The Drug Controller General of India VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”.
A day after Subject Expert Committee (SEC) of the government approved the vaccine candidate from Pune-based Serum Institute of India and Hyderabad based Bharat Biotech, the Drugs Controller General of India (DCGI) today announced in a press conference that both candidates have been approved by the regulator for emergency use.
The Drug Controller General of India VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”.
The development comes a day after the subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended Oxford-AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Bharat Biotech’s Covaxin for restricted use. Covaxin is the indigenous vaccine being developed by Bharat Biotech in collaboration with the apex medical body Indian Council of Medical Research (ICMR).
“The approval is confirmed. It’s now a mere formality for the national drugs controller to put out an order,” a senior health ministry official had earlier told Hindustan Times.
“We will have a Happy New Year with something in hand, that’s all I can hint at,” the DGCI VG Somani had said on Thursday.
With DCGI’s nod, India joins a handful of countries, including the US and UK, that have begun vaccinations.
Other than Covishield and Covaxin, two other vaccines arre waiting to be approved – Zydus Cadila’s ZyCoV-D and Russia’s Sputnik V that are both on trial in India.
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