing equipment.

  3. Labelling and packing benches.

16 Storage equipment including cold storage and refrigerators, if necessary.

Note 1.‑The above requirements of this schedule are subject to modi fications 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 fur his record.

Note 11.‑This Schedule gives equipment and space required for certain categories of drugs only. There are, in addition, other categories of drugs such as basic drugs miscellaneous pharmaceutical such as Ferriet Ammonia 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 drug. 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‑II

[See rule 20 (a)]

REQUIREMENTS AND CONDITIONS OF GOOD PRACTICES

IN THE MANUFACTURE AND QUALITY CONTROL

OF DRUGS

1. Personnel:

(1) All workers shall be free from contagious or obnoxious diseases. Their clothing shall consist of uniform suitable to the nature of work and shall be clean. Adequate facilities, for personnel cleanliness, such as, clean towels, soap and hand scrubbing brushes shall be provided separately for each sex,

(2) The workers shall be required‑

(a) to wash and change into clean overalls before entering the rooms where the manufacturing operations require such a precaution;

*(b)*to wear either a clean cap or suitable head wear so as to avoid any possibility of contamination by hair or perspiration;

(c) to cover the nostrils and mouth with suitable mask when engaged in filling and sealing of container for parenteral preparations or in powder or tablet granulation;

(d) wear cotton gloves when filling tablets or capsules when filled by hand.

  1. Medical Services

The manufacturer shall provide‑

(a) adequate facilities for first aid;

(b) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year;

(c) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and

(Q) measure to avoid industrial accident and to protect the health of the workers against hazards.

  1. Sanitation

(1) The manufacturing premises shall be kept clean, orderly and free from accumulated waste and vermin. A written sanitation programme shall be available, indicating‑

(a) areas to be cleaned, and cleaning intervals.

*(b)*cleaning procedures to be followed and, where necessary materials and equipment to be used for cleaning; and

(c) personnel assigned to and responsible for cleaning operations.

(2) Eating, smoking and unhygienic practices shall not be permitted in the manufacturing area.

  1. Equipment

(1) Manufacturing equipment shall be designed and maintained in such a way as to‑

(a) be suitable for its intended use;

(b) facilitate through cleaning wherever necessary;

(c) minimize any contamination of drugs and their containers during manufacture.

(2) Weighing and measuring equipment used in the manufacture and quality control shall be of appropriate accuracy in relation to the work being carried out and shall be caliberated and checked at suitable intervals by appropriate methods by a responsible person and adequate records of such tests shall be maintained.

(3) Manufacturing equipment and utensils shall be thoroughly cleaned and, when necessary, sterilized and maintained in a reasonably good condition in accordance with specific written directions to be given by the manufacturer and such directions should also indicate as to when the equipment and utensils should be disassembled and thoroughly cleaned so as to preclude the carry‑over of drug residues from previous operations; and adequate records of such procedure shall be maintained.

(4) Equipment used for aseptic filling shall be checked regularly to ensure thall it has been properly sterilized to avoid any microbial contamination.

5. Starting Materials

(1) An inventory shall be made of all starting materials to be used at any stage in the manufacture of drugs, and records shall be kept of the supplier, the origin, if possible, date of receipt, date of analysis, date of release by the quality control department, and their subsequent use in the manufacture.

(2) All starting materials shall be‑

*(a)*identified, and their containers examined for damage;

(b) properly stored in quarantine;

(c) properly sampled by the quality control department;

(d) tested for compliance with their specifications and shall be marked to indicate that they are undergoing testing; and

*(e)*released from quarantine by the quality control department by means of written instructions.

(3) Starting materials that are accepted or approved shall be properly and conspicuously labelled as such, and shall then be transferred, if necessary, to areas designed for the storage of such materials.

(4) All rejected starting materials shall be conspicuously identified as such, and shall be segregated from other materials and be destroyed or returned to the supplier as soon as possible.

  1. Manufacturing operations

(1) All manufacturing operations and controls shall be carried out under the supervision of the expert appointed for the purpose.

(2) Before any manufacturing operation is begun a check shall be made to ensure that all apparatus and equipments to be used in the operation has been cleaned sterilized or, cleaned and sterilized, as the case may be.

