India’s first National Essential Diagnostics List finalized by ICMR

The Indian Council of Medical Research (ICMR) has recently finalized the India’s first National Essential Diagnostics List (NEDL) that recommends that at least 159 tests should be made available for patients in even basic government health facilities. The list aims to bridge the current regulatory system’s gap that do not cover all the medical devices and In-Vitro Diagnostic device (IVD). The current system is equipped to manage only the few notified devices. 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. The list is meant for facilities from village till the district level. The list also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs) under the Pradhan Mantri Jan Arogya Yojana. 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.