Govt amends Drugs to Strengthen Regulation of High Alcohol-Containing Drug Formulations

In a significant step towards strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Ministry of Health and Family Welfare has removed the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol.

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. 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.

To address this concern, the Government has mandated that all formulations containing more than 12% v/v ethyl alcohol, in quantities exceeding 30 mL, shall no longer be covered under the exemption provided to them under Schedule K. Consequently, such products will be required to obtain the requisite licenses under the Drugs and Cosmetics Act, 1940.

The amendment also shifts these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale against the prescription of a Registered Medical Practitioner and stricter record-keeping.
(UPDATED ON 10TH JULY 2026)