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CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT 2010

THE CLINICAL ESTABLISHMENTS (REGISTRATION
AND REGULATION) ACT, 2010
NO. 23 OF 2010
[18th August, 2010.]
An Act to provide for the
registration and regulation of
clinical establishments in the country and for matters
connected therewith or incidental thereto.
WHEREAS, it is considered expedient to provide for the
registration and regulation of clinical establishments with a
view to prescribe
minimum standards of facilities and
services which may be provided by them so that mandate of
article 47 of the Constitution for
improvement in public
health may be achieved;
AND WHEREAS, Parliament has no power to make laws for
the States with respect to any
of the matters aforesaid
except as provided in articles 249 and 250 of the
Constitution;
AND WHEREAS, in pursuance of clause (1)
of article 252 of
the Constitution, resolutions have been passed by all the
Houses of the Legislatures of the States of Arunachal
Pradesh, Himachal Pradesh, Mizoram and Sikkim to the
effect that the matters aforesaid should be regulated in
those States by Parliament
by law;
BE it enacted by Parliament in the Sixty-first Year of the
Republic of India as follows:--
CHAPTER I
PRELIMINARY
1. Short
title, application and commencement. - (1) This
Act may be called the Clinical Establishments (Registration
and Regulation) Act,
2010.
(2) It applies, in the first instance, to the whole of the
States of Arunachal Pradesh, Himachal Pradesh, Mizoram
and Sikkim
and the Union territories; and it shall apply to
such other State which adopts this Act by resolution passed
in that behalf under
clause (1) of article 252 of the
Constitution.
(3) It shall come into force at once in the States of
Arunachal Pradesh, Himachal
Pradesh, Mizoram and
Sikkim and the Union territories, on such date as the
Central Government may, by notification, appoint and in
any other State which adopts this Act under clause (1) of
article 252 of the Constitution, on the date of such
adoption; and any
reference in this Act to the
commencement of this Act shall, in relation to any State or
Union territory, mean the date on which
this Act comes
into force in such State or Union territory:
Provided that different dates may be appointed for
different categories
of clinical establishments and for
different recognised systems of medicine.
2. Definitions. - In this Act, unless the context otherwise
requires,--
(a) "authority" means the district registering
authority set-up under section 10;
(b) "certificate" means certificate
of registration
issued under section 30;
(c) "clinical establishment" means--
(i) 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
recognised system of medicine established and
administered or maintained
by any person or body of
persons, whether incorporated or not; or
(ii) 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,
and shall include a clinical establishment owned,
controlled or managed by--
(a) the Government or a
department of the
Government;
(b) a trust, whether public or private;
(c) a corporation (including a society) registered
under a
Central, Provincial or State Act, whether or not
owned by the Government;
(d) a local authority; and
(e) a single doctor,
but does
not include the clinical establishments owned,
controlled or managed by the Armed Forces.
Explanation.--For the purpose of this clause
"Armed
Forces" means the forces constituted under the Army Act,
1950, the Air Force Act, 1950 and the Navy Act, 1957;
(d) "emergency medical condition" means a medical
condition manifesting itself by acute symptoms of
sufficient severity (including
severe pain) of such a
nature that the absence of immediate medical attention
could reasonably be expected to result in--
(i) placing
the health of the individual or, with
respect to a pregnant women, the health of the
woman or her unborn child, in serious jeopardy;
or
(ii) serious impairment to bodily functions; or
(iii) serious dysfunction of any organ or part of a
body;
(e) "National Council"
means the National Council
for clinical establishments established under section 3;
(f) "notification" means a notification published
in
the Official Gazette;
(g) "prescribed" means prescribed by rules made
under this Act by the Central Government or, as the
case
may be, the State Government;
(h) "recognised system of medicine" means
Allopathy, Yoga, Naturopathy, Ayurveda,
Homoeopathy, Siddha
and Unani System of medicines
or any other system of medicine as may be recognised
by the Central Government;
(i) "register" means
the register maintained by the
authority, State Government and the Central
Government under sections 37, 38 and 39 respectively
of
this Act containing the number of clinical
establishments registered;
(j) "registration" means to register under section 11
and the
expression registration or registered shall be
construed accordingly;
(k) "rules" means rules made under this Act;
(l) "Schedule"
means the Schedule appended to this
Act;
(m) "standards" means the conditions that the Central
Government may prescribe under section
12, for the
registration of clinical establishments;
(n) "State Government", in relation to a Union
territory, means the Administrator
thereof appointed
under article 239 of the Constitution; and
(o) "to stabilise (with its grammatical variations and
cognate expressions)"
means, with respect to an
emergency medical condition specified in clause (d), to
provide such medical treatment of the condition
as may
be necessary to assure, within reasonable medical
probability, that no material deterioration of the
condition is likely to
result from or occur during the
transfer of the individual from a clinical establishment.
