Regulatory developments in the conduct of clinical trials in India.

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in thewake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard ControlOrganisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of EthicsCommittees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, aswell as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research. [ABSTRACT FROM AUTHOR]