This article has been written by
, a student of Symbiosis Law School, NOIDA. This article elaborates on the need and objective of the act by explaining the significant provisions of the Act.
it has been published by Rachit Garg.
Healthcare is a necessary commodity. The need for “good quality” healthcare has risen as a result of rapidly shifting demographic patterns, an expanding population base, and rising incomes that make “good quality” healthcare more affordable. Many nations are looking at different ways to raise the standard of healthcare services. The quality of services offered to people in India by the public and private sectors remains an unresolved problem. The way the healthcare delivery system has been set up does not offer enough incentives for improvements in effectiveness. In India, there are currently no mechanisms in place to achieve higher hospital efficiency, accountability, and responsible governance. A significant amount of India’s health care is provided by the for-profit private sector (50% of inpatient treatment and 60-70% of outpatient care), although this sector has received less attention from policymakers than the public sector. As a result, the private healthcare delivery system in India has remained essentially unorganised and fragmented, and there is abundant evidence of subpar quality service.
The Government of India enacted the (hereinafter referred to as “the Act”), as per the commission, namely “Clinical Establishments, Professional Services Regulation, and Accreditation of Health Care Infrastructure” for the , to provide registration and regulation to all clinical establishments within the country with an aim to recommend the minimum standards of services and amenities provided by them to citizens of the country. The importance of this legislation comes from rising concern about the inadequacy of public healthcare facilities on the one hand and the absence of any rules controlling existing public and private facilities on the other. The complete breakdown of the public healthcare system, particularly in rural and isolated tribal regions, has exposed already disadvantaged groups to unregulated and unmonitored healthcare providers. Corporate health care has taken over health services in cities without implementing transparent accountability procedures. This Act was enacted as a response to a growing demand for increased monitoring in the wake of increasing malpractice and gross incompetence. Thus, it is a positive move in terms of its goals and justifications.
The national legislation was primarily developed out of a 1980s patient rights campaign. Health activists around the country have responded to rising charges of unethical activities within mainly private healthcare systems and the complete inability of self-regulation via medical councils to act against medical professionals. They maintained that medical treatment was primarily a consumer service and sought remedies under (CPA) against medical negligence and misconduct. (IMA) filed a lawsuit against this action. The campaign gained momentum in the year 1995, when the Supreme Court determined in the landmark case of (1995) that the CPA extended to the medical profession as well.
The medical profession’s view has always been that doctors must always put their patients’ wellness ahead of all other considerations, including their own. It contends that medical treatment is not a business transaction between consumer and provider and that considering it as such would contradict the doctor-patient relationship’s fiduciary character. The fiduciary aspect, although it is being questioned today as doctors have made their practice and medicine a massive healthcare business where their personal interests often clash with those of their patients, for instance, when medical students are ready to ‘invest’ Rs. 1 crore in a postgraduate seat, their drive to recover their investment will definitely conflict with their commitment to delivering the highest care possible to their patients. So, it can be stated that patients’ distrust in medical practitioners has reached catastrophic proportions, requiring the passage of legislation such as the Clinical Establishment Act. The objective of the government and individuals must be to fill the gaps in the legislation and ensure its correct execution.
The Act mandates registration of all clinical establishments, including diagnostic centres and single-doctor clinics, in the public and commercial sectors, except those managed by the defence services. The registering authority aids in developing policies, distributing resources, and establishing treatment standards. It has the jurisdiction to impose fines for violations of the act’s provisions.
The Act creates standard treatment guidelines for prevalent medical problems and establishes a core group of experts to monitor their implementation. Additionally, the Act mandates all clinical establishments to give the medical care and treatment necessary to stabilise any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly women who are in labour and individuals who are involved in accidents.
One of the primary aims of the Act is to ensure that certified and competent professionals administer healthcare facilities. The Act specifies that every clinical establishment must have a certified medical practitioner in charge who is responsible for supervising the quality of treatment provided by the institution. This criterion helps to guarantee that patients get high-quality medical care and that medical procedures are carried out safely and effectively.
In addition to this, the Act also lays out specific requirements for maintaining and functioning clinical institutions. These standards address aspects such as infection control, waste management, and patient safety. By implementing these principles, the Act helps to prevent the spread of infections and other diseases, safeguard the environment, and guarantee that patients receive safe and effective treatment.
Another significant purpose of the Clinical Establishments Act is to make healthcare services more accessible to the public, particularly in rural and remote locations. The Act supports the establishment of clinical establishments in certain regions and allows for the registration and control of these facilities. This helps guarantee that individuals living in these regions have access to critical healthcare services and that the quality of treatment is up to the needed standards. Furthermore, the Act also established a National Council for Clinical Establishments.
The adoption of the Clinical Establishments Act 2010 has been a slow process, with different states in India implementing the Act on different dates. As of 2021, 21 states and Union Territories in India have adopted the Act, while other states are in the process of doing so.
Vide the notification dated January 28, 2010, the Act went into force in four states of India, namely Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all Union Territories. Later, Uttar Pradesh, Rajasthan, and Jharkhand approved the Act under clause (1) of of the . In 2013, the State of Maharashtra formed a multi-stakeholder group to develop the as a key step towards the standardisation of quality and pricing in the private medical sector.
The Act defines “clinical establishment” under Section 2(c) of the Act and includes all hospitals, maternity homes, nursing homes, dispensaries, clinics, etc., as well as any other type of institution that provides services and facilities for the diagnosis, treatment, or care of illness, injury, etc., or a location established as an independent entity or as a component of an establishment in connection with the diagnosis or treatment of specific diseases. It also comprises a single doctor, a trust, a business registered under a state, national, or municipal law, or a clinical facility owned, controlled, and run by the government or a government department.
The Act’s Section 3 calls for the creation of a national council for clinical establishments. The grounds under which one would be ineligible for consideration for membership in the Council are further specified in Section 4. The Central Government appears to have a lot of discretion under this provision, especially when determining whether offences qualify as having “moral turpitude” as described in subsection (a). Since the Central Government has primary decision-making authority over this Council’s composition, this section does not agree with the idea that health is still a subject on the State List. Section 5 continues to list the fundamental duties that the National Council must carry out, including categorising the various clinical establishments, developing a minimum standard that must be prescribed, and keeping a register of all the legitimately registered establishments in coordination with the State Council. The State Council of Clinical Establishments is constituted by Section 6 of the Act, along with its composition and duties.
A clinical establishment is not allowed to function, per Section 11 of the Act, unless it has been duly registered in accordance with the Act’s rules. According to Section 12 of the Act, a clinical establishment must also comply with the following requirements in order to be registered and to remain in operation:
Based on the quality of treatment these facilities offer, minimum requirements for hospitals are developed. An application in the correct format and with the necessary fee must be made to the authority listed in Section 11 in order to receive a provisional certificate for a clinical facility as required by Section 11 of the Act. Additionally, it states that clinical establishments that already existed when the Act was enacted must submit an application for registration within a year of its implementation, and those established after that date must submit an application for permanent registration within six months of doing so. Additionally, clinical facilities that are already registered under a statute that calls for such registration must do so again in order to keep up with the Act. Each provisional registration will continue to be enforceable until the last day of the twelfth month, complying with the date of issue of the certificate of registration, and such registration shall be renewable. The authority shall issue to the applicant a certificate of provisional registration in such form and containing such particulars and information, within ten days of receipt of such an application.
The certificate must be clearly visible at the clinical establishment so that all visitors may see it. Applications for renewal must be filed within 30 days of the expiration date of the provisional certificate; if submitted beyond that period, the authority will accept renewal of registration only upon payment of the higher fees. In the case of clinical establishments that were established prior to the effective date of this Act, the period of two years from the date of notification of the standards shall apply; in the case of clinical establishments that were established after the effective date of this Act, the period of two years from the date of notification of the standards shall apply; the authority must receive applications for permanent registration of clinical establishments in the manner and with the fees specified within two years of the date of notification of the standards in the case of clinical establishments. Provisional registration regarding clinical establishments for which the Central Government has notified standards cannot be obtained or renewed.
This is how the clinical establishment must prove that it complies with the set minimum standards. Only when a clinical facility meets the registration requirements set out by the central government can permanent registration be granted. The additional requirements for clinical institutions are provided under the . The rates for each type of service and facility are prominently displayed and are available in both the native language and English. Electronic medical records or electronic health records should be maintained and made available to all patients, as decided and ordered by the central or state governments. The additional requirements for clinical establishments under the Clinical Establishments (Central Government) Rules, 2012, are provided below.
