Regulation of medicinal products containing alcohol

Notes

• The Union Health Ministry has amended the Drugs Rules, 1945, to strengthen regulatory control over medicinal products containing high concentrations of ethyl alcohol.
• Exemption from licensing requirements under Schedule K has been removed for formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml.
• Affected products must now obtain licenses under the Drugs and Cosmetics Act, 1940.
• These products have been shifted to Schedule H1 of the Drugs Rules, 1945, requiring sale only against a prescription from a registered medical practitioner.
• Schedule H1 mandates stricter record-keeping for the sale of these medicinal products.
• The amendment addresses concerns regarding the misuse of medicinal products (e.g., tinctures of cardamom and ginger) for intoxication, as some contain up to 80-90% v/v ethyl alcohol.
• The policy change aims to ensure such products are only available through the regulated pharmaceutical supply chain.

Part of a longer story

This is day 2 of 2 in Amendments to the Drugs Rules 1945, which has been running since 3 July 2026. Reading it whole is usually worth more than reading today alone — the exam asks how something developed.

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