CHAPTER II
THE NATIONAL COUNCIL FOR CLINICAL
ESTABLISHMENTS
3. Establishment of National Council. - (1) With effect
from such date as the Central Government may, by
notification
appoint in this behalf, there shall be
established for the purposes of this Act, a Council to be
called the National Council for
clinical establishments.
(2) The National Council shall consist of--
(a) Director-General of Health Service, Ministry of
Health and
Family Welfare,
ex officio, who shall be the Chairperson;
(b) four representatives out of which one each to be
elected by the--
(i)
Dental Council of India constituted under
section 3 of the Dentists
Act, 1948;
(ii) Medical Council of India constituted under
section 3 of the Indian Medical Council Act, 1956;
(iii) Nursing Council of India constituted under
section 3 of the Indian Nursing Council Act, 1947;
(iv) Pharmacy Council of India constituted under
section 3 of the Pharmacy Act, 1948;
(c) three representatives to be elected by the Central
Council of Indian Medicine representing the Ayurveda,
Siddha and Unani systems
of medicine constituted
under section 3 of the Indian Medicine Central Council
Act, 1970;
(d) one representative to be elected by
the Central
Council of Homoeopathy constituted under section 3 of
the Homoeopathy Central Council Act, 1973;
(e) one representative to be elected by the Central
Council of the Indian Medical Association;
(f) one representative of Bureau
of the Indian
Sandards constituted under section 3 of the Bureau of
Indian Standards Act, 1986;
(g) two representatives from the
Zonal Council set-
up under section 15 of the States Reorganisation Act,
1956;
(h) two representatives from the North-Eastern
Council set-up under section 3 of the North-Eastern
Council Act, 1971;
(i) one representative from the line of paramedical
systems excluding systems that have been given
representation under clause (b);
(j) two representatives from National Level
Consumer Group to be nominated by the Central
Government;
(k) one representative from
the Associations of
Indian Systems of Medicines relating to Ayurveda,
Siddha and Unani to be nominated by the Central
Government;
(l) the Secretary-General of the Quality Council of
India, ex officio.
(3) The nominated members of the National Council
shall hold
office for three years but shall be eligible for re-
nomination for maximum of one more term of three years.
(4) The elected members
of the National Council shall
hold office for three years, but shall be eligible for re-
election:
Provided that the person nominated
or elected, as the
case may be, shall hold office for such period till he holds
appointment of the office by virtue of which he was
nominated or elected to the council.
(5) The members of the National Council shall be
entitled for such allowances as may be prescribed
by the
Central Government.
(6) The National Council may, subject to the previous
approval of the Central Government, make bye-laws
fixing
a quorum and regulating its own procedure and the conduct
of all business to be transacted by it.
(7) The National Council
shall meet at least once in
three months.
(8) The National Council may constitute sub-
committees and may appoint to such sub-committee,
as it
deems fit, persons, who are not members of the National
Council, for such period, not exceeding two years, for the
consideration
of particular matters.
(9) The functions of the National Council may be
exercised notwithstanding any vacancy therein.
(10) The Central
Government shall appoint such person
to be the Secretary of the National Council as the Central
Government may prescribe, and may
provide the National
Council with such other secretarial and other staff as the
Central Government considers necessary.
4. Disqualifications
for appointment as member. - A
person shall be disqualified for being appointed as a
member of the National Council if he--
(a) has
been convicted and sentenced to
imprisonment for an offence which, in the opinion of
the Central Government, involves moral turpitude;
or
(b) is an undischarged insolvent; or
(c) is of unsound mind and stands so declared by a
competent court; or
(d) has been removed
or dismissed from the service
of the Government or a Corporation owned or
controlled by the Government; or
(e) has, in the opinion
of the Central Government,
such financial or other interest in the Council as is likely
to affect prejudicially the discharge by
him of his
functions as a member.
5. Functions of National Council. - The National Council
shall--
(a) compile and publish a National
Register of clinical
establishments within two years from the date of the
commencement of this Act;
(b) classify the clinical establishments
into different
categories;
(c) develop the minimum standards and their periodic
review;
(d) determine within a period of two years
from its
establishment, the first set of standards for ensuring
proper healthcare by the clinical establishments;
(e) collect the
statistics in respect of clinical
establishments;
(f) perform any other function determined by the Central
Government from time to
time.
