State FDAs Must Provide Crucial Vaccine Data for WHO Benchmarking

Vaccine medicine Drugs Injection
Picture: Pixabay


In the dynamic landscape of global health, the World Health Organization (WHO) plays a pivotal role in ensuring the safety and efficacy of vaccines.

A recent advisory from the Drugs Consultative Committee (DCC) highlights the imperative for all states to provide comprehensive vaccine data on manufacturing and sales to the Central Drug Regulator.

This data submission is crucial to meet the anticipated global benchmarking standards set by WHO.

Understanding WHO’s Global Benchmarking Tool (GBT)

The WHO’s GBT is the cornerstone for assessing and benchmarking a country’s regulatory functions concerning vaccines.

This tool serves as a prerequisite for the procurement of vaccines by UN agencies from Indian vaccine manufacturers.

The Central Drugs Standard Control Organisation (CDSCO) and associated institutions undergo assessments by WHO, ensuring adherence to international standards.

DCC’s Advisory: A Call to Action

In its 62nd meeting under the chairmanship of Drugs Controller General (India) [DCGI] Dr. Rajeev Singh Raghuvanshi, the DCC emphasized the necessity for re-benchmarking CDSCO concerning vaccines.

The formal agreement by the Ministry triggers this process, underlining the critical role of CDSCO in the global vaccine supply chain.

CDSCO’s Checklist and SOP: Ensuring Quality Assurance

To facilitate a standardized approach, the CDSCO is set to share a checklist and Standard Operating Procedure (SOP) for the quality of manufacturing and sales premises.

This move aims to establish common practices in the inspection process and create uniform inspection reports, aligning with global benchmarks.

States’ Role and Challenges

Despite the clear directive for states to furnish data, challenges persist.

Dr. Rubina Bose, Deputy Drugs Controller of India, informed the Committee that some states mistakenly believe they are exempt from data submission due to not being vaccine manufacturing states.

However, the DCC stressed that data from all states is essential for both manufacturing and sales premises.

Importance of State Data Submission

The upcoming National Regulatory Agency (NRA) assessment necessitates comprehensive data from all states.

This includes information on human resources, Good Distribution Practices inspection reports of vaccine distributors, and uniform checklists for licensing premises of vaccine manufacturing and sales.

The need for a robust Risk-Based Sampling plan further underscores the importance of timely and accurate data submission.

CDSCO’s communication to States: A Collaborative Effort

The CDSCO has communicated all state/UT Drugs Controllers to provide detailed information promptly.

This includes a comprehensive database of technical staff, supporting the implementation of Good Regulatory Practices, Good Review Practices, and Quality Management Systems.

Standard Evaluation of Vaccines by WHO

WHO’s evaluation of vaccines encompasses a thorough review of the manufacturing process, compliance verification, sample lot testing, and site audits.

The Global Benchmarking Tool guides this process, emphasizing a standardized approach and reliance on responsible NRAs.

Role of NRAs in Regulatory Oversight

National Regulatory Agencies (NRAs) play a crucial role in overseeing vaccines for national immunization programs.

Collaborative agreements with WHO streamline the prequalification process, allowing reliance on NRA assessments, testing, and inspection reports.

WHO’s Recognition of Indian Regulatory Authority

The WHO’s recognition of the Indian regulatory authority in 2017 marked a significant achievement.

With a maturity level of four, the highest possible, and a level three in four functions, India’s regulatory system gained international acknowledgment for its effectiveness and improvement trends.

Maturity Levels: A Measure of Success

Maturity level four indicates sustained improvement trends, while level three reflects systematic improvements and data availability.

These levels, as defined by the Ministry of Health and Family Welfare, demonstrate India’s commitment to regulatory excellence.

Acknowledgment by Health Ministry and WHO

The Minister of Health and Family Welfare, JP Nadda, celebrated the WHO’s acknowledgment of India’s regulatory system’s 100% compliance.

This recognition stands as a ‘landmark achievement,‘ showcasing India’s dedication to ensuring vaccine safety and efficacy.

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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