Bharat Biotech seeks emergency use authorization for Covid-19 vaccine
The company filed its application with the Drugs Controller General of India earlier on Monday, the source said.
After Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
On December 4, Prime Minister Narendra Modi at an all-party meeting had expressed hope that a COVID-19 vaccine may be ready in a few weeks.
That same evening, the Indian arm of US pharmaceutical giant Pfizer sought emergency use approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.
The Serum Institute sought such nod for the Oxford COVID-19 vaccine, Covishield, on December 6.
The applications of Bharat Biotech, Serum Institute of India and Pfizer will be reviewed by the subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) in the coming days.
“However, none of the applications has so far been forwarded to the committee and no date has been fixed as on when the SEC will meet for assessing and evaluating the applications,” the official source said.