Oral Medicines with Over 12% Alcohol to Face Stricter Prescription Norms Under Schedule H1: Health Ministry
New Delhi: The Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, bringing oral formulations containing more than 12% v/v ethyl alcohol in bottles or packings exceeding 30 ml under the ambit of Schedule H1 of the Drugs Rules, 1945. The amendment aims to strengthen regulatory control over the sale and distribution of such formulations.
The notification, issued on July 8, 2026, follows the publication of the draft rules on October 16, 2025 for public consultation. The Ministry stated that no objections or suggestions were received during the consultation period. Accordingly, the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), has notified the amendments under the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
The Drugs (Tenth Amendment) Rules, 2026 will come into force six months after their publication in the Official Gazette.
Under the amendment, Schedule K of the Drugs Rules, 1945 has been modified to exclude all oral formulations containing more than 12% alcohol v/v (ethyl alcohol), packed and sold in bottles or packings exceeding 30 ml, from the exemptions available under the Schedule. As a result, these products will no longer enjoy the regulatory exemptions previously applicable under Schedule K.
In a significant move, the Ministry has also amended Schedule H1 by inserting a new entry after Pregabalin. The newly added Entry No. 52 covers:
"All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters."
The inclusion of these products under Schedule H1 means they will now be subject to stricter prescription and record-keeping requirements. Schedule H1 medicines can only be sold on the prescription of a registered medical practitioner, and pharmacists are required to maintain a separate register recording details such as the patient's name, prescribing doctor's particulars, and quantity supplied, with records preserved for the prescribed period.
