Introduction to ICMR & CDSCO Release 39 Standard IVD Evaluation Protocols
The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly released a compendium of 39 standardized protocols for evaluating In-Vitro Diagnostics (IVDs). This landmark move aims to enhance the performance, reliability, and global competitiveness of diagnostic tools developed in India.
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Scope of the Protocols
The protocols cover the evaluation of diagnostic kits for a wide range of diseases, including:
- Tuberculosis
- Malaria
- Dengue
- Chikungunya
- Zika Virus
- Typhoid Fever
- Respiratory Viruses
- Chandipura Virus
- Nipah Virus
Expert Insights
Dr. Rajiv Bahl, Director General, ICMR
Dr. Bahl emphasized the importance of robust regulatory mechanisms to match India’s fast-growing diagnostic industry. He stated that standardized evaluation protocols and accredited laboratory networks are critical for timely validation and market readiness of new diagnostic kits.
Dr. Rajeev Singh Raghuvanshi, DCGI
Dr. Raghuvanshi highlighted the significance of ensuring quality and performance of IVDs both at pre- and post-market stages. He noted that this initiative marks the world’s first collaboration between a national regulatory authority and a national research institute to jointly develop standardized IVD protocols. This effort will streamline evaluation, accelerate availability, and support India’s vision of affordable, accessible, and quality healthcare for all.
Global Significance
The compendium sets minimum standards, acceptance criteria, and uniform testing methods for IVD evaluation. By strengthening the validation process, the initiative ensures faster access to high-quality diagnostic products, not only for India but also for global markets.
Role of Operon Strategist
As a trusted regulatory and compliance partner, Operon Strategist assists medical device and IVD manufacturers in navigating the evolving regulatory landscape. Our team supports companies with:
- Regulatory documentation and compliance with CDSCO standards
- IVD manufacturing and licensing guidance
- Market-entry strategies with adherence to global quality benchmarks
- End-to-end support in product development and validation processes
Through our expertise, we help manufacturers align with these newly introduced protocols, ensuring faster approvals, smoother compliance, and enhanced market readiness.
