India’s Vaccine Regulatory System Declared ‘Functional’ by WHO

India's vaccine regulatory system has been declared functional by the World Health Organization (WHO) following an evaluation conducted from September 16-20, 2024. The system achieved Maturity Level 3, signifying reliable regulation of vaccine safety, effectiveness, and quality. The WHO's assessment used its Global Benchmarking Tool, examining key areas like vaccine registration, safety monitoring, and quality control. India’s Central Drugs Standard Control Organisation (CDSCO) plays a central role in this. The evaluation enhances India's position in the global pharmaceutical industry, though WHO suggests further improvements to ensure continued regulatory strength.

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