The Indian Council of Medical Research (ICMR), in collaboration with the Central Drugs Standard Control Organisation (CDSCO), has released draft standard evaluation protocols for the performance evaluation of In-Vitro Diagnostic (IVD) kits designed to detect and differentiate various strains of Influenza viruses, SARS-CoV-2, and Respiratory Syncytial Virus (RSV).

These protocols, intended for use by IVD manufacturers and testing labs in India, aim to streamline and standardize the licensure process of IVDs under the Medical Devices Rules, 2017.

The draft protocols have been placed in the public domain for comments from relevant stakeholders. The consultation window will remain open until August 25, 2025, after which there will be minimal scope for change in these documents.

Interested stakeholders are requested to submit their feedback before this date to ivdevaluation@gmail.com using the prescribed format provided by the authorities.

The draft document provides a framework for evaluating the performance characteristics of IVD kits, aligning with international standards to ensure reliability and accuracy in diagnosis.

“The coronavirus diseases 2019 (COVID-19) pandemic, caused by the SARS-CoV-2 virus, has necessitated the rapid development and validation of in vitro molecular diagnostic kits. These kits are crucial for the timely detection and differentiation of major respiratory viruses (influenza/SARS-CoV-2/RSV) to control their spread. This protocol outlines a systematic approach for validating these diagnostic kits to ensure their accuracy, sensitivity, specificity, and reliability,” the draft guidelines state.

Once the public consultation period concludes, all comments will be reviewed and considered in finalizing the draft protocols before final clearance by ICMR and CDSCO.