The Act creates a National Council for Clinical Establishments, which is essentially responsible for setting the criteria, carrying out periodic assessments, and developing standards to guarantee that clinic founders deliver proficient and appropriate healthcare. The following are the primary responsibilities of the National Council:
The National Council also possesses the authority to establish subcommittees, nominate their heads, and select non-national Council members to serve on these subcommittees for a two-year term.
The National Council is composed of the following members under Section 3:
All states that enact this Act must constitute a State Council with a majority of its members to carry out the following functions:
The District Collector will preside over the District Registering Authority; the compiler will be the Region CMO / CMHO; and three members will be nominated by the DC. The three members are the Police Commissioner / SSP / SP, or nominee, the Chief Executive Officer of local government at the district level, and the Professional Medical Association/body.
The following are the DRA’s powers and responsibilities:
The registration procedure for a clinical establishment is covered in Chapter IV of the Act. The application for a provisional certificate of registration is made in the required form and with the payment of the prescribed fees to the authorities to register the clinical establishment under Section 10. The application can be delivered in person, mailed, or submitted electronically. The application must be submitted in the manner and with the particulars provided by this Act or its rules. Suppose a clinical establishment existed at the time of the Act’s commencement. In that case, an application for registration has to be made within a year of the Act’s inception, and a clinical establishment established after the Act’s inception must apply for permanent registration within six months of its establishment.
If a clinical facility has previously been registered under any existing legislation requiring such registration, it must apply for registration in accordance with the terms of sub-section (1). Furthermore, within ten days of receipt of such an application, the authority should give the applicant a certificate of provisional registration in the form and with the particulars and information specified.
In terms of inquiries, there will be none prior to provisional registration. The authorities shall conduct no investigation before issuing provisional registration. Regardless of whether a provisional certificate of registration is obtained, the authority shall cause the details of the clinical establishment so registered provisionally to be published in the manner necessary within 45 days of the provisional certificate of registration being issued.
Additionally, pursuant to the restrictions of Section 23, each provisional registration is valid until the last day of the twelfth month after the date of the certificate of registration’s issue, and such registrations are renewed. Furthermore, the Act mandates that the certificate be properly displayed in the clinical establishment and visible to all individuals visiting the establishment. If the certificate is lost, destroyed, deformed, or damaged, the authority must issue a duplicate upon request and payment of applicable fees.
The given certificate is non-transferable. There will be no transferable registration certificates issued. If the clinical institution’s ownership or management changes, the clinical establishment must inform the authorities in an authorised manner. If the category or location of a clinical establishment changes or if it ceases to function as a clinical establishment, the authority must revoke the clinical establishment’s registration certificate, and the clinical establishment must reapply for registration.
As per Section 22 of the Act, the authorities must cause the names of clinical establishments whose registration has expired to be published within the time and manner stipulated. Applications for renewal of registration must be submitted thirty days before the provisional registration certificate’s validity expires. If the application is submitted after the provisional registration certificate’s validity has expired, the authority might grant the renewal of registration upon payment of such increased fees as may be prescribed.
Section 23 specifies the time limit for provisional registration: provisional registration must not be granted or renewed for clinical establishments whose criteria have been published by the Central Government beyond:
Under Section 24, a clinical establishment must submit an application for permanent registration to the authorities in the form and with the fees stipulated. For application verification, the healthcare facility must produce evidence that it has satisfied the mandated minimum criteria in the manner specified. Once the clinical establishment provides sufficient proof of compliance with the stipulated minimum standards, the authority shall display all evidence of compliance with the stipulated minimum standards submitted by the clinical establishment for thirty days prior to processing for grant of permanent registration for the general public’s information and for filing objections, if any, in the manner prescribed. If objections are received within the timeframe specified in the preceding section, they must be submitted to the clinical establishment for a response within 45 days. Only when a clinical establishment meets the Central Government’s registration requirements will it be granted permanent registration.
It is the authority’s obligation to issue an order, either allowing or denying the application for permanent registration, immediately upon the expiration of the specified time and within thirty days thereafter, depending on the circumstances: However, if a permanent registration application is refused, the authority must state its reasons for doing so under Section 29 of the Act. If the application of the clinical establishment is approved, the authority will issue a certificate of permanent registration in the manner specified and with the information stated in the application. The certificate is supposed to be valid for five years after the date of issuance. The provisions of Sections 18, 19, 20, and 21 also apply to the issue of permanent registration. Applications for permanent registration renewal have to be submitted at least six months before the expiration of the validity of the certificate of permanent registration. If the renewal application is not filed within the specified time frame, the authority may grant the renewal subject to the payment of any additional fees and penalties under Section 30 of the Act.
Following the refusal of an application for permanent registration, a clinical establishment may reapply under Section 24 and provide any additional documents necessary to indicate that the problems that led to the earlier application’s rejection have been resolved.
The Act provides for the cancellation of registration in the following circumstances:
If the authority becomes convinced that a clinical establishment is not complying with the registration conditions or that the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under this Act, the authority may issue a notice to the clinical establishment that requires it to show cause within three months as to why its registration under this Act should not be revoked.
If the authority decides, after providing the clinical establishment with a reasonable opportunity, that any of the provisions of this Act or the rules made thereunder have been violated, it can revoke the clinical establishment’s registration by order, without prejudice to any other action it may take against the clinical establishment. If no appeal is filed against such an order, the order takes effect immediately upon the expiration of the time period stipulated for such an appeal; if an appeal is filed but is dismissed, the order takes effect from the date on which it was dismissed. However, suppose there is an imminent threat to patient health and safety. In that case, the authority may, upon revocation of registration for defined grounds indicated in writing, immediately prohibit the clinical establishment from continuing to operate until the issue is addressed.
Any clinic may be inspected or examined by the registered authorities as provided under Section 33 of the Act. Clinical facilities have the right to be represented during any examination or investigation. The official will express his or her view and may make recommendations. A notice of reason may be given if the official feels that the clinic is not complying with the terms of its registration or if the person in charge of the clinic has been convicted of a criminal breach under the Act. If a government official considers that an institution has broken the law, he or she has the right to revoke the institution’s registration. If the officer has reasonable reasons to suspect that the clinic is not operating under a valid licence, he or she may enter and search the facility in the manner provided after notifying the clinic of his or her purpose.
However, any individual who is aggrieved by a decision of the registering authority refusing to grant or renew a certificate of registration or cancelling a certificate of registration may submit an appeal with the State Council in the manner and within the time frame prescribed under Section 36. However, the State Council may hear an appeal filed after the limitation period has expired if it is satisfied that the appellant was prevented from filing the appeal within the prescribed time period due to an unavoidable reason. Every appeal under sub-section (1) is required to be filed in the manner and with the fee prescribed.
The requirements pertaining to the register of clinical establishments are elaborated on in Chapter V. According to Section 37 of the Act, within two years of the authority’s establishment, a register of clinical establishments registered by the authority has to be compiled, published, and maintained in digital format. The certificate’s details must be recorded in a register, which must be maintained in the manner and form mandated by the state government. The State Council of Clinical Establishments shall receive a copy of every entry made in the register of clinical establishments in digital format from each authority, including any other authority established for the registration of clinical establishments under any other law currently in force, in whatever format may be mandated, in order to make sure that the State Register is constantly up to date with the registers maintained by the registering authority in the state.
Every state government should keep a record known as the “state record of clinical establishments” in digital form, comprising such particulars as may be stipulated by the Central Government with respect to clinical establishments in that state.
Under Section 38, every state government must provide the Central Government with a digital copy of the state register of clinical establishments. It must notify the Central Government of all additions to and other changes made to the register by the 15th day of the month following the month in which they were made.
The National Register of Clinical Establishments, an amalgamation of the State Register of Clinical Establishments maintained by the State Governments, constitutes an All India Register that the Central Government is responsible for maintaining in digital format. The state governments are responsible for ensuring that the same is published digitally, as mandated by Section 39 of the Act.
Chapter VI contains the regulations for penalties in cases of default. If someone works for a clinic without being registered, he or she would face fines of up to Rs 50,000 in the first offence, Rs 2,00,000 in the second, and Rs 5,00,000 in every subsequent offence. A person who works in an unlicensed medical establishment faces a punishment of up to Rs 25,000. If someone breaches the Act and no further penalties are imposed, he or she may be fined up to Rs 10,000 for the first offence. The fine for the second offence might be up to Rs 50,000, and the fine in the succeeding case could be up to Rs 5 lakh.
