Regular market approval granted for Covishield, Covaxin for use in adult population

January 27, 2022 15:07

A Christmas tree of empty vials of Covishield vaccine

India's drug regulator on Thursday granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said.

The approval was granted under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.

Adverse event following immunisation will continue to be monitored.

The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 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 subject to certain conditions.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation for Covishield.

The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information. "Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine," he had said.

« Back to LIVE

TOP STORIES

Top-seeded Bopanna-Ebden stunned at Madrid Masters

The duo made the men's doubles semi-finals at Wimbledon and the final of the US Open in the same season.

92 Of 102 Seats In First Phase Saw Voter Turnout Drop

As the comparison between 2014 and 2019 shows, the voter turnout is not only lower than in 2019 but also lower than in 2014 in some of the larger states where polling took place.

'BJP Underperformance May Trigger Market Correction'

'This can eventually start the end of the current market frenzy, which has lasted for a full year.'

2 more Delhi Cong leaders quit over alliance with AAP

Two former MLAs Neeraj Basoya and Nasseb Singh resigned from the primary membership of the party putting the party's Lok Sabha preparations in doubt.

More than 60 Delhi-NCR schools get bomb threats, LG seeks detailed report

All five schools have been evacuated after local police were informed about the emails, they added.