2026.04.21 G.S.R. 299(E)_ Draft Notification for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F

On 21 April 2026, the Ministry of Health and Family Welfare issued draft rules (G.S.R. 299(E)) proposing amendments to the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940. The draft, published after consultation with the Drugs Technical Advisory Board, invites comments and suggestions from stakeholders within 30 days of its publication in the Gazette of India. A key change under Rule 89 expands the scope of licensing forms, replacing “Form 25 or Form 28” with a broader list that now includes Form 25A, 25F, 28A, 28B, 28D, 28DA, and 28F. This amendment aims to strengthen regulatory clarity and streamline licensing processes. Stakeholders are encouraged to review the draft carefully and submit feedback to the Ministry for consideration.