National Essential Diagnostics List | 17 Aug 2019

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.
• The World Health Organisation (WHO) released the 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.
• 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.

NEDL

• 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.
  • 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.
• Scope: 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.

Importance

• Availability of quality assured diagnostics would be helpful in optimal utilization of Essential Medicine List (EML).
• It will help India in achieving Sustainable Development Goal (SDG) 3.8 i.e. Universal Health Coverage (UHC).
• Implementation of NEDL will enable improved health care delivery through evidence-based care, improved patient outcomes and reduction in out-of-pocket expenditure; effective utilization of public health facilities; effective assessment of disease burden, disease trends, surveillance, and outbreak identification; and address antimicrobial resistance crisis.
• It will also enable standardization of technology/diagnostic services and will aid in the promotion of R&D for new appropriate and effective diagnostics which in turn will lead to reduction in costs.

Source: TH