India’s National Regulatory Authority (NRA) has achieved another milestone by meeting the World Health Organization’s (WHO) standards for a functional vaccine regulatory system. This conclusion was reached by a team of international experts from various countries, led by WHO (HQ) in Geneva, following a comprehensive and in-depth scientific review of India’s vaccine regulatory system conducted from September 16 to 20, 2024, stated the Ministry of Health & Family Welfare, PIB.
There are three basic parameters for assessment of vaccines; quality, safety, and effectiveness of vaccines, whereby, India’s vaccine regulatory system has been declared “functional” by the World Health Organization (WHO), meeting global standards for quality, safety, and efficacy, it stated.
Additionally, the WHO re-benchmarking exercise assessed India’s system against the Global Benchmarking Tool (GBT) Version VI, with stricter criteria than its predecessor, GBT Version V. India retained its Maturity Level 3 status, which demonstrates its commitment to robust vaccine regulation. This achievement solidifies India’s position as a leading vaccine producer, supplying vaccines to over 150 countries.
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The assessment covered key regulatory functions, including overview of the National Regulatory System (RS), Registration and Marketing Authorization (MA), Vigilance (VL), Market Surveillance and Control (MSC), Licensing Establishments (LI), Regulatory Inspections (RI), Laboratory Testing (LT), Clinical Trials Oversight (CT) and NRA Lot Release (LR), the Ministry noted.
India is a major vaccine producer that has 36 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries), which makes India a major vaccine supplier across the globe.
World Health Organization carried out assessment of the National Regulatory Authority (NRA) of India comprising the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Central Drugs Laboratory, Kasauli; Adverse Events Following Immunisation (AEFI) structures at the Central and States levels, Immunisation Division, Pharmacovigilance Programme of India, and other relevant institutions engaged in the regulation, control and testing of vaccines, stated the Ministry.
The WHO Prequalification Programme (PQP) is aimed at facilitating access to vaccines that meet unified standards of quality, safety and efficacy as well as programme needs. It is also prerequisite for manufacturers to supply to countries through United Nations procuring agencies. A functional NRA is a criterion for WHO pre-qualification of vaccines.
