Govt expert panel recommends regular market approval for Covishield, Covaxin

SII and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation

A regulatory expert panel on Wednesday recommended granting regular licence for Covishield and Covaxin instead of emergency use authorisation after more than a year of their use in India’s Covid-19 vaccination programme.

“The SEC (subject expert committee) of CDSCO has recommended upgrade of the (regulatory) status of Covishield and Covaxin from restricted use in emergency situations to grant of new drug permission with conditions in the adult population,” the Central Drug Standard Control Organisation said in a tweet.

“The Drugs Controller General of India will evaluate the recommendations and give its decision,” it said.

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Significance unclear

The significance of the decision is unclear at the moment as the Covid-19 vaccination in India is fully controlled by the Centre.

There are, however, speculations that a regular licence may pave the way to improve the availability of the two vaccines in the market in future as India plans to expand its booster campaign.

India has so far administered more than 159 crore doses of Covid-19 vaccines, of which 137 core plus is Covishield and 21.75 crore is Covaxin.

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