Moderna vaccine likely to get DCGI’s nod soon, Cipla to import and market COVID jab
The Drug Controller General of India (DCGI) is likely to approve Moderna's Covid-19 vaccine for emergency use in those aged 18 and above.
FollowModerna has sought regulatory approval for its Covid-19 vaccine in India. According to official sources, India's drug regulator may soon grant restricted emergency use authorisation for Moderna's Covid-19 vaccine.
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.
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.
The approval is likely to come soon as CDSCO is in favour of doing so, PTI reported.
Cipla filed an application seeking permission for import of Moderna Covid-19 vaccine on Monday. It referred to DCGI notices dated April 15 and June 1, which state that if the vaccine is approved by the USFDA for Emergency Use Approval (EUA), the vaccine can be granted marketing authorization without a bridging trial and the assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in the immunization programme.
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.
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