This article is written by Prashant Prasad, the present article intricately deals with the objective, pivotal provisions and steps to register the clinical establishment in the Tamil Nadu Private Clinical Establishment Act, 1997. Furthermore, this article deals with the recent Amendments in the present Act via Tamil Nadu Private Clinical Establishments (Regulation) Amendment Act, 2018, 2019 and 2021. The present article also deals with the Tamil Nadu Clinical Establishments (Regulations) Rules, 2018 that are currently working towards the improvement of public healthcare facilities.

This article has been published by Shashwat Kaushik.

Introduction 

Article 47 of the Indian Constitution provides that it is the duty of the state to raise the level of nutrition along with the standard of living and additionally, it’s the state’s duty to improve public health. Considering the said duty, the state of Tamil Nadu enacted the Tamil Nadu Private Clinical Establishment Act, 1997, further amended to Tamil Nadu Clinical Establishment Act, 1997 (hereinafter called “the Act”) in the year 2018. The main motive of this legislation is to register and regulate clinical establishments existing throughout the state, while laying down standards for delivery of their service.

The state of Tamil Nadu was one among those states that had enacted legislation like this, on an early basis. Considering the significant impact and huge success of this Act, the Central Government enacted The Clinical Establishment (Registration and Regulation) Act, 2010. Initially, this Act came into force in four states namely Himachal Pradesh, Arunachal Pradesh, Mizoram, and Sikkim. Later on, a few other states adopted The Clinical Establishment (Registration and Regulation) Act, 2010 under Article 252(1). In total 11 of the states and all union territories except Delhi have adopted this Act till now. The adoption of this legislation pertaining to clinical regulation signifies a major step towards improving public health and the state of Tamil Nadu was a torchbearer for the same. 

Objective of Tamil Nadu Clinical Establishment Act, 1997 

The objective of the Act is not only limited to the registration and regulation of clinical establishments in the state but also to make sure that the clinical establishments must run without any repercussions which might be faced, such as registration, renewal issues, licence of doctors, speedy treatment in case of emergency etc. Another primary objective of this Act is to enable and ensure registration of clinical establishments, both through online and offline modes. Enabling digital means of registration has simplified the process of registration and hence encourages establishments to complete the same.

In many instances, the clinical establishments are being run by bogus doctors who do not hold genuine licences for the same. The Act seeks to prevent such malpractices by mandating the requirement of licences for the clinic itself, as well as for the doctors working there, irrespective of whether the clinic is located in an urban or rural area.

The most crucial aspect which the Act aims to work on is to improve the quality of healthcare facilities throughout all clinical establishments. The Act provides a minimum standard of facilities and services which clinical establishments need to fulfil. 

Tamil Nadu Private Clinical Establishment Act, 1997

Important definitions 

Competent Authority

Section 2(a) of the Act defines competent authority. For the purpose of this Act competent authority includes any authority whether an office or a person who is appointed by the government by notification for performing the functions. Different competent authorities may be appointed for different areas.

Government

As per Section 2(b), the government refers to the State Government. 

Private Clinical Establishment

As defined under Section 2(c), The private clinical establishment includes any kind of general hospital, maternity hospital or dispensary. Further, private clinical establishments also refer to any institution (of any name), where any physically or mentally sick person is admitted (in-patient or out-patient) for treatment either with or without operative procedures. A clinic concerning radiological, biological or any other diagnostic or investigative service, is also included. All of the above would be established and administered by a person or body of persons (incorporated or not).

However, it is pertinent to note, a clinical establishment set up and maintained by a State Government or the Central Government, a local authority, a company a corporation owned or administered by a State Government or the Central Government, does not fall under the ambit of private clinical establishments.

