The Drugs Controller General of India (DCGI) has ordered compensation of ₹12 crore to those clinical trial participants who have suffered serious adverse effects during the trials in the last three years, said DCGI VG Somani said here on Friday.
Besides, the Indian drug regulator cancelled registration of at least 10 to 15 site-specific ethics committees and suspended many more for not following the rules properly, the DCGI said while participating in a webinar on regulatory pathways for Covid-19 vaccine clinical trials.
Though the virtual meeting was held in the light of a severe adverse event reported early last week by a participant who volunteered for Serum Institute of India-sponsored Covishield trial in Chennai, the drug regulator stayed away from mentioning the specific case and instead talked of the procedures followed in general.
According to Somani, India is the only major country where the drug regulator can order the payment of compensation to a participant who suffered serious adverse effect during a clinical trial. According to an amendment made in December 2016 to the Drugs and Cosmetics Act of 1945, “in case, the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation”.
The sponsor of the trial has to give it in writing before the trial is commenced that if any injury or even discomfort, occurs to the trial subject during the trial, all medical management will be borne by the sponsor and that the investigator or the institution he or she is associated with, will immediately start providing medical management and the sponsor will pay for compensation in case of trial-related injury or death, the DCGI said.
The directions of the DCGI go as an order and if the sponsor does not pay the compensation within a stipulated time, the regulator can debar or restrict the sponsor from conducting any clinical trial in future, he said.
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