Indian Council of Medical Research (ICMR) has
finalised India’s first National Essential Diagnostics List (NEDL). With this,
India has become the first country to have such a list.
The World Health Organisation (WHO) released a
first edition of its essential diagnostics list (EDL) in May, 2018. This has
acted as a reference for ICMR’s NEDL.
The NEDL is on the lines of the essential drugs
list, the National List of Essential Medicines (NLEM) which was first released
in 1996. It was last updated in 2015.
The NEDL has recommended that at least 159 tests
should be made available for patients in even primary government health
The diagnostics list mentions 105 general
laboratory tests for a broad range of common conditions. It also mentions 30
disease-specific tests such as for HIV, hepatitis, tuberculosis, and 24 imaging
tests including X-rays, CT and MRI scans and ultrasound sonography.
The NEDL has been based on 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
The NEDL is expected to improve healthcare
service delivery through evidence-based care, improved patient outcomes and
reduction in out-of-pocket expenditure. It is also expected to lead to effective
utilisation of public health facilities; effective assessment of disease burden,
identify outbreaks and curb antimicrobial resistance.
In India, diagnostics (medical devices and in
vitro diagnostics) follow a regulatory framework based on the drug regulations
under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945.
Diagnostics are regulated under the regulatory provisions of the Medical Device
The Indian Council of Medical Research (ICMR),
New Delhi, the apex body in India for the formulation, coordination and
promotion of biomedical research. It is funded by the Government of India
through the Department of Health Research, Ministry of Health & Family