SF Prep Notes

India's vaccine regulator declared 'functional' against WHO Global Benchmarking Tool VI

On 11 October 2024, in India, the Health Ministry said CDSCO and the National Regulatory Authority of India meet WHO indicators for a functional vaccine regulatory system.

Summary

On 11 October 2024, in India, the Ministry of Health and Family Welfare said the Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority (NRA) of India and affiliated institutions, meets the WHO's published indicators for a functional vaccine regulatory system. A team of international experts led by WHO headquarters in Geneva reached this conclusion after reviewing India's vaccine regulatory system from 16 to 20 September 2024. India was declared 'functional' against all core regulatory functions of the WHO Global Benchmarking Tool (GBT) Version VI. India's system was earlier benchmarked in 2017 against GBT version V.

Key facts

Announced
11 Oct 2024
Bodies
CDSCO, NRA of India and affiliated institutions
Review
16-20 Sep 2024, WHO HQ-led expert team
Result
'Functional' on all core functions of WHO GBT Version VI
Earlier
Benchmarked in 2017 against GBT V

Practice MCQs 3 questions

Q1

Which Indian body, along with the NRA of India, was found on 11 October 2024 to meet WHO indicators for a functional vaccine regulatory system?

Show answer

Correct answer: B — CDSCO

PIB (11 Oct 2024): the Central Drugs Standard Control Organisation (CDSCO), along with the NRA of India and affiliated institutions, meets the WHO indicators for a functional vaccine regulatory system.

Q2 Advanced

Against which version of the WHO Global Benchmarking Tool was India's vaccine regulatory system declared 'functional' in October 2024?

Show answer

Correct answer: C — Version VI

PIB (11 Oct 2024): India has been declared 'functional' against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI.

Q3 Advanced

Consider the following statements about the WHO re-benchmarking of India's vaccine regulatory system: 1. The review was conducted from 16 to 20 September 2024 by an expert team led by WHO headquarters. 2. India's system had earlier been benchmarked in 2017 against GBT version V. Which of the statements given above is/are correct?

Show answer

Correct answer: C — Both 1 and 2

Both statements are correct. PIB (11 Oct 2024): the WHO HQ-led review ran from September 16 to 20, 2024, and India's system was benchmarked in 2017 against GBT version V.

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