15 September 2024 | News
A pivotal step towards establishing India’s self-sufficiency in clinical development
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In a significant stride towards strengthening India’s clinical research ecosystem, the Indian Council of Medical Research (ICMR) has formalised Memorandum of Agreements (MoAs) with multiple sponsors under its network of Phase 1 clinical trials.
The agreements mark a ground-breaking entry into first-in-human clinical trials for four promising molecules. These include collaborative research over a small molecule for multiple myeloma with Aurigene Oncology , partnering for Zika vaccine development with Indian Immunologicals, coordinating seasonal influenza virus vaccine trial with Mynvax, and CAR-T cell therapy advancement study for a new indication of chronic lymphocytic leukemia with ImmunoACT. This initiative is a crucial step towards establishing India as a leader in the clinical development of pharmaceutical agents.
Dr Rajiv Bahl, Secretary, Department of Health Research & Director General, ICMR, said, “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.”
The ICMR Network for Phase 1 Clinical Trials comprises four strategically located institutions across India- King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College (KEMH & GSMC), Mumbai; The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Navi Mumbai; SRM Medical College Hospital and Research Centre (SRM MCH&RC), Kattankulathur; and Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, supported by a Central Coordinating Unit at ICMR Headquarters in New Delhi. This network is designed to build and 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.