Covaxin, Covishield granted market approval in India but conditions apply
Covaxin and Covishield were granted market approval in India for use in the adult population subject to certain conditions.
India's drug regulator granted market approval for Covid-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions on Thursday. The approval was granted under the New Drugs and Clinical Trials Rules, 2019.
Informing about the market approval for the two Covid-19 vaccines, Union Health Minister Dr Mansukh Mandaviya tweeted on Thursday, "The @CDSCO_INDIA_INF [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."
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for a programmatic setting. Adverse events following immunisation will continue to be monitored, news agency PTI quoted sources as saying.
"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," Mansukh Mandaviya said in another tweet.
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. — Dr Mansukh Mandaviya (@mansukhmandviya) January 27, 2022
These two vaccines won’t be sold at shops. However, private hospitals and clinics can buy and administer the doses to the public, sources in the Union health ministry said on Thursday.
Hospitals and clinics registered under the government’s National Health registry and/or approved by the National Accreditation Board for Testing and Calibration Laboratories (NABL) will be allowed to keep stock of these vaccines, sources said.
There will no longer be 25 per cent vaccine quota for private hospitals, they said. Earlier, the government had allowed private hospitals to buy 25 per cent of the vaccines manufactured in the country.
Sources said Covishield -- manufactured by Serum Institute of India -- and Covaxin -- manufactured by Bharat Biotech -- will be kept in stocks at hospitals and clinics only for now.
They said details of vaccines being administered must be submitted on the Cowin platform.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
(With inputs from PTI)