Both vaccines were granted Emergency Use Authorization (EUA) on 3 January.
India’s drug regulator on Thursday approved the regular market for COVID-19 vaccines Covishield and Covaxin for use in the adult population, subject to certain conditions, official sources said.
The approval was given under the New Drugs and Clinical Trials Rules, 2019.
Under the conditions, firms will submit data on vaccines to be supplied for ongoing clinical trials and programmatic settings. Post-vaccination adverse event will be monitored. Following the approval of Drug Controller General of India (DCGI) by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19 on January 19, Serum Institute of India (SII) recommended regular market approval. was done. Covishield and Bharat Biotech’s Covaxin for use in the adult population subject to certain conditions.
Prakash Kumar Singh, director of government and regulatory affairs at SII, had submitted an application to DCGI on October 25 seeking regular market authorization for Covishield. After DCGI had sought more data and documents from the Pune-based company, Singh had recently submitted a response with more data and information.
“Vaccination and prevention of COVID-19 infection on such a large scale with Kovidshield is in itself a proof of the safety and efficacy of the vaccine,” he had said.
In an application sent to DCGI, Hyderabad-based Bharat Biotech’s whole-time director V Krishna Mohan sought regular market authorization for Covaxin, along with pre-clinical and clinical data, chemistry, Presented complete information about manufacture and control.
Mohan had said in the application that Bharat Biotech International Limited (BBIL) has been involved in the development, production and diagnostics of a vaccine (Covaxin) from SARS-CoV-2 strains isolated from COVID-19 patients in India. Took the challenge of evaluating.
Covaxin and Covishield were granted emergency use authorization (EUA) on 3 January.
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