Ministry of Health and Family Welfare issues Draft Drugs and Cosmetics (Amendment) Rules, 2017

Ministry of Health and Family Welfare issues Draft Drugs and Cosmetics (Amendment) Rules, 2017

May 8, 2017 Operations 0

The Ministry of Health and Family Welfare (“Ministry”) has issued the Draft Drugs and Cosmetics (_Amendment) Rules, 2017 (“Draft Rules”) on 2nd May, 2017thereby proposing to amend Drugs and Cosmetics Rules, 1945 (“Principal Rules”).

Any objection/suggestion on the same may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or sent on email at drugsdiv-mohfw@gov.in by 1st June, 2017.

Highlights of the Draft Rules are:

  1. The Draft Rules propose to use the term ‘drugs’ in place of the words ‘patent or proprietary medicines’ in the following Rules:
  • Rule 71 (6): This Rule prescribes conditions for grant / renewal of licence in Form 25 [Licence of manufacture for sale or for distribution of drugs other than those specified in Schedules C, C(1) and X] and Form 25 F  Licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C(1)].
  • Rule 71B:  This Rule prescribes conditions for the grant or renewal of a licence in Form 25-A [Licence of manufacture for sale or for distribution of drugs other than those specified in Schedules C, C (1) and X]
  • Rule 76(7): This Rule prescribes Forms of licences to manufacture drugs specified in Schedules C and C(1), excluding those specified in Part X-B and Schedule X, or drugs specified in Schedules C, C(1) and X and the conditions for the grant or renewal of such licences.
  • Rule 76A: This Rules prescribes 76A Forms of loan licenses to manufacture for sale or distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant or renewal of such license.
  1. Under Schedule D, the Draft Rules propose to substitute entry 1 under the column ‘Class of Drugs’ with the following:

Substances not intended for medicinal use excluding those intended to be used as drugs after further purification or rendering them sterile’

For details, refer to the hyperlink given below.

Source: Ministry of Health and Family Welfare

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