THE CLINICAL ESTABLISHMENTS

(REGISTRATION AND REGULATION) ACT, 2010

Enacted by the Central Government - for

registration and regulation of all clinical
establishments in the country
Prescribe the minimum standards of facilities and
services.
 THE CLINICAL ESTABLISHMENTS
(REGISTRATION AND REGULATION) ACT, 2010
 07 Chapters
 Chapter 01 - Preliminary(Sec 01 - 02)
 Chapter 02 - National Council for Clinical Establishments (Sec 03 -
07)
 Chapter 03 - Registration and Standards for Clinical Establishments
(Sec 08 - 13)
 Chapter 04 - Procedure for Registration (Sec 14 - 36)
 Chapter 05 - Register of Clinical Establishments (Sec 37 - 39)
 Chapter 06 – Penalties (Sec 40 - 46)
 Chapter 07 – Miscellaneous (Sec 47 - 56)
 IMPLEMENTATION
• Taken effect in the four States namely, Arunachal Pradesh, Himachal
Pradesh, Mizoram, Sikkim, and all Union Territories except the NCT of
Delhi since 1st March, 2012 vide Gazette notification dated 28th February,
2012.
• The States of Jammu & Kashmir, Uttar Pradesh, Uttarakhand, Rajasthan,
Bihar, Jharkhand, Assam and Haryana have adopted the Act under clause
(1) of Article 252 of the Constitution.
• The Ministry has notified the National Council for Clinical Establishments
and the Clinical Establishments (Central Government) Rules, 2012 under
this Act vide Gazette notifications dated 19th March, 2012 and 23rd May,
2012 respectively.
 KEY PURPOSE OF EXISTENCE

To help regulate the health care services in the

nation.
With a noble intention - aims to maintain a
uniform quality of healthcare across the length
and breadth of India
 Desired purpose – improvement in public
health.
 OBJECTIVES
o 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 Armed forces.
o 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.
o lays down Standard Treatment Guidelines for common disease conditions, for
which a core committee of experts has been formed.
o 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.
 CONSTITUTIONAL BASIS

 Health is a fundamental right in view of expanded meaning given to life as

contemplated vide Article 21, as interpreted by the Supreme court of India.
 Health falls in Entry 6 of list 2 of schedule VII of the constitution. The said
entry is with reference to Public health and sanitation; hospitals and
dispensaries
 State in contrast to Union is the concerned authority to make law.
 Union has no authority to make law .
 In case if union to make law resolution to be passed.
 State law will have application with in the territory of the concerned state
and not beyond the territory of the state.
 CONSTITUTIONAL BASIS
 The Parliament has no power to make laws for the States w.r.t
any matters except those provided under Article 249 and
Article 250 of Constitution.
 Article 47 of the Constitution – it is the State responsibility to
improve public health - consider this responsibility as among its
primary duties in particular
 State Government duty - endeavour to bring about prohibition -
make sure that intoxicating drinks and drugs which are injurious
to health / harm health aren’t consumed - except for medicinal
purposes.
 WHY A CENTRAL ACT?
 One significant question that’s been raised regarding the Act is that when
states already have similar acts in place, what’s the relevance of an additional
central act.
 Reason: Addresses issues with health regulation in India - promulgation of
legislation for health facilities & services, disease control & medical care,
human power (Education, Licensing & Professional Responsibility), Ethics and
Patient’s 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, need for a central legislation for registration of clinical
establishments & uniform standards.
SECTION 2(C) - CLINICAL ESTABLISHMENT
 Essentially all institutions like hospitals, dispensaries, maternity homes, nursing
homes, clinic etc. come under the category.

 In fact, any institution (regardless of the name by which it’s known) that offers services
or facilities to diagnose or provide treatment/care for illnesses, injury etc. is also a
clinical establishment.

 It can be an independent entity or part of a larger establishment that is connected to

diagnosing/treating diseases.

 A clinical establishment that’s owned and managed by the Government, a Government

department, a trust, a corporation that’s registered under a Central, Provincial or State
Act, a local authority or a single doctor also comes under the definition.
 TYPES OF MEDICAL ESTABLISHMENTS
 Applicable to all clinical establishments, apparently - mean ‘all.’

