Govt fast-tracks emergency approvals for foreign-produced Covid-19 vaccines

FILE PHOTO: A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken October 30, 2020. REUTERS/Dado Ruvic/File Photo **(REUTERS)**

1 min read . Updated: 13 Apr 2021, 01:52 PM IST Staff Writer

India said it would fast-track emergency approvals for foreign-produced COVID-19 vaccines

India said on Wednesday it would fast-track emergency approvals for foreign-produced COVID-19 vaccines that have been granted emergency authorisation in other countries, as infections surge.

"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 programme within the country," the health ministry said in a statement.

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"The National Expert Group on Vaccine Administration for COVID-19, after comprehensive deliberation, recommended that vaccines, which have been developed & 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," the health ministry said.

The matter related to fast tracking the emergency approvals for foreign-produced COVID-19 was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on 11th April 2021, chaired by Dr. V K Paul, Member (Health), Niti Aayog.

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.

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