GUWAHATI: The Union Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, amending the Drugs Rules, 1945 to revise the provisions relating to oral formulations containing more than 12% alcohol by volume (ethyl alcohol) packed and sold in packings or bottles of more than 30 millilitres. The rules will come into force six months after their publication in the Official Gazette.
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Under the amendment, Schedule K has been amended to insert an exception under Serial No. 10 stating that the exemption shall not apply to all oral formulations containing more than 12% alcohol v/v (ethyl alcohol) packed and sold in packings or bottles of more than 30 millilitres.
The notification also amends Schedule H1 of the Drugs Rules, 1945, by inserting a new entry for all oral formulations containing more than 12% alcohol v/v (ethyl alcohol) packed and sold in packings or bottles of more than 30 millilitres. As a result, these medicines will now require a valid prescription, aiming to prevent misuse and ensure safer consumption.
According to the notification, the draft rules were published through G.S.R. 760(E) dated October 16, 2025, inviting objections and suggestions from persons likely to be affected before the expiry of 30 days from the date copies of the Gazette containing the notification were made available to the public. Copies of the Gazette were made available on October 18, 2025.
The Ministry stated that no objections or suggestions were received on the draft rules during the consultation period.
The amendment has been notified by the Central Government in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.