India's Vaccine Regulatory System Meets WHO Standards for Safety and Quality

India's top drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India, has successfully met the standards set by the World Health Organisation (WHO) for a functional vaccine regulatory system. A team of international experts, led by the WHO headquarters in Geneva, conducted a review of India's vaccine regulatory framework from September 16 to 20, as confirmed by the health ministry.

The evaluation focused on three primary criteria: safety, efficacy, and quality of vaccines. The WHO has developed global standards to ensure the quality of vaccines through tools, guidelines, and benchmarking processes. This includes the National Regulatory Authorities (NRA) benchmarking and the WHO's vaccine pre-qualification programme.

The re-benchmarking process aimed to assess and document the status of India's regulatory system for vaccines, comparing it against the WHO's Global Benchmarking Tool (GBT). The process also evaluated the maturity of India's regulatory system, ensuring it meets global standards.

"India has been declared 'functional' in all core regulatory functions under the WHO Global Benchmarking Tool Version VI," the health ministry said. India had previously been benchmarked in 2017 using Version V of the GBT, which has since been updated to Version VI with more stringent criteria. Despite these raised standards, India has retained maturity level 3, receiving top scores in several regulatory functions.

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