Ethics in Clinical Trials and Access to Medicines

Biomedical research such as clinical trials are filled with many complex ethical issues, which includes quality of health care, post-trial access to medicines for research participants as well as general population, improper compensation mechanism in any incident of trial related injury etc. With the growing number of clinical trials in India, there have been many examples of clinical trials that have taken place with disregard to ethical aspects and participants’ rights. There exists a striking lack of transparency at the levels of planning, design and implementation of these trials. In the absence of adequate regulatory jurisdiction and systematic review of the industry, the reliability and validity of drug research in the country is jeopardized.

Sama considering health a fundamental human right, advocates for a rights based approach to health care for trial participants. Sama is involved in research on ethical issues in clinical trials, and access to medicines, capacity building initiatives to raise awareness on the issue, and policy level advocacy and engagement with ICMR (Indian Council of Medical Research), CDSCO (Central Drugs Standard Control Organisation), MoHFW (Ministry of Health and Family Welfare) etc.