Lagatar24 Desk
New Delhi, Jan 27: The COVID-19 vaccines Covishield and Covaxin received normal market approval from India’s medicines regulator on Thursday, subject to certain conditions.
The New Drugs and Clinical Trials Rules of 2019 were used to grant the 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,” said Union Health Minister Dr Mansukh Mandaviya.
Under the terms of the agreement, the companies must disclose data from ongoing clinical trials as well as vaccines to be supplied for programmatic purposes. The incidence of adverse events following immunisation will be closely examined.
The Drugs Controller General of India (DCGI) gave its approval after the Central Drugs Standard Control Organisation (CDSCOSubject )’s Expert Committee (SEC) on COVID-19 recommended granting regular market approval to the Serum Institute of India’s (SII’s) Covishield and Bharat Biotech’s Covaxin for use in adult population under certain conditions on January 19.
Mandaviya tweeted that the criteria include providing programmatic settings, such as registration on the Co-Win platform, and continuing to report safety statistics on a six-monthly basis.
On October 25, Prakash Kumar Singh, SII’s Director of Government and Regulatory Affairs, filed an application with the DCGI requesting normal market authorisation for Covishield.
The DCGI had requested further data and papers from the Pune-based firm, and Singh had just responded with additional data and information.
Notably, Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
