Clinical Establishment Act: A Game changer for Indian Healthcare?

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Despite several attempts by the government, the clinical establishment act has still not been implemented in the true sense. What does it mean for healthcare sector?


The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities and services provided by them.

The Act is applicable to all kinds of clinical establishments from public and private sectors, of all recognized systems of medicine including single-doctor clinics. The only exception is establishments run by the Armed forces which will not be regulated under this Act.

So, can the act make its mark in the healthcare sector?

“CEA  if adopted completely would be an exquisite step in the history of independent India. Since decades, unorganised health sector has created major hurdles in the availability, accessibility and affordability of healthcare to common people. This act would prove handy, as this would ensure minimum standards to all the establishments providing healthcare services. As of now, 11 states and all UTs have enacted this CEA, but it's a matter of concern whether they implement this act completely or partially.  Indian Healthcare system has high expectations since it caters services  to a diverse population. Hence it is utmost necessary to bring some sort of uniformity amongst them. In addition to that, this act would also focus on the element of ‘affordability', which in turn reduces financial hardships and OOPs. Furthermore, the amendment of 2019 had given more clarity via ruling out the previous misconceptions which prevailed amongst the laboratory personnel,” says Deepak Rajan, District Epidemiologist, Integrated disease surveillance programme,District Medical Office Health, Kannur, Kerala.  

What are the Objectives of the Act?

To establish digital registry of Clinical Establishments at National, State and District level.

ii)  To prevent quackery by unqualified practitioners by introducing registration system, which is mandatory.

iii)  To improve quality of healthcare through standardization of healthcare facilities by prescribing minimum standards of facilities and services for all categories of health care establishments (except teaching hospitals), and ensuring compliance of other conditions of registration like compliance to standard treatment guidelines, stabilization of emergency medical condition, display of range of rates to be charged, maintenance of records etc.

And many point out that the act will be a dramatic leap for the Indian healthcare sector.

“As far as clinical establishment act is concerned, the major shortcoming is the approach of one size fits all wherein the heterogeneity of private sector healthcare is not adequately taken into consideration. In a country where the private sector include the independent physician, along with doctor-couple-run family clinics and small nursing homes, like in any other sector becomes difficult to implement. This heterogeneity across clinical establishments and across states is a concern and takes time to customize for each states. In the process of 'customizing', the act also gets diluted significantly.

“Another problem is the diverse rules that prevail across states, for instance in Maharashtra, it is acceptable that several of the hospitals are run by resident medical officers (RMO) who are BAMS or BHMS which is not acceptable with the act in terms of the guidelines on HR in healthcare. So is the case with the nursing staff. Regulation in healthcare is a much larger issue for which the contribution of clinical establishment is only little. Moreover, the act fail to address the processes in healthcare settings as it pertains to physical infrastructure and registration of establishments.

An act at the national level need to be accordingly tweaked to make it relevant for each state as the diversity in general and healthcare practices is phenomenally different,” says an Associate Professor at a premier educational institute, who doesn’t want to be named.

Better delayed than failed is also one thing. Frequently delayed is another. But many still believe in the potential of the act. “This Act and its objectives look very promising. The mandatory registration of all types of healthcare provisions will reduce quackery. There will be standardization of infrastructure, man power and working systems. But there are few loopholes in the Act. There are few provisions which are  actually  impossible to implement; not practical and feasible at all. For instance the Act  put forth a responsibility on every clinical establishment to provide emergency service to a person. While this is an assurance to the citizen that emergency medical service will not be denied. But is it really possible? Imagine a woman heavily in labour reaches a dental clinic. Will a single doctor be able to manage her, transfer her to appropriate place? Who will foot the cost for the same? Thus the doctor , with the fear of prosecution, may only do the necessary paperwork but not effectively treat the patient causing more harm than benefit. It is great that the Act cares about the rights of the patients. But correspondingly it should have also talked about patient’s responsibilities such as non-violence in the hospitals. The Act may be good and bad for the healthcare scenario. On one hand, it will make it easy for data collection and regulation; on the other hand, such impractical provisions and natural failure to adhere to them will bring in  increased corruption and Inspector Raj. The Act will add one more avenue for prosecution against doctors and hospitals to the already overburdened system,” says Nikhil Datar, Medical Director of Cloud Nine Hospitals, Mumbai.

New Amendments of the Act

Clearly implementing this act is not so easy. Feroz Ikbal,  Assistant Professor, Centre for Hospital  Management,  School of Health Systems Studies,  Tata institute of Social Sciences, points out that since health is largely a state subject, the state legislative assembly needs to bring in regulation. “Like MRP for consumer products, if the act is able to bring in maximum service price [MSP], it can bring in some kind of transparency in pricing. Regulation on the other hand should not bring in licence permit raj,  which can affect the existence of small and medium sized nursing home and hospitals. A disclosure regarding outcome of procedures can be helpful. Health service providers, both in private and public, are highly heterogeneous. Private sector ranges from unqualified quacks to superspeciality hospitals. Public sector ranges from sub-centres to AIIMS and other institutions of national importance. So a single regulation across the country will be of very little use. Hence, the states need to look into the region-specific requirements and incorporate it into clinical establishment act. The amendments of 2019 pertains more to laboratory services.  But this is of very little significance to common man. But can have an impact on the functioning of laboratories,” he concludes.