New Delhi
The approval was granted under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting. Adverse events following immunization will continue to be monitored. The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in an adult population subject to certain conditions.
Prakash Kumar Singh, Director, Government, and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorization for Covishield. The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.
''Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy 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 market authorization for Covaxin.
Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
Also Read: Regular market approval to Covishield, Covaxin expected soon after final price fixation: Sources
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