covaxin: Govt expert panel recommends regular market approval for Covishield, Covaxin | India News – Times of India

NEW DELHI: An expert panel of India’s Central Pharmaceutical Authority on Wednesday recommended regular market approval for the covid vaccine Covishield and covacin, which are currently only allowed for emergency use in the country subject to certain conditions, official sources said.
Pharma companies Serum Institute of India (SII) and Bharat Biotech have applied to the Drugs Controller General of India (DCGI) for regular market approval for their respective Covid-19 vaccine Covishield and Covacin.
Prakash Kumar Singh, Director (Government and Regulatory Affairs), SII, submitted an application to the DCGI on October 25 in this regard.
DCGI sought more data and documents from the Pune-based firm on the matter, after which Singh recently submitted a response with more data and information.
In addition to the successful completion of Phase 2/3 clinical studies in India, so far, more than 100 million doses of the Covishield vaccine have been given to people in this country and around the world, Singh said in response.
“Such a large-scale vaccine with Covishield and control of Covid-19 infection is itself a testament to the safety and efficacy of the vaccine,” he said.
In an application sent to DCGI a few weeks ago, V Krishna Mohan, full-time director of the Hyderabad-based company, submitted complete information on chemistry, production and control, including pre-clinical and clinical data, on a regular basis. Market approval for covaxin.
Bharat Biotech International Limited (BBIL) has taken up the challenge of developing, producing and clinically evaluating a vaccine (covacin) from the isolated SARS-CoV-2 strain from Covid-19 patients in India, Mohan said in the application.
Kovacin and Kovishield were approved for emergency use (EUA) on 3 January.
The Central Drugs Standards Control Organization’s (CDSCO) COVID-19 expert committee (SEC), which reviewed the application of SII and India Biotech for the second time on Wednesday, recommended that Covishield and Covaxin be given regular market approval subject to certain conditions, “an official source said. Reported.
At last week’s meeting, the SEC asked the two companies for more information.

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