India’s drug regulator DCGI has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
Moderna’s vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik.
“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,” a source told PTI.
The company sought Drugs Controller General of India (DCGI) nod for importing Moderna’s coronavirus vaccines, sources informed ANI. According to the sources, Cipla filed an application recently 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 trial and assessment of safety data first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
Moderna’s method to protect against Covid-19 relies on messenger RNA (mRNA) to program cells to generate immunity to the coronavirus. The vaccine has shown more than 90 % efficacy in clinical trials in protecting against Covid-19.