STOCK MARKET BSE NSE

Oxford episode fallout: Rs 12 crore relief to volunteers of clinical trial for adverse effect 

The details of the number of these participants, the companies involved and the details of the trials, however, were not made public by the Drugs Controller General of India (DCGI).

Published: 05th December 2020 02:26 AM  |   Last Updated: 05th December 2020 09:27 AM   |  A+A-

This undated file photo issued by the University of Oxford on Monday, Nov. 23, 2020, shows of vial of coronavirus vaccine developed by AstraZeneca and Oxford University. (Photo | AP)

By Express News Service

NEW DELHI: The Central Drugs Standards Control Organisation (CDSO) has ordered cumulative compensation worth Rs 12 crore in the last three years to clinical trial participants who suffered serious adverse events.

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 cancelled 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 crore and a halt to the trial.

ALSO READ | Covishield in open market after March-April: Serum Institute of India on Oxford vaccine

The details of the number of these participants, the companies involved and the details of the trials, however, were not made public by the Drugs Controller General of India (DCGI).

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.

ALSO READ | Covid-19 vaccine by AstraZeneca-Oxford sparks controversy amidst concerns that crucial information was not revealed

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.

(With PTI Inputs)



Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp