Cipla gets nod to import Moderna’s COVID-19 vaccine in India: Report

Mumbai-based pharmaceutical company Cipla has received India’s drugs regulator’s nod to import the COVID-19 vaccine developed by US-based Moderna, reported news agency PTI, quoting sources. This will be the fourth COVID vaccine to be rolled out in India after AstraZeneca’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V.

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The Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna’s vaccine for restricted use in the country, the source said. The permission was granted under the provisions of the New Drugs and Clinical Trial Rules, 2019 under the Drugs and Cosmetics Act, 1940

Cipla, on behalf of Moderna, on Monday had sought DCGI’s permission for import and marketing authorisation of the jabs. 

Meanwhile, in a separate communication on Sunday, Moderna told the DCGI that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to India for use here and sought approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.

“This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines,” the US pharma major said.

In a bid to expedite the COVID vaccine rollout in India, the DCGI decided to waive testing of batches at CDL (Central Drugs Laboratory) for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK’s MHRA or the WHO.

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In April, the Centre eased norms for the entry of foreign vaccines that have been approved for use in the US, UK, the European Union (EU), Japan and by the WHO.