Why Was The Clinic Establishment Act Not A Success?

by Pratibha Sahani Lawyer

Clinical Establishment (Registration and Regulations) Act, 2010 applies to several provinces that need to get tabled in the Maharashtra state legislature amid protests by the medical organization.

The law, which the Indian Medical Association says will lead to harassment of doctors, was born out of a long-term patient rights organization that opposes poor infrastructure and unqualified staff at small clinics, hospitals, and diagnostic laboratories.

The Department of Health and Family Welfare notified the National Council for Clinical Facilities and Regulations on the Establishment of Clinics (Central Government), 2012 under this Act by Gazette notices dated 19 March and 23 May 2012.

The Clinical establishment act applies to all kinds of clinic facilities from public and private companies and all recognized pharmaceutical programs, including single physician clinics. The only exceptions are military-operated institutions that may not be regulated under this Act.

Objects of the Act

The specific objectives are:

i) Establish digital registration of clinical establishments at National, regional and regional levels.

ii) Prevent quacks by untrained physicians by introducing a compulsory registration system.

iii) Improving the quality of health care by establishing clinical establishment facilities by setting minimum standards for facilities and services at all levels of health care facilities (excluding teaching hospitals) and ensuring compliance with other registration requirements such as compliance with standard treatment guidelines, stability, for emergency medical services, showing a list of charges to be charged, record keeping, etc.

Unresolved Issues In The Act

Although the regulatory framework is crucial in many ways, there are still unresolved issues in the Act. Some of them are listed here.

Section 12 (2)

According to this, "The clinic should take the initiative to provide in-house staff and facilities, treatment and testing that might be needed to improve the emergency medical care of anyone who comes to or referred to that clinic."

All clinic facilities need to stabilize the patient in an emergency before transferring to another hospital. Such interventions, the act says, will take place within the staff and available facilities. But one should not extend the idea to see that its interpretation may be different.

In this regard, the Supreme Court's first order intended to provide life-saving first aid to victims of accidents. It does not make sense at all - and it may not be perfect for doctors to extend this to any emergency. 

Lack of additional equipment to expand the work of managing private clinics

In this context, it is difficult to see how the proper implementation of the clinic establishment could be possible - not just for doctors but for patients. 

For example, the clinical establishment act 2010 called for establishing a National Council - which must have a special secretary: the director-general (DG) of health services, the Department of Health and Family Welfare as a member and former chairperson.

It means that crucial decisions can get delayed if the DG cannot squeeze in more time for this additional task. There should be no extra appointment at the state level to oversee the process. And at the regional level, the situation can be much worse.

In the districts, the chairperson and secretary of the registering body must be the district collector and the district health officer, respectively. It increases their workload for a long time, causing further delays in getting things done.

  • Those who wish to challenge the order of the district health authorities should speak to the national council.

Even if a small number of institutions from the government wish to complain, this would be equivalent to a large number.

Complaints are from registration authorities of different regions. But doctors should go to the country's capital for controversial issues, which can be avoided with simplified provision.

These are just a few of the many legal issues raised by the clinical establishment act 2010, which give physicians a solid basis for opposing it.

Such problems point to a need for dialogue between government and clinic establishment. The main issue here is providing adequate health care for several people. And the state must ensure that caregivers, no matter how large their institutions, can provide that in the best possible way, with the least challenges.


The Indian Parliament passed the Clinical Establishments Act on 17 August 2010 to provide for the registration and regulation of all clinics in the country to reduce the level of facilities and services provided by them so that the mandate of Article 47 of the Constitution for public health development is not achieved.

Approved in 2010 by the Central Government, the Act aims to provide for the registration and regulation of clinical facilities but has met with strong opposition from the IMA, particularly in Karnataka, where 40,000 doctors refused to report Out Patient activities in November to protest.

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About Pratibha Sahani Advanced   Lawyer

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Joined APSense since, March 3rd, 2022, From Mumbai, India.

Created on Mar 15th 2022 04:42. Viewed 257 times.


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