Last Updated on December 31, 2023 by The Health Master
The Drugs Controller General of India (DCGI) has granted permission to pharma major Cipla to import Moderna’s C-19 vaccine for restricted emergency use in the country.
Moderna’s vaccine, which is said to be 90 per cent effective against C-19, will be the fourth jab to be available in India after Covishield, Covaxin and Sputnik.
Moderna on June 27, 2021 sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines. The US drugmaker in a communication stated that the US government has agreed to donate a certain number of doses of its C-19 vaccine through COVAX to India for use.
A day later, Cipla, on behalf of Moderna, requested DCGI for import and marketing authorisation of these jabs.
Cipla, in its application to the drug regulator, pointed out the government’s decision to waive bridging trials for foreign vaccines if it is cleared for emergency use in countries like the US and if the safety assessment data of the first 100 beneficiaries is submitted before mass rollout.
According to DCGI’s revised rules issued on June 1, 2021, there is no requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli 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.
Moderna’s vaccine is an mRNA vaccine that has fragments of the genetic material known as messenger RNA. The vaccine works by giving cells temporary instructions to make the coronavirus spike protein. The protein is found on the surface of the C-19 virus.
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