Moderna seeks regulatory approval for Covid-19 vaccine in India
Moderna has sought regulatory approval for its COVID-19 vaccine in India, PTI sources said, adding that the Drugs Controller General of India (DCGI) is likely to approve the American pharmaceutical's vaccine soon for emergency use in those aged 18 and above.
Moderna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna 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.
Mumbai-based pharmaceutical firm Cipla, on behalf of the US pharma major, has requested for import and marketing authorisation of these jabs.
According to the sources, an approval is likely to come anytime as the CDSCO is in favour of doing so.
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.
READ MORE: Drones controlled from across border; RDX likely used in Jammu IAF station blast: Sources
READ MORE: UP: Twitter India chief Manish Maheshwari named in FIR over incorrect map of India
