India Rolls Out Its First-Ever Guidelines To Tackle Anti-Microbial Resistance With Better Testing Machines
According to the guidance document, delays in diagnosis, combined with a lack of affordable and reliable diagnostic tools, contribute significantly to the inappropriate use of antibiotics, further driving the emergence and spread of AMR.
To detect new pathogens and anti-microbial resistant genes, the Indian Council of Medical Research (ICMR) and the drug regulatory agency, Central Drugs Standard Control Organization (CDSCO) have rolled out India’s first guidelines for developing the latest testing machines. The move has been triggered by the central government’s focus on fighting the most challenging health hazard of increasing anti-microbial resistance. The 59-page document, accessed by News18, will help innovators understand the required evidence and prepare testing machines for the validation process.
The document has been prepared by the AMR co-ordination unit of ICMR and the document has undergone two rounds of inputs from experts and the Central Drugs Standard Control Organization (CDSCO) through e-mails and stakeholder consultations held at ICMR headquarters at New Delhi.
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The first edition document titled “Validation of rapid diagnostics for pathogen identification and antimicrobial susceptibility testing, 2025" aims to work on creating rapid and accurate diagnosis of infectious diseases – which is a critical first step in ensuring the appropriate use of antimicrobial medicines.
Highlighting the growing threat of resistance, the drug controller general of India, Rajeev Singh Raghuvanshi wrote in the foreword of the guidelines, “Antimicrobial resistance (AMR) is one of the most pressing public health challenges of our time threatening to undermine the efficacy of many life-saving antibiotics and other antimicrobial agents."
He recognised that “Unfortunately, delays in diagnosis, combined with a lack of affordable and reliable diagnostic tools, contribute significantly to the inappropriate use of antibiotics, further driving the emergence and spread of AMR." He added that in India, where infectious diseases continue to pose a significant burden on public health, the need for high-quality, affordable, and easily accessible diagnostic tools is “more urgent than ever."
Similarly, Rajiv Bahl, director general of ICMR wrote that “recent advances in molecular techniques have enabled the development of new and improved diagnostic tests capable of identifying microorganisms and detecting antimicrobial resistance genes." However, he added that “the lack of a standardised framework for the validation process to be followed for new diagnostics has impeded their progress and uptake in the health care system."
How the document streamlines the gaps?
This document has been designed to assist the innovators and testing laboratories in validating diagnostics meant for pathogen identification and antimicrobial susceptibility testing.
This document outlines the criteria for evaluating methods to detect and measure pathogens, their genetic material (DNA, RNA), toxins, or products, and for testing antimicrobial susceptibility. It also explains the steps to validate these diagnostic tests.
“This guidance document encompasses the assessment of precision, accuracy, reproducibility, and the ability to correctly identify the target pathogen and/or antimicrobial susceptibility," it said.
It clarifies that approximate cost per test may have “a decisive impact on the usability of diagnostic" which could be determined using cost-effectiveness studies. Also, it explains how validation studies can be performed. “In an ideal situation, the validation studies must preferably be carried out at multiple sites. However, in cases where this is not feasible, validation should be carried out in a minimum of two different sites representing the country’s geographic variations to test the validity and usefulness of the diagnostic."
Antimicrobial susceptibility testing
The document also clarifies several unattended issues on “antimicrobial susceptibility testing". It says that a representative number of samples positive for clinically relevant pathogens indicative of susceptibility, intermediate resistance and resistance (S/I/R) for antimicrobials “must be tested in parallel in the study."
“A minimum of 100 isolates recovered from clinical samples are recommended for each group of micro-organisms (CLSI, 2018c) to determine the relevance of antimicrobials for infectious disease management."
“Susceptibility testing will be performed for a panel of antibiotics based on the drug-bug profile combination, including the recently approved novel antibiotics using the reference broth microdilution method. However, a greater number of samples will always help in improving the confidence in test results and minimize the error or bias in the process," the document states.
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