New Delhi, Apr 13 (UNI) Amid rising cases of coronavirus infections, the government on Tuesday said it would fast-track emergency approvals for foreign-produced vaccines that have been granted emergency authorisation in other countries.
The decision was taken to augment the basket of vaccines to combat the pandemic and follows the meeting of the National Expert Group on Vaccine Administration on April 11, chaired by V K Paul, Member (Health), Niti Aayog.
“The National Expert Group on Vaccine Administration for COVID-19, after comprehensive deliberation, recommended that vaccines, 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 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 immunisation programme within the country,” it said.
The decision, the Ministry said, 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.
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