Centre Fast-tracks Emergency Approval for Foreign-produced Covid Vaccines Cleared in Other Countries

DavenRaven

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posted on 3 years ago — updated on 1 second ago

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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.

The Centre on Tuesday decided to fast track approvals for foreign produced COVID-19 vaccines that have been granted Emergency Use Authorisation (EUA) in other countries to “expand the basket of vaccines for domestic use and hasten the pace and coverage” of inoculation.

In its notification, the Centre said, “Vaccination is one of the critical pillars of COVID control and management strategy adopted by the Centre. Presently two vaccines i.e. Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII), have received Emergency Use Authorization (EUA) from the National Regulator (Drugs Controller General of India). “

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.

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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