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Drugs Rules 1945 Amended: Stem Cell & Gene Therapies Under Central Licensing Ambit

Target:UPSC GS-IIIMPSCSSC GATeachingPrelims HighMains MediumStatic GK Link
02 Jul 2026
~2 min
Source: Indian Express
Key Data:Drugs Rules, 1945Drugs and Cosmetics Act
Bodies:Central Licence Approving Authority (CLAA)
Practice MCQs from today's news ▸
What This Article Covers

1.Amendment to Drugs Rules, 1945 expands central licensing framework to include stem cell and gene therapies.

2.New products under CLAA include stem cell derived products, gene therapeutic products, and xenografts.

3.Move aims to enhance regulatory scrutiny for complex and rapidly evolving medical fields.

The Big Picture
Prelims · HighMains · Medium

The government has amended the Drugs Rules, 1945 to bring stem cell derived products, gene therapies, and xenografts under central licensing. This enhances regulatory oversight for cutting-edge treatments like CAR-T therapy, ensuring patient safety and faster adoption of emerging medical technologies.

Exam Lens

Quick Exam Facts From News

Regulation AmendedDrugs Rules, 1945
Governing ActDrugs and Cosmetics Act
New Entities CoveredStem cell derived products, gene therapeutic products, xenografts
Example TherapyCAR-T therapy (Chimeric Antigen Receptor T-cell therapy)

1-Minute Revision

  • ›Regulation Amended: Drugs Rules, 1945
  • ›Governing Act: Drugs and Cosmetics Act
  • ›Target this Data: Amendment to Drugs Rules, 1945
  • ›Target this Nodal Body: Central Licensing Approving Authority (CLAA) under Drugs and Cosmetics Act
  • ›Target this Legal Point: Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945

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Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageEasy

Which Act governs the regulation of drugs and cosmetics in India, under which the recent amendment to bring stem cell and gene therapies under central licensing was made?

Q2Statement-basedHard

Consider the following statements regarding the recent amendment to the Drugs Rules, 1945:

1. The amendment brings stem cell derived products and gene therapeutic products under the central licensing framework.

2. Xenografts, which are animal tissue-derived products used in cardiology, are excluded from the new licensing requirement.

3. The move aims to enhance regulatory scrutiny to ensure patient safety for complex therapies like CAR-T.

Which of the statements given above is/are correct?

Q3Data-centricMedium

Which of the following is an example of a gene therapy mentioned in the article that is used for treating blood cancer?

Q4Application/ImpactMedium

What is the primary objective of bringing stem cell and gene therapies under the Central Licence Approving Authority (CLAA) framework?

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