Last Updated on July 1, 2025 by The Health Master
Laboratories
Download the updated list of Medical Device Testing Laboratories, link is given below: The Central Drugs Standard Control Organisation (CDSCO) has issued a notification updating its existing list of Medical Device Testing Laboratories that will participate in the performance evaluation of In-Vitro diagnostic medical devices.
Notably, mentioning that there is an ongoing health emergency, seven new laboratories have been added to the list for performance evaluation of IVD reagents and kits for detection of COVID-19.
As the country continues to witness increasing cases of COVID-19, it is always essential to maintain the competency of diagnostic infrastructure down the line.
Therefore, stable authorities like the CDSCO realize this need and add on extra laboratories to evaluate the performance of COVID-19 rapid antigen tests, SARS-CoV-2 RT-PCR kits, etc., to ensure they are competent and safe for disease evaluation.
Where are new laboratories added?
With the updated notification, the newly added laboratories:
The National Institute of Biologicals (NIB), located in Uttar Pradesh, is one lab for performance appraisal for additional additions, as it falls under the category of RT-LAMP (Loop-mediated isothermal amplification) and RT-PCR.
Along with this Centre, four others have been added under the category of VRDLs.
There is one each in New Delhi, Assam, Puducherry, and one in Karnataka.
In addition, two VRDLs in Karnataka will also form part of the updated list.
Overall, these VRDLs will primarily be performing the performance evaluation of RTPCR kits for the detection of COVID-19.
Ongoing Efforts for Other Diseases
Other performance evaluation reports have assessed that there is a need for additional laboratories for chikungunya. The number of increased labs from 2023 to 2025 is from eight to thirteen.
This also applies to dengue diagnostic kits, as the number added from 2023 to 2025 is 12 to 18.
Such diseases occur regionally due to vectors, and these assessments have now equipped more infrastructure that should dedicate chikungunya and dengue diagnostic kits.
The same relates to influenza diagnostic kits, as from 2023 to 2025, the increased number of approved labs has gone up from seven to thirteen.
Thus, breaching the status quo not only for current pandemic readiness but also for future needs as well.
Q: How many new laboratories have been added specifically for COVID-19 IVD evaluation?
A: Seven new laboratories have been added specifically for the performance evaluation of IVD reagents and kits for the detection of COVID-19.
Q: Which types of COVID-19 tests will the newly added labs evaluate?
A: The National Institute of Biologicals (NIB) will evaluate RT-PCR and RT-LAMP kits, while the newly added VRDLs will focus on RT-PCR kits for COVID-19 detection.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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