Amendments to the Drugs Rules 1945

2 entries over 9 days, from 3 July 2026 to 11 July 2026.

01
3 July

Amendment to Drugs Rules 1945

The Central government has amended the Drugs Rules, 1945 to enhance regulatory oversight of advanced and emerging medical technologies.
The amendment brings stem cell-derived products, gene therapeutic products, and xenografts under the purview of the Centrally License Approving Authority (CLAA) framework.
The CLAA framework previously covered vaccines, large volume parenterals, and r-DNA based medicines.
The objective of the amendment is to ensure uniform regulations across the country for these advanced medical products.

02
11 July

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.

Newest first. A story that ran for 9 days is exactly the kind the mains paper asks about as one question.

Discuss the rationale behind the recent amendments to the Drugs Rules, 1945, regarding the regulation of medicinal products with high alcohol content. How does this move strengthen public health governance? 150 words · 11 July
Discuss the significance of bringing emerging medical technologies like gene therapy and stem cell-derived products under the Centrally License Approving Authority (CLAA) framework in the context of public health safety. 150 words · 3 July

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