Govt Fast-Tracks Emergency Use Approvals For Foreign-Produced COVID-19 Vaccines

In a bid to boost the nationwide Covid vaccination drive, the Centre on Tuesday (13 April) fast-tracked the emergency use approvals for foreign-manufactured Covid-19 vaccines in a move that is expected to increase the availabilty of the jabs in the country.

However, only those foreign firms that had received Emergency Use Authorisation (EUA) for their jabs from US Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK's Medicines and Healthcare products Regulatory Agency (MHRA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA) or are listed in WHO emergency use listing will be eligible for the fast-tracking of approvals.

"The matter of augmenting the Basket of Vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme 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," the Health Ministry said on Wednesday (13 April).

The NEGVAC, after comprehensive deliberation, 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, it said.

Further, 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, the ministry said.

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 etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic, the ministry added.