Antimicrobial resistance (AMR) continues to pose a grave global health challenge, particularly in densely populated nations like India, where diverse healthcare practices and a significant burden of infectious diseases lead to high antibiotic consumption. Accurate and timely diagnosis of infections using reliable diagnostic tests is essential to initiate appropriate treatment and minimize antimicrobial misuse.
To address these challenges, the Indian Council of Medical Research (ICMR) has released a comprehensive guidance document for the validation of rapid diagnostics aimed at pathogen identification and antimicrobial susceptibility testing (AST). This document bridges existing gaps in the validation process and provides a framework for innovators and developers to ensure their diagnostic tools meet regulatory standards.
The Need for Validation in AMR Diagnostics
In India, the development of indigenous diagnostic tests is gaining momentum. These tests are critical for early detection of pathogens and rapid evaluation of antimicrobial resistance markers. However, systematic validation is essential to establish their accuracy and reliability, particularly when compared to reference standard methods.
Although significant literature exists on diagnostic validation, the lack of defined, uniform protocols for AMR-related diagnostics has hindered their adoption and regulatory approvals. This new guidance document provides clarity by outlining steps, evaluation criteria, and acceptance benchmarks for indigenous diagnostic tools.
Key Features of the Guidance Document
The document outlines the following essential components:
- Validation Process:
Validation is defined as the systematic evaluation of a diagnostic test to determine its fitness for intended use. It includes assessing analytical and diagnostic performance. Parameters for testing depend on the specific diagnostic type, ensuring uniformity across all assays. - Regulatory Framework:
The Central Drugs Standard Control Organization (CDSCO) oversees the validation and approval of In Vitro Diagnostics (IVDs) in India. The guidance document aligns with CDSCO requirements and supplements existing guidelines, including the Medical Device Rules, 2017. - Performance Evaluation:
Validation studies include analytical and clinical performance evaluations. Clinical performance studies must adhere to ISO 20916:2019 and ISO 15189:2022, ensuring compliance with good study practices and ethical standards. - Licensing Process:
The regulatory process requires innovators to secure various licenses, including Test Licenses (MD-13) for producing validation batches and Clinical Performance Evaluation (CPE) approvals (MD-25). These steps ensure safety, performance, and quality assessment before final manufacturing approvals. - Risk-Based Classification:
IVD devices are classified based on risk levels (Class A to Class D). For high-risk devices (Class B, C, and D), clinical performance evaluations are mandatory.
Support for Innovators
Government initiatives like the ICMR-led MedTech Mitra platform and the Manthan digital platform aim to facilitate innovation in medical technology. These platforms provide strategic support, regulatory facilitation, and bridge the gap between industry and academia.
Future Implications
By providing a standardized approach to validation, this guidance document is expected to accelerate the development and adoption of indigenous diagnostics, ensuring they meet global quality benchmarks. The initiative underscores India’s commitment to combating AMR through innovation and robust regulatory frameworks.
The 2025 guidance document marks a significant step toward addressing the challenges of AMR diagnostics in India. By fostering innovation and streamlining validation processes, it paves the way for more accurate, reliable, and accessible diagnostic tools, ultimately contributing to better healthcare outcomes and the containment of antimicrobial resistance.
