Requirements for Phase Lag in First‐In‐Human Trials in India: Proceedings of a Panel Discussion
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.
Authors
- Soumya Vij (ORCID: https://orcid.org/0000-0002-4119-5348)
- Harish Kaushik Kotakonda
- Jerin Jose Cherian (ORCID: https://orcid.org/0000-0002-9548-7004)
- Samir Malhotra
- AK Mukherjee
- Taruna Madan
- Arun Kumar Pradhan
- Ashish K. Kakkar
- Nilima Kshirsagar
- Nusrat Shafiq
- Sadhna Joglekar
Institutions
- Ambedkar University Delhi (IN)
- Indian Council of Medical Research (IN)
- Novartis (India) (IN)
- Cellworks Research (India) (IN)
- Post Graduate Institute of Medical Education and Research (IN)
Publication Details
- Journal
- Clinical Pharmacology & Therapeutics
- Published
- 2026-02-11
- DOI
- https://doi.org/10.1002/cpt.70239
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00