local MP RK Jena, while raising issues related to health in the Parliament recently, drew attention of the authorities to the need for regulation of diagnostic laboratories in the country.
The mushrooming of unregulated laboratories has been adversely impacting patients and threatening consumer confidence in medical test results, he told.
lack of regulations and low entry barriers led to proliferation of a large number of laboratories offering various degrees of quality and reliability with no specific minimum standard that patients could expect, he had observed.
Jena had said that the diagnostic and research industry in India is passing through one its best phases and the growth of the sector in a compounding rate is about 17 per cent this year, while the revenue could touch `300 billion.
“While this is a positive aspect of the sector, on the other hand, the grey area is that only one per cent out of roughly 50,000 labs are having accreditation from the National Accreditation Board vis-à-vis 85-90 per cent in the other emerging countries like Brazil. The relevant guidelines of international standards have been put forward by accreditation bodies but it is a very small fragment of the diagnostic industry that is implementing these standards.
In the want regulation mechanism, the patients suffer a lot as they get different conflicting diagnostic reports from different labs after tests for same disease. These different test reports not only create confusion in the mind of the physicians but panic among the patients. Hence, there is an urgent need for legislation and regulation to maintain a basic minimum level of quality in labs in India.” Jena had said.
“It should be mandatory to comply with these norms to maintain quality and prevent malpractices. Once these laboratories are set up, there is a need to institutionalise regular inspections, audits or checks to ensure the maintenance of standards, procedures and quality,” Jena had maintained.