3. INTRODUCTION
The clinical establishment ( Registration and regulation) has
been enacted by the central Government to provide for the
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
It is an act of the parliament of India. It seeks to
regulate all clinical establishment in India. The act
requires all clinical establishments to register
themselves and provide a set of standard treatment
guidelines for common disease and conditions
4. DEFINATION
It is an act to provide for the registration and regulation of
clinical establishment in the country and for matters
connected therewith or incidental thereto.
This act may be called the clinical Establishment
(Registration and Regulation) Act, 2010.
It applies , in the first instance , to the whole of the states
of Arunachal Pradesh, Himachal Pradesh, Mizoram and
Sikkim and the union territories
5. OBJECTIVES OF ACT
The act makes it mandatory for registration of all clinical establishments, including diagnostic
center and single-doctor clinics across all recognized system of medicine both in public and
private sector including AYUSH except those run by the defence forces.
According to chapter I a clinical establishment may be hospital , maternity home,
dispensary, clinic, sanatorium, or any other institution that offer services for diagnosis,
care or treatment of patients.
The chapter II details the formation of a National Council.
The chapterIIIdetailsthe formation of the state and unionteritoryCouncils . It also require
formation of district registering authorities
6. CONTINUED
The change IV details the
registration procedure. The
provisional registration shall be
valid for 1year and must be
renewed.
The chapter V details the creation
of state and national level
register of Medical Establishment
in digital form.
The chapter VI details various
offences and penalties.
The act lays down standard
treatment. Guidelines for
common diseases conditions , for
which a core committee of
experts has been formed.
Further, the Act makes all clinical
establishment to provide medical
care and treatment necessary to
stabilize any individual who is
brought to the clinical
establishment in an emergency
medical conditions.
7. IMPLEMENTATION OF THE ACT
Vide the notification dated 28
January,2010 the Act came into
force in 4 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 planned a multi
stakeholder committee to
formulate the Maharashtra
Clinical Establishment Act.
Further, the Kerala Clinical
Establishment(Registration,
Accreditation, and Regulation)
Bill, 2009 is awaiting a go-ahead
from the Government to be
enforced.
8. THE NATIONAL COUNCIL FOR CLINICAL
ESTABLISHMENT
The national council shall consist of
director general of health service, four
representatives, 3 representatives to
be elected by the CCIM, 1
representative by the Central Council
of Homoeopathy, I representative by
the IMA and many more.
The nominated members of the
National Council shall hold office for 3
years.
The National Council shall meet at
least once in 3 months.
A person can be disqualified for being
appointed as a member of National
Council if he has been convicted and
sentenced to imprisonment, is an
undischarged insolvent, is of unsound
mind.
The National Council may associate
with itself any person whose
assistance or advice it may desire in
carrying out any of the provisions of
the act.
9. STANDARDS FOR CLINICAL ESTABLISHMENTS.
Further, Section 12 of the Act lays down that for registration and continuation of a Clinical
Establishment, such clinical establishment shall fulfill the conditions namely,
The minimum requirement of personnel
The minimum standards of facilities and services
Provisions for maintenance of records and reporting
Such other conditions as may be prescribed.
10. CONTINUED
Draft documents with the objective of implementation of the Clinical Establishment Act are,
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 September is divided hospitals into 4 levels of hospitals namely,
11. HOSPITAL I
• It includes services such as General Medicine, Pediatrics, First Aid to
Emergency patients, out-patient services, Obstetrics and Gynecology non-
surgical and minor surgery and have a bed strength of not more than 30 beds
12. HOSPITAL II
• This level includes services of Surgery and Anesthesia in addition to the
services provided at level 1.
• It also have other support system required for these services like Pharmacy,
Laboratory, Diagnostic facility etc.
13. HOSPITAL III
• This level includes all the services provided at level I and II and in addition the
following as well such as Multi-speciality clinical care with distinct
departments, General Dentistry, Intensive care unit
• Tertiary healthcare services can be provided through specialists. It will also
have other system like Imaging facility etc.
14. HOSPITAL IV
• This level will include all the services provided at level III. It will however have
distinction of being teaching/training institution and it will have multiple
super-specialists.
• It shall also include the requirements of MRI, other registering body.
