India fast-tracks approval for foreign-produced Covid-19 vaccines

WITH an aim to expand the basket of Covid-19 vaccines and enhance the pace of inoculation in India, the central government on Tuesday (13) said it has fast-tracked emergency approval for foreign-produced jabs that have been granted similar clearances in other countries.

The move is significant as it may make available several vaccines, including Pfizer, Moderna and Johnson & Johnson, in India with certain conditions.

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 health ministry said.

The government has decided that Covid-19 vaccines which have been developed and are being manufactured in foreign countries and 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.

They will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, 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 (use)," the ministry said.

The decision came following the recommendations of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).

Currently, two vaccines - Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) - are being used for inoculation in India.

India's drug regulator has also granted permission for the restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions on Monday (12).

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 were discussed in the 23rd meeting of NEGVAC chaired by Niti Aayog Member (Health) VK Paul on April 11 (Sunday).