6. Power to seek advice or assistance. - The National
Council may associate with itself any person or body
whose assistance
or advice it may desire in carrying out any
of the provisions of this Act.
7. National Council to follow consultative process. -
The
National Council shall follow a consultative process for
determining the standards and for classification of clinical
establishments
in accordance with such procedure as may
be prescribed.
CHAPTER III
REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS
8. State
Council of clinical establishments. - (1) Every
State Government shall by notification constitute a State
Council for clinical establishments
or the Union territory
Council for clinical establishments, as the case may be.
(2) The State Council or the Union territory Council,
as
the case may be, shall consist of the following members,
namely:--
(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 Systems
of Medicine--ex
officio members;
(d) one representative each to be elected by the
executive committee of--
(i) State Medical Council of India;
(ii)
State Dental Council of India;
(iii) State Nursing Council of India;
(iv) State Pharmacy Council of India;
(e) three representatives
to be elected by the
Executive of the State Council or the Union territory
Council, as the case may be, of Indian Medicine
representing
the Ayurveda, Siddha and Unani systems
of medicine;
(f) one representative to be elected by the State
Council of the Indian Medical
Association;
(g) one representative from the line of paramedical
systems;
(h) two representatives from State level consumer
groups
or reputed non-Governmental organisations
working in the field of health.
(3) The nominated member of the State Council or the
Union
territory Council, as the case may be, shall hold
office for a term of three years, but shall be eligible for re-
nomination for
maximum of one more term of three years.
(4) The elected members of the State Council or the
Union territory Council, as the case
may be, shall hold
office for three years, but shall be eligible for re-election:
Provided that the person nominated or elected,
as the
case may be, shall hold office for so long as he holds the
appointment of the office by virtue of which he was
nominated or
elected to the State Council or the Union
territory Council, as the case may be.
(5) The State Council or the Union territory Council
shall perform the following functions, namely:--
(a) compiling and updating the State Registers of
clinical establishment;
(b) sending
monthly returns for updating the
National Register;
(c) representing the State in the National Council;
(d) hearing of appeals against
the orders of the
authority; and
(e) publication on annual basis a report on the state
of implementation of standards within their
respective
States.
9. Providing information to National Council. - It shall be
the responsibility of the State Council for clinical
establishments to compile and update the State Register of
clinical establishments of the State and further to send
monthly returns
in digital format for updating the National
Register.
10. Authority for registration. - (1) The State Government
shall, by notification,
set-up an authority to be called the
district registering authority for each district for registration
of clinical establishments,
with the following members,
namely:--
(a) District Collector -- Chairperson;
(b) District Health Officer -- Convenor;
(c) three members
with such qualifications and on such
terms and conditions as may be prescribed by the
Central Government.
(2) Notwithstanding anything
contained in sub-section (1),
for the purposes of provisional registration of clinical
establishments under section 14, the District
Health Officer
or the Chief Medical Officer (by whatever name called)
shall exercise the powers of the authority as per procedure
that may be prescribed.
11. Registration for clinical establishments. - No person
shall run a clinical establishment unless it has
been duly
registered in accordance with the provisions of this Act.
12. Condition for registration. - (1) For registration and
continuation,
every clinical establishment shall fulfil the
following conditions, namely:--
(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.
(2) The clinical establishment shall undertake to provide
within the staff and facilities available, such medical
examination
and treatment as may be required to stabilise
the emergency medical condition of any individual who
comes or is brought to such clinical establishment.
13. Classification of clinical establishments. - (1) Clinical
establishment of different systems shall be classified into
such categories,
as may be prescribed by the Central
Government, from time to time.
(2) Different standards may be prescribed for classification
of
different categories referred to in sub-section (1):
Provided that in prescribing the standards for clinical
establishments, the
Central Government shall have regard
to the local conditions.
CHAPTER IV
PROCEDURE FOR REGISTRATION
14. Application for provisional
certificate of registration. -
(1) For the purposes of registration of the clinical
establishment under section 10, an application
in the
prescribed proforma along with the prescribed fee shall be
made to the authority.
(2) The application shall be filed in person
or by post or
online.
(3) The application shall be made in such form and shall be
accompanied by such details as may be prescribed
under
this Act or rules made thereunder.
(4) If any clinical establishment is in existence at the
time of the commencement of this
Act, an application for
its registration shall be made within one year from the date
of the commencement of this Act and a clinical
establishment which comes into existence after
commencement of this Act, shall apply for permanent
registration within a period of
six months from the date of
its establishment.
(5) If any clinical establishment is already registered
under any existing law requiring
registration of such
establishments, even then it shall apply for registration as
referred to in sub-section (1).
