Diagnostic sector requires regulation – The Hindu

Shankar Dhange, 27, has been fighting a lone battle against the private diagnostics sector in Maharashtra for years now, but he is yet to make any headway. Six years ago, his sister, Sarika Bhonglat, lost her life following complications after a surgery.  Shankar believes that the tests his sister underwent prior to the surgery were incorrect, and this led to the wrong treatment being given, causing her death. “The treatment that my sister was given was based on a lab report that was signed off by a technician and not a pathologist. It was this that led to incorrect treatment and complications and finally her death. How can a Class 12 graduate be allowed to sign off on medical imaging and diagnostic tests?” he asks.

Shankar’s case is not unique and delves into the heart of what ails the diagnostics sector in India today — a shortage of trained personnel to meet the rapid burgeoning of medical laboratories/diagnostic facilities in the country.

While there are no exact figures available, industry experts estimate that there are around 300,000 labs across the country, and this number is growing. Within the healthcare sector, diagnostics accounts for around 9% of the industry, estimated to be worth ₹860 billion in the financial year 2024, and projected to grow to about ₹1,275 billion by the financial year 2028.

This staggeringly huge sector, however, remains under-regulated, fragmented, and biased towards urban areas.

The regulations

The Clinical Establishments (Registration and Regulation) Act 2010 aims to bring all diagnostic centres and labs under its ambit, with their registration with respective State councils as clinical establishments. The Act also aims to provide guidance on the minimum standards of facilities and services that should be provided by diagnostic centres and labs. 

To date, the Act has been adopted by 12 States — Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, Uttar Pradesh, Bihar, Jharkhand, Rajasthan, Telangana, Uttarakhand, Assam, and Haryana — and all Union Territories, except Delhi. Some other States, including Kerala and Karnataka, have their own legislation to bring labs under the ambit of clinical establishments. However, implementation has, in many cases, not begun, or where it has, it often remains poor. 

The fragmented nature of the sector

Given the low entry barriers and the lack of a strong regulatory environment, there are many standalone players in the sector, making it competitive, fragmented, and prone to varying standards.  

Diagnostic centres in India can obtain accreditation voluntarily from organisations such as the National Accreditation Board for Testing and Calibration Laboratories (NABL).

N. Venkateswaran, CEO, NABL, in an email interview withThe Hindu highlighted the challenges created by the fast-paced growth of the private sector. India, he noted, has a highly fragmented market with many small, unorganised labs, largely not accredited and following uneven quality standards. “This is in terms of resources to bring in advanced diagnostic technologies, a large variation in pricing even for routine tests, and inadequately skilled manpower,” he said.

He said that while the emphasis is on the quality and accuracy of results, lab regulation needs attention. “There has to be more awareness about biomedical waste management to prevent outbreaks; maintaining better labs and hospital environments is in focus, but there is much more to be done to ensure reliable and accurate results.”

The shortage of manpower

There is a significant shortage of full-time doctors and staff in the diagnostics industry. This situation makes it difficult for standalone diagnostic centres which may not be able to employ well-trained lab technicians and pathologists, affecting the quality of outcomes. Accredited labs must mandatorily employ a full-time lab technician/phlebotomist and a radiologist. 

The Health Ministry’s own research has indicated that India has the disadvantage of not having enough microbiologists and some places do not even have enough qualified doctors or technicians to operate a lab. There is also a lack of upgrading and training, as well as geographical inequality in quality of services, the research said.

A top management official from a leading diagnostics chain based in North India points out: “The challenge lies in defining an unregulated lab. How do you define one? We do not have enough pathologists to run the number of labs there are in the country. This is where the problem comes in: some lab reports are issued with ‘bought out’ signatures from doctors, where signatures are obtained in exchange for money, but the lab has a licence obtained from local authorities and shows the presence of ghost employees and doctors.”

This problem persists across most States. In Karnataka, the Karnataka Private Medical Establishments (KPME) Act governs healthcare facilities; however, the scope and enforcement of this Act in the laboratories and diagnostics sector is limited, particularly in areas like quality assurance and patient safety. 

Many hospitals and doctors running clinics have side laboratories and sample collection centres. “These are ‘technician-only’ facilities that are not run or owned by qualified pathologists or microbiologists. With one pathologist connected to multiple laboratories, reports only have e-signatures of the pathologists. Although e-signatures are allowed, there is no rule on the number of laboratories a pathologist can be connected to,” sources in the diagnostics sector said. 

Lack of proper regulations is an area of concern in Tamil Nadu as well, said V. Parthasarathy, general secretary, Tamil Nadu Government Medical Laboratory Technicians Association. He pointed out that an announcement made in the Assembly to constitute a State Council for Laboratory Technicians in 2009 is yet to be implemented. “We still have private laboratories run by unqualified persons,” he said.

What does this mean for patients?

In 2019, Shankar tried to file an FIR with the Paranda police station and raised his concerns with the Grahak Manch (consumer forum), but to no avail. He has now appealed at the Aurangabad Bench of the Bombay High Court against the doctors of a local hospital in Barshi, where he got his sister treated.

Doctors from the Maharashtra Association of Practising Pathologists and Microbiologists (MAPPM) indicate that this is not the only such case — and their number is only rising. “A complex diagnosis requires a report from a pathologist. The machine doesn’t give reports; it gives readings. A pathologist is required to analyse it,” said Sandeep Yadav, president of MAPPM.

The issue affects doctors too: in November last year, a Maharashtra-based doctor, Rahul Mayur, filed a complaint of identity theft, stating that a diagnostic lab in Jalgaon was fraudulently using his name, degree, and signature to give fake reports to patients.  

