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Date: 05-12-2025
A WHO-led team reviewed India’s vaccine regulatory system from September 16 to 20 last month. There were three basic parameters of assessment-safety, efficacy, and quality. As per the statement released by WHO "India has been declared 'functional' against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI. India's vaccine regulatory system was benchmarked in 2017 against Global benchmarking tool (GBT) version V which is now revised to GBT VI with raised bars and stringency in bench-marking criteria."
As per their latest report drug regulator CDSCO and the National Regulatory Authority of India have met the standards set up by WHO for a functional vaccine regulatory system, and India retains maturity level 3 with the highest marks in several functions.
