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ICMR Partners with Industry to Advance First-in-Human Phase 1 Clinical Trials in India

  • The Indian Council of Medical Research (ICMR) has signed agreements to advance first-in-human Phase 1 clinical trials for four molecules.
  • Collaborations include research for multiple myeloma, Zika vaccine development, influenza vaccine trials, and CAR-T cell therapy advancements.
  • This initiative aims to establish India as a leader in pharmaceutical clinical development and affordable healthcare solutions.
  • The ICMR network includes four institutions across India, enhancing the capacity for early-phase clinical trials with robust infrastructure.
The Indian Council of Medical Research (ICMR) has formalized agreements with industry and academic partners to initiate first-in-human Phase 1 clinical trials for four promising molecules, marking a significant advancement in India's clinical research ecosystem. This initiative aims to position India as a key player in the global pharmaceutical arena by fostering the development of indigenous and affordable healthcare solutions.
The collaborations include:
  • Multiple Myeloma: Collaborative research with Aurigene Oncology Limited focusing on a small molecule therapeutic.
  • Zika Vaccine: Partnership with Indian Immunologicals Limited for the development of a vaccine against the Zika virus.
  • Seasonal Influenza Vaccine: Coordination of a seasonal influenza virus vaccine trial with Mynvax Private Limited.
  • Chronic Lymphocytic Leukemia: Advancement of CAR-T cell therapy for a new indication of chronic lymphocytic leukemia with ImmunoACT.

Strategic Importance

Union Health Minister J P Nadda emphasized that these partnerships are a crucial step towards providing affordable and accessible cutting-edge treatments for all citizens, highlighting India's potential to emerge as a global leader in healthcare innovation.
Dr. Rajiv Bahl, Secretary of the Department of Health Research & Director General of ICMR, stated, "This collaboration reflects our commitment to advancing clinical research in India through strategic public-private partnerships. Establishing Phase 1 clinical trial infrastructure is a key component in fostering the development of indigenous molecules and cutting-edge treatments. Our vision is to expand this network further, ensuring that India continues to lead in the development of innovative and affordable healthcare solutions."

ICMR's Clinical Trial Network

The ICMR Network for Phase 1 Clinical Trials comprises four strategically located institutions across India:
  • KEMH & GSMC, Mumbai
  • ACTREC, Navi Mumbai
  • SRM MCH&RC, Kattankulathur
  • PGIMER, Chandigarh
These institutions are supported by a Central Coordinating Unit at ICMR Headquarters in New Delhi. The network is designed to enhance India's capacity to conduct early-phase clinical trials, supported by robust infrastructure and dedicated manpower at each trial site, ensuring smooth and effective operations.

Impact on Healthcare

This initiative underscores ICMR's dedication to building a robust clinical trial ecosystem in India, fostering the capacity to develop new drugs from early-phase trials through to marketing. This reduces dependency on international resources and ultimately drives the mission of affordable, high-quality healthcare for all. The development of Covaxin, in collaboration with Bharat Biotech, serves as a testament to ICMR's commitment to accessible healthcare solutions.
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