Centre fast tracks Emergency Approvals for foreign produced Covid-19 Vaccines

Our Bureau New Delhi | Updated on April 13, 2021

Clearance given for restricted use

In a bid to tackle rising Covid cases, the centre has decided to give emergency use approval to the vaccines developed or being manufactured overseas and have already been given clearance for restricted use by the regulatory bodies like USFDA, EMA, UK MHRA, PMDA Japan besides those which are listed in WHO.

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 Tuesday. The decision comes after drug regulator Drugs Controller General of India (DCGI) approved Russian vaccine Sputnik V for emergency use

Also read: Dr Reddy’s gets DCGI nod to import Sputnik V for emergency use in India

The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) in its meeting held on April 11, 2021, chaired by VK Paul, Member (Health), Niti Aayog recommended that vaccines for Covid-19, which have been developed and 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, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019, as per the statement.

‘Quick access’

“This decision will help in facilitating 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 which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic,” the Health Ministry said.

Published on April 13, 2021

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