Though the Kerala High Court had, in a judgment passed in 2009, highlighted the need for starting a regulatory body to maintain adequate control over the functioning of private laboratories in the state, nothing has been done in this regard so far.
The High Court order by Justice J B Koshy and V Giri on Writ Petition No 5383, dated January 16, 2009, clearly stated that the regulatory body should be formed within six months.
The state government had framed the Kerala Clinical Establishments (Registration, Accreditation and Regulation) Bill 2009 following the judgment. But even four years later, over 10,000 private laboratories in the state remain unregulated.
The gravity of the situation is evident from the fact that nearly 90 per cent of the treatments in the state are being done based on the diagnosis given by the private laboratories.
Kerala Health Secretary K Ellangovan admitted that to the best of his knowledge, there is no regulatory body for private laboratories in the state.
The bill was prepared to prescribe basic standards of facilities and services provided by the clinical establishments, and it envisages to monitor and control the entire spectrum of healthcare service providers, both in public and private sectors of the state.
It was mooted with the intention of bringing hospitals, nursing homes, dispensaries, clinics, sanatoriums and laboratories conducting pathological, bacteriological, genetic, radiological, chemical and biological investigations, under its purview.
Secretary of the Thrissur-based Kerala Private Medical Technicians’ Association Balachandran said that while a law is vital to regulate the sector, the interests of the private laboratories should also be protected.
“Presently, anyone can start a private laboratory by procuring a licence from the local bodies. There should be a grading system for the laboratories operating in the state,” he pointed out.
Under the bill, the government had provisions to set up a state council with the power to fix the criteria for setting up clinical establishments, to grant and withdraw recognition and to fix the fees for registration and renewal of such establishments.
Though this is an urgent requirement, at present there is no accredited agency for granting permission to open laboratories in Kerala.
There is also no agency functioning under the government to inspect the qualification of the technicians and quality of equipments either.