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Lack of Regulation: A Problem for the Indian Diagnostic Industry

70% of clinical decisions are based on a diagnostic report and yet, in India, all it takes to open and run a medical laboratory is a simple shop and establishment act

By Ameera Shah 

70 per cent of clinical decisions are based on a diagnostic report and yet, in India, all it takes to open and run a medical laboratory is a simple shop and establishment act. A largely unregulated environment has left a lot of room for malpractice. It is estimated that there are over 1,00,000 laboratories in India and due to low entry barriers, there is a varying degree of quality and reliability and no minimum standard that is guaranteed to the patient.

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Patients should research before choosing a lab for their testing needs

Recently the media reported an incident in Delhi where it was found that a small non-descript lab was issuing fake COVID reports. Such practices have been rampant in the industry and patients and hospitals need to be alert and choose good labs that are reputed for quality, accuracy, and reliability. Most of the reference labs and big chains also receive samples from small labs for specialized and super-specialised testing. A rigorous audit practice to keep a tab on all institutions that we deal with is a good way to monitor any wrongdoing. Moreover, strict action against such wrongdoing will set the right precedent.

Lack of regulation an ailment for the Indian diagnostic industry
Consumers are also not aware of laboratory standards and opt for the nearest lab for their testing needs. Pexels

Accreditations in the Industry are voluntary

Adopting quality testing protocols is entirely voluntary and there are no consequences for not adhering to the minimum quality requirements. Consumers are also not aware of laboratory standards and opt for the nearest lab for their testing needs. With only 10-15 per cent of the sector being organised, there is no room for scalability or process standardisation.

Big lab chains like Metropolis have voluntarily sought accreditations from CAP (College of American Pathologists) & NABL (National Accreditation Board for Testing and Calibration Laboratories, a unit run by the Department of Science & Technology, Govt of India) which stand a testament to our quality practices.

Private labs are in the front lines and equal partners in this COVID battle

In the case of COVID testing, ICMR, and NABL has approved over 1,500 labs across India for COVID-19 testing. Kits and technology are also approved by ICMR. RT PCR is a specialised test that requires skilled manpower and sophisticated infrastructure.

All the authorized diagnostic services enlisted by ICMR have undergone a rigorous process of NABL accreditation and follow the best available protocols and quality control. Most of them use instruments that are USFDA and CE-marked from reputed and trusted medical brands. Moreover, the workforce is trained and endorsed by the accreditation agencies.

Private labs have scaled up infrastructure to be able to cater to the COVID testing needs of the country. Private labs also set up dedicated collection centres and have also ramped up isolated COVID labs to speed up diagnostics despite the initial shortage of kits and multiple logistical issues. We have also established drive-through testing centres and installed walk-in mobile kiosks to optimize the use of PPEs, masks, and gloves, minimize the inconvenience caused to patients and reduce stigma for technicians working in hazmat suits.

In addition, challenges faced by the lab workforce of Indian Diagnostic Industry to test and collect samples has been immense. Currently, many private labs are reeling under the mounting pressure of high operating costs. With advances being a norm for many manufacturers and suppliers and deferred/delayed payments from hospitals (both private and Government), the cost pressure is rising. Smaller labs are finding it difficult to scale up. The non-availability of public transport has limited access to enough supplies and manpower. Staff members are also facing public ire while on duty, but the teams have still managed to hold the fort in times of necessity to serve the nation. With the pressure to report tests in good turnaround time, lab staff are foregoing rest and personal priorities, doing 16-hour shifts each day, not meeting their families for weeks, and while putting their own lives at risk.

Lack of regulation an ailment for the Indian diagnostic industry
Private labs have scaled up infrastructure to be able to cater to the COVID testing needs of the country. Pexels

Also Read: This is a Tough Time for Theatre: Shernaz Patel

Covid-19: A catalyst for Consolidation of Indian Diagnostic Industry

The pandemic has however bought the diagnostic industry into the limelight and is a catalyst for change and consolidation.

– Covid-19 will become a new normal test in times to come; consumers will view diagnostics chains as Covid-19 capable labs & Non-COVID-19 labs
– Faster consolidation in the industry ?and? positive changes in the regulatory framework are expected
– The Indian consumer is now inclined to be more quality conscious with respect to their healthcare needs
– Unorganised standalone labs may be challenges in terms of operations due to stringent quality norms and lack of customer faith in their operations
– While legislation is the need of the hour, healthcare institutions that will operate ethically with transparency and put the patient first will stand the test of time and gain the trust of all stakeholders. (IANS)

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