ICMR & CDSCO Invite Stakeholder Comments on Standard IVD Evaluation Protocols for Tuberculosis Diagnostics

Tuberculosis (TB) remains a significant public health challenge in India, with drug-resistant strains posing an even greater threat. To address this, the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have collaborated to develop standardized protocols for evaluating In-Vitro Diagnostics (IVDs) for TB. These protocols aim to ensure the availability of high-quality diagnostic kits tailored to India’s needs, facilitating accurate detection of pulmonary TB and drug-resistant TB.

Why Standardized Protocols Matter

Under the Medical Devices Rules 2017, IVDs require rigorous performance evaluation before licensure. The newly drafted protocols by ICMR and CDSCO provide a structured framework for analytical and clinical validation of diagnostic kits. This ensures that diagnostic tools meet stringent standards for sensitivity, specificity, and reliability, ultimately improving patient outcomes and supporting India’s National TB Elimination Program (NTEP).

Key Protocols Developed

The following protocols have been drafted and are open for stakeholder feedback:

Analytical Performance Evaluation of IVDs for Pulmonary TB Focuses on evaluating the analytical sensitivity, specificity, reproducibility, and limit of detection (LOD) of diagnostic kits using archived or spiked sputum samples.
Clinical Performance Evaluation of IVDs for Pulmonary TB Aims to assess diagnostic accuracy in real-world clinical settings using prospectively collected sputum samples.
Clinical Performance Evaluation of IVDs for Pulmonary Drug-Resistant TB Evaluates the ability of diagnostic kits to detect drug resistance, including resistance to first-line drugs (Rifampicin and Isoniazid) and second-line drugs (Fluoroquinolones).

Highlights of the Protocols

Ethical Considerations: The protocols prioritize patient privacy, dignity, and safety. Leftover clinical samples are used, minimizing harm and discomfort.
Blinding: Laboratory staff performing evaluations are blinded to sample status to ensure unbiased results.
Sample Size: Rigorous calculations ensure adequate sample sizes for reliable sensitivity and specificity estimates.
Quality Control: Internal and external quality assurance measures are mandated to maintain high standards.
Acceptance Criteria: Diagnostic tests must meet minimum sensitivity (≥85%) and specificity (≥95%) thresholds to be considered satisfactory.

Stakeholder Feedback Opportunity

ICMR and CDSCO have placed these protocols in the public domain, inviting comments from relevant stakeholders. Feedback can be submitted via email to ivdevaluation@gmail.com by 7th September 2025. This is a crucial opportunity for manufacturers, researchers, and healthcare professionals to contribute to shaping the future of TB diagnostics in India.

Impact on TB Control in India

These protocols are a significant step forward in India’s fight against TB. By standardizing the evaluation process, they ensure that only high-quality diagnostic kits are approved for use. This will enhance early detection, accurate diagnosis, and effective treatment, ultimately reducing TB prevalence and mortality.

Conclusion

The ICMR-CDSCO collaboration exemplifies India’s commitment to strengthening its healthcare infrastructure. These protocols not only set a benchmark for diagnostic quality but also pave the way for innovative solutions to combat TB. Stakeholders are encouraged to review and provide feedback, contributing to this vital initiative for public health.

Listen to this on our #YouTube Channel

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

We offer Legal advice and litigation support in matters related to Indirect Tax-Customs, FTP, other Indirect Tax matters & Arbitration law, all sorts of Central licensing and related matters. Come and explore the new way of doing business with us!

Source: CDSCO

Disclaimer

Handy Download:

CDSCO Public NoticeDownload

Connect with us for more-

@ Team S J EXIM SERVICES, New Delhi, IN

CP: Ms. Shubhra Jha, Founder

Tel: +91-11-4999 2707 I +91-9999005693

Web: www.sjexim.services

EMAIL: operations@sjexim.services I shubhra@sjexim.services

Facebook: www.facebook.com/sjeximservices

LinkedIn: https://www.linkedin.com/company/90794255/admin/feed/posts/

YouTube: https://www.youtube.com/@sjeximIndia

Subscribe our WhatsApp Channel: https://whatsapp.com/channel/0029VaTxDT8JZg4CHEOSoK47

Subscribe our Telegram Channel: https://t.me/sjeximindia

S J EXIM Services