MoHFW publishes draft Drugs and Cosmetics (Amendment) Rules, 2019

Jun 25, 2019 | by Avantis RegTech Legal Research Team

The Ministry of Health and Family Welfare (MoHFW) on June 24, 2019, in consultation with the Drugs Technical Advisory Board hereby published the draft Drugs and Cosmetics (Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945. The Rules will come into force on the date of its final publication in the Official Gazette.

The amendments made in the Drugs and Cosmetics Rules, 1945 are:

1) A new Rule 2(ea) has been inserted which defines “Marketer”, means a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer for marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution.

2) a new Rule 84D has been inserted, which specifies “Responsibility of marketer of the drugs”, any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules.

All persons likely to be affected thereby are invited for objections and suggestions within thirty days from the date on which copies of the Gazette of India containing these draft Rules are made available to the public. 

The 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 emailed at [email protected]

[Notification No.: G.S.R. 447(E)]

Click here to download the Notification.



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