Govt. amends rules to strengthen regulation of drug formulations with high alcohol content
The Indian Union Health Ministry has amended drug regulations to require licenses for medicinal products containing over 12% ethyl alcohol. These products, including certain tinctures, must now be sold only via prescription and under stricter record-keeping requirements to prevent misuse for intoxication.
Why it matters
This regulatory shift aims to curb the abuse of high-alcohol medicinal products while ensuring they remain available for legitimate therapeutic purposes.
Aimed at strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Union Health Ministry has now removed the existing exemption from licensing requirements for formulations containing ethyl alcohol.
In a release issued on Friday (July 10, 2026), the Ministry said that 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,” the Ministry said.
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