The Ministry of Health and Family Welfare (MoHFW), on August 19, 2026, issued the draft Drugs (Amendment) Rules, 2026 under Sections 12(1) and 33(1) of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board. The draft proposes amendments to Schedule H1 of the Drugs Rules, 1945.
The proposal seeks to insert four additional drugs under Schedule H1, namely Flupentixol, Zopiclone, Gabapentin and Carisoprodol, as serial numbers 53 to 56 respectively. The draft rules, once finally notified, would come into force 180 days after publication of the final rules in the Official Gazette.
Objections and suggestions from affected persons are invited within 30 days from the date the Gazette containing the draft rules is made available to the public. Comments may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or through the specified email address.
[G.S.R. 745(E)]
