Centre facilitates Emergency Approval for Foreign-produced Jabs granted EUA in other countries

The Central Government has fast-tracked emergency approval for foreign-produced jabs that have been granted similar clearances in other countries.

The decision came on Tuesday after NEGVAC recommended that COVID-19 vaccines 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, 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.

Accroding to a press release by the Union Ministry of Health, “The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country. The Union Government, after due consideration, has accepted the recommendation of NEGVAC.”