CDSCO, ICMR Release Draft IVD Protocols for Arboviral Diagnostics, Seek Feedback

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The draft protocols have been placed in the public domain, inviting feedback from relevant stakeholders. ICMR and CDSCO emphasize that this is a critical opportunity for industry players, researchers, and healthcare professionals to shape the final guidelines. The consultation period closes on 15th February 2025, after which changes will be limited. Stakeholders are encouraged to submit their comments via email to ivdevaluation@gmail.com.

The protocols aim to bridge critical gaps in the evaluation of diagnostic kits by establishing clear benchmarks for sensitivity and specificity, alongside defining standardized procedures for reproducibility and field evaluations. Additionally, the guidelines emphasize ethical and transparent testing processes to maintain integrity in the evaluation framework.

Once finalized, these protocols will provide a structured approach to licensing IVD kits, ensuring that only high-quality products enter the market. Importantly, any kit found to be “Not of Standard Quality” (NSQ) during evaluations will not be eligible for retesting unless the manufacturer demonstrates substantial modifications to the kit’s composition.