Last Updated on October 24, 2024 by The Health Master
Regulatory System
India has achieved a significant milestone in its healthcare sector. The Central Drugs Standards Control Organization (CDSCO) and the National Regulatory Authority of India (NRARI) have successfully met the stringent standards set by the World Health Organization (WHO) for a functional vaccine regulatory system.
A Team of International Experts Conducted a Thorough Review
A team of international experts from various countries, led by the WHO headquarters in Geneva, conducted a comprehensive review of India’s vaccine regulatory system from September 16 to 20.
The health ministry announced the positive outcome of this evaluation in a statement.
Safety, Efficacy, and Quality Were the Key Focus Areas
The WHO team assessed India’s vaccine regulatory system based on three fundamental parameters: safety, efficacy, and quality.
These are essential elements to ensure the safety and effectiveness of vaccines.
WHO’s Global Standards and Benchmarks for Vaccine Quality
The WHO has established global standards and benchmarks to guarantee the quality of vaccines.
They have developed tools and guidelines, conducted benchmarking of National Regulatory Authorities (NRAs), and implemented a pre-qualification program for vaccines.
The Purpose of the WHO NRA Re-Benchmarking
The WHO NRA re-benchmarking aimed to:
- Assess and document the status of India’s regulatory system in the area of vaccine regulation.
- Re-benchmark the status of India’s vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT).
- Measure the maturity of the system.
India’s Achievement of “Functional” Status
India has been declared “functional” against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI.
This is a significant accomplishment, considering that India’s vaccine regulatory system was previously benchmarked in 2017 against GBT version V, which has since been revised to GBT VI with stricter criteria.
India Retains Maturity Level 3
India has maintained its maturity level 3, the highest possible rating, with exceptional scores in several regulatory functions.
Union Health Secretary’s Statement on the Achievement
Punya Salila Srivastava, Union Health Secretary, expressed her pride in this achievement, stating, “The Central Drugs Standards Control Organization (CDSCO), in collaboration with the WHO, has made exemplary efforts towards this accomplishment.”
“India is a global leader in the pharmaceutical industry, renowned for its affordable vaccines and generic medicines.”
This recognition from the WHO solidifies India’s position as a reliable and trustworthy source of high-quality vaccines, contributing to global public health efforts.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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