Anyone who maintains a clinical facility without registration faces a fine of up to 50,000 rupees for the first offence, a fine of up to 2,00,000 rupees for the second offence, and a fine of up to 5,00,000 rupees for every subsequent violation. Anyone who works in a clinical establishment that is not correctly registered under this Act receives a monetary penalty of up to 25,000 rupees. After giving any individual affected a reasonable chance to be heard, the authority shall perform the necessary investigation in order to impose any monetary penalty under subsections (1) and (2) of Section 40. While carrying out an inquiry, the authority has the power to summon and require the attendance of any person acquainted with the facts and circumstances of the case to give proof or produce any document that, in the authority’s opinion, may be useful for or relevant to the subject matter of the inquiry. Then, if the authority decides that the person has infringed on the provisions specified in subsections (1) and (2), it may impose the penalty specified in subsection (2) by order.
When determining the amount of the monetary penalty, the authorities must take into account the category, size, and type of clinical establishment, as well as the local characteristics of the location in which the establishment is located. Any individual who is dissatisfied with an authority’s decision has three months from the date of the decision to file an appeal with the State Council. The process for filing an appeal pursuant to sub-section (6) is set forth in Section 41.
Under Section 42, anyone who willfully disobeys any valid direction issued by any person or authority empowered under this Act or who obstructs any person or authority in carrying out any tasks necessary or empowered by this Act should face a monetary penalty of up to 5,00,000 rupees. Anyone who willfully refuses to furnish information requested by or under this Act or who submits information he knows to be false or does not believe to be true should face a monetary penalty of up to 5,00,000 rupees. To establish whether any monetary punishment is justified under subsections (1) and (2), the authority shall undertake the necessary investigation after giving any individual interested a reasonable opportunity to be heard.
While conducting an inquiry, the authority can summon and compel the presence of any person acquainted with the facts and circumstances of the case to give proof or produce any document that, in the authority’s opinion, may be useful for or related to the subject matter of the inquiry. If the authority determines that the individual in question has violated the provisions specified in sub-sections (1) and (2) of Section 42, it may impose the penalty specified in subsection (8). When determining the amount of the monetary penalty, the authorities must take into account the category, size, and kind of clinical establishment, as well as the local characteristics of the region in which the establishment is located. Anyone dissatisfied with an authority’s decision has three months from the date of the decision to file an appeal with the State Council. The manner in which an appeal under subsection (6) may be lodged should be specified. The monetary penalty imposed under Sections 41 and 42 shall be credited to the account specified by the order of the state government.
Whoever violates any provision of this Act or any regulation made thereunder, resulting in inadequacies that do not pose an urgent threat to any patient’s health or safety and that may be addressed within a reasonable time, will be fined up to ten thousand rupees under Section 43 of the Act.
When an individual violates any provision of this Act or any rule made thereunder, every person who is in charge of and accountable to the company for the conduct of the company’s business at the time the violation occurred, as well as the company, is deemed guilty of the violation and liable to fine: However, nothing in this subsection shall subject any such person to penalty if he proves that the violation was committed without his knowledge or that he used all reasonable care to avoid its occurrence.
Regardless of what is stated in sub-section (1), if a company violates any provision of this Act or any rule made thereunder and it is established that the violation occurred with the consent or connivance of, or is attributable to, any director, manager, secretary, or another officer of the company, such director, manager, secretary, or other officer is deemed to be guilty of the violation under Section 44.
If any department of government commits an offence under this Act within six months of its enactment, the head of the department is considered guilty of the offence and may be prosecuted and punished accordingly under Section 45. However, nothing in this section shall subject the Head of Department to penalty if he proves that the offence was committed without his knowledge or that he took all reasonable efforts to prevent it from being committed. Regardless of what is stated in sub-section (1), if an offence under this Act is committed by a department of government and it is proven that the offence was committed with the consent or connivance of, or is attributable to, any officer other than the Head of the Department, then that officer is also deemed guilty of the offence and is prosecuted and punished accordingly.
Under Section 46, if an individual refuses or fails to pay the fine, he or she may be issued a certificate by the State Council of Clinical Establishments specifying the amount payable from that person and having it signed by an authorised officer. This certificate will be sent to the Collector of the district where the non paying party owns property, resides, or conducts business, and the Collector will proceed to collect the amount specified in the certificate from the non paying party as if it were an arrear of land revenue.
The Act gives the Central Government the authority to categorise clinical facilities into various systems. As a result, the Central Government divided it into two categories: allopathic and AYUSH. Various criteria have been established for various facilities that use a range of medical approaches.
According to the Clinical Establishment Act of 2010, allopathic hospitals are classified into four levels:
Level 1 (A) and Level 1 (B) hospitals must additionally have support systems, including a pharmacy and a laboratory. For example, a general hospital, a community health centre, a sub-district hospital, a corresponding private hospital, a nursing home, a civil/district hospital in a few areas, and so on.
This level should include every service offered at levels 1(A) and 1(B), along with services offered by the other medical fields listed below, in addition to the basic medical specialties listed at level 1(B), such as orthopaedics, ENT, ophthalmology, dental, emergency with or without ICU, anaesthesia, psychiatry, skin, pulmonary medicine, rehabilitation, and so on, as well as support systems required for the above services such as pharmacy, laboratory, imaging facilities, Opera District hospitals, corporate hospitals, referral hospitals, regional/state hospitals, nursing homes, and private hospitals of comparable scope, for example.
All services provided at levels 1 (A), 1 (B), and 2 may be included, as well as services from one or more super areas of expertise with their own departments and/or dentistry, if available. Additional support systems for services such as pharmacy, laboratory, imaging facility, and operation theatre will be included. For example, corporate hospitals, referral hospitals, regional/state hospitals, nursing homes, and similar private hospitals.
This level will feature all level 2 services as well as possibly some level 3 facilities. It will be characterised, however, by its position as a teaching/training institution, as well as the presence or absence of superspecialities. Specialists, some of whom may be superspecialists (if available), provide tertiary healthcare services at this level. It will also have the support systems required to offer these services. It will also meet the standards of the MCI/other registration authorities for teaching hospitals and be controlled by their rules. However, teaching hospitals will be required to register under the Act for purposes other than those covered by the MCI, such as maintaining records and reporting information and statistics, as well as adhering to a range of rates for medical and surgical procedures, among others.
The hospitals are required to use a specific template for displaying the different rates related to PD, investigation/diagnostic, emergencies, and so on, which is detailed in draft documents provided by the Ministry in accordance with Rules 9 (ii) and (iii) of the Clinical Establishments (Central Government) Rules, 2012. It is a standard list of medical operations as well as a standard price template for medical treatments that has been issued to the states and union territories. This, however, has not been implemented in a few states. In certain states, like West Bengal and Kerala, legislation mandates that anyone requiring the services be provided with information on fees.
In the case of (2016), Ahmad Nabi, the petitioner, filed a suit against two hospitals. The petitioner claimed in the complaint that both of these establishments were owned and operated by medical practitioners who did not have a professional medical degree. He also provided evidence that the hospitals had not been registered under the Clinical Establishments (Registration and Regulations) Act of 2010. Nabi further claimed that the surgical procedures were carried out by untrained individuals acting as surgeons with no medical degree. Following a thorough investigation and an inquiry into the qualifications of the medical practitioners and the registration status of the hospitals, Nabi’s allegations were found to be true.
It was said by the court that “once any legislative enactment is made, it is the duty of the State to implement and carry it out in letter and spirit.” It was also noted that Article 47 imposes a responsibility on governments to maintain a public health standard by vigorously enforcing the legislation that governs their operations. It is the primary responsibility of the state to maintain these public health facilities, as every person has a right to life under Article 21 of the Indian Constitution.
The Uttarakhand High Court issued the following directives:
Regulations like the , the , and the already regulate doctors. The Act granted regulators disproportionate power and prevented doctors from defending themselves against charges. “Regulations and Licence Raj” would worsen the tendency of recent medical graduates to avoid family practice and choose to work in specialty hospitals. Due to the strict conditions that must be included in this legislation, including the need for a minimum number of certified paramedical personnel, it will also be impossible to satisfy them owing to the skilled labour shortage that affects even government institutions. Additionally, it will boost the price of treatment, which will increase several times over.
