Requirements for Phase Lag in First‐In‐Human Trials in India: Proceedings of a Panel Discussion

Clinical Pharmacology & Therapeutics 2026

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Authors: Nusrat Shafiq, Soumya Vij, Arun Kumar Pradhan, Jerin Jose Cherian, AK Mukherjee, Taruna Madan, Nilima Kshirsagar, Sadhna Joglekar, Harish Kaushik Kotakonda, Ashish K. Kakkar, Samir Malhotra
DOI: 10.1002/cpt.70239
Cited by: 1
References: 4

Abstract

India has strengthened its clinical research infrastructure and regulatory frameworks to support new drug development and early-phase clinical trials. However, historical concerns related to participant safety, ethics, and research capacity have limited the conduct of first-in-human (FIH) studies for products developed outside India. A multi-stakeholder panel comprising representatives from regulatory authorities, academia, industry, and funding agencies examined regulatory, ethical, infrastructural, and innovator perspectives relevant to conducting such FIH trials in India.

Fields of Study & Subjects

Ethics in Clinical Research Biomedical Ethics and Regulation Biotechnology and Related Fields

Publication details

Journal / source
Clinical Pharmacology & Therapeutics
Publisher
Wiley
Volume
119
Issue
5
Pages
1160–1163
Publication date
11 February 2026
Language
EN