2025.10.16_ G.S.R. 757(E)_ Amendment under Drugs Rules to include more categories under Schedule H2

On October 16, 2025, the Ministry of Health and Family Welfare issued a draft notification (G.S.R. 757(E)) proposing amendments to the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940. These amendments, developed in consultation with the Drugs Technical Advisory Board, aim to revise Schedule H2 by inserting “Table 1” and adding a new “Table 2” listing specific therapeutic categories.   Table 2 includes all vaccines, antimicrobials, narcotic and psychotropic drugs (as per the 1985 Act), and anticancer drugs.   The draft rules are open for public feedback, and stakeholders are invited to submit objections or suggestions within 30 days from the date the Gazette is made publicly available. Submissions should be addressed to the Director (Drugs Regulation), Ministry of Health and Family Welfare, either by mail or email. Final implementation will follow government approval and publication in the Official Gazette. These changes aim to enhance regulatory clarity and oversight.