Context
The Union Health Ministry has amended the Drugs Rules, 1945, making it mandatory for medicinal formulations containing more than 12% ethyl alcohol (v/v) in quantities above 30 ml to obtain licences. The move aims to prevent misuse of high-alcohol medicinal products and strengthen regulatory oversight.
Explanation:
- The Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 regulate the manufacture, sale, distribution, and licensing of drugs and cosmetics in India.
- Schedule K of the Drugs Rules provides exemptions from certain licensing requirements for specified drugs and formulations under prescribed conditions.
- The amendment removes the exemption for medicinal formulations containing more than 12% v/v ethyl alcohol in containers exceeding 30 ml, bringing them under mandatory licensing.
- Such formulations may contain 80–90% alcohol, making them vulnerable to misuse for intoxication instead of therapeutic purposes.
- Ethyl alcohol (ethanol) is used in medicines as a solvent, preservative, and extraction medium, especially in herbal and tincture preparations.
- The amendment strengthens record-keeping, prescription monitoring, and regulated pharmaceutical supply, helping curb misuse while ensuring legitimate medical availability.
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