The implications of waiving local clinical trials for drugs in India: a double-edged sword?
India's decision to waive local clinical trials for drugs approved in countries like the U.S., U.K., Japan, and the European Union represents a pivotal regulatory shift. While the move aims to expedite access to essential medications and enhance market availability, it raises significant concerns about patient safety, research and development (R&D), and broader healthcare implications.1
Authors
- Rajmohan Seetharaman (ORCID: https://orcid.org/0000-0002-4605-2805)
Institutions
- Mahatma Gandhi Mission Institute of Health Sciences (IN)
- Mahatma Gandhi Mission Medical College and Hospital (IN)
Publication Details
- Journal
- The Lancet Regional Health - Southeast Asia
- Published
- 2024-10-18
- DOI
- https://doi.org/10.1016/j.lansea.2024.100501
- Citations
- 1
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 1.13