Ensuring Global Standards: DCC Urged all States to Submit Vaccine Data for WHO Benchmarking

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In a significant move towards global vaccine quality benchmarks, the Drugs Consultative Committee (DCC) has called upon all Indian states to provide crucial data on vaccine manufacturing and sales. The World Health Organization (WHO) mandates this data for its Global Benchmarking Tool (GBT) assessment, a prerequisite for UN agencies to procure vaccines from Indian manufacturers.

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The DCC, in its 62nd meeting chaired by Dr. Rajeev Singh Raghuvanshi, highlighted the need for data submission to meet WHO benchmarks. The Central Drugs Standard Control Organisation (CDSCO) is expected to share a checklist and SOP for quality control, facilitating uniform inspection reports.

Importance of Data Submission:
WHO’s GBT assesses regulatory functions, influencing UN agencies’ vaccine procurement decisions. CDSCO, along with associated institutions, is subject to WHO assessments, with a potential re-benchmarking on the horizon.

Challenges Faced:
Despite the requirement, several states have not submitted data, assuming non-relevance due to not being vaccine manufacturing states. Dr. Rubina Bose notes the confusion and emphasizes the need for data from all states for upcoming NRA assessments.

CDSCO’s Response:
CDSCO commits to sharing checklists and SOPs for manufacturing and sales premises to ensure a standardized inspection process. The importance of risk-based sampling of vaccines across states is stressed, with the data to be provided promptly to CDSCO-HQ.

Information Required from States/UT Drugs Controllers:
Details on human resources, Good Distribution Practices, inspection reports of vaccine distributors, and retail premises are mandated. Uniform checklists and procedures for licensing premises, a database of sales premises, and a risk-based sampling plan for vaccines are essential.

WHO’s Evaluation Process:
WHO’s GBT includes manufacturing process reviews, compliance verification, sample lot testing, and site audits. Collaboration with National Regulatory Agencies (NRAs) is key to streamline assessments, relying on the NRA’s reports for expedited processes.

India’s Regulatory Achievement:
In 2017, WHO recognized India’s regulatory authority, attaining a maturity level of four, the highest level for five functions and level three for four functions. Maturity levels signify sustained improvement trends and a systematic process-based approach.

Ministry’s Announcement:
The Ministry of Health and Family Welfare highlights WHO’s acknowledgment of 100% compliance in the benchmarking of the Indian vaccine regulatory system as a ‘landmark achievement.’

As India aims for continued success in global vaccine quality standards, the collaboration between states and regulatory bodies becomes paramount. The timely submission of data is not only a regulatory requirement but a crucial step in ensuring that Indian vaccines meet the stringent benchmarks set by the WHO, contributing to global health security.

Stay tuned for updates on India’s progress in meeting global vaccine quality standards and how this collaboration enhances the country’s role in the international vaccine landscape.

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