The Drugs Controller General of India (DCGI) on Thursday granted conditional market approval for Covishield and Covaxin.

This means that these two vaccines will be available in the local market, but only with hospitals and clinics. This will not be available in regular medical shops.

The approval has been granted under the New Drugs and Clinical Trials Rules, 2019.

Earlier, it was reported that the National Pharmaceutical Pricing Authority (NPPA), has been asked to start working towards capping the price to make the vaccine affordable. There was reports that the price of Covishield and Covaxin is likely to be capped at Rs 275 per dose plus an additional service charge of Rs 150.

Currently, Covaxin is priced at Rs 1,200 per dose, while Covishield costs Rs 780 in private facilities. The prices include Rs 150 service charge.

Last week, the Subject Expert Committee (SEC), of the Central Drugs Standard Control Organisation(CDSCO), in India had recommended that Covishield and Covaxin vaccines be granted regular market approval but with certain conditions, the CDSCO had tweeted.

The Serum Institute of India (SII) and Bharat Biotech had submitted their respective applications to the country’s drug regulator, the Drugs Controller General of India (DCGI), seeking full market authorisation for their vaccines. The vaccines are currently only authorised for emergency use in the country.

A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions. For full market authorisation, the regulator would need to evaluate more data about the vaccines collected over a longer period of time.