Delegation of Powers by the Central Licence Approving Authority

Section 68B of the Drugs and Cosmetics Act and Rules deals with delegation of Powers by the Central Licence Approving Authority. The Central Licence Approving Authority may with the approval of the Central Government, by notification delegate his powers of signing licences and any other powers under the rules to any person under his control having same qualifications as prescribed for controlling authority under Rule 50A for

The Central Licence Approving Authority may with the approval of the Central Government, by notification delegate his powers of signing licences and any other powers under the rules to any person under his control having same qualifications as prescribed for controlling authority under Rule 50A for such areas and for such periods as may be specified.] sode areas and for such 1[69. Application for licence to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules .-- [(1) Application for grant or renewal of 3[licence to manufacture for sale or for distribution] of drugs, other than those specified in Schedules C and C (1) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made- (a) in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in, Form 24-B;

(b) in the case of manufacture of drugs included in Schedule X, in Form 24-F;

(c) in any other case, in Form 24.] 4[(2)(a) Every application in Form 24-B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees five hundred plus and an inspection fee of rupees two hundred for every inspection or for the purpose of renewal of the licence. 1. Amendedby Notfn. F. 1-22/59-D, dt. 9-4-1960. 2. Subs. by G.S.R 462 (E), dt. 22-06-1982. 3 Subs. by G.S.R.788 (E), dt. 10-10-1995. 4. Subs. by G.S.R 601(E), dt. 21-8-2001.

(b) Every application in Form 24B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every subsequent inspection or for the purpose of renewal of licence.

(c) Every application in Form 24 shall be made up to ten items for each category of drugs catogarised in Schedule M and Schedule M-III and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of one thousand and five hundred for every inspection or for the purpose of renewal of the licence.] 1[(3) If a person applies for the renewal of a licence after the expiry thereof but within six months of such expiry the fee payable for the renewal of such licence shall be-] 2[(i) in the case of Form 24-B a licence fee of rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in addition to an inspection fee of rupees two hundred; aC Wo hundred, (ii) in the case of Form 24-F a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand;

(iii) in the case of Form 24 a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand and five hundred.] 1[(4) A fee 2[rupees one thousand shall be paid] for a duplicate copy of the licence issued under clause (a), clause (b) or clause (c) of sub-Rule (1) if the original is defaced, damaged or lost.] 2[(5) Applications by licensees to manufacture additional items of drugs shall, in the case of a licence to manufacture for sale and distribution for repacking and other than those specified in Schedule C and Schedule C (I), be made to the Licensing Authority. Such applications shall, if the additional items of drugs applied for belong to categories which are not already included in the licence, be accompanied by an additional fee at the rate of rupees one hundred for each additional item of drug for repacking and rupees three hundred per additional item of drugs categorised in Schedule M and Schedule M-III.] 1. Subs. by G.S.R 462 (E), dt. 22-6-1982. 2. Subs. by G.S.R 601 (E), dt. 24-8-2001. 1[(6) Where an application under this Rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122-E, such application shall also be accompanied with approval, in writing in favour of the applicant, from the licensing authority as defined in clause (b) of rule 21.] Explanation .- For the purpose of these Rules, the term 'repacking' means the process of breaking up any drug from a bulk container into small packages and the labelling of each such package with a view to its sale and distribution, but does not include the compounding or dispensing or the packing of any drug in the ordinary course of the retail business. 2[69-A. Loan Licences .- 3[(1) Application for the grant or renewal of loan licences to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C (1) and Schedule X shall be made up to ten items for each category of drugs categorised in Schedule M and Schedule M-III and shall be made in Form 24-A accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority: dials1 Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or part thereof.] Explanation. - For the purpose of this rule a loan licence means a licence which the Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.

