India fast tracks emergency approvals for foreign-produced Covid vaccines

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, says govt
The union government on Tuesday said it is speeding up emergency approvals for foreign-made vaccines that have been granted emergency use authorisation (EUA) in other countries amid alarming spike of coronavirus infections across India.

This is being done to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination, according to an official statement from the government.

India, now the second most affected nation by Covid-19, on Tuesday recorded a massive surge of 161,736 Covid-19 cases. With this, India's Covid tally has shot up to 13,689,453 cases, according to Ministry of Health and Family Welfare data. The country also witnessed 880 fatalities due to Covid-19 in a single day. The death toll from the deadly infection stands at 171,089.

Presently three vaccines --- Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) and Sputnik by Dr Reddy's --- have received emergency approvals from the national regulator Drugs Controller General of India.

India's drug regulator, Drugs Controller General of India (DCGI), has granted permission for restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions, the Union Health Ministry announced on Tuesday, while stating that Dr Reddy's Laboratories will import the vaccine for use in the country.

The approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.

The matter of augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) held on April 11, chaired by Dr. V K Paul, Member (Health), Niti Aayog.

NEGVAC, after comprehensive deliberation, recommended that vaccines for Covid-19, which have been developed and 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.

"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," the health ministry said in a statement.

The government, after due consideration, has accepted the recommendation of NEGVAC.

This decision 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, said the ministry.

Centre's latest move comes at a time when the country is grappling with second wave of coronavirus and vaccine shortage has been rampant and fast tracking the approvals for more vaccines will provide a much-needed breather. 


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