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Bharat Biotech writes to DCGI seeking full marketing approval for Covaxin – Details

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Bharat Biotech writes to DCGI seeking full marketing approval for Covaxin – Details


Representational Image.&nbsp | &nbspPhoto Credit:&nbspAP

Key Highlights

  • Covaxin is the only jab that is administered to youngsters in the age-group of 15-18 years, for whom the vaccination programme began on January 3

  • India’s Covid-19 vaccination coverage has crossed 154.61 crore as per provisional reports till 7 am on Thursday

New Delhi: Hyderabad-based Indian pharmaceutical company Bharat Biotech has reportedly urged the Drugs Controller General of India (DCGI) to give a regular market approval for its Covid-19 vaccine – Covaxin – an authorised jab for emergency use in the country.

V Krishna Mohan, the whole-time director of the company, submitted a written application to DCGI for complete information regarding the chemistry, manufacturing and controls, along with pre-clinical and clinical data while seeking regular market authorisation for Covaxin, news agency PTI quoted official sources as saying on Thursday.

“The company, however, is yet to submit the full follow up data of clinical trials of Covaxin to DCGI,” a source informed.

Covaxin accounts for 12 per cent of the total Covid-19 vaccines administered in India so far since January 2021. It is also the only jab that is administered to youngsters in the age-group of 15-18 years, for whom the vaccination programme began on January 3.

“Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a COVID-19 vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan said in the application. It was granted the permission to manufacture Covaxin for restricted use in emergency situations on January 3. In the current submission, all the required complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data have been provided in five modules. The information contained in the modules is uploaded on SUGAM portal for your kind perusal. We request you to kindly review the same and grant the marketing authorisation, at the earliest,” Mohan’s application to DCGI stated.

Notably, Prakash Kumar Singh, director of Government and Regulatory Affairs at Serum Institute of India (SII), had on October 25 submitted an application to the DCGI seeking the same authorisation for Covishield, also an indigenous Covid-19 vaccine authorised for emergency use in India.

In response to his application, the DCGI had sought more information following, which Singh submitted last week.

Following the successful completion of Phase 2/3 clinical trials in India, over 100 crore doses of Covishield have been administered to people in India and worldwide till now.

“Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine,” he told DCGI.

India’s Covid-19 vaccination coverage has crossed 154.61 crore as per provisional reports till 7 am on Thursday.

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