Moderna has applied for DCGI approval for its Covid-19 vaccine in India. Phrama major Cipla has applied for a license to import and sell Moderna’s Covid vaccine in India, according to government sources.
A vial of the Moderna Covid-19 vaccine in a clinic in Germany. (Reuters photo)
Moderna has filed for regulatory approval for its Covid-19 vaccine in India. According to official sources, the Indian Medicines Agency could soon issue a restricted emergency approval for Moderna’s Covid-19 vaccine.
The Drug Controller General of India (DCGI) is likely to approve Moderna’s Covid-19 vaccine for emergency use in people aged 18 and over, sources told India Today on Tuesday.
Mumbai-based pharmaceutical company Cipla has applied to DCGI for permission to import the Covid-19 vaccine from Moderna into India. Cipla has also applied for marketing authorization for these injections on behalf of the US pharmaceutical company.
Cipla filed an application for import authorization for Moderna’s vaccine on Monday, referring to DCGI releases dated April 15 and June 1.
In its filing, Cipla said that if the vaccine is approved for EUA by the USFDA, the vaccine can be approved without a bridging attempt and an assessment of the safety data of the first 100 vaccine beneficiaries must be submitted prior to entry into the immunization program.
The decision on DCGI approval of Moderna’s Covid-19 vaccine is expected to be finalized this week. “The DCGI could consider Cipla to import Moderna’s Covid-19 vaccine in three days,” added sources.
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Moderna has also announced that the U.S. government has agreed to donate a certain number of doses of the Moderna Covid-19 vaccine via COVAX to the Government of India for use and the Central Drugs Standard Control Organization (CDSCO) approval for it applied for these vaccines.
If Moderna gets the DCGI nick, around a hundred people will receive a dose of the Covid vaccine. Those 100 people will then be watched before the Moderna vaccine is made available to the public, it said.
This is imperative as Moderna did not conduct a bridge study in India.
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