15. Provisional
certificate. - The authority shall, within a
period of ten 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.
16. No inquiry prior to provisional registration. - (1) The
authority shall not conduct any inquiry prior to the grant of
provisional
registration.
(2) Notwithstanding the grant of the provisional certificate
of registration, the authority shall, within a period
of forty-
five days from the grant of provisional registration, cause to
be published in such manner, as may be prescribed, all
particulars
of the clinical establishment so registered
provisionally.
17. Validity of provisional registration. - Subject to the
provisions
of section 23, every provisional registration shall
be valid to the last day of the twelfth month from the date
of issue of the certificate
of registration and such
registration shall be renewable.
18. Display of certificate of registration. - The certificate
shall be
kept affixed in a conspicuous place in the clinical
establishment in such manner so as to be visible to every
one visiting such establishment.
19. Duplicate certificate. - In case the certificate is lost,
destroyed, mutilated or damaged, the authority shall issue a
duplicate
certificate on the request of the clinical
establishment and on the payment of such fees as may be
prescribed.
(i) the minimum standards
of facilities and services as
may be prescribed;
20. Certificate to be non-transferable. - (1) The certificate
of registration shall
be non-transferable.
(2) In the event of change of ownership or management,
the clinical establishment shall inform the authority
of such
change in such manner as may be prescribed.
(3) In the event of change of category, or location, or on
ceasing to function
as a clinical establishment, the
certificate of registration in respect of such clinical
establishment shall be surrendered to the
authority and the
clinical establishment shall apply afresh for grant of
certificate of registration.
21. Publication of expiry of
registration. - The authority
shall cause to be published within such time and in such
manner, as may be prescribed, the names of
clinical
establishments whose registration has expired.
22. Renewal of registration. - The application for renewal
of registration shall
be made thirty days before the expiry
of the validity of the certificate of provisional registration
and, in case the application
for renewal is made after the
expiry of the provisional registration, the authority shall
allow renewal of registration on payment
of such enhanced
fees, as may be prescribed.
23. Time limit for provisional registration. - Where the
clinical establishments in
respect of which standards have
been notified by the Central Government, provisional
registration shall not be granted or renewed
beyond,--
(i) the period of two years from the date of notification
of the standards in case of clinical establishments which
came
into existence before the commencement of this
Act;
(ii) the period of two years from the date of notification
of the standards for
clinical establishments which come
into existence after the commencement of this Act but
before the notification of the standards;
and
(iii) the period of six months from the date of
notification of standards for clinical establishments
which come into existence
after standards have been
notified.
24. Application for permanent registration. - Application
for permanent registration by a clinical
establishment shall
be made to the authority in such form and be accompanied
by such fees, as may be prescribed.
25. Verification
of application. - The clinical establishment
shall submit evidence of having complied with the
prescribed minimum standards in such
manner, as may be
prescribed.
26. Display of information for filing objections. - As soon
as the clincial establishment submits the
required evidence
of having complied with the prescribed minimum
standards, the authority shall cause to be displayed for
information
of the public at large and for filing objections,
if any, in such manner, as may be prescribed, all evidence
submitted by the clinical
establishment of having complied
with the prescribed minimum standards for a period of
thirty days before processing for grant of
permanent
registration.
27. Communication of objections. - If objections are
received within the period referred to in the preceding
section, such objections shall be communicated to the
clinical establishment for response within a period of forty-
five days.
28.
Standards for permanent registration. - Permanent
registration shall be granted only when a clinical
establishment fulfils the prescribed
standards for
registration by the Central Government.
29. Allowing or disallowing of registration. - The authority
shall pass an
order immediately after the expiry of the
prescribed period and within the next thirty days thereafter
either--
(a) allowing the
application for permanent registration;
or
(b) disallowing the application:
Provided that the authority shall record its reasons,
if it
disallows an application, for permanent registration.
30. Certificate of permanent registration. - (1) The
authority shall,
if it, allows an application of the clinical
establishment, issue a certificate of permanent registration
in such form and containing
such particulars, as may be
prescribed.
(2) The certificate shall be valid for a period of five years
from the date of issue.
(3)
For the purposes of sub-section (1), the provisions of
sections 18, 19, 20 and 21 shall also apply.
(4) The applications for renewal
of permanent registration
shall be made within six months before the expiry of the
validity of the certificate of permanent registration
and,
in case the application of renewal is not submitted within
the stipulated period, the authority may allow renewal of
registration
on payment of such enhanced fees and
penalties as may be prescribed.
