National Essential Diagnostics List

Recently, India has got its first National Essential Diagnostics List (NEDL) finalised by the Indian Council of Medical Research (ICMR).
Now, India has become the first country to compile such a list that would provide guidance to the government for deciding the kind of diagnostic tests that different healthcare facilities in villages and remote areas require.

World Health Organisation(WHO) released first edition of essential diagnostics list (EDL) in May 2018, which has been used as reference for development of NEDL. India’s list has been customised and prepared as per landscape of India’s health care priorities.
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 levels of the public health system.
The list also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs) under the PradhanMantri Jan ArogyaYojana.
The list mentions 105 general laboratory testsfor a broad range of common conditions, 30 disease-specific tests such as for HIV, hepatitis, tuberculosis, and 24 imaging tests including X-rays, CT and MRI scans and ultrasound sonography
It is a complete list of diagnostic tests, medical devices and in-vitro diagnostic device (IVD) for all levels of health care – village level, primary, secondary and tertiary care.

To bridge the current regulatory system’s gap those do not cover all the medical devices and in-vitro diagnostic device (IVD).
To enhance accessibility to diagnostic tests and reduce out-of-pocket expenditure.

WHO Model List of Essential Medicines (EML)

The WHO Model List of Essential Medicines (EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health system.
The list has been updated every two years since 1977.
The current versions are the 21st WHO Essential Medicines List (EML) and the 7th WHO Essential Medicines List for Children (EMLc) updated in June 2019.

Non-affordability of Diagnostic Test: 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.
Inadequate Lab Infrastructure: Absence of lab infrastructure or resources mainly in rural areas is another major concern, giving rise to serious health issues. The diagnostic laboratories sector in India is highly fragmented with standalone centres accounting for 45-50% of the market and organized ones having a 25-30% share.
Lack of Awareness:There is no stratification of labs and there is lack of awareness. People don’t know the difference between an accredited lab and any other lab.

It would enable improved health care services delivery through evidence-based care, improved patient outcomes, effectiveutilisation of public health facilities; effective assessment of disease burden, disease trends, surveillance, and outbreak identification; and address antimicrobial resistance crisis too.
It will help India in achieving Sustainable Development Goal (SDG) 3.8 i.e. Universal Health Coverage (UHC).
It will help to set standard of requirement of minimum distance to a healthcare facility, equipments, skilled health workers, accessibility to diagnostic tests.
It will also help in reducing out-of-pocket expenditure by promoting research and development for new, appropriate and effective diagnostics.
Availability of quality assured diagnostics will also be helpful in optimal utilization of Essential Medicine List (EML).

Regulatory Challenges: The current regulatory systems do not cover all the medical devices and IVD. Thesystem is currently equipped to manage only the few notified devices. There is no set classification/classification system in current device rules for both notified and non-notified devicescategory for innovative products/ technologies and needs guidance from regulators tobring clarity on the category.
Inadequate Hospital Infrastructure: Indian hospitals are understaffed, overburdened and ill-with absence of high quality and required lab equipmentswhich would be a major hindrance in implementation of NEDL.
Shortage of Medical Professionals:There is acute shortage of trained professionals—microbiologists, pathologists, trained lab technicians. Without skilled professionals or advanced technology, achieving accurate diagnosis and effective prognosis will be a challenge.
Adoption by States: Adoption by States and harmonization with local standard diagnostic protocols andtreatment guidelines is another major challenge in the path of NEDL implementation.
Rural Areas Access: The access to diagnostics in remote areas and even in tier-2 and tier-3 cities is another challenge in providing quality and right diagnostic services.

If implemented in a phased manner, NEDL could potentially improve access to safe and effective diagnostic tests for patients. However, this needs a streamlined approach in synchrony with other changes being proposed, such as revision of Indian Public Health Standards (IPHS), HWCs and free diagnostic service initiative of the government.
Equitable accessibility, affordability and appropriate use of good quality diagnostics are integral to high quality health care. Diagnostics serve a key role in improving health and quality of life and the essential diagnostic list is important for developing countries like India that look at universal health care as one of their prime objectives.