The firms, in this case, Bharat Biotech (Covaxin) and Serum Institute of India (Covishield), shall submit data of ongoing clinical trials. All vaccination data will be recorded on the CoWIN platform. The approval is only for adult population.
Adverse events following immunisation will continue to be monitored as part of the conditions.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation 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.
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 authorisation for Covaxin.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