31. Fresh application for permanent registration. - The
disallowing
of an application for permanent registration
shall not debar a clinical establishment from applying
afresh for permanent registration
under section 24 and after
providing such evidence, as may be required, of having
rectified the deficiences on which grounds the earlier
application was disallowed.
32. Cancellation of registration. - (1) If, at any time after
any clinical establishment has been registered, the authority
is satisfied
that,--
(a) the conditions of the registration are not being
complied with; or
(b) the person entrusted with the management of the
clinical establishment has been convicted of an offence
punishable under this Act,
it may issue a notice to the clinical establishment
to show
cause within three months' time as to why its registration
under this Act should not be cancelled for the reasons to be
mentioned
in the notice.
(2) If after giving a reasonable opportunity to the
clinical establisment, the authority is satisfied that there has
been a breach of any of the provisions of this Act or the
rules made thereunder, it may, by an order, without
prejudice to any other
action that it may take against such
clinical establishment, cancel its registration.
(3) Every order made under sub-section (2)
shall take
effect--
(a) where no appeal has been preferred against such
order immediately on the expiry of the period prescribed
for such appeal; and
(b) where such appeal has been preferred and it has
been dismissed from the date of the order of such
dismissal:
Provided that the authority, after cancellation of
registration for reasons to be recorded in writing, may
restrain immediately the
clinical establishment from
carrying on if there is imminent danger to the health and
safety of patients.
33. Inspection of registered
clinical establishments. - (1)
The authority or an officer authorised by it shall have the
right to cause an inspection of, or inquiry
in respect of any
registered clinical establishment, its building, laboratories
and equipment and also of the work conducted or done
by
the clinical establishment, to be made by such multi-
member inspection team as it may direct and to cause an
inquiry to be made
in respect of any other matter connected
with the clinical establishment and that establishment shall
be entitled to be represented
thereat.
(2) The authority shall communicate to the clinical
establishment the views of that authority with reference to
the results
of such inspection or inquiry and may, after
ascertaining the opinion of the clinical establishment
thereon, advise that establishment
upon the action to be
taken.
(3) The clinical establishment shall report to the authority,
the action, if any, which is proposed
to be taken or has been
taken upon the results of such inspection or inquiry and
such report shall be furnished within such time,
as the
authority may direct.
(4) Where the clinical establishment does not, within a
reasonable time, take action to the satisfaction
of the
authority, it may, after considering any explanation
furnished orrepresentation made by the clinical
establishment, issue
such directions within such time as
indicated in the direction, as that authority deems fit, and
the clinical establishment shall
comply with such
directions.
34. Power to enter. - The authority or an officer authorised
by it may, if there is any reason to suspect
that anyone is
carrying on a clinical establishment without registration,
enter and search in the manner prescribed, at any
reasonable
time and the clinical establishment, shall offer
reasonable facilities for inspection or inquiry and be
entitled to be represented
thereat:
Provided that no such person shall enter the clinical
establishment without giving notice of his intention to do
so.
35.
Levy of fee by State Government. - The State
Government may charge fees for different categories of
clinical establishments, as may
be prescribed.
36. Appeal. - (1) Any person, aggrieved by an order of the
registering authority refusing to grant or renew a certificate
of registration or revoking a certificate of registration may,
in such manner and within such period as may be
prescribed, prefer
an appeal to the State Council:
Provided that the State Council may entertain an appeal
preferred after the expiry of the prescribed period if it
is
satisfied that the appellant was prevented by sufficient
cause from preferring the appeal in time.
(2) Every appeal under sub-section
(1) shall be made in
such form and be accompanied by such fee as may be
prescribed.
CHAPTER V
REGISTER OF CLINICAL ESTABLISHMENTS
37. Register of clinical establishments. - (1) The authority
shall within a period of two years from its establishment,
compile,
publish and maintain in digital format a register of
clinical establishments, registered by it and it shall enter the
particulars
of the certificate so issued in a register to be
maintained in such form and manner, as may be prescribed
by the State Government.
(2) Each authority, including any other authority set-up for
the registration of clinical establishments under any other
law for
the time being in force, shall supply in digital
format to the State Council of clinical establishments a
copy of every entry made
in the register of clinical
establishments in such manner, as may be prescribed to
ensure that the State Register is constantly up-to-date
with
the registers maintained by the registering authority in the
State.
38. Maintenance of State Register of clinical
establishments.
- (1) Every State Government shall
maintain in digital and in such form and containing such
particulars, as may be prescribed by
the Central
Government a register to be known as the State Register of
clinical establishments in respect of clinical establishments
of that State.
(2) Every State Government shall supply in digital format
to the Central Government, a copy of the State Register
of
clinical establishments and shall inform the Central
Government all additions to and other amendments in such
register made, for
a particular month by the 15th day of the
following month.
