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This article is written by Shriya Singh. The article seeks to discuss in depth pertaining to the provisions of the Clinical Establishments (Registration and Regulation) Act, 2010. It provides provision-wise detail regarding all the seven chapters of the Act. It covers the establishment of the National Council as well as the State or Union Territory Council of clinical establishments and the registration process for them. It further provides for the provisions regarding the functioning of such clinical establishments and penalties in the course of any contravention.

Table of Contents

Introduction 

The Clinical Establishment Act, 2010 (from now on to be referred to as Act, 2010) addresses issues related to or incidental to the registration and regulation of clinical institutions throughout the nation. 

In order to fulfil the mandate of Article 47 of the Constitution of India to improve public health, it is deemed necessary to provide for the registration and regulation of clinical establishments to establish minimum standards of facilities and services that they may offer. 

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Furthermore, in accordance with Article 252(1) of the Constitution of India, resolutions have been passed by the legislatures, stating that parliament should regulate the matters related in such States by law, of all the four states, namely – 

  1. Arunachal Pradesh,
  2. Himachal Pradesh,
  3. Mizoram, and
  4. Sikkim. 

Parliament has no authority to make laws for the states regarding any of the matters stated above except for the matters that are provided in Article 249 and Article 250 of the Constitution of India.

The Act, 2010 comprises 7 chapters and 56 sections in toto.

Let us discuss the Act, 2010 in detail.

Chapter I- Preliminary

Chapter I of the Act, 2010 provides for provisions regarding the applicability of the Act. It further provides for definitions of various terms that would be important in the better understanding of the Act in toto.

Let us discuss the provisions in detail.

Application

Section 1(2) provides that the Act, 2010 first and foremost applies to the entire States of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim as well as the Union Territories.

The provision further states that the Act shall be applicable to any other state that adopts it by resolution enacted in that regard under Article 252(1) of the Constitution of India.

Important Definitions

Section 2 of the Act, 2010 provides for various definitions from Section 2(a) to Section 2(o) to facilitate a better understanding of the provisions of the entire Act. 

Let us discuss some important definitions of the Act.

Clinical establishment

According to Section 2 (c) of the Act, 2010, “clinical establishment” is defined as: 

  • A hospital, maternity home, nursing home, dispensary, clinic, sanitorium or any other type of institution that provides services and facilities necessary for the diagnosis, treatment or care of illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any individual or body of individuals, whether incorporated or not.
  • An establishment that is either standalone or a component of the previously mentioned establishment and is used for the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical biological or other diagnostic or investigator services are performed with the use of laboratory or other medical equipment. The services can be established, administered or maintained by any individual or group of individuals, whether they are incorporated or not. These include a clinical Establishment that is controlled or managed by: 
  • The government or department of the government,
  • A trust, either private or public,
  • A company including a society that is registered under a Central, Provincial or State Act, regardless of whether the government own it or not,
  • A local government, and 
  • A single physician or doctor but excludes any clinical Establishment that is owned, operated or managed and controlled by the Armed Forces.

The explanation to this section provides that  Armed Forces means the forces constituted under the:

Emergency medical condition

Section 2(d) defines the term “emergency medical condition”. It states that it refers to any medical illness exhibiting acute symptoms severe enough, including extreme pain, that one may reasonably expect, in the event that prompt medical assistance is not received, to result in:

  • Putting in grave danger the health of the person or in the case of a pregnant woman the health of the mother or her unborn child, 
  • Severe impairment of physiological processes,
  • Severe malfunction of any physical component or organ of a body.

Recognised system of medicine

Section 2(h) of the Act, 2010 states that a “recognised system of medicine” refers to any medical system that the central government may recognise. It may include- 

  • Allopathy, 
  • Yoga, 
  • Naturopathy, 
  • Ayurveda, 
  • Homoeopathy, 
  • Siddha, and 
  • Unani.

To stabilise

Section 2(o) of the Act, 2010 defines the term “to stabilise”. It states that concerning an emergency medical condition, the term “to stabilise” with its grammatical variations and cognate expressions, means to provide such medical treatment as may be necessary to ensure that no material deterioration of the condition is likely to result from or occur during the transfer of an individual from a clinical establishment, within a reasonable medical probability.

Chapter II- The National Council for Clinicial Establishment

Chapter II of the Act, 2010 provides for provisions regarding the establishment of the National Council of Clinical Establishment, and disqualifications regarding the appointment of members in such council. It further entails provisions regarding the functions of the National Council and empowers it to seek assistance.

Let us discuss the provisions in detail.

Establishment of the National Council

According to Section 3(1), a council to be known as the National Council for Clinical Establishments must be created for the purpose of this Act. This National Council would be effective from such date that the central government may by notification appoint in this regard.

Section 3(2) of the Act, 2010 provides for the composition of the National Council of Clinical Establishment. The provision states that the National Council consist of the following members- 

  • An ex officio, the director general of the Health Service from the  Ministry of Health and Family Welfare. He shall be the chairperson of the council. 
  • There would be four representatives each of whom would be elected by the:

Section 3(3) provides that the National Council members who are nominated will serve 3 years term of office. Also, those members will be entitled to re-nomination for a maximum of three years term. 

According to Section 3(4), the elected members of the National Council will serve a term of 3 years but they will be eligible for re-election. However, the nominee or elected official will remain in office until they are appointed to the position for which they are nominated or elected, whichever that may be.

Section 3(5) states that the members of the National Council are eligible to receive any allowance that the central government specify and deems fit.

Section 3(6) envisages that the National Council may establish bylaws defining a quorum for it. Also, regarding the regulation of its own procedure and conduct of all the business that would be transacted by it. However, such bye-laws are to be established with prior approval of the central government.

