Sandhya Srinivasan | Infochange News and Features | August 2015
In the last decade, there have been many reports of unethical and illegal clinical trials in India. It is only recently that the government framed rules to monitor their conduct. In 2014, rules were devised on compensation to be paid to participants or their families in cases of injury and death in clinical trials. However, there are challenges to be met much before compensation amounts can be determined, starting from the manner in which trials are conducted extending to the procedure for assessing whether an injury is related to the trial. Some of these problems may be reduced with the planned improvements in regulation. However, trial sponsors are likely to resist regulation, participants remain vulnerable, and regulatory agencies have a poor track record in protecting people’s rights.