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Outside the Lab Regulation and standards, Quality assurance and quality control, Point of care testing, Laboratory management

A Distant Dream

What exactly is an in vitro diagnostic medical device (IVD)? It’s the instrumentation needed to carry out a particular pathology test (or tests) on human samples to assist in clinical diagnosis or treatment decision-making. These devices include the laboratory or point-of-care devices, calibrators, controls, kits, reagents, and accessories used to perform diagnostic tests. IVDs are distinct from medical devices in that they never come into direct contact with the patient; however, they still have an impact on life-changing, and potentially life-saving, treatment decisions.

The World Health Organization (WHO) published the first edition of its Model List of Essential In Vitro Diagnostics in May 2018, recognizing that IVDs are an essential component to their three strategic priorities: advancing universal health coverage, addressing health emergencies, and promoting healthier populations. Now, India has become the first country to compile a National Essential Diagnostics List (NEDL) to guide the government on the diagnostic tests required by healthcare facilities in villages and remote areas.

With a population of more than 1.33 billion, India is the world’s second-largest country and Asia’s fourth-largest (and rapidly growing) market for IVDs.

Factors including a growing demand for personalized medicine, innovations in diagnostic techniques, an increasing preference for point-of-care testing among the general population, a growing geriatric population, and an increase in disposable income are driving the growth of India’s IVD sector. With a population of more than 1.33 billion, India is the world’s second-largest country and Asia’s fourth-largest (and rapidly growing) market for IVDs. The global IVD market is estimated to reach US$97 billion in 2022 – a market share of which India held just 1 percent five years ago, but anticipates doubling by 2020. India’s IVD market is likely to exceed US$ 1.8 billion by 2025.

Pathology is the cornerstone of modern medicine, ensuring that patients are correctly diagnosed and given appropriate treatment. However, a recent series in The Lancet (1) highlights the frequency of presumptive treatment (that is, treatment without a confirmed diagnosis) in many low- and middle-income countries. Why? Because of unregulated laboratory services and basic medical tests. Although India’s new NEDL provides a list of important tests required at various levels of the healthcare system, the list cannot have an impact without an integrated, connected, tiered laboratory system, adequate human resources, training, laboratory infrastructure, and regulatory/quality assurance systems.

At the moment, the Indian healthcare sector (particularly with regard to clinical/pathological laboratories) is completely unregulated and has no clear rules for regulating registration, inspection, and penalties. Even the WHO has recommended that India develop a national health laboratory policy to regulate clinical laboratories in India. Some areas where medical diagnostic laboratories lack standards include: minimum qualifications for human resources in basic labs that cater to over 90 percent of the country’s population; sample collection centers and sample transport; use of scanned/electronic signatures; number of laboratories a pathologist may visit in a day; daily internal quality control; the unregulated sale and purchase of IVDs; and health insurance claims on the basis of illegal laboratory reports. There is no central allied health, paramedical, or medical lab technology council. No data are collected on the numbers of medical lab technicians, trained medical postgraduates in pathology, or institutes offering medical lab technology courses.

Only by developing these standards and regulations can we close the gap between the services we offer and the services our patients need.

In my view, this degree of unregulated operation leads to quackery in medical diagnostics – and the government of India turns a deaf ear, putting the lives of billions of patients in jeopardy. Even with the NEDL, we lack the necessary infrastructure to offer our citizens and visitors universal health coverage in a safe, effective, and regulated way. Only by developing these standards and regulations can we close the gap between the services we offer and the services our patients need. And for this, we need a global alliance for medical diagnostics. In resource-limited settings where pathologists play a key part in disease diagnosis and treatment, such an alliance would allow us to step into leadership and advocacy roles by setting standards for appropriate test type and frequency, maximizing the quality of the laboratory systems available, and ensuring that scarce health testing resources are used in the best way possible.

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About the Author
Rohit Jain

Consultant Pathologist at Santokba Durlabhji Memorial Hospital and Founder Secretary of the Practicing Pathologists Society, Jaipur, Rajasthan, India.

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