ICMR signs pacts for clinical trials for four drug molecules

  • September 15, 2024
  • Posted by: OptimizeIAS Team
  • Category: DPN Topics
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ICMR signs pacts for clinical trials for four drug molecules

Sub: Sci

Sec: Health

Context:

  • The Indian Council of Medical Research (ICMR) has formalised Memorandums of Agreement (MoAs) with multiple sponsors under its ‘Network for Phase 1 Clinical Trials’.
  • The agreements mark an entry into first-in-human clinical trials for four promising molecules, the council said.

The four agreements:

  • Collaborative research over a small molecule for multiple myeloma with Aurigene Oncology Limited with Indian Immunologicals Limited
  • Coordinating a seasonal influenza virus vaccine trial with Mynvax Private Limited
  • CAR-T cell therapy advancement study for a new indication of chronic lymphocytic leukaemia with ImmunoACT.

Significance:

  • It is a crucial step towards establishing India as a leader in the clinical development of pharmaceutical agents.
  • The collaboration between ICMR and prominent industry and academic partners is a key milestone in the pursuit of affordable and accessible cutting-edge treatments for all citizens.

ICMR’s ‘Network for Phase 1 Clinical Trials’

  • 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.
  • The network comprises of four strategically located institutions across India
    • King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai
    • Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai
    • SRM Medical College Hospital and Research Centre, Kattankulathur
    • Postgraduate Institute of Medical Education and Research, Chandigarh.
  • They are supported by the Central Coordinating Unit at the ICMR’s headquarters in New Delhi.

4 stages of clinical trials:

  • Phase I:
    • This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor.
    • The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
  • Phase II:
    • During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centres to determine its effect and also to check for any unacceptable side effects.
  • Phase III:
    • Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate.
    • In this phase, the group is between 1000-3000 subjects.
    • If the results are favourable, the data is presented to the licensing authorities for a commercial license to market the drug for use by the patient population for the specified and approved indication.
  • Phase IV:
    • Phase of surveillance after the medicine is made available to doctors, who start prescribing it.
    • The effects are monitored on thousands of patients to help identify any unforeseen side effects.
ICMR signs pacts for clinical trials for four drug molecules Science and tech