Pharmaceutical company Cipla, according to sources, has now got Drugs Controller General of India’s (DCGI) nod to import Moderna’s COVID-19 vaccine for restricted emergency use in India. Cipla had sought DGCI’s permission for importing and marketing authorisation of Moderna’s coronavirus vaccine earlier on Tuesday (June 29). There are currently two homegrown vaccines for the coronavirus in India, Covishield and Covaxin, along with Russia’s Sputnik V. Moderna will be the fourth vaccine to be in use in the country.
Cipla gets DCGI nod to import Moderna’s COVID-19 vaccine for restricted emergency use in India: Sources
— Press Trust of India (@PTI_News) June 29, 2021
Cipla filed an application on Monday seeking permission for import of Moderna’s COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 as per which if the vaccine is approved by the US Food and Drug Administratio (USFDA) for Emergency Use Authorization (EUA), the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
Also, the requirement of testing of every batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin. However, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release as per standard procedures, Cipla said referring to the DCGI’s new revised rules.
Moderna through a separate communication had 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 had submitted the dossiers through e-mail. “This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines,” Moderna said.
(With PTI inputs)