India has got its first National Essential Diagnostics List (NEDL) finalised by the Indian Council of Medical Research (ICMR).
NEDL aims to bridge the current regulatory system’s gap that does not cover all the medical devices and in-vitro diagnostic device (IVD).
Significance: With this, India has become the first country to compile such a list that would provide guidance to the government for deciding the kind of diagnostic tests that different healthcare facilities in villages and remote areas require.
Uses: The list is meant for facilities from village till the district level.
NEDL builds upon 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.
Need for NEDL:
- Diagnostics serve a key role in improving health and quality of life.
- While affordability of diagnostics is a prime concern in low, middle-income countries like India, low cost, inaccurate diagnostics have made their way into the Indian market which has no place in the quality health care system.
- The implementation of NEDL would enable improved health care services delivery through evidence-based care, improved patient outcomes and reduction in out-of-pocket expenditure; effective utilisation of public health facilities.
- It would help in effective assessment of disease burden, disease trends, surveillance, and outbreak identification; and address antimicrobial resistance crisis too.
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.