New Delhi | Updated: July 10, 2026
The government has tightened rules for medicinal formulations containing high levels of alcohol to prevent their misuse.
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, removing the exemption earlier available for certain medical formulations containing high concentrations of ethyl alcohol.
Under the revised norms, all formulations containing more than 12 percent v/v ethyl alcohol and sold in quantities exceeding 30 mL will now require licenses under the Drugs and Cosmetics Act, 1940.
These products will also be brought under Schedule H1 of the Drugs Rules, 1945.
Schedule H1 requires sale only against the prescription of a registered medical practitioner and mandates stricter recordkeeping by sellers.
Earlier, some medicinal products, including tinctures of cardamom, ginger, and other aromatic preparations, were exempt from licensing requirements under Schedule K.
Officials said some of these formulations contain 80 to 90 percent v/v ethyl alcohol, making them vulnerable to misuse for intoxication.
The ministry said references had also been received from certain state governments regarding the misuse of such products.
To address the concern, the government has decided that formulations containing more than 12 per cent v/v ethyl alcohol in quantities above 30 mL will no longer qualify for the Schedule K exemption.
As a result, these products will now be supplied only through the regulated pharmaceutical supply chain.
The ministry said the amendment will strengthen regulatory oversight over alcohol-containing medicinal products.
It added that the revised norms will help reduce the possibility of diversion and misuse while ensuring that such medicines remain available for legitimate therapeutic use.
