Draft Drugs and Cosmetics (Tenth Amendment) Rules, 2019

Apr 24, 2019 | by Avantis RegTech Legal Research Team


The Ministry of Health and Family Welfare (MoHFW) on April 18, 2019, after consultation with the Drugs Technical Advisory Board, has published a draft Drugs and Cosmetics (Tenth Amendment) Rules, 2019, to further amend the Drugs and Cosmetics Rules, 1945. It will come into force on the date of their publication in the Official Gazette.

The amendments have been made in Schedule A, in FORM 45 and FORM 46 under the sub-heading of “Conditions for grant of approval / permission”.

The objections and suggestions are invited from persons likely to be affected thereby, before the expiry of a period of ten days from the date on which the copies of the Official Gazette containing the said Notification were made available to the public.

[Notification No. G.S.R. 317(E)]

Click here to download the Notification.


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