Government amends rules to regulate drugs with high alcohol content, preventing misuse
The Union Health Ministry has amended rules to strengthen regulatory control over medicinal products with high alcohol content, aiming to prevent their misuse. The amendment removes the exemption from licensing requirements for formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml, previously covered under Schedule K of the Drugs Rules, 1945. These products will now require requisite licenses under the Drugs and Cosmetics Act, 1940, and will be shifted to Schedule H1 of the Drugs Rules, 1945, mandating sale against prescription and stricter record-keeping. This move addresses concerns from State governments about misuse for intoxication.
Key Points
- The Union Health Ministry has amended rules to tighten regulation on medicinal products with high alcohol content.
- Formulations with over 12% v/v ethyl alcohol (exceeding 30 ml) now require licenses, removing a previous exemption.
- These products will be moved to Schedule H1, requiring prescriptions and stricter record-keeping.
- The amendment aims to prevent the misuse of such formulations for intoxication and strengthen the pharmaceutical supply chain.
Exam Facts
- Ministry: Union Health Ministry.
- Previous exemption: Schedule K of the Drugs Rules, 1945.
- New requirement: Requisite licenses under the Drugs and Cosmetics Act, 1940.
- New classification: Schedule H1 of the Drugs Rules, 1945.
- Targeted products: Formulations with more than 12% v/v ethyl alcohol, exceeding 30 ml.
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