National Essential Diagnostics list
NATIONAL ESSENTIAL DIAGNOSTICS LIST
What’s in news?
First National Essential Diagnostics List (NEDL) finalised by the Indian Council of Medical Research (ICMR) that recommends that at least 159 tests should be made available for patients in even rudimentary government health facilities.
- Diagnostics serve a key role in improving health and quality of life.
- 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.
- The list is on the lines of the essential drugs list, the National List of Essential Medicines (NLEM) which was first released in 1996 and last updated in 2015.
- 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).
- 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 diagnostics list mentions105 general laboratory tests for a broad range of common conditions, 30 disease-specific tests such as for HIV, hepatitis, tuberculosis, and 24 imaging tests including X-rays, CT and MRI scans and ultrasound sonography.
- 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.
- The list is meant for facilities from village till the district level. The current system is equipped to manage only the few notified devices.
WHO EDL List:
- 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.
- 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 utilization of EDL tests for making informed decisions for treatment protocols.
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