DCGI Grants Conditional Market Approval For Covishield and Covaxin

Drugs Controller General of India (DCGI) grants conditional market approval for Covishield and Covaxin.

New Delhi: The Drugs Controller General of India (DCGI) on Thursday granted conditional market approval for Covishield and Covaxin. However, it is important to note that the market approval does not mean that the vaccines will be available in medical shops. People will have to buy Covishield and Covaxin from hospitals and clinics. Vaccination data has to be submitted to DCGI every six months and data will have t to be updated on CoWIN app also.

“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,” Union Health Minister Dr Mansukh Mandaviya tweeted.

“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,” he added.

The @CDSCO_INDIA_INF 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.

— Dr Mansukh Mandaviya (@mansukhmandviya) January 27, 2022

Earlier, reports had suggested that the DCGI is expected to give the regular market approval to both the vaccines after the price fixation. A PTI report, quoting official sources, had stated 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.

According to them, the National Pharmaceutical Pricing Authority (NPPA) has been directed to start working towards capping the price to make the vaccines affordable. As of now, Covaxin is priced at Rs 1,200 per dose while Covishield costs Rs 780 in private facilities. The prices include Rs 150 service charge. Both the vaccines are only authorised for emergency use in the country.

An Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation on January 19 recommended granting regular market approval to Covid vaccines Covishield and Covaxin for use in the adult population subject to certain conditions.

Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin, which are currently only authorised for emergency use in the country.

“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech’s application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions,” an official source had said earlier.