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Vaccines developed abroad will need to undergo bridging studies in India

All covid-19 vaccines that have been proven to be safe and efficacious in clinical trials outside India will need to undergo bridging studies to prove their safety and immunogenicity in the Indian population as well, Union health minister Harsh Vardhan said on Sunday.
These studies though can be conducted with much smaller sample size and end quickly, the health minister said in his virtual interaction in the fourth episode of Sunday Samvaad.

All proposed clinical trials in India are designed using set principles and are stringently reviewed by the Subject Expert Committee set up by the Drug Controller General of India (DGCI), the health minister said.

“Recently, the DCGI has also formulated draft guidelines on regulatory requirements for licensure of covid-19 vaccines in India,” said Harsh Vardhan.

About phase 3 clinical trial of Russia’s “Sputnik-V” vaccine in India, the health minister said the matter is still under consideration, and no decision has been taken as yet.

The health minister said India is not planning to venture into human challenge experiment trials until the method is proven to have an established benefit as per global experience.

“India has robust processes in place to ensure the vaccines that successfully complete the clinical trials are safe and effective against the novel coronavirus,” the health minister adding that when conducted, human challenge studies should be undertaken with abundant forethought, caution, and oversight. The value of the information to be gained should clearly justify the risks to human subjects, he added.

Union health ministry has started preparing a format in whichstates will submit lists of priority population groups to receive vaccine, especially health workers engaged in the management of covid-19, the health minister said.

The Centre is also working on plans for building capacities in HR, training, supervision etc on a massive scale and roughly estimates to receive and utilise 400-500 million doses covering 20-25 crore people by July, said the health minister.

A high level committee under the chairmanship of Niti Aayog Member (Health) V K Paul is drawing up the entire process.

Harsh Vardhan said the vaccine procurement is being done centrally and each consignment will be tracked real time until delivery to ensure it reaches those who need it most.

The total tally of covid-19 cases on Sunday crossed 66 lakhs. Maharashtra contributed more than 14,000 to the new cases. Karnataka and Kerala reported 9886 and 7834 new cases, respectively.

Around 940 deaths have been registered in the last 24 hours taking the toll tally to 102,251. Around 80.5% of new reported fatalities are from 10 States and UTs. About 29.6% of deaths reported yesterday are from Maharashtra with 278 deaths followed by Karnataka with 100 deaths. Maharashtra’s contribution to the death toll has been on a decline, the health ministry said. – Livemint