Pathology labs need to be regulated


The last decade has seen the mushrooming of diagnostic centres all over India. Many small and big pathology labs came under the scanner during the pandemic for indulging in malpractices. Considering the critical role they play in preventive healthcare, this segment needs to be regulated soon, writes Jyothi Menon.

While all of India rooted for the COVID Warriors, the nation saluted frontline health workers i.e., the doctors and nurses treating and caring for the patients infected with the novel Coronavirus. Yet, there were those who risked their lives and continue to do so even now while remaining unnoticed: Like the pathology lab personnel for example, who have been on their toes since the beginning of the viral outbreak, running COVID tests tirelessly and in high risk environment.

Sadly, the laboratories for which they work have been facing a lot of flak for a range of malpractices, particularly during these times. There have been several instances of labs indulging in profiteering practices, taking undue advantage of the situation, furnishing fake reports or giving erroneous reports to patients.

All of this while their ‘crucial’ role in identifying COVID-positive patients, COVID hotspots and in treatment and management of the disease is expected to help civic health officials immensely in charting out the COVID strategies across India.

In India, pathology is a booming industry and a multi-billion dollar segment of the even bigger healthcare industry. Diagnostics play a very important role in health management in India. Clinical lab tests and profiles are used for early detection, prediction, diagnostic screening, monitoring and confirmation of diseases.

Medical practitioners rely heavily on diagnostic reports and according to some estimates 70 per cent of medical decisions today are based on these reports. Recent trends are witnessing big corporate entities, industrial groups and conglomerates entering the pathology/diagnostics segment – a fast growing sector with tremendous future potential.

Misdiagnosis needs to be ‘checked’

Sadly, diagnosis which is the foremost step of treatment can often go wrong too. Misdiagnosis is a highly common occurrence in the diagnostics segment. There have been several instances where wrong reports have led to incorrect treatment causing serious health trouble and suffering to the patient. “My brother was misdiagnosed for chronic myelogenous leukaemia (CML) as acute lymphoid leukaemia… he could have lost his life if the doctors weren’t alert and quick to observe his changing condition and change the line of treatment,” says Delhi-based restauranteur Rakesh Sharma.

Fake lab reports have led to millions of erroneous medical cases in the country. According to a Harvard study, over ‘5.2 million medical error cases have been accounted for in India’ annually – caused primarily due to ‘lack of skills’ and ‘lack of proper training’ of the lab personnel. They contribute significantly to the high number of misdiagnosis and improper treatment meted out to the unassuming patients in India.

“This situation must be addressed with urgency. For a helpless patient and his family, this is a life and death situation. There should be more accountability and a penalising procedure in place,” feels Rakesh.

Fake path labs playing with people’s lives

There have been numerous cases in the past where fake pathology labs were found operational in plain sight. In 2018, Delhi Police busted a fake pathology lab run by a ‘courier boy’ and his brother. They had managed to furnish 30,000 fake lab reports including tests for ‘haematology, immunology, hepatitis profile, cytopathology, urine examination and thyroid hormone assay’.

In 2019, a pathology lab owner in Vadodara and his three accomplices were arrested for duping gullible patients with fake reports. The arrest exposed a ‘nexus’ of doctors and the lab where the fake lab reports would show the patients falsely positive for certain diseases.

Path labs exploiting the COVID-19 panic

In May 2020, the Gautam Budh Nagar district health department issued notices to six private pathology laboratories in the Delhi-NCR area for falsely declaring patients COVID-positive.

In June 2020, a civil surgeon in Amritsar sought action against private labs that were giving false COVID-positive reports. Many such patients were later found negative by tests conducted in government diagnostic labs.

In Kolkata, three pathologists were arrested in August 2020 for preparing fake COVID reports, duping patients. They charged premium from the patients for the tests. A pathologist was arrested by the East Jadavpur police for faking to be a hospital personnel authorised to conduct COVID tests at home.

With the onset of the pandemic, many such instances of path labs and doctors duping patients by charging excessive amounts for COVID tests came to light.

Understanding the industry segment

In India, the diagnostic sector is uneven and a heterogeneous mix comprising standalone diagnostic centres (45 – 50 per cent) and organised labs (about 35 per cent). The rest are primarily hospital-based diagnostic centres and pathology labs that mostly provide both anatomic (surgical pathology, cytopathology, autopsy) and clinical (laboratory medicine) pathology services. Most pathology labs now have automated equipment and advanced computer technology for accurate results, timely, high quality and affordable services.

The sector is ‘highly fragmented’ and unorganised. Traditionally, the diagnostic industry had been dominated by small, unorganised stakeholders. It’s only recently that bigger groups have begun gaining a stronghold by acquiring local labs. Such acquisitions of smaller labs by bigger diagnostic chains are gradually morphing the market, changing trends towards a more ‘organised’ segment and increasing the competition.

In December 2019, the biotech subsidiary of Reliance Industries Limited (RIL), Reliance Life Sciences (RLS) announced its plans to start pathology labs across India through partnerships with local entrepreneurs. Another big group, Carlyle-backed Metropolis Healthcare Ltd., announced the acquisition of four pathology laboratories in Surat for a consideration of ₹18 crore. The pathology segment is hugely lucrative in India and bigger groups are now eyeing local entities to enter this business.

According to a report by the world’s largest market research store, Research and Markets, the meaty pathology and diagnostics segment of the healthcare industry is expected to get more organised and witness ‘consolidation with several small and independent laboratory players becoming franchisees for the larger players’.

Industry growth a welcome trend

Diagnostics is a staggering nine billion dollar industry in India and growing at a fast pace. “India is the second most populous country in the world and also a hub for medical tourism. So, the growth of the diagnostics segment is only going to accelerate,” says Mumbai-based pathology lab owner Jayesh Shah. Some of the important factors aiding growth of the industry include increased health awareness among the urban populace, rising attention towards preventive health and management, changing lifestyle trends and more health management options available to city residents.

“Not only that, medical insurance is also playing an important role in the growth of preventive healthcare segment. More people today are buying health insurance for their families and they and many big groups have ventured into health insurance providing a range of options to the end user,” maintains Jayesh.

Accurate diagnostics a boon in healthcare

With the influx of larger players, the industry is experiencing some positive outcomes and a welcome change. More pathology laboratories are now ensuring high-quality and world-class disease management. Increased competition has helped in raising the standards and accuracy of the diagnostic tests and has improved customer experience greatly.

“Higher expectations and availability of many more options have led to the labs installing technologically-advanced equipment, ensuring quality standards and even increasing their spending on associated research. It’s a different game altogether now and the medical fraternity is very happy with it,” says Vadodara-based pathologist Dr Yogesh Patel. Doctors work very closely with clinicians who help them in making informed decisions about the diagnosis and treatment of diseases for their patients.

“Accuracy is the key here… test results with higher accuracy are needed to provide the best possible line of treatment to a patient. Even a simple test like blood sugar or RBC/haemeoglobin count, if inaccurate, can lead to incorrect diagnosis and change the entire course of treatment. We have to be even more careful with complicated tests such as genetic tests,” maintains Dr Patel.

Pathology labs or diagnostic centres play a critical role in preventive healthcare and healthcare management in general. With the world facing unprecedented situation like the current pandemic, their role becomes even more important. It’s important to regulate the sector, ensure recruitment of trained and skilled personnel and guarantee accountability by legislative means to protect rights of the patients.

Jyothi Menon

Jyothi Menon is a health law activist working with – A DraftCraft International Initiative to spread awareness among patients of legal rights and position in law, boost medico-legal awareness, initiate legislative change and enforce accountability among healthcare players.