- Research Article
- 10.1002/cpt.70239
Requirements for Phase Lag in First-In-Human Trials in India: Proceedings of a Panel Discussion.
- Feb 11, 2026
- Clinical pharmacology and therapeutics
- Nusrat Shafiq + 10 more +10
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.
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