India fast-tracks emergency approvals for foreign produced COVID-19 vaccines

at 4:31 pm
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New Delhi (NVI): The Centre will fast-track approvals for foreign-produced Covid-19 vaccines that have been granted emergency use authorisation in other countries.

The recommendation was made to expedite the pace and coverage of the ongoing vaccination drive in the country.

Calling vaccination as one of the critical pillars of Covid-19 control and management, the government said that fast-tracking of approvals will facilitate easier access to foreign Covid-19 vaccines approved by credible foreign regulators including USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO(Emergency Use Listing).

A meeting of National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) was held on April 11, where the issue was discussed.

“The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO(Emergency Use Listing) may be granted emergency use approval in India,” the government said in a release.

The Centre, after due consideration, accepted the recommendation of NEGVAC, it added.

The government also said that first 100 beneficiaries of such foreign vaccines will be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.

This comes shortly after Russia’s Sputnik V was approved by India’s drug regulator Drugs Controller General of India (DCGI) for emergency use.

Presently, two Covid-19 vaccines – Covaxin by Bharat Biotech and AstraZeneca-Oxford University’s Covishield which is being made by Serum Institute of India (SII) – have received emergency use authorization (EUA) from the DCGI.