Form of order not to dispose of stock.

1. Short title, extent and commencement. ___ (1) These Rules may be called the Drugs and Cosmetics Rules, 1945. (2) They extend to the whole of India. 2. Definitions. ___ In these Rules, unless there is anything repugnant in the subject or context ___ (a) “the Act” means the Drugs and Cosmetics Act, 1940 (XXIII of 1940) as amended from time to time; 3[(b) “Central Licence Approving Authority” means the Drugs Controller, India, appointed by the Central Government;] (c) “Director” means the Director of the Central Drugs Laboratory; (d) “Form” means a form set forth in Schedule A; 4[(dd) Homoeopathic medicines include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route;] (e) “Laboratory” means the Central Drugs Laboratory; 5[(ea) “registered Homoeopathic medical practitioner” means a person who is registered in the Central Register or State Register of Homoeopathy;] 6[(ee) “Registered medical practitioner” means a person __ (i) holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or (ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine excluding the Homoeopathic system of medicine; or ____________________________________________________________ 1. Subs. by G.S.R. 370(E), dt. 7-4-1994. 3. Subs. by G.S.R. 923(E), dt. 14-12-1992. 4. Ins. by Notfn. No. F. 1-59 / 68-D, dt. 19-11-1969. 2. Amended by G.S.R. 358, dt. 15-3-1975. 5. Ins. by G.S.R 680 (E), dt. 5-12-1980. 6. Ins. by Notfn. F. 1-22 / 59-D, dt. 9-4-1960. 7. Amended by S. O. 2139, dt. 12-8-1972. Drugs and Cosmetics Rules, 1945 32 (iii) registered in a medical register, other than a register for the registration of Homoeopathic practitioner, of a State, who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practising the modern scientific system of medicine for the purposes of this Act; or (iv) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or (v) who is engaged in the practice of veterinary medicine and who possesses qualifications approved by the State Government;] 2[(f) “retail sale” means a sale 3[whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person] other than a sale by way of wholesale dealing; 4[(g) “sale by way of wholesale dealing” means sale to a person for the purpose of selling again and includes sale to a hospital, dispensary, medical, educational or research institution;] 5[(h) “Schedule” means a Schedule to these Rules;] 6[(i) State Government in relation to a Union Territory means the Administrator thereof; (j) “Poisonous substance” means a substance specified in Schedule E.] 3. Functions. ____ It shall be the function of the Laboratory ___ (i) to analyse or test such samples of drugs as may be sent to it under sub- section (2) of section 11, or under sub-section (4) of section 25 of the Act; • * * * * (iii) to carry out such other duties as may be entrusted to it by the Central Government or, with the permission of the Central Government, by a State Government after consultation with the Drugs Technical Advisory Board. 8[3A. (1)The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute : ___ (1) Sera. (2) Solution of serum proteins intended for injection. ____________________________________________________________________ 1. Amended by S. O. 2139, dt. 12-8-1972. 2 Subs. by Notfn. No. F. 1-3/51-DS., dt. 15-11-1954. 3. Added by G.S.R 681 (E), dt. 6-6-1988. 4. Amended by Notfn. F-1-16/57, dt. 15.6.1957. 5. Subs. by Notfn. No. F. 28-10/45-H (1), dt. 31-3-1957. 6. Subs. by Notfn. No. F-1-16/57-D, dt. 15-6-1957. 7. Omitted, ibid. 8 Ins. by Notfn. No. F. 4-1 / 60-D, dt. 15-5-1961. (3) Vaccines. Drugs and Cosmetics Rules, 1945 33 (4) Toxins. (5) Antigens. (6) Anti-toxins. (7) Sterilized surgical ligature and sterilised surgical suture. (8) Bacteriophages: 1[Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central Research Institute, Kasauli only.] 2[(1A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes and the functions of the Director in respect of the said drugs shall be exercised by the Director of the respective Institutes :- (a) Pasteur Institute of India, Coonoor. (b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute Compound, Parel, Bombay-400012.] 3[(c) The National Institute of Biologicals, NOIDA.] 4[(2) The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes. (1) Anti-sera for veterinary use. (2) Vaccines for veterinary use. (3) Toxoids for veterinary use. (4) Diagnostic Antigens for veterinary use.] 5[(3) The functions of the laboratory in respect of condoms shall be carried out at the Central Indian Pharmacopoeia Laboratory, Ghaziabad, and the functions of the Director in respect of the said condoms shall be exercised by the Director of the said Laboratory.] 6[(4)] The functions of the Laboratory in respect of the following drug shall be carried out at the Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta and the functions of the Director in respect of the said drug shall be performed by the Serologist and Chemical Examiner of the said Laboratory : __ VDRL Antigen. ____________________________________________________________________ 1. Ins. by G.S.R.62(E), dt. 15-2-1982 and Subs. by G.S.R.445(E), dt. 30-4-1992. 3. Ins. by G.S.R.249(E), dt. 4-4-2002. 2. Added by G.S.R. 445(E), dt. 30-4-1992. 4. Amended by Ministry of Health, F P&W.H. & U.D. Notfn. No. F.-1-6/62-D, dt. 2-7-1969. 5. Amended by S. O. No. 2139, dt. 12-8-1972. 