Clinical trial participants paid over Rs 12 crore compensation in last 3 years for adverse events: DCGI
Addressing a webinar, ''Regulatory Pathways for COVID19 Vaccines, Clinical trials, Rolling Reviews and Adverse Event Monitoring'', Drugs Controller General of India (DCGI) V G Somani said registration of 10 to 15 ethics committees at trial sites across the country were canceled and even more than that were suspended for not adhering to the rules.;
New Delhi: Over Rs 12 crore has been paid since 2013 as damages to participants suffering serious adverse events (SAEs) during clinical trials, officials said on Friday.
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.
Read also: Envoys of 80 countries to visit Bharat Biotech, Biological E on December 9
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.