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Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned

Nusrat Shafiq1, Ashok Kumar2, Jerin Jose Cherian3,4,5

  • 1Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India. nusrat.shafiq.pgi@gmail.com.

Clinical Drug Investigation
|May 26, 2026
PubMed

Insights

A workshop addressed regulatory and ethical challenges in first-in-human (FIH) clinical trials in India. Discussions focused on harmonizing policies and building capacity to advance early phase clinical research in the country.

Area of Science:

  • Clinical Research
  • Regulatory Affairs
  • Medical Ethics

Background:

  • A workshop convened stakeholders to discuss regulatory and ethical issues in first-in-human (FIH) clinical trials in India.
  • The event aimed to address the evolving landscape and operational challenges of early phase trials.

Purpose of the Study:

  • To summarize the proceedings of a workshop on regulatory and ethical frameworks for FIH trials in India.
  • To highlight critical insights for developing a robust system to support early phase clinical research.

Main Methods:

  • Interactive sessions covering investigational new drug (IND) applications, mock regulatory meetings, and monitoring simulations.
  • Hands-on exercises on regulatory submission pathways, trial reporting, documentation, safety oversight, and informed consent.
  • A panel discussion on the phase lag policy for FIH studies involving experts from regulatory agencies, ICMR, industry, and academia.

Main Results:

  • Discussions emphasized the need for policy harmonization to streamline early phase clinical trials.
  • Enhanced site preparedness and sustained capacity-building were identified as crucial for India's leadership in clinical research.
  • The workshop provided critical insights into developing a comprehensive regulatory and ethical framework.

Conclusions:

  • Strengthening the regulatory and ethical framework is essential for advancing FIH clinical trials in India.
  • Collaborative efforts among regulators, academia, and industry are key to overcoming operational challenges.
  • Positioning India as a leader in early phase clinical research requires strategic policy development and capacity enhancement.

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