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.