2019 – Posted in: Daily News – Tags: In Vitro Diagnostics device, In Vitro Diagnostics Directive, The Indian Council of Medical Research

NATIONAL ESSENTIAL DIAGNOSTICS LIST

For: Preliminary and Mains

Topics covered:

What is NEDL- Its needs and significances, implementing challenges
In Vitro Diagnostics Directive (IVDD), In Vitro Diagnostics Device (IVD)
The Indian Council of Medical Research

News Flash

India has got its first National Essential Diagnostics List (NEDL) finalised by the Indian Council of Medical Research.

Highlights

India has become the first country to compile an essential diagnostic list that would provide guidance to the government.
It helps in deciding the kind of diagnostic test require.
The list is meant for facilities from the village till the district level.
India’s diagnostics list has been prepared as per the landscape of India’s health care priorities.
The list also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs)
In addition to diagnostics tests, corresponding IVD products have also been recommended.

World Health Organisation (WHO) released the first edition of the essential diagnostics list in 2018.

Aim

It aims to bridge the current regulatory system’s gap that do not cover all the medical devices and in-vitro diagnostic device (IVD).
Diagnostics serve a key role in improving the health and quality of life.

National Essential Diagnostics List (NEDL)

NEDL builds upon the Free Diagnostics Service Initiative and other diagnostics initiatives of the Health Ministry.
Its implementation would enable improved health care services delivery through evidence-based care.

Significance

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.
Address antimicrobial resistance crisis.

Challenges during the implementation of NEDL

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 (External Quality Assurance Scheme) and quality control
Adequate utilisation of EDL tests for making informed decisions for treatment protocols

In Vitro Diagnostics device (IVD)

IVDs are medical devices and accessories used to perform tests on samples, (e.g., blood, urine and tissue that has been taken from the human body) in order to:

Help detect infection
Diagnose a medical condition
Prevent disease
Monitor drug therapies

The In Vitro Diagnostics Directive (IVDD)

IVDD is a set of regulatory requirements that medical device manufacturers must comply with in order to place a CE Mark (certification mark) to their product.

The Indian Council of Medical Research

ICMR is the apex body in India for the coordination, formulation and promotion of biomedical research. It addresses the growing demands of scientific advances in biomedical research and helps in finding practical solutions to the health problems of the country.

Background

The First meeting of the Governing Body of the Indian Research Fund Association (IRFA) was held on November 15, 1911.
In 1949, IRFA was redesignated as the Indian Council of Medical Research.

Important Info

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.

Source: The Hindu

Also, read more daily News

You are on the Best Online IAS preparation platform. You are learning under experts.

We are present on Facebook- Diligent IAS, LinkedIn- Diligent IAS, YouTube- Diligent IAS, Instagram- Diligent IAS. Get in touch with us.