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 The Central Drugs Standard Control Organisation (CDSCO) has revised the list of laboratories for conducting performance evaluation of In-Vitro Diagnostic (IVD) medical devices, adding seven laboratories for evaluation of IVD reagents and kits for detection of Covid-19, removing categories of reagents and kits for detection of autoimmune disorders and human genetic testing. The addition to the list comes in the backdrop of the increasing number of Covid-19 cases in the country in recent times.
The drug regulator has listed the National Institute of Biologicals in Uttar Pradesh, one VRDL each in New Delhi, Assam, Telangana and Puducherry, and two VRDLs in Karnataka, for performance evaluation of IVD reagents or kits for detection of SARS-CoV-2. While the NIB has been approved for testing RT PCR, RT LAMP, the VRDLs has been listed to test the RTPCR kits for detection of Covid-19.
The updated list has also registered an increase in the number of laboratories to test IVDs for detection of chikungunya (from eight in 2023 to 13 in 2025) and laboratories to tests the kits for detection of Dengue (from 12 in 2023 to 18 in 2025). The number of laboratories listed for performance evaluation of IVD reagents and kits for detection of influenza has been increased from seven in 2023 to 13 in 2025.
However, while the previous list mentioned that the IVD reagents or kits for detection of autoimmune disorders and human genetic testing can be conducted in any Central government or state government laboratory of any hospital or of any institute, this has been now removed from the latest list. In total, the latest update has enlisted laboratories to test reagents or kits to detect 22 categories of diseases, under the IVD medical devices list as against 23 in November, 2023 list.
According to the provisions under the Fourth Schedule of the Medical Devices Rules, 2017, which enlists the documents required for grant of licence to manufacture for sale or for distribution or import of medical devices, for IVD medical devices the manufacturer should submit a performance evaluation report (PER) for approval.
In a guidance document on the performance evaluation of IVD medical devices, the CDSCO has in 2018 said that when the State Licensing Authority specifically requires for Class B or the Central Licence Authority for Class B, Class C and Class D in-vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH) or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority.
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