How and why India adopted an Essential Diagnostics List

Access to medical diagnostic tests is a challenge the world over. Just over half of the global population has access to diagnostic tests at the primary health care level. According to the Lancet Commission on Diagnostics, the situation is more dire in low- and middle-income countries (LMICs), where only an estimated 19% of patients have access to appropriate diagnostics at the primary health care level.

A 2018 survey in three Indian states demonstrated the scale of the shortfall. Many critical diagnostic tests were completely unavailable at primary healthcare facilities, including blood lactate, hepatitis B e-antigen, anti-hepatitis C virus antibody, malaria rapid diagnostic tests, the sputum tuberculosis loop-mediated isothermal amplification test, the anti-HIV/p 24 rapid test, and a combined test for syphilis and HIV. The researchers concluded that these gaps in diagnostics availability, “can limit the ability of health workers to manage common diseases, and the ability of the health systems to respond to threats such as outbreaks or antimicrobial resistance.”

To support access to diagnostic tests, in 2018, the World Health Organization (WHO) developed its first Essential Diagnostics List (EDL), a basket of 113 recommended diagnostics that should be made available at point-of-care and in laboratories in all countries. The list has since been regularly updated and expanded. The WHO recommends that each country develop its own EDL, tailored to its needs, and update it regularly.

“The global health community has focused on access to health products for prevention (vaccines) and treatment (medicines) over the last 20 years, but despite the consequences of underdiagnosis and misdiagnosis (including mistreatment, health complications, and costly unnecessary interventions), there has been very little focus in the global health dialogue to date on access to appropriate diagnostic tests to ensure appropriate treatment,” WHO leaders wrote in the BMJ article announcing the list.

Just 18 months later, in 2019, India became one of the first LMICs to adapt and adopt the WHO’s EDL, when the country's National Essential Diagnostics List (NEDL) was released by the Indian Council of Medical Research (ICMR), under the Ministry of Health and Family Welfare.

Exemplars News spoke with Dr. Kamini Walia, senior scientist at the ICMR's Division of Epidemiology and Communicable Diseases, who led the effort, about how and why India adopted its NEDL and how that list is impacting health outcomes.

Why did India develop an Essential Diagnostics List?

Dr. Walia: India has had a national list of essential medicines for more than 20 years. However, diagnostics remained a neglected area.

The WHO’s EDL came out at the right time, just as the Indian government was preparing to launch its free drug service and free diagnostics service initiative, which was first laid out in 2015, to deliver health services and make diagnostics and healthcare more affordable to all. We knew we needed to develop a list of essential diagnostics to support the free drug and diagnostics initiative.

How did India develop the list?

Dr. Walia: The effort was led by me and my colleagues at the Indian Council of Medical Research, supported by experts, with a focus on evidence-based decision making.

We held five consultations.

The first was a very wide consultation and highly participatory. We invited all the stakeholders, representatives of clinicians, microbiologists, hematologists, radiologists, NGOs, managers of the big vertical national programs, and the diagnostics industry to understand their expectations. At one point, we realized we hadn’t included pathologists, so we hurriedly recruited pathologists. Each of these specialists can give you insights into the level of demand for each test.

We realized that everyone was excited, and everyone had an interest in a certain outcome. We had advocates for some of the biggest vertical programs pushing the diagnostics they needed for their programs: malaria, HIV, tuberculosis (TB), etc.

India has a long history of successful vertical programs such as HIV, TB, and malaria, and they had succeeded in improving access to treatment and diagnostics for the specific disease of interest to each of those programs. But at the same time, we knew that over the last few decades, the burden of disease in India has shifted dramatically. In 1990, noncommunicable diseases represented 30% of the burden. By 2016, the figure was 55%. Our EDL needed to reflect that shift.

We looked for experts who had a wider view of things.

Also, we wanted to make the list relevant for different zones in our country. We knew the list had to reflect the burden of disease in each area of our country.

We decided to take a list from each of the vertical programs, such as TB, malaria, and HIV, and then we had consultations about what kinds of tests were needed for NCDs (noncommunicable diseases), for microbiology, and so on.

We then developed the first draft, which we used for more consultations.

During this process we were approached by many individuals, clinicians, groups, etc. We realized that each group has its own agenda and its own list of diagnostic tests that they see as essential. And they want it all available at the primary care level.

But you can’t treat everything at the primary care level. So, there is no point in detecting something at the primary care level if you can’t treat it there. The list focused only on what tests are available at what level of care.

What is included in the list?

Dr. Walia: The list includes 117 general laboratory tests for the diagnosis of a broad range of common conditions that includes both communicable and noncommunicable diseases. There are 29 disease-specific tests for HIV, hepatitis, tuberculosis, dengue, malaria, and area-endemic diseases, and 24 imaging tests such as X-rays, computerized tomography scans, magnetic resonance imaging scans, and ultrasound sonography.

We tried to harmonize our list with other ongoing government initiatives and priorities. Critically, about 96% of thediagnostics listed on India’s EDL are available free of charge.

Share with us some of the impact you are seeing.

Dr. Walia: We are doing surveys in five states to look at the availability of tests at all levels of the health system and we are seeing how what is being procured by the government is used by medical teams.

One thing we can already see is that the free diagnostics, supported by our EDL, dramatically increased footfall at our facilities and patient visits. [Editor's Note: in India and many low- and middle-income countries a majority of healthcare is delivered in private unlicensed health facilities.]

So, patients don’t flock to quacks anymore. Why would they? They can now get properly tested and get clear answers at the primary care level. Having diagnostics available from the frontline health and wellness centers on up definitely adds value for patients.

We expect the EDL to translate into increased demand, improved patient outcomes, and reduction in out-of-pocket expenses on diagnostics.

This interview has been edited for length and clarity