India has got its first National Essential Diagnostics List (NEDL) finalized by the Indian Council of Medical Research (ICMR). The objective of the list is to bridge the current regulatory system’s gap that does not cover all the medical devices and in-vitro diagnostic device (IVD). With this, India became the first country to compile such a list.
Key Points:
- Power: 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.
- Features: 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. It encompasses tests relevant for new programmes like Health & Wellness Centers (HWCs) under Pradhan Mantri Jan Arogya Yojana (PMJAY). It will enable improved health care services delivery through evidence-based care, improved patient outcomes and reduction in out-of-pocket expenditure; effective utilization of public health facilities.
- Significance: It provides guidance to the government for deciding the kind of diagnostic tests that different healthcare facilities in villages and remote areas require.
- Use: The list is meant for facilities from village till the district level.
- EDL: In May 2018, World Health Organization (WHO) had released the first edition of Essential Diagnostics List (EDL). It was the reference for the development of NEDL. NEDL is customized and prepared as per the landscape of India’s health care priorities.
About ICMR:
♦ Headquarters: New Delhi
♦ Founded: 1911
♦ Director General: Professor Balram Bhargava
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