India Fast Tracks Emergency Approvals for Foreign Produced COVID-19 Vaccines

New Delhi: The Centre on Tuesday said that it has fast tracked emergency approvals for foreign produced COVID-19 vaccines that have been granted Emergency Use Authorization (EUA) in other countries to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination.

“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 Union Health Ministry said in a statement.

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, it added.