Above: The Delhi government must report on the plan of action vis-a-vis mushrooming of fake path labs in the capital in two weeks’ time

NCR has only 207 NABL-accredited path labs but countless unauthorised ones flourish, churning out reports causing misdiagnoses and deaths. A PIL calls for their closure

~By Sucheta Dasgupta

In February this year, a teenager from a village in Haryana arrived at a Jaipur hospital with a report from a Gurugram-based lab in the National Capital Region. The report showed the presence of the BCR-ABL fusion gene in his blood which marked him as a patient of chronic myelogenous leukemia (CML). The doctor, pathologist Rohit Jain, who was attending to him, was perplexed as CML is said to typically affect only those older than 50 years. The 16-year-old’s condition soon deteriorated and he was put on the ventilator. On closer scrutiny, Jain noticed that the report was signed by a pair of veterinarians, and he ordered a fresh test. This time the BCR-ABL result was negative, and the patient was diagnosed with acute lymphoid leukemia. He was administered appropriate treatment and he soon recovered.

In May, a pathology lab running out of a dingy room in northwest Delhi’s Adarsh Nagar was raided by police. Ajay Yadav and Sanjay Yadav, who ran it, were arrested for issuing at least 23,000 bogus test reports in around a year. They had prepared set templates of 2,500 lab tests and were handing these over to clients without actually carrying out a single test.

Though it is an India-wide problem, the capital seems to be having the worst of it as unauthorised pathology labs are being operated with impunity and without a certified pathologist or trained lab scientist, in the absence of a clear-cut law or regulatory mechanism. On September 19, the Delhi High Court issued a notice to the AAP government on a PIL seeking closure of all pathological and diagnostics laboratories being run by unqualified laboratory technicians in the national capital. The government was given two weeks to report on the plan of action.

The petition was filed by Bejon Kumar Misra, consumer policy expert, a former member of Food Safety and Standards Authority of India and currently governing member of the International Alliance of Patients’ Organisation. Through his counsel Shashak Deo Sudhi, Dr Shashi Bhushan, Bijender P Kumar, and Dinesh Dakoria, he has said illegal pathology laboratories (path labs) are killing people by providing incorrect test reports. He has urged stringent implementation of the Clinical Establishment (Registration and Regulation) Act, 2010, by the Delhi government. Under this Act, all path labs are mandatorily required to register themselves with the National Accreditation Board for Testing and Calibration Laboratories (NABL), under the Quality Council of India.

“Based on data received from NABL, there are only 207 accredited medical labs in NCR—Delhi has 132 labs, Haryana-NCR 36 and UP-NCR 39. As per the report published in an English daily, several hundreds of diagnostic labs are existing in Delhi-NCR out of which only 10 percent are accredited by NABL,” the petition read.

The petition lists several illegalities that these path labs indulge in, including lack of calibration of equipment and machinery, leading to incorrect reports, syringes being reused, and scanned signatures of a single pathologist being used by scores of such labs without the actual presence of any qualified personnel to generate reports. “Numerous such businesses are being opened by unscrupulous elements and they are operating with impunity, resulting in faulty diagnosis and death of patients and endangering the life of the common man,” Misra told India Legal.

His efforts have not gone waste. A bench of Chief Justice Rajendra Menon and Justice V Kameswar Rao said, “It is a serious issue. Till the legislature brings a law, what steps can be taken to regulate such activity?” However, it steered clear of asking the state government to implement the central Act.

Misra’s petition has been welcomed by doctors and the larger medical community. Dr Navin Dang, founder of Dr Dangs Lab, among the oldest and leading path labs in Delhi, said there is “total havoc going on in a sector which is dominated by unscrupulous elements who are taking advantage of a legal loophole”, and the petition is “very much justified”. “All these labs and diagnostics centres must be brought under some kind of regulation by a government authority. I have long been an advocate for the same. Today, from a halwai to a doctor, anyone can open a path lab. NABL accreditation in Delhi remains entirely voluntary, and many are deterred by the high costs involved and the fact that it is a time-taking procedure,” he told India Legal.

