Govt fast-tracks emergency approval for foreign-made COVID-19 vaccines

Govt fast-tracks emergency approval for foreign-made COVID-19 vaccines

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

With an aim to expand the basket of COVID-19 vaccines and enhance the pace of inoculation in India, the Central government on Tuesday said 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 immunisation programmes within the country, the Union Health Ministry said.

The Centre's decision came after an expert panel recommended that COVID-19 vaccines that 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.

Govt fast-tracks emergency approval for foreign-made COVID-19 vaccines
Recommendation for emergency use authorisation granted to Russian COVID-19 vaccine Sputnik V

"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.

India's drug regulator has also granted permission for the restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions on Monday.

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