Section 3(7) states that the National Council must convene a meeting at least once in every 3 months.

According to Section 3(8), the National Council has the authority to form sub-committees and designate individuals who are not National Council members to serve on such sub-committees for a maximum period of 2 years in order to address certain issues. 

Section 3(8) states that the National Council may continue to perform its duty irrespective of the vacancy. 

Section 3(9) provides that the secretary of the National Council will be appointed by the central government. The central government is also empowered to appoint such other secretaries and other staff in the National Council as it may deem necessary, as per Section 3(10).

Disqualifications for appointment as a member

Section 4 of the Act, 2010 provides that an individual will not be eligible to be chosen as a member of the National Council if-

  • He has been found guilty of an offence and has been given an imprisonment term because the central government is of the opinion that the offence entails moral turpitude,
  • He is an undischarged insolvent,
  • He has a competent court pronounced him to be mentally incompetent or of unsound mind,
  • He has been removed or dismissed from the service of the government or a corporation that is owned or controlled by the government, or
  • He has financial or other interests in the council that might adversely impact his ability to perform his duties as a member of the National Council and Central Government is of such opinion.

Functions of the National Council

Section 5 of the Act, 2010 states that the following are the functions that will be carried out by the National Council- 

  • The National Council has to gather and publish a national registry of clinical institutions within 2 years of the enactment of this Act, 
  • The council has to divide clinical facilities into several groups or different categories,
  • It has to create minimal requirements pertaining to standards and schedule regular reviews for them,
  • The council would develop the first set of guidelines for clinical establishments to follow in order to guarantee appropriate health care within 2 years of its founding, 
  • It is required to compile data pertaining to the healthcare facilities or clinical establishments, and 
  • It is required to carry out such additional duties as periodically decided by the central government.

Power to seek advice or assistance

Section 6 states that the National Council may affiliate or associate with any individual or entity whose assistance or support it finds necessary in executing the provisions of this Act. 

National Council to follow a consultative process

According to Section 7, the National Council will classify clinical establishments in compliance with any procedure that may be specified by using a consultation method to determine criteria or standards, as may be prescribed.

Chapter III- Registration and Standards for Clinical Establishments

Chapter III of the Act, 2010 provides for provisions regarding the establishment of the State Council of Clinical Establishment. It also gives the provisions for the provision of information to the National Council. Also covers the provisions for authority for registration and conditions for such registration as well as classification of the clinical establishments.

Let us discuss the provisions in detail.

State Council of Clinical Establishments

Section 8 of the Act, 2010 provides for the State Council of clinical establishments. 

Section 8(1) states that a state council of clinical establishments or a union territory council for clinical establishments must be established by notification from each state government, as appropriate. 

Section 8(2) provides a list of individuals that would constitute these state councils or union territory councils, as the case may be. Such individuals are- 

  • An ex-officio secretary of health who will serve as chairman,
  • Member secretary ex-officio would be the director of health services,
  • Ex officio members who serve as directors of several Indian systems of medicine in different streams,
  • There would be one representative who is required to be fixed from the committee of- 
  1. The State Medical Council of India, 
  2. The State Dental Council of India, 
  3. The State Nursing Council of India, and 
  4. The State Pharmacy Council of India. 
  • They would be three representatives from the Ayurveda Siddha and Unani medical systems who are required to be chosen by the executive of the state council or the union territory council, depending on the situation,
  • One representative to be elected by the state council of the Indian Medical Association,
  • One delegate to be chosen from the line of the paramedical systems,
  • Two representatives from the consumer associations at the state level or reputable non-governmental organisations involved in the health sector,

Section 8(3) of the Act, 2010 provides that the designated or nominated members of the state council or the union territory council, as suitable, will serve a time period of 3 years in office and would be eligible for renomination for a maximum of one more term of period of 3 years.

Section 8(4) states that the elected members of the union territory council or the state council, as applicable, would be eligible for re-election for the further term of 3 years in office with one restriction. It states that the nominee or elected individual will remain and office for the duration of their appointment to the state council or union territory council, as applicable, in accordance with their nomination or election. In simple words, it means that such members who are nominated would serve the state council or the union territory council, as the case may be, until the time his appointment holds in the office, by virtue of which he was nominated or elected. 

Section 8(5) envisages the functions of the State Council of Clinical Establishment or the Union Territory Council for Clinical Establishment. They are given as follows – 

  • They are required to assemble and maintain the register for the clinical Establishment,
  • They have to submit monthly reports to keep the national register up to date,
  • They pose as representatives of state or union territory in the National Council,
  • They are empowered to consider and here appeal against the order of the authority, and
  • They are required to publish an annual report on the status of standard implementation in their respective States or Union Territories as the case may be.

Providing information to the National Council

Section 9 of the Act, 2010 talks about providing information to the National Council. The provision states that the state council for clinical establishments will be in charge of gathering and maintaining the state register of clinical establishments in the particular state. 

Furthermore, it states that it would also send monthly returns to update the national register, in the digital format.

Authority for registration

Section 10 provides provisions regarding authority for registration. 

Section 10(1) states that the state government may establish a district registering authority for the purpose of registering clinical establishments in each district, by notification. The provision further states that the authority shall consist of the following members- 

  • The District Collector would act as the Chairman of such authority,
  • The Convener of the authority would be the District Health Officer, and 
  • There would be three members who would meet the requirements and agree to the terms and circumstances that the central government may specify.

Section 10(2) further states that the district health officer or the chief medical officer, by whatever title they may go by, shall exercise the authority in accordance with the procedure that may be prescribed for the purpose of registering the clinical establishments under Section 14.

Registration for clinical establishments

Section 11 of the Act, 2010 provides that no person is allowed to run a clinical establishment in the state or union territory until and unless it has been duly registered in accordance with the provisions of this Act.

