This article is written by Gautam Badlani. It provides a detailed analysis of the Tamil Nadu Clinical Establishments Act, 1997. It gives an overview of the provisions relating to the establishment and registration of private clinics in Tamil Nadu. The article also sheds light on some landmark judgments relating to the regulation of private medical clinics.

This article has been published by Shashwat Kaushik.

In the past few years, there has been an exponential rise in the number of private clinics throughout the country. The healthcare sector has witnessed the entry of many aspiring doctors who set up their own clinics. 

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However, certain private clinics started exploiting ignorant and unaware patients. Thus, the Tamil Nadu Government enacted the Tamil Nadu Private Clinical Establishments (Regulation) Act, 1997. This Act was enacted to regulate the conduct of private clinic establishments in the state of Tamil Nadu. In 2018, the word ‘Private’ was removed from the title of the Act and the name of the Act was changed to the Tamil Nadu Clinical Establishments (Regulation) Act, 1997. 

A major amendment was made to the Act in 1997. Most of the provisions of the Act were modified by the 2018 Amendment.  In this article, we will discuss the important provisions of the Act and the changes brought about by the 2018 Amendment. 

Section 2(a) states that the expression ‘clinic establishments’ includes all clinic establishments under any recognised system of medicine, such as Homeopathy, Ayurveda, Allopathy, Yoga, etc. Moreover, the definition also includes:

  • General hospitals 
  • Institutions or centres which treat injured, infirm and mentally and physically sick people, 
  • Clinics offering radiological, biological and other diagnostic services. 

The definition also includes clinics which are established or administered by the Central or state government. However, the clinics which are established or managed by the Armed Forces do not fall within the scope of the definition, and thus, the Act does not apply to such clinics.

Section 3 of the Act makes it mandatory for all new clinics to get themselves registered with the competent authority. The clinics that were already existing at the time of coming into force of the Act were given a 3-month window to get themselves registered. If an existing clinic failed to get itself registered, then it shall cease to operate within four months from the date on which the Act came into force. As per the government notification, the Joint Director of Medical and Rural Health Services is the competent authority, and the clinics have to submit the registration application to the Joint Director. 

The 2018 Amendment altered the time period for the registration of clinics. It provided that all clinical establishments existing at the time of the notification of the Amendment shall get themselves registered within a period of 9 months from the date of the notification of the Amendment. All new clinics have to get themselves registered within a period of 6 months of their establishment. 

A maximum fee of Rs. 5,000 can be prescribed by the competent authority for the registration of private clinics. The authorities will approve the registration of private clinics only if they are satisfied that the clinic possesses the ability to provide specialised services and facilities to its patients. 

Section 4 states that if the authorities are satisfied that the applicant has fulfilled all the requisite conditions, then the registration will be approved and a certificate of registration will be issued. The certificate of registration would be valid for a period of 5 years. The registration can be renewed for five years at a time. The periodic renewal provides an opportunity for the authorities to constantly assess whether the clinics fulfil the requirements of providing specialised facilities and services and possess the necessary skills and manpower needed to run a medical clinic. The application for renewal has to be submitted to the competent authority at least 90 days before the expiration of the validity of the registration. 

However, Section 4 provides that if the competent authority feels that the clinic has not fulfilled the requisite conditions, then the authority may reject the application after recording the reasons in writing. 

Inquiry 

Section 6 provides that the competent authority has the right to authorise any person to inspect any clinic, its instruments, buildings and laboratories. The authority has to communicate the results of the inquiry to the clinic after ascertaining the views of the clinic and examining the action taken by the clinic. As per Section 6, the private clinic can also inform the authority of any action that has been taken or that it proposes to take on the basis of the results of the inquiry. 

Cancellation and suspension of registration 

Section 5 of the Act provides that the competent authority can, either suo motu or, upon receiving a complaint, issue a notice to a private clinic asking it to show cause as to why the registration should not be cancelled or suspended. The reasons for the proposed cancellation or suspension of registration should be specified in the notice. The authority has to provide a reasonable opportunity to be heard at the clinic before making a decision. If, after the hearing, the authority is satisfied that the clinic has infringed the provisions of the Act, then the authority may cancel or suspend the registration for such period as it deems it appropriate. 

