Centre steps in, drafts norms for relief to drug trial victims
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The government has finally stepped in to curb the practice of paying variable or no compensation by pharma firms for deaths due to clinical trials. It has notified rules for granting relief in case of Serious Adverse Events like death or injuries.
The grant will depend on categories fixed by the government such as death, severe injury and minor injury. The minimum compensation amount would be notified soon. Recently the Supreme Court had directed the health ministry to monitor all clinical trials after stating that the government was in "deep slumber".
So far, the Drugs and Cosmetics Rules did not have any provision for compensation. But from now, compensation would be awarded within three months, once the injury or death is reported.
As per the health ministry data, in the last five years, 2,242 people have died during drug trials in India. The average compensation awarded per death is a meagre Rs 2.2 lakh.
"With the notification of procedures for compensation, the government has ensured safety and rights of subjects participating in clinical trials. All trials will be monitored at all the stages," a senior health ministry official said.
From now, Drug Controller General of India (DCGI), and not the ethics committee of the medical institute, would approve the final compensation amount. The DCGI would also decide on the cause of injury or death in clinical trials.
The new rules say that the ethics committee of the medical institute conducting the trial, its sponsor and its principal investigator will have to report the injury or death within 24 hours of the incident. They will have to submit separate reports to the independent expert committee set up by the DCGI for review. Based on the panel report, the DCGI would recommend the final compensation amount.