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 In a major collaborative effort to enhance accuracy and regulatory robustness of diagnostic tools used in the fight against tuberculosis (TB), the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have released draft standard protocols for the evaluation of in-vitro diagnostics (IVDs). These protocols specifically target diagnostic technologies used for pulmonary tuberculosis and drug-resistant tuberculosis.
The document, titled ICMR-CDSCO/IVD/TB/PROTOCOLS/2025, marks a significant step towards standardizing the performance evaluation of IVDs under the Medical Devices Rules, 2017. The initiative is being spearheaded by the ministry of health and family welfare, through its key agencies—the Department of Health Research and the CDSCO.
According to the official statement, the protocols are intended to guide IVD manufacturers and testing laboratories in India in conducting robust and consistent performance evaluations. These evaluations are crucial for ensuring that TB diagnostic tools meet the quality and sensitivity standards required for effective public health outcomes.
The draft comprises three major evaluation protocols- Analytical Performance Evaluation of In-Vitro Diagnostics for Pulmonary Tuberculosis, Clinical Performance Evaluation of In-Vitro Diagnostics for Pulmonary Tuberculosis and Clinical Performance Evaluation of In-Vitro Diagnostics for Pulmonary Drug-Resistant Tuberculosis.
Each of these protocols outlines the detailed methodologies and parameters by which a diagnostic test must be assessed before it can receive regulatory approval for use in India.
In an effort to ensure transparency and stakeholder engagement, ICMR and CDSCO have placed the draft protocols in the public domain for consultation. All interested parties, including medical device manufacturers, diagnostic laboratories, researchers, healthcare professionals, and patient advocacy groups, are invited to review the protocols and submit their comments.
The feedback window will remain open until September 7, 2025. Stakeholders are encouraged to send their inputs to ivdevaluation@gmail.com using the prescribed Standard IVD Performance Evaluation Protocol Stakeholder Feedback Form.
India has one of the highest burdens of TB in the world. Effective and accurate diagnostics play a pivotal role in early detection, timely treatment, and overall TB control. The release of these standardized protocols is being seen as a crucial move toward the broader goals of the National Strategic Plan for TB Elimination.
Health policy experts have welcomed the initiative, stating that consistent and transparent evaluation of diagnostics will foster greater innovation and trust in India's growing medical device ecosystem. By setting a clear regulatory path, the government aims to accelerate the availability of high-quality diagnostic solutions in the market.
CDSCO and ICMR have aimed at facilitating the availability of quality-assured diagnostic kits appropriate for use in India. This protocol gives the methods to be used for evaluating the analytical performance characteristics of the in-vitro diagnostic test in detecting pulmonary tuberculosis and drug-resistant tuberculosis.
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