The Maharashtra Paramedical Council Act, 2011, has established a council to regulate paramedical personnel, including medical laboratory technicians. This Act and the National Commission for Allied and Healthcare Professions (NCAHP) Act 2021 do not permit laboratory technicians to practice independently and issue reports without certification by a pathologist. 

However, Dr. Yadav said such fraudulent practices were common. He highlighted the issue of “ghost pathologists” at many labs and underscored: “everything done at a lab needs to be supervised by pathologists and not technicians.” 

The urban-rural divide

One of the other issues in India is the concentration of labs in the urban areas. As of the financial year 2023, only 24% of diagnostics revenue came from rural areas in India, though nearly 70% of the population in the country resides rurally. This is also mirrored in the government–private labs divide, with both doctors and patients pointing out that multiple gaps exist in government sector labs that make them a less favoured option for patients. 

For instance, in Telangana, a government doctor said lack of essential upgrades was a hindrance. Both Osmania and Gandhi hospitals — major State healthcare facilities in Hyderabad —  urgently required improvements, the doctor said, further noting that limited operational hours at government laboratories restricted access for patients who require after-hours services. “Even after diagnosis, the unavailability of specialists at government hospitals discourages patients and forces them to seek private care,” the doctor added.

The problem of varying standards and shortage of staff ails the government sector too.

Paramita Sarkar, a final year MD pathology student from Medical College, Kolkata, said there was a huge workload — over 800 tests per day — but a serious staff shortage. “Three of us work in shifts in the labs, but that is not enough. We need more technicians and people who can run the testing machines to ensure work gets done on time and faster.”  Tapas Pramanick, a medical officer at R.G. Kar Medical College and Hospital in Kolkata, also said that with many district hospitals lacking decent testing facilities, most tests come to city hospitals, increasing the workload. 

The pricing problem

Pricing, as is always the issue when it comes to the private health sector, is of concern in diagnostics as well. A few government programmes and certain States are going some way towards addressing this. In January 2018, Telangana began the Telangana Diagnostics Programme or  ‘T-Diagnostics’ initiative. As of October 2024, over 18.10 crore tests have been conducted benefiting 1.01 crore individuals, collectively resulting in an estimated saving of ₹1,100 crore in out-of-pocket expenses for patients. However, supply issues such as those of reagents are marring the programme, a lab technician said.

In Kerala, the government has invested significantly in upgrading primary health centres to family health centres to provide a range of services, including basic laboratory investigations (at nominal rates) as part of its ‘Aardram Mission.’

Issues faced by labs

While there are many issues in terms of regulation that still need to be streamlined and implemented, representatives from the diagnostics sector say they too, want change. 

In Kerala for instance, lab representatives say the space and educational requirements under the Kerala State Clinical Establishments Act are unviable. “There are some 6,500 independent small and medium paramedical labs in the State and if one were to go by the minimum standards only about 1,000 will be able to function. We have sought relaxations in the clauses regarding space requirement,” says Shareef Paloli, State General Secretary of Kerala Private Medical Technicians’ Association, and head, Kerala Paramedical Coordination Committee.

The State government also does not recognise paramedical degrees/diplomas even from recognised institutions in other States, he says. A two-year MLT Diploma/BSc MLT or MSc MLT conducted by medical colleges or other government approved agencies is required. “We are cooperating with the government, but our request was that rather than render professionals who have studied outside the State jobless, the government could conduct a training programme/exam for them. The government has now agreed to this in principle,” he says.

The space constraints are a problem in T.N. as well: in November 2024, the Health Department, brought in amendments to the Tamil Nadu Clinical Establishments (Regulations) Rules, 2018, stipulating minimum space for sample collection for clinical laboratories — 300 sq ft in rural areas and 500-700 sq ft in urban areas. P. Kalidasan, national president, Paramedical Laboratory Educational and Welfare Association, says there is no need for such specifications. “There are nearly 10,000 laboratories in the State. Of these, at least 80% are small-sized. Among them 30% are in rural areas. Small labs cater to around 10 patients a day and mandating 300 sq feet area for clinical laboratories cannot be accepted. The focus should be on adherence to external quality assurance and internal quality control assurance programmes,” he said.

The sector is willing to have regulations to bring in standardisation: the Karnataka Chapter of the Indian Association of Pathologists and Microbiologists (KCIAPM) is asking for the strengthening of the Karnataka Act. “The KPME Act must be expanded to include licensing criteria, accreditation mandates, and penalties for non-compliance. Mandatory SOPs for sample collection, testing, and reporting should be put in place to minimise errors. Besides, there should be regular audits by a designated State regulatory body to monitor compliance with quality standards,” said Aditya Agnihotri, KCIAPM secretary.

KCIAPM president Vijay Shankar S. said ensuring every lab is supervised by qualified pathologists and supported by trained technicians was vital. “Licensing should include a needs assessment to prevent over-saturation in certain areas while ensuring coverage in underserved regions,” he said.

Patient-driven demand

The demand for better laboratories and standardisation has been driven by the public themselves, who are increasingly concerned about quality, said one lab owner in Kerala.  

Ensuring minimum standards at all labs with fully-trained staff in adequate numbers, alongside improving State-run labs is vital — this, says a senior Health official in Kerala, will help weed out labs that do not adhere to standards and place pressure on others to clean up their act. Enforcing the Clinical Establishments Act or the various State-level Acts is vital to this.

Diagnostic services are a crucial cog in the healthcare machinery — unless they function well, the health and lives of millions of patients could be at risk.

(Collated by Zubeda Hamid, with inputs from Maitri Porecha and Bindhu Shajan Perappadan in Delhi; Afshan Yasmeen in Bengaluru; C. Maya in Thiruvanathapuram; Siddharth Kunar Singh in Hyderabad; Snehal Mutha in Mumbai; Shrabana Chatterjee in Kolkata and Serena Josephine M. in Chennai)