The Central Drugs Standard Control Organisation (CDSCO), in collaboration with the Indian Council of Medical Research (ICMR), recently issued draft standard TB IVD protocols for licensing In-Vitro Diagnostic (IVD) devices specific to Tuberculosis. These comprehensive guidelines aim to standardize the evaluation of quality and performance for IVDs used in diagnosing pulmonary TB and drug-resistant TB (DR-TB) across India.
India’s Medical Device Rules of 2017 mandate a detailed evaluation protocol for IVDs to ensure their quality and performance before licensure. This is a crucial step to ensure the safety, sensitivity, and accuracy of diagnostic devices available for public use in the country. The evaluation process validates both analytical and clinical performance, which is essential for issuing product licenses.
Understanding the Importance of TB IVD Protocols
In-Vitro Diagnostics (IVDs) are vital medical devices. They analyze samples such as blood, urine, or tissue outside the human body to diagnose diseases, conditions, or infections. Furthermore, IVDs monitor a person’s health based on predefined biomarkers. Therefore, establishing robust TB IVD protocols directly impacts the accuracy and reliability of TB diagnosis, a critical public health concern in India. The newly drafted protocols span 54 pages, detailing requirements for evaluating both analytical and clinical performance of these devices. For those interested in diagnostic advancements, exploring courses in Radiology Speciality Courses can provide valuable insights into imaging and diagnostic techniques.
The ICMR generally develops evaluation protocols, thereby standardizing the assessment process for diagnostic kits. Meanwhile, CDSCO oversees the evaluation and subsequent enforcement of these protocols. This collaborative effort ensures that IVDs meet rigorous performance standards and align with international best practices. Stakeholders, including manufacturers and testing laboratories, benefit from clear, standardized guidelines for performance evaluation.
Public Consultation and Finalization of Guidelines
CDSCO has opened the draft protocols for public consultation, inviting comments from relevant stakeholders until September 7, 2025. This allows industry experts, healthcare professionals, and the public to contribute to the finalization of these important guidelines. Once the public consultation period concludes, all submitted comments will undergo thorough review. Following this, ICMR and CDSCO will consider feedback before providing final clearance, thereby shaping the regulatory landscape for TB IVDs.
Earlier in August 2025, CDSCO released separate draft protocols for 15 other types of IVD kits. These include diagnostics for diseases such as Dengue, Malaria, Influenza, Nipah, Chandipura, and SARS-CoV-2. This broader initiative underscores India’s commitment to enhancing the quality and reliability of a wide range of diagnostic tools within its healthcare system.
Frequently Asked Questions
Q1: What is the primary purpose of the new TB IVD protocols?
The primary purpose of the new TB IVD protocols is to standardize the evaluation of the quality and performance of In-Vitro Diagnostic devices used for diagnosing pulmonary and drug-resistant tuberculosis, ensuring their safety, sensitivity, and accuracy for licensing in India.
Q2: Which organizations are responsible for drafting and enforcing these protocols?
The Indian Council of Medical Research (ICMR) drafts the evaluation protocols, while the Central Drugs Standard Control Organisation (CDSCO) oversees their evaluation and enforcement in India.
Q3: When is the deadline for public comments on the draft TB IVD protocols?
Stakeholders can submit their comments on the notified draft TB IVD protocols by September 7, 2025.
References
- CDSCO issues draft protocols to obtain license for TB IVDs – ETHealthworld
- Civis. Draft standard IVD evaluation protocols drafted by ICMR and CDSCO.
- ICMR, CDSCO Invite Public Comments on Draft Evaluation Protocols for In-Vitro Diagnostics.
- Medical Buyer. ICMR, CDSCO issue draft standard evaluation IVD protocols; seek stakeholders’ feedback.
- CDSCO & ICMR Introduce Draft IVD Protocols to Standardize Diagnostic Testing in India.
- Medgate Today. CDSCO Unveils Draft Standard Evaluation Protocols for IVD Licenses, Seeks Stakeholder Input.
Disclaimer: This article was automatically generated from publicly available sources and is provided for informational and educational purposes only. OC Academy does not exercise editorial control or claim authorship over this content. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider and refer to current local and national clinical guidelines.