The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing the existing exemption from licensing requirements for certain formulations containing ethyl alcohol

The amendments have been notified through a Gazette notification. The move is aimed at strengthening drug regulation and curbing the misuse of medicinal products containing high levels of alcohol.

The decision follows concerns that several medicinal preparations exempted under Schedule K including tinctures of cardamom, ginger, and other aromatic formulations, contain high concentrations of ethyl alcohol, in some cases as much as 80–90% v/v, making them vulnerable to diversion and misuse for intoxication. 

The Ministry said it had also received representations from several state governments highlighting the issue.

Under the amended rules, medicinal formulations containing more than 12% v/v ethyl alcohol in pack sizes exceeding 30 mL will no longer qualify for the licensing exemption available under Schedule K. Manufacturers and marketers of such products will now be required to obtain the necessary licences under the Drugs and Cosmetics Act, 1940.

In addition, these formulations have been brought under Schedule H1 of the Drugs Rules, 1945. As a result, they can only be sold on the prescription of a Registered Medical Practitioner, and pharmacies will be required to maintain stricter records of their sale in accordance with Schedule H1 provisions.

According to the Ministry, the amendment is expected to significantly strengthen regulatory oversight by ensuring that medicinal products containing high levels of alcohol are distributed exclusively through the regulated pharmaceutical supply chain.