The decision came after the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) 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.
The first 100 beneficiaries of the 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 Ministry said.
The expert panel also mandated 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.
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.
Currently, two vaccines i.e. Covaxin by Bharat Biotech International Limited and Covishield by Serum Institute of India, have received Emergency Use Authorization from Drugs Controller General of India.
On Monday, Russia’s Sputnik V became the third Covid-19 vaccine to receive permission from India’s drug regulator for the restricted emergency use with certain conditions.