Centre amends Drugs Rules, 1945 to ensure uniform regulation of advance cell and gene therapies

The central government issued a notification amending the Drugs Rules, 1945 to bring advanced cell therapies, gene therapeutic products, and xenografts under...

What Happened

The central government issued a notification amending the Drugs Rules, 1945 to bring advanced cell therapies, gene therapeutic products, and xenografts under the Centrally Licence Approving Authority (CLAA) framework.
The amendment expands the list of products subject to joint central-state regulatory oversight, which previously covered vaccines, large-volume parenterals (intravenous solutions above 100 ml), and recombinant DNA-based medicines.
CAR-T (Chimeric Antigen Receptor T-cell) therapies, stem cell-derived regenerative treatments used against blood cancers such as leukaemia and lymphoma, are now explicitly within the regulatory perimeter.
Gene therapeutic products — covering gene replacement, gene editing, and gene-silencing therapies for genetic disorders and cancers — are also newly included.
Xenografts (animal-tissue-derived products, such as porcine heart valves transplanted into humans) used in cardiology and orthopaedics are brought under the same framework.
The stated goal is to ensure uniform evaluation and approval standards before such therapies reach patients, closing a gap where some therapies were being regulated inconsistently across states.

Static Topic Bridges

Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945

The Drugs and Cosmetics Act, 1940 is the principal legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act established a dual regulatory structure: state licensing authorities regulate manufacture at the state level, while the Central Government — acting through the Central Drugs Standard Control Organisation (CDSCO) — oversees import, clinical trials, and certain high-risk product categories. The Drugs Rules, 1945 are the subordinate legislation (delegated legislation) made under the Act; they specify licensing procedures, schedules of drugs requiring central approval, and technical standards. Because the Rules are subsidiary legislation, they can be amended by the executive through a gazette notification without requiring fresh parliamentary approval — the mechanism used in this instance.

Drugs and Cosmetics Act, 1940: primary statute; Section 5 empowers the Central Government to regulate import of drugs
Drugs Rules, 1945: subordinate rules; Schedules C and C(1) historically listed products requiring central-level oversight (e.g., vaccines, sera, biologics)
CDSCO is headed by the Drugs Controller General of India (DCGI), who functions as the Central Licensing Authority (CLA)
The CLAA framework: joint central-state approval for complex/high-risk biologics to ensure uniform standards nationwide

Connection to this news: The 2026 amendment adds new product categories (cell/gene therapies, xenografts) to the CLAA schedule, meaning that no single state licensing authority can independently approve these therapies — both central CDSCO and the state body must sign off.

CAR-T Cell Therapy — Mechanism and Indian Context

CAR-T (Chimeric Antigen Receptor T-cell) therapy is a form of adoptive immunotherapy in which a patient's own T-lymphocytes are extracted, genetically engineered in a laboratory to express a synthetic receptor targeting a cancer antigen, expanded in culture, and reinfused into the patient. It is a living therapy — not a conventional small-molecule drug — which is why existing drug regulatory frameworks designed for chemical entities have struggled to accommodate it. India became the first country in Asia to develop an indigenously manufactured CAR-T cell therapy: NexCAR19, developed jointly by IIT Bombay and Tata Memorial Hospital, received approval from the CDSCO in 2023 and is used against B-cell lymphomas and leukaemias.

Target cancers: B-cell acute lymphoblastic leukaemia (ALL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (emerging)
NexCAR19: India's first indigenous CAR-T therapy; approved 2023; priced significantly lower than imported equivalents (~₹40–42 lakh vs. ₹3–4 crore for foreign versions)
Global context: FDA (US) first approved CAR-T therapies in 2017 (Kymriah, Yescarta)
Challenge: "vein-to-vein" time (patient cell extraction to reinfusion) and cold-chain logistics make uniform regulation critical

Connection to this news: The amendment directly addresses the regulatory inconsistency that could allow some states to permit unvalidated CAR-T or stem cell products while others maintain stricter standards — a patient safety risk given the complexity and cost of these therapies.

Gene Therapy — Types and Regulatory Considerations

Gene therapy involves the delivery of genetic material into a patient's cells to treat or prevent disease by replacing a faulty gene, inactivating a malfunctioning gene, or introducing a new gene. Delivery vectors include viral vectors (adeno-associated virus/AAV being the most common), non-viral lipid nanoparticles (as used in mRNA vaccines), and direct gene editing using CRISPR-Cas9 systems. Gene therapy products are classified as Advanced Therapy Medicinal Products (ATMPs) in the European Union regulatory framework, and as Biologics License Applications (BLA) by the US FDA — both require multi-stage clinical trial evidence and post-marketing surveillance.

Key gene therapy types: gene replacement (e.g., Zolgensma for SMA), gene silencing (RNA interference), gene editing (CRISPR)
CRISPR-Cas9: gene-editing tool that won the 2020 Nobel Prize in Chemistry (Jennifer Doudna and Emmanuelle Charpentier)
India's Biomedical Research Regulatory Authority: CDSCO regulates gene therapy trials under the New Drugs and Clinical Trials Rules, 2019
New Drugs and Clinical Trials Rules, 2019: define "gene therapy product" and "new drug" — the basis on which CDSCO exercises pre-market approval authority

Connection to this news: By placing gene therapeutic products under the CLAA framework, the government requires that any gene therapy product — whether domestically manufactured or imported — receive central-level approval before reaching Indian patients, aligning India closer to international best-practice regulatory standards.

Key Facts & Data

Principal Act: Drugs and Cosmetics Act, 1940
Subordinate legislation amended: Drugs Rules, 1945 (gazette notification, July 2026)
Regulatory authority: CDSCO under Ministry of Health and Family Welfare; headed by the Drugs Controller General of India (DCGI)
Products newly covered: (1) cell/stem cell-derived products including CAR-T therapies; (2) gene therapeutic products; (3) xenografts
Previously covered under CLAA: vaccines, large-volume parenterals (>100 ml IV solutions), recombinant DNA-based biologics
India's first indigenous CAR-T therapy (NexCAR19): approved by CDSCO in 2023, developed by IIT Bombay + Tata Memorial Hospital
New Drugs and Clinical Trials Rules, 2019: existing regulatory basis for new drug and gene therapy clinical trials in India
Nobel Prize in Chemistry 2020: awarded for CRISPR-Cas9 gene-editing technology