In a landmark move to safeguard the quality and reliability of diagnostic tools in Indian healthcare, the Central Drugs Standard Control Organisation (CDSCO), in partnership with the Indian Council of Medical Research (ICMR), has released comprehensive draft standard evaluation protocols for issuing licenses to In-Vitro Diagnostic (IVD) devices. These protocols, now open for public consultation until August 25, 2025, set rigorous benchmarks for the assessment of IVDs, aiming to enhance patient safety and trust in medical diagnostics nationwide.

The newly announced 180-page document offers precise evaluation and field assessment procedures for 15 categories of diagnostic kits, including those used for detecting Dengue, Malaria, Influenza, Nipah virus, Chandipura virus, SARS-CoV-2 molecular detection, and other critical diseases. IVDs play a pivotal role in medicine by enabling disease diagnosis, monitoring, and management through tests performed on samples like blood, urine, or tissue outside the human body.

Manufacturers and testing laboratories will be required to follow these standardized protocols to validate device safety, sensitivity, accuracy, and clinical performance before being granted a license, as mandated by the Medical Device Rules of 2017. By implementing uniform standards, the authorities intend to ensure accurate and dependable diagnostic results while promoting best practices across the sector.

The joint initiative is also designed to create a robust regulatory pathway, streamlining the approval process and reducing ambiguity for manufacturers. The move is expected to foster innovation and raise the quality bar for diagnostics available in India. Stakeholders—including manufacturers, healthcare professionals, and laboratory experts—are encouraged to submit feedback during this open consultation phase. After August 25, only limited changes will be considered before the protocols are finalized for nationwide enforcement.

This strategic development reaffirms CDSCO and ICMR’s commitment to public health, signaling a new era of stringent quality assurance and transparency in India’s rapidly evolving medical device landscape.