39. Maintenance of National Register of clinical
establishments. - The
Central Government shall maintain in
digital format an All India Register to be called as the
National Register of clinical establishments
that shall be an
amalgam of the State Register of clinical establishments
maintained by the State Governments and shall cause the
same to be published in digital format.
CHAPTER VI
PENALTIES
40. Penalty. - Whoever contravenes any provision of this
Act shall,
if no penalty is provided elsewhere, be
punishable for the first offence with fine which may extend
to ten thousandrupees, for any
second offence with fine
which may extend to fifty thousand rupees and for any
subsequent offence with fine which may extend to five
lakh
rupees.
41. Monetary penalty for non-registration. - (1) Whoever
carries on a clinical establishment without registration
shall,
on first contravention, be liable to a monetary penalty
up to fifty thousand rupees, for second contravention with a
monetary penalty
which may extend to two lakh rupees
and for any subsequent contravention with a monetary
penalty which may extend to five lakh rupees.
(2) Whoever knowingly serves in a clinical establishment
which is not duly registered under this Act, shall be liable
to a monetary
penalty which may extend to twenty-five
thousand rupees.
(3) For the purpose of adjudging under sub-sections (1) and
(2), the authority
shall hold an inquiry in the prescribed
manner after giving any person concerned a reasonable
opportunity of being heard for the
purpose of imposing any
monetary penalty.
(4) While holding an inquiry the authority shall have
power to summon and enforce the attendance
of any person
acquainted with the facts and circumstances of the case to
give evidence or to produce any document which in the
opinion
of the authority, may be useful for or relevant to
the subject matter of the inquiry and if, on such inquiry, it
is satisfied that
the person has failed to comply with the
provisions specified in sub-sections (1) and (2), it may by
order impose the monetary penalty
specified in those sub-
sections to be deposited within thirty days of the order in
the account referred to in sub-section (8) of section 42.
(5) While
determining the quantum of monetary
penalty, the authority shall take into account the category,
size and type of the clinical establishment
and local
conditions of the area in which the establishment is
situated.
(6) Any person aggrieved by the decision of the
authority
may prefer an appeal to the State Council within a
period of three months from the date of the said decision.
(7) The manner of filing
the appeal referred to in sub-
section (6) shall be such as may be prescribed.
42. Disobedience of direction, obstruction and refusal
of
information. - (1) Whoever wilfully disobeys any direction
lawfully given by any person or authority empowered
under this Act
to give such direction, or obstructs any
person or authority in the discharge of any functions which
such person or authority is
required or empowered under
this Act to discharge, shall be liable to a monetary penalty
which may extend to five lakh rupees.
(2)
Whoever being required by or under this Act to
supply any information wilfully withholds such information
or gives information which
he knows to be false or which
he does not believe to be true, shall be liable to a monetary
penalty which may extend to five lakh
rupees.
(3) For the purpose of adjudging under sub-sections (1)
and (2), the authority shall hold an inquiry in the prescribed
manner
after giving any person concerned a reasonable
opportunity of being heard for the purpose of imposing any
monetary penalty.
(4) While
holding an inquiry the authority shall have
power to summon and enforce the attendance of any person
acquainted with the facts and
circumstances of the case to
give evidence or to produce any document which in the
opinion of the authority, may be useful for or
relevant to
the subject matter of the inquiry and if, on such inquiry, it
is satisfied that the person has failed to comply with
the
provisions specified in sub-sections (1) and (2), it may by
order impose the monetary penalty specified in those sub-
sections
to be deposited within thirty days of the order in
the account referred to in sub-section (8).
(5) While determining the quantum
of monetary
penalty, the authority shall take into account the category,
size and type of the clinical establishment and local
conditions
of the area in which the establishment is
situated.
(6) Any person aggrieved by the decision of the
authority may prefer an appeal
to the State Council within a
period of three months from the date of the said decision.
(7) The manner of filing the appeal referred
to in sub-
section (6) shall be such as may be prescribed.
(8) The monetary penalty levied under sections 41 and
42 shall be credited
to such account as the State
Government may by order specify in this behalf.
43. Penalty for minor deficiencies. - Whoever contravenes
any provision of this Act or any rule made thereunder
resulting in deficiencies that do not pose any imminent
danger to the health
and safety of any patient and can be
rectified within a reasonable time, shall be punishable with
fine which may extend to ten thousand
rupees.