Conditions for registration

Section 12 provides conditions for registration of the clinical establishments.

Section 12(1) provides that to be registered and remain an operation each clinical Establishment must meet to requirements that are listed below-

  • The minimum standard or requirement of facilities and services that might be prescribed, 
  • The bare minimum requirement of personnel that may be necessary,
  • Any requirement that may be specified regarding maintenance of reporting and record-keeping, and 
  • Such other conditions that may be prescribed on this behalf.

Section 12(2) entails that any person who visits or is taken to the clinical establishment will be given the necessary medical evaluation and treatment within the limits of staff and facilities available to stabilize their emergency medical condition.

Classification of clinical establishments

Section 13 provides for the classification of clinical establishments. 

Section 13(1) entails that the categorization of clinical establishments across various systems will follow any guidelines that the central government may prescribe from time to time.

Section 13(2) provides that various standards or criteria may be stipulated for the categorization of distinct categories with the understanding that the central government would take local conditions into consideration while establishing requirements for the clinical establishments of states or union territories, as the case may be.

Chapter IV- Procedure for Registration

Chapter IV of the Act, 2010 provides for provisions regarding the application for registration of clinical establishment, provisional certificate, display of the certificate, validity of provisional registration, cancellation, inspection, appeal, etc.

Let us discuss the provisions in detail.

Application for provisional certificate of registration

Section 14 of the Act,2010 provides for provisions regarding the application for provisional certificate of registration.

Section 14(1) states that the authority must receive an application in the appropriate performa and along with the necessary fee in order to register the clinical establishment under Section 10.

Section 14(2) further states that the application must be submitted by post or online via mail.

Section 14(3) provides that the application must be submitted in the format and with the supporting documentation that may be required by this Act or any regulations enacted under it.

Section 14(4) further states that a clinical establishment that is ready in operation at the time this Act is enacted must apply for registration within a year from the commencement of the Act. Also, a clinical establishment that is established after the commencement of the Act, must apply for permanent registration within 6 months of the commencement date of the Act.

Section 14(5) states that a Clinical Establishment must apply for registration in accordance with Section 4(1) even if it is already registered under an existing legislation requiring such registration.

Provisional certificate

Section 15 of the Act, 2010 provides for provision regarding the provisional certificate.

It states that within 10 days of receiving the application, the authority must provide the applicant with a certificate of provisional registration in the format and with the details and information that may be required.

No inquiry before provisional registration

Section 16 of the Act, 2010 provides for provisions regarding no inquiry prior to provisional registration. 

Section 16(1) states that before planting a provisional registration, the authority is not permitted to carry out any investigation.

Section 16(2) further provides that in spite of the provisional certificate of registration being granted, the authority must publish all relevant information about the clinical establishment that was provisionally registered in a prescribed manner within 45 days of the provisional registration being granted.

Validity of provisional registration

Section 17 of the Act, 2010 provides for provisions regarding the validity of provisional registration. 

It states that all provisional registrations are renewable and valid until the final day of the twelfth month from the day a certificate of registration was issued subject to the conditions of Section 23.

Display of certificate of registration

Section 18 of the Act, 2010 provides for provisions regarding the display of certificate of registration. It states that it is required that the certificate be prominently displayed at the clinical establishment so that everyone who visits may visibly see it.

Duplicate certificate

Section 19 of the Act, 2010 provides for provisions regarding the duplicate certificate.

It states that in the event that the certificate is misplaced, destroyed, altered or damaged, the authority will upon request from the clinical establishment and upon payment of any applicable fee, issue a duplicate certificate.

Certificate to be non-transferable

Section 20 of the Act, 2010 provides for provisions regarding the non-transferability of certificates.

Section 20(1) explicitly states that the registration certificate is not transferable.

Section 20(2) provides that the clinical establishment shall notify the authority of any change in ownership or management in the manner as may be prescribed.

Section 20(3) further provides that is certificate of registration for a clinical establishment must be resorted to the appropriate authority in the event that the establishment changes categories, relocates or stops operating as a clinical establishment. The clinical establishment must then re-apply to be granted a certificate of registration afresh.

Publication of expiry of registration

Section 21 of the Act, 2010 provides for provisions regarding the publication of the expiry of registration.

It states that the names of clinical establishments whose registrations have expired must be disclosed by the authority in the manner and within the time frame that may be specified.

Renewal of registration

Section 22 of the Act, 2010 provides for provisions regarding the renewal of registration.

The provision states that the request to renew registration must be submitted 30 days prior to the expiry of the certificate of provisional registration. If the request is submitted after the provisional registration has expired, the authority will permit the renewal of registration in exchange for the additional fee that may be prescribed. 

Time limit for provisional registration

Section 23 of the Act, 2010 provides for provisions regarding the timeline for provisional registration.

It states that in cases where the Central Government has issued requirements for clinical establishments, interim registration cannot be granted or renewed beyond the following- 

  • For clinical establishments that were founded prior to the effective date of this Act, the two years after the date of notice of the standards,
  • For clinical establishments that are established after the incorporation of this Act but before the standards are notified, the two-year period from the date of notice of the standards, and 
  • 6 months from the date of standard notice for clinical establishments that are established subsequent to the announcement of standards.

Application for permanent registration

Section 24 of the Act, 2010 provides for provisions regarding the application for permanent registration.

It states that a clinical establishment must submit an application for permanent registration to the authorities using the form and any applicable fees that may be specified.

Verification of application

Section 25 of the Act, 2010 provides for provisions regarding the verification of application.

It provides that the clinical Establishment must provide evidence in the way that may be prescribed that it has completed with the minimum standards.

