Millennium Post (Kolkata)

Govt fast-tracks approvals for foreign-produced Covid vaccines cleared in other countries

The first 100 beneficiar­ies of such foreign vaccines shall be assessed for 7 days for safety outcomes


NEW DELHI: With an aim to expand the basket of COVID19 vaccines and enhance the pace of inoculatio­n in India, the Central government on Tuesday 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 those made by 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 immunisati­on 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 utilisatio­n 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 granted permission for restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions, the Union Health ministry announced on Tuesday while stating that Dr Reddy's Laboratori­es will import the vaccine for use in the country. The approval by the Drugs Controller General of India (DCGI) paves the way for a third vaccine to be available in the country.

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