A lot of the Clinical Establishment Act’s provisions are controversial. Many of them stem from a few broad provisions. For example, Section 12(2) states that “the clinical establishment shall undertake to provide, within the capacity of its staff and facilities, such medical examination and treatment as may be needed in order to stabilise any individual’s emergency health condition who comes or is brought to the such clinical establishment.”
This implies that all clinical institutions will be required to intervene to “stabilise” the patient before transferring a patient with an emergency medical condition. This puts an excessive burden on medical facilities. The proviso that such interventions must be made “within the scope of available staff and facilities” is included, but its interpretation will be in contention.
The original directive from the Supreme Court dealt with giving accident victims immediate life-saving aid. It is impractical, unrealistic, and unjust to expect doctors to use it in all emergency situations. Such restrictions offer doctors a compelling reason to oppose regulation in general. Indeed, the legitimacy of this section may be contested by medical organisations, which caused problems with the Act’s adoption.
Also, no provision is made for additional machinery to handle the increased workload brought on by regulating private clinical establishments. Therefore, either the Act is not implemented, or it is carried out ineffectively; either way, both honest physicians and their patients lose.
The hospital owners can only appeal through the state council to a district health authority. There are hundreds of medical establishments in every state, so there will undoubtedly initially be many conflicts with the district registering authority. For any work pertaining to these concerns, these doctors will need to go to the state capital. The Jan Aarogya Abhiyan proposed the creation of a “multistakeholder district advisory committee” to advise the district authority when the Bombay Nursing Home Registration Act’s rules were being drafted in 2005. This would have provided a forum for discussion with the district registering authority and, consequently, some accountability at the district level. This suggestion was denied. Such suggestions may still be made if all parties pressure the administration.
There are several more challenges, all of which call for proactive, active interaction with the relevant authorities. The central government then said that it would develop a “National Standard Treatment Policy”. In order to prevent patients from being overcharged or over-drugged during treatment, this policy is intended to guarantee that doctors employ the best available treatments and only prescribe the necessary amount of medications.
Health and human rights advocates have been calling for more thorough scrutiny of medical establishments and healthcare systems for at least 20 years. Along with a more widespread desire for more efficient public health services, this demand has concentrated on various issues, including mental health care, primary healthcare, and sex-selective abortions, to mention a few. Additionally, allopathic professionals have received rising recognition of potential discussions between allopathy and other Indian medical systems. At the same time, there has been widespread resistance among medical professionals to regulations. The regulation under the is the most striking example.
This Act came into being as a response to the call for greater scrutiny following the escalating malpractices and blatant carelessness. In terms of its objective, it is a welcome move. However, in terms of its operational components, there are too many gaps, which might very well mean that it cannot be put into effect. Finally, professional organisations and individual practitioners need to keep coming back to the issue of self-regulation, transparency, and its future in relation to clinical establishments. Resistance to unethical, unlawful practices and the commercialization of healthcare must come from within.
The Act contains numerous flaws and unresolved difficulties, and it is far from perfect. However, one must keep in mind that there are a variety of demands from a variety of stakeholders when passing an act. The country’s clinical establishments must be open and responsible in order to enhance the quality of healthcare provided there.
While the aforementioned effort is commendable, it is insufficient to address the medical industry’s problems. It is necessary to approach the matter from a much wider and more thorough perspective. The need of the hour is to develop a comprehensive action plan dedicated to medical negligence and medical malpractice in order to govern all areas of the conduct of doctors and hospitals delivering health services to Indians.
A clinical establishment is defined as a hospital, maternity home, nursing home, dispensary, clinic, or any other facility that provides services or facilities for illness, injury, deformity, abnormality, or pregnancy under any recognised system of medicine. It also includes laboratories and diagnostic centres, as well as any other location where pathological, bacteriological, genetic, radiological, chemical, or biological investigations or other services are performed using laboratory or other medical equipment.
This Act does not apply to clinical institutions owned, controlled, or administered by the Armed Forces. Clinical establishments exempted by the state government, as well as those situated in the states/UTs listed in the Act’s schedule, unless these states/UTs repeal their current Act and adopt the Clinical Establishments Act.
Under this Act, the owner of the clinical establishment has the responsibility for registering the clinical establishment.
In the case of a change in ownership/management, the clinical facility must notify the authorities in writing, signed by both the former and new owners.
The District Registering Authority, a multi-member authority at the district level, is the registering authority for clinical establishments operating in that district.
Yes, the certificate should be displayed in a prominent location where it can be seen clearly.
If an application is made in person or by mail, it should be sent to the district registering authority (i.e., the District Health Officer / Chief Medical Officer) in the prescribed proforma along with the prescribed fee.
There are two kinds of registration: provisional and permanent. Provisional registration is granted ‘as is, where is basis.’ Provisional registration would be granted within 10 days after filing the application.
Once the government has notified the minimum standards for clinical establishments, permanent registration will be granted to all those who meet the notified standards for that category of clinical establishments.
Every provisional registration is valid until the last day of the twelfth month after the date of issuing the certificate of registration, and it is renewed on an annual basis.
The district registration authority is to be established by notice from the state government. The three nominated members of the district registering authority serve for a term of two years.
Students of regularly produce writing assignments and work on practical exercises as a part of their coursework and develop themselves in real-life practical skills.
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it has been published by Rachit Garg.
Introduction
Healthcare is a necessary commodity. The need for “good quality” healthcare has risen as a result of rapidly shifting demographic patterns, an expanding population base, and rising incomes that make “good quality” healthcare more affordable. Many nations are looking at different ways to raise the standard of healthcare services. The quality of services offered to people in India by the public and private sectors remains an unresolved problem. The way the healthcare delivery system has been set up does not offer enough incentives for improvements in effectiveness. In India, there are currently no mechanisms in place to achieve higher hospital efficiency, accountability, and responsible governance. A significant amount of India’s health care is provided by the for-profit private sector (50% of inpatient treatment and 60-70% of outpatient care), although this sector has received less attention from policymakers than the public sector. As a result, the private healthcare delivery system in India has remained essentially unorganised and fragmented, and there is abundant evidence of subpar quality service.
The Government of India enacted the (hereinafter referred to as “the Act”), as per the commission, namely “Clinical Establishments, Professional Services Regulation, and Accreditation of Health Care Infrastructure” for the , to provide registration and regulation to all clinical establishments within the country with an aim to recommend the minimum standards of services and amenities provided by them to citizens of the country. The importance of this legislation comes from rising concern about the inadequacy of public healthcare facilities on the one hand and the absence of any rules controlling existing public and private facilities on the other. The complete breakdown of the public healthcare system, particularly in rural and isolated tribal regions, has exposed already disadvantaged groups to unregulated and unmonitored healthcare providers. Corporate health care has taken over health services in cities without implementing transparent accountability procedures. This Act was enacted as a response to a growing demand for increased monitoring in the wake of increasing malpractice and gross incompetence. Thus, it is a positive move in terms of its goals and justifications.
Need for the Clinical Establishments (Registration and Regulation) Act, 2010
The national legislation was primarily developed out of a 1980s patient rights campaign. Health activists around the country have responded to rising charges of unethical activities within mainly private healthcare systems and the complete inability of self-regulation via medical councils to act against medical professionals. They maintained that medical treatment was primarily a consumer service and sought remedies under (CPA) against medical negligence and misconduct. (IMA) filed a lawsuit against this action. The campaign gained momentum in the year 1995, when the Supreme Court determined in the landmark case of (1995) that the CPA extended to the medical profession as well.
The medical profession’s view has always been that doctors must always put their patients’ wellness ahead of all other considerations, including their own. It contends that medical treatment is not a business transaction between consumer and provider and that considering it as such would contradict the doctor-patient relationship’s fiduciary character. The fiduciary aspect, although it is being questioned today as doctors have made their practice and medicine a massive healthcare business where their personal interests often clash with those of their patients, for instance, when medical students are ready to ‘invest’ Rs. 1 crore in a postgraduate seat, their drive to recover their investment will definitely conflict with their commitment to delivering the highest care possible to their patients. So, it can be stated that patients’ distrust in medical practitioners has reached catastrophic proportions, requiring the passage of legislation such as the Clinical Establishment Act. The objective of the government and individuals must be to fill the gaps in the legislation and ensure its correct execution.
