India on Tuesday fast-tracked approvals for foreign-produced COVID-19 vaccines that have been granted emergency use authorisation (EUA) in other countries
India wants Pfizer, Moderna and Johnson & Johnson to seek licence for their COVID-19 vaccines as soon as possible, a senior government official said on Tuesday. "We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others...to be ready to come to India as early as possible," Vinod Kumar Paul, a senior government health official, told during the weekly press briefing, reported Bloomberg.
Amid rising number of coronavirus cases in the country, India on Tuesday fast-tracked approvals for foreign-produced COVID-19 vaccines that have been granted emergency use authorisation (EUA) in other countries. This move will help in expanding "the basket of vaccines for domestic use and hasten the pace and coverage of vaccination," ministry of health and family welfare mentioned in a release.
"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," the statement read.
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, the health ministry added.
This decision will facilitate quicker access to such foreign vaccines by India, the central government said. "It 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 ministry added.