Delhi-NCR has many fake labs that do not even have the equipment to carry out blood tests. Shockingly, the clinical establishments law to regulate path labs has not yet been implemented in Delhi, pushing the diagnostic system in a mire

“The report stated that I was HIV positive. I was scared for my child as I was pregnant then,” says Aparna Mathur, a 27-year-old residing in Shalimar Bagh, who was misdiagnosed with HIV during her pregnancy. She underwent an HIV test on her doctor’s recommendation. “I was told by the gynaecologist that an early detection can prevent transmission of the disease to the child, so I should get the test done,” she says.

Mathur adds that her gynaecologist — who had a small clinic in Shalimar Bagh, which is no longer in existence — had taken her oral fluid sample for her HIV test that was conducted in July last year. “The report that she gave us was from a path lab called Unicare Path Solution Pvt Ltd,” she says, adding, “Since we were under the impression that I am HIV positive, we went to a better doctor for a second opinion.”

“She referred me to a different pathology and asked me to go for a re-test. The report that we got from there read that I was not suffering from HIV. This entire confusion, that too during pregnancy, was extremely disturbing for me and my family,” she says. But the earlier results had instilled such fear in her that she got herself tested again. The result was again negative. “We were so relieved when the second report also showed negative results. It was an extremely terrible phase and I suffered mental agony because of the incorrect report,” she adds.

The Unicare Path Solution Pvt Ltd (which gave Mathur the wrong results) was a fake path lab operating from Adarsh Nagar (West Delhi). In May 2018, Ajay Yadav and Sanjay Yadav (residents of Jaunpur, UP) who were running this lab, were arrested by the Delhi police for conducting over 23,000 fake tests last year. On being interrogated by the police, Ajay revealed that he gained knowledge about medical tests from his work experience as an assistant in several path labs in UP. A probe also revealed that samples were brought to this lab from other laboratories in Delhi and neighbouring areas.

The lab was set up in a dingy and unhygienic room, where no medical equipment required for conducting the tests was found. It did not even have basic equipment for testing blood groups. Their reports had digital signatures of doctors, but when the MCI (Medical Council of India) and the DMC (Delhi Medical Council) were contacted for information on these doctors, it was found that those doctors were not even registered with the council.

Investigators suspected that some of the big names in the pathology industry were also using the services of this lab, which is now sealed. It was also revealed that the operators of this fake lab had test report templates, which they had procured from various labs. They would just assign random values in a specific test report template and then hand over the bogus reports to their clients.

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Major hospitals in the region run their own path labs and there are reputed networks which are trustworthy. But what about the labs which can be found in every market and every neighbourhood under different names? What if the doctor in your local clinic asks you to “Get the tests done anywhere,” where should you go?

According to NABL data, there are only 194 accredited medical labs in Delhi-NCR, out of which Delhi has 119 labs, Haryana 36 and UP 39. “Lakhs of such fake path labs operate across the country, with thousands operating in Delhi alone. There is a lacuna in the law and because of a few greedy health practitioners, the problem is worsening. I know doctors who have told me that they had no contact with the path lab but they received a cheque at the end of the month, suggesting them to join hands in the business,” says Bejon Kumar Misra, founder of non-profit Patient Safety and Access Initiative.

Misra was a member of the expert committee that was constituted by the Ministry of Health after a sting operation by a media channel exposed a fake lab. He says, “We gave a comprehensive report but the government is not acting on it because they keep politicising the issue. Since the government turned a deaf ear to this problem, I had to take the legal course.”

Dr KK Aggarwal, former President of IMA (Indian Medical Association), says that there is no data on the number of fake labs. “Unauthorised path labs are mushrooming across the country because there is no regulation and no accountability,” he says. “There is no law in effect which can prohibit you from establishing a diagnostic centre. Anyone can open a lab, with investment as low as Rs 3,000 and conduct medical tests.”

There are many such fake path labs, which neither have qualified technicians/pathologists nor are registered or accredited by the NABL (National Accreditation for Testing and Calibration Laboratories), in Delhi-NCR. In September, the Delhi High Court sought a report from the AAP government on steps that can be taken to check the mushrooming of such unauthorised path labs, terming it a serious issue. While hearing a PIL filed by Misra, the Delhi HC directed the government to inspect labs and once that is completed, to file a report enumerating all the measures that will be taken. The court gave six weeks’ time to the government to indicate the status of the law that is still being chalked out to regulate path labs in Delhi.

