Covishield, Covaxin Cleared For Market Approval By Expert Panel
An expert panel of India’s central drug authority today recommended granting regular market approval to Covid vaccines Covishield and Covaxin, which are currently only authorised 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 Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective vaccines.
Prakash Kumar Singh, Director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter.
On that, the DCGI had sought more data and documents from the Pune-based company following which Mr Singh recently submitted the firm’s response with more data and information.
In addition to the successful completion of phase 2/3 clinical study in India, till now, over 100 crore doses of Covishield vaccine have been administered to people in this country and worldwide, Mr Singh is learnt to have stated in the response.
“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 has said.
In an application sent to the DCGI a couple of weeks ago, V Krishna Mohan, Whole-Time Director at Hyderabad-based Bharat Biotech, submitted complete information on chemistry, manufacturing, and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine, from the SARS-CoV-2 strains isolated from Covid patients in India, Mr Mohan has said in the application.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech’s application for the second time today has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions,” an official source said.
During last week’s meeting, the SEC had sought more data and information from the two companies.