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.

WHO Recognition of India’s Vaccine Regulatory System

Why in News Key Points
WHO Recognition India’s vaccine regulatory system recognized as “functional” by WHO after an evaluation in September 2024.
WHO Evaluation Overview Evaluation covered registration, licensing, market surveillance, inspections, and clinical trials. India’s National Regulatory Authority (NRA), led by CDSCO, meets global standards.
Continuous Improvement and Global Role WHO proposed an Institutional Development Plan for further enhancement. India’s leadership in global vaccine supply reaffirmed.

Piyush Shukla

Recent Posts

A Journey Of Five Years of the National Education Policy (NEP) 2020

The National Education Policy (NEP) 2020, India’s third education policy since Independence, was introduced as…

33 mins ago

What is Tsunami? – Definition & Overview

What is a Tsunami? – Definition & Overview A tsunami is a series of huge…

37 mins ago

Private Sector to Invest ₹77,000 Crore in Thermal Power by FY28: Crisil

In a major development for India’s energy sector, the thermal power industry is set to…

49 mins ago

Top-10 Best Countries for Startups in 2025, Check the List

In 2025, the world's startup scene is more vibrant than ever, with several countries emerging…

49 mins ago

How Much 11 PSBs Collected as Penalty for Low Bank Balances In FY21-FY25?

Between FY21 and FY25, eleven public sector banks (PSBs) in India collected nearly ₹9,000 crore…

1 hour ago

India Records 65,000 Crore Digital Payments Worth ₹12,000 Trillion in Six Years

India’s journey toward becoming a digital economy has seen remarkable progress over the last six…

2 hours ago