6. Sub-rule (4) omitted and sub-rule (5) renumbered as sub-rule (4) by Notfn. No. G.S.R. 62(E), dt. 15-2-1982. Drugs and Cosmetics Rules, 1945 34 1[(5) The function of the Laboratory in respect of Intra-Utrine Devices and Falope Rings shall be carried out at the Central Drugs Testing Laboratory, Thane, Maharashtra and the functions of the Director in respect of the said devices shall be exercised by the Director of the said Laboratory.] 2[(6) The functions of the Laboratory in respect of human blood and human blood products including components, to test for freedom of HIV antibodies, shall be carried out by the following Institutes/Hospitals and the functions of the Director in respect of the above mentioned products shall be exercised by the head of the respective Institute, namely:- (a) National Institute for Communicable Disease, Department of Microbiology, Delhi. (b) National Institute of Virology, Pune (c) Centre of Advanced Research in Virology, Christian Medical College, Vellore.] 3[(7) The functions of the Laboratory in respect of Homoeopathic medicines shall be carried out at the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.] 4[(8) The functions of the Laboratory in respect of Blood Grouping reagents and diagnostic kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus shall be carried out at the National Institute of Biologicals, NOIDA and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said laboratory.] 4. Despatch of samples for test or analysis. __ (1) Samples for test or analysis under sub-section (4) of section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director. (2) The packet as well as the outer cover, shall be marked with a distinguishing number. (3) A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director. 5. Recording of condition of seals. __ On receipt of the packet, it shall be opened by an officer authorised in writing in that behalf by the Director who shall record the condition of the seal on the packet. __________________________________________________________________ Drugs and Cosmetics Rules, 1945 35 6. Report of result of test or analysis. __ After test or analysis the result of the test or 1. Ins. by G.S.R. No. 865 (E), dt. 25-10-1990 and subs. by G.S.R 242(E), dt. 18-3-1998. 2. Ins. by G.S.R 16(E), dt. 10-1-1990. 3. Ins. by G.S.R 246(E), dt. 1-5-1991. 4. Ins. by G.S.R. No. 249 (E), dt. 4-4-2001. analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2. 7. Fees. __ The fees for test and analysis shall be those specified in Schedule B. 8. Signature of certificates. __ Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorised by the Central Government by Notification in the Official Gazette to sign such certificates. Rules 9 to 20-Omitted 2[AND REGISTRATION] 21. In this Part.– 3[(a) “import licence” means either a licence in Form 10 to import drugs • * *; excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X;] (b) “licensing authority” means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22; (c) “licence for examination, test or analysis” means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis; 2[(d) “manufacturer” includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and /or in other major countries; (e) “Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.] 22. The licensing authority may with the approval of the Central Government by an order in writing delegate the 2[power to sign licences and Registration Certificate and] such other powers as may be specified in the order to any other person under his control. ____________________________________________________________________ 2. Ins. by G.S.R 604 (E), dt. 24-8-2001. 3. Subs. by G.S.R 462 (E),dt. 22-6-1982. 4. Omitted by G.S.R 604 (E), dt. 24-8-2001. 1. Part III (Rules 9 to 20) omitted by Notfn. No. F. 1-16/57-D, dt. 15-6-1957. Drugs and Cosmetics Rules, 1945 36 1[23. Import licences.–An import licence in Form 10 shall be required for 2[import of drugs], excluding those specified in Schedule X, and an import licence in Form 10- A shall be required for the import of drugs specified in Schedule X.] 2[24. Form and manner of application for import licence.– (1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these Rules, or by the manufacturer’s agent in India either having a valid licence under the Rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these Rules, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer: Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug: (2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27-A: Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing. 3[Provided further that Registration certificate shall not be required to be accompanied with an application for an import licence under the Rules for the import of in-vitro diagnostic kits and regents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3.] (3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this Rule, if the original is defaced, damaged or lost.] 4[24-A. Form and manner of application for Registration Certificate.