Supreme Court of India ruling may finally ignite a crackdown on illegal medical laboratories that operate without a licensed pathologist

What would happen if 80% of Americans did not trust the medical laboratories that run their diagnostic tests? What impact would that have on this country’s clinical laboratory and anatomic pathology industry? Certainly, a significant one.

Well, that’s exactly what has happened in India. A survey on graft in India’s healthcare system conducted by LocalCircles, a community social media platform, has highlighted citizens’ distrust and disgust with the nation’s pathology laboratories. Only 20% of the 29,000 citizens surveyed said they “fully trusted” the pathology lab they use, while 32% of respondents said they had received one or more incorrect pathology reports in the past three years.

In India, the term “pathology laboratories” describes what are called clinical laboratories in the United States and Canada. Histopathology laboratories in India perform testing on tissue, just as anatomic pathology and surgical pathology laboratories do in North America.

According to the survey results, 91% of respondents believe clinical laboratories should lose their licenses if found to be giving incentives to doctors for prescribing tests. In addition:

  • 86% of those surveyed feel doctors’ earnings in hospitals should be unrelated to the value of tests they refer to the hospital’s pathology lab; and,
  • 59% believed kickbacks from labs incentivized doctors to prescribe unnecessary tests.

“One of the important cogs in the wheel of the medical system in our country are the pathology labs,” LocalCircles noted in the survey results. “Being a high profit business, thousands of them have mushroomed in different parts of the country. Many people say these pathology labs have a tie up with the doctors and pass on a commission to the doctors for every patient they send to them.”

India’s Medical Laboratories Under Increasing Scrutiny

The LocalCircles survey underscores the ongoing concerns in India over the quality of its medical laboratories, which have come under fire for lack of regulations and accreditation standards.

In India, the term “pathology” describes a laboratory performing standard medical laboratory tests, such as chemistry, hematology, immunoassay, and microbiology. Histopathology is the term used to describe diagnostic testing that utilizes tissue specimens.

Last year we reported on the tens of thousands of lab companies that continue to operate in India without certified pathologists and other trained lab scientists. (See Dark Daily, “Shortage of Registered Pathologists in India Continues to Put Patients at Risk in Illegal Labs that Defy Bombay Court Orders,” April 12, 2017.)

Technicians Cannot Run Pathology Laboratories, Supreme Court of India Rules

There are signs, however, that the tide may be turning against unqualified pathology labs. Last year, The Supreme Court of India upheld a lower court order that directed only a “qualified and registered pathologist, with a postgraduate qualification in pathology” can countersign a patient’s pathology report, the Times of India (TOI) reported.

The TOI quoted an unnamed senior food and drug department official as saying, “Many technicians with [a] diploma in Medical Laboratory Technology and other equivalent qualifications are operating pathology laboratories,” because no laws currently exist requiring a qualification in pathology as a prerequisite for running a private laboratory.

“If unqualified people certify medical reports, it will hamper patient treatment,” Sadhana Kothari, MD, Associate Professor, Department of Pathology at Gujarat Cancer Society Medical College in Gujarat, India, told the TOI. “A doctor’s analysis and patient’s treatment [are] dependent on clinical tests. The Supreme Court judgment will ensure that illegal labs do not operate.”

Times of India story on illegal labs

Local press coverage like that above highlights the severe pressure India’s pathology laboratory industry faces following the Supreme Court of India’s ruling that only qualified and registered pathologist—with a postgraduate qualification in pathology—can run pathology laboratories or sign off on pathology reports. (Image copyright: VAPM Pathologists and Microbiologists Welfare Society.)

Illegal Labs Continue to Operate Despite India Court Rulings

The Supreme Court decision means that PhDs, laboratory technicians, and others without proper medical credentials can no longer sign laboratory reports. The Supreme Court verdict emphasized that labs operating without a qualified pathologist should cease operations until a qualified pathologist can be hired. However, earlier verdicts in the Indian court system have failed to end the proliferation of illegal labs.

According to the TOI, the Association of Practicing Pathologists (India) (APPI) first filed a writ in 1998 to prevent individuals not qualified in pathology and/or registered with the Medical Council of India from running laboratories. In 2010, the Gujarat High Court ruled, “Laboratory technicians are not pathologists and cannot run any laboratory independently.”

A month after the Gujarat High Court decision, pathologists in Gujarat complained the state government had failed to initiate criminal action against people running unauthorized labs. The Indian Express reported the Gujarat Association of Pathologists and Microbiologists was starting a public awareness campaign to stop illegal labs from operating because the state government had not shut down illegal operators.

Number of Qualified Pathologists Decreasing

The ruling by the Supreme Court of India, however, may result in concrete action being taken by the states. On February 6, 2018, the Pune Mirror reported the Maharashtra State Human Rights Commission (MSHRC) ordered the state public health department and the director of medical education and research to identify and take action against labs working without valid licenses.

According to the Pune Mirror, only 2,200 of the state’s 10,000 diagnostic laboratories are headed by certified pathologists. The Maharashtra Association of Practicing Pathologists and Microbiologists (MAPPM), the largest body of certified pathologists in the state, claims as many as 8,000 pathology labs in Maharashtra function without licenses.

“The state government has the mechanism to keep a tab on such labs, but they don’t take action,” Sandeep Yadav, MD, President of MAPPM, told the Pune Mirror. “It has become an easy way to earn money because there is no law yet around registering labs. Many people open laboratories simply by observing pathologists over time, and it could be a threat to a patient’s life, as it has been observed that many labs are illegal or run by technicians. The number of qualified pathologists is decreasing and genuine people don’t want to pick up the profession.”

Also in February 2018, the New India Assurance Company, the country’s largest insurer, instructed its regional offices to not approve medical claims from pathology laboratories if the reports are signed by unlicensed and unqualified staff, the Pune Mirror reported.

 

The challenges of providing first-line medical laboratory testing services in countries like India demonstrate how expectations of quality and accuracy are driving change in these rapidly-developing nations. It is a reminder to clinical laboratory managers and pathologists in the United States that the trust of patients and government regulators is a valuable asset.

—Andrea Downing Peck

Related Information:

Majority Say a Corrupt Nexus Exists Between Pathology Labs and Doctors

GAPM: Bogus Pathology Labs Playing with People’s Lives

State to Crack Down on Illegal Path Labs

Pathologists Start Awareness Campaign after HC Order

Pathologist Body Launches Campaign Against Rogue Labs

Insurance Major Says No to Illegal Lab Reports

Shortage of Registered Pathologists in India Continues to Put Patients at Risk in Illegal Labs that Defy Bombay Court Orders