The KERALA CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2018

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[Translation in English of “2018-981 ca.og gloiéacs Tondaimesnus 
wwe 
(@XIMSE(SaMJo MI@MLAMeMaHo) GH” published under the authority of 
the Governor.] 
ACT 2 OF 2018 
THE KERALA CLINICAL ESTABLISHMENTS (REGISTRATION 
AND REGULATION) ACT, 2018 
AN 
ACT 
to provide for the registration and regulation of clinical establishments 
rendering services in recognised systems of medicine in the State 
and for matters connected therewith or incidental thereto, 
Preamble —Wuereas, it is expedient to provide for the registration 
and regulation of clinical establishments with a view to prescribe 
standards of facilities and services which may be provided by them for 
the improvement of public health; : 
BE it enacted in the Sixty-ninth Year of the Republic of India as 
follows:— 
CHAPTER I 
PRELIMINARY 
1. Short title and commencement.—(1) This Act may be called the 
Kerala Clinical Establishments (Registration and Regulation) Act, 2018. 
(2) It shall come into force on such date as the Government may, 
by notification appoint and different dates may be appointed for different 
recognized system of medicines. 
2. Definitions.—In this Act, unless the context otherwise requires,— 
(a) “Appellate Authority” means the Appellate Authority 
constituted under sub-section (1) of section 34; 
(b) “Authority” means a District Registering Authority constituted 
under sub-section (1) of section 14; 3
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(c) “clinical establishment” means,— 
(i) a hospital, maternity home, nursing home, clinic, 
sanatorium or an institution, by whatever name called, that offers services, 
facilities with or without beds requiring treatment, diagnosis, or care for 
illness, injury, deformity, abnormality, dental care, pregnancy or infertility in 
any recognised system of medicine established and administered or 
maintained by any person or bady 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 investigation 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. individual proprietorship or partnership firm; 
d. a corporation whether or not owned by the 
Government (including a co-operative society registered under the Kerala 
Co-operative Societies Act, 1969 (21 of 1969) or a charitable society 
registered under the Travancore-Cochin Literary, Scientific and Charitable 
Societies Registration Act, 1955 (12 of 1955) or under the Societies 
Registration Act, 1860 (Central Act 21 of 1860); 
e. Local Self Government Institutions, 
but does not include the clinical establishments which provide only 
consultation services and the clinical establishments owned, controlled or 
managed by the Armed Forces.
af. 
Explanation:—For the purposes of this clause,— 
(i) “Armed Forces” means the forces constituted under the 
Army Act, 1950 (Central Act 46 of 1950), the Air Force Act, 1950 
(Central Act 45 of 1950) and the Navy Act, 1957 (Central Act 
62 of 1957); 
(ii) “consultation services” means medical examination, 
prescribed types of diagnosis and accordingly to administer the medicines 
and also the first aid and observation; 
(d) “Council” means the State Council for clinical establishments 
established under section 3; 
(e) “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 life of the individual or, with respect to a 
pregnant woman, the health of the woman or unborn 
child, in serious jeopardy; or 
(ii) serious impairment to bodily functions; or 
(iii) serious dysfunction of any organ or part of a body: 
(f) “Government” means the Government of Kerala: 
(g) “Local Self Government Institution” means a Panchayat at 
any level constituted under section 4 of the Kerala Panchayat Raj Act, 
1994 (13 of 1994) or a Municipality constituted under section 4 of the 
Kerala Municipality Act, 1994 (20 of 1994); 
(h) “notification” means a notification published in the Official 
Gazette; 
(i) “prescribed” means prescribed by rules made under this Act: 
(j) “recognised-system of medicine” means Modern Medicine 
(including dentistry), Naturopathy, Ayurveda, Homoeopathy, Sidha and 
Unani systems of medicine or =~ other system of medicine recognised by 
the Government; 
(k) “register” means the State register maintained and published 
by the Authority under sub-section (1) of section 12 of the Act containing 
details of the registered clinical establishments;
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(1) “registration” means the registration under section 16 and the 
expression registration or registered shall be construed accordingly; 
(m) “standards” means the standards that may be prescribed by 
the Government under section 13 for the registration of clinical 
establishments; 
(n) “to stabilize” with its grammatical variations and cognate 
expressions means, with respect to an emergency medical condition 
specified in clause (e), 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. 
