The Central Government on Tuesday has expedited the process of emergency approvals for foreign produced Covid-19 vaccines that have received Emergency Use Approval (EUA) in other countries in order to boost the vaccination coverage in the country.
In a press release, the Government said that the matter was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) on 11th April, 2021.
The statement said, “The 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.”
Furthermore, the first 100 beneficiaries of such vaccines will be assessed for safety outcomes for 7 days before the vaccines are utilized for further immunization programme in the country. The Union Government has accepted the recommendation.
“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,” said the statement.
The decision comes at a time when the second wave of the pandemic has hit the country and a day after Sputnik-V vaccine was granted EUA.
