As for Hyderabad-primarily based Bharat Biotech, “after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration,” the suggestions by the SEC stated.
“The SEC on COVID-19 of the CDSCO held a detailed deliberation on both the applications for around four hours. The recommendations by the SEC have been approved by the Drugs Controller General of India (DCGI),” an official supply told PTI.
The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation on Wednesday as the firm sought far more time for producing a presentation prior to the committee.
When did they apply for emergency use authorisation?
On December 7, Bharat Biotech had applied to the Drugs Controller General of India (DCGI) searching for emergency use authorisation for its COVID-19 vaccine Covaxin. Covaxin is getting indigenously created by the Hyderabad-primarily based pharmaceutical firm in collaboration with the Indian Council of Medical Research (ICMR).