Guwahati: India’s drug’s regulator gave normal market approval for the COVID-19 vaccines Covishield and Covaxin for use in the adult population today, subject to certain conditions.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019.
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.
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.
He had stated, “Such a large-scale immunisation with Covishield and control of COVID-19 infection is in itself a witness of the vaccine’s safety and efficacy.”