—(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by the fee specified in sub-rule (3) and the informations and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer. ____________________________________________________________________ Drugs and Cosmetics Rules, 1945 37 (2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate. (3) (i) A fee of one thousand and five hundred US dollars 1[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India (ii) A fee of one thousand US dollars 1[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug: Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars 1[or its equivalent in Indian rupees] for each drug. (4) The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines”: Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account “0210- Medical and Public Health, 04- Public Health, 104-Fee and Fines”, and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment. (5) The applicant shall be liable for the payment of a fee of five thousand US dollars 1[or its equivalent in Indian rupees] for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under Rule 22. (6) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug. (7) A fee of three hundred US dollars 1[or its equivalent in Indian rupees] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost. (8) No Registration Certificate shall be required under these Rules in respect of an inactive bulk substance to be used for a drug formulation, with or without pharmacopoeial conformity.] ____________________________________________________________________ Drugs and Cosmetics Rules, 1945 38 25. Licences for import of drugs manufactured by one manufacturer.– (1) A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer: 1[Provided that the drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit: Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of the drugs manufactured by each such factory.] • * * * * 3[25A. Condition to be satisfied before a licence in Form 10 or Form 10-A is granted. ___ (1) A licence in Form 10 or in Form 10-A shall be granted by the licensing authority having regard to– (i) the premises, where the imported substances will be stocked, are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and (ii) the occupation, trade or business ordinarily carried out by the applicant: Provided that the licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,-- (a) that the applicant has not complied with the provisions of the Act or these rules; or (b) that by reasons of— 4[(i) his conviction under the Act or these Rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) or the rules made thereunder;] (ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted. (2) Any person who is aggrieved by the order passed by the licensing authority under this Rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit.] ____________________________________________________________________________________ 1. Subs. by G.S.R. 462 (E), dt. 22-6-1982. 2. Subs. by G.S.R 604 (E), dt. 24-8-2001. 3. Ins. by G.S.R. 35(E), dt. 20.1.2005. 4. Ins. by G.S.R 604 (E), dt. 24-08-2001. 1. Ins. by G.S.R. 35(E), dt. 20.1.2005. 2. Omitted Notfn. No.F. 1-16/57-D, dt. 15-6-1957. 3. Subs. by G.S.R 462(E), dt. 22-6-1982. 4. Subs. by G.S.R 604 (E), dt. 24-8-2001. 1. Added by Notfn. No. F. 1-19/48-D, dt. 27-10-1949. 1[25B. Registration Certificate for import of drugs manufactured by one manufacturer.--(1) A single application may be made, and a single Registration Drugs and Cosmetics Rules, 1945 39 Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer: Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit: Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.] 26. Conditions of import licence. ____ An import licence shall be subject to the following conditions: (i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9; (ii) the licensee shall allow any Inspector authorised by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples; (iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied; (iv) if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate authorising the sale of the batch has been issued to him by or on behalf of the licensing authority; (v) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall the issues already made from that batch; (vi) the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorised in that behalf by the licensing authority: Drugs and Cosmetics Rules, 1945 40 1. Ins. by G.S.R. No. 604(E), dt. 24-8-2001. 1[Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely: ___ 1. Name of the Drug, 2. Batch number, 3. Name and address of the manufacturer, 4. Date of transaction, 5. Opening stock on the business day, 6. Quantity of drug received, if any, and the source from which received, 7. Name of the purchaser, his address and licence number, 8. Balance quantity of drug at the end of the business day, 9. Signature of the person under whose supervision the drugs have been supplied.] (vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any Rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months’ notice. 27. Grant of import licence. ____ On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 1[or From 10-A, as the case may be]. 2[27-A Grant of Registration Certificate. ___ (1) On receipt of an application for Registration Certificate in the Form and manner specified in Rule 24-A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41: Provided further that if the application is complete in all respects and informations specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit. (2) If the applicant does not receive the Registration Certificate within the period as specified in the proviso to sub-rule (1), he may appeal to the Central Government and the Central Government may after such enquiry into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.] _____________________________________________________________________ 2. Ins. by G.S.R 604 (E), dt. 24-8-2001. 