Clinical trial participants paid over Rs 12 crore compensation in last 3 years for adverse events: DCGI

The provision for providing compensation to subjects who suffer serious injury or death during participation in clinical trials was included under the Drugs and Cosmetics Rules in 2013.

Addressing a webinar, ''Regulatory Pathways for COVID-19 Vaccines, Clinical trials, Rolling Reviews and Adverse Event Monitoring'', Drugs Controller General of India (DCGI) V G Somani said registration of 10-15 ethics committees at trial sites across the country were canceled and even more than that were suspended for not adhering to the rules.

In the context of alleged serious adverse events reported during the vaccine clinical trials of Serum Institute of India and the Bharat Biotech, Somani said: "It has been found things are going on as per the process."

The comments come days after an Oxford COVID-19 vaccine trial volunteer from Chennai alleged that he suffered SAE after taking the shot and sued the Serum Institute of India and others, seeking a compensation of Rs 5 and a halt to the trial. The SII has rejected the charges as "malicious and misconceived" and said it would seek damages in excess of Rs 100 crore.

A probe initiated by the DCGI into the matter found that the SAE was not related to the shot administered to him. The DCGI''s conclusions were based on the recommendations of an independent expert committee, which also opined that compensation should not be paid to the volunteer.

Asked about the quantum of compensation given in past clinical trials, Somani said: "I don''t have the figures offhand, but I can certainly tell you it is more than Rs 12 crore."

The DGCI, however, did not mention any timelines or details of the cases and elaborated procedures followed for giving approvals for phase 1, 2 and 3 clinical trials and in case of SAEs during such tests.

Somani said over 10-15 ethics committees had been cancelled and more suspended for not following due processes, adding that he did not have an offhand figure. He added that compensation was given when the causality was found to be related to the trial.

At present, clinical trials and new drugs are regulated under the New Drugs and Clinical Trials Rules. It contains various provisions for ensuring ethical conduct of clinical trials and provisions for inspection, compensation, accelerated review process and regulatory action in case of non-compliance.

Somani said the principal investigator of a would have to report a SAE within 24 hours, while the institutional ethics committee of a trial site would have to send its report over the same and state whether there was a causal link between serious adverse effect and the investigational product. The sponsor of the trial will have to report the serious adverse event within 14 days.

Then, there is the Data Safety and Monitoring Board, which is independent of the vaccine manufacturing company and the government, and consists of domain experts who also monitors the clinical trial on a day-to-day basis and report on adverse events, according to Somani.

All the reports are analysed by the Central Drugs Standard Control Organisation and an independent expert committee. If the SAE (of hospitalisation or death) are found related to the trial, the compensation is ordered by central licensing authority as per rules, which has to be paid by the sponsor to the subject, Somani added.