Healthcare NGO raises concerns over Covaxin

New Delhi: A day before India begins the world’s largest Covid-19 vaccination drive, a group of healthcare-focused NGOs has sought clarifications from the government on the approval given to Bharat Biotech’s Covaxin. Concerns have been raised on whether legal protection will be available under the law for those taking Covaxin, which is still undergoing clinical trials.

The All India Drugs Action Network has sought information on the protocol through which the vaccine’s use will be restricted, how informed consent from individuals will be taken and whether individuals being vaccinated will benefit from protections available under law to clinical trial participants, including compensation in case of trial-related injury or death, and whether there will be ethics committee oversight of the use of Covaxin. “We are unable to comprehend the meaning of ‘clinical trial mode’ as we are not aware of any such terminology in the Drugs and Cosmetics Act, 1940 and Rules, 1945 or the New Drugs and Clinical Trials Rules, 2019,” said the letter.

The group said there is no information on the Clinical Trials Registry India (CTRI) website on the protocol that was approved by the subject expert committee (SEC), though CTRI registration is a requirement before the enrolment of participants in a clinical trial. It has also sought clarification on how the permissions granted to the vaccines of Bharat Biotech and Serum Institute of India fall short of full licensure.

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