Objective of the Clinical Establishments (Registration and Regulation) Act, 2010
The Act mandates registration of all clinical establishments, including diagnostic centres and single-doctor clinics, in the public and commercial sectors, except those managed by the defence services. The registering authority aids in developing policies, distributing resources, and establishing treatment standards. It has the jurisdiction to impose fines for violations of the act’s provisions.
The Act creates standard treatment guidelines for prevalent medical problems and establishes a core group of experts to monitor their implementation. Additionally, the Act mandates all clinical establishments to give the medical care and treatment necessary to stabilise any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly women who are in labour and individuals who are involved in accidents.
One of the primary aims of the Act is to ensure that certified and competent professionals administer healthcare facilities. The Act specifies that every clinical establishment must have a certified medical practitioner in charge who is responsible for supervising the quality of treatment provided by the institution. This criterion helps to guarantee that patients get high-quality medical care and that medical procedures are carried out safely and effectively.
In addition to this, the Act also lays out specific requirements for maintaining and functioning clinical institutions. These standards address aspects such as infection control, waste management, and patient safety. By implementing these principles, the Act helps to prevent the spread of infections and other diseases, safeguard the environment, and guarantee that patients receive safe and effective treatment.
Another significant purpose of the Clinical Establishments Act is to make healthcare services more accessible to the public, particularly in rural and remote locations. The Act supports the establishment of clinical establishments in certain regions and allows for the registration and control of these facilities. This helps guarantee that individuals living in these regions have access to critical healthcare services and that the quality of treatment is up to the needed standards. Furthermore, the Act also established a National Council for Clinical Establishments.
Implementation of the Clinical Establishments (Registration and Regulation) Act, 2010
The adoption of the Clinical Establishments Act 2010 has been a slow process, with different states in India implementing the Act on different dates. As of 2021, 21 states and Union Territories in India have adopted the Act, while other states are in the process of doing so.
Vide the notification dated January 28, 2010, the Act went into force in four states of India, namely Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all Union Territories. Later, Uttar Pradesh, Rajasthan, and Jharkhand approved the Act under clause (1) of of the . In 2013, the State of Maharashtra formed a multi-stakeholder group to develop the as a key step towards the standardisation of quality and pricing in the private medical sector.
Major provisions under the Clinical Establishments (Registration and Regulation) Act, 2010
Definition of the clinical establishments
The Act defines “clinical establishment” under Section 2(c) of the Act and includes all hospitals, maternity homes, nursing homes, dispensaries, clinics, etc., as well as any other type of institution that provides services and facilities for the diagnosis, treatment, or care of illness, injury, etc., or a location established as an independent entity or as a component of an establishment in connection with the diagnosis or treatment of specific diseases. It also comprises a single doctor, a trust, a business registered under a state, national, or municipal law, or a clinical facility owned, controlled, and run by the government or a government department.
Establishment of a National Council for Clinical Establishments
The Act’s Section 3 calls for the creation of a national council for clinical establishments. The grounds under which one would be ineligible for consideration for membership in the Council are further specified in Section 4. The Central Government appears to have a lot of discretion under this provision, especially when determining whether offences qualify as having “moral turpitude” as described in subsection (a). Since the Central Government has primary decision-making authority over this Council’s composition, this section does not agree with the idea that health is still a subject on the State List. Section 5 continues to list the fundamental duties that the National Council must carry out, including categorising the various clinical establishments, developing a minimum standard that must be prescribed, and keeping a register of all the legitimately registered establishments in coordination with the State Council. The State Council of Clinical Establishments is constituted by Section 6 of the Act, along with its composition and duties.
Registration of the clinical establishments
A clinical establishment is not allowed to function, per Section 11 of the Act, unless it has been duly registered in accordance with the Act’s rules. According to Section 12 of the Act, a clinical establishment must also comply with the following requirements in order to be registered and to remain in operation:
- minimum standards for facilities and services;
- minimal staffing requirements; provisions for record-keeping and reporting; and
- any other requirements that may be prescribed.
Based on the quality of treatment these facilities offer, minimum requirements for hospitals are developed. An application in the correct format and with the necessary fee must be made to the authority listed in Section 11 in order to receive a provisional certificate for a clinical facility as required by Section 11 of the Act. Additionally, it states that clinical establishments that already existed when the Act was enacted must submit an application for registration within a year of its implementation, and those established after that date must submit an application for permanent registration within six months of doing so. Additionally, clinical facilities that are already registered under a statute that calls for such registration must do so again in order to keep up with the Act. Each provisional registration will continue to be enforceable until the last day of the twelfth month, complying with the date of issue of the certificate of registration, and such registration shall be renewable. The authority shall issue to the applicant a certificate of provisional registration in such form and containing such particulars and information, within ten days of receipt of such an application.
The certificate must be clearly visible at the clinical establishment so that all visitors may see it. Applications for renewal must be filed within 30 days of the expiration date of the provisional certificate; if submitted beyond that period, the authority will accept renewal of registration only upon payment of the higher fees. In the case of clinical establishments that were established prior to the effective date of this Act, the period of two years from the date of notification of the standards shall apply; in the case of clinical establishments that were established after the effective date of this Act, the period of two years from the date of notification of the standards shall apply; the authority must receive applications for permanent registration of clinical establishments in the manner and with the fees specified within two years of the date of notification of the standards in the case of clinical establishments. Provisional registration regarding clinical establishments for which the Central Government has notified standards cannot be obtained or renewed.
This is how the clinical establishment must prove that it complies with the set minimum standards. Only when a clinical facility meets the registration requirements set out by the central government can permanent registration be granted. The additional requirements for clinical institutions are provided under the . The rates for each type of service and facility are prominently displayed and are available in both the native language and English. Electronic medical records or electronic health records should be maintained and made available to all patients, as decided and ordered by the central or state governments. The additional requirements for clinical establishments under the Clinical Establishments (Central Government) Rules, 2012, are provided below.
- The rates for each sort of service and facility are prominently displayed and are available in both the native language and English.
- As established and issued by the central or state governments, maintaining and providing electronic medical or health records for all patients is necessary.
- Clinical establishments must charge fees for operations and services in line with the fee schedule set by the central government in consultation with the state governments from time to time.
- The central or state governments should publish standard treatment guidelines. Clinical establishments are responsible for complying with these guidelines and for ensuring that data and statistics are preserved in conformity with all relevant laws and regulations.
Institutional arrangements under the Clinical Establishments (Registration and Regulation) Act, 2010
The Act creates a National Council for Clinical Establishments, which is essentially responsible for setting the criteria, carrying out periodic assessments, and developing standards to guarantee that clinic founders deliver proficient and appropriate healthcare. The following are the primary responsibilities of the National Council:
- Assembling and publishing the National Register of Clinical Institutions within two years after the Act’s passage;
- Categorising clinic locations according to different criteria; enhancing lower standards, and carrying out regular assessments;
- Establishing the first set of guidelines for clinical facilities to follow within two years of being operational;
- Collecting information at treatment centres; and
- Carrying out any other tasks mandated by the Central Government.
The National Council also possesses the authority to establish subcommittees, nominate their heads, and select non-national Council members to serve on these subcommittees for a two-year term.
The National Council is composed of the following members under Section 3:
- The Secretary of Health serves as the chairperson of the council.
- The Director of Health Services is a senior member of the secretary’s office.
- Ex officio members include directors of multiple streams of Indian Systems of Medicine.
- Each person’s representative will be chosen by the executive committee of the Indian State Medical Council, State Dental Council, State Nursing Council, and State Pharmacy Council.
- The Executive of the State Council or the Union Territory Council, as applicable, nominates three members for Indian Medicine, representing the Ayurveda, Siddha, and Unani medicine initiatives.
- One representative is recommended by the State Council of the Medical Association of India.
- One member of the emergency services.
- Two representatives from state-level consumer associations.
All states that enact this Act must constitute a State Council with a majority of its members to carry out the following functions:
- Compiling and updating state clinic establishment registers;
- Providing a monthly return on National Register renewal;
- representing the government in the National Assembly;
- Complaints about high-level order violations; and
- Annual reports on the implementation of standards in respective provinces must be published.
The District Collector will preside over the District Registering Authority; the compiler will be the Region CMO / CMHO; and three members will be nominated by the DC. The three members are the Police Commissioner / SSP / SP, or nominee, the Chief Executive Officer of local government at the district level, and the Professional Medical Association/body.
