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<p>A two-and-a-half-day workshop on regulatory and ethical issues in first-in-human (FIH) clinical trials in India was held at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, on 7–9 November 2024, under the aegis of the Indian Council of Medical Research (ICMR) Phase I Network. The workshop brought together regulators, academic investigators, and industry representatives to examine the evolving regulatory landscape of early phase trials in India and the operational challenges associated with it. Through interactive sessions, including preparation of investigational new drug (IND) application, mock pre-IND/IND and mock subject expert committee (SEC) meetings, on-site monitoring simulations, and structured hands-on exercises, the workshop navigated regulatory submission pathways, trial reporting, documentation standards, safety oversight, and informed consent processes. A panel discussion on the phase lag policy for FIH studies in India was held with expert personnel from regulatory agencies, ICMR headquarters, industry, and academia. The workshop discussions underscored the need for policy harmonization, enhanced site preparedness, and sustained capacity-building to position India as a leader for early phase clinical research. The present article summarizes the proceeding of the workshop and highlights the critical insights for developing a regulatory and ethical framework to support FIH trials in India.</p>

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

  • 期刊论文

  • 发表日期：

    2026年5月26日

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  • Nusrat Shafiq,
  • Ashok Kumar,
  • Jerin Jose Cherian,
  • Taruna Madan,
  • Nilima Kshirsagar,
  • Aparna Mukherjee,
  • Soumya Vij,
  • Pawan Kumar Singh,
  • Geetika Srivastava,
  • Annam Visala,
  • Akhil Kumar,
  • Anita Soman,
  • Harish Kaushik Kotakonda,
  • Sadhna Joglekar,
  • Mahendra Joshi,
  • Venkatesha Udupa,
  • Aruvi Poomali,
  • Nikhil Benroy Noronha,
  • Nithya Gogtay,
  • Manjunath Nookala Krishnamurthy,
  • Satyajit Mohapatra,
  • Nilanjan Saha,
  • Vikram Gota,
  • A. K. Pradhan,
  • Priyadarshini Chatterjee,
  • Amit Kumar,
  • Animesh Chaturvedi,
  • Mahesh Kumar Balasundaram,
  • Gaurav Prakash,
  • Ashish K. Kakkar,
  • Samir Malhotra

摘要

A two-and-a-half-day workshop on regulatory and ethical issues in first-in-human (FIH) clinical trials in India was held at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, on 7–9 November 2024, under the aegis of the Indian Council of Medical Research (ICMR) Phase I Network. The workshop brought together regulators, academic investigators, and industry representatives to examine the evolving regulatory landscape of early phase trials in India and the operational challenges associated with it. Through interactive sessions, including preparation of investigational new drug (IND) application, mock pre-IND/IND and mock subject expert committee (SEC) meetings, on-site monitoring simulations, and structured hands-on exercises, the workshop navigated regulatory submission pathways, trial reporting, documentation standards, safety oversight, and informed consent processes. A panel discussion on the phase lag policy for FIH studies in India was held with expert personnel from regulatory agencies, ICMR headquarters, industry, and academia. The workshop discussions underscored the need for policy harmonization, enhanced site preparedness, and sustained capacity-building to position India as a leader for early phase clinical research. The present article summarizes the proceeding of the workshop and highlights the critical insights for developing a regulatory and ethical framework to support FIH trials in India.