India fast tracks emergency approvals for foreign-produced Covid-19 vaccines
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes
Amid an alarming spike of coronavirus infections across India, the central government on Tuesday said it is speeding up emergency approvals for foreign-made vaccines that have been granted emergency use authorization (EUA) in other countries.
“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 use,” the Ministry of Health and Family Welfare said.
The matter of augmenting the Basket of Vaccines available for fighting the pandemic as well as to accelerate the pace & 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.
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.
The group mandated 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 and Clinical Trials Rules 2019.
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 programmes within the country, the health ministry said.
The Centre's latest move comes at a time when the country is grappling with the second wave of coronavirus and states have been complaining about vaccine shortage.
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.
Sputnik V receives emergency use approval
Two vaccines - Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) - had received emergency approvals from the national regulator Drugs Controller General of India and are being used in the nationwide vaccination drive.
On Tuesday, India's drug regulator, Drugs Controller General of India (DCGI), also granted permission for restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions.
The Union Health Ministry stated 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.
Experts assured that regulators will consider the relevant safety and efficacy issues, on the trials of the recently approved Sputnik V vaccine.
Replying to questions sent by India News Network via email, Former Director General of Indian Council of Medical Research (ICMR) VM Katoch said, “I will not like to comment on the future of new vaccines that will be approved against Covid. Sputnik vaccine has already been used extensively. I am sure that our regulator will assess the relevant safety and efficacy issues. We have established procedures to monitor the phase IV of introduction in the community.”
India has been undertaking the world’s largest vaccination drive since January 16. In less than three months, the country has managed to provide more than 100 million doses across the country. The country has already achieved one of the highest average daily vaccinations per day across the globe with 4.3 million vaccinations.
India has also achieved the fastest rate of reaching the 100 million vaccination
milestone, ahead of the United States (US) and China.
Earlier, Katoch, in an interview with India News Network in January, had said that the Made-in-India vaccines were safe to use. He had assured that there was no need to worry.