. Cuapter II 7 
THE STATE COUNCIL FOR CLINICAL ESTABLISHMENTS 
3. Establishment of State Council.—() With effect from such date 
as the Government may, by notification, appoint in this behalf, there shall 
be established for the purposes of this Act, a Council to be called the 
State Council for Clinical Establishments. 
(2) The Council shall consist of the following members, namely:— 
(a) Secretary, Health and Family Welfare Department, 
ex-officio, who shall be the Chairperson; 
(b) Secretary, Ayush Department, ex-officio, who shall be 
the Vice-Chairperson; 
(c) Director of Health Services, ex-officio; 
(d) Director of Medical Education, ex-officio; 
(e) Director, Indian Systems of Medicine, ex-officio; 
(f) Director, Homoeopathy Department, ex-officio; 
(g) Director, Public Health Laboratory, ex-officio; 
(h) one representative each to be nominated by,— 
(i) the Council of Modern Medicine; 
(ii) the Council of Indigenous Medicine;
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(ii) the Council of Homoeopathy; 
constituted under the provisions of the Travancore-Cochin Medical 
Practitioners Act, 1953 (IX of 1953); 
(i) one representative each to be nominated by,— 
(i) the Kerala Dental Council constituted under 
section 21 of the Dentists Act, 1948 (Central Act 16 of 1948): 
(ii) the Kerala Nursing Council constituted under 
section 3 of the Nurses and Midwives Act, 1953 (10 of 1953); 
(j) Government nominees,— 
(i) one representative from welfare organisations of the 
patients in the State; 
(ii) an Officer not below the rank of Additional Law 
Secretary to Government, Law Department; , 
(ili) an officer not below the rank of Additional Secretary 
to Government, Finance Department; 
(iv) one representative of Indian Medical Association of the 
Kerala Unit; ; 
(v) one representative of Ayurveda Medical Association of 
India of the Kerala Unit; - © 
(vi) one representative of Indian Dental Association of the 
Kerala Unit; 
(vii) one representative of the "Association of Homoeopathy 
Doctors in Kerala; E 
(viii) one representative of Medical Laboratory Owner’s 
Association in Kerala; 
(ix) one representative of the Association of . 
Physiotherapists of Kerala; 
(k) Secretary.of the Council. 
4. Functions of the Council{(1) The Council ‘shall carry out the 
following functions, namely:— 
(a) determine, within a period of two years from the 
commencement of this Act, the first set of standards for ensuring proper 
healthcare by the clinical establishments;
  
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(b) classify and categorise the clinical establishments and to 
recommend the Government to prescribe the standards for each category; 
(c) compile and publish State Register of Clinical 
Establishments in such manner as may be prescribed; 
(d) appoint panel of assessors for inspection and assessment 
of the clinical establishments in such manner as may be prescribed; 
(e) conduct periodic inspection of clinical establishments for 
ensuring the standards to be maintained in such manner as may be 
prescribed; 
(f) recommend to the Government any modification required in 
the rules in accordance with the changes in technology or social 
conditions; 
(g) notify data and information which are to be mandatorily 
provided by clinical establishments including their periodicity; analyse the 
data and make results available in the public domain in such manner as 
may be prescribed; 
(h) send periodic returns for updating the National Register as 
required by the Central Government or the National Council constituted 
under the Clinical Establishments (Registration and Regulation) Act, 2010 
(Central Act 23 of 2010); 
(i) direct the cancellation of registration of such clinical 
establishments where there is imminent danger to public health and the 
health and safety of patients and staff; and 
(j) perform such other functions as may be assigned to it by 
the Government from time to time. 
