Centre fast-tracks emergency approval of foreign-produced COVID-19 vaccines

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The Union government on April 13 decided to fast track emergency approvals for foreign-produced COVID-19 vaccines that have been granted Emergency Use Authorization (EUA) in other countries. The move will expand the basket of vaccines for domestic use.

Vaccination is one of the critical pillars of COVID control and management strategy adopted by the Centre. Presently two vaccines i.e. Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII), have received Emergency Use Authorization (EUA) from the National Regulator (Drugs Controller General of India), the health ministry said in a statement.

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, it added.

The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), after comprehensive deliberation, 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, the Ministry of Health said.

This decision will facilitate quicker access to such foreign vaccines by India & 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 health ministry said.

India’s drug regulator on April 13 granted permission for restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions. The approval by the Drugs Controller General of India (DCGI) paves the way for a third vaccine to be available in the country.

The approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.