The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) are collaborating to improve the accuracy and efficiency of In-Vitro Diagnostic (IVD) testing in India. They have published a draft STANDARD PERFORMANCE EVALUATION PROTOCOLS manual for stakeholder comments.
What are IVDs?
In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, since these tests are usually conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself. Accurate IVD testing is crucial for timely and appropriate healthcare interventions.
The Importance of Standardized Protocols
The licensure of IVDs under the Medical Devices Rules 2017 requires a thorough evaluation of their performance. To ensure consistency and streamline this process, ICMR and CDSCO have developed a series of draft standard evaluation protocols for specific IVDs. These protocols outline the methodologies and criteria for testing the quality and performance of these diagnostic tools.
Public Consultation on Draft Protocols
Currently, draft protocols have been developed for a range of IVDs commonly used to diagnose diseases like Chikungunya, Dengue, and Zika virus.
ICMR and CDSCO are now inviting comments from all interested stakeholders on these draft protocols. This window for public input closes on February 15, 2025. Stakeholders are encouraged to provide their comments through email to ivdevaluation@gmail.com using a specific format provided by ICMR and CDSCO.
Once the public consultation period concludes, ICMR and CDSCO will review all received comments. This feedback will be considered in finalizing the draft protocols before their official adoption.
