Subject: GS 2: Polity & Governance
Context: The Central Government has amended the Drugs Rules, 1945 to bring stem cell-derived products, gene therapeutic products and xenografts under the Centrally Licensed Approving Authority (CLAA) framework.
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About the recent Amendment
- Expanded CLAA Framework: The amendment brings stem cell-derived products, gene therapies and xenografts (Cross-species transplants) under the Centrally Licensed Approving Authority (CLAA), which earlier covered products such as vaccines, large-volume parenterals and recombinant DNA (r-DNA)-based medicines.
- Enhanced Regulatory Oversight: Manufacturers of these advanced biological products will now require central approval in addition to State regulatory oversight before production and marketing.
- Objective: To strengthen quality assurance, safety standards, scientific evaluation and uniform regulation of complex biological therapies.
About Stem Cell Therapy
- Stem Cell Therapy is a form of regenerative medicine that uses stem cells to repair, replace or regenerate damaged tissues and organs, restoring normal function.
- How it Works: Stem cells possess the unique ability to self-renew and differentiate into specialised cell types (e.g., blood, nerve, muscle or bone cells), enabling tissue regeneration.
- Types of Stem Cells:
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- Embryonic Stem Cells (ESCs): Pluripotent cells capable of developing into almost any cell type.
- Adult (Somatic) Stem Cells: Found in tissues such as bone marrow and fat, primarily used for tissue repair.
- Induced Pluripotent Stem Cells (iPSCs): Adult cells genetically reprogrammed to behave like embryonic stem cells, avoiding ethical concerns.
- Applications: Used in the treatment of blood cancers (bone marrow transplantation), spinal cord injuries, Parkinson’s disease, diabetes, burns, corneal disorders and other degenerative diseases.
About Gene Therapy
- Gene Therapy is an advanced medical technique that modifies, replaces, repairs or introduces genes into a patient’s cells to treat or prevent diseases caused by defective genes.
- How it Works: Functional genetic material is delivered into target cells using viral vectors (e.g., adenoviruses, lentiviruses, adeno-associated viruses) or non-viral delivery systems, enabling correction of disease-causing mutations.
- Types:
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- Somatic Gene Therapy: Targets body (somatic) cells; changes are not inherited by future generations.
- Germline Gene Therapy: Alters reproductive cells or embryos; changes are heritable but are not permitted in humans in most countries due to ethical concerns.
- Applications: Used to treat genetic disorders (e.g., thalassaemia, haemophilia, spinal muscular atrophy), certain cancers (CAR-T cell therapy), inherited retinal disorders and some rare diseases.
- Recent Advances: Technologies such as CRISPR-Cas9 gene editing, CAR-T cell therapy and base editing have significantly expanded the therapeutic potential of gene therapy.
- Challenges: High costs, off-target genetic effects, immune responses, ethical concerns and ensuring long-term safety and efficacy.
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About the Centrally Licensed Approving Authority (CLAA)
- The CLAA is a regulatory mechanism under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945, whereby certain critical biological products are subject to joint regulation by the Central and State drug authorities.
- Nodal Authority: The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), grants central approval for specified categories of drugs and biological products.
- Objective: To ensure uniform quality standards, patient safety, scientific scrutiny and regulatory consistency for high-risk biological products across the country.
What are These Emerging Therapies?
- Stem Cell-Derived Products: Therapeutic products developed from stem cells that can regenerate or replace damaged tissues, with applications in regenerative medicine, neurological disorders and tissue repair.
- Gene Therapy: A treatment approach that modifies, replaces or introduces genetic material into a patient’s cells to treat or prevent inherited diseases, cancers and other serious disorders.
- Xenografts: Medical products or tissues derived from animals and transplanted into humans, such as porcine heart valves, skin grafts and other biological implants.
- CAR-T Cell Therapy: A form of gene-modified immunotherapy in which a patient’s T-cells are genetically engineered to recognise and destroy cancer cells, particularly in blood cancers such as leukaemia and lymphoma.
Need for Enhanced Regulation
- Rapid Technological Advancements: Advances in gene editing, cell therapy and regenerative medicine require specialised regulatory oversight to keep pace with scientific innovation.
- Patient Safety: These therapies involve complex biological processes with potential risks relating to immune reactions, genetic alterations, long-term safety and treatment efficacy.
- Uniform National Standards: Centralised approval promotes consistent quality, manufacturing practices and clinical evaluation across States.
- Public Confidence: A robust regulatory framework strengthens trust in advanced therapies and facilitates their safe adoption.
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Recent Developments:
- India’s First Indigenous CAR-T Therapy: India recently developed NexCAR19, the country’s first indigenously developed CAR-T cell therapy, making advanced cancer treatment more affordable and strengthening India’s biotechnology capabilities.
- National Biopharma Mission: Supports research, innovation and indigenous development of biopharmaceuticals, vaccines, biosimilars and advanced therapeutics.
- BioE3 Policy (2024): Promotes high-performance biomanufacturing and supports innovation in precision therapeutics, synthetic biology and biotechnology-based healthcare.
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3 Jul 2026
