The requests for emergency use of vaccines being manufactured by the Serum Institute (SII) and the Bharat Biotech were not cleared on Wednesday by a panel of health experts, sources in the Union Health Ministry said, adding that both companies have been asked to submit more data at the next meeting, the date of which has not yet been decided.
The final call on the suitability of the vaccine will be taken by the Drug Controller of India or DCGI.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met to review the applications of Pfizer, Serum Institute of India and Bharat Biotech. Pfizer was on the agenda but was not considered as their experts were not available.
Approvals are a long process and today’s review is only the start, sources said.
Reuters quoted a “source with direct knowledge of the matter” as saying that a decision on the vaccines would be taken “in toto” and it was too early to say whether they would be rejected or accepted.
“It is standard practice for the Government to hold several meetings. The process is expected to go on for one or two weeks,” sources in Serum Institute said on the development.
On December 6, the Pune-based Serum Institute, the world’s largest vaccine-maker, requested approval for the Oxford-AstraZeneca vaccine candidate, Covishield while pharma giant Pfizer sought Indian approval after securing clearances in the UK and Bahrain.
On Monday, Hyderabad-based Bharat Biotech became the third vaccine-maker to apply to the DCGI for emergency use authorisation for its indigenously-developed Covid-19 vaccine Covaxin.