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Process To Receive WHO Pre-qualification For Covaxin On: Govt

The World Health Organisation has conducted a pre-submission meeting with the company following which a dossier was submitted by Bharat Biotech to WHO in early July, which is now under review.

The World Health Organisation has conducted a pre-submission meeting with the company following which a dossier was submitted by Bharat Biotech to WHO in early July, which is now under review.

The Minister of State for Health Bharati Pravin Pawar said the data required for approval was submitted by Bharat Biotech International Limited to WHO on July 9

Of the two vaccines presently being procured for the ongoing COVID-19 vaccination, Covishield manufactured by the Serum Institute of India (SII) has received the WHO pre-qualification, while the process of pre-qualification for Bharat Biotech’s Covaxin is going on, the government informed Parliament on Tuesday.

In a written reply to a question in the Rajya Sabha, Minister of State for Health Bharati Pravin Pawar said the application for pre-qualification is submitted by the manufacturer directly to the World Health Organization (WHO).

In response to a question on when the WHO approval for Covaxin is expected, the minister said the data 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 said.

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On the steps that the government is taking or has taken to ensure that more WHO-approved vaccines are made available in the country, Pawar said the regulatory norms have been streamlined for the approval of import and usage of the offshore-manufactured vaccines in India that have received 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 further informed that the Covid vaccine manufactured by Moderna has already been approved for import and usage in the country by the Drugs Controller general of India (DCGI).

The National Empowered Group on Vaccine Administration against COVID-19 (NEGVAC) is in regular talks with offshore manufacturers for facilitating the import of Covid vaccines, some of which have already received the WHO pre-qualification, she added.

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first published:July 20, 2021, 23:19 IST