The Ministry of Health and Family Welfare announced on Tuesday said that it is speeding approvals for foreign-produced Covid-19 vaccines that have been granted the Emergency Use Authorisation (EAU) in other countries. This is likely to help expand the basket of jabs available for domestic use and speed-up the nationwide vaccination exercise.
India, now the second most affected nation by Covid-19, on Tuesday recorded a massive surge of 161,736 Covid-19 cases.
The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), in its meeting on April 11, recommended that vaccine candidates that have been developed and are being manufactured in foreign countries and which have been granted EUA by the USFDA, EMA, UK MHRA, PMDA Japan or those listed in the World Health Organisation (WHO)’s emergency use list, may be granted approval in India.
This recommendation by the NEGVAC was accepted after due consideration, the Union Government said. However, post-approval parallel bridging trial instead of conducting local clinical trials will be mandatory. The first 100 beneficiaries of such foreign-made Covid-19 vaccines will be assessed for seven days before the doses are administered to others.
Presently three Covid-19 vaccines — Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) and Sputnik by Dr Reddy’s — have received emergency approvals from the national regulator Drugs Controller General of India.
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.
“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,” the health ministry said in a statement.
Covid-19 vaccines developed by Pfizer-BioNTech, Moderna and Johnson & Johnson, among others, currently do not hold an emergency use approval in India.