The following are the DRA’s powers and responsibilities:
- Providing temporary (within ten days) / permanent registration;
- Publication of the Provisional Registrations List (within 45 days of grant);
- Clinical establishments that provide proof of permanent registration and encourage opposition (30 days);
- Registration that is no longer valid should be cancelled;
- Enter and search for unregistered clinical establishments (after due notice);
- Evaluating and inquiring about registered clinic facilities through a multi-member evaluation team – informs the clinical establishment of concerns and necessary remedial activities;
- If the threat to the patient’s health and safety is imminent, immediately prohibit the clinic from establishing itself after withdrawing the registration; and
- Maintaining a regional register of clinic locations.
Procedure for registration under the Clinical Establishments (Registration and Regulation) Act, 2010
The registration procedure for a clinical establishment is covered in Chapter IV of the Act. The application for a provisional certificate of registration is made in the required form and with the payment of the prescribed fees to the authorities to register the clinical establishment under Section 10. The application can be delivered in person, mailed, or submitted electronically. The application must be submitted in the manner and with the particulars provided by this Act or its rules. Suppose a clinical establishment existed at the time of the Act’s commencement. In that case, an application for registration has to be made within a year of the Act’s inception, and a clinical establishment established after the Act’s inception must apply for permanent registration within six months of its establishment.
If a clinical facility has previously been registered under any existing legislation requiring such registration, it must apply for registration in accordance with the terms of sub-section (1). Furthermore, within ten days of receipt of such an application, the authority should give the applicant a certificate of provisional registration in the form and with the particulars and information specified.
In terms of inquiries, there will be none prior to provisional registration. The authorities shall conduct no investigation before issuing provisional registration. Regardless of whether a provisional certificate of registration is obtained, the authority shall cause the details of the clinical establishment so registered provisionally to be published in the manner necessary within 45 days of the provisional certificate of registration being issued.
Additionally, pursuant to the restrictions of Section 23, each provisional registration is valid until the last day of the twelfth month after the date of the certificate of registration’s issue, and such registrations are renewed. Furthermore, the Act mandates that the certificate be properly displayed in the clinical establishment and visible to all individuals visiting the establishment. If the certificate is lost, destroyed, deformed, or damaged, the authority must issue a duplicate upon request and payment of applicable fees.
The given certificate is non-transferable. There will be no transferable registration certificates issued. If the clinical institution’s ownership or management changes, the clinical establishment must inform the authorities in an authorised manner. If the category or location of a clinical establishment changes or if it ceases to function as a clinical establishment, the authority must revoke the clinical establishment’s registration certificate, and the clinical establishment must reapply for registration.
As per Section 22 of the Act, the authorities must cause the names of clinical establishments whose registration has expired to be published within the time and manner stipulated. Applications for renewal of registration must be submitted thirty days before the provisional registration certificate’s validity expires. If the application is submitted after the provisional registration certificate’s validity has expired, the authority might grant the renewal of registration upon payment of such increased fees as may be prescribed.
Section 23 specifies the time limit for provisional registration: provisional registration must not be granted or renewed for clinical establishments whose criteria have been published by the Central Government beyond:
- Two years after the date of notification of the standards in the case of clinical establishments established before the commencement of this Act;
- Two years from the date of notification of the standards for clinical establishments established after the commencement of this Act but before the notification of the standards; and
- Six months from the date of notification of standards for clinical establishments that come into existence after standards have been announced.
Under Section 24, a clinical establishment must submit an application for permanent registration to the authorities in the form and with the fees stipulated. For application verification, the healthcare facility must produce evidence that it has satisfied the mandated minimum criteria in the manner specified. Once the clinical establishment provides sufficient proof of compliance with the stipulated minimum standards, the authority shall display all evidence of compliance with the stipulated minimum standards submitted by the clinical establishment for thirty days prior to processing for grant of permanent registration for the general public’s information and for filing objections, if any, in the manner prescribed. If objections are received within the timeframe specified in the preceding section, they must be submitted to the clinical establishment for a response within 45 days. Only when a clinical establishment meets the Central Government’s registration requirements will it be granted permanent registration.
It is the authority’s obligation to issue an order, either allowing or denying the application for permanent registration, immediately upon the expiration of the specified time and within thirty days thereafter, depending on the circumstances: However, if a permanent registration application is refused, the authority must state its reasons for doing so under Section 29 of the Act. If the application of the clinical establishment is approved, the authority will issue a certificate of permanent registration in the manner specified and with the information stated in the application. The certificate is supposed to be valid for five years after the date of issuance. The provisions of Sections 18, 19, 20, and 21 also apply to the issue of permanent registration. Applications for permanent registration renewal have to be submitted at least six months before the expiration of the validity of the certificate of permanent registration. If the renewal application is not filed within the specified time frame, the authority may grant the renewal subject to the payment of any additional fees and penalties under Section 30 of the Act.
Following the refusal of an application for permanent registration, a clinical establishment may reapply under Section 24 and provide any additional documents necessary to indicate that the problems that led to the earlier application’s rejection have been resolved.
The Act provides for the cancellation of registration in the following circumstances:
If the authority becomes convinced that a clinical establishment is not complying with the registration conditions or that the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under this Act, the authority may issue a notice to the clinical establishment that requires it to show cause within three months as to why its registration under this Act should not be revoked.
If the authority decides, after providing the clinical establishment with a reasonable opportunity, that any of the provisions of this Act or the rules made thereunder have been violated, it can revoke the clinical establishment’s registration by order, without prejudice to any other action it may take against the clinical establishment. If no appeal is filed against such an order, the order takes effect immediately upon the expiration of the time period stipulated for such an appeal; if an appeal is filed but is dismissed, the order takes effect from the date on which it was dismissed. However, suppose there is an imminent threat to patient health and safety. In that case, the authority may, upon revocation of registration for defined grounds indicated in writing, immediately prohibit the clinical establishment from continuing to operate until the issue is addressed.
Inspection of the clinical establishments
Any clinic may be inspected or examined by the registered authorities as provided under Section 33 of the Act. Clinical facilities have the right to be represented during any examination or investigation. The official will express his or her view and may make recommendations. A notice of reason may be given if the official feels that the clinic is not complying with the terms of its registration or if the person in charge of the clinic has been convicted of a criminal breach under the Act. If a government official considers that an institution has broken the law, he or she has the right to revoke the institution’s registration. If the officer has reasonable reasons to suspect that the clinic is not operating under a valid licence, he or she may enter and search the facility in the manner provided after notifying the clinic of his or her purpose.
However, any individual who is aggrieved by a decision of the registering authority refusing to grant or renew a certificate of registration or cancelling a certificate of registration may submit an appeal with the State Council in the manner and within the time frame prescribed under Section 36. However, the State Council may hear an appeal filed after the limitation period has expired if it is satisfied that the appellant was prevented from filing the appeal within the prescribed time period due to an unavoidable reason. Every appeal under sub-section (1) is required to be filed in the manner and with the fee prescribed.
Register of the clinical establishments
The requirements pertaining to the register of clinical establishments are elaborated on in Chapter V. According to Section 37 of the Act, within two years of the authority’s establishment, a register of clinical establishments registered by the authority has to be compiled, published, and maintained in digital format. The certificate’s details must be recorded in a register, which must be maintained in the manner and form mandated by the state government. The State Council of Clinical Establishments shall receive a copy of every entry made in the register of clinical establishments in digital format from each authority, including any other authority established for the registration of clinical establishments under any other law currently in force, in whatever format may be mandated, in order to make sure that the State Register is constantly up to date with the registers maintained by the registering authority in the state.
Every state government should keep a record known as the “state record of clinical establishments” in digital form, comprising such particulars as may be stipulated by the Central Government with respect to clinical establishments in that state.
Under Section 38, every state government must provide the Central Government with a digital copy of the state register of clinical establishments. It must notify the Central Government of all additions to and other changes made to the register by the 15th day of the month following the month in which they were made.
The National Register of Clinical Establishments, an amalgamation of the State Register of Clinical Establishments maintained by the State Governments, constitutes an All India Register that the Central Government is responsible for maintaining in digital format. The state governments are responsible for ensuring that the same is published digitally, as mandated by Section 39 of the Act.
