Fri Sep 20 12:22:00 UTC 2024: ## WHO Conducts Assessment of India’s Vaccine Regulatory System

**New Delhi:** The World Health Organization (WHO) has conducted an assessment of India’s National Regulatory Authority (NRA), the Central Drugs Standard Control Organization (CDSCO) and Drugs Controller General of India (DCGI), to evaluate the country’s vaccine regulatory system. This assessment, which took place from September 16-20, focused on India’s vaccine regulations, regulatory protocols, new vaccine development, and good manufacturing practices (GMP) followed by Indian vaccine manufacturers.

The WHO conducts these assessments every five years to ensure the quality of vaccines produced in a country. India, known as the “pharmacy of the world”, supplies 60-70% of WHO’s vaccines for immunization, making the assessment critical for maintaining the quality and efficacy of Indian-made vaccines.

This assessment comes in the wake of several incidents in the past two years where India-made cough syrups failed quality tests overseas due to alleged contamination. In 2022, contaminated cough syrups were linked to the deaths of 66 children in Gambia and 18 children in Uzbekistan.

The WHO uses the Global Benchmarking Tool (GBT) to evaluate regulatory systems, assessing maturity level and compliance with UN health agency standards. The 2017 assessment resulted in India’s NRA being categorized as “maturity level 3,” indicating a stable and well-functioning system. This re-benchmarking aims to determine the current maturity level and identify areas for improvement.

The assessment covers various aspects, including registration and marketing authorization, vigilance, laboratory access and testing, regulatory inspection, clinical trial oversight, NRA lot release, licensing premises, and market surveillance and control. The WHO’s NRA assessment scores maturity levels on a scale of 1 to 4, with level 4 considered the strongest.

This assessment is expected to provide a clear picture of India’s vaccine regulatory system and ensure continued confidence in the quality and safety of Indian-made vaccines for both domestic and international markets.

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