(2) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence. 3[(3) Subject to the provisions of sub-rule (2), application for manufacture of more than ten items for each category of drug on a loan licence shall be accompanied by an additional fee of rupees three hundred per additional item specified in Schedule M and Schedule M-III.] 1. Ins. by G.S.R 311 (E), dt. 1-5-2002. 2. Amended by Notfn. No. F. 1-16/57-D, dt. 15-6- 1957. 3. Subs. by G.S.R 601(E) dt. 24-8-2001. 1[(4) If the Licensing Authority is satisfied that a loan licence is defaced, damaged or lost or otherwise rendered useless, he may, on payment of a 2[fee of rupees one thousand] issue a duplicate licence. 4[70. Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1). - Licences for repacking of drugs against application in Form 24-B shall be granted in Form 25-B, licences for manufacture of drugs included in Schedule X and against application in Form 24-F shall be granted in Form 25-F and licences for manufacture of drugs against application in Form 24 shall be granted in Form 25.] 570-A. Form of loan '[licence to manufacture for sale or for distribution] of drugs other than those [specified in Schedules C, C(1) and X] .- A loan [licence to manufacture for sale or for distribution] or drugs other than those "[specified in Schedules C, C(1) and X] shall be issued in Form 25-A. 871. Conditions for the grant or renewal of a licence in Form 25 9[or Form 25-F] .- Before a licence in Form 25 9[or Form 25-F] is granted or renewed, the following conditions shall be complied with by the applicant .- (1) The manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is- o's staff und (a) a graduate in Pharma or Pharmaceutical Chemistry of 1º[a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] and has had at least eighteen months practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course; or (b) a graduate in Science of 1º[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] who for the purpose of his degree has studied Chemistry as a principal subject and has 1. Ins. by Notfn. No. F.1-20/64-D, dt. 26.10.1968. 2. Subs. by Notfn. No. G.S.R. 601 (E), dt. 24.8.2001. 3. Rule 69 omitted by G.S.R. 944 (E), dt. 21-9-1988. 4. Subs. by Notfn. No. G.S.R. 462 (E), dt. 22.6.1982. 5. Ins. by Notfn. No. F.1-16/57 D, 15-6-1957 & No. F.1/22/59-D, dt. 9.4.1960. 6. Subs. by Notfn. No. G.S.R. 788 (E), dt. 10-10-1985. 7. Subs. by Notfn. No. G.S.R. 462 (E), dt. 22-6-1982. 8. Amended by Notfn. No. F.1-16/57-D, dt. 15-6-1957. 9. Ins. by G.S.R. 462(E), dt. 22-6-1982. 10. Subs. by Notfn. No. G.S.R. 71 (E), dt. 30-1-1987. had at least three years practical experience in the manufacture of drugs after his graduation; or (c) a graduate in Chemical Engineering or Chemical Technology or Medicine of [a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or 2(d) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b) or clause (c) and is permitted to work as competent technical staff under this Rule by the Central Government:] Provided that any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any licence granted in Form 25 3[or Form 25-F] as it existed before the date shall be deemed to be qualified for the purposes of this rule: 4[Provided further that for drugs other than those specified in Schedules C, C(1) and X and meant for veterinary use, the whole-time employee under whose supervision the manufacture is conducted shall be a graduate in Veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years practical experience in the manufacture of drugs excluding graduate in Pharmacy who shall have at least eighteen months practical experience in the manufacture of drugs:] 5[Provided 4[also] that the Licensing Authority may, in the matter of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of Paris and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included in clause (a), (b) or (c) of this rule, has, in the opinion of the Licensing Authority, adequate experience in the manufacture of such substance.] 1. Subs. by G.S.R. 71(E), dt. 30-1-1987. 2. Added by Notfn. NO. F. 1-19/59-D, dt. 13-6-1961. 3. Ins. by. G.S.R. 462 (E), dt. 22-6-1982. 4. Ins. by. G.S.R. 93 (E), dt. 24-2-1999. 5. Added Notfn. No. F. 1-14/68-D, dt. the 26-10-1968.

