The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, introducing stricter regulatory controls on medicinal formulations containing high concentrations of ethyl alcohol. Under the revised rules, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will now require manufacturing and sale licences and can only be dispensed on the prescription of a Registered Medical Practitioner (RMP).

The amendment, notified by the Ministry on July 10, 2026, removes the long standing exemption available under Schedule K of the Drugs Rules, 1945, for such products. These formulations have now been brought under Schedule H1, making them subject to stricter prescription requirements, record keeping obligations and regulatory oversight under the Drugs and Cosmetics Act, 1940.

According to the Ministry, the decision was taken following concerns raised by several State Governments regarding the misuse of medicinal products containing high levels of alcohol for intoxication. Certain formulations, including tinctures of cardamom, ginger and other aromatic medicinal preparations, were previously exempt from licensing despite containing 80–90% v/v ethyl alcohol in some cases, making them vulnerable to diversion and non medicinal use.

With the latest amendment, manufacturers and distributors of these formulations will now be required to obtain the necessary licences, while pharmacies can dispense the products only against a valid medical prescription. The Schedule H1 classification also mandates the maintenance of detailed sales records, enabling authorities to better monitor distribution and prevent misuse.

The Ministry stated that the revised regulatory framework is intended to strengthen oversight of alcohol containing medicinal products without affecting their legitimate therapeutic use. Officials said the amendment will help ensure that such medicines are supplied only through the regulated pharmaceutical supply chain while reducing the risk of diversion, abuse and unauthorized sale.

Healthcare experts have welcomed the move, noting that stronger regulation of medicinal formulations containing high concentrations of alcohol is essential to safeguard public health. They believe the amendment will improve accountability across the pharmaceutical supply chain while preserving access to genuine medicines for patients who require them.

The amendment forms part of the Centre’s broader efforts to modernize India’s drug regulatory framework, promote the rational use of medicines and strengthen patient safety through enhanced regulatory compliance and monitoring.