ICMR and CDSCO develop framework for validation of pathogen identification and antimicrobial susceptibility testing

New Delhi: The Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organisation (CDSCO) have developed a test for identifying antimicrobial pathogens and susceptibility to antimicrobial resistance among patients. This will help innovators and testing laboratories in performing rapid diagnostic tests.

Antimicrobial resistance (AMR) threatens the efficacy of many life-saving antibiotics and medicines.

However, despite AMR being recognized by the World Health Organization as one of the top 10 global public health threats, there is an absence of a clear and standardized framework for validating these diagnostic tests.

Surge in AMR cases

According to the health ministry, reported AMR cases in India spiked more than 4.5 times from 25,833 in 2017 to 119,686 in 2022.

Inability to provide accurate and timely diagnosis is one of the major contributors to the misuse and overuse of antimicrobial drugs.

In India, there is a pressing need for high quality, affordable diagnostics tools tailored to meet the specific requirements of the healthcare system, said Dr Rajiv Bahl, Director General, ICMR in a guidance document issued for validation of rapid diagnostic for pathogen identification and antimicrobial susceptibility testing.

Import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated under the Drugs and Cosmetic Act, 1945 and Medical Device Rules, 2017.

The guidance document has been developed keeping in mind the safety and performance of IVD devices, in line with Medical Device Rules, 2017 and CDSCO requirements.

“This protocol provides guidance to innovators and developers for evaluating their test and demonstrating their effectivness. By adhering to these standardiesed process, innovators can expeidte validation, reducing the time and steps required for regulatory approvals,” Bahl said.

He said recent advances in medicine have enabled the development of new and improved diagnostic tests capable of identifying microorganisms and detecting antimicrobial resistance genes.

The guidance document has been developed with a view to ensuring the safety and performance of IVD devices, in line with Medical Device Rules, 2017 and CDSCO requirements.

Last year, the Drugs Controller General of India (DCGI) urged the state governments to identify the antibiotics being sold in the market to ensure that there is no misuse and over of such drugs.

This initiative will play a pivotal role in the fight against AMR in the country, the DCGI said in the document.