India – National Regulatory Authority of India meets WHO international standards for vaccine regulations

India’s vaccine regulatory system was benchmarked in the year 2017 against Global benchmarking tool version V which is now revised to GBT VI with raised bars and stringency in benchmarking criteria

The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet the World Health Organization (WHO) published indicators for a functional vaccine regulatory system. This conclusion was reached by a team of international experts from various countries, led by WHO (HQ) in Geneva, following a comprehensive and in-depth scientific review of India’s vaccine regulatory system conducted from September 16 to 20, 2024.

Safety, efficacy, and quality are three basic parameters of assessment of vaccines. WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the NRA and prequalification programme of vaccines…