Penalties under the Clinical Establishments (Registration and Regulation) Act, 2010
Chapter VI contains the regulations for penalties in cases of default. If someone works for a clinic without being registered, he or she would face fines of up to Rs 50,000 in the first offence, Rs 2,00,000 in the second, and Rs 5,00,000 in every subsequent offence. A person who works in an unlicensed medical establishment faces a punishment of up to Rs 25,000. If someone breaches the Act and no further penalties are imposed, he or she may be fined up to Rs 10,000 for the first offence. The fine for the second offence might be up to Rs 50,000, and the fine in the succeeding case could be up to Rs 5 lakh.
Anyone who maintains a clinical facility without registration faces a fine of up to 50,000 rupees for the first offence, a fine of up to 2,00,000 rupees for the second offence, and a fine of up to 5,00,000 rupees for every subsequent violation. Anyone who works in a clinical establishment that is not correctly registered under this Act receives a monetary penalty of up to 25,000 rupees. After giving any individual affected a reasonable chance to be heard, the authority shall perform the necessary investigation in order to impose any monetary penalty under subsections (1) and (2) of Section 40. While carrying out an inquiry, the authority has the power to summon and require the attendance of any person acquainted with the facts and circumstances of the case to give proof or produce any document that, in the authority’s opinion, may be useful for or relevant to the subject matter of the inquiry. Then, if the authority decides that the person has infringed on the provisions specified in subsections (1) and (2), it may impose the penalty specified in subsection (2) by order.
When determining the amount of the monetary penalty, the authorities must take into account the category, size, and type of clinical establishment, as well as the local characteristics of the location in which the establishment is located. Any individual who is dissatisfied with an authority’s decision has three months from the date of the decision to file an appeal with the State Council. The process for filing an appeal pursuant to sub-section (6) is set forth in Section 41.
Under Section 42, anyone who willfully disobeys any valid direction issued by any person or authority empowered under this Act or who obstructs any person or authority in carrying out any tasks necessary or empowered by this Act should face a monetary penalty of up to 5,00,000 rupees. Anyone who willfully refuses to furnish information requested by or under this Act or who submits information he knows to be false or does not believe to be true should face a monetary penalty of up to 5,00,000 rupees. To establish whether any monetary punishment is justified under subsections (1) and (2), the authority shall undertake the necessary investigation after giving any individual interested a reasonable opportunity to be heard.
While conducting an inquiry, the authority can summon and compel the presence of any person acquainted with the facts and circumstances of the case to give proof or produce any document that, in the authority’s opinion, may be useful for or related to the subject matter of the inquiry. If the authority determines that the individual in question has violated the provisions specified in sub-sections (1) and (2) of Section 42, it may impose the penalty specified in subsection (8). When determining the amount of the monetary penalty, the authorities must take into account the category, size, and kind of clinical establishment, as well as the local characteristics of the region in which the establishment is located. Anyone dissatisfied with an authority’s decision has three months from the date of the decision to file an appeal with the State Council. The manner in which an appeal under subsection (6) may be lodged should be specified. The monetary penalty imposed under Sections 41 and 42 shall be credited to the account specified by the order of the state government.
Whoever violates any provision of this Act or any regulation made thereunder, resulting in inadequacies that do not pose an urgent threat to any patient’s health or safety and that may be addressed within a reasonable time, will be fined up to ten thousand rupees under Section 43 of the Act.
When an individual violates any provision of this Act or any rule made thereunder, every person who is in charge of and accountable to the company for the conduct of the company’s business at the time the violation occurred, as well as the company, is deemed guilty of the violation and liable to fine: However, nothing in this subsection shall subject any such person to penalty if he proves that the violation was committed without his knowledge or that he used all reasonable care to avoid its occurrence.
Regardless of what is stated in sub-section (1), if a company violates any provision of this Act or any rule made thereunder and it is established that the violation occurred with the consent or connivance of, or is attributable to, any director, manager, secretary, or another officer of the company, such director, manager, secretary, or other officer is deemed to be guilty of the violation under Section 44.
If any department of government commits an offence under this Act within six months of its enactment, the head of the department is considered guilty of the offence and may be prosecuted and punished accordingly under Section 45. However, nothing in this section shall subject the Head of Department to penalty if he proves that the offence was committed without his knowledge or that he took all reasonable efforts to prevent it from being committed. Regardless of what is stated in sub-section (1), if an offence under this Act is committed by a department of government and it is proven that the offence was committed with the consent or connivance of, or is attributable to, any officer other than the Head of the Department, then that officer is also deemed guilty of the offence and is prosecuted and punished accordingly.
Under Section 46, if an individual refuses or fails to pay the fine, he or she may be issued a certificate by the State Council of Clinical Establishments specifying the amount payable from that person and having it signed by an authorised officer. This certificate will be sent to the Collector of the district where the non paying party owns property, resides, or conducts business, and the Collector will proceed to collect the amount specified in the certificate from the non paying party as if it were an arrear of land revenue.
Classification of clinical establishments under the Clinical Establishments (Registration and Regulation) Act, 2010
The Act gives the Central Government the authority to categorise clinical facilities into various systems. As a result, the Central Government divided it into two categories: allopathic and AYUSH. Various criteria have been established for various facilities that use a range of medical approaches.
According to the Clinical Establishment Act of 2010, allopathic hospitals are classified into four levels:
Level 1 hospital
- Level 1 Hospital (A): General medical services, including indoor admission, are supplied by recognised allopathic medical graduates, and general dentistry services, including indoor admission, may be offered by recognised BDS graduates. PHCs, government and private hospitals, and nursing homes, for example, are all administered by MBBS physicians.
- Level 1 Hospital (B): This level of the hospital should include all general medical services offered at level 1 (A) above, as well as professional medical services provided by physicians practising in one or more basic specialties, such as general medicine, general surgery, paediatrics, obstetrics and gynaecology, and dentistry, providing both inpatient and outpatient care.
Level 1 (A) and Level 1 (B) hospitals must additionally have support systems, including a pharmacy and a laboratory. For example, a general hospital, a community health centre, a sub-district hospital, a corresponding private hospital, a nursing home, a civil/district hospital in a few areas, and so on.
Level 2 hospital (non-teaching)
This level should include every service offered at levels 1(A) and 1(B), along with services offered by the other medical fields listed below, in addition to the basic medical specialties listed at level 1(B), such as orthopaedics, ENT, ophthalmology, dental, emergency with or without ICU, anaesthesia, psychiatry, skin, pulmonary medicine, rehabilitation, and so on, as well as support systems required for the above services such as pharmacy, laboratory, imaging facilities, Opera District hospitals, corporate hospitals, referral hospitals, regional/state hospitals, nursing homes, and private hospitals of comparable scope, for example.
Level 3 hospital (non-teaching) specialised services
All services provided at levels 1 (A), 1 (B), and 2 may be included, as well as services from one or more super areas of expertise with their own departments and/or dentistry, if available. Additional support systems for services such as pharmacy, laboratory, imaging facility, and operation theatre will be included. For example, corporate hospitals, referral hospitals, regional/state hospitals, nursing homes, and similar private hospitals.
Level 4 hospital (teaching)
This level will feature all level 2 services as well as possibly some level 3 facilities. It will be characterised, however, by its position as a teaching/training institution, as well as the presence or absence of superspecialities. Specialists, some of whom may be superspecialists (if available), provide tertiary healthcare services at this level. It will also have the support systems required to offer these services. It will also meet the standards of the MCI/other registration authorities for teaching hospitals and be controlled by their rules. However, teaching hospitals will be required to register under the Act for purposes other than those covered by the MCI, such as maintaining records and reporting information and statistics, as well as adhering to a range of rates for medical and surgical procedures, among others.
Template for rates display
The hospitals are required to use a specific template for displaying the different rates related to PD, investigation/diagnostic, emergencies, and so on, which is detailed in draft documents provided by the Ministry in accordance with Rules 9 (ii) and (iii) of the Clinical Establishments (Central Government) Rules, 2012. It is a standard list of medical operations as well as a standard price template for medical treatments that has been issued to the states and union territories. This, however, has not been implemented in a few states. In certain states, like West Bengal and Kerala, legislation mandates that anyone requiring the services be provided with information on fees.
Case study on the Clinical Establishments (Registration and Regulation) Act, 2010
Ahmad Nabi v. State of Uttarkhand & Ors. (2016)
In the case of (2016), Ahmad Nabi, the petitioner, filed a suit against two hospitals. The petitioner claimed in the complaint that both of these establishments were owned and operated by medical practitioners who did not have a professional medical degree. He also provided evidence that the hospitals had not been registered under the Clinical Establishments (Registration and Regulations) Act of 2010. Nabi further claimed that the surgical procedures were carried out by untrained individuals acting as surgeons with no medical degree. Following a thorough investigation and an inquiry into the qualifications of the medical practitioners and the registration status of the hospitals, Nabi’s allegations were found to be true.