However, he added that there are several small, good labs which have not gone for accreditation. “If a 38-year-old qualified doctor opens a path lab, he avoids an NABL registration as it might take 15-20 years. The fact remains that authorisation is necessary. Also, a lab must be operated by a qualified pathologist, or a haematologist, or a microbiologist, or a specialist in lab medicine,” Dr Dang said.

Thus, there seems to be a need for simplifying the process of accreditation without compromising on its rigour. Only 11 states in India have implemented the Clinical Establishment Act, health being a state subject. The Delhi government has admitted in court that a problem exists in this sector. Standing counsel Rahul Mehra said a Delhi Health Bill is under way, and its tabling has been delayed by the centre-state tussle. Fourteen other bills have also been similarly stalled. “The principal secretary (health) has now been asked to submit an affidavit in court, detailing the steps to be taken by the government to deal with the situation till the time this bill is passed, and mentioning the approximate time required for the tabling of the bill,” Mehra told India Legal. Nagendra Sharma, media adviser to the Delhi government, told India Legal, “We welcome the petition. These labs must be closed. We have been doing our best to crack down on them.”

But why have a separate health bill for the National Capital Territory? Dr RN Das, additional director, department of health and family welfare, Government of the National Capital Territory of Delhi, listed its improvements over the central Act. “Hospitals and clinics in Delhi are governed by the Delhi Nursing Homes Registration Act of 1953. It is quite toothless and has to be first repealed. When the Clinical Establishment Act first came about in 2010, a number of stakeholders had objected to it on various grounds. The then Delhi government had appointed an interlocutor, Prof AK Agarwal. He suggested a few amendments and the centre was approached. The current government, too, has sent reminders and now come to the conclusion that a separate act for Delhi is the solution,” he said.

Asked to elaborate on the reasons, he said land is scarce in Delhi, so stipulations regarding size of building and premises have to be modified. But there are other, more important, concerns. To begin with, the definition of a clinical establishment has to be expanded to include all such establishments, including cosmetic centres, as well as those dispensing Ayurvedic and Unani medicine, not only allopathy. Pertinently, the provisions and rules regarding registration must be simplified. The minimum size of the operation theatre and minimum area of beds must be specified. There is no mention of the requirement to adhere to fire safety norms for such establishments in the central Act. This must be added. Some people are even advocating incorporation of criminality in the Act. For instance, hospitals and doctors who turn away patients, resulting in their death, or those who indulge in gross negligence must be prosecuted under criminal law. The central act, however, does not have such provisions, Das said.

The central act also has many arbitrary provisions. For instance, single doctor clinics are required to register themselves under it. But why should a doctor not see a patient or two, even out of goodwill and the desire to serve society? “Should he have to undergo a lengthy procedure for that or risk prosecution?” Das said. He added that all hospitals run by the Delhi government are currently required to keep 10 percent of the beds in the inpatient department for economically weaker sections (EWS) and charge them nothing, and see 25 percent of the patients in the outpatient department who must be from EWS free of cost. As the central act has no such provision, the health bill will continue this practice. A first draft is ready, but “bills are not prepared overnight, and a final draft will take some time coming,” Das said.

The situation is no different elsewhere in the country. In Maharashtra, which has not implemented the central act and is also planning a state version, having drafted a bill to curb unjustified profiteering by private establishments, pathologist organisations have been calling for an increase in raids on illegal laboratories, or suspension of the head of the Directorate of Medical Education and Research (DMER), Dr Pravin Shingare, for “protecting the interests of illegal laboratories”. The DMER has responded with claims that a shortage of qualified pathologists has left them with no choice but to suspend government crackdowns, particularly in rural areas. The controversy has survived, and so has Shingare.

There have also been intermittent reports in the media about scores of illegal labs running in many districts of Bihar, Punjab, Uttarakhand, Rajasthan and Madhya Pradesh. Thus, hurdles remain for governments and law enforcement though they are by no means insurmountable. But until governments display the will and the tenacity to crack down, the quacks and the fakes will continue to flourish.