Important provisions of Tamil Nadu Clinical Establishment Act, 1997 

Section 3 – Registration of Private Clinic Establishment

On and after the commencement of this Act a person cannot run a private clinical establishment unless it has been registered as per the Act. Such establishments in existence on the date of commencement of the Act must apply for registration within three months from that date. However, four months from the date of commencement, the establishment would cease to exist, unless it has applied for registration and is so registered or until such an application is disposed of, whichever occurs earlier. The process for registration would be as prescribed by the competent authority, along with a maximum fee of five thousand rupees. In order for a private clinical establishment to be registered under the Act, the competent authority must be satisfied with the establishment’s manpower, equipment, skills and ability to provide the concerned specialised services and facilities.

Section 4 – Certificate of Registration

After holding an inquiry and being entirely satisfied that the applicant has adhered to the requirements prescribed under the Act, the competent authority may grant the certificate of registration, in accordance with such form and subject to such conditions as laid down under the Act. 

If the competent authority is of the opinion that the applicant has not complied with the conditions and requirements of this Act, the competent authority shall reject the application for registration and record the reasons for the same, in writing.

A certificate of registration shall remain valid for a period of five years and may be renewed for a period of 5 years every time. The application for the renewal of registration shall be made within such time as may be prescribed by the provision of this Act. In case the certificate of registration is lost, destroyed or damaged, the competent authority may, on receiving an application and a payment as prescribed, issue a duplicate certificate.

Section 5 – Cancellation or Suspension of Registration

The competent authority on receiving any kind of complaint or on its own motion can ask the private clinic to show cause regarding why the registration of that clinic should not be cancelled or suspended for the reasons stated in the notice.

After giving the concerned clinic a reasonable opportunity of being heard, if the competent authority is satisfied that there has been a contravention of any of the provisions of the Act, the registration of such private clinical establishment will be suspended for a period as the competent authority deems fit or cancelled.

If the competent authority is satisfied that in the interest of the general public, it is necessary to do so, it shall record the reason in writing and suspend the registration of such private clinics without issuing a notice.

Section 6 – Power of Inquiry or Inspection

The competent authority holds the power to conduct an inspection or inquiry of any private clinical establishments, in terms of the building, laboratories, equipment, and the work performed by the clinic. The inspection or inquiry can be done by any person as directed by the competent authority, and the inquiry can also be made regarding any other matter which is connected with the private clinical establishment.

After inspection or inquiry, the competent authority shall communicate the results and the views of the authority on the same to the private clinical establishment, gather their opinion on it as well and then advise them on further action that must be taken.

Private clinical establishments must furnish to the competent authority, within such period as specified by it, a report regarding the action taken by them based on the authority’s recommendations. In case the action is not taken within a reasonable time, the competent authority may, after considering any explanation or representation by the private clinical establishment, issue any direction as it may deem fit and the private clinical establishment must comply with the same.

Section 7 – Appeals

In case a private clinical establishment is aggrieved by an order of the competent authority, rejecting an application under Section 4(2) or suspending or cancelling registration under Section 5 or any other direction under Section 6, it may, within 30 days from the date of receipt of the order, appeal to the authority and in the manner as prescribed by the Act. 

Section 8 – Punishment for Contravention of Any Provisions of this Act

In case of a contravention of the provisions of this Act, a fine starting from five thousand rupees and extending to fifteen thousand rupees may be imposed.

Section 9 – Offences committed by Companies

If the offence which is punishable under this Act is committed by a company, every person who was in charge of and responsible for the conduct of the business of that company at the time the offence was committed, along with the company, shall be deemed to be guilty and liable for the punishment.

This Section further states that, if the person concerned proves that the offence was committed without his knowledge or that he had taken the due diligence necessary to prevent the commission of such an offence. 

Section 9(2) states that notwithstanding anything contained under Sub-Section (1), if the offence is committed by the company under this Act and, it has been proved that the offence has been committed with the consent of, or due to neglect on the part of the secretary, director, manager or any other officer, they shall also be deemed to be guilty and will be liable to be proceeded against and punished. 

