Clinical establishments Bill to ensure quality, accountability, transparency in the hitherto unregulated sector which caters for 70% people

It took the death of a poor migrant labourer, the emotion and outrage it created, to mobilise support for a Bill which has been in cold storage for so many years now.

The Kerala Clinical Establishments (Registration and Regulation) Bill, 2017, presented in the Assembly on Thursday is a major step towards bringing in quality, accountability and transparency in a health-care system where nearly 70% of the people depend on private health sector, one which has remained totally unregulated till now.

The Central Act was enacted in 2010 and while many States adopted it, Kerala chose to have its own Act. The first draft brought in 2013 was opposed tooth and nail by organisations like the Indian Medical Association and professional bodies in the private sector.

The 2017 Bill retains the core concepts of the 2013 draft, but the accent is on registering all clinical establishments, setting certain minimum standards of facilities and services that each should provide based on categorisation of health care institutions and transparency.

“The Central Act was very regulatory in nature, hospital-unfriendly and gave a lot of room for corruption. In drafting this Bill, we have gone out of our way to protect hospitals, especially the small ones. No rigid time frame has been fixed for registration. Clinical establishments with NABH accreditation will get permanent registration without inspection and will not be subjected to inspection as long as their accreditation is valid. Small hospitals that have secured entry-level accreditation also will not have to face inspection.

“Many have been opposing the Bill saying the government would step in to regulate the rates of treatment and procedure . The Bill only says that clinical establishments be transparent about the services provided, the rates for various procedures and to display it openly, so that people have the option of choosing between hospitals,” Additional Chief Secretary (Health) Rajeev Sadanandan said.

The Bill seeks to establish a State Council for Clinical Establishments, which will classify and categorise clinical establishments and fix minimum standards for each category. The council will publish a State Register of Clinical Establishments, notify data and information which are to be mandatorily provided by these institutions and publish it in the public domain.

Notably, the Bill talks about the treatment of victims in emergencies and that the council will notify the life-saving services to be provided by each category of institution.

“This Bill is the first step towards establishing transparency in the health system, putting in public domain, who is providing what service and at what rate. The accent is on quality and transparency at all levels, from providing data on notifiable diseases to information on the services and facilities in each institution, which at present the government does not know. It might “hurt” some in the private sector to reveal their rates because naturally, the public will demand standardisation of rates for various procedures,” a public health expert, said.

The government is only asking for accountability and transparency and this Bill is not about licence raj. Not just private, but public hospitals too are bound to provide minimum standards of care under the Bill. This is a positive legislation which will promote quality in health care and any organisation concerned about improving quality of care will not oppose it. The implementation of the Bill will still be a challenge but this was one legislation which has been long overdue,” the expert pointed out.



The Clinical Establishments (Amendment) Bill gains significance in the wake of reports most of the private labs were functioning without  proper accreditation/certification and run by untrained staff.The Bill proposes a state council with the Health Secretary as its chairperson for monitoring the whole system.

The bill titled ‘Kerala Clinical Establishments (Registration and Regulation), 2017’, was moved by Health Minister K.K Shailaja.

The committee will have the powers to classify the clinical establishments into different categories according to minimum standards. With respect to registration, the Bill proposes the constitution of an authority for each district with the District Collector as its chairperson.

The clinical establishments that have received accreditation from the National Accreditation Board for Hospitals or the National Accreditation Board for Laboratories should be granted permanent registration without inspection. A notable provision in the Bill is every clinical establishment should display the rates charged for each type of services provided and facilities available in Malayalam and English in a conspicuous place.

Replying to the discussion on the Clinical Establishments Registration and Regulation Bill, Health Minister K K Shylaja said, since 1970, the successive governments had forgotten the primary health sector. Once the Bill is enacted, it will help bring uniformity in health care system by prescribing minimum standards of facilities and services that may be provided by the clinical establishments, she said.

The bill stated that nearly 70 per cent of health services are being carried out in private hospitals, dispensaries and laboratories and that there was no law to effectively control its functioning.

It said government had decided to bring in a suitable law to regulate these institutions after holding discussions with experts in this field.

The bill also envisages steps to check the fee for tests and negligence in these institutions.