India introduces stricter compensation laws for clinical trial injuries
In the past five years, 2,242 people have died during drug trials in India with average compensation per death starting at approximately $4,078.60. The compensation amount was determined by ethics committees set up by the sponsors of the clinical trials, Eye for Pharma reports.
Recent reports by Indian media and India's Supreme Court chided the government for its haphazard regulation of clinical trials.
Pharmaceutical companies conducting clinical drug trials in India will now be subject to a greater level of analysis through the trial process, particularly when it comes to injuries or fatalities as a result of any treatments received during a trial.
The government will also set payment guidelines for patients or their next of kin in the event of such injuries or deaths. The change will make compensation mandatory and provide participants of trials with more security, Eye for Pharma reports.
Doctors involved in clinical research must now inform the pharmaceutical company, the clinical research organization and the ethics committee within 24 hours of injuries or deaths during a trial. The pharmaceutical company and the CRO will then have 10 days to submit a detailed report on the event and an additional 10 to 11 days to evaluate compensation for the participant using an independent expert team. The panel must advise the drug regulator on the level of compensation due within 30 days of receiving the report.
Pharmaceutical companies and CROs failing to pay the apportioned compensation in a timely manner could face trial suspension or a permanent ban.