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Cipla Gets DCGI’s Approval to Import Moderna’s COVID Vaccine For Emergency Use in India

New Delhi: Hours after it sought approval, the Drugs Controller General of India (DGCA) on Tuesday granted consent to Cipla to import Moderna’s COVID-19 vaccine. ANI news agency stated that the Centre is likely to make a detailed announcement soon. Notably, Cipla is a multinational pharmaceutical company headquartered in Mumbai.

It was earlier in the day reported that the DGCA may soon grant restricted emergency use authorisation for Moderna’s COVID-19 vaccine, official sources said on Tuesday.

Moderna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COVAX to the Government of India for use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.

Mumbai-based pharmaceutical firm Cipla, on behalf of the US pharma major, has requested for import and marketing authorisation of these jabs.

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



source https://www.india.com/news/india/moderna-gets-dcgi-approval-to-import-covid-vaccine-for-emergency-use-in-india-4776084/

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