Cipla gets govt's nod to import Moderna vaccine

June 29, 2021 15:15

Jab we met

India's drug regulator CDSCO has granted restricted emergency use authorisation for Moderna's COVID-19 vaccine to pharmaceutical company Cipla.

In a separate communication, Moderna has informed that the US has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to the Government of India and has sought approval from the Central Drugs Standard Control Organisation (CDSCO).

Cipla, on behalf of the US pharma major, had requested for import and marketing authorization of these jabs.

CDSCO was in favour of granting permission to Cipla for import of Moderna's COVID-19 vaccine for restricted emergency use in India considering the pandemic situation in the country and in public interest.

Cipla had filed an application on Monday seeking permission for import of Moderna's COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 as per which if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.

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