(2) The Council shall recommend to the Government to 
prescribe the registration and other fees, as it deems fit from time to time. 
(3) Any dispute as to whether an establishment is a clinical 
establishment or not shall be referred to the State Council and the State 
Council, after giving the interested parties a reasonable opportunity to 
adduce evidence and of being heard, decide such disputes. 
ee
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5. Secretary and other employees of the Council.—(1) The 
Government shall appoint an officer not below the rank of 
Deputy Director of Health Department to be the Secretary of the Council. 
(2) The Council may, with the permission of the Government, 
employ such employees as are necessary for its proper functioning. 
6.. Power to seek advice or assistance.—(1) The Council may 
associate itself with any person or body and obtain technical assistance or 
advice as it may deem necessary for carrying out the provisions of this 
Act. 
(2) The Council may appoint such sub-committees as it deems fit, 
with members or persons who are not members of the Council, for such 
period, not exceeding two years, for thé consideration of any particular 
matter under this Act or such other matter as may be prescribed. 
7. The Council to follow consultative process.—The Council shall 
follow. a consultative and transparent process, including public hearing in 
such places as may be determined by the Council, with adequate notice 
for making suggestions for altering the mandatory standards and 
classification of clinical establishments and any other matter under the 
provisions of this Act and the rules. 
  
8. Executive Committee.—The Council shall have an Executive 
Committee consisting of the following members, namely:— 
: (i) Secretary, Health and Family Welfare Department, who shall be 
the Chairperson; 
(ii) Secretary, Ayush Department, who shall be the 
Vice-Chairperson; 
(iii) Director of Health Services; 
(iv). Director of Medical Education: 
(v) Director of Indian Systems of Medicine; 
(vi) Director of Homoeopathy Department; 
(vii) Director of Public Health Laboratory; 
(viii) one representative of the welfare organisation of patients, 
nominated by the Government; and 
(ix) Secretary of the Council, who shall be the Convenor. 
33/687/1B ;
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9. Powers and functions of the Executive Committee.—The 
Executive Committee shall exercise such powers and perform such 
functions as may be prescribed. 
10. Vacancy etc. not to invalidate the proceedings of the 
Council.—No act or proceedings of the Council shall be invalid on the 
ground merely of the existence of any vacancy or defect in the 
constitution of the Council. 
11. Procedure and conduct of business.—The quorum and the 
procedure for the conduct of business to be transacted in the meetings of 
the Council shall be such as may be prescribed. 
CHAPTER III 
REGISTER OF CLINICAL ESTABLISHMENTS 
12. Register of Clinical Establishments.—(1) The Council shall 
compile, maintain and publish a register to be known as the State Register 
of Clinical Establishments in such form containing such particulars as may 
be prescribed. 
(2) The Secretary of the Council shall be responsible for 
compiling and updating the State Register of Clinical Establishments. 
CHAPTER IV 
REGISTRATION AND STANDARDS FOR CLINICAL 
ESTABLISHMENTS 
13. Categories and standards.—(1) Different standards shall be 
prescribed by the Government for clinical establishments of different 
categories and registration shall be granted to the establishments that have 
standards in each category. 
(2) The Council shall determine, within a period of two years 
from the date of commencement of this Act, the first set of standards for 
ensuring proper healthcare. in clinical establishments. 
14. Authority for registration —(1) The Government shall, by 
notification, constitute an Authority for each District for registration of 
clinical establishments with the following members, namely:— 
(a) District Collector, ex-officio—Chairperson; 
(b) District Medical Officer (Health), ex-officio— 
Vice-Chairperson;
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(c) an,officer not below the rank of Assistant Director of 
Health and Family Welfare Department nominated by the Government 
who shall be the Convenor of the Authority; 
(d) a Medical Officer of the Indian Systems of Medicine 
nominated by the Government; 
(e) a Medical Officer of Homoeopathic System of Medicine 
nominated by the Government; 
(f) one member whose tenure shall be three years to be 
nominated by the District Collector from a professional association in the 
health sector. 
