In a recent notification dated April 12th, 2018, the Ministry of Health and Family Welfare (“Ministry”) has invited suggestions and objections to the draft Drugs and Cosmetics (Amendment) Rules, 2018 (“Draft Amendment Rules”), that proposes to amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).
Key Highlights of the Draft Amendment:
| Principal Rules | Draft Amendment Rules | Impact |
| Rule 89: Licence to manufacture drugs for the purpose of Examination Testing and Analysis
If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29.
Provided that in the case of a drug the composition of which is such that the drug is not generally recognised among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the licensing authority mentioned in rule 21, to the effect that there would be no objection to such licence being granted.
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Rule 89: Licence to manufacture drugs for the purpose of Examination Testing and Analysis
If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29.
Provided that in the case of a drug the composition of which is such that the drug is not generally recognised among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the licensing authority mentioned in rule 21, to the effect that there would be no objection to such licence being granted.
Provided further that if Licensing Authority referred in rule 21, is satisfied that the human vaccine is safe and effective for human use based on the clinical trial data and other information generated with the vaccine or drug substance manufactured under this licence, may grant permission to consider remaining quantities of such batch used in the clinical trial shall be deemed to have been manufactured under Form 28D or Form 28DA as the case may be. Further, permission for the said vaccine is granted in Form 46 and the licence is granted to manufacture the said vaccine in Form 28D or Form 28DA as the case may be and the manufacturer shall comply with all the conditions specified under the said Forms.
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The Amendment has added a second proviso, which states that on the basis of clinical trial data and information generated from drugs manufactured under this licence, if the licensing authority is convinced that a human vaccine is safe and effective for human use, it may grant permission to process the remaining quantities of that batch to be manufactured under either of the following forms:
i. Form 28D: Licence to manufacture for sale or for distribution of 2 [Large Volume Parenterals /Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] specified in Schedules C and C(I) excluding those specified in Schedule X
ii. Form 28DA: Loan licence to manufacture for sale or for distribution of 2 [Large Volume Parenterals /Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] excluding those specified in Schedule X
A manufacturer must compulsorily comply with the conditions mentioned under each of these Forms.
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| 92. Conditions of licence in Form 29
A licence in Form 29 shall be subject to the following conditions:
(a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence;
(b) the licensee shall allow any 1 Inspector appointed under the Act to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted;
(c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied;
(d) the licensee shall comply with such further requirements, if any, applicable to the holders of licences in Form 29 as may be specified in any Rules subsequently made under the Act and of which the Licensing Authority has given him not less than one month’s notice;
(e) the licensee shall maintain an Inspection Book to enable an Inspector to record his impressions and defects noticed.
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92. Conditions of licence in Form 29
A licence in Form 29 shall be subject to the following conditions:
(a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence;
(b) the licensee shall allow any 1 Inspector appointed under the Act to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted;
(c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied;
(d) the licensee shall comply with such further requirements, if any, applicable to the holders of licences in Form 29 as may be specified in any Rules subsequently made under the Act and of which the Licensing Authority has given him not less than one month’s notice;
(e) the licensee shall maintain an Inspection Book to enable an Inspector to record his impressions and defects noticed.
(f) the licensee shall release the clinical trial batches to be used for marketing with the approval of the Central Drugs Laboratory, Kasauli;
(g) the licensee shall have a post marketing surveillance mechanism for monitoring of adverse drugs reactions in respect of the clinical trial batches to be used for marketing;
(h) the licensee shall comply with rule 122 DAB in case of any injury or death due to administration and adverse effect of vaccines related to any quality failure, manufactured under clinical trial batches and are permitted for marketing under rule 89.
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The amendment rules have incorporated additional clauses to impose further obligations on licensees.
i. Prior to sending clinical trial batches for marketing, licensees have been mandated to seek the approval of the Central Drugs Laboratory, Kasauli.
ii. The licensee is required have a post marketing surveillance mechanism for monitoring of adverse drugs reactions in respect of the clinical trial batches to be used for marketing.
iii. Licensees are bound to pay compensation in case of injury or death during clinical trial, and adverse effect of vaccines related to any quality failure in accordance with Rule 122 DAB.
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Comments/ suggestions have been invited to the following address, within a period of forty-five days from the date of the above-mentioned notification, i.e. before May 27,2018.
Under Secretary (Drugs)
Ministry of Health and Family Welfare,
Government of India,
Room No. 414 A, D Wing,
Nirman Bhavan,
New Delhi – 110011
Email: drugsdiv-mohfw@gov.in
Source: Ministry of Health and Family Welfare
