The Central Drugs Standard Control Organisation (CDSCO) has successfully met the World Health Organization’s (WHO) indicators for a functional vaccine regulatory system, specifically in terms of safety, efficacy, and quality, the Union Health Ministry announced.
Comprehensive Review by International Experts
A comprehensive and in-depth scientific review of India’s vaccine regulatory system was conducted by a team of international experts from various countries, led by the WHO headquarters in Geneva. The review took place from September 16 to 20 and focused on assessing India’s adherence to global standards.
Meeting WHO’s Global Standards
The CDSCO and the National Regulatory Authority of India (NRA) have successfully met the standards set by WHO for a functional vaccine regulatory system. These standards focus on the following key areas:
- Safety
- Efficacy
- Quality
These parameters form the basis of WHO’s assessment tools and guidelines, which include the benchmarking of National Regulatory Authorities (NRAs) and pre-qualification programmes for vaccines.
WHO’s Re-Benchmarking and Global Benchmarking Tool (GBT)
The WHO conducts re-benchmarking to assess the status of a country’s regulatory system. For India, this re-benchmarking aimed to:
- Assess the status of India’s vaccine regulation system using the Global Benchmarking Tool (GBT).
- Re-benchmark India’s system against updated standards (GBT Version VI) with stricter criteria.
- Evaluate the maturity level of India’s regulatory functions.
India has retained its Maturity Level 3, achieving high marks in several regulatory functions. This recognition was a significant milestone, with India initially benchmarked against GBT Version V in 2017, and now successfully passing the more stringent criteria of GBT Version VI.
Key Statements from Health Officials
- Punya Salila Srivastava, Union Health Secretary, hailed the collaboration between the CDSCO and WHO, stating that India’s strong performance reinforces its position as a global leader in the pharmaceutical industry.
- Dr Roderico H. Ofrin, WHO Representative to India, emphasized the role of WHO in supporting the strengthening of regulatory systems globally, ensuring equitable access to safe, effective, and affordable vaccines.
- Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), CDSCO, noted that India, as a large vaccine-producing country, is currently supplying vaccines to UN agencies such as UNICEF, WHO, and PAHO. He affirmed that India’s National Regulatory Authority meets the WHO’s stringent functional regulatory system indicators for vaccines.
India’s Role as a Major Vaccine Producer
India stands as a major player in global vaccine production with 36 major vaccine manufacturing facilities. These vaccines are not only used for the domestic market but are also exported to over 150 countries, making India a key supplier in the global vaccine supply chain.
WHO Prequalification Programme
The WHO Prequalification Programme (PQP) ensures access to vaccines that meet unified global standards of quality, safety, and efficacy. A functional National Regulatory Authority (NRA) is a prerequisite for manufacturers to qualify for supplying vaccines to countries through United Nations procuring agencies.
Conclusion
India’s successful compliance with WHO standards reaffirms its significant role in global health. The continued technical support from WHO and collaboration with the Health Ministry, including CDSCO, has strengthened India’s vaccine regulation system, further enhancing its capacity to supply vaccines across the globe.
Multiple Choice Questions (MCQs):
- What were the key indicators assessed by WHO for India’s vaccine regulatory system?
- a) Cost, Distribution, Accessibility
- b) Safety, Efficacy, Quality
- c) Innovation, Production, Marketing
- d) Dosage, Application, Side Effects
Answer: b) Safety, Efficacy, Quality
- What is the maturity level achieved by India’s vaccine regulatory system according to WHO’s GBT Version VI?
- a) Level 1
- b) Level 2
- c) Level 3
- d) Level 4
Answer: c) Level 3
- What is a prerequisite for WHO Prequalification of vaccines?
- a) High production capacity
- b) A functional National Regulatory Authority (NRA)
- c) Approval from the United Nations
- d) Government subsidy
Answer: b) A functional National Regulatory Authority (NRA)
- How many vaccine manufacturing facilities does India have?
- a) 20
- b) 25
- c) 36
- d) 40
Answer: c) 36
- Which organization led the team of international experts reviewing India’s vaccine regulatory system?
- a) UNICEF
- b) WHO Headquarters in Geneva
- c) World Bank
- d) UN General Assembly
Answer: b) WHO Headquarters in Geneva