Display of information for filing objections

Section 26 of the Act, 2010 provides for provisions regarding the display of information for filing objections.

It states that the authority must arrange for all pieces of evidence submitted by the clinical Establishment to have complied with the prescribed minimum standards to be displayed for public viewing an object filing, if any. Such objection must be sent in the prescribed manner. Such display must be made as soon as the clinical establishment summits the necessary proof of having done so. This display must last for 30 days before the application for permanent registration is processed.

Communication of objections

Section 27 of the Act, 2010 provides for provisions regarding the communication of objections.

It states that if objections are received in the time frame mentioned, they must be reported to the clinical establishment and answered within 45 days.

Standards for permanent registration

Section 28 of the Act, 2010 provides for provisions regarding the standards for permanent registration.

It states that only once a clinical establishment satisfies the requirements set out by the central government for registration can it be given permanent registration.

Allowing or disallowing registration

Section 29 of the Act, 2010 provides for provisions regarding allowing or disallowing of registration.

It states that after the allotted time has passed, the authority must issue an order either immediately or within the following 30 days, either- 

  • Approving the permanent registration application, or
  • Rejecting the application. 

However, in the event that an application is rejected, the authority will document its reasoning for permanent registration.

Certificate of permanent registration

Section 30 of the Act, 2010 provides for provisions regarding the certificate of permanent registration.

Section 30(1) states that the authority will issue a certificate of permanent registration in the format and with the information that may be prescribed if it approves the application of clinical establishment for the same.

Section 30(2) states that after the date of issuance, the certificate will be valid for a period of 5 years

Section 30(3) states that the provisions of Sections 18,19,20 and 21 shall also be applicable for the purpose of Section 30(1)

Section 30(4) provides that applications for permanent registration renewal must be submitted not later than 6 months prior to the expiry of the certificate of permanent registration. If the application is not submitted within the allotted time period, the authority may permit registration renewal on the payment of an additional fee and penalty that may be prescribed in that regard. 

Fresh application for permanent registration

Section 31 of the Act, 2010 provides for provisions regarding the fresh application of permanent registration.

It states that the disallowing of a permanent registration application does not preclude a clinical establishment from submitting a new application under Section 24 after supplying any necessary evidence that the deficiency that led to the denial of the previous application has been addressed. 

Cancellation of registration

Section 32 of the Act, 2010 provides provisions regarding the cancellation of registration. 

Section 32(1) states that after a clinical institution or establishment has been registered, the authority may send a notice to the clinical establishment to show cause within 3 months as to why its registration under this action not be cancelled for the reason specified in the notice, if at any point it is convinced that-

  • The conditions of registrations are not being followed, or 
  • The person in charge of the management of the clinical establishment has been found guilty of an offence punishable under this Act. 

Section 32(2) provides that the authority mechanical the registration of a clinical establishment by order, without affecting any other actions it may take against it if it is satisfied that any of the provisions of this act or the rules made there under it have been violated after providing a reasonable opportunity to the clinical establishment of being heard in light of natural justice.

Section 32(3) provides that every order taken will be effective-

As soon as the allotted time period for an appeal against the order expires, if no appeal has been filed, or 

As soon as the appeal has been filed and dismissed, starting from the date of the order of dismissal. 

Provided that as long as there is no urgent threat to the health or safety of the patient, the authority may immediately suspend the operations of the clinical establishment following the revocation of registration for reasons that must be documented in writing.

Inspection of registered clinical establishments

Section 33 of the Act, 2010 provides for provisions regarding the inspection of registered clinical establishments.

Section 33(1) states that the authority or an officer designated by it shall have the authority to cause an inspection of or inquiry into any registered clinical establishment including its structure laboratories and equipment as well as the work the clinical establishment conducts or completes. The inspection may be conducted by a multi-member inspection team and the clinical establishment shall be entitled to be represented at the inquiry.

Section 33(2) further states that the authority will inform the clinical establishment of its opinions and about the findings of the inspection or inquiry. Once the clinical establishment has been consulted, the authority may advise the establishment on the appropriate course of action.

Section 33(3) provides that following an inspection or inquiry, the clinical establishment is required to report to the authority any action that has been taken or is intended to be taken. This report must be provided within a time frame that the authorities specify in this regard.

Section 33(4) purports that if, within a reasonable time frame, the clinical establishment fails to satisfy the authority, the authority mein after taking into account any justification offered or representations made by the clinical establishment, issues such directions within the time frame specified in the direction as the authority may deem appropriate. The clinical establishment shall abide by such directions dutifully.

Power to enter

Section 34 of the Act, 2010 provides provisions regarding the power to enter. 

It provides that the clinical establishment shall provide reasonable facilities for inspection or inquiry and be entitled to be represented there. However, no such person shall enter the establishment without giving notice of his intention to do so. The authority or an officer authorised by it may enter and search in the manner prescribed at any reasonable time if there is any reason to suspect that anyone is carrying on a clinical establishment without registration.

Levy of fee by State Government Appeal

Section 35 of the Act, 2010 provides for provisions regarding the levy of fees by the State Government.

It purports that the state government may impose fees on different categories of clinical establishments as may be prescribed.

Appeal

Section 36 of the Act, 2010 provides for provisions regarding appeal.

Section 36(1) states that anybody who feels aggrieved by an order made by the registry authority that denies them a certificate of registration renews their registration certificate or revokes their certificate of registration may file an appeal with these State Councils in a way and within the time frame that is specified by the State Council. However, the state Council may consider an appeal filed after the expiry of such prescribed period if it determines that the apparent was prevented from filing the appeal in a timely manner for a reason valid enough to explain the delay.

Section 36(2) further states that the appeal must be submitted in the format specified and it shall be accompanied with any fees that are prescribed in this regard.

