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Trial volunteers given Rs 12 cr in compensation in the last 3 years: DCGI

New Delhi: The Drug Controller General ofIndia(DCGI) on Friday said India had paid Rs 12 crore of compensation toclinical trialparticipants who had suffered serious adverse effects during trials in the last three years. The regulatory authority has cancelled registration of at least 10-15 site ethics committees and suspended many others for not properly following rules on clinical trials, DCGI VG Somani said during a webinar on regulatory pathways for Covid-19vaccineclinical trials.

In India, compensation is granted by the regulator, a practice which is unique, Somani said. “There is no regulator in the world where the compensation is granted by the regulator or where it is decided by the regulator,” he added. He said this has been done to ensure the safety of the patients.

“Looking at the particular Indian scenario to ensure patient safety and patients’ rights, this has been incorporated as the specific rule into the Drugs and Cosmetics Act. There are also provisions for an accelerated review process. Had this provision not been there, we could not have been in the position to do interim analysis and complete accelerated review of the vaccines which are being developed in the country. These rules give the provisions for accelerated review and there are provisions for taking the regulatory actions which were not there earlier. In case of non-compliance which are of serious nature, in that case the regulatory actions can be taken based on these rules,” Somani said.

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