1. Added by G.S.R 462 (E), dt. 22-6-1982. Drugs and Cosmetics Rules, 1945 41 28. Duration of import licence. __ A licence unless, it is sooner suspended or cancelled, shall be 2[valid for a period of three years from the date of its issue:] Provided that if application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application. 3[28-A. Duration of Registration Certificate.—- A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue: Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.] 4[29. Suspension and cancellation of import licence. __ If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit, either wholly or in respect of some of the substances to which it relates: Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.] 3[29A. Suspension and cancellation of Registration Certificate. —If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates: Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.] ____________________________________________________________________ 2. Subs. by G.S.R 604 (E), dt. 24-8-2001. 3. Ins. by G.S.R 604 (E), dt. 24-8-2001. 4. Subs. by G.S.R 604 (E), dt. 24-8-2001. 1. Amended by Notfn. No. F. 1-10/62-D, dt. 19-4-1964. Drugs and Cosmetics Rules, 1945 42 30. Prohibition of import after expiry of potency. —No biological or other special product specified in Schedule C or C (I) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test. • * * * * 30AA. Import of new Homoeopathic medicine.—(1) No new Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority. (2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it. 2[Explanation. —For the purpose of this rule, ‘New Homoeopathic Medicine’ means— (i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or (ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or (iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended.] 3[30-B. Prohibition of import of certain drugs. ___ No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.] 4[31. Standard for certain imported drugs.—No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the Rules shall be applicable for determining whether any such imported drug complies with the said standard: Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary: ___________________________________________________________________ 1. Rules 30A and 30AA ins. by Notfn. F. 1-30/48-G, Dt. 14.4.1952 rule 30A omitted by G.S.R. 2. Subs. G.S.R. 680 (E) ,dt. 5-12-1980. 4. Subs. G.S.R. 604 (E), dt. 24-8-2001. 944 (E), dt. 21-9-1988. 3. Amended by Notfn. No. F. 1-45 4-1-1951. Drugs and Cosmetics Rules, 1945 43 Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent residual shelf-life period as on the date of import: Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow, the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.] 1[32. Packing and labelling of imported drugs. __ No drug shall be imported unless it is packed and labelled in conformity with the Rules in Parts IX and X • * * and further conform to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform to the rules in Parts IX and X and Schedule F(1)]. 3[32A Packing and Labelling of Homoeopathic medicine. __ No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.] 33. Import of drugs for examination, test or analysis __ Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions: __ (a) No drug shall be imported for such purpose except under a licence in Form 11; (b) the licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorise; (c) the licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof; (d) the licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer; (e) the licensee shall comply with such further requirements, if any, applicable to the holders of licences for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month’s notice. ___________________________________________________________________ 1. Subs. by Ministry of Health, F. P. & W. H. & U. D. Notfn. No. F. 1-6/62-D, dt. 2-7-1969. 3. Ins. by S. O. No. 2139, dt. 12-8-1972. 2. Certain words omitted by G.S.R. 661(E), dt. 3-7-1992. Drugs and Cosmetics Rules, 1945 44 1[33-A Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.—Small quantities of new drug, as defined in Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:- (a) no new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin; (b) the licensee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorise; (c) the licensee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof ; (d) the licensee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease; (e) the licensee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month’s notice; (f) the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist; (g) the quantity of any single drug so imported shall not exceed 100 average dosages per patient: Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug of a larger quantity.] 34. Application for licence for examination, test or analysis. __ (1) An application for a licence for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted. ___________________________________________________________________ Drugs and Cosmetics Rules, 1945 45 (2) The licensing authority may require such further particulars to be supplied as he may consider necessary. 1[(3) Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug. (4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210-Medical and Public Health, 04- Public Health, 104- Fees and Fines.] 2[34A. