Understanding complexities in the uptake of indigenously developed rapid point-of-care diagnostics for containment of antimicrobial resistance in India

Abstract

A good point-of-care diagnostic test holds a promise to reduce inappropriate use of antibiotics by enabling early detection of the pathogen and facilitating rapid testing of antimicrobial susceptibility. India has taken many initiatives in the recent past to augment the development and deployment of diagnostics in Indian health care system. Funding opportunities to promote innovation in diagnostics development were started in early 2000s through various ministries and departments. India released National Essential Diagnostics List which enlists essential tests and there is now Free Diagnostics Service Initiative of Government of India under National Health Mission that mandates to provide all essential tests free of cost. We wanted to understand how these initiatives have impacted the diagnostics that could be of use in containment of antimicrobial resistance (AMR) and whether there is a smooth process for bringing indigenously developed products relevant to AMR into the healthcare system. We conducted a longitudinal survey (January 2019 and January 2021) to understand the availability of market ready indigenous rapid diagnostics for AMR in the country and their progress towards introduction in the private market or uptake in healthcare system. We found that many innovators and developers are working towards development of rapid tests that can be useful in the containment of AMR in India. While there are many promising diagnostics on the horizon, the pathway for uptake of indigenously developed diagnostics in healthcare system remains disjointed and needs to be harmonised for the investments made towards development to translate as tangible gains. Since most of these efforts are government funded, it is incumbent upon the government to also provide a seamless pathway to make these diagnostics available in health care system. In absence of this guidance, most of these diagnostics will sit with the innovators/developers and will never be used for the purpose they were intended to serve.

India’s ban on antimicrobial fixed-dose combinations: winning the battle, losing the war?

“…At the health-systems level, reasons as to why the FDCs have come to be the preferred prescribing choices must be addressed [ 16 ]. Uncertainty regarding the causative microorganism that might make concurrent use of antimicrobials preferred should be countered by developing and expanding cheap and accurate point-of-care antimicrobial diagnostics [ 17 , 18 ]. Similarly, healthcare providers should be regularly updated on the common bacterial pathogens causing prevalent infections in the facilities they serve and their antimicrobial susceptibility patterns [ 19 , 20 ].…”

Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation

“…Many rapid diagnostics for the detection of sepsis are available in Indian markets at prohibitively high costs. Despite the presence of prolific innovation sector in India, few indigenously developed diagnostics are finding place in the Indian healthcare system 29 . TPPs can channelize the investments towards developing ‘fit-for-use’ rapid diagnostics.…”

Fast Track Diagnostic Requisite for Sepsis and its Antimicrobial Resistance in Low Resource Settings: A Step Towards Antimicrobial Stewardship

“…According to a WHO report (2016), only 15 of the 48 high TB-burden countries have used the Xpert tests for all suspected TB cases (WHO, 2017b) and same could happen in case of sepsis. In India, only two diagnostic platforms are under development stage (TRL4) for Sepsis (bacteraemia) and neonatal sepsis detection and no diagnostic has yet been released for clinical utility [19] indicating a need for indigenously developed rapid POC diagnostics for AMR containment in India.…”