newspop
New Delhi : In a significant step to strengthen drug regulation and curb the misuse of alcohol-based medicinal products, the Centre has amended the Drugs Rules, 1945. Under the new rules, medicinal formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer be exempt from licensing requirements.
These products must now obtain licences under the Drugs and Cosmetics Act, 1940, and have been brought under Schedule H1, meaning they can only be sold against a valid prescription from a registered medical practitioner, with stricter record-keeping by pharmacies.
The decision follows concerns raised by several state governments over the misuse of high-alcohol medicinal preparations—including tinctures of cardamom, ginger, and other aromatic formulations—some of which contain 80–90% v/v ethyl alcohol and were allegedly being diverted for intoxication.
The Ministry of Health and Family Welfare said the amendment is aimed at ensuring these medicines are supplied only through regulated pharmaceutical channels, while preserving access for legitimate therapeutic use.
The move is part of the government’s broader effort to strengthen India’s drug regulatory framework, promote the rational use of medicines, and safeguard public health.
