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SII had applied for market approval for the Covishield vaccine in December 2021 and Bharat Biotech has also applied for the same 10 days ago.
Drugs Controller General of India (DCGI)'s Subject Expert Committee on Friday sought more data from Bharat Biotech and Serum Institute of India (SII) before granting full market approval to Covaxin and Covishield, said sources.
Sources added that SII and Bharat Biotech can't be allowed to sell Covaxin and Covishield in open market till government is mapping vaccination through specific nationwide drive via Cowin App.
SII had applied for market approval for the Covishield vaccine in December 2021 and Bharat Biotech has also applied for the same 10 days ago.
However, both Covaxin and Covishield are currently authorized for emergency use only. EUA does not represent approval of a vaccine in the full statutory term but authorises the use of an unapproved product or unapproved use of an approved product in a declared state of emergency such as a pandemic. A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions.
(Edited by : Aditi Gautam)
First Published: Jan 14, 2022 10:56 PM IST
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