Legal loopholes
It is not mandatory to have NABL accreditation before opening a path lab in Delhi. Also the Clinical Establishment Act, 2010 (which was enacted by the Central Government for the regulation and registration of all clinical establishments in the country, with a view to prescribe the minimum standards of facilities provided by them) that can curb the growth of such spurious labs by imposing strict regulations, has not yet been implemented in the capital. In the absence of a proper mechanism or regulatory law, these labs have been growing in number by the day and are becoming a major concern.

“Unqualified lab technicians are not only conducting various tests but are also providing inferences based on unscientific and unqualified outcomes, which undermine the health and safety of the patients,” Misra’s plea alleged, adding that such labs prepare reports in a fraudulent manner by using scanned signatures of doctors.

Explaining how these illegal pathologies survive and gain ground, Misra says, “Healthcare providers and pathologies have a nexus on which they thrive. They are operating in tandem — these path labs are able to function because doctors refer patients to such labs, for which they are paid a commission by the path labs. This network is not allowing the healthcare system to function effectively.”

Dr KK Aggarwal seconds this opinion that the network between doctors and path labs enable them to function smoothly, giving them validity. He says, “The healthcare practitioners and these labs share the profit. The doctors refer their patients to path labs and they get commission for it, but they have no legal accountability, which is wrong.”

But this network is not just limited to doctors. “Sometimes the patient is not even suffering from the disease but reports of such labs will falsely point towards a particular ailment, so that the patient ends up buying medicines from medical stores which these path labs have tie-ups with. So, they will be making money from those medical stores as well,” Misra alleges.

He adds, “Another issue is that the Clinical Establishment Law has not been implemented in many states, including Delhi. NABL accreditation can solve this problem to a large extent.” Effective implementation of the law can be the only solution to this problem, otherwise these unregulated path labs will continue to grow and adversely affect the lives of hundreds of patients. Aggarwal, too, says, “The only solution to this menace is bringing all the path labs under the NABL regulation. And there are so many of such labs that once this comes into force, only a few labs will be left.”

Worried doctors
The magnitude of the problem can be understood from the fact that many responsible doctors are now questioning the reliability of medical tests. “Every day, we see so many cases of patients who have been misdiagnosed due to incorrect reports that we are now used to it. Many a times, we have to ask patients to repeat their tests,” says Aggarwal, as he goes on to add that this happens so frequently that the system is surviving only because of the clinical acumen of a few doctors who are able to catch the inaccuracy.

An incorrect diagnosis can put the life of a patient in grave danger, which is why bringing these path labs under stringent check is important. Dr KK Agarwal informs that he once had a patient from Jalandhar whose reports were incorrect, resulting in his typhoid being undiagnosed for four weeks.

Rohit Jain, founder member of the Forum of Practicing Pathologists, says that in February, a 16-year-old boy came to him with lab reports that he had blood cancer. Later, it was found that the boy was actually suffering from a different kind of cancer. Presenting a copy of the report, Jain alleges that the reports were signed by a veterinarian and not an authorised pathologist.

“There are hundreds of such cases. I do not consider NABL accreditation any good. I have been fighting a battle against it since the last six years. The basic intent is good, but NABL is just an autonomous body recognised by the government. It is not a statutory body. We need to have a proper government body to regulate these path labs which are in lakhs. In Delhi, 20,000 to 30,000 labs are operating currently,” he says.

In 2017, SC had upheld the stand taken by MCI that laboratory reports can be signed only by a registered medical practitioner with a post graduate qualification in pathology. Despite this, Jain says that reports signed by unauthorised people are being given to patients. “When we don’t allow any other person except a pilot to fly a plane, then why do we allow this? If a peon can’t sign in place of a judge, then how can unqualified people sign on medical reports?” questions Jain.

He blames the government for not taking adequate steps to put an end to such malpractices. “They themselves travel abroad for treatment and leave us to a healthcare system that is in such a pitiable state,” he says, adding that the Clinical Establishment Act too, has certain flaws which first need to be amended and then the law should be implemented whole-heartedly.

Pointing out towards a loophole in the Clinical Establishment Amendment Rules, 2018, which divides path labs in — basic, medium and advanced — categories, he says, “According to this, in case of these basic path labs, any random person can supervise the reports. In India, 80% of the labs will fall in the category of basic labs and only a few will be in the advanced category, which means that in most of the labs the reports will continue to be signed by unauthorised people even if the law comes into effect and illegal labs will continue to function.”

Thereby, he asks for an amendment of these rules before they are fully brought into effect.

“We are dependent on medical reports since our birth. A wrong report can also lead to death. The situation is worse than one can imagine,” he concludes.