Kerala: The state committee members of the Kerala Medical Laboratory Owners Association have opposed the implementation draft regulation under the Kerala Clinical Establishments (Registration and Regulation) Act, stating that it will lead to the shutdown of a great number of small-scale private medical laboratories.
According to a recent media report, the Act was passed in 2018 and the process of registration of laboratories started in 2019. The sub-committee of specialists to the Kerala Clinical Establishment Council submitted their reports on the draft regulation which would give guidelines to the laboratories. The draft was published for public feedback on October 14.
As per the Act, major changes in the operation of the clinical labs and medical diagnostics across the state would be introduced. Objecting the same, the association pointed out that a great number of laboratories may fail to gain registration and many lab technicians will lose their job if the regulations are implemented.
However, the association clarified that they are not opposing the idea of ensuring proper standards of the laboratories but the regulation should not be imposed without having a proper discussion with them. According to the association, the registration process of existing labs has already been completed, and limiting their authority is illegal. The new regulations must not be made mandatory as it will bar thousands of small labs from conducting tests.
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On the other hand, the officials have clarified that only the process of granting provisional registration of all clinical establishments has started and the new regulations are implemented in order to ensure proper quality of services of the labs. The registrations are granted to the lab owners after verification of documents and it will give the labs a validity of 2 years, confirmed Dr. Sanil Kumar, the secretary of Kerala State Council of Clinical Establishment.
As far as the question of the necessary pathologist is concerned, he further added that " the guidelines for appointing qualified persons was intended to avoid any sort of dilution in tests. Qualified pathologists are required in providing authentic reports and it will only be going to benefit the public in the long run. The draft regulations are currently published for month-long public feedback. We will publish the final notification only after considering the feedback from all stakeholders."
Commenting on the same, C Balachandran, President, State Committee of Medical Laboratory Owners Association (MLOA) told The New Indian Express, "Once the regulations are implemented, small-scale labs in villages and towns will cease to exist. The three categories of laboratories will also lose their right to conduct several tests in the wake of certain regulations like space requirements and qualified physicians. As per the new draft prepared by the subcommittee, medical labs of level 2 and level 3 should appoint a 'Doctor of Medicine (MD) in Pathology' who will have to be paid around Rs 1 lakh in salary per month. Eventually, basic medical tests will become costly."
Hamsa Miladi, another member of the State Committee also raised questions on the fixation of the lab's space requirement. Calling the expansion impractical, he further stated "If the government is moving ahead without considering the concerns of the owners, almost 95 percent of the labs in the level-1 category will be forced to shut down. As per the draft, the minimum space requirement for the smallest lab is 500 square feet."