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.
Shafiq et al. (Wed,) studied this question.