Centre Ends OTC Sale Of High-Alcohol Medicinal Formulations To Curb Misuse

In a move aimed to curb the misuse of medicinal products containing high levels of alcohol, the Union Health Ministry has ended their over-the-counter (OTC) sale by withdrawing a long-standing exemption from licensing requirements.

The formulations will now be sold only against the prescription of a registered medical practitioner.

Under the amendment, medicinal formulations containing more than 12 per cent ethyl alcohol in quantities exceeding 30 ml will no longer enjoy the exemption available under Schedule K of the Drugs Rules, 1945.

As a result, these products will now require licences under the Drugs and Cosmetics Act, 1940, and can no longer be sold freely without medical supervision.

The ministry has also brought these formulations under Schedule H1, making prescriptions mandatory and requiring pharmacies to maintain records of every sale.

The move is aimed at preventing diversion and misuse while strengthening regulatory oversight of medicines containing high concentrations of alcohol.

Explaining the rationale behind the decision, a senior official from the Ministry said certain medicinal preparations, including tinctures of cardamom, ginger and other aromatic formulations, had historically been exempted from licensing requirements under Schedule K. However, some of these preparations contain ethyl alcohol in concentrations as high as 80 to 90 per cent, making them vulnerable to misuse as intoxicants.

He said the ministry had also received representations from several state governments flagging instances of abuse and seeking tighter regulation of such products.

"The amendment is expected to strengthen regulatory oversight over medicinal products containing alcohol by ensuring that they are supplied only through the regulated pharmaceutical supply chain. It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use," said the official.

The decision marks an important shift in the regulation of alcohol-containing medicinal products, many of which were previously available without a prescription because of the exemption under Schedule K. By removing this exemption, the government has effectively prohibited their OTC sale.

Public health experts have long argued that medicinal formulations containing very high concentrations of alcohol should be subjected to the same safeguards as other prescription medicines, particularly in view of reports of their misuse in several parts of the country.

The officials clarified that the amendment does not affect the existing regulatory framework governing homoeopathic medicines, which continue to be regulated under separate provisions.

The latest amendment is also part of the government's broader effort to tighten drug regulation and close loopholes that allow medicinal products to be diverted for non-therapeutic use. Manufacturers, distributors and pharmacies dealing with such formulations will now have to comply with licensing requirements, prescription-only dispensing and mandatory record-keeping under Schedule H1.

The official further said the revised framework seeks to strike a balance between ensuring access to these medicines for patients who genuinely require them and preventing their misuse through unrestricted over-the-counter sale.

Homoeopathic medicines already have a governance structure in place, he said.

“Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945.”