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Home / India / India speeds up approval of foreign-made jabs granted emergency access

India speeds up approval of foreign-made jabs granted emergency access

Decision will facilitate availability, first 100 beneficiaries to be assessed
An expert panel mandated the requirement of post-approval parallel bridging clinical trials in place of conduct of local clinical trials.
An expert panel mandated the requirement of post-approval parallel bridging clinical trials in place of conduct of local clinical trials.
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Our Bureau, Agencies   |   New Delhi   |   Published 13.04.21, 02:48 PM

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, 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 trials in place of conduct of local clinical trials.

"This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilisation 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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