This decision will facilitate quicker access to such foreign vaccines by India, the central government said
India on Monday approved Russia's COVID-19 vaccine Sputnik V for emergency use in India
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. The aim is to "accelerate the pace & coverage of domestic vaccination programme," ministry of health and family welfare mentioned in a release. This move will help in expanding "the basket of vaccines for domestic use and hasten the pace and coverage of vaccination".
COVID-19 vaccination as one of the critical pillars of COVID-19 control and management, the government said. The decision was taken in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on 11th April 2021, chaired by Dr V K Paul, Member (Health), Niti Aayog.
A requirement for pre-approval clinical trials would be replaced by post-authorisation trials. 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.
"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.
"I think it's significant... it's basically one more step to opening vaccinations to the private sector, and it's good, because the government sector alone will not be able to take care of the load," virologist Shahid Jameel told AFP.
"So if Pfizer or Moderna wants to bring in their vaccines through a supplier, not a manufacturer, then it is now possible," he 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.
COVID-19 vaccine drive in India
The drug regulator Drugs Controller General of India (DCGI) on Monday approved Russia's coronavirus vaccine Sputnik V for emergency use. Earlier, two COVID-19 vaccines - Covaxin by Bharat Biotech International Limited and AstraZeneca-Oxford University's Covishield which is being made by Serum Institute of India (SII) - have received emergency use authorization from the DCGI.
The nationwide COVID-19 inoculation drive began on 16 January this year, with healthcare and frontline workers. The drive was later expanded to include those above the age of 60 and 45 with comorbidities.
From 1 April, the government opened the drive for everyone above the age of 45.
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