India: An Overview Of The Clinical Establishments (Registration And Regulation) Act, 2010

Introduction

The Clinical Establishments (Registration and Regulation) Act, 2010 ("Act") has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescribing the minimum standards of facilities and services provided by them.

As per a report submitted by the Government of India, planning commission namely "Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure" for the 11th Five-Year Plan,1 Health regulation in India encompasses a variety of factors and issues. These include promulgation of legislation for health facilities & services, disease control & medical care, human power (Education, Licensing & Professional Responsibility), Ethics and Patients Rights, Pharmaceuticals & Medical Devices, Radiation Protection, Poisons & Hazardous Substances, Occupational Health and Accident Prevention, Elderly, Disabled & Rehabilitation Family, Women and child Health, Mental Health, Smoking/Tobacco Control, Social Security & Health Insurance, Environmental Protection, Nutrition. Hence, the report highlighted for the need for a central legislation for registration of clinical establishments in the country and uniform standards need to be developed for the entire country.

Objective of the Act

The Act makes it mandatory for registration of all clinical establishments, including diagnostic centres and single-doctor clinics across all recognized systems of medicine both in the public and private sector except those run by the defence forces. The registering authority facilitates policy formulation, resource allocation and determines standards of treatment. It can impose fines for non-compliance of the provision of the Act. The Act lays down Standard Treatment Guidelines for common disease conditions, for which a core committee of experts has been formed. Further, the Act makes all clinical establishments to provide medical care and treatment necessary to stabilize any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly women who come for deliveries and accident cases.

Implementation of the Act

Vide the notification dated 28 January, 2010 the Act came into force in four states of India, namely Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all Union Territories. Later, Uttar Pradesh, Rajasthan and Jharkhand have adopted the Act under clause (1) of article 252 of the Constitution. In 2013, the State of Maharashtra planed a multi-stakeholder committee to formulate the Maharashtra Clinical Establishment Act to an important step towards standardization of quality and costs in the private medical sector. Further, the Kerala Clinical Establishments (Registration, Accreditation and Regulation) Bill, 2009 is awaiting a go-ahead from the Government to be enforced.

An overview of the Clinical Establishments (Registration and Regulation) Act

Article 47 of the Constitution lays down a responsibility upon the State for aiming at improvement in public health and shall consider this responsibility as among its primary duties in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.

Hence, with the objective to strive at fulfill this responsibility, the Government of India enacted the Act with the objective to provide for the registration and regulation of clinical establishments in India and for matters connected therewith or incidental thereto.

The Act defines "Clinical Establishment" and bring under the ambit of clinical establishment all hospitals, maternity home, nursing home, dispensary, clinic, etc or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, etc or a place establishmed as an independent entity pr part of an establishment in connection with the diagnosis or treatment of certain diseases. It also includes a clinical establishment which is owned, controlled and managed by government or a department of the Government, a trust, a corporation registered under a Central, Provincial or State Act, a local authority and a single doctor.

The National Council for Clinical Establishment

The Act lays down establishment for the a Council Body called The National Council for Clinical Establishment which is responsible primarily for setting up standards for ensuring proper healthcare by the clinical establishment and develop the minimum standards and their periodic review.

Clinical Establishments and procedure for registration of the Clinical Establishment

Section 11 of the Act mandates that no person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act.

In September 2014, the Government of India, the Ministry of Health and Family Welfare2 issued the Application format for Permanent Registration of Clinical Establishments which requires the applicant to provide information such as, among others, establishment details, types of service, system of medicine, etc.

Minimum Standards to be followed by Clinical Establishments

Further, Section 12 of the Act lays down that for the registration and continuation of a Clinical Establishment, such clinical establishment shall fulfill the conditions namely,

  1. the minimum standards of facilities and services
  2. the minimum requirement of personnel
  3. provisions for maintenance of records and reporting
  4. such other conditions as may be prescribed.

The minimum standards for hospitals are implemented on the basis of level of care provided by such hospitals.

Recently in September 2014, the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India in consultation with various stakeholders has prepared following draft Documents with the objective of implementation of the Clinical Establishments Act3:

  1. Application format for Permanent Registration of Clinical Establishments
  2. Minimum Standards
  3. Formats for Collection of information and Statistics
  4. Template for Display of Rates
  5. Standard Treatment Guidelines of Ayurveda Accordingly, the draft document issued by the Government this September4 divided hospitals into 4 levels of hospitals, namely -

Accordingly, the draft document issued by the Government this September4 divided hospitals into 4 levels of hospitals, namely -

Hospital Level 1-

Hospital Level 1 are the primary healthcare services provided by qualified doctors. It includes services such as General Medicine, Pediatrics, First aid to emergency patient and Out Patient Services, Obstetrics & Gynecology Non-surgical and Minor Surgery and have a bed strength of not more than 30 which can be provided through trained and qualified manpower with support/supervision of registered medical practitioners with the required support systems for this level of care.

Hospital Level 2-

This level includes services of Surgery and Anesthesia in addition to the services provided at level 1 through registered medical practitioner under supervision and with support of specialists. It will also have other support systems required for these services like pharmacy, laboratory, diagnostic facility, etc.

Hospital Level 3-

This level includes all the services provided at level 1 and 2 and in addition the following as well such as Multi-specialty clinical care with distinct departments, General Dentistry, Intensive Care Unit,. Tertiary healthcare services can be provided through specialists. It will also have other support systems required for these services like pharmacy, Laboratory, and Imaging facility.

Hospital Level 4 –

This level will include all the services provided at level 3. It will however have the distinction of being teaching/ training institution and it will have multiple superspecialties. Tertiary healthcare services that can be provided through specialists. It shall have other support systems required for these services. It shall also include the requirements of MCI/other registering body.

Template for Display of Rates

The Hospitals are required to follow a particular template for display of the various rates related to PD, Investigation /diagnostic, emergencies, etc which is detailed in the draft documents issued by the Ministry.

Conclusion

To conclude with, India is already outshining itself in the global strata of pharmaceutical market. It is apparently a boon above that for the fact that India is expected to witness a tremendous improvement in its public health as the Government is showing enthusiastic approach towards striving at the objective of the Clinical Establishments (Registration and Regulation) Act, 2010. With the implementation of the diligently drafted standards through this Act, it is expected that in the coming years each and every clinical establishment in India will be systematized and stringently compelled equipped with all the basic minimum standard of medical care and hence, the scenario of healthcare section in India is expected to grow through a tremendously appreciable revolution.

Footnotes

1. planningcommission.nic.in/aboutus/committee/.../wg11_hclinic.pdf

2. http://clinicalestablishments.nic.in/En/1070-draftminimum-standards.aspx

3. Available at the official website of Ministry of Health and Family Welfare http://clinicalestablishments.nic.in/En/1070-draft-minimum-standards.aspx

4. http://clinicalestablishments.nic.in/En/1070-draftminimum-standards.aspx

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