Last Updated on September 17, 2025 by The Health Master
Medical Devices
The Drugs Controller General of India (DCGI) has determined new guidelines to align the approval process of Tuberculosis (TB) diagnostic medical devices with the newer things.
The Central Drugs Standard Control Organisation (CDSCO) has released a draft of guidelines that pertain to the standardization of the licensure of Tuberculous In Vitro Diagnostics (IVDs) focused on quality assessment and performance.
Such TB IVD medical devices will be more easily acquired and likely approved for efficacious testing across the country very soon.
What’s Included?
This 54-page draft comes from the Indian Council of Medical Research (ICMR) and CDSCO and contains proposed drafts to assess the various analytical and clinical performances relative to IVDs.
This impacts the most common forms of IVD medical devices, which reflect diagnoses for pulmonary TB but even more so for the more complicated and difficult-to-treat drug-resistant TB (DR-TB), which influences entire communities at risk.
Therefore, any assessment includes an assessment of safety, sensitivity, and specificity, meaning that it must perform as intended and the intended conclusions must be validated before the comprehensive assessment for licensure in India is determined.
What are in vitro diagnostics?
In vitro diagnostics are instruments that diagnose tests that are performed on samples taken from inside the body, such as blood, tissue, serum, urine, etc.
IVDs assess certain “biomarkers” within the sample taken to assess the individual’s state of health or whether that person has been infected with some type of disease.
These new assessments are specifically applied to licensed IVDs used for stating a positive determination of TB.
What Happens Next?
The public comment window for this proposed draft decision is open until September 7, 2025, at which point CDSCO and ICMR will decide what to take from the commentary before completing the cycle.
This requires such testing based on the Medical Device Rules of 2017, which ensures that quality measures are maintained prior to licensure.
It’s important that India recognize this process independent from comparative processes from the past, as only earlier this month drafts were created for licensing approval of 15 other kinds of IVD kits unassociated with TB but with dengue, malaria, SARS-CoV-2, etc.
Importance of These New Guidelines
For the public health panorama, this means a faster and more assured process for those seeking TB diagnostic medical devices.
This is pivotal for a medical landscape that must strive toward prevention and treatment of TB challenges that occur with frequency for millions of Indians annually.
The clearer the device acquisition process becomes, the better it will be for the laypersons and their disease treatment pathways.
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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