Vaccine no. 4 is here! DGCI Approves Moderna Vaccine for India
- Cipla to import Moderna COVID-19 vaccine for emergency use
- Moderna will be the fourth COVID-19 vaccine available in the country
- Will have to submit a 7-day assessment of its first 100 vaccine administrations
New Delhi: India’s drug regulator DCGI has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna
COVID-19 vaccine for restricted emergency use in the country, official sources reported on Tuesday.
After Covishield, COVAXIN and Sputnik, Moderna would be the fourth COVID-19 vaccine available in the country.
A source reported PTI- “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.”
Modena on June 27 informed DGCI that the US government had agreed to donate a few 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.
Cipla, on Monday, on behalf of the US pharma major, requested the drug regulator for import and marketing authorisation of these jabs. As reported by an official, the vaccine is restricted to be used in emergency situations in the public interest. The firm is instructed to submit a 7-day assessment of the vaccine in its first 100 administrations before rolling out for commercial use.
The Central government, April issued detailed guidelines and proactively eased the entry of foreign-made COVID-19 vaccines approved by the US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India.
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