For the purpose of this particular Section:-

• Company – A body of individuals, any body corporate and which includes a firm society.
• Director – With respect to a firm, a director refers to a partner of the firm. With respect to a society or association of individual directors, it refers to any person who is entrusted under the rules of society or other association with the management of affairs relating to that society of individuals.

Section 10 – Cognizance of Offences 

No court is authorised to take cognizance of an offence, unless the complaint is made by the competent authority or any official which is authorised by the competent authority. 

Section 11- Protection of Action Taken in Good Faith

There shall be no initiation of suit or any kind of legal proceeding against any person or the government, for anything which is done in good faith or was intended to be done for the furtherance of the provisions of the Act.

Section 12 – Furnishing of Returns etc. 

Every private clinical establishment must furnish to the competent authority such returns, information, or statistics which it may require, within a period (may be extended by the competent authority) as prescribed by the competent authority.

Section 13 – Competent Authority etc. to be Deemed as a Public Servant

Every official, authority that is empowered to discharge their duty which is imposed on them for carrying out the purpose of this Act shall be deemed to be a public servant within the ambit of Section 21 of the Indian Penal Code.

Section 14 – Power to Make Rules 

The government may by notification make rules for carrying out the purpose of this Act.

Any such rule and any order under Section 15 must be presented before the Legislative Assembly as soon as possible. The Assembly holds the power to modify or even reject these rules and orders.

It is pertinent to note that the modification of a rule or order, or any annulment in the rules or order shall be without prejudice to the validity of anything which was done previously under that particular rule or order.

Section 15 – Power to Remove Difficulties

In case of any difficulty in giving effect to the provisions of this Act, the Government may do anything as it sees fit, provided it is not inconsistent with the Act, to remove such difficulties. However, no order can be made after the expiration of 2 years from the date of commencement of this Act. 

Judicial pronouncements

The Director of Medical & Rural Health v. Sudha Hospital (2022)

Facts 

In this case, two writ petitions were filed by the respondent and among them, one was under the provisions of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997. An order was passed under Sections 5(2) and 6(1), directing the respondents to not admit new patients to the hospital and the patients who were undergoing the treatment must be discharged within two weeks after giving appropriate treatment. Therefore, on this ground and aggrieved by the order, a writ petition was filed.

Issues 

• Whether the order passed, which prohibited them from admitting new patients, amounts to an infringement of their fundamental right i.e., the right to carry out any profession, as guaranteed under Article 19(1) (g) of the Indian Constitution.
• Whether it is mandatory to give a reasonable opportunity to be heard before passing an order under Section 5(2) of the Act?
• Whether the competent authority needs to be satisfied that there is a breach of provision before issuing such orders. 

Judgement 

It was held by the court of law that the order passed under Section 5(2) and Section 6(1), must be done so only after giving the reasonable opportunity of being heard before passing of any final order regarding suspension of registration. It was further stated that only in extraordinary circumstances registration can be suspended without any notice. Therefore the order which was passed previously by the single judge bench was set aside and the writ petition was allowed.

D.Dharmabalan v. The Secretary (2019)

Facts 

In this particular case, a writ petition was filed challenging the constitutional validity of Sections 2(a), 3, 4 and 5 of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 as amended by the Tamil Nadu Clinical Establishments (Regulation) Rules, 2018. It was contended that the provision of this Act is ultra-virus and arbitrary as the Act made applicability of consulting rooms for medical practitioners.

Issues 

• Whether the said Act and rules are treated as unequal and are therefore violative of Article 14 of the Indian Constitution.
•  Whether the consultation room forms part of the clinical establishment.
• Whether a small medical practitioner giving consultation in a small room, after excessive restriction regarding the consultation is acting as an impediment to Article 19(1)(g) of the Indian Constitution.

