Vaccine of Corona
Image by- DNA India
On Wednesday, an expert committee of the country's Central Drugs Authority recommended that the anti-Covid vaccinations Covishield & Covaxin be given regular marketing authorization, subject to specific limitations. This information came from official sources. The use of these vaccines in an emergency is currently permitted in the country. The Drug Controller General of India (DCGI) had received applications from Serum Institute of India (SII) and Bharat Biotech requesting regular marketing licenses for their anti-Covid vaccines, Covishield and Covaxin, respectively.
Vaccine of Corona
Image by- The Indian Express
On October 25, SII Director (Government and Regulatory Affairs) Prakash Kumar Singh filed an application with the DCGI. DCGI had requested further data and papers from the Pune-based firm, and Singh had just responded with additional data and information.
In his response, Singh is claimed to have stated that since the phase 2/3 clinical research in India was completed, more than 100 crore doses of the Covidshield vaccine had been provided to patients in India and around the world.
'Vaccination on such a broad scale with Covidshield and prevention of Covid-19 is in and of itself a confirmation of the vaccine's safety and efficiency,' he had stated.
Simultaneously, in an application made to DCGI a few weeks ago, Hyderabad-based Bharat Biotech's whole-time director V Krishna Mohan requested regular marketing authorization for Covaxin and included all relevant information.
Bharat Biotech International Limited (BBIL), according to Mohan's application, took up the challenge of developing, producing, and clinically assessing the vaccine (Covaxin) in India.
"On COVID-19, the Central Drugs Standard Control Organization (CDSCO Subject) Expert Committee (SEC) reviewed the applications of SII and Bharat Biotech for the second time on Wednesday, subject to certain stipulations," according to an official source. Approval for regular Covaxin marketing is recommended.
The SEC requested more data and information from both companies during their meeting last week.
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