The Government of India on Tuesday announced that the Centre has fast tracked Emergency Approvals for foreign-produced COVID-19 vaccines that have been granted Emergency Use Authorization (EUA) in other countries to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination.
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The Ministry of Health and Family Welfare in an official release said that Vaccination is one of the critical pillars of COVID control and management strategy adopted by the Centre. At present, National Regulator Drugs Controller General of India has approved Emergency Use Authorization (EUA) to two vaccines i.e. Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII).
Now, the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) after a comprehensive meeting on April 11, 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.
The ministry clarified that 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.
After due consideration, the government of India has accepted the recommendation of NEGVAC with the aim to facilitate quicker access to such foreign vaccines by India. The health ministry said that the move 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.