Judgement 

The court held that the Act is not violative of Article 19(1) (g) of the Constitution. The court further added that the Act provides for regulation of the clinical establishments in such a way that would ensure the safety and interest of the patient and cannot be held as violative of Article 19(1) (g). Furthermore, it was held that there is nothing on record to show that the restriction that is mentioned in the Act is violative of any rights that are provided under Part III of the Indian Constitution. Therefore, the said Act is not arbitrary and cannot be struck down. 

Tamil Nadu Private Clinical Establishments (Regulation) Amendment Act, 2018

The name of the Act was amended to Tamil Nadu Clinical Establishments (Regulations) Act, 1997. 

Clinical Establishment

The Tamil Nadu Private Clinical Establishments (Regulation) Amendment Act, 2018 lays down the amended definition of Section 2 for clinical establishment, as any recognized system of medicine and includes –

• A general hospital which includes a dental hospital, maternity hospital, consultant room, dispensary, clinic, polyclinic, or nursing home. 
• An institution or centre by whatever name it may be called, where a physically or mentally sick, injured person is admitted either as an in-patient or out-patient for the treatment, which may be without the aid of operative procedures. 
• A clinic that is catering radiology, biology or other diagnostic or investigative services either with the aid of a laboratory or other medical equipment.

This clinic may be established and administered by any person or body of persons, whether incorporated or not or the state or central government or any department of state or central government or trust, whether public, private or a company, which might be owned or not owned by the government or local authority, but does not include such clinical establishment which is managed by the Armed Force. 

Establishment of State Level Advisory Committee

Section 2-A – Constitution of State Level Advisory Committee 

The government, by notification, shall constitute a committee and that committee will be known as the state level advisory committee. The state level advisory committee shall consist of the following members –

• The Director of Medical and Rural Health Service, ex-officio.
• Director of Medical Education, ex-officio or his nominee.
• The Commissioner of Indian Medical and Homoeopathy, ex-officio or any of his nominees.
• The Director of Public Health and Preventive Medicine, ex-officio or his nominee.

• One member from Ayurveda, Siddha, Unani, Yoga and Naturopathy who shall be nominated by the state council on the rotation period of one year.
• One member nominated by the Indian Medical Association.
• One member nominated by the Tamil Nadu Medical Council.
• One member nominated by the Tamil Nadu Dental Council. 
• One member nominated by the State’s Nurse Midwives Council.

Nominated members hold the office for the period of 3 years but can also be re-nominated for a further extension of three years.

Section 2-B – Meetings of State Level Advisory Committee 

The state level advisory committee needs to meet at least once in a year at such place and time which may be prescribed. In case the chairperson is absent or not available then in his absence any member chosen by the committee shall preside over the meeting. The number of members required to form the quorum and the procedure of the meeting shall be as prescribed.

Section 2-C – Functions of State Level Advisory Committee 

This Section states that the state level advisory committee shall advise the government regarding regulation of clinical establishment. Further, the state level advisory committee also performs such other functions as may be prescribed by the government from time to time.

Establishment of District Committee

Section 2-D – Constitution of District Committee

The government shall by notification constitute a committee for each district known as a District Committee. The members that constitute the District Committee are –

• Deputy Director of Medical and Rural Health Services, ex-officio, who shall be the chairperson.
• The Dean of the Government Medical College in the district.
• The District Siddha Medical Officer or any of his nominees.
• One of the members nominated by the Tamil Nadu Medical Council.
•  One member nominated by the Indian Medical Association.
• One member from Ayurveda, Unani, Yoga and Naturopathy, Siddha and Homeopathy system of medicine nominated by the state council on the rotation period of one year in the order of Ayurveda, Unani, Yoga and Naturopathy, Siddha and Homeopathy.
• One member nominated by the State’s Nurse Midwives Council.

The nominated members hold office for the period of 3 years but can also be re-nominated for a further extension of three years.

Section 2-E – Meetings of District Committee 

The district committee shall meet at least once in every six months, at such time and place which may be prescribed. In case the chairperson is absent or not available then in his absence any member chosen for the committee shall preside over the meeting. The number of members that form the quorum and the procedure that needs to be followed by them shall be as prescribed.