(3) All equipment for various manufacturing operations, as approved at the time of obtaining drug manufacturing licence, shall be kept at the factory promises unless otherwise permitted by the Central Licensing Board

Provided that any such equipment may be removed from the factory

premises for the purpose of repair and the record of such removal shall be kept at the factory premises.

(4) The contents of all vessels and containers used in the manufacture and storage between manufacturing stages shall be identified be conspicu ously placing clearly legible labels, bearing the name or identification code of the processed materials and the necessary batch identification data. Such labels shall, whenever practicable, be securely attached to the vessels and containers concerned. Similar labels shall be attached to mechanical manu facturing equipment during its operation, listing the name or identification code of the manufactured product and where necessary, its batch identification.

(5) All manufacturing operations shall be confined to separate areas intended for such purposes, with complete equipment used exclusively in those areas, or measures should be taken to ensure that neither contamination nor confusion or mix‑up can occur.

(6) Sterile operations shall be performed in areas specially designed and constructed for their intended purposes, whenever the different operations are not physically separated and there is a possibility that unsterilized and sterilized products might be confused; all containers of batches of products for sterilization shall bear a clear indication of whether or not their contents have been sterilized.

(7) All dust producing operations in which highly potent drugs, including antibiotics, are weighed, mixed, micronized, encapsulated, formed into tablets, placed in containers, etc., should be conducted in confined areas.

(8) In manufacturing areas, clean working garments should be worn.

(9) Products that undergo sterile operations shall be protected from contamination by either (a) using methods such as Laminar flow techniques, or (b) ensuring that personnel wear clean, sterile gown, head coverings, masks, rubber gloves and shoe coverings. Before dressing and entering sterile areas, personnel shall wash their hands with a suitable disinfectant.

(10) Documents relating to manufacturing procedures for each drug shall be prepared under the direct supervision of experts who have the necessary authority and shall contain at least the following information for each drug :‑

(a) name and presentation;

(b) a description or identification of the finalcontainers, packing materials and lables;

(c) the identity, quantity and quality of each starting material to be used, irrespective of whether or not it appears in the finished drug (the permissible excess (overage) that may be included in a formulated batch shall be indicated);

(d) the theoretical yields to be expected from the formulations and the permissible yield limits;

(e) detailed instructions for, and precautions to be taken in, manufacture and storage of the drug and of half finished products; and

(f) a description of all necessary quality control tests and analysis to be carried out during various stages of manufacture including the designation of persons responsible for the execution of such tests and analysis.

(11) Manufacturing records shall provide a complete account of the manufacturing history of each batch of a drug, showing that it has been manufactured, tested and analysed in accordance with the manufacturing procedure and written instructions.

7. Labelling and Packaging

(1) Labelling and packaging materials, including leaflets, shall be stored and handled in such a way as to ensure that labels, packaging materials and leaflets relating to different products do not become intermixed and access to such materials shall be restricted to authorized personnel.

(2) Prior to being issued, all labels for containers, cartons and boxes and

all circulars, inserts and leaflets shall be examined and declared as satisfactory for use by the Quality Control Department.

(3) To prevent packaging and labelling errors, a known number of labelling and packaging units shall be issued and, if required, coded. Such issuance shall be made against a written and signed request that indicates the quantity and type required. Upon completion of the packaging and labelling operation, a comparison shall be made between the number of labelling and packaging units issued and the number of items labelled and packaged plus the number of units nit used. All units of labelling and packaging with batch shall be destroyed. Any significant or unusual discre pancy in the number shall be carefully investigated.

8. Quality Control System t

(1) The Quality Control Department shall control all starting materials, monitor the quality aspects of manufacturing operations and ensure the quality and stability of the drugs.

(2) The quality control department shall have the following principal duties‑

(i) to prepare and issue detailed instructions in writing for carrying out each test and analysis;

(ii) to release or reject each batch of starting materials

(iii) to release or reject half finished products, if any;

(iv) to control and release packaging and labelling materials and the final containers in which drugs are to be placed;

(v) to evaluate the adequacy of the conditions under which starting materials, "in process" products, and finished drugs are stored;

(vi) to evaluate the quality and stability of finished drugs and when necessary of starting materials and half finished products;

(vii) to establish expiry dates and shelf‑life specifications, wherever necessary, on the basis of stability test related to storage conditions;

(viii) to establish and, when necessary, revise control procedures and specifications; and

(it) to be responsible for the examination of returned drugs to determine whether such drugs should be released, processed or destroyed. Adequate records of the disposition of such drugs shall be maintained.

