Representational image (Source: Reuters)
With the reliability of tests done by certain laboratories is increasingly coming under scanner both India and abroad, the National Accreditation Board for Testing and Calibration Laboratories (NABL), the agency that gives accreditation to the diagnostic labs that conduct these tests said it is not responsible for the regulation of these labs.
“NABL is a voluntary accreditation body and has no regulatory powers,” said N Venkateswaran, CEO of NABL.
“Checking of compliance to the regulatory requirements falls under the purview of the respective applicable regulator,” Venkateswaran added.
“In all cases, it is the responsibility of the laboratory to abide by the National and State statutory requirements, Acts, Ordinance, Rules, Regulations, Legal orders, Court decisions/orders issued by the government statutory bodies, courts as applicable and in force from time to time,” he said.
NABL has been drawing flak, especially for issuing accreditation for labs that are not complying with regulatory practices.
“While the labs have mushroomed, the regulation didn’t catch up,” said an executive of a lab chain who didn’t want to be named.
“So the big lab chains often go for international accreditations like CAPÂ (the College of American Pathologists) and CLIA, not every lab will be able to get these accreditations,” the executive added.
The legal framework for the regulation of diagnostic labs is set up under the Clinical Establishments Act, 2010. Only 11 states have implemented the Clinical Establishments Act. Most labs come under the purview of Shops and Establishments Act (relating to hours of work, cleanliness, holidays, etc.) and the provisions of the Biomedical Waste Management Rules, 2016. Beyond these labs operate under self-imposed norms. There is no specific regulator to inspect and check whether a lab is compliant with good laboratory practices or not.
With most countries, airlines, and even some state governments making RT-PCR test reports conditional for accepting people – there were reports about people carrying fake negative RT-PCR test reports. There were also reports questioning the quality and reliability of the testing at certain laboratories that have NABL accreditation.
To be sure, NABL has stepped in to stop such practices. It has directed the labs to provide QR codes on all test reports and issue calibration certificates which can be scanned using any QR scanning application available on mobile or any devices to authenticate and reproduce the test report online.
This will prevent the manipulation of test results and the circulation of forged test reports in the market.
As of September, NABL has accredited 1,567 labs operated by government and private in India, of which 1,499 were listed by the India Council of Medical Research (ICMR).