44. Contravention by companies. - (1) Where a person
committing contravention of any of the provisions of this
Act or of
any rule made thereunder is a company, every
person who, at the time the contravention was committed,
was in charge of, and was responsible
to the company for
the conduct of the business of the company, as well as the
company, shall be deemed to be guilty of the contravention
and shall be liable to fine:
Provided that nothing contained in this sub-section shall
render any such person liable to any punishment
if he
proves that the contravention was committed without his
knowledge or that he had exercised all due diligence to
prevent the
commission of such contravention.
(2) Notwithstanding anything contained in sub-section (1),
where a contravention of any of the
provisions of this Act
or of any rule made thereunder has been committed by a
company and it is proved that the contravention has taken
place with
the consent or connivance of, or is attributable to
any neglect on the part of, any director, manager, secretary
or other officer
of the company, such director, manager,
secretary or other officer shall also be deemed to be guilty
of that contravention and shall
be liable to fine.
Explanation.--For the purpose of this section,--
(a) "company" means a body corporate and includes a
firm or other
association of individuals; and
(b) "director", in relation to a firm, means a partner in
the firm.
45. Offences by Government Departments.
- (1) Where an
offence under this Act has been committed by any
Department of Government within a period of six months
after the
commencement of this Act, the Head of the
Department shall be deemed to be guilty of the offence and
shall be liable to be proceeded
against and punished
accordingly:
Provided that nothing contained in this section shall render
such Head of the Department liable
to any punishment if he
proves that the offence was committed without his
knowledge or that he exercised all due diligence to prevent
the commission of such offence.
(2) Notwithstanding anything contained in sub-section
(1), where an offence under this Act has been
committed by
a Department of Government and it is proved that the
offence has been committed with the consent or connivance
of, or
is attributable to any neglect on the part of, any
officer, other than the Head of the Department, such officer
shall also be deemed
to be guilty of that offence and shall
be liable to be proceeded against and punished accordingly.
46. Recovery of fine. - Whoever
fails to pay the fine, the
State Council of clinical establishment may prepare a
certificate signed by an officer authorised by it
specifying
the fine due from such person and send 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
receipt of such certificate, shall proceed to recover from
such person the
amount specified thereunder, as if it were
an arrear of land revenue.
CHAPTER VII
MISCELLANEOUS
47. Protection of action taken in
good faith. - (1) No suit,
prosecution or other legal proceedings shall lie against any
authority or any member of the National Council
or State
Council or any officer authorised in this behalf in respect of
anything, which is in good faith done or intended to be
done
in pursuance of the provisions of this Act or any rule
made thereunder.
(2) No suit or other legal proceedings shall lie against
a
State Government or the Central Government in respect of
any loss or damage caused or likely to be caused by
anything which is
in good faith done or intended to be done
in pursuance of the provisions of this Act or any rule made
thereunder.
48. Furnishing
of returns, etc. - Every clinical
establishment shall, within such time or within such
extended time, as may be prescribed in that
behalf, furnish
to the authority or the State Council or the National Council
such returns or the statistics and other information
in such
manner, as may be prescribed by the State Government,
from time to time.
49. Power to give directions. - Without prejudice
to the
foregoing provisions of this Act, the authority shall have
the power to issue such directions, including furnishing
returns,
statistics and other information for the proper
functioning of clinical establishments and such directions
shall be binding.
50.
Employees of the authority, etc., to be public servants. -
Every employee of the authority, the National Council and
the State Council
shall be deemed to, when acting or
purporting to act in pursuance of any of the provisions of
this Act, be public servants within
the meaning of section
21 of the Indian Penal Code.
51. Power to remove difficulties. - (1) If any difficulty
arises in giving effect
to the provisions of this Act, the
Central Government may, by order published in the
Official Gazette, make such provisions not inconsistent
with the provisions of this Act
as may appear to it to be
necessary or expedient for removal of the difficulty:
Provided that no such order shall be made after the
expiry
of a period of two years from the date of commencement of
this Act.
(2) Every order made under this section shall, as soon
as
may be after it is made, be laid before each House of
Parliament.
52. Power of Central Government to make rules. - (1) The
Central
Government may, by notification, make rules for
carrying out all or any of the provisions of this Act.
