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The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination, and promotion of biomedical research, has invited suggestions for the revision of the National Essential Diagnostics List (NEDL) by February 29, 2024.
It is unclear whether the finalisation of the NEDL will lead to price capping of diagnostic tests in line with drugs.
The ICMR released a document inviting suggestions for the revision of the NEDL. Business Standard has a copy of the document.
The ICMR had released the first NEDL in 2019 to make the availability of diagnostics an essential component of the healthcare system.
The list includes general laboratory tests for a broad range of common conditions for the diagnosis of communicable and non-communicable diseases, disease-specific tests for HIV, hepatitis, tuberculosis, dengue, malaria, and area-endemic diseases, and imaging tests such as X-rays, computerised tomography scans, magnetic resonance imaging scans, and ultrasound sonography.
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Essential diagnostic tests are defined as those "that satisfy the priority healthcare needs of the population and are selected with due regard to disease prevalence and public health relevance, evidence of efficacy and accuracy, and comparative cost-effectiveness”. The test should focus on conditions with a high disease burden or having significant public health relevance, where the introduction of a diagnostic test will have a clear impact on disease diagnosis and management.
India is the first country to release the NEDL. The list enumerates the minimum number of tests that should be available at various levels of healthcare facilities, including – village level, Sub Health Centre or Health & Wellness Centres (HWCs), Primary Health Centres (PHCs), Community Health Centres (CHCs), Sub-District Hospital (SDH), and District Hospital (DH).
Since 2018, the World Health Organisation (WHO) recommends the development and implementation of a National Essential Diagnostics List (NEDL) to facilitate the availability of In-Vitro Diagnostics (IVDs) across the various tiers of the healthcare pyramid, facilities with or without a laboratory onsite.
India’s NEDL was based on consideration of the disease burden data across different states of the country, in alignment with the national programmes.
“The required manpower, infrastructure, and logistical support required at each health facility to carry out the tests were also recommended in line with the Indian Public Health Standards (IPHS) (2012) guidelines. In a positive outcome following the development of the NEDL, the list has been adopted by the Free Diagnostic Service Initiative (FDSI) of the National Health Mission (NHM) in 2019,” the ICMR document said.
It added that since a considerable time has elapsed following the release of the first NEDL in 2019, the ICMR invites suggestions for the revision of the existing list, that is, the addition or deletion of diagnostic tests, from all relevant stakeholders.
The stakeholders have been asked to consider some criteria before proposing any additional tests to the existing list: Essentiality of the test, disease burden, alignment with Indian Public Health Standards (IPHS) 2022, suggestions for the inclusion of point-of-care tests are encouraged, and the diagnostics suggested for addition should have obtained the necessary regulatory approvals.
