Centre Tightens Rules For High-Alcohol Oral Medicines, Ends OTC Sales

Oral drug formulations containing more than 12% alcohol by volume and sold in bottles exceeding 30 millilitres will no longer be available over the counter under amendments to the Drugs Rules, 1945 notified by the Ministry of Health and Family Welfare.

According to a notification issued by the ministry on July 8, the Central Government has notified the Drugs (Tenth Amendment) Rules, 2026, after consultation with the Drugs Technical Advisory Board.

The notification said the amended rules will come into force six months after their publication in the Official Gazette.

The amendment inserts a new provision in Schedule K of the Drugs Rules, 1945. Under the revised rules, the existing exemption from the provisions of the Drugs and Cosmetics Act and the rules made thereunder will no longer apply to "all oral formulations containing more than 12% alcohol (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters."

Rules Cleared After Consultation

The notification also amends Schedule H1 of the Drugs Rules, 1945 by inserting a new entry after "51. Pregabalin".The new entry reads, "52. All oral formulations containing more than 12% alcohol (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters."

The notification stated that a draft of the proposed amendments had been published on October 16, 2025, through notification G.S.R. 760(E), inviting objections and suggestions from persons likely to be affected before the expiry of 30 days from the date the Gazette was made available to the public.

Copies of the Gazette containing the draft rules were made available on October 18, 2025.

According to the notification, no objections or suggestions were received from the public on the draft rules. The amendments have been notified in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.