ICMR signs agreements to advance first-in-human Phase 1 clinical trials

New Delhi: In a significant stride towards strengthening India's clinical research ecosystem, the Indian Council of Medical Research (ICMR) has formalised memorandum of agreements with multiple sponsors to advance first-in-human phase 1 clinical trials.

"The agreements mark a ground-breaking entry into first-in-human clinical trials for four promising molecules," the Union Health Ministry said in a statement.

These include collaborative research over a small molecule for multiple myeloma with Aurigene Oncology Limited, partnering for Zika vaccine development with Indian Immunologicals Limited, coordinating seasonal Influenza virus vaccine trial with Mynvax Private Limited, 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," the statement said.

Union Health Minister J P Nadda, commended the strategic collaboration between ICMR and prominent industry and academic partners, emphasising it as a key milestone in the pursuit of affordable and accessible cutting-edge treatments for all citizens.

He noted that this initiative positions India to emerge as a global leader in healthcare innovation.

Dr Rajiv Bahl, Secretary, Director General, ICMR, emphasised the transformative potential of the project, 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.” "Our vision is to expand this network further, ensuring that India continues to lead in the development of innovative and affordable healthcare solutions," the statement said.

Dr Bahl also highlighted the broader impact of ICMR's initiatives, such as the Network for Phase 1 Clinical Trials, INTENT Network, and MedTech Mitra, aligning with the government's vision of a "Viksit Bharat" (Developed India).

He cited ICMR's pivotal role in development of Covaxin in collaboration with Bharat Biotech as a testament to the organisation's commitment to affordable and accessible healthcare for all.

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; and PGIMER, Chandigarh – supported by a Central Coordinating Unit at ICMR Headquarters, New Delhi., the statement said.

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, it stated.

The signing of these agreements reinforces the strong partnerships ICMR has cultivated with key industry players.

"It underscores the institute's dedication to building a robust clinical trial ecosystem in India, fostering capacity to develop new drugs from early-phase trials through to marketing, thereby reducing dependency on international resources, and ultimately driving the mission of affordable, high-quality healthcare for all," the statement said.