Chapter V- Register of Clinical Establishments

Chapter V of the Act, 2010 provides for provisions regarding the register of clinical establishment. Also, the provision entails the maintenance of state as well as national registers.

Let us discuss the provisions in detail.

Register of clinical establishments

Section 37 of the Act, 2010 provides for provisions regarding the register of clinical establishments. 

Section 37(1) purports that the authority must gather, publish and maintain a register of clinical establishments that it has registered within 2 years of its incorporation, in the digital format. It must also enter the details of the certificate it has issued in a register that will be kept in the format and style that the respective state government may specify.

Section 37(2) entails that to guarantee that the state register is always up to date with the registers maintained by the registering authority in a state, each authority shall provide a copy of every entry made in the register of clinical Establishment in digital format to the state council of clinical establishments in the manner that may be prescribed. It shall be further noted that such above-mentioned authority includes any other authority that has been set up for the registration of clinical establishments under any law currently in effect, for the specific purpose of this provision.

Maintenance of State Register of clinical establishments

Section 38 entails provisions regarding the maintenance of the state register of clinical establishments. 

Section 38(1) provides that for the benefit of a particular clinical establishment, the respective state government is required to keep a record known as the state record of clinical Establishment which must be maintained in digital format and with such information that the central government may specify on this behalf.

Section 38(2) further provides that each state government shall provide a copy of the state register of clinical establishments to the central government in digital format. Furthermore, the state government shall notify the central government by the 15th day of the subsequent month of any additions or modifications that are made to the state register of clinical establishments for that particular month.

Maintenance of the National Register of Clinical Establishments

Section 39 of the Act, 2010 provides for provisions regarding the maintenance of a national register for clinical establishments.

The provision states that these state registers of the State Government for clinical establishments will be combined into one register which would contain the particulars regarding all over India clinical establishments. Such all India register would be known as a national register for clinical establishments. Further, the central government will maintain this register in digital format and will arrange for it to be published in such format as well.

Chapter VI- Penalties

Chapter VI of the Act, 2010 provides for penalties regarding non-registration and minor deficiencies. It also covers the provisions regarding the contravention by companies and government departments. Also, provides for the recovery of fines.

Let us discuss the provisions in detail.

Penalty

Section 40 of the Act, 2010 talks about penalties. It states that if no punishment or penalty is specified anywhere else, then, anyone found in violation of any of the provisions of this Act would be subjected to penal consequences. The punishment would be in the manner stated below-

  • A fine up to the amount of ten thousand rupees for the first offence, 
  • Fifty thousand rupees for the second offence, and 
  • Five lakh rupees for subsequent offences.

Monetary penalty for non-registration

Section 41 of the Act, 2010 entails provisions regarding the monetary penalty for non-registration situations.

Section 41(1) states that anybody operating a Clinical Establishment without registration faces financial penalties in such manner- 

  • penalty up to the amount of fifty thousand rupees for the first offence, fine up to the amount of two lakh rupees for the second offence, and 
  • fine up to the amount of five lakh rupees for any subsequent offences.

Section 41(2) states that anybody who intentionally works in a clinical establishment that is not properly licensed under this Act would face a penalty of fine that may extend up to the amount of twenty-five thousand rupees. 

According to Section 41(3), in order to make a decision and impose any financial penalty upon any clinical establishment or anyone related to it, the authority must convene and enquiry in the way specified after providing a fair chance of representation to the alleged, in the light of principles of natural justice.

Section 41(4) envisages that if after conducting an enquiry it is determined that the subject has not complied with the specified provisions, the authority may impose the monetary penalty by order regarding them. Such penalty has to be deposited within 30 days of the order in the account that the state government may specify as per Section 42. Furthermore, the authority shall have the power to summon and enforce the attendance of any person who is well acquainted with the facts and circumstances of the case in order to give testimony or to produce any document which may be useful or relevant to the subject matter of the inquiry in the opinion of the authority.

As per Section 41(5), two factors should be taken into consideration by the authority when establishing the amount of financial penalties. They are as follows –

  • the category, size and type of the clinical establishment, and 
  • the local characteristics of the region in which the establishment is situated.

Section 41(6) states that within 3 months of the date of the decision, anybody who feels aggrieved by the judgement of the authority may file an appeal with the State Council.

Section 41(7) further provides that the appeal must be filed in accordance with the provision that may be prescribed.

Disobedience of direction, obstruction and refusal of information

Section 42 of the Act, 2010 provides for provisions regarding the disobedience of direction, obstruction and refusal of information.

Section 42(1) purports that a monetary penalty of up to the amount of five lakh rupees shall be imposed upon anyone who willfully disobeys a lawful direction given by any person or authority authorised under this Act to give such a direction. The fine also extends to anyone who obstructs any person or authority in the performance of a function that such person or authority is required or empowered under this Act to perform.

Section 42(2) states that anybody who knowingly withholds information that they are required by this Act to provide or provides information that they know is incorrect or that they do not believe to be accurate will be subjected to a fine that might extend up to the amount of five lakh rupees. 

According to Section 42(3), after providing any affected party with a reasonable chance to be heard, the authority shall convene an inquiry in a manner that is provided for adjudication and impose any monetary penalty. 

Section 42(4) provides that if after conducting an enquiry it is determined that the subject has not complied with the specified provisions, the authority may order the imposition of the monetary penalty which is specified under the offences. The amount of fine is required to be deposited in the account that is specified by the state government, within 30 days from such order. The authority may also summon and in force the attendance of any person who is well acquainted with the facts and circumstances of the case to give testimony or to produce any document that may be, in the opinion of the authority, useful or relevant to the subject matter of the inquiry. 

