Compensation for trial-related injury: does simplicity compromise fairness.

ABSTRACT

India’s regulatory framework for research ethics is two pronged. Schedule Y of the Drugs and Cosmetics Act, 1940, of the Government of India, lays down the requirements for undertaking clinical trials for drugs and medical devices in India; it also requires compliance with the ICMR’s Ethical guidelines for biomedical research on human participants for such trials. Other health research may use the ICMR’s guidelines but this is not mandatory. The regulatory framework is operationalised through the offices of the Central Drugs Standard Control Organisation. However, the mechanisms of monitoring drug trials using this framework have proved to be rather weak.