(2) Notwithstanding anything contained in sub-section (1), for the . 
purposes of provisional registration of clinical establishments under 
sub-section (1) of section 17, the Vice-Chairperson of the Authority shall 
exercise the powers of the Authority in such manner as may be 
prescribed. 
(3) The Authority shall perform the following functions, 
namely:— 
(a) grant, renew, suspend or cancel registration of a clinical 
establishment; 
(b) ensure compliance of the provisions of the Act and the 
‘rules made thereunder; 
(c) cancel the registration of such clinical establishment 
where there is imminent danger to public health and the health and safety 
of patients and staff; 
(d) prepare and submit reports periodically of such nature as 
directed by the Council; 
(e) perform such other functions as may be prescribed. 
15. Conditions for registration.—Every Clinical Establishment shall 
fulfil the following conditions for the purpose of registration, namely:— 
(a) shall have the standards according to the category of clinical 
establishment; f 
(b) the medical and paramedical staff shall have the minimum 
qualifications fixed by the authorities concerned and advertised by the 
Council;
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(c) undertake to mandatorily comply with the orders issued by 
the Council from time to time, in such form as may be prescribed; 
(d) undertake to furnish such information to the State 
Government as notified; 
(ec) maintain standards of safety, infection control and method of 
treatments maintaining standards, as may be notified. 
(f) such other conditions as may be prescribed. 
16. Registration, of clinical establishments.—(\) All clinical 
establishments in Kerala shall be registered with the Authority concerned 
under the provisions of this Act and the rules made thereunder. 
(2) No person shall run a clinical establishment unless it has been 
duly registered in accordance with the provisions of this Act and the rules 
made thereunder. 
(3) All clinical establishments functioning at the commencement 
of this Act shall be granted provisional registration by the Authority 
concerned. 
(4) All clinical establishments having provisional registration shall 
acquire the standards for permanent registration in the category wie 
such period as may be prescribed. 
(5) All clinical establishments which come into existence after 
the commencement of this Act shall apply for permanent registration with 
the Authgrity within such period as may be prescribed. 
(6) Where a clinical establishment is offering services in different 
‘medical category, such clinica! establishment shall apply for separate 
provisional or permanent registration for each category under this Act: 
Provided that a laboratory or a diagnostic centre which is a part of a 
clinical establishment need not be registered separately. 
17. Anpleendan’ for provisional registration.—(1) ively clinical 
establishment functioning on the date of commencement of this Act shall 
apply for provisional registration in such form along with such fee, as may 
be prescribed.
  
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(2) All clinical establishments, whether registeréd or not under 
any existing law requiring registration of such establishments, an apply 
for registration as referred to in sub-section (1). 
(3) The Authority shall, within forty five days of the date of 
‘receipt of the application, grant to the applicant a certificate of provisional 
registration in such form and containing such particulars as may be 
prescribed and if the registration is not granted or declined within this 
period it shall be deemed to have been granted. 
(4) If it is found that provisional registration granted under 
sub-section (3) was given not in accordance with law, disciplinary 
proceedings may be initiated against the officer responsible for granting or 
not declining the registration within the said period. 
18. Validity of provisional registration —Provisional registration shall 
be valid for a period of two years from the date of issuance of the 
certificate of registration. 
19. Application for permanent registration of a clinical 
establishment.—(1) Application for permanent registration of a clinical 
establishment shall be made to the Authority in such form and in such 
manner with such fees as may be prescribed, accompanied by such 
evidence to the effect that the clinical establishment has complied eae the 
standards prescribed for the category. 
