The Evolving Regulatory Landscape for Clinical Trials in India

Mark Barnes, Jamie Flaherty, Minal Caron, Alishan Naqvee, Barbara Bierer


Since 2013, India has undergone a significant regulatory transformation in regard to clinical trials. Following controversial media coverage of deaths that were allegedly related to clinical trials, the Indian government attempted to bolster its regulatory framework by releasing a number of new and complex regulations that quickly made India an unpredictable jurisdiction in which to site and conduct clinical trials. This article describes the events and regulatory changes that have shaped India’s clinical trial landscape over the past several years. The article ultimately concludes that many of the well-meaning requirements imposed on researchers and sponsors beginning in 2013 chilled the clinical trial environment, yet the requirements also brought appropriate attention to complex ethical issues. While many of the more stringent regulations have since been clarified or withdrawn through the Indian government’s continuing reform efforts, the recent India experience demonstrates how regulatory uncertainty can deter advances in clinical research.