Image created by Dr. Michael J. Miller
India’s Central Drugs Standard Control Organization (CDSCO) has published guidance on validating rapid diagnostics for pathogen identification and antimicrobial susceptibility testing.
The guidance, created with the Indian Council of Medical Research (ICMR), sets out “a comprehensive framework to systematically evaluate and confirm the diagnostic performance of a given test, ensuring its reliability and its utility for clinical decision making,” according to the agencies.
Rajiv Bahl, ICMR director general, framed the guidance as India’s response to the rise of antimicrobial resistance and the development of molecular techniques for identifying microorganisms and detecting drug-resistance genes. India has a “pressing need for high-quality, affordable diagnostic tools tailored to meet the specific requirements of the healthcare system,” Balh said. Molecular techniques could address the need, but the lack of a standardized framework for validation has impeded uptake, according to Bahl.
The protocol provides guidance on evaluating a test and showing its effectiveness. Companies that adhere to the standardized process can “expedite validation, reducing the time and steps required for regulatory approval,” Bahl said. He added that by bridging the gap between developers and regulatory bodies, the guidance could minimize delays and facilitate the timely introduction of tests into the Indian healthcare system.
The guidance includes “evaluation criteria for methods to detect, identify and quantify pathogenic microorganisms,” the agencies said, and methods for antimicrobial susceptibility testing. The collaborators have illustrated the steps to validate such diagnostic tests.
CDSCO and ICMR said the document will help companies “understand the kind of evidence required to be generated before approaching the validating laboratory and prepare for the validation process.” The document “delineates the steps in the pathway of regulatory approval for a test,” the agencies said.
Guidance link: https://www.cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNTE=