Regular market approval granted for Covishield, Covaxin for use in adult population

India's drug regulator has granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, Health Minister Mansukh Mandaviya said on Thursday.

The minister also said that the government's vaccination drive will continue as it is to provide first and second doses for all and a precautionary dose for senior citizens.

''The regulator has upgraded the permission for COVAXIN and Covishield from restricted use in emergencies to normal new drug permission in the adult population with certain conditions,'' Mandaviya said.

Soon after the approval, highly-placed sources said the two vaccines will now be available in private clinics at pre-decided MRP and people can buy those.

Gradually, the vaccine will be available in the market at a price lower than what it was being sold earlier at private hospitals, sources added.

''The idea is that those who are keen to get a booster dose can now avail it through private clinics as the vaccine available in private clinics can be used for any purpose, whether it's first dose, second dose, or a booster as one wishes,'' a source said.

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 besides recording all vaccinations done within the country on the Cowin platform.

Adverse events following immunization will continue to be monitored as part of the conditions.

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.