Section 2-F – Function of District Committee

The District Committee shall aid and advise the competent authority of the district regarding the registration of the clinical establishment. Moreover, the district committee shall perform such other functions and duties as may be prescribed.

Substitution for Section 3(1)

This substituted Section states that no person shall carry any clinical establishment unless such clinical establishment is duly registered under this Act.

However, every clinical establishment in existence on the date of the commencement of the Tamil Nadu Private Clinical Establishments (Regulation) Amendment Act, 2018 (hereinafter called “notified date”), shall apply for registration within a period 9 months from such notified date and a clinical establishment established after the notified date, shall apply for registration within a period of 6 months from the date of its establishment. 

It is further provided that every clinical establishment which is existing on the notified date shall cease to carry on its business after the expiry of 12 months from the notified date unless such clinical establishment has applied for registration and is registered or till the date such application is disposed of, whichever is earlier. 

Amendment of Section 5

It has been added that, if a person holding the certificate of registration has been convicted under any of the provisions of this Act, three times in total, the competent authority shall cancel the certificate of registration and the clinical establishment shall not be permitted to apply for a fresh registration. 

Provisions regarding services and duties of clinical establishments

Section 5-A- Maintenance of facilities and services by clinical establishment 

It shall be the duty of every clinical establishment to maintain the minimum standard of facilities and services which may be prescribed. The government shall prescribe the minimum standard of facilities and services for the different categories of clinical practice across all systems of medicine. 

Section 5-B- Duties and responsibilities of the Clinical Establishment 

Every clinic establishment shall follow some duties and responsibilities, which are –

• In medico-legal or possible medico-legal cases such as road accidents, criminal assault, poisoning, or accidental or induced burns, it is the responsibility of the clinical establishment to administer the first aid and other lifesaving or stabilising measures when the victim is brought to them.
• The clinical establishment must participate in the implementation of National and State level health programs in any manner as the government may prescribe. Moreover, the report regarding the same must be furnished to the authorities concerned by the clinical establishment on a periodic basis.
• The clinical establishment must maintain the medical record in any manner as may be prescribed for the respective system of medicine.
• The clinical establishment must take necessary steps in order to prevent the spread of communicable disease and to control the non-communicable disease, as the government may from time to time specify.
•  Any other duties and responsibilities which may be prescribed.

Section 5-C – Annual publication of lists pertaining to the clinical establishment

The competent authority shall maintain a register of clinical establishments, in the prescribed form and every January, a list of registered clinical establishments along with their details needs to be published, in the Tamil Nadu Government Gazette.

Alteration of Section 8 

Penalties 

Anyone who breaches Sub-Section (1) of Section 3, shall be punished, with a fine which shall not be less than five hundred rupees which can further be extended to five thousand rupees. Furthermore, whoever breaches any other provision of this Act or any rule made or any other conditions of the registration, must be punishable with a fine which shall not be less than five thousand rupees but which may extend to fifty thousand rupees, provided that, for the purpose of Sub-Section (2) and Sub-Section (1), the Court may, for any adequate or special reasons in the judgement, may impose a fine which may be less than five thousand rupees. 

Any person who disobeys any direction which is lawfully given by the authority or any person who is empowered under this Act, to give such direction, or if any obstruction is made while performing the function of the authority or the person empowered under this Act, shall be punished with a fine which may extend to thirty thousand rupees. Additionally, any person who is required to give any information under this Act, if wilfully withholds such information, or gives such information which he believes to be false, or believes not to be true, shall be punished with the fine which may extend to thirty thousand rupees. 

Tamil Nadu Private Clinical Establishments (Regulation) Amendment Act, 2019

Amendment of section 3

Under Sub-Section (1), the expression “nine months” shall be substituted with “fifteen months” and the expression “twelve months” shall be substituted with “eighteen months” 

Under Sub-Section (2), it shall be provided that no fee shall be collected from the clinical establishment which is administered and maintained by the state or central government or any department of central or state government or any company which is owned by the state or central government or local authority. 

