New Delhi, July 10 (IANS): The Centre on Friday tightened regulations governing medicinal formulations containing high levels of ethyl alcohol by bringing them under licensing requirements and prescription-only sale, a move aimed at preventing misuse while ensuring their availability for legitimate therapeutic purposes. The Ministry of Health and Family Welfare said several medicinal preparations, including tinctures of cardamom, ginger and other aromatic formulations, were previously exempt from licensing requirements under Schedule K despite containing ethyl alcohol concentrations as high as 80–90 per cent v/v. Citing concerns raised by state governments regarding misuse of such products for intoxication, the government has now mandated that medicinal formulations containing more than 12 per cent v/v ethyl alcohol and packaged in quantities exceeding 30 mL will no longer qualify for exemption under Schedule K.
The amendment also places these formulations under Schedule H1 of the Drugs Rules, 1945, making them subject to stricter regulatory oversight. Products covered under Schedule H1 can only be sold on the prescription of a registered medical practitioner and require enhanced record-keeping by sellers. According to the ministry, the revised framework will strengthen monitoring of alcohol-containing medicinal products, reduce the risk of diversion and misuse, and ensure continued access for patients with genuine therapeutic needs. The changes have been notified through a Gazette notification issued by the Ministry of Health and Family Welfare as part of the government’s broader efforts to strengthen drug regulation and safeguard public health.