(2) The factory premises shall comply with the conditions prescribed in Schedule M.

(3) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; the space, plant and equipment recommended for various operations are given in Schedule M. 1[(4) The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit, which shall be separate from the manufacturing unit and the head of the testing unit shall be independent of the head of the manufacturing unit :

Provided that the manufacturing units, which, before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements up to the 30th June, 1977 :

Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it under Part XV(A) of these Rules for this purpose.] 2[(4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate.] (5) The applicant shall make adequate arrangements for the storage of drugs manufactured by him. 3[(6) The applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines- - (i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful; 1. Subs. by G.S.R. 926 dt. 16-7-1977. 2. Ins. by G.S.R. 681(E), dt. 5-12-1980. 3. Ins. by G.S.R. 515 dt. 10-4-1976.

(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation and under the conditions in which the formulation for administration and use are recommended;

(iii) are stable under the conditions of storage recommended;

(iv) contain such ingredients and in such quantities for which there is therapeutic justification; and 1[(v) have the approval, in writing, in favour of the applicant to manufacture drugs formulations falling under the purview of new drug as defined in Rule 122-E, from the Licensing Authority as defined in clause (b) of rule 21.] 2[(7) The licensee shall comply with the requirements of Good Manufacturing Practices as laid down in Schedule M. de 3[71A. Conditions for the grant or renewal of a licence in Form 25B. - Before a licence in Form 25-B is granted or renewed the following conditions shall be complied with by the applicant :- dia (1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person; 4(2) the factory premises shall comply with the conditions prescribed in Schedule M; and 5(3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit:

Provided that the repacking units, which before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1977, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf, may continue such arrangements up to the 31st July, 1977: 1. Ins. by G.S.R. 311 (E), dt. 1-5-2002. 2. Ins. by G.S.R. 735 (E), dt. 24-6-1988. 3. Ins. by No. F.1-22/59-D, dt. 9-4-1960. 4. Amended by S.O. 2139 dt. 12-8-1972. 5. Amended by G.S.R. 926 dt. 16-7-1977.

Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may permit such test to be conducted by institutions approved by it under Part XV(A) of these Rules for this purpose.

Explanation .- A person who satisfies the following minimum qualifications shall be deemed to be a "competent person" for the purposes of rule 71-A or 74-A of these Rules, namely: - (a) a person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is registered under the said Act, or (b) a person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the Licensing Authority as equivalent to it; or de (c) a person who has passed the Matriculation examination or an examination recognized by the Licensing Authority as equivalent to it and has had not less than four years' practical experience in the manufacture, dispensing or repacking of drugs. Ind [71-B. Conditions for the grant of renewal of a licence in Form 25-A .- Before a licence in Form 25-A is granted or renewed, the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines: - (i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;

(ii) are safe for use in the context of the vehicles, recipients, additives and pharmaceutical aids used in the formulations and under conditions in which the formulations for administration and use are recommended;

