The Indian Council of Medical Research (ICMR) has recently signed Memoranda of Agreements (MoAs) with several industry and academic partners to advance First-in-Human Phase-1 clinical trials.
This initiative marks a key milestone in India's clinical research ecosystem, focusing on four promising molecules:
1. Multiple Myeloma: Collaborative research with Aurigene Oncology Limited.
2. Zika Vaccine: Development in partnership with Indian Immunologicals Limited.
3. Seasonal Influenza Vaccine: Trials coordinated with Mynvax Private Limited.
4. CAR-T Cell Therapy: Advancement study for chronic lymphocytic leukemia with ImmunoACT.
This collaboration aims to establish India as a leader in the clinical development of pharmaceutical agents, ensuring affordable and accessible cutting-edge treatments for all citizens.
First-in-Human (FIH) clinical trials are a critical phase in the development of new medical treatments. FIH trials are the first time a new drug or treatment is tested in humans. They primarily focus on assessing the safety and tolerability of the treatment. These trials help determine the appropriate dosage range for the treatment, identifying the maximum tolerated dose and any potential side effects.
FIH trials study how the drug is absorbed, distributed, metabolized, and excreted in the body (pharmacokinetics) and its biological effects (pharmacodynamics). Successful FIH trials pave the way for subsequent phases of clinical trials, which further evaluate the efficacy and safety of the treatment in larger populations.
These trials are essential for ensuring that new treatments are safe and effective before they become widely available to patients.
By collaborating with industry and academic partners, the ICMR can expedite the development of new treatments, ensuring they reach patients faster.
Besides, Industry-Partnerships can reduce the financial burden on any single entity, making the research and development process more cost-effective. This can lead to lower costs for the end treatments. Moreover, combining the strengths of industry and academia brings together a wealth of knowledge and resources, improving the quality and efficiency of the research.
Developing treatments within India can reduce dependency on international pharmaceuticals, potentially lowering costs and improving accessibility for Indian citizens. Successful FIH trials can streamline the regulatory approval process, ensuring that safe and effective treatments are available to the public sooner.
By focusing on diseases like multiple myeloma, Zika, and chronic lymphocytic leukemia, these trials address significant public health challenges, aiming to provide cutting-edge treatments that are both affordable and accessible.
This initiative not only strengthens India’s position in global clinical research but also promises to make advanced medical treatments more accessible to its population.
Union Health and Family Welfare Minister, Shri J P Nadda, commended the strategic collaboration between ICMR and prominent industry and academic partners, emphasizing 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, Department of Health Research & Director General, ICMR, emphasized 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.”
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