Official sources said yesterday that Bharat Biotech has sought from the Drugs Controller General of India (DCGI) regular market approval for its C-19 vaccine, Covaxin’, which is currently only authorized for emergency use in the country, according to official sources.
In an application sent to the DCGI this week, V Krishna Mohan, Whole-Time Director, Bharat Biotech, submitted complete information regarding chemistry, manufacturing, and controls, along with pre-clinical and clinical data, while seeking regular market authorization for Covaxin.
The company, however, is yet to submit the full follow up data of clinical trial of Covaxin to DCGI, a source said.
On 25th October, Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum Institute of India (SII), had submitted an application to the DCGI seeking regular market authorisation for Covishield which is also authorised for emergency use in the country.
In response to the application, DCGI had asked for some more information, following which Singh last week submitted a response along with all the desired data and information to DCGI.
In addition to the successful completion of phase-II/III clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in India and worldwide, Singh is learnt to have stated in the response.
Such a large-scale vaccination with Covishield and containment of C-19 infection is in itself a testimony of the safety and efficacy of the vaccine, he said.
Meanwhile, Covaxin comprises 12 percent of the total C-19 vaccine jabs administered in the country so far and it is the only vaccine that is being given to youngsters in the age group of 15-18 years, inoculation of whom began on January 3rd in the country.
In the application, Bharat Biotech took up the challenge of developing, producing, and clinically evaluating Covaxin, from the SARS-CoV-2 strains isolated from C-19 patients in India, Mohan said.
It was granted the permission to manufacture Covaxin for restricted use in emergency situations on 3rd January.
“In the current submission, all the required complete information regarding chemistry, manufacturing, and controls, along with the pre-clinical and clinical data, has been provided in five modules.
The information contained in the modules is uploaded on the SUGAM portal for your kind perusal. We request you to kindly review the same and grant the marketing authorization at the earliest, ” the application by Mohan read.
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