India has got its first National Essential Diagnostics List (NEDL) finalised by the Indian Council of Medical Research (ICMR) which 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.
WHO released first edition of essential diagnostics list (EDL) in May 2018. Even though WHO’s EDL acts as a reference point for development of national EDL, India’s diagnostics list has been customised and prepared as per landscape of India’s health care priorities.
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, explained a senior ICMR official.
He said 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; effective assessment of disease burden, disease trends, surveillance, and outbreak identification; and address antimicrobial resistance crisis too.
“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,” said a senior official at ICMR.
“The list also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs) under the Pradhan Mantri Jan Arogya Yojana. In addition to tests, corresponding IVD products have also been recommended,” he added.
Diagnostics serve a key role in improving health and quality of life and the ICMR has noted that the key challenges anticipated during implementation of the National EDL include — “Adoption by States and harmonisation with local standard diagnostic protocols and treatment guidelines, provision of requisite infrastructure, processes and human resources, ensuring quality of tests including EQAS and quality control and adequate utilisation of EDL tests for making informed decisions for treatment protocols.”
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.