Centre tightens rules for medicinal products containing high levels of Ethyl Alcohol: Here's what changes

Under the earlier provisions of Schedule K, certain medicinal preparations—including tinctures of cardamom, ginger and other aromatic formulations—were exempt from licensing requirements.

"Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90% v/v, making them susceptible to misuse for intoxication. References were also received from certain State Governments in this regard," the ministry said in a statement.

To address these concerns, the government has mandated that all medicinal formulations containing more than 12% v/v ethyl alcohol and packaged in quantities exceeding 30 mL will no longer be eligible for exemption under Schedule K.

As a result, manufacturers and sellers of such products will now be required to obtain the necessary licences under the Drugs and Cosmetics Act, 1940, the ministry said.

The amendment also moves these formulations to Schedule H1 of the Drugs Rules, 1945, under which they can be sold only against the prescription of a Registered Medical Practitioner and are subject to stricter record-keeping requirements.

According to the government, the revised regulations will strengthen oversight of alcohol-containing medicinal products by ensuring that they are supplied only through the regulated pharmaceutical distribution chain.

The move is expected to significantly reduce the risk of diversion and misuse while ensuring that these medicines remain available for legitimate therapeutic purposes.

The ministry said the initiative is part of the government's broader efforts to strengthen the country's drug regulatory framework, promote the rational and responsible use of medicines, and safeguard public health.