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients. __ (1) An application for an import licence for small quantities of a new drug, as defined in Rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be. (2) The licensing authority may require such further particulars to be supplied, as he may consider necessary. (3) Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug. (4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210- Medical and Public Health, 04- Public Health, 104- Fees and Fine.] 35. Cancellation of licence for examination, test or analysis. __ (1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued. (2) A licensee whose licence has been cancelled may appeal to the Central Government within three months of the date of the order.] _____________________________________________________________ Drugs and Cosmetics Rules, 1945 46 1[35A. Cancellation of licence for import of small quantities of new drugs. __ (1) A licence for import of small quantities of a new drug, defined in Rule122-E, for the purpose of the treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which 1. Ins. by G.S.R 604 (E), dt. 24-8-2001. 1. Subs. by G.S.R 604 (E), dt. 24-8-2001. 2. Ins. by G.S.R 604 (E), dt. 24-8-2001. the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder. (2) A licensee whose licence has been cancelled may appeal to the Central Government within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit.] 36. Import of drugs for personal use. __ Small quantities of drugs, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions: __ (i) the drugs shall form part of a passenger’s bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger; (ii) the drugs shall be declared to the Customs authorities if they so direct; (iii) the quantity of any single drug so imported shall not exceed one hundred average doses : Provided that the licensing authority may in an exceptional case in any individual case sanction the import of a larger quantity: 2[Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely: __ (i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use; (ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and (iii) the licensing authority grants a permit in respect of the said drug in Form 12-B.] 37. Packing of patent or proprietary medicine. —Patent or proprietary medicines shall be imported in containers intended for retail sale: Provided that such medicines may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission. 38. Statement to accompany imported drugs . __ All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the name and quantities of the drugs. 39. Documents to be supplied to the Customs Collector . __ Before drugs for the import of which a licence is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall be supplied to the Customs Collector. ______________________________________________________________ 1. Ins. by G.S.R 604 (E), dt. 24-8-2001. 2. Added by Notfn. No.F-1-36/54-D.S.,dt. 3-3-1955. 3. Amended by Notfn. No.F-1-3/51-D.S.,dt. 15-10-1954. 4. Amended by Notfn. No.F-1-45/58-D, dt. 4-1-1961. Drugs and Cosmetics Rules, 1945 47 40. Procedure for the import of drugs. __ (1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions of Chapter III of the Act and Rules thereunder he may, and if requested by an officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the Director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the Director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government, on such samples is received : Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall make over the consignment to the importer. (2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required by the Customs Collector to return the consignment or any portion thereof he shall return the consignment or portion thereof within ten days of receipt of the notice. 2[41. (1) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government, reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall cause them to be destroyed : Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs Collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final. 3[(2) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorised in this behalf by the Central Government.]] • * * * * ____________________________________________________________________ 1. Amended by Notifn. 1-99/52-D.S., dated 3-11-1953. 2. Amended by Notfn. No. F. 7-7/47-D, dt. 5-1-1954. 3. Added by Notfn. No. 7-11/47-D, dt. 5-10-1951. 4. Rule 42 omitted by Notfn. No. F. 1-9/52-DS., dt. 3-11-1953. Drugs and Cosmetics Rules, 1945 48 43. The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule. 1[43A. No drug shall be imported into India except through one of the following places, namely: __ Freozepore Cantonment and Amritsar Railway Stations: In respect of drugs imported by rail across the frontier with Pakistan. Ranaghat, Bongaon and Mohiassan Railways Stations: In respect of drugs imported by rail across the frontier with Bangladesh. 2[Raxaul: In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal.] 3[Chennai, [Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla]: In respect of drugs imported by sea into India. 4[Chennai, Kolkata, Mumbai, Delhi, Ahemdabad and Hyderabad: In respect of drugs imported by sea into India.] 5[43-B. Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Rules made thereunder: Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences.] 1. Subs. by G.S.R 478 (E), dt. 6-8-1981. 2. Ins. by G.S.R 120 (E), dt. 5-3-1998. 3. Subs. by G.S.R 504 (E), dt. 18-7-2002. 4. Subs. by G.S.R 647 (E), dt. 28-10-1998. ____________________________________________________________________ (The word Calcutta, Subs. with a word ‘Kolkata’ as per this Notfn..) (The words “Madras” and “Bombay” Subs. by “Chennai” and “Mumbai” as per Notfn..) 