DCC: All states to provide data on Vaccine

This lamentable observation was underscored in the recent DCC congregation held at the close of January of the present year.

The Health Master

April 3, 2024

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Last Updated on September 30, 2024 by The Health Master

DCC

In a resounding call to action, the Drugs Consultative Committee (DCC) has once more implored the State and Union Territory (UT) Drugs Controllers to furnish critical insights regarding vaccine production and distribution to the Central Drugs Standard Control Organisation (CDSCO).

This endeavor is indispensable to align with the anticipated global standards set forth by the World Health Organization (WHO).

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Despite the Committee’s earlier entreaties in its preceding assembly convened last annum, several States have yet to comply with the CDSCO’s missive pertaining to this matter.

This lamentable observation was underscored in the recent DCC congregation held at the close of January of the present year.

“The committee further noted the imperativeness of ongoing data submission, emphasizing the requisite for updated information in accordance with the prescribed checklist and Standard Operating Procedure (SOP) delineated by CDSCO.

This is crucial for maintaining uniformity in the inspection protocols and the formulation of standardized inspection reports across all States,” remarked the Committee.

Consequently, all State/UT Drugs Controllers were once again enjoined to expedite the furnishing of pertinent information without delay.

Read and Download minutes of all meetings of DCC

Global Benchmarking Imperatives

The World Health Organization (WHO) adheres to a stringent Global Benchmarking Tool (GBT) for the comprehensive evaluation and benchmarking of regulatory functions across nations.

This procedural benchmarking is a prerequisite for the procurement of vaccines by United Nations (UN) agencies from Indian vaccine manufacturers.

Institutions such as CDSCO, in conjunction with ancillary entities like Central Drugs Laboratory and the Adverse Events Following Immunisation (AEFI) surveillance system, undergo evaluation by WHO.

CDSCO has solicited an array of information encompassing a roster of departmental officials along with their qualifications, prior experience, ongoing regulatory engagements, and training endeavors.

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Furthermore, information regarding the number of facility inspections conducted, recruitment protocols, organizational structures delineating job responsibilities under the Quality Management System (QMS), risk-based sampling strategies, and quarterly vaccine sampling plans are among the requisite data sought by CDSCO.

In the preceding assembly convened at the denouement of September 2023, under the stewardship of Drugs Controller General (India) [DCGI] Dr. Rajeev Singh Raghuvanshi, the Committee acknowledged the imminent prospect of WHO’s re-benchmarking of CDSCO concerning vaccine regulation, subject to formal ratification by the Ministry.

Emphasizing the indispensability of comprehensive data aggregation from all states encompassing manufacturing and sales premises, the Committee reiterated the urgency in light of the impending National Regulatory Agency (NRA) assessment.

WHO’s Stipulated Evaluation Framework

WHO’s evaluation framework for vaccines encompasses a multifaceted review of the manufacturing processes, compliance verification, lot testing, and site audits.

Stringent procedures are in place to ensure a standardized approach aimed at expediting assessments, including reliance on responsible NRAs.

WHO’s vaccines prequalification process hinges on the recognition of NRAs attaining a requisite level of “maturity” as delineated by WHO’s GBT.

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NRAs play a pivotal role in the regulatory oversight of vaccines slated for integration into national immunization programs.

In select instances, WHO may opt to forge collaborative agreements or arrangements with NRAs, thereby streamlining the prequalification process through reliance on NRA’s assessments, testing, and inspection reports.

WHO commended the Indian regulatory authority following a successful assessment in 2017, affirming its “functional” status with a maturity level of four, the highest tier as per the contemporary definitions, across five functions.

Additionally, a maturity level of three was attributed to four functions, signifying a commendable achievement during that period.

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