 Sec 2 (h) “recognized system of medicine” means allopathy, yoga, naturopathy,

ayurveda, homoeopathy, siddha and unani system of medicines or any other
system of medicine as may be recognized by the Central Government;
 Whether it be a diagnostic centre or a single-doctor clinic functioning under all
recognized systems of medicine.
 For controlling the hospitals that are managed by qualified doctors or
Registered Medical Practitioners.
 To bring under its ambit those establishments that are managed by un-qualified
persons. The IMA has raised the demand to the government to insert one more
clause that will prohibit and punish such persons and also shut down
operations of such establishments
 HOSPITAL LEVELS
 Government has divided hospitals into four levels

 Hospital Level 1 - This level comprises of establishments in which primary healthcare services are
provided by qualified doctors. The services include the likes of General Medicine, Paediatrics, Out
patient Services and Obstetrics & Gynecology. The maximum bed strength for these hospitals is 30.
Qualified and well-trained manpower who function with the support/supervision of registered medical
practitioners and with the support systems required for this level of care is a feature of such hospitals.
 Hospital Level 2 - Establishments that provide services such as surgery and anaesthesia in addition
to those provided at level 1 come in this level. These establishments will also have such services as
pharmacy, laboratory and diagnostic facility.
 Hospital Level 3 - Including all services from level 1 and level 2, the establishments in this level can
also be multi-specialty clinics with distinct departments. Support systems will include services such as
imaging facility and laboratory.
 Hospital Level 4 - The establishments in this level will provide all the services from level 3. But they
will have the distinction of being a teaching/training institute. Not only that, these establishments will
also have different super specialties.
 STANDARD TREATMENT GUIDELINES
These guidelines are to be followed.
 If someone comes /is brought in to the clinical establishment in an
emergency medical condition, the onus is on the establishment to provide
the care necessary to stabilize the individual - particularly with women who
come in for deliveries and those who suffered accidents.
 Section 11 - No one is to run a clinical establishment if it’s not registered in
accordance with the provisions of the Act.
 Section 12 - some of the conditions that an establishment must fulfill for the
registration and continuation of a Clinical establishment are the following:
 Minimum standards of the facilities and the services
 The minimum requirement of personnel in the establishment
 Adequate provision for maintaining records and reporting
 As for hospitals, the minimum standards will be implemented based on the
level of care that’s provided by the hospital
 MINIMUM STANDARDS
1) Integrated Counselling Centre
2) Dietetics
3) Hospital (Level 1)
4) Hospital(Level 2)
5) Hospital(Level 3)
6) Mobile Clinic Only Consultation
7) Mobile Clinic With Procedure
8) Mobile Dental Van
9) Dental Lab
10) Physiotherapy Centre
11) Health Check up Centre
12) Clinic/Polyclinic Only Consultation
13) Clinic/Polyclinic With Diagnostic Support
14) Clinic/Polyclinic With Dispensary
15) Clinic/Polyclinic With Observation
16) Collection Centres and point of care testing etc.
17) Speciality / Super-Speciality Specific
 THE AUTHORITY AND ITS
FUNCTIONS
 The National Council For Clinical Establishments- Its functions
include facilitating policy formulations, allocating resources and
determining treatment standards.
 The State Council of clinical establishments — Every State
Government shall by notification constitute a State Council for
clinical establishments or the Union territory Council for clinical
establishments.
 District registering authority - it’s functions include registering the
medical establishments and also imposing fines for not
complying with the provisions mandated by the Act
 NATIONAL COUNCIL
National Council for clinical establishments.
Chairperson: Director-General of Health Service, Ministry
of Health and Family Welfare
Secretary: ex-officio from QCI, GOI
FOUR members reps – one from each - MCI, DCI, NCI, PCI
THREE members – from Central council of Indian Medicine
 12 other members from various zones, Bureau of Indian
Standards, councils reps etc.
 FUNCTIONS OF NATIONAL COUNCILS