It was said by the court that “once any legislative enactment is made, it is the duty of the State to implement and carry it out in letter and spirit.” It was also noted that Article 47 imposes a responsibility on governments to maintain a public health standard by vigorously enforcing the legislation that governs their operations. It is the primary responsibility of the state to maintain these public health facilities, as every person has a right to life under Article 21 of the Indian Constitution.
The Uttarakhand High Court issued the following directives:
- The Court ruled that it is the state’s obligation to shut down any public health institutions that have not been registered in accordance with the Clinical Establishments (Registration and Regulation) Act of 2010.
- The state government must also guarantee that all clinical institutions that are already registered under the 2010 Act implement the Operational Guidelines for a Clinical Establishment. Registered institutions must also adhere strictly to the criteria outlined in the Clinical Establishment Act Standard for Hospitals (Levels 1A and 1B).
- The Court also noted that many hospitals and clinics routinely subject their patients to unnecessary diagnostic testing. So, in order to counter this, the Court ordered that healthcare facilities throughout Uttarakhand refrain from subjecting patients to unnecessary diagnostic testing. Only tests necessary to diagnose the patient’s real medical condition are approved.
- Patients should not be forced to purchase expensive medicines when commonly accessible medications have the same effect. As a result, all doctors in Uttarakhand (even government doctors) are obligated to prescribe only generic medications.
- The numerous diagnostic tests or treatments performed on patients by various clinical facilities must be set by the state.
- The outside wall (one of the sides) of Intensive Care Units must be made of transparent glass with cloth curtains. It would allow the patient’s attendants to view the patient. Every 12 hours, the patient’s attendants must be informed of the patient’s well-being or condition.
Critique
Regulations like the , the , and the already regulate doctors. The Act granted regulators disproportionate power and prevented doctors from defending themselves against charges. “Regulations and Licence Raj” would worsen the tendency of recent medical graduates to avoid family practice and choose to work in specialty hospitals. Due to the strict conditions that must be included in this legislation, including the need for a minimum number of certified paramedical personnel, it will also be impossible to satisfy them owing to the skilled labour shortage that affects even government institutions. Additionally, it will boost the price of treatment, which will increase several times over.
A lot of the Clinical Establishment Act’s provisions are controversial. Many of them stem from a few broad provisions. For example, Section 12(2) states that “the clinical establishment shall undertake to provide, within the capacity of its staff and facilities, such medical examination and treatment as may be needed in order to stabilise any individual’s emergency health condition who comes or is brought to the such clinical establishment.”
This implies that all clinical institutions will be required to intervene to “stabilise” the patient before transferring a patient with an emergency medical condition. This puts an excessive burden on medical facilities. The proviso that such interventions must be made “within the scope of available staff and facilities” is included, but its interpretation will be in contention.
The original directive from the Supreme Court dealt with giving accident victims immediate life-saving aid. It is impractical, unrealistic, and unjust to expect doctors to use it in all emergency situations. Such restrictions offer doctors a compelling reason to oppose regulation in general. Indeed, the legitimacy of this section may be contested by medical organisations, which caused problems with the Act’s adoption.
Also, no provision is made for additional machinery to handle the increased workload brought on by regulating private clinical establishments. Therefore, either the Act is not implemented, or it is carried out ineffectively; either way, both honest physicians and their patients lose.
The hospital owners can only appeal through the state council to a district health authority. There are hundreds of medical establishments in every state, so there will undoubtedly initially be many conflicts with the district registering authority. For any work pertaining to these concerns, these doctors will need to go to the state capital. The Jan Aarogya Abhiyan proposed the creation of a “multistakeholder district advisory committee” to advise the district authority when the Bombay Nursing Home Registration Act’s rules were being drafted in 2005. This would have provided a forum for discussion with the district registering authority and, consequently, some accountability at the district level. This suggestion was denied. Such suggestions may still be made if all parties pressure the administration.
There are several more challenges, all of which call for proactive, active interaction with the relevant authorities. The central government then said that it would develop a “National Standard Treatment Policy”. In order to prevent patients from being overcharged or over-drugged during treatment, this policy is intended to guarantee that doctors employ the best available treatments and only prescribe the necessary amount of medications.
Conclusion
Health and human rights advocates have been calling for more thorough scrutiny of medical establishments and healthcare systems for at least 20 years. Along with a more widespread desire for more efficient public health services, this demand has concentrated on various issues, including mental health care, primary healthcare, and sex-selective abortions, to mention a few. Additionally, allopathic professionals have received rising recognition of potential discussions between allopathy and other Indian medical systems. At the same time, there has been widespread resistance among medical professionals to regulations. The regulation under the is the most striking example.
This Act came into being as a response to the call for greater scrutiny following the escalating malpractices and blatant carelessness. In terms of its objective, it is a welcome move. However, in terms of its operational components, there are too many gaps, which might very well mean that it cannot be put into effect. Finally, professional organisations and individual practitioners need to keep coming back to the issue of self-regulation, transparency, and its future in relation to clinical establishments. Resistance to unethical, unlawful practices and the commercialization of healthcare must come from within.
The Act contains numerous flaws and unresolved difficulties, and it is far from perfect. However, one must keep in mind that there are a variety of demands from a variety of stakeholders when passing an act. The country’s clinical establishments must be open and responsible in order to enhance the quality of healthcare provided there.
While the aforementioned effort is commendable, it is insufficient to address the medical industry’s problems. It is necessary to approach the matter from a much wider and more thorough perspective. The need of the hour is to develop a comprehensive action plan dedicated to medical negligence and medical malpractice in order to govern all areas of the conduct of doctors and hospitals delivering health services to Indians.
Frequently asked questions (FAQs)
What is a clinical establishment?
A clinical establishment is defined as a hospital, maternity home, nursing home, dispensary, clinic, or any other facility that provides services or facilities for illness, injury, deformity, abnormality, or pregnancy under any recognised system of medicine. It also includes laboratories and diagnostic centres, as well as any other location where pathological, bacteriological, genetic, radiological, chemical, or biological investigations or other services are performed using laboratory or other medical equipment.
Are there any specific clinical institutions that fall outside the scope of the Act?
This Act does not apply to clinical institutions owned, controlled, or administered by the Armed Forces. Clinical establishments exempted by the state government, as well as those situated in the states/UTs listed in the Act’s schedule, unless these states/UTs repeal their current Act and adopt the Clinical Establishments Act.
Under this Act, who is responsible for registering a clinical establishment?
Under this Act, the owner of the clinical establishment has the responsibility for registering the clinical establishment.
Do I need to reapply for registration if I buy/rent a registered clinical establishment?
In the case of a change in ownership/management, the clinical facility must notify the authorities in writing, signed by both the former and new owners.
Who is the registering authority?
The District Registering Authority, a multi-member authority at the district level, is the registering authority for clinical establishments operating in that district.
What are the institutional frameworks established by this Act?
- The Central National Council for Clinical Establishments
- At the state level, there is a State Council for Clinical Establishments.
- The District Registering Authority is located at the District Headquarters level.
Is it necessary for a clinical facility to display its registration certificate?
Yes, the certificate should be displayed in a prominent location where it can be seen clearly.
Where should one register their clinical facility? Or, what is the registration procedure?
If an application is made in person or by mail, it should be sent to the district registering authority (i.e., the District Health Officer / Chief Medical Officer) in the prescribed proforma along with the prescribed fee.
What is provisional registration?
There are two kinds of registration: provisional and permanent. Provisional registration is granted ‘as is, where is basis.’ Provisional registration would be granted within 10 days after filing the application.
What exactly is permanent registration?
Once the government has notified the minimum standards for clinical establishments, permanent registration will be granted to all those who meet the notified standards for that category of clinical establishments.
What is the duration of a provisional registration certificate?
Every provisional registration is valid until the last day of the twelfth month after the date of issuing the certificate of registration, and it is renewed on an annual basis.
How will the district registration authority be established? What is the term for the district registering authority?
The district registration authority is to be established by notice from the state government. The three nominated members of the district registering authority serve for a term of two years.
References
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