India Pharma Outlook Team | Friday, 15 August 2025
The Central Drugs Standard Control Organisation (CDSCO) has released draft standards for In-Vitro Diagnostics (IVD) medical devices, inviting comments from stakeholders. Developed jointly with the Indian Council of Medical Research (ICMR), the protocols are aimed at standardizing performance evaluation for IVD manufacturers and testing labs across India.
Under the Medical Devices Rules 2017, licensure of IVDs requires a detailed performance evaluation to ensure quality and reliability. As per the draft, once a kit is found to be not of Standard Quality, no request for repeat testing of the same kit will be accepted.
"Any request of re-validation from the same manufacturer for the same test type will only be entertained after a minimum of 3 months and only if a high-level technical summary of modifications or functional improvements to the kit design is submitted, without explicit disclosure of proprietary information," the CDSCO clarified.
The draft also notes that repeat evaluation using the same or different well-characterized clinical sample panels may be considered only for kits claiming high sensitivity and specificity (95% and above) that fail performance evaluation by a margin of 5%.
The protocols cover 15 key IVDs, including SARS-CoV-2 molecular detection assays, influenza virus multiplex assays, malaria rapid diagnostic tests, Nipah and Chandipura virus PCR assays, and dengue IgG/IgM tests.
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"These protocols are now being placed in the public domain for comments from relevant stakeholders," CDSCO said. "This window of opportunity will close on 25th August 2025, and, once finalized, there will be minimal scope for change in these documents. Therefore, all interested stakeholders are requested to provide their comments before 25th August 2025...."
After completion of the public consultation, all the feedback would be considered by CDSCO and ICMR and the protocols are then finalized to enhance the IVD regulatory base in India and increase regulatory compliance in the industry.
