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New Delhi, 14 September 2024 – In a major development for India’s clinical research landscape, the Indian Council of Medical Research (ICMR) has signed a series of Memorandum of Agreements (MoAs) with leading industry and academic partners under its Network of Phase 1 Clinical Trials. These agreements pave the way for First-in-Human clinical trials of four promising pharmaceutical agents, marking a significant step in India’s journey towards self-reliance in drug development.

The collaboration involves four distinct research initiatives:

  • Aurigene Oncology Limited for a small molecule targeting multiple myeloma,
  • Indian Immunologicals Limited for Zika vaccine development,
  • Mynvax Private Limited for a seasonal influenza virus vaccine, and
  • ImmunoACT for CAR-T cell therapy in chronic lymphocytic leukemia.

These partnerships signal India’s growing leadership in the clinical development of innovative pharmaceutical agents, with the potential to revolutionize the treatment landscape across multiple therapeutic areas.

Union Health and Family Welfare Minister Shri J P Nadda, in his address at the signing ceremony, praised the initiative as a “key milestone in the pursuit of affordable and accessible cutting-edge treatments for all citizens.” He highlighted how these partnerships will establish India as a global leader in healthcare innovation, adding that “the efforts align with our vision of a self-sufficient India in clinical research and pharmaceutical development.”

Advancing Indigenous Research Capabilities

Dr. Rajiv Bahl, Secretary of the Department of Health Research and Director General of ICMR, emphasized the transformative impact of these agreements, stating, “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.”

Dr. Bahl also pointed to ICMR’s ongoing efforts to bolster the country’s research capabilities, citing the Network for Phase 1 Clinical Trials, the INTENT Network, and MedTech Mitra as pivotal initiatives. “These programs align with the government’s vision of a ‘Viksit Bharat’ (Developed India),” he said, highlighting ICMR’s role in the development of Covaxin during the COVID-19 pandemic as a testament to the organization’s commitment to affordable and accessible healthcare.

Building a National Clinical Trial Network

The ICMR Network for Phase 1 Clinical Trials includes four premier institutions across India:

  • KEM Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai,
  • ACTREC, Navi Mumbai,
  • SRM Medical College Hospital & Research Centre, Kattankulathur, and
  • PGIMER, Chandigarh.

Each of these institutions is equipped with robust infrastructure and a dedicated workforce, ensuring the smooth and effective execution of early-phase clinical trials. A Central Coordinating Unit at ICMR Headquarters in New Delhi oversees the network, ensuring that trials are conducted with high standards of safety, efficiency, and scientific rigor.

The collaboration signals ICMR’s ongoing commitment to reducing India’s dependence on international resources for drug development. By strengthening the country’s capacity to conduct early-phase trials, ICMR is helping to position India as a major player in global clinical research, with the potential to bring innovative treatments to market faster and at lower costs.

A Milestone for Affordable Healthcare

The signing of these agreements is a bold step toward realizing India’s vision of providing high-quality, affordable healthcare for all. By advancing indigenous drug development through Phase 1 clinical trials, ICMR is not only addressing critical healthcare needs but also driving forward India’s mission of becoming a self-reliant nation in the pharmaceutical sector.

This partnership between ICMR and its industry and academic partners is expected to have far-reaching impacts, not just within India, but globally, as the country takes on a leadership role in clinical research and drug development.

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