15. PROCEDURE
FOR
REGISTRATION
For the purposes of registration of the clinical establishment
under section 10, and application in the prescribed proforma
along with the prescribed fees shall be made to the authority.
The application shall be filled in person or by post or online.
The authority shall within a period of 10 days from the date of
receipt of such application, grant to the applicant a certificate of
provisional registration in such form and containing such
particulars and such information as may be prescribed.
The authority shall not conduct any enquiry prior to the grant of
provisional registration.
16. CONTINUED
• Subject to the provision of sec.23, every provisional registration
shall be valid to the last day of the 12th month from the date of
issue of the certificate and such registration maybe renewable.
• The certificate shall be kept affixed in a conspicuous place in the
clinical establishment in such manner so as to be visible to
everyone visiting such establishment.
• Incase the certificate the lost, destroyed, damaged, the authority
shall issue duplicate certificate on the request of the clinical
establishment and on the payment of such fees as maybe
prescribed.
• The application for renewal for the registration shall be made 30
days before the expiry of the validity of the certificate of
provisional registration.
17. PENALITIES AND OFFENCES
Whoever carries on a clinical
establishment without
registration shall, on I
contravention, be liable to a
penalty of up to fifty
thousand rupees, for 2
contravention with a penalty
which may extent to 2 lakh
rupees and for any
subsequent contravention
with a penalty which may
extend to 5 lakh rupees.
Whoever knowingly serves in
a clinical establishment which
is not duly registered under
this act, shall be liable to a
penalty which may extend to
25 thousand rupees.
Whoever fails to pay the fine,
the state council of clinical
establishment may prepare a
certificate signed by an
officer authorized by it
specifying the fine due from
such person and sent it to the
Collector of the District in
which such person owns any
property or resides or carries
on his business and the said
Collector, on receipts of such
certificate shall proceed to
recover from such person the
amount specified. as if it
were and arrear of land
revenue.
18. CONCLUSION
• To conclude with, India is already outshining
itself in the global strata of pharmaceutical
market. With the implementation of the
diligently drafted standards through this act,
it is expected that in 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.
20. ABOUT KPME
• The government has passed the Karnataka Private Medical
Establishment act in the 2007 for bringing comprehensive
legislation in India.
• They replaced The Karnataka Private Nursing
Home(Regulation act of 1976).
• The KPME act controls the medical establishments that are
private in the state of Karnataka.
21. SHORT TITLE
• This act may be called the Karnataka Private Medical
Establishments(Amendment) Act, 2017.
• It shall come into force on such date as the state government
may, by notification, appoint and different dates maybe
appointed for different provisions of this act.
22. AUTHORITY
• Following members are nominated in such manner with such qualification
as maybe prescribed namely
• Deputy Commissioner of the District
• District Health and Family Welfare Officer
• District AYUSH Officer
• I member each from IMA
• 1 woman representative.
23. • Provided that no new private clinical laboratory shall be permitted within
a radius of 200 meters from the government hospital.
• Every private medical establishment for the information for the patients
and general public shall notify and make available the schedule of charges
for consultation fee, investigation, medical treatments, procedures,
hospital charges and other services.
• In case of Patients dead hand over the body of the deceased
immediately, without insisting on prior payment of the dues.
• Provided that in case the patient was admitted and any of the healthcare
assurance schemes the private medical establishment shall claim the
amount as per the scheme norms from the government.
24. PATIENTS RIGHTS
• Care: Every patient shall have a right to receive treatment.
• Confidentiality and Dignity: Every patient shall have a right to personal
dignity and to care without any form of stigma and discrimination, privacy
during examination and treatment.
• Information: Every patient or his authorized family member shall have
right to information to be provided to him which are meant to be and in a
language of patient's preference and in a manner that is effortless to
understand.
• Preferences: Every patient shall have rights to seek a second opinion on
his medical condition and get his treatment options, so that he can select
what works best for him.
25. REFERENCES
• CLINICAL ESTABLISHMENT ACT;
Notification published by Authority, THE GAZETTE OF INDIA,
Ministry of LAW and JUSTICE(Legislative Department)
New Delhi (August 19,2010)
KPME ACT;
Notification published by GOVERNMENT OF KARNATAKA,
Bengaluru (January 06, 2018)
