High-alcohol medicines, including homeopathy, now need licence and prescription

The Centre has amended the Drugs Rules to tighten controls on medicinal formulations with high ethyl alcohol content. The change brings licences, prescriptions and stricter sale records to curb misuse and keep supplies within the regulated system.

In Short

• Some exempt tinctures contain 80% to 90% ethyl alcohol by volume
• State governments had reported misuse of certain formulations for intoxication
• Products above 12% alcohol in packs over 30 mL lose exemption

The Centre has tightened rules for medicines that contain high amounts of alcohol, saying these products can no longer be sold as freely as before and will now require licences and a doctor's prescription.

In a notification issued on Friday, the Ministry of Health and Family Welfare amended the Drugs Rules, 1945 to bring stricter regulation for medicinal formulations containing high levels of ethyl alcohol.

The move comes after concerns that some alcohol-containing medicinal products were being misused for intoxication rather than for treatment.

Until now, certain medicinal formulations, including tinctures of cardamom, ginger and other aromatic preparations, were exempt from licensing requirements under Schedule K of the Drugs Rules.

Some of these products contain very high concentrations of ethyl alcohol, ranging from 80% to 90% by volume.

The Health Ministry said it had also received reports from some state governments about the misuse of such formulations.

Under the amended rules, formulations containing more than 12% ethyl alcohol by volume in quantities exceeding 30 mL will no longer qualify for the Schedule K exemption.

Manufacturers of these products will now have to obtain licences under the Drugs and Cosmetics Act, 1940.

The government has also shifted these products to Schedule H1 of the Drugs Rules. Medicines listed under Schedule H1 can only be sold with a prescription from a registered medical practitioner. Pharmacies will also have to maintain stricter records of their sale.

According to the ministry, the change is aimed at ensuring that medicines containing high amounts of alcohol are supplied only through the regulated pharmaceutical system.

The government said the new rules are expected to reduce the risk of these products being diverted for non-medical use while ensuring they remain available for patients who genuinely need them.

The ministry added that the amendment is part of its broader effort to strengthen drug regulation, encourage the responsible use of medicines and protect public health.

The ministry also clarified that similar restrictions have already been in place for homeopathic medicines since 1994.

Under those rules, homeopathic medicines containing more than 12% ethyl alcohol cannot be packed and sold in bottles larger than 30 mL, except when supplied to hospitals and dispensaries, where bottles of up to 100 mL are permitted.

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