What is the common examiner trap about Science & Tech in UPSC exams?

Examiners may confuse 'Drugs Rules, 1945' with 'Drugs and Cosmetics Act, 1940' — the amendment is to the Rules, not the Act. They may also swap 'Central Licence Approving Authority (CLAA)' with 'State Licensing Authority' or claim the amendment makes therapies automatically approved/cheaper (the article explicitly says it does not).

What should UPSC aspirants remember about Science & Tech for Prelims?

1. Target this Data: Amendment to Drugs Rules, 1945 (not the Act) — Rules 75, 75A, 76, 76A revised; new Forms 27D, 27DA, 28D, 28DA. 2. Target this Nodal Body: Union Ministry of Health & Family Welfare; Central Licence Approving Authority (CLAA); Drugs Controller General of India (DCGI). 3. Target this Legal Point: Classification of stem cell products as 'new drugs' since 2018 vs. the new dedicated manufacturing licence pathway under CLAA.

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News 4 of 20

Drugs Rules 1945 Amended: Stem Cell, Gene Therapies Under CLAA to Curb Unproven Cures

Q: Which ministry is responsible for the amendment to the Drugs Rules, 1945, bringing stem cell and gene therapies under the CLAA framework?

Ministry of Health and Family Welfare, The Union Ministry of Health is the nodal ministry for the Drugs and Cosmetics Act and the Drugs Rules. The amendment was introduced by the Health Ministry, not the Ministry of Science and Technology or Chemicals and Fertilizers.

Q: Consider the following statements regarding the recent amendment to the Drugs Rules, 1945: 1. The amendment brings cell and stem cell products, gene therapies, and xenografts under the Central Licence Approving Authority (CLAA) framework. 2. The amendment automatically approves all stem cell therapies for clinical use in India. 3. The amendment introduces new licensing forms (27D, 27DA, 28D, 28DA) for these product categories. Which of the statements given above is/are correct?

Both 1 and 3, Statement 1 is correct as the article states the amendment brings these products under the CLAA framework. Statement 2 is incorrect because the Health Ministry clarified that the amendment does not amount to automatic approval; manufacturers must still prove safety, quality, and efficacy. Statement 3 is correct as the amendment revises Rules 75, 75A, 76, and 76A and introduces new licensing forms 27D, 27DA, 28D, and 28DA.

Q: What is the name of India's first indigenous CAR-T cell therapy, which was approved in 2023 after regulators worked out evaluation standards on a case-by-case basis?

NexCAR19, The article specifically mentions that ImmunoACT won approval for NexCAR19, India's first indigenous CAR-T therapy, in 2023. BIRSA-101 is a CRISPR-based gene-editing therapy for sickle cell disease under development by CSIR-IGIB and Serum Institute. The other options are distractors from companies mentioned in the article (Immuneel Therapeutics and Dr. Reddy's Laboratories) but their products are not named.

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

To close a regulatory gap and curb unproven, costly stem cell treatments marketed by clinics, The article states the amendment targets unproven cures and addresses a regulatory grey zone that allowed clinics to market dubious 'stem cell' cures while charging patients large sums. It explicitly notes the amendment does not make therapies cheaper or more accessible immediately, nor does it amount to automatic approval. The framework involves joint Central-State oversight, not a complete transfer of powers.

Science & Tech Health & Education PolityCORE

Target:UPSC GS-IIIMPSCSSC GATeachingPrelims HighMains HighStatic GK Link

04 Jul 2026

~2 min

Source: The Hindu

Key Data:Drugs Rules, 1945Rules 75, 75A, 76, 76AForms 27D, 27DA, 28D, 28DA2018 (new drugs classification)2023 (NexCAR19 approval)BIRSA-101 (CRISPR therapy)

Bodies:Union Ministry of Health and Family WelfareCentral Licence Approving Authority (CLAA)ImmunoACTCSIR-IGIBSerum Institute of IndiaImmuneel TherapeuticsDr. Reddy's LaboratoriesC.K. Birla Hospital

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~2 min · Quick mode

What This Article Covers

1.The Union Ministry of Health amended the Drugs Rules, 1945 to bring cell/stem cell products, gene therapies, and xenografts under the CLAA framework, closing a long-standing regulatory gap.

2.The amendment revises Rules 75, 75A, 76, and 76A and introduces new licensing forms (27D, 27DA, 28D, 28DA) for these advanced therapies.

3.Examiners will focus on the shift from State-level licensing to a joint Central-State oversight model for high-risk biologics, and the distinction between 'new drugs' classification (since 2018) and the new dedicated licensing pathway.

The Big Picture

Prelims · HighMains · High

India has closed a critical regulatory gap by bringing stem cell, gene therapies, and xenografts under the Central Licence Approving Authority (CLAA) framework via an amendment to the Drugs Rules, 1945. This move targets unproven and costly 'stem cell' cures being marketed by clinics, but does not automatically approve therapies or make them cheaper immediately.

