New Delhi, April 7, 2021: National Essential Diagnostics List (NEDL) is an opportunity to build upon the existing initiatives of Free Diagnostics Service Initiative (FDI), Indian Public Health Standards (IPHS) and National Health Programmes.
In 2019, Indian Council of Medical Research (ICMR) released India’s first National Essential Diagnostics List, which is a part of MoH & FW formulated guidelines for strengthening diagnostic services in the country.
What is National Essential Diagnostics List?
The National Essential Diagnostics List (NEDL) is a comprehensive list compiled by the Indian Council of Medical Research (ICMR) that aims to guide the government in deciding the diagnostic tests that different healthcare facilities in villages and remote areas require.
India has become the first country in the world to compile such a list. The World Health Organisation (WHO) released the first edition of the essential diagnostics list (EDL) in May 2018. Even though WHO’s EDL acts as a reference point for national EDL development, India’s diagnostics list has been customized and prepared as per the landscape of India’s health care priorities.
Need for National Essential Diagnostics List
– While affordability of diagnostics is a prime concern in low, middle-income countries like India, low-cost, inaccurate diagnostics have made their way into the Indian market, which has no place in the quality health care system.
– The implementation of NEDL would enable improved health care services delivery through evidence-based care, improved patient outcomes, reduction in out-of-pocket expenditure, effective utilization of public health facilities.
– It would help in the practical assessment of disease burden, disease trends, surveillance, and outbreak identification; and address the antimicrobial resistance crisis.
Accurate and affordable diagnostics are central to adequate health care. When made available as part of healthcare services, quality diagnostics influence disease diagnosis and treatment outcomes in patients and improve disease surveillance.
Recognizing that absence of quality diagnosis is an essential gap in the healthcare system, the World Health Organization (WHO) published the First WHO model list of essential in vitro diagnostics in 2018; the Indian Council of Medical Research (under the Ministry of Health and Family Welfare) followed in its footsteps and released its first National essential diagnostics list in 2019.
India has had a national list of vital medicines in the past 20 years; however, diagnostics remained a neglected area. With the Indian government aiming to achieve universal health coverage, the diagnostics list is a breakthrough step to make reliable, high-quality diagnostic testing an essential component of the healthcare system.
Features of NEDL
– India’s essential diagnostics list is comprehensive and ambitious; through this list, the Indian Council of Medical Research seeks to cement diagnostics as an essential component in health care.
– ICMR drafted the list through a consultative process spearheaded by the Indian Council of Medical Research. The process of reaching a consensus on which diagnostics to include in the list consisted of five consultative meetings with clinicians, microbiologists, pathologists, radiologists, civil society representatives, managers of national programs, and diagnostics representatives industry, and other technical experts over 15 months.
– The list includes 117 general laboratory tests for a broad range of common conditions for the diagnosis of communicable and non-communicable diseases: the 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.
NEDL builds upon the Free Diagnostics Service Initiative and other diagnostics initiatives of the Health Ministry to provide an expanded basket of tests at different public health system levels.
Free Diagnostics Service Initiative
The NEDL builds upon the Free Diagnostics Service Initiative (FDI) and other diagnostics initiatives of the Health Ministry to provide an expanded basket of tests at different public health system levels.
– FDI was launched in July 2015. Under this initiative, the National Health Mission (NHM) supports all states to provide essential diagnostics – laboratory and radiology at their public health facilities, free of cost.
The initiative, aimed at reducing out-of-pocket expenses on diagnostics by providing free quality diagnostics services at all levels of health care, has adopted the diagnostics list’s recommendations. The initiative and the states make annual investments into the service of about 175 million United States dollars to meet the costs of conducting tests, maintaining equipment and consumables.
– The initiative, aware of the deficient laboratory systems and how these deficiencies may impact the implementation of the diagnostics list, has released a guidance document to assist the states in strengthening healthcare systems to deliver diagnostics services.
The initiative encourages states to create systems to deliver diagnostics using public–private partnerships, strengthening in-house capacities, or using private providers when required. The initiative is being implemented in 24 states through different models. Many states have adopted the suggested solutions to their local context. They are successfully implementing the initiative, indicating that the proposed mechanisms will help overcome the challenges of implementing the diagnostics list.
Advantages of NEDL
– Having a national essential diagnostics list endorsed by all major stakeholders would have several advantages, mainly homogenizing diagnostics availability at every level.
– States can use the list as a reference document to forecast needs and guide their procurement; the list can also help them determine the volumes of tests and mechanisms required to meet demand and negotiate diagnostics’ prices.
– Special pricing initiatives driven by aggregated volumes have been practiced by some disease control programs in low- and middle-income countries to improve diagnostics availability.
– The list is also an opportunity for the industry to focus its resources on the diagnostics that the government is expected to procure, thus contributing to avoiding shortages and maintaining supply chains.
The list can also simplify the regulators’ task of stopping suboptimal diagnostics, such as the tuberculosis serodiagnostic test kits, typical in a climate of poor regulatory set-up misguided tuberculosis diagnosis India.
Through the national essential diagnostics list, the Indian government has taken a positive step in making quality diagnostics an integral component of the healthcare system; it can also become a guidance document for other countries to develop a similar tool.
Strengthening diagnostics infrastructure and improving diagnostics’ availability will be vital to achieving diagnostics availability across all healthcare levels.