Essential Diagnostic List - another step towards a Healthy India (PART I)

WHO’s latest announcement on introducing an Essential Diagnostic List further emphasizes the need to widen the reach of important diagnostic tests for timely disease management. The good news is India has taken the lead to develop its own National EDL. What needs to be seen is how the government and the industry come together to integrate the EDL to further boost the efforts towards a Healthier India.

The impact of global warming is not just on our melting glaciers. The rampant spread in infectious diseases, both new and old; has become a big concern for the healthcare specialists. Gone are the days when malaria was associated only with monsoons. Weather variations bring with it the unpredictable onset of host of diseases, further pushing the health machinery into action to contain the spread. The recent outbreak of Nipah virus in Kerala, once again highlights the crucial role played by diagnostic tests for the precise and early detection of emerging diseases. Clinicians have long relied on error-free diagnosis in addition to symptoms, for appropriate disease management. Unfortunately, half of the under developed & developing countries still prescribe medication without a confirmed laboratory test; culminating in multiple drug resistances.

Accessibility to reliable and affordable diagnostic tests continues to pose a greater challenge in the healthcare value chain. Considering the indispensability of medical diagnosis, the WHO has finally released the first model list for Essential Diagnostics. EDL just like its counterpart- Essential Medicines List (EML), is a list of essential tests which each country should have at minimum affordable prices. It is intended to serve as a reference to the country programmers to draft their own EDL based on national or regional burden of disease, unmet needs and priorities. The ultimate objective is to ensure availability of the selected tests at various levels of tiered national health care, be it the PHCs or SHCs. Thus, EDL will complement the already present EML and enhance its impact on universal health coverage, addressing health emergencies, and promoting healthier populations; the three strategic priorities of the WHO Thirteenth General Programme of Work (2019–2023).

The good news is, India has taken the lead, in initiating its own model EDL, spearheaded by ICMR with active participation from WHO India, McGill University and industry and government officials. While we are all aware of the mammoth task that lies ahead, the proposed EDL, while concentrating on in-vitro tests like tests of blood and urine, is expected to address detection, diagnosis and monitoring of 'priority' diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.

In a nutshell, the EDL will impact healthcare as well as diagnostic manufacturers in India as well as globally by acting at multiple levels. In this edition of the two part series, let us first identify the impact on healthcare:

The Indian Government recently announced the 'Ayushman Bharat scheme, intended to make healthcare free for the financially marginalized section of the society, through government aided health insurance services. An EDL will thus help provide easy access of essential diagnostics to these patients.

In the case of Ebola and Zika elsewhere, a wide time gap was experienced between the outbreak of the epidemics and its confirmed diagnostic recognition, highlighting the need for diagnostic facilities at every tier of the health system. An EDL is set to increase the laboratory capacity at every level and in turn help countries like India in their readiness for any epidemics.

In 2013, The Initiative for Promoting Affordable & Quality TB tests (IPAQT), was launched to bring together various private labs and test manufacturers to provide the most advanced diagnostic assays from GeneXpert at almost 50% of the original price. In a similar manner, an EDL will encourage bulk purchasing of the essential diagnostics by international organizations, a practice commonly followed for critical vaccines & drugs. Thus these larger predictable volume sale & pooling methods would enable manufacturers to lower their prices making these tests affordable to patients.

Anti Microbial Resistance (AMR) is becoming a growing concern in India, especially in the treatment of TB, and this is where EDL could play a crucial role in tackling this menace. Unnecessary antibiotic use can be avoided with the introduction of high quality point of care testing to differentiate between virus and bacterial infections, and minimizing more and more strains of these pathogens becoming resistant. Further, this can be made efficient by collecting data from low and middle income countries on resistance patterns to inform policy makers on actions required, and ensuring proper treatment.

Listing of essential diagnostics is meaningless in the absence of standard practice by the laboratorians. Inefficient training is a major concern not only in under developed countries but also developing countries like ours. EDL can be used as a reference by the national laboratory accreditation bodies to establish a quality assurance system in low tier labs by training of professionals if required.

Poor infrastructure and inefficient supply chain often cripple all kind of initiatives that policy makers undertake. The National Rural Health Mission (NRHM), under National Health Mission is a government initiative to address the health needs of under-served rural areas. They could refer to EDL and ensure the necessary infrastructure and better supply chain management at Primary Health Centres (PHCs) and Community Health Centres (CHCs).

One of the issues that low tier healthcare facilities face is the availability of sub-standard diagnostic tests, which often lead to false negative results. As a result, physicians often administer treatment even if the patient is not diagnosed for a particular infection. Physicians will thus have more confidence when they have access to standardized, advanced diagnostic tests, enlisted under the EDL.

Policy makers regularly seek data on disease burden and efficacy of the interventions. An EDL along with an EML can be referred by the organizations involved in national surveys, thus providing the much needed data to the health care policy makers.

The second part in this series will focus on EDL and the role of the Indian IVD manufacturers.

Authored By:

Dr. Manoj Chugh
General Manager - R&D (Reagents)