Bharat Biotech seeks full marketing approval from DCGI for Covaxin – World Affairs SRS

Bharat Biotech seeks full marketing approval from DCGI for Covaxin

– World Affairs SRS

Bharat Biotech has sought regular market approval from the Drug Controller General of India for its COVID-19 vaccine Covaxin, which is currently authorized only for emergency use in the country, official sources said on Thursday.

In an application sent to the Drugs Controller General of India (DCGI) this week, V Krishna Mohan, whole-time director of the Hyderabad-based company, shared pre-clinical and clinical data as well as chemistry, manufacturing and control. Presented complete information about Seeking regular market authorization for Covaxin.


A source said that the company, however, is yet to provide complete follow-up data of the clinical trial of Covaxin to DCGI.

On October 25, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), submitted an application to DCGI seeking regular market authorization for Covishield which is also authorized for emergency use in the country.

In response to the application, DCGI had sought some more information, following which Singh submitted a response with all desired data and information to DCGI last week.

In addition to the successful completion of the Phase 2/3 clinical study in India, more than 100 crore doses of the Kovidshield vaccine have been administered to people in India and across the world so far, Singh said in the response.

He said that such large-scale vaccination with Kovidshield and prevention of COVID-19 infection is a proof of the vaccine’s safety and efficacy in itself.

Meanwhile, Covaxin comprises 12 per cent of the total COVID-19 vaccine jabs administered in the country so far and is the only vaccine that is being administered to youth in the age group of 15-18 years, whose vaccination began in January. in the country 3.

Mohan said in the application, Bharat Biotech International Limited (BBIL) has been involved in the development, production and development of a COVID-19 vaccine (Covaxin) from SARS-CoV-2 strains isolated from COVID-19 patients in India. Took the challenge of clinically evaluating.

It was granted permission on January 3 to manufacture Covaxin for restricted use in emergency situations.

“In the current presentation, all necessary complete information about chemistry. Manufacturing and Control, along with pre-clinical and clinical data is provided in five modules. The information contained in the modules is for your kind. has been uploaded on Sugam Portal for perusal. We request you to kindly review the same and grant marketing authorization at the earliest,” read the application by Mohan.

With the administration of over 76 lakh vaccine doses in the last 24 hours, India’s COVID-19 vaccination coverage has crossed 154.61 crore, as per provisional reports as of 7 am on Thursday.

(Only the title and image of this report may have been reworked by Business Standard staff; the rest of the content is generated automatically from a syndicated feed.)

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