Tamil Nadu Private Clinical Establishments (Regulation) Amendment Act, 2021

Amendment of section 2-D

Under Sub-Section (2) of Section 2-D, which talks about the members of the district committee, after clause (a), the following clause shall be inserted –

(aa) – The Deputy Director of Public Health and Preventive Medicine in the district.

Tamil Nadu Clinical Establishments (Regulations) Rules, 2018

Important Definitions 

Clinic

A clinic, under Section 2(c), is defined as a place where treatment for illness is offered either with or without injections, dressing, any minor operation etc. to the patients. A clinic for this purpose may include an endoscopic clinic, AYUSH clinic or any other establishment that offers treatment to the patient suffering from any kind of illness with the help of medicine or any therapy under Allopathy, Ayurveda, Siddha Yoga and Naturopathy or Homoeopathy (AYUSH) or any other systems of medicine recognized by the government.

Consultant Room

A consultant room, under Section 2(e), is defined as a room where the examination of a patient, issuance of prescription and conveyance of advice, take place.

Hospital

Hospital, under Section 2(k), includes a nursing home or health care or treatment centre or any other place as an in-patient for treatment of any illness which can be either with or without surgery or conduct of delivery etc., with or without out-patient facilities and diagnostic facility like laboratory etc., in any recognized system of medicine. 

Patient 

Patient, under Section 2(m), refers to any person who is brought to any hospital, including a dental hospital for treatment, consultation or to seek any kind of service which is offered by the hospital.

Polyclinic

Polyclinic under Section 2(n) is defined as a clinic in which more than one doctor offers consultation either with or without treatment, for illness in any recognized system of medicine.

Registered Medical Practitioner 

Under Section 2(o), registered medical practitioners are those who possess any government recognized medical qualification or are enrolled in the register of the Medical Council, Dental Council, Siddha Council, Ayurveda Council, Unani or Homoeopathic Council or are registered by the Board of Indian Medicine or any such statutory body that is recognized by the Tamil Nadu Government.

Staff Nurse

As per Section 2(p), a staff nurse is any person who possesses the required qualification from any of the nursing Teaching Institute, which is recognized by the government of Tamil Nadu and the person who possesses that qualification must be enrolled in the Tamil Nadu Nurses and Midwives Council under the Indian Nursing Council Act, 1947. The qualification can also be from any of the State Nursing Councils in India which is recognized by the Indian Nursing Council and Indian Medicine for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy establishments. 

Important provisions 

Section 3 – Procedure, Quorum and Minutes of Meeting of State Level Advisory Committee

This Section states that every notice calling for the meeting of the state level advisory committee must specify the place, date and hour of that meeting. The notice of the meeting must be given to each member of the committee at least 7 days prior to the date of the meeting.

The chairperson of the state level advisory committee shall prepare and circulate along with the notice, an agenda of the meeting, which would reflect the business to be conducted. It has been stated that the total quorum of the meeting must not be less than 4. However, if within 30 minutes of the time specified, the quorum fails to be present, the meeting shall adjourn to the same day at the same time and place in the following week. The presiding officer of the meeting must communicate this information to the members present and also to the other members by speed post. Furthermore, the government must be informed about the minutes of the meeting.

Section 4 – Procedure, Quorum and Minutes of Meeting of District Committee

This Section states that every notice calling for the meeting of the district committee must specify the place, date and hour of that meeting. The notice of the meeting must be given to each member of the committee at least 7 days prior to the date of the meeting.

The chairperson of the district committee shall prepare and circulate along with the notice an agenda of the meeting, which would reflect the business to be conducted. It has been further stated that the total quorum of the meeting must not be less than 4. However, if within thirty minutes of the time specified the quorum failed to present, the meeting shall adjourn to the same day at the same time and place in the following week. The presiding officer of the meeting must communicate this information to the members present and also to the other members by speed post. Furthermore, the government and the competent authority must be informed about the minutes of the meeting.

