Drug major Cipla on Tuesday received a nod from the Drugs Controller General of India (DCGI) to import Moderna's COVID-19 vaccine for restricted emergency use in India, sources told CNBC-TV18. It will be the fourth vaccine to be administered in India after Covishield, Covaxin and Sputnik V.
Cipla is currently facilitating Moderna for the import of donated vaccines into the country. No commercial supplies or deal has been reached yet. On the other hand, Cipla will not need separate DCGI approval as and when they work out a commercial deal with Moderna.
Cipla had on June 28 filed an application with the DCGI to import Moderna vaccine in India.
Moderna through a separate communication has informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 Vaccine, mRNA-1273, through COVAX to the Government of India for use in India and has submitted the dossiers through e-mail.
The Centre had in 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. According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.
With inputs from PTI