The Drugs Controller General of India (DCGI) has given its approval for Cipla to import the Moderna vaccine against coronavirus in India, a day after the pharmaceutical major filed its application. However, the approval is restricted for emergency use in the country, said Niti Aayog member Dr V.K. Paul.
Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik. "We will soon close the deal on Pfizer as well," Paul added.
Moderna has proposed to launch a single-dose vaccine for the Indian market.
Cipla filed an application on Monday 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 bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
"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.
Also, the requirement of testing of every batch by 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 according to standard procedures, Cipla said referring to the DCGI's new revised rules.
Further, Moderna through a separate communication has informed that the US government has agreed to donate a certain number of doses of the Moderna vaccine, mRNA-1273, through COVAX to the government of India for use in the country and has submitted the dossiers through e-mail.
