Mandatory provisions have been made to ensure patient safety during clinical trials and compensation to any victim, Lok Sabha was informed today.
Expert committees have been constituted to examine the reports of deaths in clinical trials.
Health Minister J P Nadda said during Question Hour that mandatory provisions have been made to ensure safety during clinical trials, new drug applications of new chemical entity and global clinical trials.
These expert committees have prepared detailed guidelines for examination of reports of deaths and also formulas for determining the quantum of compensation in case of clinical trial related deaths and injury, other than death, he said.
The Minister was asked what steps had been taken by the government after the Supreme Court urged the government in 2013 to create mechanism to monitor clinical trials for new drugs in the country and what infrastructure had been developed for the purpose so far.
Nadda said suggestions for improving the system for conducting clinical trials have been received from time to time from various stakeholders.
The suggestions received also include creation of conditions conducive for improving the ease of conducting clinical trials in the country so that these trials are not shifted to other countries, he said.
