Drugs Rules, 1945
2 checked stories, newest 4 Nov 2026.
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Health Ministry proposes immediate suspension of licences for drugs declared not of standard quality
Background fact, detailsBackground fact: The Drugs Rules, 1945 are made under the Drugs and Cosmetics Act, 1940
Details
On 4 November 2026 the Union Health Ministry proposed an amendment to the Drugs Rules, 1945, to let regulators suspend a manufacturer's licence immediately once a government analyst declares a drug Not of Standard Quality (NSQ) on specified parameters such as assay, dissolution, impurities or sterility. Suspension would last until the maker finds the root cause and fixes it.
- Proposal announced by the Union Health Ministry on 4 November 2026
- It adds an immediate manufacturing licence suspension clause to the Drugs Rules, 1945
- Triggered by a government analyst report declaring a drug NSQ on assay, dissolution, related substances, impurities or sterility
- Suspension continues until root cause analysis and corrective action are completed
- It is a proposed draft amendment, not yet final
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Drugs Rules, 1945 amended to bring cell, gene therapies and xenografts under CLAA
The Centre changed the Drugs Rules so advanced treatments like stem cell therapies (including CAR-T), gene therapies and animal-tissue transplants come under joint central and state licensing oversight, for uniform standards.
Exam angle, detailsExam angle: Drugs and Cosmetics Act 1940 is the parent law; CLAA already covered vaccines and recombinant DNA drugs.
Details
The Centre amended the Drugs Rules, 1945, adding stem cell and cell-derived products (including CAR-T), gene therapeutic products and xenografts to the Centrally Licence Approving Authority framework. The change gives joint central and state oversight and aims at uniform standards.
- Reported 2 July 2026
- New categories: cell or stem cell-derived products, gene therapeutic products, xenografts
- CLAA previously covered vaccines, large volume parenterals and r-DNA derived drugs
- Examples: CAR-T therapies, gene replacement and editing, animal-tissue heart valves