Setting the Minimum Standards: A Deep Dive into the Clinical Establishments (Registration And Regulation) Act, 2010
This article delves into the regulatory framework of the Clinical Establishments Act, 2010
This article is all about understanding the regulatory framework established by the Clinical Establishments Act, 2010, which aims to ensure quality healthcare services by setting minimum standards for clinical establishments across India. Through this deep dive, readers will gain insights into the Act's provisions, its implications for healthcare facilities, and the broader impact on the delivery of healthcare services to the public.
Introduction
India’s healthcare system has grown tremendously over the last three decades due to the advancement of scientific technology, policies, and measures. Despite this, millions of Indians every year die due to the low quality of healthcare services while seeking medical treatment, which underscores the need for urgent revamping of the existing healthcare legal framework and system for regulating clinical establishments.
The relaxations of government rules, policies, or regulations in the healthcare sector are likely to have mushroomed in clinical establishments in the absence of a stringent, unregulated environment, which often lacks the minimum standard of healthcare services that are essential to cater to the needs of patients. Ethical and medico-legal issues like human resources, manner of functioning, lack of an exact number of hospitals or clinics, lack of quality of care, overcharging, standard of care, unnecessary surgeries, or use of excessive technology persist and hinder the delivery of quality healthcare services.
That is why government intervention is required not only in private-run establishments but also in government-run establishments, as it is patients who bear the brunt of these issues.
To achieve a sustainable, healthier future for all, it is essential to refine the legal framework to keep pace with the advancement of science and technology by giving priority to the lives of its citizens, as it is recognised as one of the fundamental rights under Article 21 of the Constitution of India through the application of a holistic approach. No doubt, to deliver the minimum standard of quality healthcare services and facilities by clinical establishments throughout India, the Government of India enacted the Clinical Establishments (Registration and Regulation) Act, 2010. After that, the Central Government passed the Clinical Establishment (Central Government) Rules 2012 by Section 52 of the Act.
Since health is a subject matter of the state, under Article 252(1) of the Constitution, States such as Arunachal Pradesh, Himachal Pradesh, Jharkhand, Mizoram, Rajasthan, Sikkim, Uttar Pradesh, and all Union Territories made it applicable. Notably, the States of Goa, Gujarat, Kerala, Punjab, Tamil Nadu, and Tripura have their legislation. The present article critically examines the Act in detail.
Understanding the Act: Essential Provisions
Section 2(c) defines “clinical establishment” to mean a hospital, maternity home, nursing home, dispensary clinic, sanatorium, or an institution where facilities on diagnosis, treatment, care, or services are offered for illness, injury, deformity, abnormality, or pregnancy in any approved medicine system by any person or body of persons.
The definition also includes any facility that establishes itself as an independent entity or part of a larger establishment to diagnose or treat diseases through bacteriological, biological, chemical, genetic, pathological, or radiological investigations. It also covers establishments that are under the control of the government, trusts, either private or public, registered corporations under central, state, or local acts, local authorities, or single doctors. However, it does not include clinical establishments managed, owned, or controlled by the Armed Forces.
Notably, eleven states decided not to apply the act to government-run establishments, while states such as Goa, Gujarat, Kerala, Punjab, and Tamil Nadu regulate clinical establishments owned, managed, or controlled by the government as well. The Act explicitly provides institutional arrangements to regulate it. Sections 3 to 13 of the Act mention the authorities who are concerned with regulating, monitoring, and controlling matters related to clinical establishments. Section 3 constitutes the National Council for Clinical Establishment.
Section 5 of the Act enunciates the primary functions of the council: to compile and publish a national register of clinical establishments. The national council will also classify the clinical establishments into different categories by rules prescribed from time to time to accomplish the purpose of the Act. Apart from this, the council will have to explicate the minimum standards for ensuring suitable services offered by clinical establishments. Similarly, the States enforcing this Act will constitute the State Council of Clinical Establishment under Section 8 of the Act, which controls, monitors, or regulates the clinical establishment within their territories.
Section 10 further empowers the state governments to set up the District Registering Authority for each district in the respective states for the registration of clinical establishments.
Moreover, as per Section 11, the clinical establishments, to carry out the activities further, must get themselves registered with the concerned authority following procedures notified by appropriate authorities. Accordingly, registration has become mandatory for all clinical establishments. The concerned authorities can also refuse the registration if the applicant fails to comply with the procedure.
The registration is now subject to the conditions enumerated under Section 12 of the Act. The Rules of 2012 (amended in 2020) attach a schedule, outlining the minimum standards of facilities and services that must be provided under the given conditions. The section expressly provides that they must undertake the necessary medical examination and treatment using the staff and facilities available to stabilise the emergency medical condition of any patient who arrives at or is brought to the clinical establishment. Rule 9 explicitly lays down the other conditions for registration and continuing clinical establishment.
As per the condition enumerated in the rule, the clinical establishments must display the rate of charges for different types of services provided in both the local and English languages. This condition discourages the practice of overcharging.
The charges for the different types of services offered or provided by the clinic must be in line with the charges set out by the Central Government. Also, the clinical establishment has to ensure compliance with the Standard Treatment Guidelines of the appropriate government. The rule also expressly provides for the mandatory maintenance of electronic health/medical records. The clinical establishment will also maintain statistics.
