High alcohol-containing formulations to require licenses, prescription: Govt

The Centre has tightened rules for medicinal formulations containing over 12 per cent ethyl alcohol, requiring licences and prescription-only sales. The move aims to curb misuse, strengthen regulatory oversight, and ensure these medicines remain available solely for legitimate therapeutic purposes

New Delhi: The Centre on Friday tightened regulations governing medicinal formulations containing high levels of ethyl alcohol by making them subject to licensing requirements and prescription-only sale, a move aimed at preventing misuse while ensuring their availability for legitimate therapeutic purposes.

The ministry said that several medicinal preparations, including tinctures of cardamom, ginger and other aromatic formulations, were previously exempt from licensing requirements under Schedule K. However, some of these products contain ethyl alcohol in concentrations as high as 80–90 per cent v/v, making them vulnerable to misuse for intoxication.

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The Centre also noted that it had received references from some state governments highlighting concerns over such misuse. To address the issue, the government has mandated that all medicinal formulations containing more than 12 per cent v/v ethyl alcohol and packaged in quantities exceeding 30 mL will no longer be eligible for exemption under Schedule K.

As a result, manufacturers and sellers of such products will now be required to obtain the necessary licences under the Drugs and Cosmetics Act, 1940. The amendment also places these formulations under Schedule H1 of the Drugs Rules, 1945, bringing them under stricter regulatory control. Products listed under Schedule H1 can only be sold against the prescription of a registered medical practitioner and are subject to enhanced record-keeping requirements.

According to the ministry, the revised framework is expected to strengthen oversight of alcohol-containing medicinal products by ensuring that they are supplied only through the regulated pharmaceutical distribution chain. It said the move would significantly reduce the risk of diversion and misuse while ensuring continued access for patients requiring these medicines for genuine therapeutic purposes.

The ministry said the amendment is part of the government’s broader efforts to strengthen the country’s drug regulatory framework, promote the rational and responsible use of medicinal products, and safeguard public health. The detailed amendments have been notified through a Gazette notification issued by the Ministry of Health and Family Welfare.