According to Section 42(5), there should be two factors taken into account by the authority when establishing the amount of monetary penalty, they are as follows – 

  • The category, size and type of the clinical establishment, and
  • The local characteristics of the region in which the establishment is located. 

Section 42(6) states that anybody who feels aggrieved by the judgement of the authority may file an appeal with the State Council within 3 months of the date of the decision.

Section 42(7) provides that the appeal must be filed in accordance with the procedure that is prescribed. 

As per Section 42(8), the monetary penalty that is assessed under Sections 41 and 42 will be credited to the account that the state government may designate in this regard, by order.

Penalty for minor deficiencies

Section 43 of the Act, 2010 provides for the provisions regarding the penalty of minor deficiencies.

It states that a punishment of up to the amount of ten thousand rupees may be imposed on anybody who violates the provisions of this Act or any regulation issued there under. Such a violation must result in inadequacy that does not immediately endanger the health and safety of any patient and which may be resolved within a reasonable amount of time.

Contravention by companies

Section 44 of the Act, 2010 provides for provisions regarding the contraventions done by the companies. 

Section 44(1) provides that if any company contravenes any of the provisions of this Act or any rules made there under it, everyone who was in charge of and accountable to the company for the business conduct of the company at that time when such violation was made would be considered guilty of the same and will be subjected to a monetary penalty. 

However, such a fine would not apply if the person can demonstrate that the violation was committed without their knowledge or that they took all reasonable precautions and due diligence to stop it from happening.

Section 44(2) further provides that if a company violets any of the provisions of this Act or of any rules made thereunder and it is established that any director, manager, secretary or other officers of the company participated in that violation or that the violation was the result of their negligence, then, such director, manager, secretary or other officers of the company will also be considered guilty of the violation and would be subjected to a monetary penalty.

The explanation attached to Section 44 provides

  • The term “company” is defined as a body corporate which might include a form or any other group of persons.
  • The term “director” in relation to the firm means a partner in that firm.

Offences by Government Departments

Section 45 of the Act, 2010 provides for provisions regarding the offences by government departments. 

Section 45(1) states that if a department of government commits an offence under this Act within 6 months of its enactment, the head of the department will be considered guilty of the offence and will face legal action and punishment. However, nothing in the section will hold the head of the department accountable for any punishment if you can demonstrate that the offence was committed without his knowledge or that he took all reasonable precautions and exercised his due diligence to prevent it from happening.

Section 45(2) provides that in the event that the department of government commits an offence under this Act and it is established that the offence was carried out with the knowledge or cooperation of any officer other than the head of the department or that the offence was caused by their negligence, such officer will also be considered guilty of the offence and will face the appropriate legal as well as penal consequences.

Recovery of fine

Section 46 of the Act, 2010 entails provisions regarding recovery of fine. 

It states that if a person does not pay the fine that is imposed upon him, the State Council of Clinical Establishment may prepare a certificate outlining the amount owed by that person. Such certificate must be signed by an authorised officer and should be sent to the collector of the district in which the non-paying individual resides owns property or conducts business. The collective will then proceed to collect the amount specified in that certificate from such an individual, just as if it were an arrear of land revenue.

Chapter VII- Miscellaneous

Chapter VII of the Act, 2010 covers all the miscellaneous provisions, such as protection regarding the actions taken in good faith, furnishing of returns, powers to give directions as well as to remove difficulties. Further, it also covers the powers of the state and Central Government to make rules.

Let us discuss the provisions in detail.

Protection of action taken in good faith

Section 47 of the Act, 2010 provides for provisions regarding the protection of action taken in good faith.

Section 47(1) states that regarding anything done or intended to be done in good faith in accordance with the provisions of this Act or any rule made thereunder, no suit, prosecution or other legal proceeding may be brought against any authority, member of the National Council, State Council or officer authorised in this behalf.

Section 47(2) further provides that if anything is done or intended to be done in good faith in accordance with the provisions of this Act or any regulations established thereunder, no action or other legal proceedings may be brought against a State Government or Central Government for any laws or damage caused or expected to be incurred.

Furnishing of returns, etc

Section 48 of the Act, 2010 provides for provisions regarding furnishing of returns.

It states that every clinical establishment is required to provide the authority, the State Council or the National Council with the returns, statistics and other pieces of information in the manner that may be prescribed from time to time by the State Government in this regard. This must be done within the time frame or the extended time frame that may be prescribed. 

Power to give directions

Section 49 of the Act, 2010 provides for provisions regarding the power to give directions.

It states that the authority shall have the jurisdiction to provide such instructions including providing returns, statistics and other information for the appropriate running of clinical establishments. Such directions shall be binding subject to the provisions of this Act.

Employees of the authority, etc., to be public servants

Section 50 of the Act, 2010 provides for provisions regarding employees of the authority to be public servants.

The provision states that Section 21 of the Indian Penal Code,1860 defines public workers to include all employees of the government, the National Council and the State Council who act or pretend to act in accordance with any of the provisions of this Act. 

Power to remove difficulties

Section 51 of the Act, 2010 provides for provisions regarding the power to remove difficulties.

Section 51(1) states that in the event that the central government encounters difficulties in implementing the provisions of this Act, pick me my order publish in the official gazette make such provisions that are not in conflict with the provisions of the act as missing necessary or expedite to resolve the issue. However, no such order may be made after the Act has been in effect for 2 years.

Section 51(2) provides that any order issued in accordance with the section should be presented to each house of parliament as soon as practical after it is made.

Power of Central Government to make rules

Section 52 of the Act, 2010 provides for provisions regarding the power of the Central Government to make rules.

Section 52(1) empowers the central government to establish rules, by notification, to implement all or any of the provisions of this Act.