(2) Every clinical establishment having provisional registration 
shall apply for permanent registration sixty days prior.to the date of expiry 
of the provisional registration. 
(3) The Authority shall, ensure that the details’ of clinical 
establishments that have applied for registration are caused to "ve 
published, in the manner as may be prescribed, within a period of seven 
days from the date of receipt of application. 
_ (4) The Authority shall, before granting permanent registration. 
inspect or cause to be inspected the clinical establishment. 
(5) Permanent registration shall be granted by the Authority only 
when a clinical establishment has fulfilled the prescribed standards. 
 
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(6) The Authority shall, within sixty days of the date of receipt 
of the application, grant to the applicant a certificate of permanent 
registration in such form and containing such particulars as may be 
prescribed and if the registration is not declined or granted within this 
period it shall be deemed to have been granted. 
(7) Where the Authority is of the opinion that the clinical 
establishment has not acquired the standard notified and has submitted 
incomplete information or if relevant documents are not provided, it shall 
inform the applicant of its intention to disallow permanent registration with 
reasons for the same. 
(8) The applicant shall, within thirty days from the date of 
communication received under sub-section (7) respond to the Authority and 
produce evidence to the effect that the standards have been acquired and 
informations and documents have been submitted and the Authority may, 
on examination of the evidence and after a re-examination of the 
evidence by the assessors, if required, either grant or decline the ~ 
application for registration. 
(9) Where the Authority decides to decline the application for 
permanent registration, the reason for the same shall be communicated to 
the applicant within thirty days of the date of such decision. 
(10) Rejection of an application for permanent registration shall 
not be a bar for applying afresh for permanent registration after rectifying 
the defects and producing the required evidence to show that prescribed 
standards are being maintained. 
(11) The Authority shall ensure that the registered clinical 
establishments maintain the prescribed standards as long as the registration 
remains valid and the Authority shall call for periodic reports, inspect or 
cause to be inspected every registered clinical establishment at least once 
in two years to ensure compliance with the standards prescribed and the 
results of the inspection shall be made available to the public in such 
manner as may be prescribed. 
(12) The Council shall notify a panel of independent assessors to 
inspect and examine whether the registered clinical establishment adhere 
to the prescribed standards.
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(13) Clinical establishments having received accreditation or 
certification from the National Accreditation Board for Hospitals or 
National Accreditation Board for Laboratories or any other body approved 
for this purpose by Government shall be granted permanent registration 
without inspection as provided in sub-section (4) and such establishments 
need not be subjected to inspection by the assessors of the Council till 
such time the accreditation or certification, as the case may be, remains valid: 
Provided that where the accreditation or certification be cancelled or has 
expired, the Authority shall cause the clinical establishments to be inspected 
within a period of thirty days from the date of such cancellation or expiry. 
(14) Where the clinical establishment has not acquired the 
standards prescribed, the Authority shall proceed to cancel its provisional 
or permanent registration in such manner as may be prescribed. 
20. Validity of permanent registration Permanent registration shall 
be valid for a period of three years following which it may be renewed 
prior to expiry on payment of such fees as may be prescribed. 
21. Renewal of permanent registration.—Application for renewal of 
permanent registration shall be made sixty days prior to the expiry of the 
validity of the certificate of permanent registration and in case the 
application for renewal is made after the expiry of such date, the 
Authority may allow such application on payment of such enhanced fees 
as may be prescribed. 
22. Acknowledgment of application.—The Authority shall 
acknowledge the receipt of the application for provisional registration or 
permanent registration, as the case may be, in such form as may be 
prescribed. 
23. Certificate of registration —(1) The Authority shall issue the 
certificate of provisional or permanent registration, as the case may be, in 
such form and containing such particulars as may be prescribed. 
(2) The provisional or permanent registration certificate shall be 
displayed in a conspicuous place in the clinical establishment. 
