National Regulatory Authority (NRA) of India meets WHO international standards for vaccine regulations

Posted 14 Oct 2024

2 min read

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.

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:

Import/manufacturing: Regulated by Drugs and Cosmetics Act, 194o, and related rules.
- Manufacturing license is granted after joint evaluation by concerned State Licensing Authority & Central Drugs Standard Control Organization (CDSCO).
New vaccines manufacturing: New Drugs and Clinical Trials Rules, 2019 outlines requirements for clinical studies and approvals.
r-DNA vaccines: Compliance with Department of Biotechnology guidelines is also required.