The Indian drug regulator—Drugs Controller General of India (DCGI)—has granted pharma major Cipla the required permission to import the COVID-19 vaccine manufactured by US-based vaccine maker Moderna for restricted emergency use in India. Cipla had approached the DCGI seeking its nod to import and market the jabs.
In a bid to fast-track the approval process, the DCGI had earlier announced relaxation from bridging trials if a foreign-made vaccine is already approved by the USFDA or drug regulators of developed countries and the WHO.
Taking advantage of this relaxation, Cipla in its application had informed the DGCA that the Moderna jab has already been granted emergency use authorisation by US FDA and the European Medical Association.
Cipla has said that since the vaccine has been granted emergency use authorization by the USFDA, it can be granted marketing authorization without a bridging trial. It has also said that the assessment of safety data of the first 100 beneficiaries of vaccines will be submitted before rolling out the immunization drive.
Moderna has also informed that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to the Government of India for use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
India’s vaccination drive
The Indian drug regulator has so far approved three COVID-19 vaccines for emergency use in India—Covishield, Covaxin and Sputnik-V. Many other Indian vaccines candidates are also likely to seek a nod from the drug regulator for emergency use authorization. This apart, US-based vaccine maker Pfizer has also sought permission for emergency use authorization.
India’s immunization drive started in January and has gradually picked up pace as the threat of a third wave of the pandemic looms large. The ministry also informed that over 32.90 crore COVID-19 jabs have been administered so far. Of it, over 52.76 lakh people were vaccinated on Monday.
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