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

The subject matter with respect 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.

After bouts of deliberations, the NEGVAC has recommended that:

“vaccines for COVID-19, 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.”

On April 13, 2021, the Union Government has accepted the recommendation of NEGVAC after due deliberation. The Government has also considered that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes and then it will be rolled out for further immunization programme within the country. This decision is meant to facilitate quicker access to such foreign vaccines by India and would to expedite the vaccination drive within the country. It would further hasten the pace and coverage of vaccination.

*Tanvi Singh, Editorial Assistant has put this story together.