In an article on The New Indian Express, members of the Indian Society for Clinical Research (ISCR) say that recent regulations are to blame for a drop in the number of clinical trials being conducted in India. The Indian government introduced new regulations following a Supreme Court ruling in 2013, one of which requires trial sponsors to make an audio-visual recording of clinical trials participants giving their consent. But this requirement makes it tougher to get people to participate in trials as some patients are reluctant to be recorded.
There is also much uncertainty among researchers about parts of the regulations including compensation for patients. Dr Viraj Suvarna, a member of ICSR’s executive council, says that because of this uncertainty “doctors and researchers will not get to be involved in medical breakthroughs. Our health statistics will not improve.” Members of ICSR say that the regulations need to change to encourage more clinical trials, leading to new and improved treatments.