Medicines with over 12% alcohol can no longer be sold without prescription: Govt

The government has decided that medicines with high alcohol content can no longer be sold freely without a license.

According to the new notification, going forward, they will be treated like other prescription drugs and sold only against a doctor’s prescription. The new order removes the exemption for any formulation containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL.

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“Manufacturers of such products will now need to obtain proper licenses under the 1940 Act, and the products themselves have been moved into Schedule H1, the category reserved for medicines that can only be sold against a registered medical practitioner’s prescription, with strict record-keeping obligations for pharmacies,” said an official.

According to the health ministry, the high alcohol content of these formulations has been found to be misused. The issues have been flagged by various state governments.

The Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) had earlier examined proposals to shift high-alcohol preparations out of Schedule K’s exemption and into Schedule H1, and a draft notification on the 12% v/v, 30 mL threshold was circulated for public comment in October 2025.

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Under Schedule K of the Drugs Rules, 1945, certain formulations, including tinctures of cardamom, ginger, and other aromatic preparations, had long been exempt from the licensing requirements otherwise mandated by the Drugs and Cosmetics Act, 1940.

Some of these products contain ethyl alcohol concentrations as high as 80–90% v/v.

Officials say the change should curb diversion and misuse while keeping the products available for genuine therapeutic purposes through pharmacies operating under the tighter Schedule H1 controls.