Section 52(2) states that in particular and without limiting the power of the authority mentioned above, such rules must address all or any of the following matters-

  • Allowance under Section 3 (5) for the members of the National Council,
  • The central government appoints such individual to serve as the secretary of the State Council in accordance with Section 3(10), 
  • Establishing criteria and recognising clinical establishments in accordance with Section 7,
  • The requirements and guidelines set 4th in Section 10(1) for the members of the authority,
  • The process by which the Chief Medical Officer or District Health Officer may exercise the power of authority to temporarily register a clinical establishment in accordance with section 10(2),
  • The minimal requirements for amenities and services outlined in Section 12(1),
  • The bare minimum of employees required by Section 12(1),
  • The record-keeping and reporting requirements by the clinical establishment under Section 12(1),
  • The additional requirement for registration and maintenance of clinical establishment provided under Section 12(1),
  • The characterization or classification of the clinical establishment under Section 13(1), 
  • The various criteria of standards used under Section 13(2) two categorize the clinical establishments, 
  • The requirements set out for permanent registration in Section 28, and 
  • The details and formats of the register must be kept in accordance with Section 38.

Laying of rules

Section 53 of the Act, 2010 provides for provisions regarding the laying of rules made by the Central Government.

It envisages that all rules made by the Central Government under this Act shall be laid before each House of Parliament while it is in session as soon as possible after they are made. This total period must be 30 days and it may be made of one session, or two or more subsequent sessions. If, before the end of the session that follows the session or the sessions above mentioned, both houses agree to make any modification to the rule or agree that the rule should not be made, the rule will thereafter only be in effect in the modified form or have no effect, as the case may be. 

However, whatever is done earlier and in accordance with the regulation will remain lawful, not with standing any such amendment or annulment.

Bihar rules and Lakshwadeep Rules are some examples.

Power of State Government to make rules

Section 54 of the Act, 2010 provides for provisions regarding the power of state government to make rules.

Section 54(1) states that the state government may establish rules by notification for the purpose of carrying out in relation to subjects that are not covered by Section 52.

Section 54(2) provides that in particular and without limiting the power of the authority mentioned above, such rules may address all or any of the following issues- 

  • The proforma and the registration fee required by Section 14(1), 
  • The format and information required for an application under Section 14(3),
  • The details and particulars included for the certificate of temporary registration under Section 15, 
  • The process by which all information about the clinical establishment that is intended to be registered is published under Section 16, 
  • The fees associated with issuing a duplicate certificate in accordance with Section 19, 
  • The clinical institution or establishment is required to notify the authorities of any change in ownership or management under Section 20(2), 
  • How the authority will list the clinical establishment whose registration has lapsed in accordance with Section 21,
  • The higher renewal fees will be assessed in accordance with Section 22 once the provisional registration expires,
  • The application format and fees that the State Government will impose in accordance with Section 24,
  • How to provide evidence that clinical establishments have adhered to the minimum requirement provided under Section 25, 
  • To know how the information would be displayed by the clinical establishment in relation to their compliance with the minimum requirement for submitting an objection under Section 26, 
  • The conclusion of the time frame indicated in Section 29, 
  • The details and format of the certificate of registration are provided in Section 30, 
  • The time frame for filing an appeal in accordance with Section 32(3),
  • How a clinical establishment is searched and admitted in accordance with Section 34,
  • The fees that the State Government will impose in accordance with Section 35 for various categories of clinical establishments,
  • The process and time frame for submitting an appeal to the State Council in accordance with Section 36(1),
  • The form and fees required for an appeal under Section 36(2),
  • The format and procedure for maintaining the register required under Section 37(1), 
  • How the Enrique created in the clinical establishment registry is provided in digital format to the State Council as per Section 37(2),
  • How the authority will Undertaker and inquiry in accordance with Sections 41 and 42(3),
  • How the appeal should be submitted in accordance with Sections 41 and 42(7),
  • The process and time frame for providing the information required by Section 48 to the relevant authority, State Council or National Council, as may be applicable, and 
  • Any additional matter that is mandated or the state government may prescribe. 

Laying of rules

Section 55 of the Act, 2010 provides for provisions regarding the laying of rules made by the State Government.

It states that any regulation or rules adopted by the state government under Section 53 must be presented before each of the two houses of the State Legislature or in the case of one House Legislature before that House, as soon as possible after it is formed.

Savings

Section 56 of the Act, 2010 provides for provisions regarding savings.

Section 56(1) provides that the states where the enactment listed in the Schedule is applicable are exempt from the requirement of this Act. The provision of this act shall take effect in the state in which the enactments are applicable provided that the state adopts this act in accordance with Article 252 of the Constitution of India after it is enacted.

Section 56(2) further provides that the schedule may be amended by the Central Government by notification as and when it is found necessary and appropriate.

Schedule

The Schedule provided under the Act, 2010, in reference to Section 56, provides the list of enactments applicable for exemption under this act, they are- 

1. The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002.

2. The Bombay Nursing Homes Registration Act, 1949.

3. The Delhi Nursing Homes Registration Act, 1953.

4. The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue        (Ragistrikaran Tatha Anugyapan) Adhiniyam, 1973.

5. The Manipur Homes and Clinics Registration Act, 1992.

6. The Nagaland Health Care Establishments Act, 1997.

7. The Orissa Clinical Establishments (Control and Regulation) Act, 1990.

8. The Punjab State Nursing Home Registration Act, 1991.

9. The West Bengal Clinical Establishments Act, 1950

Related case laws

Ranjit Kumar Ghose vs. Secretary, Indian Psycho-Analytical Society and others (1962)

Facts of the case

In this case, a petition was filed by Ranjit Kumar Ghosh under Article 227 of the Constitution of India. It sought the release of Sanat Chandra Bose, who was allegedly being unlawfully and illegally detained at Lumbini Park, a mental hospital and clinic run by the Indian Psycho-Analytical Society. 

