Indian Council of Medical Research (ICMR) has finalized India’s first National Essential Diagnostics List (NEDL). With this, India has become the first country to compile such list that will provide guidance to government for deciding kind of diagnostic tests that different healthcare facilities in villages and remote areas require.
National Essential Diagnostics List (NEDL)
Its implementation will enable improved health care services delivery through evidence-based care, effective assessment of disease burden, disease trends, surveillance, and outbreak identification and effective utilisation of public health facilities etc.
It also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs) under Pradhan Mantri Jan Arogya Yojana. In addition to tests, it also has recommended corresponding IVD products.
It aims to bridge current regulatory system’s gap that do not cover all medical devices and in-vitro diagnostic device (IVD). It is meant for facilities from village till the district level.
It builds upon Free Diagnostics Service Initiative and other diagnostics initiatives of Union Health Ministry to provide an expanded basket of tests at different levels of the public health system.
WHO released first edition of essential diagnostics list (EDL) in May 2018, it acts as reference point for development of national EDL? However, India’s diagnostics list (NEDL) has been customized and prepared as per landscape of India’s health care priorities
In India, current diagnostics system (medical devices and in vitro diagnostics) is equipped to manage only the few notified devices. It follows regulatory framework based on drug regulations under Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945. Whereas, diagnostics are regulated under regulatory provisions of Medical Device Rules, 2017.