India’s Vaccine Regulatory System Declared Functional by WHO

India’s vaccine regulatory system has been recognized as “functional” by the World Health Organization (WHO) following an evaluation from September 16-20, 2024. The WHO assessment team confirmed that India meets global standards for ensuring vaccine safety, quality, and efficacy. This recognition reaffirms India’s significant role in the global pharmaceutical industry, especially in vaccine production, while showcasing its regulatory strength through Maturity Level 3 certification in the WHO Global Benchmarking Tool.

WHO Evaluation Overview

The WHO team evaluated key areas such as registration, licensing, market surveillance, regulatory inspections, and clinical trial oversight. India’s National Regulatory Authority (NRA), led by the Central Drugs Standard Control Organisation (CDSCO), was found to meet the required standards for a well-functioning vaccine regulatory system. The WHO Prequalification Programme underscores the importance of a robust NRA for global vaccine distribution.

Continuous Improvement and Global Role

While India’s regulatory system has reached a high benchmark, the WHO team has proposed an Institutional Development Plan for further enhancement. Union Health Secretary Punya Salila Srivastava, WHO Representative Dr. Roderico H. Ofrin, and Drugs Controller General Dr. Rajeev Singh Raghuvanshi highlighted India’s leadership in supplying vaccines globally, reaffirming its commitment to maintaining the highest standards in vaccine production and regulation.