Introduction

The Indian Council of Medical Research (ICMR) has initiated the revision of the National Essential Diagnostics List (NEDL), acknowledging the evolving healthcare landscape since its first release in 2019.
This move aims to optimize the availability of essential diagnostic tests across all tiers of healthcare facilities in India.

What is NEDL?

Inception: The NEDL extends and builds upon initiatives like the Free Diagnostics Service Initiative (FDI) under which was launched in July 2015 under National Health Mission (NHM).
Comprehensive List: The NEDL is designed to cater to all levels of healthcare, including village-level healthcare, primary care, secondary care, and tertiary care facilities.
Scope of Tests: The NEDL focuses on diagnostic tests essential for diseases with significant burdens, such as vector-borne diseases (Malaria, Dengue, Filariasis, Chikungunya, Japanese encephalitis), as well as Leptospirosis, Brucellosis, Tuberculosis, Hepatitis (A, B, C, and E), HIV, and Syphilis. Specific tests are marked as desirable, recommended for regions or states with high disease prevalence.
In Vitro Diagnostics (IVD): Alongside diagnostic tests, the NEDL recommends corresponding In Vitro Diagnostics (IVD) products, which are tests conducted on samples like blood or tissue taken from the human body.
Regulatory Guidance: The NEDL includes a comprehensive guidance document on the “Regulatory framework for diagnostics: National and International.”
Human Resources: It also recommends the allocation of human resources, such as ASHA workers, lab technicians, and pathologists, tailored to the proposed list of diagnostics for different healthcare levels.

Quality Assurance: The availability of quality-assured diagnostics enhances the optimal utilization of the Essential Medicine List (EML).
SDG Achievement: Implementation of the NEDL contributes to the realization of Sustainable Development Goal (SDG) 3.8, aiming for Universal Health Coverage (UHC).
Enhanced Healthcare: The NEDL facilitates evidence-based healthcare, improving patient outcomes, reducing out-of-pocket expenses, and ensuring the effective use of public health facilities. It aids in disease burden assessment, trend analysis, surveillance, outbreak identification, and addressing antimicrobial resistance.
Standardization and R&D: The NEDL encourages the standardization of technology and diagnostic services, fostering research and development (R&D) for innovative diagnostics, ultimately leading to cost reduction.

Disease Burden Analysis: The inclusion of diagnostic tests in the NEDL is based on rigorous assessments of disease burden data across India’s diverse states.
Alignment with National Programs: Tests align with national health programs to address specific health needs.
Adherence to Standards: The NEDL adheres to Indian public health standards and considers the necessary resources, infrastructure, and personnel required at each healthcare facility.

Essential Test Criteria: Stakeholders are encouraged to propose tests that meet specific criteria:

1. Priority for healthcare needs
2. Alignment with disease prevalence and public health significance
3. Demonstrated efficacy, accuracy, and cost-effectiveness

Impact on Disease Management: Tests should focus on conditions with high disease burdens and substantial public health relevance. The introduction of these tests should significantly enhance disease diagnosis and management.
Appropriate Utilization: Any proposed addition to the NEDL must align with the availability of equipment, infrastructure, and qualified personnel, by the Indian Public Health Standards of 2022.

The revision of India’s National Essential Diagnostics List is a crucial step towards ensuring that essential diagnostic tests are accessible at all healthcare levels.
By aligning with disease burden data and adhering to stringent criteria, India aims to enhance its public health infrastructure, making diagnostics an integral part of healthcare delivery.
The involvement of stakeholders ensures a comprehensive and effective approach to meet the evolving healthcare needs of the nation.