5. Added by Notfn. No. E. 1-60/D, dt. 19-3-1964. Drugs and Cosmetics Rules, 1945 49 44. Qualifications of Government Analyst. ____ A person appointed as a Government Analyst under the Act shall be a person who ____ (a) is a graduate in medicine or science or pharmacy or Pharmaceutical Chemistry of a 3[University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had not less than five years’ post-graduate experience in the testing of drugs in a laboratory under control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority, 4[or has completed two years’ training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory], or (b) possesses a post-graduate degree in medicine or science or pharmacy or Pharmaceutical chemistry of a 3[University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] or possesses the Associateship Diploma of the Institution of Chemists (India) obtained by passing the said examination with ‘Analysis of Drugs and Pharmaceuticals’ as one of the subjects and has had after obtaining the said post-graduate degree or diploma not less than three years’ experience in the testing of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority 4[or has completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory]: Provided that- 4[(i) for purpose of examination of items in Schedule C,- (ia) the persons appointed under clause (a) or (b) and having degree in Medicine, Physiology, Pharmacology, Microbiology, Pharmacy should have experience or training in testing of said items in an institution or laboratory approved by the appointing authority for a period of not less than six months; (ib) the person appointed under clause(a) or (b) but not having degree in the above subjects should have experience or training in testing of said Schedule C drugs for a period of not less than three years in an institution or laboratory approved by the appointing authority or have completed two years training on testing of drugs including items stated in Schedule C in Central Drugs Laboratory;] ____________________________________________________________________ 1. Subs. by G.S.R 443 (E), dt. 12-4-1989. 3. Subs. by G.S.R. 71(E), dt 30.1.1987. 4. Ins. by G.S.R 697(E) dt. 26-10-1995. 2. Amended by G.S.R. No. 1427, dt. 22-10-1977. Drugs and Cosmetics Rules, 1945 50 (ii) for a period of four years from the date on which Chapter IV of the Act takes effect in the States, persons whose training and experience are regarded by the appointing authority as affording, subject to such further training, if any, as may be considered necessary, a reasonable guarantee of adequate knowledge and competence, may be appointed as Government Analysts. The persons so appointed may, if the appointing authority so desires, continue in service after the expiry of the said period of four years; (iii) no person who is engaged directly or indirectly in any trade or business connected with the manufacture of drugs shall be appointed as a Government Analyst for any area : Provided further that for the purpose of examination of Anti-sera, Toxoid and Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a person who is a graduate in Veterinary Science, or general science, or medicine or pharmacy and has had not less than five years’ experience in the standardization of biological products or person holding a post-graduate degree in Veterinary Science, or general science, or medicine or pharmacy or pharmaceutical chemistry with an experience of not less than three years in the standardization of biological products : Provided also that persons, already appointed as Government Analysts may continue to remain in service, if the appointing authority so desires, notwithstanding the fact that they do not fulfil the qualifications as laid down in clause (a), clause (b) or the preceding proviso. 45. Duties of Government Analysts.−(1) The Government Analyst shall cause to be analysed or tested such samples or drugs 1[and cosmetics as may be sent to him by Inspectors or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these Rules. (2) A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government. 46. Procedure on receipt of sample.−On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet 2[or on portion of sample or container] with the specimen impression received separately and shall note the condition of the seals on the 3[packet or on portion of sample or container]. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied: ____________________________________________________________________ Drugs and Cosmetics Rules, 1945 51 1[Explanation. __ It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests or analysis applied”, if ____ (1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report; (2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report; (3 )for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report; (4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report; (5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report. 