Draft of Drugs and Cosmetics (…. Amendment) Rules, 2019

Feb 27, 2019 | by Avantis RegTech Legal Research Team

Ministry of Health and Family Welfare (MoHFW) on February 26, 2019, after the consultation with the Drugs Technology Advisory Board, has passed a draft Notification to further amend the Drugs and Cosmetic Rules, 1945, and the new Rule may be called as Drugs and Cosmetics (…. Amendment) Rules, 2019. It will come into force on the date of final publication in the Official Gazette.

In Rule 71, 71A, 71B, 76, 76A of the Drugs and Cosmetic Rules, 1945, which specifies the “conditions for the grant or renewal of a license in Form 25, Form 25B, Form 25A and Forms of licence to manufacture drugs specified in Schedules C and C (1)”, a new sub-rules 71(9), 71A(5), 76(11) and new sub-clauses 71B(v), 76A(iv) has been inserted, namely:-

“In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking to the licensing authority that such or similar brand name or trade name is not already in existence so that the brand name or the trade name to be used by the applicant shall not lead to any confusion or deception in the market.”

All the people likely to be affected are invited to bring objections and suggestions within of 45 days from the date on which the copies of the draft are published in Official Gazette. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414A, D Wing, Nirman Bhavan, New Delhi -110011 or email at [email protected]

[Notification No.: G.S.R. 152(E).]


URL: http://egazette.nic.in/WriteReadData/2019/198746.pdf


Related Updates

Alternate Text

Get updates on the go on RuleZbook Mobile App.