May 13, 2021
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Centre Fast Tracks Emergency Use Approval For Many International Covid-19 Vaccines

The Centre on Tuesday fast tracked the emergency use approval for many internationally produced Covid-19 vaccines to ramp up the vaccination process in the country.

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Centre Fast Tracks Emergency Use Approval For Many International Covid-19 Vaccines
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Centre Fast Tracks Emergency Use Approval For Many International Covid-19 Vaccines
outlookindia.com
2021-04-13T14:03:28+05:30

The Centre on Tuesday fast tracked the emergency use approval for many internationally produced Covid-19 vaccines to ramp up the vaccination process in the country.

The move comes just a day after the DGCI issued a green signal for Russia’s Sputnik V Vaccine, making it the third vaccine in the country to receive restricted use approval.

At the moment, the country is facing a vaccine crunch with the second wave of the pandemic gripping the country. Covid-19 infections have steadily increased since one month and on Tuesday the country logged 1,61,736 new infections.

Amid this, the Union health ministry announced that it has fast-tracked emergency approval for foreign-produced jabs that have been granted similar clearances in other countries.

The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country, the Union Health Ministry said.

The Centre's decision came after an expert panel recommended that Covid-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing may be granted emergency use approval in India.

The expert panel also mandated the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial.

"This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity, etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use)," the ministry said.

Currently, two vaccines -- Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) -- are being used for inoculation in India.

(With PTI inputs)


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