Issues raised

The main issue of the petitioner was that Sanat Chandra Bose was not a lunatic and thus should not be detained.

Judgement of the court

The Calcutta High Court issued a writ of Habeas Corpus commanding the respondents to produce Sanath Chandra Bose and their respective warrants of authority to detain him. 

It was found that the lunacy proceedings and adjudication order made by the district judge were void and without jurisdiction. The court held that the Lumbini park had no legal authority to detain Sanath Chandra Bose against his wish.

The court finally held that the detention was illegal and it infringed the fundamental right of personal liberty guaranteed to Sanat Chandra Bose. It found the clinical establishment at fault and quashed the lunacy proceedings. It further ordered the release of Sanat Chandra Bose.

Sameer Kumar vs. State of Uttar Pradesh (2014)

Facts of the case

In this case, the mother of Sameer Kumar was admitted to Ford Hospital of Lucknow where she was treated by Dr. K.P. Chandra. It was a legend that Dr Chandra did not recommend any generic medicine and instead treated the patient with large quantities of the costly antibiotic “Doripenum” without conducting a culture test. It was after the petitioner had insisted, that the culture test was conducted revealing that the infection of the patient was resistant to the antibiotic “Meropenem” but the patient was being administered “Doripenum”, which was similar to “Meropenem”. 

Issues raised

The issue of the case revolved around the supply of medical records to the patient or their authorised attendance during or after treatment.

Judgement of the court

The Calcutta High Court concluded it to be a potential case of medical negligence. It further found that in the state of Uttar Pradesh, government hospitals nursing homes and even medical colleges or hospitals run by the government and private individuals do not provide medical records to patients of their authorised agents. This lack of access to medical records hinders the ability of citizens to file complaints for damages or prosecute those responsible for medical negligence. 

The court also emphasized the importance of the right to life and equality of life as fundamental rights guaranteed by Article 21 of the Constitution of India. Additionally, it highlighted the obligations of the medical profession to provide service with reasonable skill and competence.

Conclusion

The Clinical Establishment (Registration and Regulation) Act, 2010 is a vital legislation in India which aims to regulate clinical establishments and ensure quality healthcare services. The Act envisages certain minimum standards and norms that clinical establishments must follow, such as the maintenance of proper records, providing essential facilities and services, etc. 

The Act emphasizes the safety and well-being of patients by mandating the presence of qualified medical staff and ensuring hygiene and safety standards. 

It constitutes the state Council and Central Council to oversee the implementation of the act and advise the government on matters related to the registration and regulation of clinical establishment. By doing so it makes the clinical establishments accountable for the quality of healthcare services that are provided by them. 

Most importantly, the Act, 2010 provides for the regulations of clinical establishments, which help in maintaining uniform standards and preventing malpractices.

Frequently Asked Questions (FAQs) 

Should private hospitals be regulated?

Regulation is required in the private sector if it is utilized by all segments of society, regardless of their financial situation. This is so that the public sector’s function is supplemented by the private sector in this instance. In a scenario like this, the health care system has to have some kind of regulation to guarantee the cost and calibre of services rendered by private physicians. Regulation can take the form of guidelines for the medical community, medical ethics and practice, cost containment, and consumer rights protection.

What does Article 47 of the Constitution of India state?

Article 47 of the Constitution of India states that it is the duty of the State to raise the level of Nutrition as well as the standard of living along with improving public health. It should be considered as any state’s primary duty in such a manner that the state shall bring about the prohibition on the consumption except for medicinal purposes of intoxicating drinks and drugs which are injurious to health otherwise.

What does Article 249 of the Constitution of India state?

Article 249 states that it shall be loafer for parliament to make laws for the whole or any part of the territory of India with respect to any matter enumerated in the state list specified in the resolution, provided the Council of States has declared by resolution supported by not less than two third of the members present and voting, that is necessary or expedite in the national interest that Parliament may laws with respect to that matter.

The provision further states that an approved resolution will be operative for the duration mentioned in such a solution which cannot exceed 1 year, provided that the resolution will remain in effect for an additional year from the date on which it would have otherwise ceased to be enforced if the resolution authorising its stay is approved in the specified manner. 

Furthermore, it is stated that with the exception of actions taken or not before the end of the specified period, a law passed by parliament that parliament would not have been able to make had it not passed a resolution will, to the extent of that incompetence, no longer be in effect 6 months after the resolution has ceased to be enforced.

What does Article 250 of the Constitution of India state?

Article 250 provides for the powers of parliament to legislate with respect to any matter in the state list if a proclamation of emergency is an operation. It states that while a proclamation of emergencies is in effect, parliament shall have the authority to enact legislation pertaining to any of the subject matters included in the state list for the entire or any portion of the territory of India. 

It further states that a law passed by parliament that it would not have been able to pass had not a proclamation of emergency been issued will, to the extent of its incompetence, no longer be in effect 6 months after the proclamation has ended, with the exception of actions taken or not taken before the end of the specified period.

What does Article 252(1) of the Constitution of India state?

Article 252(1) provides that if the legislatures of two or more States decide that loss governing any subject on which parliament is unable to legislate for the states, aside from those covered by articles 249 and 250, should be passed by the legislatures of those state, then such laws shall be enacted.

Furthermore, if resolutions to the effect are passed by both houses of the legislatures in those States, the parliament may then pass legislation regulating the matter in accordance with those resolutions. Any Act so passed will apply to those States as well as any other state in which it is later adopted by resolution approved by the House, or in the case of a state with two houses, by each house of the legislature.

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