47. Report of result of test or analysis. ___ An application from a purchaser for test or analysis of a drug under section 26 of the Act shall be made in Form 14 A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14-B.] 48. Fees. ___ The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a drug purchased by him shall be those specified in Schedule B. 2[49. Qualifications of Inspectors. —A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law: Provided that only those Inspectors: ⎯ ___________________________________________________________________ Drugs and Cosmetics Rules, 1945 52 (i) Who have not less than 18 months’ experience in the manufacture of at least one of the substances specified in Schedule C, or (ii) Who have not less than 18 months’ experience in testing of at least one of the substances in Schedule C in a Laboratory approved for this purpose by the licensing authority, or (iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors; shall be authorised to inspect the manufacture of the substances mentioned in Schedule C:] 1[Provided further that the requirement as to the academic qualification shall not apply to persons appointed as Inspectors on or before the 18th day of October, 1993.] 2[ 49A. Qualification of a Licensing Authority.—No person shall be qualified to be a Licensing Authority under the Act unless:- (i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and (ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:] 3[ Provided that the requirements as to the academic qualification shall not apply to those inspectors and the Government Analysts who were holding those positions on the 12 th day of April,1989. 1. Ins. by S.O. 2139 dt. 12-8-1972. 2. Ins. by G.S.R. 59(E), dt. 7-2-1995. 3. Subs., ibid., dt. 7-2-1995. 1. Ins. by No. F. 1-60/61-D, dt. 12-7-1962. 2. Subs. by No. G.S.R 658 (E), dt. 19-10-1993. 4[50. Controlling authority. __ (1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central Government. (2) All Inspectors appointed by the State Government shall be under the control of an officer appointed in this behalf by the State Government. (3) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2), shall be a controlling authority.] ____________________________________________________________________ 2. Ins. by G.S.R 443 (E), dt. 12-4-1989. 3. Subs. by G.S.R. 532 (E), dt. 14.8.1991. 4. Subs. by S.O. 2139, dt. 12-8-1972. 1. Added by G.S.R 552 (E), dt. 4-12-1996. Drugs and Cosmetics Rules, 1945 53 1[50A. Qualification of a Controlling Authority. __ (1) No person shall be qualified to be a Controlling Authority under the Act unless __ (i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law; and (ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years: 2[Provided that the requirements as to the academic qualifications shall not apply to those Inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989.] 51. Duties of Inspectors of premises licensed for sale. ___ Subject to the instructions of the controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for the sale of drugs __ (1) to inspect 3[not less than once a year] all establishments licensed for the sale of drugs within the area assigned to him; (2) to satisfy himself that the conditions of the licences are being observed; (3) to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules thereunder; (4) to investigate any complaint in writing which may be made to him; (5) to institute prosecutions in respect of breaches of the Act and Rules thereunder; (6) to maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and the seizure of stocks, and to submit copies of such record to the controlling authority; (7) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention of the Act; ____________________________________________________________________ Drugs and Cosmetics Rules, 1945 54 (8) when so authorized by the State Government, to detain imported packages which he has reason to suspect contain drugs, the import of which is prohibited. 52. Duties of Inspectors specially authorized to inspect the manufacture of 1[drugs or cosmetics]. __ Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs ____ (1) to inspect 2[not less than once a year], all premises licensed for manufacture of 1[drugs or cosmetics] within the area allotted to him to satisfy himself that the conditions of the licence and provisions of the Act and Rules thereunder are being observed; (2) in the case of establishments licensed to manufacture products specified in Schedules C and C(1) to inspect the plant and the process of manufacture, the means employed for standardizing and testing the 2[drugs or cosmetics], the 1. Ins. by G.S.R 443 (E), dt. 12-04-1989. 2. Subs. by G.S.R 532 (E), dt. 14-8-1991. 3. Subs. by G.S.R. 700 (E), dt. 28-9-2001. methods and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the product; (3) to send forthwith to the controlling authority after each inspection a detailed report indicating the conditions of the licence and provisions of the Act and rules thereunder which are being observed and the conditions and provisions, if any, which are not being observed; (4) to take samples of the 1[drugs or cosmetics] manufactured on the premises and send them for test or analysis in accordance with these Rules; (5) to institute prosecutions in respect of breaches of the Act and Rules thereunder. 53. Prohibition of disclosure of information. ___ Except for the purposes of official business or when required by a Court of Law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him in the course of his official duties. 1. Subs. by G.S.R 504 (E), dt. 18-7-2002. 2. Subs. by G.S.R 700 (E), dt. 28-9-2001. ___ An order in writing by an Inspector under clause (c) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form 15. ____________________________________________________________________ Drugs and Cosmetics Rules, 1945 55