It is pertinent to note that the authority may even cancel or suspend the registration without issuing any notice to the clinic if the authority is satisfied that such actions are necessary in the public interest. However, the authority would have to record the reasons for the cancellation of the licence in writing. 

Section 8 provides that anyone who violates the rules and provisions of the Act relating to the registration of clinical establishments shall be punishable with a fine of up to Rs. 50,000. The provision also provides that the fine shall not be less than Rs. 5,000. However, in certain cases, the court may impose a fine of less than Rs. 5,000 after recording the reasons for leniency. 

Any person who willfully disobeys or obstructs the authority empowered under the Act shall be punishable with a fine of up to Rs. 30,000.

If the offence is committed by a company, then the persons who were in charge of the company at the time of the commission of the offence will be deemed guilty of the offence. Moreover, if any person who is under an obligation to supply any information under the provision of the Act, wilfully withholds such information or furnishes false and misleading information, then such person shall be punishable with a fine of up to Rs. 30,000. 

Further, as per amended Section 5 of the Act, if the holder of the certificate of registration of any clinic is convicted of offences under the Act three times in aggregate, then the competent authority will cancel the registration of such a clinical establishment, and the establishment would not be permitted to make a fresh application for registration. 

The state government has the power to make rules under Section 14 of the Act. The rules have to be placed before the Legislative Assembly as soon as possible. The Legislative Assembly may make any modifications to the rules or may nullify their effect. Moreover, Section 15 provides that the state government may pass any order to remove any difficulty in the implementation of the Act. However, such an order should not be inconsistent with the provisions of the Act. 

2018 Rules 

In exercise of the powers conferred under Section 14, the Tamil Nadu government enacted the Tamil Nadu Clinical Establishments (Regulation) Rules, 2018 (hereinafter referred to as the 2018 Rules).

Section 2A stipulates the establishment of a state-level Advisory Committee. The provisions for the Advisory Committee were not in the original 1997 Act. These provisions were inserted by the 2018 Amendment. 

Composition 

The Director of Medical and Rural Health Services will serve as the ex-officio chairperson of the Committee. The following would be the ex-officio members of the Committee:

  • Director of Medical Education serves as the ex-officio chairperson
  • Director of Public Health and Preventive Medicine 
  • Commissioner of Indian Medicine and Homeopathy 
  • One person representing Ayurvedic, Unani, Yoga, Naturopathy, Siddha and Homeopathy system of medicine 

The following organisations would be appointing one member each to the Advisory Committee:

  • Indian Medical Association 
  • Tamil Nadu Medical Council 
  • Tamil Nadu Dental Council 
  • Tamil Nadu Nurses and Midwives Council

The nominated members will hold office for a period of 3 years. However, they are eligible for re-nomination for a further period of 3 years. 

Meetings and functions 

The State Advisory  Committee has to meet at least once every year. The Chairperson will preside over the meeting. In the absence of the Chairperson, the members may choose any person among them to preside over the meeting. The Committee has to advise the state government regarding the measures that can be taken to regulate medical clinics effectively. 

Rule 3 of the 2018 Rules provides that the Chairperson would circulate the notice calling a State Advisory Committee meeting and such notice shall be accompanied by the agenda of the meeting. The notice must specify the place and time at which the meeting will be held. Such notice should be served on every member of the Committee at least 7 days prior to the day scheduled for the meeting. 

The quorum of the meeting cannot be less than four members. If the quorum is not fulfilled within the first 30 minutes of the meeting, then the meeting will be adjourned to the same day of the following week. The minutes of the meeting have to be provided to the state government. 

Section 2-D provides that the state government shall establish a District Committee for each district. 

Composition 

The Deputy Director of Medical and Rural Health Services would be the ex-officio Chairperson of the Committee. The Committee will also consist of the dean of a government medical college in the District and the District Siddha Medical Officer. The following establishments will appoint one member each to the Committee:

  • Indian Medical Association,
  • Tamil Nadu Medical Council,
  • Tamil Nadu Nurses and Midwives Council,
  • Tamil Nadu Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy systems of medicine.

