Moderna seeks regulatory approval for its Covid vaccine in India: Report1 min read . Updated: 29 Jun 2021, 12:47 PM IST
- Cipla has applied for import and marketing authorisation of Moderna's covid jabs, sources told PTI
The Drugs Controller General of India (DCGI) likely to approve Moderna's Covid-19 vaccine soon for emergency use in those aged 18 and above as the US pharma company seeks regulatory approval for its vaccine in India, sources told news agency PTI.
As per the sources, Mumbai-based Cipla has applied for import and marketing authorisation of Moderna's covid jabs.
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.
According to the sources, an approval is likely to come anytime as the CDSCO is in favour of doing so.
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.
Several foreign vaccine makers such as Pfizer, Moderna have demanded an indemnity bond that will exempt them from legal claims in case there are any adverse effects from the vaccines when administered in India.
(With inputs from PTI)
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