The government has put in place 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. Minister of State for Health and Family Welfare Anupriya Patel in Rajya Sabha said 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 judgment 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 judgment. 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 committee 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 Rajya Sabha 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 specicially 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.
The recommendations of the 59th Standing committee of Parliament expressed reservations of 33 clinical trials that were waived of. She said after that an expert committee was set up that was chaired by Ranjit Roy Chaudhary, which said exemptions to clinical trials should be given under only specific conditions like national emergency or an urgency or may be a drug is needed for an orphan or any such event.
In her written reply, she said in 2014, there were 443 cases of serious adverse events leading to deaths, of which 23 cases are related to clinical trials. In 2015, there were as many as 381 cases of serious adverse events and deaths were reported, of which 13 cases of deaths were related to clinical trial based examinations.