The Ministry of Health and Family Welfare has formally amended the Drugs Rules, 1945, restricting the free sale of alcohol-based liquid medicines. Notified as the Drugs (Tenth Amendment) Rules, 2026 through G.S.R. 607(E) on July 8, the change follows powers granted under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, and consultation with the Drugs Technical Advisory Board.
A draft version was released for public feedback in October 2025, and since no objections were raised during the comment window, the rules now stand finalized. The amendment removes the earlier blanket retail exemption for oral drug formulations exceeding 12% alcohol by volume when sold in containers larger than 30 millilitres. Such products have also been added to Schedule H1, placing them in the prescription-controlled category alongside medicines like Pregabalin.
This effectively means larger bottles of high-alcohol-content liquid medications can no longer be sold over the counter without a doctor’s prescription. The rules will take effect six months after gazette publication, giving manufacturers and retailers time to comply.
Written By: Sayan Das
Graphics by: Pramit Hazra
