Introduction:
Article 47 of the Indian Constitution states that: “The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavor to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.” This article, as part of the Directive Principles of State Policy, provides the crucial backbone behind the proposal of the Clinical Establishments (Registration and Regulation) Act, 2010. The Act aims to collectively ensure the proper registration of all medical establishments across the country and standardize the medical practices across the same by setting up the minimum requirements to be fulfilled by these establishments. It was implemented with a view to not only address the disparities between the medical assistance provided in private and public sector facilities but also across urban and rural spaces.
As part of the 11th Five Year Plan for the year 2007-2012, the Ministry of Health and Family Welfare and the Planning Commission released a report titled ‘Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure’, which dealt with the importance of Central legislation regulating clinical establishments as well as uniformly maintained registrations for the same. It also emphasized the importance of a uniform set of rules and regulations to be implemented for these establishments, not only in regards to their infrastructure but also regarding the quality of service delivery to ensure a minimum standard being maintained across the nation. Hence, in essence, the report outlined the requirements that eventually led to the formulation of the 2010 Act. In 2013, the State of Maharashtra planned a multi-stakeholder committee to formulate the Maharashtra Clinical Establishment Act as an important step towards the standardization of quality and costs in the private medical sector. Further, the Kerala Clinical Establishments (Registration, Accreditation, and Regulation) Bill, 2009 is awaiting a go-ahead from the Government to be enforced. There has also been an active attempt by doctors in Uttarakhand to get the provisions of CEA, 2010 implemented in the state
Overview of the Act
The Clinical Establishments (Registration and Regulation) Act, 2010 was formally introduced on 18th August 2010 and was hence, put into effect in the states of Arunachal Pradesh, Himachal Pradesh, Sikkim, and Mizoram, and maybe further implemented in any states which shall adopt the Act under the clause (1) of Article 252 of the Constitution. Section 2 of the Act defines the phrase ‘clinical establishment’ as a hospital, maternity home, clinic, or other such medical institution run by either a public or a private sector undertaking. The exception mentioned under the section is that such an institution must not be run by any of the ‘Armed Forces. The registering authority facilitates policy formulation, resource allocation and determines standards of treatment. The Act lays down Standard Treatment Guidelines for common disease conditions, for which a core committee of experts has been formed.
While Section 3 of the Act prescribes for the establishment of a National Council for clinical establishments, Section 4 goes on to prescribe the conditions upon which one would be disqualified from consideration for being a part of the Council. This section seems to place a large amount of discretion upon the Central Government, especially while deciding what offenses can be considered involving ‘moral turpitude’ as mentioned in subsection (a). Since, the power to determine the constitution of this Council vests major decision-making power onto the Central Government, this section is not in concurrence with the fact that health remains a subject under the State List currently. Further, Section 5 goes on to outline the basic functions to be undertaken by the National Council, such as classifying the various clinical establishments, formulating a minimum standard to be prescribed, and maintaining a register of all the authentically registered establishments in concurrence with the State Council. Under Section 6, the Act formulates the constitution and functions of the State Council of clinical establishments.
According to Section 11, no clinical establishments can run the country without due registration to the relevant authorities and go on to prescribe the conditions that must be fulfilled for the availing of such authentication. The conditions as mentioned in the Act are as follows:
- “the minimum standards of facilities and services as may be prescribed;
- the minimum requirement of personnel as may be prescribed;
- provisions for maintenance of records and reporting as may be prescribed;
- such other conditions as may be prescribed.”[1]
The Act also avails the option of a provisional certificate in the absence of a permanent one, if required, which can be duly renewed. It is curious to note, however, that while the time prescribed for seeking such a certificate differs in accordance with the date at which the specific clinical establishment came into existence, the period prescribed for those that were established after the Act came into existence is only 6 months. This may cause hindrance in compliance as this time period may be considered too short, especially when compared to the two-year time period given to the establishments that came into existence before or during the implementation of the Act. Further, under Section 25, the Act mentions the requirement of the submission of evidence of compliance but fails to mention any parameters with which the same can be undertaken. Hence, the section seems ambiguous and leaves scope for interpretation regarding its execution. The Act also mandates it for all clinical establishments to accept patients with medical emergencies and women in labor, and provide them with the requisite treatment to stabilize them.
Under Sections 37-39, the Act prescribes the various ways in which the record of authentically registered clinical establishments must be maintained by the National and State Councils. Further, the Act goes on to describe the penalties imposed upon breach of the terms mentioned in the act. Section 41(1) prescribes the upper limit for such penalties to be five lakh rupees but fails to mention the various degrees of breach or contraventions, and the penalties for the same, while clause (2), describing penalties for those knowingly serving in an unregistered clinic, fails to mention the criterion by which to determine such ‘knowledge’ or lack thereof. Further, clause (5) asserts that the monetary penalties will be determined by considering the factors such as category, size, and type of the clinical establishment, and thus vests a large amount of power in the hands of the authorities to determine the penalties to be imposed upon them. Hence, the various conditions regarding monetary penalties require more uniformity in their implementation to ensure ethical execution. A similar issue arises yet again when considering Section44(1) and Section 45(1) regarding the vagueness of the term ‘due diligence’, and these ambiguities may have adverse results as these sections deal with the contravention by Companies and Government Departments and the penalties for the same.
In September 2014, the Government of India, the Ministry of Health and Family Welfare2 issued the Application format for Permanent Registration of Clinical Establishments which requires the applicant to provide information such as, among others, establishment details, types of service, a system of medicine, etc. The Ministry of Health and Family Welfare further introduced a report titled ‘Clinical Management Protocol: COVID-19’ [2]to address the discrepancies that arose in the execution of medical practices across the nation in the wake of the pandemic. The report outlines the various factors relating to the biological makeup of the disease itself, elucidating upon the epidemiology of the disease itself, and then further, prescribes the method of treatment to be undertaken in the various degrees of cases and the medicinal usage in differential cases.
Conclusion
The Clinical Establishments Act aimed to bridge the gap between private and public healthcare services in India by providing for a standardized minimum to be followed by all medical establishments as well as regulating the quality of services availed through urban and rural spaces alike. While the initiative of bringing about the Act was a milestone in the right direction, the implementation fell short of the requirements. This was majorly due to the reason that Health remains a State subject and despite Central Legislations, there can be no proactive measures undertaken in the absence of the states ratifying the same. Although some states did ratify the Act way back in the year 2010 and many others did so subsequently, it remains to be seen whether the Act was implemented in its entirety or partially. While the Act does make the necessary steps of standardizing and regulating the medical establishments across the country, there need to be state legislation introduced in accordance with the CEA, 2010, to ensure that the regional variations and requirements are adequately answered. The discrepancies between private and public sector facilities are also too vast for a single person to adequately encompass these variations. This approach of one-size-fits-all is the major setback for the execution of this act and steps must be taken to bridge the gap between the various regions of the country as well as the socio-economic differences across the medical practice itself.
References:
[1]Ministry of Health and Family Welfare, THE CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010, https://www.indiacode.nic.in/bitstream/123456789/7798/1/201023_clinical_establishments_%28registration_and_regulation%29_act%2C_2010.pdf
[2]Ministry of Health and Family Welfare, Clinical Management Protocol: COVID-19’ <http://clinicalestablishments.gov.in/WriteReadData/2801.pdf
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