India’s new policy to protect research participants

India, the country with the largest disease burden in the world,1 is now a major international hub for clinical research. However, a recent policy that was meant to mitigate important ethical concerns may have profound and unintended consequences for public health and may threaten the viability of clinical research in India.

India has an impressive profile of research. Its clinical research market alone has been estimated to be worth nearly $500m (Rs30 240m; £326m; €376m) in revenues.2 India has also been an active partner in international collaborative global health research, including the recent development of a low cost rotavirus vaccine Rotavac.3

In 2011, the Clinical Trials Registry of India registered more than 1800 trials.4 These included studies of treatments for cancer, diabetes, and cardiovascular disease, as well as public health trials of optimal childhood vaccination and HIV treatment. In addition, India is the world’s largest producer of generic drugs—$10bn worth—and the main supplier of antiretrovirals to donor supported HIV treatment programmes in developing countries.5 6 Furthermore, the country supplies nearly 80% of the global supply of DPT (diphtheria, pertussis, and tetanus) and BCG vaccines and 90% of the measles vaccine.7

Several factors have contributed to India’s global leadership in research and the production of generic drugs. Most important is the presence of a cadre of well trained multilingual professionals with relevant expertise in research. Research in India is also less expensive than in many other countries; …