Government expert panel recommends regular market approval for Covishield, Covaxin

Prakash Kumar Singh, director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter.

Published: 19th January 2022 09:15 PM  |   Last Updated: 20th January 2022 08:13 AM   |  A+A-

Covishield and Covaxin (Image for Representational Purpose)

By Express News Service

NEW DELHI: In a much-anticipated move, an expert panel of the Central drug authority approved Covishield and Covaxin in the open market on Wednesday. The two Covid-19 vaccines were until now authorised for emergency use only.

“Subject Expert Committee of Central Drugs Standard Control Organization (CDSCO) has recommended upgrading Covishield and Covaxin status from restricted use in emergency situations to grant new drug permission with conditions in the adult population. The Drugs Controller General of India (DCGI) will evaluate the recommendation and decide,” tweeted CDSCO on Wednesday.

Serum Institute of India (SII) and Bharat Biotech — which was pressing for large-scale vaccination and even supplying abroad — had submitted applications to the Drugs Controller General of India (DCGI), which approvaes licenses of specified categories of drugs, seeking regular market authorisation for their vaccines.

Serum Institute of India’s director Prakash Kumar Singh had applied for approval last October, but the government had sought more details from the company. After the company supplied the relevant data and documents, the expert committee went through them. 

Covaxin-maker Bharat Biotech, the indigenous vaccine supplier, made a similar request recently. The company attached data to substantiate its claim for regular market sale approval. What worked in their favour was that already, the two pharma companies were supplying the vaccines. Over 100 crore doses of Covishield have been administered to date.

In India, 158.88 crore doses of the two vaccines had been administered as of January 19. The Central government has allowed vaccines to be given to persons in the age group of 15-18.

50% of infected SC staff back in duty
New Delhi: Over 50 per cent of the total 322 Covid positive Supreme Court employees have reported back to duty. Others are recovering with hardly any case needing hospitalisation, sources said on Wednesday. “Only 322 cases were reported as positive in the third wave and most importantly, over 50 per cent have reported back to duty,” officials said. On the number of judges affected by the virus, they said out of four judges, two have started holding court.


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