[18 OF 2021] [22 May 2021] AN ACT to provide for the registration and regulation of clinical
establishments in the State of Gujarat 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 prescribing the 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; It is hereby
enacted by in the Seventy-second Year of the Republic of India as follows:- PRELIMINARY (1) This Act may be
called the Gujarat Clinical Establishments (Registration and Regulation) Act,
2021. (2) It extends to the
whole of the State of Gujarat. (3) It shall come
into force on such date as the State Government may, by notification in the
Official Gazette, appoint: Provided that
different dates may be appointed for different categories of clinical
establishments and for different recognised systems of medicine. In this Act, unless the context otherwise requires,- (a) "Authority"
means the District Registering Authority constituted under section 5; (b) "certificate"
means a certificate of registration issued under this Act; (c) "clinical establishment" means- (d) 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 (e) 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- (f) the Government or
a Department of the Government; (g) a trust, whether
public or private; (h) a corporation
(including a society) registered under a Central, Provincial or State Act,
whether or not owned by the Government; (i) a local
authority; and (j) 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 (46 of 1950) , the Air Force Act, 1950 (45
of 1950) and the Navy Act, 1957 (62 of 1957); (k) "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- (l) 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 (m) serious
impairment to bodily functions; or (n) serious
dysfunction of any organ or part of a body; (o) "prescribed"
means prescribed by rules made under this Act; (p) "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; (q) "register"
means the register maintained by the Authority, State Government and the
Central Government under sections 32 and 33, respectively containing the number
of clinical establishments registered; (r) "registration"
means to register under section 6 and the expression registration or registered
shall be construed accordingly; (s) "standards"
means the conditions that the State Government may prescribe under section 23,
for the registration of clinical establishments; and (t) "to
stabilize (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. REGISTRATION AND STANDARDS FOR CLINICAL
ESTABLISHMENTS (1) The State
Government shall, by notification in the Official Gazette, constitute a State
Council for clinical establishments. (2) The State Council
shall consist of the following members, namely:- (a)
Minister of Health and Family Welfare, ex-officio, who shall be the
Chairperson; (b)
Additional Chief Secretary/Principal Secretary/Secretary, Health and
Family Welfare Department-ex-officio, who shall be the
Member-Secretary;Commissioner of Health Services and Medical
Education-ex-officio Member; (c)
Additional Secretary/Joint Secretary/Deputy Secretary, Medical
Services-ex-officio, Member; (d)
Additional Director, Medical Services-ex-officio, Member; (e)
Directors/ Additional Directors of different streams of Indian Systems
of Medicine-ex-officio Members; (f)
one
representative of the Gujarat Medical Council; (g)
one representative of the Gujarat Nursing Council; (h)
two representatives of the Council working in State medical field,
nominated by the State Government; (i)
four Members of Parliament/Members of Legislative Assembly-who shall
be the Doctor by profession. (3) The State Council
shall perform the following functions, namely:- (a) to determine the
standards of Clinical Establishments and to specify the rights of patient; (b) implementation of
this Act in the State; (c) compiling and updating the State
Registers of clinical establishment; (d) representing the
State in the National Council; (e) hearing of
appeals against the orders of the Authority; and (f) publication on
annual basis a report of implementation of standards. It shall be the
responsibility of the State Council 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. (1) The State
Government shall, by notification in the Official Gazette, constitute an
Authority to be called the District Registering Authority for each district for
registration of clinical establishments, with the following members, namely:- (a)
the District Collector - ex-officio Chairperson; (b)
the Chief District Medical Officer /Associate Civil Surgeon/Medical
Superintendent -Member -Secretary; (c)
Chief District Health Officer of the concerned District; (d)
Representative of the Grant-in-Aid Organisation which runs a Hospital
in the concerned District (if any); (e)
the expert in the concerned subject-nominated by the District
Collector (if required); (f)
one representative of the local Medical Association (if any)
-nominated by the District Collector; (g)
one Dean of the Medical Faculty of the University having jurisdiction
in the concerned District; (h)
four representatives concerned with the Ayush, Physiotherapy, Dental
and Homeopathy- nominated by the District Collector; (i)
Local Member of Parliament/Member of Legislative Assembly-if he is a
Doctor (in Allopathic or Ayurveda) by profession. (2) Notwithstanding
anything contained in sub-section (1), for the purposes of provisional
registration of clinical establishments under section 9 and 19, the District
Health Officer or the Chief Medical Officer, as the case may be, shall exercise
the powers of the Authority as per the procedure as may be prescribed. No person shall
run a clinical establishment unless it has been duly registered in accordance
with the provisions of this Act. (1) For registration
and continuation, every clinical establishment shall fulfill the following
conditions, namely:- (i) the standards
of facilities and services as may be prescribed; (ii) the
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. (1) The clinical
establishment of different systems shall be classified into such categories, as
may be prescribed by the State Government, from time to time. (2) The 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 State Government
shall have regard to the local conditions. PROCEDURE FOR
REGISTRATION (1) For the purposes
of registration of the clinical establishment under section 6, 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 accompanied by
such details as may be prescribed. (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 the 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). The Authority
shall, within a period of fifteen 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. (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. Subject to the
provisions of section 18, 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. 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. In case the
certificate is lost, destroyed, mutilated or damaged, the Authority shall issue
a duplicate certificate on the request of the clinical establishment on payment
of such fees as may be prescribed. (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. 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. 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. Where the
clinical establishments in respect of which standards have been notified by the
State Government, the provisional registration shall not be granted or renewed beyond,- (i) the period of one