 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 clinical
establishments;
 Collect the statistics in respect of clinical establishments;
 Perform any other function determined by the Central Government
from time to time.
 STATE COUNCIL FOR CLINICAL
ESTABLISHMENTS
Every state government shall constitute a state council for clinical
establishments.

a. Secretary Health – ex officio, who shall be the chairman;

b. Director of Health Services – ex officio member-secretary
c. Directors of different streams of Indian System of Medicine
d. One Rep from each Council – Medical, Dental, Nursing & Pharmacy.
e. Seven other members from state councils of Indian systems of
medicine(03), Paramedical system(01), IMA(01), NGO(02).
 FUNCTIONS OF STATE COUNCIL
 Compiling and updating the State Registers of clinical
establishment;
 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.
 DISTRICT REGISTERING
AUTHORITY
The state government shall, set-up district registering
authority.
a. District Collector - Chairperson
b. District Health Officer – Convenor
c. 3 members
 1. From police
 2. From NGO
 3. From Professional association
 FUNCTIONS OF DISTRICT REGISTERING
AUTHORITY

 The District registering authority shall be responsible for

 Grant, renewal, suspension or cancellation of registration
 Enforcing compliance
 Investigation of complaints
 Preparation and submission of report
 The District Medical Officer shall exercise the powers of the
district health authority
 REGISTRATION OF ESTABLISHMENTS
● 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 Act:
 The application format for Permanent Registration of Clinical
Establishments
 Minimum Standards
 The formats to collect information and statistics
 The template for displaying rates - The hospitals should template to
display the different rates for OPD/IPD, investigation/diagnostic,
emergencies etc.
PROCEDURE FOR REGISTRATION
- MEDICAL ESTABLISHMENT
 The Application format for Permanent Registration of Clinical
Establishments was issued by the Ministry of Health and
Family Welfare in September 2014.
 Among the information that the applicant is required to
provide include the establishment details, services provided
and the system of medicine.
 PROCESS FOR REGISTRATION
- MEDICAL ESTABLISHMENT
 Provisional registration with time limit
 Inspection
 Permanent registration
 Standards for permanent registration
 The certificate shall be valid for a period of five years
from the date of issue.
 CONDITIONS FOR REGISTRATION
- MEDICAL ESTABLISHMENT
For registration and continuation, every clinical
establishment shall fulfill the following conditions, namely:-
I. The minimum standards of facilities and services as may be
prescribed;
II. The minimum requirement of personnel as may be
prescribed;
III. Provisions for maintenance of records and reporting as may
be prescribed;
IV. Such other conditions as may be prescribed.
MANDATORY CLAUSE FOR REGISTRATION
- MEDICAL ESTABLISHMENT
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.
 PENALTIES
 Monetary penalty for non-registration
 Disobedience of order, obstruction and refusal of information (five
lakh rupees).
 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
programs and furnish the same to the district authorities in
form of quarterly reports.
 THE CLINICAL ESTABLISHMENTS
(REGISTRATION AND REGULATION) RULES, 2012

 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.
 THE CLINICAL ESTABLISHMENTS
(REGISTRATION AND REGULATION) RULES, 2012
 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 language.
 THE CLINICAL ESTABLISHMENTS
(REGISTRATION AND REGULATION) RULES, 2012

 shall establish mechanisms for review and audit for the

purpose of provision of rational practice and service.
 shall carry out every prescription audits every THREE months.
 NATIONAL REGISTER OF CLINICAL ESTABLISHMENTS
Homoeo - Natura - Sowa -
State Allopathy Ayurveda Unani Siddha Yoga Total
pathy pathy Rigpa
ANDAMAN & NICOBAR
112 23 1 2 31 7 4 0 134
ISLANDS (UT)