Section 5 – Duty of District Committee

Apart from the duties and responsibilities that are specified in the Act, the district committee shall perform the following as well-

• Scrutinise the application which is received as directed by the competent authority.
• Inspect the clinic establishment in the manner as specified by the competent authority.
• Examine the complaint which is received, if any, regarding the implementation of the Act and must be referred to the government through the competent authority.
• Any other duty which may be specified either by the competent authority or by the government.

Section 6 – Minimum Facilities of a Clinical Establishment 

The floor space, the minimum number of staff and their respective qualifications, the minimum equipment and the other conditions which are required for a clinical establishment of different systems, to provide various medical services, including specialised ones, shall be in accordance with the norms and conditions as specified in Annexure-I of this rule. 

Section 7 – Application for Registration 

The application for the registration of clinic establishment can be made in person or through registered post with acknowledgment due to the competent authority in a manner as prescribed by Form I. The form for registration must be accompanied by a fee of rupees five thousand, in the manner of a demand draft or treasury challan drawn in favour of the competent authority. 

If the clinical establishment offers services in more than one recognized system of medicine, a separate application of registration for each recognized system of medicine. 

Section 8 – Certificate of Registration

When the competent authority receives an application for the registration of a clinical establishment, if it is satisfied that the applicant has fulfilled all the requirements of the Act and these rules, it may grant a certificate of registration within one eighty days from the date of receipt of such application, such a certificate is non-transferable.

Section 9 – Time Limit for Renewal 

For the renewal of the certificate of registration, the clinical establishment must submit an application for the same, to the competent authority, ninety days prior to the expiry of registration.

Section 10 – Duplicate Certificate

There may be instances where the original certificate might get lost, or damaged. In that scenario, the clinical establishment can apply to the competent authority with an application for issuing a duplicate copy, along with a fee of three hundred rupees. 

Section 11 – Duties of Clinical Establishment

Apart from the duties and responsibilities that are specified in the Act, the clinical establishment shall perform the following duties as well –

• Display the certificate of registration in a conspicuous part of the premises which is open to the general public.
• Maintain a record in an electronic form containing names, qualifications and addresses of its employees and equipment maintained by the establishment. 
• To record and preserve all the changes which might have been made in the equipment or in the employment of staff. Further, this change of record must be intimated to the competent authority.
• Maintain the clinical records relating to its patients, such as any paper, printout, slide, or solution which can be used to indicate and diagnose the condition of the human body or any part of any material that might be taken out during the course of treatment undergone by a person. 
• Keep all the records for inspection by the competent authority.
• Surrender certificate of registration in case the clinical establishment ceases to exist. 

Section 12 – Maintenance of Medical Record 

Every clinical establishment must maintain records relating to the observations made, tests performed, investigation done, diagnostic opinion, advice and treatment given to any person who has visited the hospital either as an in-patient or as an out-patient, under Form III.

Section 13 – Annual Publication of the list of clinical establishments

Every January, the competent authority shall publish the list of clinical establishments in the Tamil Nadu Government Gazette, in Form IV.

Section 14 – Appeal

In case a private clinical establishment is aggrieved by an order of the competent authority, rejecting an application under Section 4(2) or suspending or cancelling registration under Section 5 or any other direction under Section 6, it can be appealed before the Director of Medical and Rural Health Services, within 30 days from the date of receipt of the order.

The Director of Medical and Rural Health Services may pass an interim order if it sees fit. This Section further states that the Director of Medical and Rural Health Services may within sixty days of receipt of the appeal and after giving the parties the reasonable opportunity of being heard can pass such an order as he may deems fit. The decision given by the appellate authority must be communicated to the concerned person who has preferred the appeal, within seven days from passing of that order. The decision which is given by the appellate authority shall be final and will have a binding effect on the concerned parties. 

