The Central Drugs Standard Control Organisation (CDSCO) has sought more data from Serum Institute of India (SII) and Bharat Biotech in order to clear their COVID-19 vaccine candidates for emergency use in the country, sources said on December 9.
Applications seeking emergency use authorisation for Oxford-AstraZeneca's Covishield, being manufactured by SII, and Covaxin, being developed by Bharat Biotech, were not considered for clearance by the Subject Expert Committee (SEC) due to "lack of safety" and inadequate data on efficacy, the sources told News18.
"Both proposals were not considered due to inadequate safety and efficiency data available currently. Both the companies have been asked for more data," the sources said.
"Both Bharat Biotech and SII will need to come back again to the SEC with more data, trial information, and documents," the sources added.
Bharat Biotech declined to comment, while SII hasn't responded to messages from Moneycontrol seeking comment on the drug regulator's decision.
The CDSCO expert panel took the decision in its meeting held on December 9 to review the applications of Pfizer, SII, and Bharat Biotech.
"It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks," NDTV quoted sources in SII as saying.
Pune-based SII and Hyderabad-based Bharat Biotech had applied for emergency use authorisation (EUA) of their respective vaccine candidates on December 6 and 7, respectively.
The Indian arm of the US pharmaceutical giant Pfizer on December 4 sought approval for its vaccine from the drug regulator after the firm secured clearance in the UK and Bahrain.
The UK became the first country in the world to began immunizing its citizens against the viral disease when it rolled out Pfizer's vaccine on December 8.