Drug regulator CDSCO and the National Regulatory Authority of India have met the standards set up by the WHO for a functional vaccine regulatory system.
Safety, efficacy, and quality were the three basic parameters of assessment of vaccines.
India has been declared 'functional' against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI.
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