Exam Lens

Quick Exam Facts From News

Regulation AmendedDrugs Rules, 1945

New Licensing AuthorityCLAA (Central Licence Approving Authority)

Products CoveredCell/stem cell products, gene therapies, xenografts

Revised RulesRules 75, 75A, 76, 76A

New Licensing FormsForms 27D, 27DA, 28D, 28DA

India's 1st Indigenous CAR-T TherapyNexCAR19 (by ImmunoACT, 2023)

CRISPR Therapy for Sickle CellBIRSA-101 (by CSIR-IGIB & Serum Institute)

1-Minute Revision

›Regulation Amended: Drugs Rules, 1945
›New Licensing Authority: CLAA (Central Licence Approving Authority)
›Target this Data: Amendment to Drugs Rules, 1945 (not the Act) — Rules 75, 75A, 76, 76A revised; new Forms 27D, 27DA, 28D, 28DA.
›Target this Nodal Body: Union Ministry of Health & Family Welfare; Central Licence Approving Authority (CLAA); Drugs Controller General of India (DCGI).
›Target this Legal Point: Classification of stem cell products as 'new drugs' since 2018 vs. the new dedicated manufacturing licence pathway under CLAA.

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News Snapshot

⚖️

Regulatory Gap Closed

The amendment brings stem cell and gene therapies under a uniform Central licensing framework for the first time, addressing a grey zone that allowed clinics to market unproven treatments.

🔬

Advanced Therapies Covered

The framework now covers regenerative treatments, CAR-T cell therapies, gene replacement/editing products, and animal-tissue-derived products like heart valves.

⚠️

No Immediate Approval or Cost Relief

The Health Ministry clarified the amendment does not amount to automatic approval or make therapies cheaper; manufacturers must still prove safety, quality, and efficacy.

Detailed Analysis & Strategic Depth

Context / Background

India's drug regulatory architecture was built around its generics industry, which evaluates equivalence to approved drugs — a model ill-suited for novel cell and gene therapies. Since 2018, stem cell products were classified as 'new drugs' requiring regulatory clearance, but the Drugs Rules lacked dedicated provisions (Forms 27D, 27DA, 28D, 28DA) for issuing manufacturing licences, leaving a regulatory vacuum exploited by clinics offering unproven, costly 'stem cell' cures for conditions like autism and spinal cord injury.

Core Analysis & Implications

The amendment revises Rules 75, 75A, 76, and 76A to bring cell/stem cell products, gene therapies, and xenografts under the CLAA framework. This means both Central and State licensing authorities will now jointly oversee these products, ending the case-by-case assessment without a formal pathway. The need for this framework became apparent in 2023 when ImmunoACT's NexCAR19, India's first indigenous CAR-T therapy, was approved only after regulators and the company worked out evaluation standards during the process itself. While the move should curb unregulated therapies, analysts caution that the added compliance layer could lengthen approval timelines and raise costs, especially for smaller biotech firms.

Future Outlook / Way Forward

The new framework lays the regulatory groundwork for safer, more reliable access to advanced treatments over time. However, broader constraints remain unaddressed: limited manufacturing infrastructure, a shortage of specialised workforce, and constrained clinical research capacity. Companies like Immuneel Therapeutics, Dr. Reddy's Laboratories, and the CSIR-IGIB-Serum Institute partnership (developing BIRSA-101, a CRISPR-based therapy for sickle cell disease) will now have a formal pathway, but the speed and cost of bringing these therapies to patients will depend on how efficiently the CLAA system operates.

Key Facts at a Glance

Regulation AmendedDrugs Rules, 1945

New Licensing AuthorityCLAA (Central Licence Approving Authority)

Products CoveredCell/stem cell products, gene therapies, xenografts

Revised RulesRules 75, 75A, 76, 76A

New Licensing FormsForms 27D, 27DA, 28D, 28DA

India's 1st Indigenous CAR-T TherapyNexCAR19 (by ImmunoACT, 2023)

CRISPR Therapy for Sickle CellBIRSA-101 (by CSIR-IGIB & Serum Institute)

You've read the full analysis. Now test your understanding.

Practice exam-style questions based on this article.

Q1Static LinkageEasyUPSC, SSC, Banking, State PSC

Which ministry is responsible for the amendment to the Drugs Rules, 1945, bringing stem cell and gene therapies under the CLAA framework?

Q2Statement-basedHardUPSC, SSC

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

1. The amendment brings cell and stem cell products, gene therapies, and xenografts under the Central Licence Approving Authority (CLAA) framework.

2. The amendment automatically approves all stem cell therapies for clinical use in India.

3. The amendment introduces new licensing forms (27D, 27DA, 28D, 28DA) for these product categories.

Which of the statements given above is/are correct?

Q3Data-centricMediumUPSC, SSC, Banking

What is the name of India's first indigenous CAR-T cell therapy, which was approved in 2023 after regulators worked out evaluation standards on a case-by-case basis?

Q4Application/ImpactMediumUPSC, SSC, Banking

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

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Drugs Rules 1945 Amended: Stem Cell, Gene Therapies Under CLAA to Curb Unproven Cures

Exam Lens

Quick Exam Facts From News

1-Minute Revision

News Snapshot

Regulatory Gap Closed

Advanced Therapies Covered

No Immediate Approval or Cost Relief

Detailed Analysis & Strategic Depth

Context / Background

Core Analysis & Implications

Future Outlook / Way Forward

Prelims Flashpoints

Key Facts at a Glance