The clinical establishments (registration and regulation) act 2010 and rules 2012
Department of Hospital Administration
Regulation of quality of services provided by healthcare
delivery system to the people by both public and private
sectors has largely remained a contentious and therefore,
Private sector healthcare delivery system in India has
remained largely unregulated and uncontrolled.
Concerns about how to improve healthcare quality continue to
be frequently raised by the general public and a wide variety of
stakeholders, including Government, professional associations,
private providers, agencies financing healthcare, Human Rights
Commission and judiciary among others.
Despite many state legislatures having enacted laws for
regulating healthcare providers, the general perception is that
current regulatory process for healthcare providers in India is
inadequate or not responsive to ensure healthcare services of
acceptable quality and prevent negligence
A need has been felt for a central legislation for ensuring
uniform standards of facilities and services by the clinical
establishments throughout the country
This Act is for the Registration and Regulation of the clinical
establishments in the country and for matters connected
Act passed by Parliament in Aug 2010 and notified on 1st
march,2012. National Council under the Act notified on 19th
march 2012 and Central Rules notified on 23rd may 2012.
Model State Rules have been circulated to the State/UT’s .
Ministry has requested the chief ministers to adopt and
implement the act
Highest priority of gov for implementation and monitored by
States – Arunachal Pradesh, Himachal Pradesh, Mizoram and
Union Territories – Andaman and Nicobar Islands, Chandigarh, NCT
of Delhi, Dadra and Nagar Haveli, daman and Diu, Lakshadweep,
States who have adopted the act – Uttar Pradesh , Rajasthan and
Such other states which adopt this act under clause (1) of article 252
of the constitution
Does not include the clinical establishments owned, controlled or
managed by the Armed Forces.
An act to provide for the registration and regulation of clinical
establishments in the country.
To prescribe minimum standards of facilities and services which
may be provided by them.
Desired impact : improvement in public health.
Parliament has no power to make laws for the states with respect to any
of the matters aforesaid articles 249 and 250 of the constitution.
A hospital, maternity home, nursing home, dispensary, clinic,
sanatorium or an institution by whatever name called that
offers services, facilities requiring diagnosis, treatment or care
for illness, injury, deformity, abnormality or pregnancy in any
recognized system of medicine established and administered or
maintained by any person or body of persons, whether
incorporated or not;
a place established as an independent entity or part of an establishment
referred to in sub-clause (i), in connection with the diagnosis or treatment of
diseases where pathological, bacteriological, genetic, radiological, chemical.
biological investigations or other diagnostic or investigative services
with the aid of laboratory or other medical equipment, are usually
carried on, established and administered or maintained by any person
or body of persons, whether incorporated or not
COVERAGE – All clinical establishments – including diagnostic
centers and single doctors clinics, across all recognized systems of
medicine in both public and private sector. (exception establishments
of the armed forces ).
REGISTRY – Digital registry of all types of clinical establishments at
national state & district level available in public domain .registry
would aid in policy formulation and resource allocation.
STANDARD APPLICATION FORM - For registration of
clinical establishments to ensure uniformity of information.
Application for registration by post, in person, or online.
TRANSPARENCY – Entire process of registration and data in
public domain. data collected to be utilized for public health
Implementation of the act is with states. District registering
authority under chairperson ship of district collector .
The district health officer / chief medical officer will exercise the
power of the district registering authority for provisional
registration of clinical establishments .
Since information in public domain , any complaints appropriate
action can be taken
The authority shall have power to inspect a registered clinical
establishment with prior information.
Any person aggrieved by an order of the registering authority
shall refer an appeal to the state council.
Provisional registration, through a process of self declaration
without any inspection .
Permanent registration would be undertaken after categorization
and development of minimum standards.
Every clinical establishment has to be registered – norms
required to be met prior to registration include:
Minimum standards of facilities and services
Minimum qualifications for the personnel
Provision and maintenance of records and reports
Any other condition that may be prescribed
National council, through multi stakeholders participation
and consultative process would classify clinical
establishments into different categories and determine
uniform minimum standards and their periodic review.
A survey of existing clinical establishment has been
outsourced to QCI –IMA for defining draft minimum
Mandatory for every clinical establishment to provide
treatment “ with in the staff and facilities available” to
stabilize the emergency medical condition.
Details of charges, facilities available would be prominently
displayed by each establishment at a conspicuous place at each
Clinical establishments shall charge the rates for procedure and
services with in the range of rates determined by the central
government from time to time in consultation with the state
Compliance to standard treatment guidelines as may be issued
by central /state govt. to be ensured by CEs.
If any person contravenes any, provisions of the proposed
legislation or any rules made thereunder, he shall be punished
with fine and wide ranging penalties.
Amounts collected by way of fees, fines, penalties etc. to be
utilized for implementation of the act.
Cancelation of the registration would occur at any time, if
conditions for registration are not compiled.
There shall be established for the purposes of this act, a council to be
called the National Council for clinical establishments.
Chair Person: Director-General of Health Service, Ministry of Health
and Family Welfare
Secretary: Joint Secretary MOH GOI
Compile and publish a National Register of clinical establishments
within two years from the date of the commencement of this act;
Classify the clinical establishments into different categories;
Develop the minimum standards and their periodic review
Determine within a period of two years from its establishment,
the first set of standards for ensuring proper healthcare by the
Collect the statistics in respect of clinical establishments;
Perform any other function determined by the Central
Government from time to time.
Every state government shall constitute a state council for clinical
Secretary, Health – ex officio, who shall be the chairman;
Director of Health Services – ex officio member-secretary
Sending monthly returns for updating the National Register;
Representing the State in the National Council;
Hearing of appeals against the orders of the authority; and
Publication on annual basis a report on the state of implementation
of standards within their respective states.
The state government shall, set-up district registering authority.
District Collector - Chairperson
District Health Officer – Convener
From Professional association
The District registering authority shall be responsible for
Grant, renewal, suspension or cancellation of registration
Investigation of complaints
Preparation and submission of report
The District Medical Officer shall exercise the powers of the district
Provisional registration with time limit
Standards for permanent registration
The certificate shall be valid for a period of five years from the
date of issue.
For registration and continuation, every clinical establishment shall
fulfill the following conditions, namely :I.
The minimum standards of facilities and services as may be
The minimum requirement of personnel as may be prescribed;
Provisions for maintenance of records and reporting as may be
Such other conditions as may be prescribed.
The clinical establishment shall undertake to provide within the staff
and facilities available, such medical examination and treatment as
may be required to stabilize the emergency medical condition of any
individual who comes or is brought to such clinical establishment.
Monetary penalty for non-registration
Disobedience of order, obstruction and refusal of information
Every clinical establishment shall, furnish such returns or the
statistics and other information in such manner, as may be prescribed
shall maintain medical records of patients treated by it and health
information and statistics in respect of national programmers and
furnish the same to the district authorities in form of quarterly
copies of all records and statistics shall be kept with the clinical
establishment concerned for at least 3 or 5 years.
shall comply with the Standard Treatment Guidelines and maintain
electronic medical records of every patient as may be notified by the
Central Government from time to time.
shall charge the rates for each type of procedure and service within
the range of rates to be notified by the central government from time
to time, for such procedures and services.
shall display the rates charged for each type of service provided
and facilities available, for the benefit of the patients at a
prominent place in the local dialect and as well as in English
shall establish mechanisms for review and audit for the purpose
of provision of rational practice and service.
shall carry out every prescription audits every 3 months.
Clinical establishment act aims for quality health care for own
Quality health care has three components
Freedom for errors Consistent best practices Great service -
A safe system
A reliable system
A great system