Diagnostic laboratories which have been operating unbraided across the country will be soon come under the legal ambit.
With States showing dismal response to implement the Clinical Establishment Bill 2011, which has path labs under its purview, the Government is working on ways to frame a separate set of rules for their regulation.
As per an estimate, there are at least 100,000 diagnostic laboratories in the country, majority of which are in unorganized sector.
The long-awaited move aims to tighten the noose around the path labs which are facing various complaints ranging from fleecing the patients, incorrect reports and to unethical practices where even doctors were also found to be involved.
“The issue of regulation of path labs was taken up at the Drugs Consultative Committee of the Drug Controller General of India early this month. Stakeholders in the sector are being consultated to chalk out ways to prevent them from misusing their services,” a senior official from the Ministry said. With increasing non-communicable diseases due to sedentary lifestyle as well as patients becoming more health conscious, the official said, it has been noted that diagnostic industry is becoming a quick way to earn money for path centres owners.
There is check as most of the States have failed to adopt the Clinical Establishment Act. The legislation makes it mandatory for all the diagnostic laboratories to be registered with the authorities.
The Act which was passed by Parliament in way back in 2011 has in detail safety standards and parameters that the path labs have to follow before they start functioning.
Currently, a large number of the path labs are being run by technicians with Diploma in Medical laboratory Technology (DMlT) or equivalent qualifications. These technicians collect samples, conduct tests and certify reports. As per the norms laid by Medical Council of India, a registered medical practitioner having a post-graduate degree in pathology can only certify test reports.There are no checks to ensure these labs are maintaining standards, procedures and quality.
In fact, in 2014, the Medical Council of India (MCI) had issued an advisory to all medical councils, asking them to monitor diagnostic centres and take immediate action whenever there is a complaint for unethical practices such as accepting commissions or referrals for diagnostic tests.
The council had written to the Delhi government too to enforce necessary legal provisions for registration of private diagnostic centres in the capital and put in place mechanisms to monitor and prosecute any unethical practices among doctors in prescribing diagnostic tests.The MCI’s move came in the wake of Union Health Minister Harsh Vardhan ordering an inquiry into the issue following a sting by a television channel exposing around nine leading diagnostic chains in an alleged nexus with doctors for prescribing tests.
However, the MCI was told that since the Delhi Government had not implemented the Clinical Establishment Act, the diagnostic centres were not registered with the Health Department.
Of these, 70 per cent offer pathology services and the rest provide radiology and imaging such as MRI, CT scan X-ray and ultrasound.