Mumbai-based Pharma company CIPLA has received regulator's approval to import Moderna's Covid- 19 Vaccine for restricted use in India, as per news agency PTI.
“Drug 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,” sources said.
“This permission is for restricted use in an emergency situation in the public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of the vaccine for further immunization programme, according to the approval”, an official told PTI.
Moderna’s vaccine will be the fourth Covid 19 jab to be available in India after Covishield, Covaxin, and Sputnik.
Cipla and filed an application seeking permission for import of Moderna’s vaccine on Monday. It referred to DCGI notices dated April 15 and June 1, which state that if the vaccine is approved by the USFDA for Emergency Use Approval (EUA), the vaccine can be granted marketing authorization without a bridging trial.
Moderna is said to be 90 percent effective against Covid. Like Pfizer, Modena is an mRNA vaccine that has fragments of the generic material known as messenger RNA.
Source: Livemint