India plans to enforce strict rules for gene and stem cell therapies to improve patient safety and ethical governance. The move includes updated regulatory timelines, enhanced oversight by ICMR and CDSCO, better clinical trial monitoring, and fostering innovation under government-backed biotech initiatives, aiming to boost global competitiveness.
The Indian government is moving towards a stringent regulatory environment for gene and stem cell therapies, reflecting the rapidly evolving biotech landscape and public health priorities. The Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) are revising guidelines to emphasize safety, ethical conduct, and expedited approvals.
Stem cell therapies are allowed only under strictly controlled clinical trials, with commercial use prohibited due to earlier malpractice cases. Gene therapy development follows a detailed pathway involving several layers of governance, including Institutional Bio Safety Committees, Review Committee on Genetic Manipulation, and Gene Therapy Advisory Evaluation Committee for clinical trial permissions. The government aims to simplify approval processes while maintaining thorough scientific and ethical scrutiny.
India's support for innovation is visible through initiatives under the “Make in India” program, focusing on domestic manufacturing of gene therapy and associated biotech products, including indigenous CAR-T therapies. Streamlining regulatory pathways is expected to encourage investments and collaborations, positioning India as a leading player in advanced therapeutics.
Important Points:
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Strict regulatory overhaul by ICMR and CDSCO for gene and stem cell therapies.
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Stem cell commercial use banned; allowed only in approved clinical trials.
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Multi-tier governance including IBSC, RCGM, and GTEAC ensures safety and oversight.
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Promotion of innovation under Make in India, with indigenous CAR-T therapies approved.
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Efforts to expedite approvals while ensuring ethical and scientific rigor.
Sources: Indian Council of Medical Research (ICMR) Guidelines, CDSCO Notifications, Department of Biotechnology, Financial Express, Science Direct.