Drug regulator grants conditional market approval to Covishield and Covaxin

The regular market approval to the two vaccines has been granted for use in the adult population, said official sources.

Sources said the vaccines will not be available in medical stores even after the market approval has been granted. Hospitals and other health clinics are now allowed to purchase the vaccines but the vaccination data has to be submitted to DCGI every six months. This data will also be required to be updated on CoWIN app also.

It was reported that the market approval, which is subject to certain conditions, was given under the New Drugs and Clinical Trials Rules, 2019.

Sources said the firms manufacturing the vaccines – the Serum Institute of India (Covishield) and Bharat Biotech (Covaxin) will have to submit data of clinical trials that are underway as well as of vaccines to be supplied for programmatic setting.

The firms would also have to monitor any adverse events that are seen following immunisation.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had on January 19 cleared the proposal to grant regular market approval to the two vaccines.

Union Health Minister Dr Mansukh Mandaviya tweeted following the grant of market approval: “The Central Drugs Standard Control Organisation (CDSCO) has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.

“The conditions include supply for programmatic settings including registration on the CoWIN platform and to continue to submit safety data on a six-monthly basis.”

The minister clarified that the government-run drive of free vaccination for COVID-19 will continue despite the development.

While Covaxin has been developed indigenously by Hyderabad-based Bharat Biotech, the Pune-based SII is manufacturing Covishield under license from the University of Oxford and Swiss pharma giant AstraZeneca, which have jointly developed the vaccine.

Prakash Kumar Singh, the director of government and regulatory affairs at SII, had submitted an application with the DCGI on October 25 to seek regular market approval for Covishield.

The DCGI had then asked for more data and documents from SII, and Singh recently submitted the response.

“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 is reported to have stated.

The DCGI had granted Emergency Use Authorisation (EUA) to both Covaxin and Covishield on January 3 last year. The COVID-19 immunisation programme had started in the country on January 16, 2021.