India’s Vaccine Wait Over: DCGI Approves Serum, Bharat Biotech Vaccines For Emergency Use

DCGI VG Somani said both the drug firms have submitted data on their trial runs and both have been granted permission

On Sunday, the Drugs Controller General of India (DCGI) formally announced the final approval for emergency use of the Oxford-AstraZeneca and Bharat Biotech coronavirus disease (Covid-19) vaccines.

“CDSCO (Central Drugs Standard Control Organisation) accepts rations for reform of Serum and Bharat Biotech Covid vaccines from the subject expert committee,” DCGI VG Somani said in a press conference.

The Oxford-AstraZeneca vaccine, which is manufactured by the Serum Institute of India (SII) as Covishield for emergency use and Covaxin for restricted use, was recommended by the Subject Expert Committee (SEC) under CDSCO. Covaxin is an indigenous vaccine developed by Bharat Biotech in partnership with the Medical Research Council of India (ICMR).

“We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 percent safe. Some side effects like mild fever, pain, and allergy are common for every vaccine,” Somani said.

After receiving emergency clearance for the two vaccines, Prime Minister Narendra Modi congratulated India’s hard-working scientists and innovators.

Prime Minister Narendra Modi tweeted, hailing the scientific community, “It would make every Indian proud that the two vaccines that have been approved for emergency use are made in India!”

“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers, and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” wrote the PM.

On Saturday, India moved a step closer to having a novel coronavirus vaccine as two candidates — Hyderabad-based Bharat Biotech’s Covaxin and India’s Covishield Serum Institute — have been recommended to the DCGI for emergency use in the last two days by a government-appointed panel.

The Subject Expert Committee (SEC) met on Friday and Saturday and accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.

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