Drugs Rules, 1945 amended to bring cell and gene therapies under CLAA framework
The Centre amended the Drugs Rules, 1945 on 2 July 2026 to bring cell or stem cell derived products, gene therapeutic products and xenografts under the Centrally License Approving Authority (CLAA) framework.
Summary
The Central Government amended the Drugs Rules, 1945 to bring cell or stem cell derived products, gene therapeutic products and xenografts under the Centrally License Approving Authority (CLAA) framework, the Health Ministry said on 2 July 2026. Under the Drugs and Cosmetics Act, some critical drugs and biologicals such as vaccines, large volume parenterals (IV solutions over 100 ml) and r-DNA based medicines are already under joint supervision of Central and State regulators. Stem cell treatments and CAR-T cell therapies are used for blood cancers, gene therapies for genetic disorders and cancers, and xenografts are animal tissue-derived products such as heart valves transplanted into humans. Joint oversight is meant to ensure uniform regulatory standards across the country.
Key facts
- Rules amended
- Drugs Rules, 1945
- Brought under CLAA
- Cell/stem cell derived products; gene therapeutic products; xenografts
- Already under CLAA
- Vaccines; large volume parenterals (IV > 100 ml); r-DNA based medicines
- Xenografts
- Animal tissue-derived products such as heart valves
- Effect
- Joint Central-State oversight; uniform standards
Practice MCQs 2 questions
The July 2026 amendment to the Drugs Rules, 1945 brought cell or stem cell derived products, gene therapeutic products and xenografts under the:
Show answer
Correct answer: B — Centrally License Approving Authority (CLAA) framework
The amendment brings these products under the Centrally License Approving Authority (CLAA) framework of joint Central and State oversight.
In the context of the July 2026 amendment to the Drugs Rules, 1945, 'xenografts' refer to:
Show answer
Correct answer: C — Animal tissue-derived products such as heart valves transplanted into humans
Xenografts are animal tissue-derived products, such as heart valves, which can be transplanted into humans; they are used in cardiology and orthopaedics.