The Ministry of Health and Family Welfare (MoHFW), on April 21, 2026, issued a draft notification proposing amendments to the Drugs Rules, 1945 under the powers conferred by the Drugs and Cosmetics Act, 1940. The draft has been published for public consultation after due consultation with the Drugs Technical Advisory Board.
The proposed amendment seeks to modify Rule 89 by expanding the list of applicable license forms. Specifically, the existing reference to “Form 25 or Form 28” is proposed to be substituted with a broader set of forms including Form 25A, 25F, 28A, 28B, 28D, 28DA, and 28F, thereby widening the regulatory framework and applicability for drug manufacturing licenses.
Stakeholders and affected persons have been invited to submit objections or suggestions within 30 days from the date of publication of the draft in the Official Gazette. The final rules will come into force three months after their publication in the Official Gazette.
[Notification No.: G.S.R. 299(E)]
