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- A DCGI Committee Recommends Regular Market Approval to Covishield and Covaxin
- Covishield and Covaxin are currently authorized for emergency use only in the country
- SII and Bharat Biotech submit applications for regular market approval to DCGI
Official sources said an expert panel of the Central Drugs Authority of India on Wednesday recommended regular market approval of the Kovid vaccines Covishield and Covaxin, which are currently authorized only for emergency use in the country, subject to certain conditions. , official sources said.
Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drug Controller General of India (DCGI) seeking regular market authorization for their respective COVID-19 vaccines Covishield and Covaxin.
SII Director (Government and Regulatory Affairs) Prakash Kumar Singh had given an application in this regard to DCGI on October 25.
To that DCGI had sought more data and documents from the Pune-based company, following which Singh had recently submitted a response with more data and information.
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 this country and around the world so far, Singh said in the response.
“Vaccination and prevention of COVID-19 infection on such a large scale with Kovidshield is in itself a proof of the safety and efficacy of the vaccine,” he had said.
In an application sent to DCGI a few weeks ago, V Krishna Mohan, whole-time director of the Hyderabad-based company, made regular demands for pre-clinical and clinical data as well as chemistry, manufacturing and control. Presented complete information about Market authorization for Covaxin.
Mohan had said in the application that Bharat Biotech International Limited (BBIL) has been involved in the development, production and diagnostics of a vaccine (Covaxin) from SARS-CoV-2 strains isolated from COVID-19 patients in India. Took the challenge of evaluating.
Covaxin and Covishield were granted emergency use authorization (EUA) on 3 January.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) reviewed the applications of SII and Bharat Biotech for the second time on Wednesday, subject to certain conditions that Covishield and Covaxin can be marketed in the regular market. has been recommended for approval,” an official source said.
The recommendations will be sent to DCGI for final approval. During last week’s meeting, the SEC asked for more data and information from both companies.
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