ARUNACHAL PRADESH 62 5 0 0 12 0 2 0 75

ASSAM 5122 721 31 17 245 70 29 1 5349

CHANDIGARH (UT) 644 99 3 2 37 10 7 2 707

DADRA & NAGAR HAVELI (UT) 271 62 1 0 69 2 1 0 357

DAMAN & DIU (UT) 193 49 7 0 79 4 2 0 277

HARYANA 822 75 10 7 66 32 18 2 834

HIMACHAL PRADESH 4782 2609 134 27 229 66 65 11 6967

JAMMU & KASHMIR 19 1 0 0 0 0 0 0 19

JHARKHAND 8838 502 79 7 353 92 57 0 9270
MIZORAM 15 0 0 0 6 0 0 0 16
PUDUCHERRY (UT) 797 40 0 38 31 4 4 0 844
RAJASTHAN 2181 166 34 16 140 62 43 5 2304
UTTARAKHAND 1055 254 36 1 92 55 122 0 1407
Total 24913 4606 336 117 1390 404 354 21  
The difference in total is due to a Clinical Establishments may have
more than one system of medicine operational

Allopathy

  Ayurveda

  Unani

  Siddha

  Homoeopathy

  Yoga

  Naturopathy

  Sowa-Rigpa
 STATE ACTS
o Karnataka Private Medical Establishments Act. 2007
o Maharashtra Clinical Establishment Act, 2013.
o Kerala Clinical Establishments ( Registration and Regulation ) Act, 2018-
Act 2 of 2018.
o Gujarat Clinical Establishments (Registration and Regulation) Act, 2021-
Act 18 of 2021
o Telangana Allopathic Private Medical Care Establishments (Registration
And Regulation) Act, 2002.
o Haryana Clinical Establishment (Registration and Regulation) Adoption
Act, 2018
 STATES : RULES
o West Bengal Clinical Establishments Rules, 2003
o Bihar Clinical Establishments (Regulations) Rules, 2013
o Tamil Nadu Clinical Establishments (Regulations) Rules, 2018
o Andhra Pradesh Allopathic Private Medical Care Establishments
(Registration and Regulation) Rules, 2007
o Uttar Pradesh Clinical Establishments ( Registration and
Regulation ) Rules, 2016
o Jharkhand State Clinical Establishments ( Registration and
Regulation ) Rules, 2013
 STATES : RULES
 Mizoram Clinical Establishments ( Registration and Regulation )
Rules, 2014
 Arunachal Pradesh Clinical Establishments Rules, 2011
 Chhattisgarh Nursing Home Rules, 2013
 The Goa Clinical Establishments (Registration and Regulation)
Rules, 2021
 IN DRAFT / BILL STAGE / ORDINANCE
 The Draft Madhya Pradesh Clinical Establishments
(Registration and Regulation) Bill,2019
 The Delhi Health Bill, 2019 (Revised Draft)
 The Andhra Pradesh Informed Choice of Clinical
Establishments Bill, 2017
 The Punjab Clinical Establishments (Registration and
Regulation) Ordinance, 2020. (Punjab Ordinance No. 2 0f
2020)
 Rajasthan Clinical Establishments (Registration & Regulation)
Bill, 2006
 CLINICAL ESTABLISHMENTS (CENTRAL
GOVERNMENT) AMENDMENT RULES

● 18th May, 2018 Clinical Establishments (Central Government) Amendment Rules,

2018- Minimum Standards for Medical Diagnostic Laboratories (or Pathological
Laboratories) — Every clinical establishment relating to diagnosis or treatment of
diseases, where pathological, bacteriological, genetic, radiological, chemical,
biological investigations or other diagnostic or investigative services, are usually
carried on with the aid of laboratory or other medical equipment, shall comply with
the minimum standards of facilities and services as specified in the Schedule.”

