India’s Central Drugs Standard Control Organisation (CDSCO), in collaboration with the Indian Council of Medical Research (ICMR), has released draft standard protocols for evaluating the quality and performance of in-vitro diagnostic (IVD) devices. The draft covers 15 categories of diagnostic kits and is open for stakeholder feedback until August 25, 2025.
According to The Economic Times, the 180-page draft outlines detailed procedures for both performance and field evaluation of IVDs, including those used for detecting dengue, malaria, influenza, Nipah virus, Chandipura virus, and SARS-CoV-2. These devices are used to analyse samples such as blood, urine, or tissue outside the human body, providing crucial information for diagnosis and monitoring.
Under India’s Medical Device Rules, 2017, the issuance of IVD licenses requires a comprehensive evaluation protocol to verify device safety, sensitivity, accuracy, and overall clinical and analytical performance. The new draft aims to formalise these requirements, creating a uniform framework for manufacturers, testing laboratories, and regulators. Once finalised, the protocols are expected to leave limited room for subsequent modifications.
ICMR’s role in developing these protocols reflects its ongoing responsibility to standardise diagnostic kit assessment, while CDSCO is tasked with ensuring compliance and enforcement. By setting clear benchmarks for evaluation, the draft seeks to enhance regulatory consistency and transparency in the licensing process.
For manufacturers, the move introduces a more structured pathway to market approval, potentially reducing ambiguities in compliance expectations. For testing laboratories, it offers a reference framework for quality assurance, while for public health authorities, it strengthens confidence in the reliability of diagnostics used in disease surveillance and patient care.
Industry stakeholders, particularly those in the diagnostics and MedTech sectors, are expected to review the draft closely and submit comments before the August deadline. The finalisation of these protocols will be a key step in aligning India’s diagnostic regulatory practices with global standards, while addressing the country’s public health priorities in infectious disease management.
