March 19, 2023

Process of pre-qualification for Bharat Biotech’s Covaxin is occurring: Government knowledgeable Parliament

New Delhi:

Of the 2 vaccines presently being procured for the continuing COVID-19 vaccination, Covishield manufactured by the Serum Institute of India (SII) has obtained the WHO pre-qualification, whereas the method of pre-qualification for Bharat Biotech’s Covaxin is occurring, the federal government knowledgeable Parliament on Tuesday.

In a written reply to a query within the Rajya Sabha, Minister of State for Health Bharati Pravin Pawar stated the applying for pre-qualification is submitted by the producer on to the World Health Organization (WHO).

In response to a query on when the WHO approval for Covaxin is predicted, the minister stated the info required for approval was submitted by Bharat Biotech International Limited to WHO on July 9.

“Based on the time taken for approval of other COVID-19 vaccines, it is estimated that the WHO-EUL process takes approximately two to three months from the date of submission,” she stated.

On the steps that the federal government is taking or has taken to make sure that extra WHO-approved vaccines are made accessible within the nation, Ms Pawar stated the regulatory norms have been streamlined for the approval of import and utilization of the offshore-manufactured vaccines in India which have obtained the Emergency Use License (EUL) by the FDA of the United States, the MHRA of the United Kingdom, the PMDA of Japan or the WHO-EUL.

The minister additional knowledgeable that the Covid vaccine manufactured by Moderna has already been authorised for import and utilization within the nation by the Drugs Controller basic of India (DCGI).

The National Empowered Group on Vaccine Administration towards COVID-19 (NEGVAC) is in common talks with offshore producers for facilitating the import of Covid vaccines, a few of which have already obtained the WHO pre-qualification, she added.

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