The nominated members will have a 3-year term and will be eligible for re-nomination for another 3-year term. 

Meetings and functions

The District Committee has to meet at least once every six months. The District Committee has to advise the competent authority of the district on matters relating to the registration of clinical establishments. 

Rule 5 of the 2018 Rules provides that the District Committee should also carry out clinic inspections and should examine complaints relating to the implementation of the Act.

Section 5-B prescribes the duties of the clinical establishments. It states that every clinical establishment must administer first aid and take other stabilising and life-saving measures when a victim of medico-legal cases is brought to them. Medico-legal cases include road accidents, poisoning cases and instances of criminal assault. Moreover, the clinics must maintain proper medical records and participate in the implementation of the national and state health programmes. They must take proper measures to prevent the spread of communicable diseases and to control non-communicable diseases. 

Section 5-A states that all clinical establishments must comply with the minimum standards of services and facilities that the government may prescribe from time to time. 

Rule 11 of the 2018 Rules enlists certain additional duties of the clinical establishments. These duties are:

  • The clinical establishment must display the registration certificate in a prominent place on its premises. 
  • It must keep a record of all changes in the staff and instruments and must also keep a proper record of the qualifications of the employed staff. 
  • The clinic must keep its records available for inspection by the competent authority. 
  • Moreover, it must surrender the registration certificate if it ceases to operate.  

Sudha Hospital v. the Director of Medical And Rural Health (2022)

It is mandatory for the competent authorities to provide the reasons for the suspension of the licence in writing. In Sudha Hospital v. the Director of Medical & Rural Health (2022), the licence of a hospital was suspended after it was reported that the hospital had illegally sold the oocyte of a 16-year-old girl. However, the Court noted that the authorities had not recorded the allegations against the hospital in writing. Moreover, a reasonable opportunity to be heard was not provided to the hospital authorities. Thus, the order of licence suspension was quashed, and the state authorities were directed to consider the matter afresh.

D. Dharmabalan v. the Secretary (2019)

In this case, the constitutionality of the Act was challenged on the ground that it was violative of Article 19(1)(g) of the Constitution. The petitioner contended that the Act was applicable to consulting rooms as well, and it would be difficult for small medical practitioners, who provide consultations in their private consulting rooms, to comply with the rules stipulated in the Act. Thus, the Act violates their fundamental freedom of trade, business and profession. The petitioner pleaded that medical clinics and consulting rooms are different, and thus, it would violate Article 14 if the Act is selectively applied to medical clinics and not to consulting rooms. 

However, the Madras High Court dismissed the petition and held that the Act is intended to safeguard the interests of the patients, and thus, it cannot be said to be infringing upon Article 19(1)(g). The purpose of the Act is to regulate the functioning of private clinics within the state of Tamil Nadu, and it provides different compliance requirements for different clinics. 

There has been a surge in the number of private clinics in the past few decades. Some clinics have also been engaged in exploitative practices, and there have been numerous instances where private clinics have decreased their clients. Thus, it is imperative for the state government to regulate the establishment and functioning of clinics. 

Health is a state subject, and thus, the primary responsibility of regulating medical institutions and their services is on the state governments. The Tamil Nadu government took more than 20 years to frame the Rules under the Tamil Nadu Private Clinical Establishments (Regulation) Act, 1997. Due to this lackadaisical attitude, the Act could not be effectively implemented for nearly two years. Such inordinate delays should be avoided. The states must proactively legislate to ensure that the basic minimum standards of healthcare are fulfilled by the medical institutions.

Which law has been enacted by the Parliament for the regulation of clinical establishments in India?

The Clinical Establishments (Registration and Regulation) Act, 2010 deals with the registration of clinical establishments and the matters connected therewith. It prescribes the minimum standards of services and facilities that must be provided by the clinical establishments. 

In which list does the subject of ‘Health’ fall?

Health is a state subject and is provided under List II of the Seventh Schedule of the Constitution. Thus, the states have the power to enact laws relating to the regulation of clinical establishments. The Central law, that is, the Clinical Establishments (Registration and Regulation) Act, 2010, applies to a state only after the state legislature adopts the Act through a resolution. 



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