With an objective to achieve Universal Health Coverage by 2030, the Government of India has initiated significant reforms to improve citizens' access to good quality, affordable healthcare. There remains, however, a need to strengthen the broad ecosystem in which health services are delivered. Patient testing forms the major component of diagnosis and treatment. The cause of delayed treatment was not lack of access, but rather missing or inaccurate diagnoses say Niti Ayog’s November 2019 Publication “Health system for a New India: Building Blocks – Potential Pathways to reform”. NITI Aayog is responsible for charting India's road map towards attaining the commitments under the Sustainable Development Goals, particularly in critical social sectors such as health and education. (NITI -National Institution for Transforming India)
An in-vitro-diagnostic medical device (IVD) is 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. India has became the first country to compile a National Essential Diagnostics List (NEDL) in August 2019 to guide the government on the diagnostic tests required by healthcare facilities at different levels of healthcare.
The growing demand for personalized medicines, innovations in diagnostic techniques, increasing preference for point-of-care testing among the general population, a growing geriatric population base and an increase in disposable incomes are driving the growth of the IVD sector in India. 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$97 billion in 2022 – a market share of which India held just 1 percent five years ago, but anticipates doubling to 2 percent by 2020 and is likely to exceed US$ 1.8 Billion mark by 2025.
Pathology is the cornerstone of modern medicine, ensuring that patients are correctly diagnosed and given appropriate treatment. However, a new series in The Lancet highlights how common is presumptive treatment (i.e., treatment without a confirmed diagnosis), in many low- and middle-income countries 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 qualification of human resources (in basic composite labs as defined by Clinical Establishment Amendment Rules 2018 catering to more than 90 percent of the India’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 checks; 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.
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 universal health coverage in a safe, effective, and regulated way (supplemented by the results of a recent National performance audit, which found that 87% of public facilities that had been upgraded through National Rural Health Mission (NRHM) were not functioning for want of staff, equipment and basic utilities (Source: MoHFW Report No. 25 of 2017, Performance Audit). Only by developing these standards and regulations can we close the gap between the services we offer and the services our patients need.
An initiative for “Global Alliance for Medical Diagnostics” is the need of the hour in resource limited settings in which the pathologists / IVD manufactures plays a key part, step forward into leadership and advocacy roles by setting the standards for appropriate test type and frequency, by maximizing the quality of the laboratory systems available, and by ensuring that scarce health testing resources are used in the best way possible.
