The Indian Council of Medical Research (ICMR) has accomplished a groundbreaking initiative by completing the country’s first National Essential Diagnostics List (NEDL). This marks India as the first country globally to formulate such a list, which aims to guide the government in identifying necessary diagnostic tests for various healthcare facilities, particularly in remote and rural areas.
The Background and Regulatory Framework
In May 2018, The World Health Organisation (WHO) introduced its first edition of the essential diagnostics list (EDL) to serve as a blueprint for adopting national EDLs worldwide. Although WHO’s EDL is a valuable reference, the diagnostics list prepared by India aligns specifically with the nation’s healthcare priorities.
Diagnostics in India fall under the regulatory provisions of the Medical Device Rules, 2017. Medical devices and in vitro diagnostics adhere to a regulatory framework patterned on the drug regulations under the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945.
NEDL Level of Healthcare
The NEDL encompasses all levels of healthcare – from local villages to primary, secondary, and tertiary care centres. It enhances the Free Diagnostics Service Initiative (FDI) and other diagnostic efforts by the Health Ministry. This provision enables a wider array of tests at varying levels of the public health system. Launched in July 2015, the FDI allows the National Health Mission (NHM) to offer essential, cost-free diagnostics – laboratory and radiology – at public health facilities across all states.
Scope of the Diagnostic List
The NEDL features a range of general laboratory tests for routine patient care and diagnosis of communicable and non-communicable diseases. Specific diseases were selected based on disease burden and include vector borne diseases (Malaria, Dengue, Filariasis, Chikungunya, Japanese encephalitis), Leptospirosis, Brucellosis, Tuberculosis, Hepatitis A, B C and E, HIV, Syphilis. It also incorporates tests that are relevant for new programmes such as Health and Wellness Centres (HWCs) under the Pradhan Mantri Jan Arogya Yojana. Additionally, corresponding In Vitro Diagnostics (IVD) products are recommended.
The NEDL is not merely a list of tests but a comprehensive document that includes a guidance section on “Regulatory framework for diagnostics: National and International”. It also suggests a list of human resources required at different levels of healthcare.
Values and Impact of NEDL
Quality assured diagnostics increases the effective utilisation of the Essential Medicine List (EML). This assists India in achieving Sustainable Development Goal (SDG) 3.8 i.e., Universal Health Coverage (UHC).
| Benefits of NEDL | Examples |
|---|---|
| Enhanced Healthcare Delivery | Makes healthcare delivery more effective through evidence-based care, improved patient outcomes, and reduction in out-of-pocket expenditure. |
| Effective Utilization of Public Health Facilities | Facilitates better use of public health facilities. |
| Improved Assessment of Disease Burden | Helps in precise evaluation of disease burden, disease trend analysis, surveillance, and outbreak identification. |
| Crisis Management | Helps in tackling the antimicrobial resistance crisis by suggesting appropriate tests. |
About Indian Council of Medical Research
The Indian Council of Medical Research (ICMR), located in New Delhi, is India’s principal authority for formulating, coordinating, and promoting biomedical research. Founded in 1911 as the Indian Research Fund Association (IRFA) by the Government of India, it aimed to sponsor and coordinate medical research within the country. Post-independence, several significant changes were made to IRFA’s organisation and functions. In 1949, it was renamed the Indian Council of Medical Research (ICMR) and was given a considerably broadened scope of responsibilities.