Sections 14 to 32 of the Act deal with the procedure for registration. The Act provides two kinds of registration: (i) Provisional Registration as given under Sections 14 to 23; and (ii) Permanent Registration as given under Sections 24 to 32.
To obtain a provisional certificate for clinical establishment, an applicant whose clinical establishment was in existence at the time of the commencement of the Act is required to apply to Section 10 of the Act within one year. And for those clinical establishments that come into existence after the commencement of this Act, must apply for permanent registration within six months from the date of establishment. In the context of a provisional certificate, the authority is not under a mandatory legal obligation to conduct any kind of inquiry relating to it as provided under Section 16.
The concerned authority will have to then grant a provisional certificate as per Section 15. Additionally, the provisional certificate of registration is valid for 12 months but is subject to Section 23. Similarly, there are provisions for permanent registration. To get a certificate of permanent registration, an applicant first complies with all the requirements that are prescribed under the rules, and the certificate can only be granted if the establishments fulfil the standards enumerated under the guidelines under Section 28 and submit proof of compliance for the same under Section 25.
Upon the submission of the application, the relevant authority will publicly display all evidence for 30 days, during which any person can raise objections. After the expiration of the said period, the concerned authority will pass an order that either allows or disallows an application.
The authority grants a certificate that is valid for 5 years, and the clinical establishment is duty-bound to renew it. Provisions also require the concerned authority to conduct an inspection or inquiry in respect of its clinical establishment, maintain a register of clinical establishments, and undertake to supply such information in digital format to the State Council Clinical Establishments.
After that, the state Governments are required to maintain the same in the State Register and forward the same to the Central Government. Similarly, the Central Government is also required to maintain the same. Failure to register the clinical establishment, disobedience of direction, obstruction, and refusal of any information shall invite monetary penalties. Moreover, the Act prescribes the provisions of an appeal for grievances.
Implications of the Act
Having highlighted the aim of the Act and the essential provisions with which it seeks to achieve them, this section highlights the implication of the said Act. The most thorough method of assessing the implication of the Act would be an analysis of the report of the Vidhi Centre for Legal Policy titled “Holding Healthcare Providers Accountable: Regulation of Healthcare Facilities.”
The varied composition of district registering authorities across several states is the main lacuna of the Act, which points to a general trend of lack of will in regulating clinical establishments. Another lacuna of the Act is that it fails to ensure that the government properly maintains the records of clinical establishments. As per this report, despite the separate provision for provisional and permanent registration of certificates, the national register fails to distinguish between the data for provisional and permanent registrations.
Although the Act places an obligation on appropriate governments and authorities to maintain the record in the register as well as electronic records, the information collected doesn’t indicate the categories of clinical establishments, such as private or government and provisional or permanent. In the context of permanent registration, the act has several problems.
First, the registration process often lacks the administrative capacity to carry out the task in a speedier manner. Second, by placing an obligation on the central government to frame the minimum standards for various categories of clinical establishments, the registration procedure is vulnerable to delay by the central government. Third, and probably most significantly, all district-registered authorities allowed the applications without any kind of objection from the general public.
A crucial weakness of the implementation of the Act is that the district authorities conduct inspections and inquiries into the clinical establishment except in Srinagar districts and Aizawl (one of the districts of Mizoram). In addition to this, the report also found that most of the district registering authorities do not take action against non-compliance since its enforcement is in their respective jurisdictions.
A likely reason for this seeming reluctance on the part of the district registering authorities not to take action against the violators is that they do not conduct the inspection periodically. The authority’s inability to inspect the clinical establishments is further undermined by either a lack of clear guidelines or insufficient administrative support.
Another major implication of the Act is that States are not bound by its provisions, as earlier stated. The States, therefore, either regulate it by passing appropriate state laws or come under the pressure of various stakeholders not to regulate it. The central government’s role is, therefore, limited to the extent to which States adopt and enforce the said Act.
Given the findings of the reports, it is impossible to evaluate the implications of the Act on a larger scale due to the absence of accurate data. The failure of the Act can also be attributed to several weaknesses in the appeal mechanism, as it is underdeveloped because the rules have not been notified yet. The failure was also exacerbated by the absence of a patient-centric approach.
Strengthening the Act for Better Healthcare Services
Reforming the Act needs to be based on acknowledging the fact that the Act is ineffective due to the absence of a uniform law to regulate clinical establishments. The solution to this problem would be a multi-pronged approach. The immediate task is the political will and commitment on the part of the government to take concrete steps. The Central Government needs to hold negotiations with various states regarding the uniform applicability of the Act where the States have not enacted or adopted any law. It must also notify the states of the minimum standards so that the States can also proceed with the implementation of the same.
The States where this Act is applicable must either form the governing authorities or expand the existing governing authorities with multi-stakeholders to combat the issues of bureaucratic structure, which often lacks expertise in those matters. Also, the States where they have their legislation must regulate it by framing the guidelines after taking into consideration all the key stakeholders involved therein.
The authorities also have to make sure that all clinical establishments display the patient’s rights charter. The majority of health care services are still delivered by small or individual-run clinical establishments; however, the Act seems to ignore these clinical establishments and give undue importance to the other establishments. Notably, the central government should either omit or amend the provisions that are redundant to the current pace of development.