India’s drug regulator on 27 January 2022 granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions. The clearance was granted under the New Drugs and Clinical Trials Rules, 2019. Market approval, however, does not mean that the vaccines will be available in medical shops. People will have to buy Covishield and Covaxin from hospitals and clinics, and the vaccination data have to be updated on Co-Win.
The Drugs Controller General of India’s (DCGI) permission came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended vesting regular market license to the Serum Institute of India’s (SII’s) Covishield and Bharat Biotech’s Covaxin for use in the adult population subject to certain conditions. Under the circumstances, 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.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had proposed 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.
In an application sent to the DCGI, V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech, presented complete information concerning chemistry, manufacturing, and controls, along with the pre-clinical and clinical data while seeking regular market authorization for Covaxin.
The National Pharmaceutical Pricing Authority (NPPA) has been directed to start working towards capping the price to make the vaccines affordable. the vaccine is likely to be capped at ₹275 per dose plus an additional service charge of ₹150, official sources said.