Concerned over the rampant growth of unorganised diagnostic laboratories and centres across the country, the diagnostics industry has sought urgent intervention of the government to address this matter at the earliest. Industry wants the government to take steps to regulate the laboratories and diagnostic sector in the country, to ensure credibility and recognition to the authentic diagnostic laboratories across the country.

There is no statutory body or a set of rules in the country to regulate or check the operations of the about Rs. 12,000 crore industry consisting of numerable pathology laboratories and diagnostic centres in the country responsible to diagnose and provide health care reports of the patients. This absence of regulatory machinery has led to the mushrooming of laboratories and diagnostic centres in the country.

Dr Sanjay Arora, who is associated with Indian Association of Pathologist and Microbiologists and the Indian Medical Association (IMA), pointed out that at present setting up a diagnostic centre is as easy as setting up any grocery shop in the city, with just a no objection certificate (NOC) from the local governing authority. Whereas, to create a benchmark of being a recognised and reputed service provider, interested companies have to voluntarily approach to get an NABH accreditation, as it is the only body authorised to recognise and certify the centres. Interestingly, getting regulatory approval is a must and compulsory norm in all other areas of healthcare sector.

Arora who is also the director, Suburban Diagnostics, further stated that lack of rules and policing is actually providing a safe haven to unscrupulous operators to open a diagnostic centre without having either any expertise, technical knowledge and qualification on the modalities of testing and proper diagnosis. “In fact, most of the laboratory equipments that are used for the diagnosis at this small and mushrooming centres are seldom of highest quality, imported either from China or other low quality cheap product market. Thus there is no guarantee that results that are drawn out of this equipments are precise, putting at risk the health and life of patients,” he said.

He stressed that lack of regulatory monitoring and guidelines brings in a bad image to the industry which affect the growth of this sector. “The biggest problem is that such activities can directly impact a patient's life due to wrongly diagnosed reports. We have been struggling from years to get the wheels running on this matter but our demands have yet not been met with any attention. Quality healthcare starts with proper diagnosis of any tests which should be based on authenticated process that are of highest standard. It is indeed a huge flaw in the healthcare system of our country which has been ignored by the healthcare regulators and needs to be looked at urgently to ensure patient welfare.”