(2) In particular and without
prejudice to the generality
of the foregoing power, such rules may provide for all or
any of the following matters, namely:--
(a)
allowances for the members of the National
Council under sub-section (5) of section 3;
(b) appointment of such person to be the Secretary
of
the State Council by the Central Government under sub-
section (10) of section 3;
(c) the determination of standards and for
classification
of clinical establishments under section 7;
(d) the qualification and the terms and conditions for
the members of the authority under
clause (c) of sub-
section (1) of section 10;
(e) the procedure under which the powers of the
authority may be exercised by the District
Health
Officer or Chief Medical Officer for the purpose of
provisional registration of clinical establishment under
sub-section (2)
of section 10;
(f) the minimum standards of facilities and services
under clause (i) of sub-section (1) of section 12;
(g) the minimum
number of personnel under clause
(ii) of sub-section (1) of section 12;
(h) the maintenance of records and reporting by the
clinical
establishment under clause (iii) of sub-section
(1) of section 12;
(i) other conditions for registration and continuation
of clinical
establishment under clause (iv) of sub-section
(1) of section 12;
(j) classification of clinical establishment under sub-
section
(1) of section 13;
(k) the different standards for classification of
clinical establishments under sub-section (2) of section
13;
(l) the minimum standards for permanent registration
under section 28;
(m) the form and particulars to be contained in the
register
to be maintained under section 38.
53. Laying of rules. - Every rule made by the Central
Government under this Act shall be laid,
as soon as may be
after it is made, before each House of Parliament, while it
is in session, for a total period of thirty days which
may be
comprised in one session or in two or more successive
sessions and if, before the expiry of the session
immediately following
the session or the successive
sessions aforesaid, both Houses agree in making any
modification in the rule or both Houses agree that
the rule
should not be made, the rule shall thereafter have effect
only in such modified form or be of no effect, as the case
may
be; so, however, that any such modification or
annulment shall be without prejudice to the validity of
anything previously done under
that rule.
54. Power of State Government to make rules. - (1) The
State Government may, by notification, make rules for
carrying
out in respect of matters which do not fall within
the purview of section 52.
(2) In particular and without prejudice to the generality
of the foregoing power, such rules may provide for all or
any of the following matters, namely:--
(a) the proforma and the fee to
be paid for
registration under sub-section (1) of section 14;
(b) the form and details of application under sub-
section (3) of section
14;
(c) the particulars and information contained in
certificate of provisional registration under section 15;
(d) the manner of
publication of all particulars of the
clinical establishments proposed to be registered under
sub-section (2) of section 16;
(e)
the fees to be paid to issue a duplicate certificate
under section 19;
(f) the change of ownership or management to be
informed by
the clinical establishment to the authority
under sub-section (2) of section 20;
(g) the manner in which the authority shall publish
the names of
the clinical establishments whose
registration expired under section 21;
(h) the enhanced fees to be charged for renewal after
expiry
of the provisional registration under section 22;
(i) the form of the application and fees to be charged
by the State Government
under section 24;
(j) the manner of submitting evidence of the clinical
establishments having complied with the minimum
standards
under section 25;
(k) the manner of displaying information of the
clinical establishments having complied with the
minimum standards
for filing objection under section
26;
(l) the expiry of period specified in section 29;
(m) the form and particulars of the certificate
of
registration under section 30;
(n) the period within which an appeal shall be
preferred under clause (a) of
sub-section (3) of
section 32;
(o) the manner of entry and search of clinical
establishment under section 34;
(p) the fees to be charged by the State
Government
for different categories of clinical establishments under
section 35;
(q) the manner and the period within which an
appeal
may be preferred to the State Council under sub-
section (1) of section 36;
(r) the form and the fee to be paid for an appeal
under
sub-section (2) of section 36;
(s) the form and the manner in which the register to
be maintained under
sub-section (1) of section
37;
(t) the manner of supply to the State Council in
digital format the entry made in the register of clinical
establishment under
sub-section (2) of section 37;
(u) the manner of holding an inquiry by the
authority under sub-section (3) of sections 41 and 42;
(v) the manner of filing the appeal under sub-section
(7) of sections 41 and 42;
(w) the manner and the time within which the
information
is to be furnished to the authority or the
State Council or the National Council as the case may
be, under section 48;
(x) any other
matter which is required to be or may
be prescribed by the State Government.
55. Laying of rules. - Every rule made by the State
Government under this section shall be laid, as soon as may
be after it is made, before each House of the State
Legislature where
it consists of two Houses, or where such
Legislature consists of one House, before that House.
56. Savings. - (1) The provisions
of this Act shall not
apply to the States in which the enactments specified in the
Schedule are applicable:
Provided that the States
in which the enactments
referred to in sub-section (1) are applicable, and such
States subsequent to the commencement of this Act,
adopts
this Act under clause (1) of article 252 of the Constitution,
the provisions of this Act shall, subsequent to such
adoption,
apply in that State.
(2) The Central Government may, as and when consider
necessary, by notification amend the Schedule.
THE SCHEDULE
[See section 56]
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.
V. K. BHASIN,
Secy.
to the Govt. of India.