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Full Market Approval For Covishield, Covaxin: DCGI Panel To Meet Again Soon To Review Proposals
Covaxin and Covishield.
The expert panel of the Indian drug regulator is likely to meet again soon to review applications filed by Serum Institute of India (SII) and Bharat Biotech for full market approval to their respective Covid-19 vaccines.
The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) had met on Friday (14 January) to decide on full market approval to Bharat Biotech's Covaxin and SII's Covishield Covid vaccine.
However, the SEC could not finish the review on Friday due to the "huge amount of data" related to the two vaccines, reports Economic Times.
"The data is huge which has to be reviewed and it needs a considerable amount of time. The SEC will meet in the next 1-2 days to finish the review," people in the know of the matter were quoted in the ET report as saying.
A market authorisation label for a vaccine means it can be authorised for use without any reservations or conditions.
Bharat Biotech had on Thursday (13 January) sought regular market approval from the drug regulator for its indigenous Covid-19 vaccine Covaxin.
Earlier last month, SII had also filed an application for full market approval to Covishield.
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