India gets first national essential diagnostics list

3 min read
  1. 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.
  2. 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.
  3. 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.
  4. The NEDL has recommended that at least 159 tests should be made available for patients in even primary government health facilities.
  5. 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.
  6. 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 system.
  7. 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.
  8. 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 Rules, 2017.
  9. 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 Welfare.