Govt Panel Recommends Regular Market Approval For Covishield And Covaxin


New Delhi: An expert panel of India’s federal drug regulator on Wednesday recommended providing regular market permission to Covid vaccines Covishield and Covaxin, which are presently only approved for emergency use in the country, subject to specific restrictions, as per the official sources.

Serum Institute of India (SII) and Bharat Biotech have applied to the Drugs Controller General of India (DCGI) for general market authorization for their respective COVID-19 vaccines, Covishield and Covaxin, PTI reported.

On October 25, Prakash Kumar Singh, SII’s director (government and regulatory relations), filed an application with the DCGI.

On that basis, DCGI requested further data and documentation from the Pune-based firm, to which Singh recently responded with additional data and information.

In addition to the successful conclusion of Phase 2/3 clinical research in India, more than 100 crore doses of the Covishield vaccine have been provided to patients in this nation and throughout the world, according to Singh’s statement.

“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 was quoted by PTI in its report.

V Krishna Mohan, a full-time director at the Hyderabad-based firm, presented entire information on chemistry, manufacturing, and controls, as well as pre-clinical and clinical data, in an application to the DCGI a few weeks ago.

According to Mohan’s application, Bharat Biotech International Limited (BBIL) accepted the challenge to develop, manufacture, and clinically assess a vaccine (Covaxin) based on SARS-CoV-2 strains obtained from COVID-19 patients in India.

On January 3, Covaxin and Covishield were given Emergency Use Authorization (EUA).

“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) which reviewed SII and Bharat Biotech’s application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions, ” an official source was quoted by PTI in its report.

During the meeting last week, the SEC requested further data and information from the two firms.

(With PTI Inputs)

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