Under the Drugs (Eighth Amendment) Rules, 2026, which category of therapeutic products has been brought under the Centrally License Approving Authorit

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Under the Drugs (Eighth Amendment) Rules, 2026, which category of therapeutic products has been brought under the Centrally License Approving Authority (CLAA) framework?

TodaySprint · Accepted Answer

The correct answer is Option C: Cell and gene therapies. The Drugs (Eighth Amendment) Rules, 2026 brought advanced cell and gene therapies under the Centrally License Approving Authority (CLAA) framework. The Drugs Rules, 1945 were framed under the Drugs and Cosmetics Act, 1940, which is the parent law regulating drugs in India. Advanced cell and gene therapies include cell-derived products, stem cell-derived products, gene therapeutic products, and xenografts. CAR-T cell therapy is a form of immunotherapy used for treating certain blood cancers. Xenografts are living tissues or organs transplanted from one species to another. The CLAA framework ensures joint regulatory oversight by Central and State Licensing Authorities with uniform standards across India. The amendment applies to therapies requiring specialised manufacturing, quality testing, and post-market surveillance. The draft amendment was issued through Gazette Notification G.S.R. 758(E)on 16 October 2025 for public consultation before final notification.

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Recombinant vaccines

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Biosimilar medicines

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Blood plasma products

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Monoclonal antibodies

Under the Drugs (Eighth Amendment) Rules, 2026, which category of therapeutic products has been brought under the Centrally License Approving Authority (CLAA) framework?

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Under the Drugs (Eighth Amendment) Rules, 2026, which category of therapeutic products has been brought under the Centrally License Approving Authority (CLAA) framework?

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