DCGI issues licensing permit to Bharat Biotech for Covaxin manufacture

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The Drugs Controller General of India (DCGI) on Sunday issued the licensing permit to Bharat Biotech for manufacturing Covaxin, according to the reports of ANI news agency. The Hyderabad based company has been asked to present the revised data pertaining to the aspects of safety, efficacy and immunogenicity data obtained from the ongoing clinical trials at different stages of Phase 1, 11 and 111 till the trials are completed, the agency said.

The DCGI passed a final approval for two Covid-19 vaccine candidates on Sunday, thereby curating the way for a huge inoculation programme for stemming the pandemic in India, which has the second highest number of Covid-19 cases in the world.

Randeep Guleria, director, All India Institute of Medical Sciences appreciated the development and said, “It is a great day for the country and a good way to start the new year.” He further termed Covaxin, which is developed in India, to be used as a back-up.

The DCGI has granted approval for emergency use authorization of two vaccines, one developed by AstraZeneca – Oxford University and the second vaccine developed by Hyderabad based Bharat Biotech with collaboration from Indian council of Medical Research (ICMR) and National Institute of Virology (NIV).

The approvals were passed by DCGI based on the recommendations given by Central Drugs Standard Control Organization (CDSCO). While addressing the media, DCGI Dr V G Somani said, “After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations.” The vaccines are based on a two-dose regimen and require 2 – 8 degree Celsius temperature conditions for storage which makes them more cost-effective when compared with the vaccine candidate by Pfizer and BioTech

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