(3) In order to fulfil its responsibilities, the Quality Control Departments shall take samples in sufficient quantities, according to established procedures and keep appropriate analytical records. The samples shall be properly labelled and portions thereof shall be kept for future reference.

(4) The Quality Control Department shall maintain adequate analytical records concerning the examination of all samples taken and such records

shall include.

SCHEDULE B‑III

[Seerule i20 (b)]

PARTICULARS TO BB SHOWN IN MANUFACTURE IN RECORDS

A. Substances other than 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 manufacture was completed .

  6. Name of all ingredients. quantities required for the batch size, quantities actually used. (All weighing and measurements shall be checked and initialled by the competent person in the section).

  7. Control reference numbers in respect of raw materials used in formulation.

g. Date of mixing in case of dry products e.g., powder, powder mixture for capsule products, etc.

  1. Date of granulation wherever applicable.

  2. Weight of granules.

  3. Date of compression in case of tablets/date of filling in case of capsules.

  4. Date ofcoating wherever applicable.

  5. Records of test to be carried out in case of tablets as under :‑

*(a)*Average weight every thirty minute.

(b) Disintegration time as often as practicable.

  1. Records of readings taken to check weight variation in case of capsules.

  2. Reference to Analytical Report number stating whether of standard quality or otherwise.

  3. Records on the disposal of rejected batches and batches withdrawn from the market.

  4. Actual production and packing particulars indicating the size and quantity offinished packings.

*18.*Date of release of finished packings for distribution or sale.

  1. In case ofHypodermic 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.

  2. Signature of the expert staff responsible for the manufacture.

B. Parenteral preparations'

  1. Batch number (if bulk lot is divided into various batches and pro. ceased separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch).

  2. Date of commencement of manufacture and date of completion.

  3. 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).

  4. Control reference numbers in respect of raw materials used.

  5. pH of the solution wherever applicable.

  6. Date and methods of filtration.

  7. 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).

  8. Date of filling.

  9. Records of tests employed :‑

(a) To ensure that sealed ampoules are leak‑proof.

(b) To check the presence of foreign particles.

(c) For pyrogens wherever applicable.

  1. Record of sterilisation in case of parenteral preparations which are heat sterilised including particulars of time, temperature and pressure employed.

  2. Number and size of containers filled and number rejected.

  3. Reference to Analytical Report numbers stating whether of standard quality or otherwise.

  4. Records of the disposals of rejected batch and batches withdrawn from the market.

  5. Actual production and packing particulars.

  6. Date of release of finished packings for distribution or sale.

  7. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained.

  8. Control reference numbers in respect of the lot of glass containers used for filling.

  9. 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 quantaties 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. 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 regarding 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.

  1. Signature of the Analyst.

  2. Opinion and signature of the approved Analyst.

B. Parenteral Preparations

  1. Batch number.

  2. Date of receipt of sample. . 5. Number of containers filled.

  3. Number of containers packed.

  4. Protocols of tests applied a

(a) Clarity.

*(b)*pH, wherever applicable.

' (c) Identification.

*(d)*Volume in container.

(e) Sterility‑(i) Bulk sample wherever applicable (ii) container sample.

(f) Pyrogen test, wherever applicable.

(g) Toxicity test, wherever applicable.

(h) Any other tests.

(1) 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.

  1. Signature of the Analyst.

  2. Opinion and signature of the approved Analyst Pyrogen Tests

  3. Test Report 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.

  8. Temperature of each rabbit noted at suitable intervals.

  9. Maximum temperature.

  10. Response.

  11. Summed response.

  12. Signature of the Analyst.

  13. Opinion and signature of the approved Analyst,

Toxicity Test

  1. Test Report ember,.

  2. Name of the Sample.

  3. Number of mice used and weight of each mouse.

  4. Strength and volume of the drug injected.

  5. Date of injection.

  6. Results and remarks.

  7. Signature of Analyst.

  8. Opinion and signature of the approved Analyst.

C. For other drugs

Batch number.

Date of receipt of sample.

Protocols of tests applied

(a) Description.

(b) Identification.

(c) Any other tests.

(d) Results of assay.

Note.‑Particulars regarding various tests applied (including readings and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 5 wherever necessary.

