New Delhi: Union Minister of State for Health and Family Welfare Anupriya Patel said the government has developed a "good and robust" system of supervising clinical trials by strengthening the regulatory provisions to check any serious adverse effects, including deaths, caused by them.
Patel said in RajyaSabha there have been 378 cases of deaths due to "serious adverse events" in 2016 and 11 of them related to clinical trials based on available status of examination done.

She said a high-powered committee was formed by the government, after the Supreme Court judgement in this regard, which had made recommendations on when to give permission to drugs without holding clinical trials.

She said the system was strengthened after the Supreme Court judgement. The Parliamentary Standing Committee on Health had also raised concerns over permission granted to 33 medicines without holding clinical trials.

"We have actually set up a good, robust system after the Supreme Court's order in 2013, that is a three-level committees consisting of the subject expert committee, the technical committee and the apex-level committee which actually gives the permission on whether the clinical trials have to be conducted or waived of," she said in RajyaSabha in a written reply.

Patel said before 2013, there was no proper system of compensation in case of any serious adverse events, "but in 2013, we have a proper system in place to address any such serious adverse events." 

"We have a properly detailed formula which has been established in order to give compensation to such cases where death takes place and there are several factors which are taken into account. After these systems have come into place, the adverse events have gone down in number and we are making sure that compensations are being given by the sponsored investigators," she said.

After the Supreme Court order, she said the government came up with a system under which there are five situations in which exemptions to clinical trials are given, which involve life-threatening disease, serious disease or if there is a disease which is specially suited to Indian conditions and there is an unmet need.

"There was reservation only about 33 clinical trials and we have made sure that there is a proper system to give exemptions to clinical trials," she told the House.