Centre Tightens Rules on High-Alcohol Medicinal Products

The Health Ministry said the revised regulations are designed to improve control over medicinal products containing alcohol by ensuring they move only through the regulated pharmaceutical supply chain.

The Ministry of Health and Family Welfare has introduced stricter rules for medicinal products containing high levels of ethyl alcohol, bringing them under a stronger regulatory framework to prevent misuse while ensuring they remain available for genuine medical treatment.

The decision removes the existing exemption under Schedule K of the Drugs Rules, 1945, for formulations containing more than 12% v/v ethyl alcohol when sold in quantities exceeding 30 mL. These products will now require licences under the Drugs and Cosmetics Act, 1940, strengthening oversight over their manufacture and distribution. The move follows concerns raised by several state governments about the potential misuse of certain medicinal formulations that contain very high concentrations of ethyl alcohol.

Products with high alcohol content to face stricter controls

Schedule K had earlier exempted a range of medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, from licensing requirements. Some of these formulations contain ethyl alcohol levels as high as 80% to 90% by volume, making them vulnerable to diversion for intoxication instead of therapeutic use.

Under the revised rules, these products will no longer qualify for the exemption if they contain more than 12% alcohol by volume and are packaged in quantities above 30 mL. Manufacturers and distributors will now have to obtain the necessary licences before these medicines can be supplied through the market. The amendment also places these formulations under Schedule H1 of the Drugs Rules, 1945. Medicines listed under Schedule H1 can only be sold against the prescription of a registered medical practitioner, while pharmacies must maintain stricter records of their sale.

Government seeks safer use of alcohol-based medicines

The Health Ministry said the revised regulations are designed to improve control over medicinal products containing alcohol by ensuring they move only through the regulated pharmaceutical supply chain. The changes are expected to reduce the risk of diversion and misuse without affecting access for patients who require these medicines for legitimate treatment.

Officials said the amendment forms part of the government's broader effort to strengthen drug regulation, encourage the responsible use of medicines and improve public health safeguards across the country. By introducing tighter licensing and prescription requirements, the ministry hopes to balance patient access with stronger protection against misuse of high-alcohol medicinal formulations.