With fewer than 2,200 of India’s nearly 3 lakh laboratories accredited, millions depend on diagnostic reports of uncertain accuracy, raising serious concerns about safety, trust, and regulatory oversight.
In India’s fast-growing healthcare ecosystem, diagnostic laboratories play a central role in nearly every medical decision. From routine blood sugar tests to critical cancer diagnoses, doctors rely on data generated behind the scenes – figures that patients seldom question.
However, beneath this reliance lies a deep structural concern. Of the nearly 3 lakh diagnostic laboratories across the country, only around 2,165 are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), widely regarded as the benchmark for quality assurance.
In other words, fewer than 1 percent of laboratories in the country are accredited. The remainder operate within a vast, fragmented, and largely unregulated system, where oversight is limited and quality can vary significantly.
For patients, this leads to a simple reality: the test report they receive may not always be reliable – and there is often no straightforward way to verify its accuracy.
Data Without Verification
“You are given a set of test numbers, but there is no way to verify how those results were generated,” says Harsh Mahajan, a prominent voice in the diagnostics sector.
His observation highlights a core concern: unlike imaging tests, where scans can be reviewed, laboratory tests yield abstract figures that offer little visibility into the processes behind them.
Dr Mahajan, mentor at FICCI Health and founder and chairperson of Mahajan Diagnostics, describes the situation as “shocking,” noting that despite the National Accreditation Board for Testing and Calibration Laboratories (NABL) being in place for nearly three decades, accreditation is still voluntary.
“Only a small fraction of labs are accredited… because there is no mandatory requirement,” he explains.
The consequences are significant. In the absence of enforced standards, laboratories can vary widely in terms of equipment quality, calibration practices, and even the expertise of their staff. In some cases, experts say, outcomes may depend largely on individual ethics.
“Ethics in medicine is highly individual, and may not always be strong among all service providers,” admitted the chairman of a Chennai-based lab chain who requested anonymity.
The concern is compounded by a gap between infrastructure and available expertise. India is estimated to have between 5,500 and 12,000 pathologists and 10,000 to 20,000 radiologists – far fewer than the total number of labs operating across the country.
As a result, the system remains overstretched, with many facilities functioning without adequate specialist supervision.