Medicines With Over 12% Alcohol to Require Prescription, Licence

The Central government has introduced stricter controls on medicinal products containing high concentrations of ethyl alcohol , ending a key exemption that previously allowed certain formulations to be sold without a licence. The move is aimed at preventing their misuse as intoxicants while ensuring access for genuine medical needs.

According to the Ministry of Health and Family Welfare, medicinal formulations containing more than 12 per cent ethyl alcohol (v/v) in pack sizes exceeding 30 ml will no longer be covered under the exemption provided in Schedule K of the Drugs Rules, 1945 . Manufacturers and sellers of these products must now obtain licences under the Drugs and Cosmetics Act, 1940 .

In addition, these formulations have been brought under Schedule H1 , meaning they can only be dispensed against a registered medical practitioner's prescription . Pharmacies will also have to maintain detailed records of their sale in line with Schedule H1 requirements.

The ministry said the decision was taken after reports from several states highlighted the misuse of some medicinal preparations containing cardamom, ginger and other aromatic ingredients . While marketed as medicines, some of these products reportedly contained 80–90 per cent ethyl alcohol , making them vulnerable to abuse.

Officials said the revised rules will create a uniform regulatory framework for alcohol-based medicinal formulations and strengthen oversight across the pharmaceutical supply chain. The government expects the changes to curb diversion for non-medicinal use without affecting the availability of these products for legitimate treatment.

Existing regulations already cap alcohol content in several traditional medicines, allowing up to 16 per cent in Ayurvedic, Siddha and Unani syrups and 12 per cent in Homoeopathic medicines. The amended rules have been notified through an official Gazette notification .