In response to a Rajya Sabha query, the Ministry of Science & Technology outlined the nation’s strategy to achieve self‑reliance in CRISPR‑based therapies. The plan hinges on the BioE3 Policy, backed by the DBT, and coordinated regulatory oversight by CDSCO, ICMR and the BIRAC.
Key Developments
- Release of the National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019 by CDSCO, ICMR and DBT.
- First‑in‑human Phase‑I trial for Hemophilia A gene therapy, showing stable Factor VIII production; results published in the New England Journal of Medicine.
- BioE3‑funded academic projects targeting Hemophilia A, Thalassaemia, Hemophilia B (mRNA‑based), and CAR‑T therapies for multiple myeloma.
- DBT grant to Tata Institute for Genetics and Society for an indigenous mRNA‑based in‑vivo gene‑editing platform for propionic academia.
- Establishment of the मूलांकुर BioEnablers scheme to provide pilot‑scale manufacturing facilities.
- BIRAC’s programmes – BIG, SEED, LEAP, PPP – supporting biotech start‑ups, including two home‑grown anti‑CD19 CAR‑T products (Qartemi & NexCAR19) now commercially available.
- ICMR’s grant ecosystem (First‑in‑the‑world‑challenge, Small, Intermediate, Centre for Advanced Research) and support mechanisms like “Biomedical Innovations Patent Mitra”, “MedTechMitra”, and the “Indian Clinical Trial and Education Network (INTENT)” with 85 trial sites.
- CSIR‑IGIB’s technology transfer to Serum Institute for commercialisation of a novel gene therapy (agreement signed Nov 2025).
Important Facts & Regulatory Landscape
The biosafety framework operates under the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro‑organisms/Genetically Engineered Organisms or Cells, 1989, notified by the Environment (Protection) Act, 1986. Oversight during laboratory work is provided by Institutional Biosafety Committees (IBSCs) and the Review Committee on Genetic Manipulation (RCGM), guided by the 2017 Recombinant DNA Guidelines and the 2020 IBSC Handbook.
Clinical development is regulated by the New Drugs and Clinical Trials (NDCT) Rules, 2019 under the Drugs and Cosmetics Act, 1940. Human subject protection is ensured by Institutional Ethics Committees operating per the ICMR National Ethical Guidelines (2017). After successful trials, a comprehensive dossier on quality, safety and efficacy is submitted to CDSCO for marketing approval.
UPSC Relevance
Understanding India’s biotech policy framework is essential for GS 3 (Science & Technology) and GS 4 (Ethics) papers. The integration of research, funding, and regulation illustrates the country’s approach to strategic autonomy in health‑care, a recurring theme in UPSC questions on self‑reliance (Atmanirbhar Bharat). The involvement of multiple agencies (DBT, BIRAC, ICMR, CDSCO) showcases inter‑ministerial coordination, relevant for Polity (GS 2) and Governance. Moreover, the ethical oversight mechanisms (IBSC, IEC) tie directly to the Ethics syllabus.
Way Forward
- Scale‑up of successful Phase‑I trials to Phase‑II/III, leveraging the BioEnablers GMP facilities.
- Strengthen public‑private partnerships to accelerate commercialization of affordable gene‑editing therapeutics.
- Expand the INTENT network beyond 85 sites to ensure geographic equity in clinical trial participation.
- Enhance capacity building for regulatory personnel to keep pace with rapid advances in CRISPR and CAR‑T technologies.
- Promote indigenous intellectual property generation through schemes like “Biomedical Innovations Patent Mitra”.
Collectively, these measures aim to create a sustainable pipeline of home‑grown cell and gene therapies, reducing dependence on imports and positioning India as a global biotech hub.