Govt Panel Recommends Regular Market Approval for Covishield, Covaxin
The recommendations will be evaluated by the DCGI, which will then announce a final decision in the matter.
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A government expert panel on Wednesday, 19 January, recommended the granting of regular market approval to Covishield and Covaxin.
The vaccines against COVID-19, manufactured by Serum Institute of India (SII) and Bharat Biotech, have hitherto received authorisation only for emergency use in the country.
The recommendations of the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) will be evaluated by the Drugs Controller General of India (DCGI), which will then announce a final decision in the matter.
"SEC of CDSCO has recommended for upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions In adult population, DCGI will evaluate the recommendations and give its decision," CDSCO said in a statement on Wednesday.
The committee has recommended the granting of regular market approval to Covishield and Covaxin subject to certain conditions, an official source told news agency PTI.
Earlier this month, the panel has sought more information from both Bharath Biotech and SII to grant regular approval.
The development comes at a time when India is witnessing a nationwide surge in coronavirus infections. The country reported 2.82 lakh new COVID-19 cases on Wednesday. A total of 158.88 crore vaccine doses have been administered in India so far.
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