WHO Declares India Vaccine Regulatory System "Functional"

WHO international experts evaluated the vaccination authorities of India. In such a situation, the evaluation confirmed that India meets WHO criteria to efficiently implement a vaccination control system. This distinction highlights India's important role in the global pharmaceutical sector and as one of the largest manufacturers of vaccines.

WHO Evalutaion of Indias Vax Regulatory System

• WHO Assessment of National Regulatory System for vaccines in India-Isolated visit to India between the period of 16th Sept 2024 to 20th Sept 2024
• The effectiveness of the regulatory system was assessed from the perspective of international good practices through the Global Benchmarking Tool (GBT).
• The Vaccine Regulatory System for India was assigned Maturity Level 3, or Intermediate, identifying a well-established system
• The areas included National Regulatory Authority (NRA), Registration and Marketing Authorisation (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).
• WHO Prequalification Programme (PQP) guarantees standards of quality, safety and efficacy for vaccines. India having now reached Maturity Level 3, is a recognition of trust in the regulatory authority.
• The evaluation team perceived an Institutional Development Plan necessary to strengthen the regulatory system so that the India would remain preeminent in vaccine production and safety.
• The evaluation shows India is available to the production and regulation of vaccine in a high status.