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

Last Updated: 25 November
2015
Article by Rajdutt S. Singh

Singh
& Associates

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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,

the minimum standards of facilities and
services

the minimum requirement of personnel

provisions for maintenance of records and
reporting

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:

Application format for Permanent Registration of
Clinical Establishments

Minimum Standards

Formats for Collection of information and
Statistics

Template for Display of Rates

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

The content of this article is intended to provide a general guide to the
subject matter. Specialist advice should be sought about your specific
circumstances.

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Rajdutt S. Singh

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