Centre tightens rules on high-alcohol medicines to curb misuse

The Centre has amended drug rules to bring high-alcohol medicinal products under prescription-only sale. The change tightens oversight after states flagged their diversion for intoxication.

In Short

• Products with over 12% ethyl alcohol above 30 ml lose exemption
• Manufacture and sale now need licences under the Drugs and Cosmetics Act
• Pharmacies can dispense these formulations only on registered doctors' prescriptions

In a significant move to curb the misuse of medicinal products containing high levels of ethyl alcohol for intoxication, the Centre has amended the drug rules, withdrawing a long-standing exemption that had allowed certain alcohol-based medicinal preparations to escape licencing and prescription controls despite containing very high levels of alcohol.

The Union health ministry has amended Schedule K of the drugs rules to ensure that medicinal preparations containing more than 12% v/v (volume by volume) ethyl alcohol can no longer claim exemption merely because they contain ingredients such as cardamom, ginger or other spices.

Officials said the exemption had been misused in parts of the country, allowing products with ethyl alcohol content as high as 80% to be sold as medicinal preparations without the regulatory safeguards applicable to most prescription medicines.

As a result, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml will now require manufacturing and sale licences under the Drugs and Cosmetics Act, 1940, and will be brought under Schedule H1 of the drugs rules.

The amendment means these formulations can now be dispensed only against the prescription of a registered medical practitioner and will be subject to stringent record-keeping requirements by pharmacies.

Government sources said the changes are intended to create a uniform regulatory framework for medicines containing ethyl alcohol while closing a loophole in Schedule K that had enabled certain products to bypass prescribed alcohol limits applicable to other systems of medicine.

Officials pointed out that the Drugs Rules already prescribe alcohol limits for several traditional systems of medicine.

Under Rule 161, Ayurvedic, Siddha and Unani syrups are permitted to contain a maximum of 16% alcohol, while Rule 106B limits the alcohol content in homoeopathic medicines to 12%.

The latest amendment aligns Schedule K with this broader regulatory approach by ensuring that products with higher alcohol content are subject to appropriate licencing and prescription requirements.

The decision follows persistent concerns over the diversion and misuse of certain medicinal preparations, including tinctures and aromatic formulations containing cardamom, ginger and other spices, some of which have been marketed with ethyl alcohol content ranging between 80% and 90% v/v.

Government sources said several state governments had flagged instances of these products being consumed for intoxication because they remained available without the regulatory controls applicable to prescription medicines.

STRICTER REGULATORY OVERSIGHT

Officials said the revised rules are designed to ensure that high alcohol-containing medicinal products remain available for genuine therapeutic use while preventing their diversion into unregulated channels.

"The amendments seek to change the part under Schedule K of the Drugs Rules that was misused in certain parts of the country," government sources said.

"The proposed changes seek to ensure a uniform regulatory framework across all categories of medicines containing ethyl alcohol while ensuring that genuine medicinal formulations continue to be regulated under the appropriate provisions of the Drugs Rules."

The ministry said bringing these formulations under licensing requirements and Schedule H1 would strengthen oversight of their manufacture, distribution and retail sale through the regulated pharmaceutical supply chain, significantly reducing the scope for misuse.

The latest notification is part of the government's broader effort to tighten regulation of medicines vulnerable to abuse.

In recent months, authorities have introduced stricter controls on drugs such as pregabalin and other medicines prone to misuse through enhanced monitoring, tighter prescription requirements and intensified enforcement against illegal distribution amid growing concerns over recreational abuse.

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