The approval was granted under the New Drugs and ClinicalTrials Rules, 2019. Under the conditions, the firms shall submit data ofongoing clinical trials and the vaccines to be supplied for programmaticsetting besides recording all vaccinations done within the country on the CoWINplatform, the sources said. Adverse event following immunisation will continueto be monitored as part of the conditions.
The Drugs Controller General of India's (DCGI) approval cameafter the Subject Expert Committee (SEC) on COVID-19 of the Central DrugsStandard Control Organisation (CDSCO) on January 19 recommended grantingregular market approval to the Serum Institute of India's (SII's) Covishieldand Bharat Biotech's Covaxin for use in adult population subject to certainconditions.
Prakash Kumar Singh, Director, Government and RegulatoryAffairs at SII, had submitted an application to the DCGI on October 25 seekingregular market authorisation for Covishield. The DCGI had sought more data anddocuments from the Pune-based company following which Singh recently hadsubmitted a response along with more data and information.
"Such a large-scale vaccination with Covishield andcontainment of COVID-19 infection is in itself a testimony of the safety andefficacy of the vaccine," he had said. In an application sent to the DCGI,V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech,submitted complete information regarding chemistry, manufacturing and controls,along with the pre-clinical and clinical data while seeking regular marketauthorisation for Covaxin.
Bharat Biotech International Limited (BBIL) took up thechallenge to develop, produce and clinically evaluate a vaccine (Covaxin), fromthe SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had saidin the application. Covaxin and Covishield were granted Emergency UseAuthorisation (EUA) on January 3