CDSCO meets WHO standards for functional vaccine regulatory system

Drug regulator CDSCO and the National Regulatory Authority of India have met the standards set up by the World Health Organisation for a functional vaccine regulatory system A team of international experts from various countries led by the World Health Organisation (WHO) headquarters in Geneva reviewed India's vaccine regulatory system from September 16 to 20, the health ministry said in a statement. 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 ...