Topic : National Essential Diagnostics List (NEDL)
Topic in Syllabus: Indian Society
- The Indian Council of Medical Research (ICMR) has finalised the country’s first National Essential Diagnostics List (NEDL).
- India has become the first country in the world 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.
- In India, diagnostics are regulated under the regulatory provisions of the Medical Device Rules, 2017.
- 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.
- Level of Healthcare: NEDL has been developed for all levels of health care – village level, primary, secondary and tertiary care.
- It builds upon the Free Diagnostics Service Initiative (FDI) and other diagnostics initiatives of the Health Ministry to provide an expanded basket of tests at different levels of the public health system.
Free Diagnostics Service Initiative (FDI):
FDI was launched in July 2015. Under this initiative, the National Health Mission (NHM) is supporting all states to provide essential diagnostics – laboratory and radiology at their public health facilities, free of cost.
- It includes a group of general laboratory tests for routine patient care and for diagnosis of communicable and non- communicable diseases.
- Inclusion of the diagnostic test on specific diseases selected on the basis of disease burden: Vector borne diseases (Malaria, Dengue, Filariasis, Chikungunya, Japanese encephalitis); Leptospirosis, Brucellosis, Tuberculosis, Hepatitis A, B C and E, HIV, Syphilis.
- Certain tests have been put as desirable tests and should be included in regions or states with high disease burden of that disease.
- It 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 In Vitro Diagnostics (IVD) products have also been recommended. In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body
- A guidance document on “Regulatory framework for diagnostics: National and International” has been included.
- It also recommends list of human resources such as ASHA workers, lab technicians pathologists for different levels of health care as per the proposed list of diagnostics.
- Diagnostics serve a key role in improving health and quality of life.
- 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.
- The 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.
- It would help in effective assessment of disease burden, disease trends, surveillance, and outbreak identification; and address antimicrobial resistance crisis too
Which organisation launched the Malaria Elimination Research Alliance recently?
(A)Indian Council of Medical Research
(B)World Health Organisation
(C)Ministry of Women and Child Development
Indian Council of Medical Research (ICMR) recently launched the Malaria Elimination Research Alliance (MERA)- India and organised the Stakeholders’ Meeting at ICMR headquarters, New Delhi to have vibrant discussions on the roadmap of the Alliance.