US-Based Moderna Seeks DCGI Approval For Its mRNA COVID-19 Vaccine In India: Report
Sophy Ridge (Twitter)In a positive development, United States based biotech firm Moderna has sought approval from Drug Controller General of India (DCGI) for emergency authorisation of its messenger RNA based Covid-19 vaccine in the country.
The Indian drug regulator is likely to grant restricted emergency use authorisation for Moderna's Covid-19 vaccine soon, reports Economic Times.
In addition, the US biotech firm has reportedly informed that under the COVAX initiative, the US government has agreed to donate a certain number of doses of the Moderna Covid-19 jab to India and the company has sought regulatory nod from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
According to the report, Mumbai-based pharma major Cipla filed an application on behalf of Moderna with the CDSCO seeking permission for import and marketing authorisation of these jabs.
An approval for Cipla's request is likely to come soon as the CDSCO is in favour of doing so, sources were quoted in the report as saying.
Cipla, in its application filed on Monday (28 June) has sought permission for import of Moderna Covid-19 jab and referred to the DCGI notices issued earlier in which the drug regulator stated that if any jab is approved by US FDA for EUA, the vaccine can be granted marketing authorisation without bridging trial.
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