year 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 one year from the date of notification of the standards
for clinical establishments which come into existence after the commencement of
this Act but before the date of notification of 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. The 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. The clinical
establishment shall submit evidence of having complied with the prescribed
minimum standards in such manner, as may be prescribed. As soon as the
clinical establishment submits the required evidence of having complied with
the prescribed 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 evidences 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. If objections are
received within a period as referred to in section 21, such objections shall be
communicated to the clinical establishment for response within a period of
forty-five days. The permanent
registration shall be granted only when a clinical establishment fulfils such
standards for registration prescribed by the State Government. 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. (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 13, 14, 15 and 16 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 as may be prescribed. The disallowing
of an application for permanent registration shall not debar a clinical
establishment from applying afresh for permanent registration under section 19
and after providing such evidence, as may be required, of having rectified the
deficiencies on which grounds the earlier application was disallowed. (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 a period of one month
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 establishment, 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. (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 its views to the clinical establishment 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 or representation 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. 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. The State
Government may charge fees for different categories of clinical establishments,
as may be prescribed. (1) Any person,
aggrieved by an order of the 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. 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. (2) Each Authority,
including any other authority constituted 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. (1) The State Council
shall maintain in digital and in such form and containing such particulars, as
may be prescribed, a register to be known as the State Register of clinical
establishments in respect of clinical establishments. (2) The State Council
shall supply in digital format to the National Council, a copy of the State
Register of clinical establishments and shall inform the National Council, all
additions to and other amendments in such register made, for a particular month
by the 15th day of the following month. PENALTIES Whoever
contravenes any of the provisions of this Act shall, if no penalty is provided
elsewhere, be punishable for the first offence with fine which may extend to
ten thousand rupees, for the second offence with fine which may extend to fifty
thousand rupees and for any subsequent offence with fine which may extend to
one lakh rupees. (1) Whoever carries
on a clinical establishment without registration shall, on first contravention,
be liable to a monetary penalty up to twenty-five thousand rupees, for second
contravention with a monetary penalty which may extend to fifty thousand rupees
and for any subsequent contravention with a monetary penalty which may extend
to one 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 fifty 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 the 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 36. (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 receipt of such
decision. (7) The manner of
filing the appeal referred to in sub-section (6) shall be such as may be
prescribed. (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 receipt of such
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 35 and under this section shall be credited to
such account as the State Government may by order specify in this behalf. Whoever
contravenes any of the provisions 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. (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. (1) Where an offence
under this Act has been committed by any Clinical Establishment of Government
within a period of six months after the commencement of this Act, the Head of
the Clinical Establishment 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 Clinical
Establishment 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 Clinical Establishment 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 Clinical Establishment, such officer shall also be deemed to be guilty of
that offence and shall be liable to be proceeded against and punished
accordingly. 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. MISCELLANEOUS (1) No suit,
prosecution or other legal proceedings shall lie against any member of the
Authority or any member of the 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 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. Every clinical
establishment shall, within such time or within such extended time, as may be
prescribed in that behalf, furnish to the Authority such returns or the
statistics and other information in such manner, as may be prescribed. Without prejudice
to the foregoing provisions of this Act, the State Government 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. Every employee of
the Authority 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 (45 of
1860). (1) The State
Government may, by notification in the Official Gazette, subject to the
condition of previous publication, make rules for carrying out the purposes of
this Act: Provided that if
the State Government is satisfied that the circumstances exist which render it
necessary to take immediate action, it may dispense with the previous
publication of any rule to be made under this Act. (2) All rules made
under this section shall be laid for not less than thirty days before the State
Legislature as soon as possible after they are made, and shall be subject to
rescission by the State Legislature or to such modifications as the State
Legislature may make, during the session in which they are so laid or the
session immediately following. (3) Any rescission or
modification so made by the State Legislature shall be published in the
Official Gazette and shall thereupon take effect. (1) If any difficulty
arises in giving effect to the provisions of this Act, the State Government
may, by an 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
State Legislature. (1) On the
commencement of this Act, the Gujarat Nursing Homes Registration Act, 1949 in
its application to the State of Gujarat shall stand repealed. (2) Notwithstanding
such repeal of the said Act, anything done or any action taken (including any
rule or order made, notification issued or appointment made) by or under that
Act shall, in so far as it is not inconsistent with the provisions of this Act,
be deemed to have been done or taken by or under this Act and shall continue to
be in force until superseded by anything done or any action taken under the
provisions of this Act.Gujarat
Clinical Establishments (Registration And Regulation) Act, 2021