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

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

Share this:

0