How to register a clinical establishment under the Act online

Registration of a clinical establishment is the initial and most crucial stage. As per Section 7 of the Tamil Nadu Clinical Establishments (Regulations) Rules, 2018 which deals with the application of registration, it is mentioned that the application for the clinical establishment can either be made in-person or through registered post with acknowledgment due to the competent authority. The form for the registration must be accompanied by a fee of five thousand rupees. It is also possible to initiate the registration procedure online. The procedure for the same has been detailed below-

Step 1 – Creating a new account for registration

The first step for the registration of clinical establishments is to create a new account. One can directly go to the website at http://www.tnhealth.co.in/dms/tncea/login.php to do so.

The following instructions must be kept in mind –

• Correctly choose the Revenue District, as it cannot be changed once your new ID is created.
• Verify the presence of a Taluk for the chosen district. 
• Enter the name of the clinical establishment correctly, since it is the name that will appear on the certificate of registration.
•  Enter a valid email ID.

Step 2 – Get acquainted with the application form

There is a form of a specific format which needs to be filled. The person registering for the clinical establishment must gather the documents required by the form. The form can be accessed at – http://www.tnhealth.co.in/dms/tncea/Read_before_Registering.zip 

Step 3 – Fill out the Application Form

The form must be filled with credible information, as asked for. Every detail put in the form will be verified by the competent authority at a later stage and should therefore be authentic and reliable.

Step 4 – Submitting the Application Form

After the form is filled, it can be submitted, along with the necessary documents. Once the application form is submitted, the person can log out and log in again, to avail the opportunity to download an acknowledgement as well as the submitted form. 

Step 5 – Inspection by the Competent Authority

Once the application form is submitted, the competent authority shall verify the information given by the applicant for the registration of the clinical establishment. After it is satisfied that the applicant has complied with all the conditions and requirements of the Act, the competent authority may move ahead with the process.

Step 6 – Approval and Issue of Certificate

After the competent authority is satisfied that the application has complied with the necessary requirements of the Act, it may approve the application form, post which, the certificate of registration may be granted, within 180 days from the date of receiving the application. 

Conclusion 

Tamil Nadu Clinical Establishment Act, 1997 is a great initiative that is working towards the improvement of healthcare facilities throughout the state. The provisions of this Act work towards a wide range of healthcare facilities, from working to providing licences, setting standards for the clinical establishment, and addressing the grievances of the patient as well as the clinical establishment. 

However, the effective implementation of this Act has been a matter of question. There is a pressing need for the proper implementation of this Act so that the subsisting problem with regard to healthcare facilities can be eradicated. All the stakeholders must collaborate and join hands together to achieve the ultimate goal of this Act with its proper implementation. The subsisting problems that have surged in contemporary times and which are marked as major lacuna in this legislation are the allocation of resources, compliance issues, infrastructure complications, etc. These problems need to be addressed in order to achieve the purpose of this Act. Awareness among the general people regarding this Act would make them vigilant about the importance of this Act which can be done with some social activities. The essence of this Act lays a solid foundation in the healthcare facility which is bringing and is expected to bring huge positive results in the upcoming times. 

Frequently Asked Questions (FAQs) 

What is the applicable standard for the infrastructure of consultation rooms mentioned under the Tamil Nadu Clinical Establishments (Regulations) Rules, 2018?

In the Act, the consultation room, which is the most important for carrying out the purpose of this Act, must be 100 square feet. Apart from the mentioned area, the consultation room must have sufficient light and ventilation, there needs to be a separate space for the patient waiting for consultation. 

References

• https://prsindia.org/files/bills_acts/acts_states/tamil-nadu/1997/1997TN4.pdf
• https://www.bareactslive.com/TN/tn1012.htm
• http://www.tnhealth.co.in/dms/tncea/login.php