New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued draft standard protocols for issuing licenses of TB In-Vitro Diagnostics (IVDs) devices, based on their performance and quality.
The 54-page document issued by the regulator details standard protocols for evaluating analytical and clinical performance of IVDs used for Pulmonary TB and drug-resistant TB (DR-TB).
The notified evolution guidelines has been drafted by the Indian Council of Medical Research (ICMR) and the regulator, CDSCO has sought has sought stakeholders’ comments over the notified draft by September 7 2025.
As per the issued notice, 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.
In Vitro Diagnostics (IVDs) are medical devices used to test samples such as blood, urine, or tissue outside the human body, to diagnose diseases, conditions, or infections, and to monitor a person’s health based on predefined bio markers.
Under the Medical Device Rules of 2017, “Licensure of In-Vitro Diagnostics (IVDs) requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance.”
The evaluation protocol helps to test the device safety, sensitivity, and accuracy, to validate the device clinical and analytical performance, required for issuing the product license, thereby allowing its usage in the country.
In India the ICMR develops evaluation protocols to standardize the process of assessing the performance of diagnostic kits, particularly In Vitro Diagnostics (IVDs) and the CDSCO oversees the evaluation and enforcement of the protocols.
Earlier this month, the CDSCO had issued a separate draft protocol for 15 types of IVDs kits used for diagnosing Dengue, Malaria, Influenza, Nipah, Chandipura SARS-CoV-2, among several others.
