India permits Cipla to import Moderna vaccines for restricted emergency use

Drugs Controller General of India (DCGI) today permitted Indian pharma giant Cipla to import Moderna's Covid-19 vaccine for restricted emergency use in the country, sources said.

Moderna's vaccine will be the fourth Covid-19 jab to be granted emergency use permission by India.

Serum Institute of India's Covishield, Bharat Biotech's Covaxin, and Russia's Sputnik V have already received emergency use approval in India.

"Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under Drugs and Cosmetics Act, 1940," sources said.

The development comes in the backdrop of Moderna seeking approval from DCGI for its vaccines to be used in India after the US government agreed to donate to India through COVAX.

On Monday, Cipla has, on behalf of the US pharma major, requested the Indian drug regulator for import and marketing authorisation of these jabs.

According to the DCGI notices dated April 15 and June 1, vaccines used in India will be granted marketing authorisation without trials if approved by the USFDA for EUA. However, assessment of safety data of the first 100 jabs has to be submitted before rolling out in immunisation programme.