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The Pune-based Serum Institute, the world’s largest vaccine-maker, requested approval for the Oxford vaccine, Covishield, on December 6.
New Delhi: Serum institute and Bharat Biotech’s proposals for emergency vaccine use were not cleared today over inadequate safety and efficacy data, sources said on Wednesday. The two have been asked by a panel of experts to provide more data that will be considered in the next meeting.
“Both proposals are not approved due to inadequate safety and efficacy data available currently. Both have been asked for more data,” the sources told NDTV.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met today to review the applications of Pfizer, Serum Institute of India and Bharat Biotech. Approvals are a long process and this is only the start, sources said.
The committee can make recommendations but it is the Drugs Controller General of India (DCGI) that decides on approvals, the health ministry said.
“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.
The Pune-based Serum Institute, the world’s largest vaccine-maker, requested approval for the Oxford vaccine, Covishield, on December 6.
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.
News Credit NDTV