● 14th February, 2020 Clinical Establishments (Central Government) Amendment

Rules, 2020: Human resources related amendment.
 THE SCHEDULE- [ SECTION 56]
 The provisions of this Clinical Establishment Act shall not apply to the
States in which the enactments specified in the Schedule are applicable:
 1. The Andhra Pradesh Private Medical Care Establishments (Registration and
Regulation) Act, 2002.
 2. The Bombay Nursing Homes Registration Act, 1949.
 3. The Delhi Nursing Homes Registration Act, 1953.
 4. The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue
(Ragistrikaran Tatha Anugyapan) Adhiniyam, 1973.
 5. The Manipur Homes and Clinics Registration Act, 1992.
 6. The Nagaland Health Care Establishments Act, 1997.
 7. The Orissa Clinical Establishments (Control and Regulation) Act, 1990.
 8. The Punjab State Nursing Home Registration Act, 1991.
 9. The West Bengal Clinical Establishments Act, 1950.
 Survey in the Selected States/ UTs of the Country by I
MA for Defining the Minimum Requirements for Differ
ent Types of Clinical Establishments
-2013
THANK YOU
 ARTICLE 47
DUTY OF THE STATE TO RAISE THE LEVEL OF NUTRITION AND
THE STANDARD OF LIVING AND TO IMPROVE PUBLIC HEALTH

 The State shall regard the raising of the level of nutrition and the standard of living of its
people and the improvement of public health as among its primary duties and, in
particular, the State shall endeavor to bring about prohibition of the consumption except
for medicinal purposes of intoxicating drinks and of drugs which are injurious to health
 ARTICLE 249
POWER OF PARLIAMENT TO LEGISLATE WITH RESPECT TO A
MATTER IN THE STATE LIST IN THE NATIONAL INTEREST

(1) Notwithstanding anything in the foregoing provisions of this Chapter, if the Council of States has
declared by resolution supported by not less than two-thirds of the members present and voting that
it is necessary or expedient in the national interest that Parliament should make laws with respect to
any matter enumerated in the State List specified in the resolution, it shall be lawful for Parliament to
make laws for the whole or any part of the territory of India with respect to that matter while the
resolution remains in force.
(2) A resolution passed under clause (1) shall remain in force for such period not exceeding one
year as may be specified therein: Provided that, if and so often as a resolution approving the
continuance in force of any such resolution is passed in the manner provided in clause (1), such
resolution shall continue in force for a further period of one year from the date on which under this
clause it would otherwise have ceased to be in force.
(3) A law made by Parliament which Parliament would not but for the passing of a resolution under
clause (1) have been competent to make shall, to the extent of the incompetency, cease to have
effect on the expiration of a period of six months after the resolution has ceased to be in force,
except as respects things done or omitted to be done before the expiration of the said period.
 ARTICLE 250
POWER OF PARLIAMENT TO LEGISLATE WITH RESPECT TO ANY MATTER
IN THE STATE LIST IF A PROCLAMATION OF EMERGENCY IS IN OPERATION

(1) Notwithstanding anything in this Chapter, Parliament shall, while a Proclamation of

Emergency is in operation, have power to make laws for the whole or any part of the
territory of India with respect to any of the matters enumerated in the State List.
(2) A law made by Parliament which Parliament would not but for the issue of a
Proclamation of Emergency have been competent to make shall, to the extent of the
incompetency, cease to have effect on the expiration of a period of six months after the
Proclamation has ceased to operate, except as respects things done or omitted to be
done before the expiration of the said period.
 ARTICLE 252
POWER OF PARLIAMENT TO LEGISLATE FOR TWO OR MORE
STATES BY CONSENT AND ADOPTION OF SUCH LEGISLATION BY
ANY OTHER STATE
(1) If it appears to the Legislatures of two or more States to be desirable that any of
the matters with respect to which Parliament has no power to make laws for the
States except as provided in articles 249 and 250 should be regulated in such
States by Parliament by law, and if resolutions to that effect are passed by all the
Houses of the Legislatures of those States, it shall be lawful for Parliament to pass
an Act for regulating that matter accordingly, and any Act so passed shall apply to
such States and to any other State by which it is adopted afterwards by resolution
passed in that behalf by the House or, where there are two Houses, by each of the
Houses of the Legislature of that State.
(2) Any Act so passed by Parliament may be amended or repealed by an Act of
Parliament passed or adopted in like manner but shall not, as respects any State to
which it applies, be amended or repealed by an Act of the Legislature of that State
 ARTICLE 21 - PROTECTION OF
LIFE AND PERSONAL LIBERTY
21. Protection of life and personal liberty
No person shall be deprived of his life or
personal liberty except according to
procedure established by law