In the $5 billion a year Indian diagnostics laboratory industry, only 1% of laboratories are accredited
Pathology and clinical laboratory testing in India is growing at a double-digit pace. However, pathologists and medical laboratory scientists are raising the alarm about a disturbing lack of quality and accuracy that exposes patients to unnecessary harm.
In fact, there are loud voices within the pathology profession in India who are urging government officials to more actively regulate the country’s diagnostics industry, according to a story published by the Business Standard, a national newspaper in India.
In India, Medical Laboratory Testing is Fast-Growth Industry
Even without licensing or accreditation requirements, the $5 billion-a-year, Indian medical laboratory testing industry is growing at 15% to 16% per year. But lack of regulation threatens to curtail growth there.
It is significant that the loudest outcry for government intervention in establishing quality and licensing standards comes from pathologists and laboratory professionals. These highly trained laboratory scientists recognize that the worst medical laboratory operators in India are painting the entire profession of pathology and laboratory medicine with a black brush.
Big Business, but Quality and Consistency Seem to Be Lacking
It is estimated that more than 100,000 diagnostic laboratories operate in India. About 70% of them provide pathology services, as medical laboratory testing is known in that country. The remaining 30% of diagnostic laboratories offer radiology and imaging services, including as CT scanning, MRI, ultrasound, and X-ray, said the Business Standard.
The Business Standard noted that some pathology lab companies India are recognized brands, including Dr. Lal Pathlabs, Quest Diagnostics India, and SRL Diagnostics. These labs pursue voluntary accreditation from national groups like the National Accreditation Board for Testing and Calibration Laboratories and the College of American Pathologists.
But only 1% of diagnostic laboratories are accredited in India, the Business Standard estimated. When compared to medical laboratories that operate in Northern Europe and North America, diagnostic laboratories in India lack basic laws that govern quality, staff qualifications, and technology. Small, privately-owned laboratories have proliferated across the Indian subcontinent. They make up 88% to 90% of the country’s diagnostic industry market.
Calls for More Government Action to Regulate Diagnostic Laboratories
Laboratory professionals are calling for the government intervention and legislation that makes accreditation mandatory for diagnostic laboratories. “There is an urgent need for legislation and regulation to maintain a basic minimum level of quality in labs in India,” declared pathologist Namita Mathur, M.D.. “The relevant guidelines of international standards have been put forward by accreditation bodies, but it is a very small fragment of the diagnostic industry that is implementing these standards.
“I definitely believe that it should be mandatory to comply with these norms to maintain quality and prevent malpractices,” added Mathur, who is a consultant pathologist at Rockland Hospital in Manesar. She was quoted by the Business Standard.
False lab reports and questionable doctor qualifications reported
Indian newspapers regularly report stories about unhappy patients who learn that their pathology laboratory has produced erroneous lab test results. For example, two employees of a Malad-based pathology laboratory were accused of producing a false HIV positive report from a specimen provided by a 38-year-old real estate consultant. The patient contacted police, according to the story, which was printed in the Times of India.
National pathology societies and pathologist groups in India have urged their colleagues not to do business with rogue medical labs. “We have been receiving information on illegal labs every day. After the Indian Medical Association (Maharashtra) asked its doctor members not to refer patients to labs that do not have qualified pathologies, three to four centers have already closed down in Jalgaon, and some are on the verge of folding up,” observed Rajiv Rao, M.D., executive council member, Maharashtra Association of Practicing Pathologists and Microbiologists, in the DNA India story.
Is it time for a change that sticks?
This is not the first time Dark Daily has reported on pressure to improve laboratory services in India. The loss of confidence in reliability of Indian lab test results was explored in December 2012. (See Dark Daily “India, Nepal and Sri Lanka Move to Improve Medical Laboratory Services in Response to Public Pressure”.)
In fact, during 2012 government officials issued closure notices to 22 laboratories in southwest India following raids. These agencies apparently acted after patients complained about inaccurate laboratory test results and price-gouging.
For medical laboratory professionals here in the United States, the problems of the pathology laboratory industry in India are instructive for two reasons. First, American pathologists and laboratory executives contemplating business relationships with medical laboratory companies in India will want to be diligent in investigating the quality of their potential business partners.
Second, issues of poor quality and lack of government regulation demonstrate the opportunity that exists within the world’s second most populous nation. It is no coincidence that American investors have pumped capital into a handful of the better-managed, Indian pathology laboratory companies in recent years. Demand for reliable and accurate medical laboratory testing exceeds the available supply.
—by Donna Marie Pocius