(iii) are stable under the conditions of storage recommended; and (iv) contain such ingredients and in such quantities for which there is therapeutic justification. 1. Ins. by G.S.R. 515, dt. 10-4-1976. 1[72. Duration of licence .- An original licence or a renewed licence in Form 25, 2[Form 25-B or Form 25-F] unless sooner suspended or cancelled shall be 3[valid for a period of five years on and from the date on which] it is granted or renewed: 4Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry. 2[73. Certificate of renewal .- The certificate of renewal of a licence in Form 25 or Form 25-F shall be issued in Form 26 or Form 26-E respectively]. 573-A. A certificate of renewal of loan licence .- The certificate of renewal of a loan licence in Form 25-A shall be issued in Form 26-A. liaCte 573-AA. Duration of loan licence .- An original loan licence in Form 25-A or a renewed loan licence in Form 26-A, unless sooner suspended or cancelled, shall be 3[valid for a period of five years on and from the date on which] it is granted or renewed: 'Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry. 773-B. Certificate of renewal of licence in Form 25-B .- The certificate of renewal of a licence in Form 25-B shall be issued in Form 26-B. 1. Amended by Notfn. No. F.1-10/62-D, dt. 10-4-1964. 2. Subs. by G.S.R. 462 (E), dt. 22-6-1982. 3. Subs. by G.S.R. 601 (E), dt. 24-8-2001. 4. Amended by S.O. 2139 dt. 12-8-1972. 5. Amended by Notfn. No. F.1-10/62-D, dt. 10-4-1964. 6. Amended by S.O. 2139 dt. 12-8-1972. - 7. Ins. by Notfn. No. F.1-22/59-D, dt. 9-4-1961. 1[74. Conditions of licence in Form 25 .- A licence in 2[Form 25 and Form 25-F] shall be subject to the conditions stated therein and to the following further conditions, namely :- (a) the licensee shall provide and maintain staff, premises and the equipment as specified in rule 71;

(b) the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the Rules, these would come into force, four months after publication in the Official Gazette;

(c) the licensee shall either in his own laboratory or in any other laboratory approved by the Licensing Authority under Part XV (A) of these Rules test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of 5 years from the date of manufacture; Colled (d) the licensee shall keep records of the details of manufacture as per particulars given in Schedule U of each batch of the drugs manufactured by him and such records shall be retained for a period of five years;

(e) the licensee shall allow an 3Inspector appointed under the Act, to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture and the means employed in standardizing and testing the drugs;

(f) the licensee shall allow an 3Inspector appointed under the Act to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules thereunder have been observed;

(g) the licensee shall, from time to time, report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the drugs and any material alterations in the premises or plant used for the purpose which have been made since the date of the last inspection made on behalf of the licensing authority; 1. Amended by Notfn. No. F. 1-20/64-D, dt. 26-10-11968. 2. Subs. by G.S.R. 462 (E), dt. 22-6-1982. 3. Amended by G.S.R. 444 dt. 28-4-1973. 1(h) the licensee shall, on request, furnish to the Licensing Authority, the Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct from every batch, or batches of drugs as the Licensing Authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of tests which have been applied;] (i) if the Licensing Authority or the Controlling Authority so directs and if requested by the licensee who had also furnished prima facie reasons for such directions, the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under clause (h) until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the Licensing Authority or the Controlling Authority;

(j) the licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch of the drug has been found by the Licensing Authority or the Controlling Authority not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch; dia (k) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed; 1 [(l) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;] 2[(m) the licensee, who has been granted a licence in Form 25-F, shall- (i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months;

(ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later :- 1. Amended by G.S.R. No. 444 dt. 23-4-1973. 2. Ins. by G.S.R. 462 (E), dt. 22-6-1982. A. Accounts of the drugs specified in Schedule X used for the manufacture: 1. Date of issue. 2. Name of the drug. 3. Opening balance of stock on the production day. 4. Quantity received, if any, and source from where received. 5. Quantity used in manufacture. 6. Balance quantity on hand at the end of the production day. 7. Signature of the person in charge. B. Accounts of production: 1. Date of manufacture. 2. Name of the drug. 3. Batch Number. 4. Quantity of raw material used in manufacture. 5. Anticipated yield. 6. Actual yield, 7 Wastage, diaC 8. Quantity of the manufactured goods transferred. C. Accounts of the manufactured drugs: 1. Date of manufacture. 2. Name of the drug. 3. Batch Number. 4. Opening Balance. 5. Quantity manufactured. 6. Quantity sold. 7. Name of the purchaser and his address. 8. Balance quantity at the end of the day. 9. Signature of the person in charge.

(n) the licensee shall store drugs specified in Schedule X in bulk form and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person;] "[(o) the licensee shall comply with the requirements of 'Good Manufacturing Practices' as laid down in Schedule M.]

Section 68B, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).