CDSCO, ICMR Release Draft IVD Protocols for Arboviral Diagnostics, Seek Feedback
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have jointly released draft protocols for the performance evaluation of In-Vitro Diagnostic (IVD) kits for arboviral infections.
The move aims to streamline the licensing process under the Medical Devices Rules (MDR), 2017, ensuring the availability of high-quality, standardized diagnostic tools in India.
The draft protocols include performance and field evaluation guidelines for diagnostic tests targeting critical arboviral infections, including Chikungunya, Dengue, and Zika virus. Specific tests covered include Chikungunya IgM ELISA, Dengue NS1 RDT, and Zika virus real-time PCR, among others.
These evaluation protocols are designed to independently verify manufacturers’ claims about their products’ performance. By implementing uniform testing standards, the initiative seeks to ensure that diagnostic kits meet India-specific needs for sensitivity, specificity, and reliability.
Also Read: Maha FDA seizes in-vitro diagnostic kits worth Rs 12.40 lakh in Thane
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.