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:*Particulars regarding various tests applied (including readings and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 6 wherever necessary.

E. Container, packing material, etc.

  1. ' Name of the item.

  2. Results of tests applied.

Note.‑Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered in serial No. 6, wherever necessary.

  1. Remarks.

  2. Signature of the examiner.

*Note.‑(1)*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.

(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 this Schedule are complied with.

(3) The Central Licensing Board may at 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 rule16(c)(iii) and (e)]

  1. Sera.

  2. Solution of serum proteins intended for injection.

  3. Vaccines.

  4. Toxins.

  5. Antigen.

  6. Antioxins.

  7. Insulin.

  8. Pituitary (Posterior Lobe) Extract.

y. Sterilized surgical ligature and sterilized surgical suture.

  1. Bacteriophages.

SCHEDULE D

[See rule 17 (1)]

Drugs for repacking

  1. Acriflavin Neutral. 15. Calamine.

  2. Alcohol Methylated. 16. Calcium Carbonate.

  3. Amethocaine. 17. Calcium Lactate.

  4. Ammonium Bicarbonate. 18. Castor Oil.

  5. Ammonium Chloride. 19. Calcium Gluconate.

  6. Aspirin. 20. Cetrimide Powder.

  7. Barium Sulphate. 21. Chalk Powder.

  8. Benzocaine. 22. Chloroform.

  9. Benzoic Acid. 23. Chloral Hydrate.

  10. Bismuth Carbonate. 24. Copper Sulphate.

  11. Boric Acid. 25. Ephedrine Hydrochloride.

  12. Borax. 26. Ephedrine Sulphate.

  13. Brilliant Green. 27. Ferrous Sulphate.

  14. Caffein Citrate. 28. Ferric Ammonium Citrate,

  15. Irish Liver Oil. 57. Potassium Acetate.

  16. Fluorescin. 58. Pottassium Citrate.

  17. Fructose. 59. Potassium Bromide.

  18. Gentian Violet. 60. Potassium Iodide.

  19. Glycerin. 61. Potassium Permanganate.

  20. Hydrogen Peroxide. 62. Quinine and its salts.

  21. Ichthamol. 63. Resocrin.

  22. Ispaghula. 64. Salicylic Acid.

  23. Kaolin. 65. Santonin.

  24. Liquor Ammonia Acetate 66. Senna.

Forte. 67. Siver Nitrate.

  1. Liquid Paraffin. 68. Silver Protienate.

  2. Lead Acetate. 69. Sodium Bicarbonate.

  3. Magnesium Sulphate. 70. Sodium Thiosulphate.

  4. Magnesium Carbonate. 71. Sodium Citrate.

  5. Magnesium Hydroxide. 72. Sodium Chloride.

  6. Magnesium Trislicate. 73. Sodium Salicylate.

  7. Menthol. 74. Spirit Methylated.

  8. Mercurous Chloride (Calo‑ 75. Sulphadiazine.

me]). 76. Sulphadimidine.

  1. Methylene Blue. 77. Sulphur.

  2. Methyl Salicylate. 78. Sulphuric Acid Dilute.

  3. Peppermit Oil. 79. Tannic Acid.

  4. Pepsin. 80. Turpentine Oil.

  5. Phenacetin. 81. Yellow Mercuric Oxide

  6. Phenol. 82. Zinc Oxide.

  7. Phenobarbitone. 83. Zinc Sulphate.

  8. Phthalylsulphathiazole. 84. Aluminium Hydroxide Gel

  9. Physostigmme Dried.

  10. Pix Carbonis. 85. Atropine Sulphate.

Conditions.‑The Licensee shall test each batch of drug and maintain such recorcs for a period of five years from the date of its manufacture.

SCHEDULE E

[Seerule 31 (10)]

DISEASES, ADVERTISEMENT FOR TREATMENT OF

WHICH IS PROHIBITED

  1. Tuberculosis.

  2. Cancer.

  3. Venereal diseases.

  4. Sexual impotence.

  5. Amenorrhoea metrorrhagia, memorrhagia, metrosalpingitis ovaritis, ftbromas. cysts.

  6. Bright's disease, cataract, glaucoma, epilepsy, diabetes, locomotive 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.*pneu monai, pleurisy, abscess of the lung).

  9. Contagious diseases. [No. F. 6‑4/76‑L.& R.]

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