Indian Drug Regulator Meets WHO Standards for Functional Vaccine Regulatory System
New Delhi: The Central Drugs Standard Control Organization (CDSCO) and the National Regulatory Authority of India have successfully met the World Health Organization’s (WHO) standards for a functional vaccine regulatory system. A team of international experts, coordinated by WHO’s headquarters in Geneva, conducted a review of India's vaccine regulatory system from September 16 to 20, according to a statement from the health ministry.
Safety, efficacy, and quality were the three basic parameters of assessment of vaccines, it said.
The WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the National Regulatory Authorities (NRA) and pre-qualification programme of vaccines, the statement said.
The WHO NRA re-benchmarking was aimed to assess and document the status of the India regulatory system in the area of vaccine regulation, re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT) and measuring the maturity of the system.
"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," the statement said.
India retains maturity level 3 with highest marks in several functions.
Speaking about the achievement, Punya Salila Srivastava, Union Health Secretary, stated, "The Central Drugs Standards Control Organisation (CDSCO, in collaboration with WHO, has made exemplary efforts towards this achievement. India is one of the main players in the pharmaceutical industry worldwide and is known for its affordable vaccines and generic medicines."
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