India’s Vaccine regulatory systems (NRA and affiliated institutions) has been declared "functional" in all key regulatory functions according to WHO's Global Benchmarking Tool (GBT).
- In 2017, India’s NRA was assessed with older GBT version V, but now it has been reassessed using updated GBT VI.
- India retained Maturity Level 3 with highest marks in several functions.
- Maturity Level 3 confirms a stable, well-functioning and integrated regulatory system.
- India retained Maturity Level 3 with highest marks in several functions.
About WHO’s GBT:
- It is used to evaluate national regulatory systems for various products like medicines, vaccines, blood products, and medical devices.
- GBT incorporates concept of ‘maturity level’ on scale of 1 (existence of some elements of regulatory system) to 4 (Advanced level of performance & continuous improvement).
National Regulatory Authority (NRA) of India:
- These are institutions engaged in regulation, control and testing of vaccines, responsible for ensuring that vaccines meet international standards of quality, safety and efficacy.
- Composed of CDSCO, State Drug Regulatory Authorities, Central Drugs Laboratory, Immunization Division, PvPI etc.
Regulation of Vaccines in India:
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