  
 
  
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24. Certificate of registration to be non-transferable.—(1) The 
certificate of registration both provisional and permanent shall be 
non-transferable. 
: (2) In the event of change in the name of the establishment, 
ownership, category, management, location or on the cessation of 
functioning, such clinical establishment shall return the certificate within 
thirty days to the Authority. 
(3) Where the registration certificate of a clinical establishment 
is returned under sub-section (2), fresh application shall be submitted to 
carry on such clinical establishment: 
Provided that in the case of change of ownership, new application 
for registration shall be submitted within thirty days from the date of 
change of such ownership and if new registration is not received the 
functioning of such clinical establishment shall be restrained. 
~ (4) If new services are provided in addition to the services being 
provided by a clinical establishment, it shall be communicated to the 
authority concerned and within thirty days from the date of 
commencement of such services, required standards shall be acquired for 
such new services and it shall be convinced to the authority. 
25. Cancellation of registration.—(1) If, at any time, after any 
clinical establishment has been registered, the Authority or the Council is 
satisfied that,— 
(a) the conditions of the registration are not complied with; or 
(b) the clinical establishment has knowingly or negligently carried 
out an act that is harmful to the health of the person seeking care from 
the clinical establishment, 
it may issue notice to the clinical establishment to show cause why its 
registration should not be cancelled for the reasons to be mentioned in the 
notice. 
(2) Where the Authority or Council is satisfied, ‘after giving a 
reasonable opportunity to the clinical establishment to be heard, that there 
has been a breach of any of the provisions of this Act or the rules made 
thereunder, it may, without prejudice to any other action that may be 
taken against such clinical establishment, by order cancel its registration. ‘
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(3) Every order made under sub-section (2) shall take effect,— 
(i) where no appeal has been preferred against such order 
immediately on the expiry of the period prescribed for such 
appeal; and 
(ii) 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, shall restrain immediately the clinical 
establishment from functioning, if there is imminent a to the health 
and safety of patients. 
CHAPTER V 
PENALTIES 
26. Penalty for contravention: of the provisions of the Act.—(1) 
The Council under this section, and the Authority under other sections of 
this Act, as the case may be, shall have power to adjudicate upon, enquire 
and impose penalty regarding contravention of the provisions of this Act 
and shall exercise such powers and follow such procedures as may be 
prescribed. 
(2) Whoever contravenes any of the provisions of this Act shall, if 
penalty is not provided elsewhere, be liable for the first contravention to a 
monetary penalty which may extend to ten thousand rupees, for the 
second contravention a monetary penalty which may extend to fifty 
thousand rupees and for any subsequent contravention to a monetary 
penalty which may extend upto five lakh rupees: 
Provided if the Council determines, after notice to the establishment 
and conducting enquiry that the offence is of such serious nature as to 
attract the provisions of this section, in addition to the penalty, the Council 
may order the closure of the establishment. 
27. Penalty for non-registration.—({1) Whoever carries on a clinical 
establishment without registration shall, for the first contravention, be liable 
to a monetary penalty which may extend to fifty thousand rupees, for the 
second contravention to a monetary penalty which may extend to 
_ two lakh rupees and for any subsequent contravention to a monetary 
33/6e7he 
  
 
  
  
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penalty which may extend to five lakh rupees and in case of continuing 
contravention a monetary penalty of ten thousand rupees for every 
additional day the clinical establishment functions without registration 
subject to a maximum of five lakh rupees. 
(2) For the purpose of adjudging an offence or contravention 
under sub-section (1), and for imposing any monetary penalty, the 
Authority’ shall conduct an inquiry in the prescribed manner after giving 
the person concerned a reasonable opportunity of being heard. 
(3) While holding an inquiry, the Authority shall have power to 
summon and enforce the attendance of any person acquainted with the 
facts and the 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-section (1) 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 section 32. 
(4) While determining the quantum of monetary penalty, the 
Authority shall take into account the category, the size and the type of the 
clinical establishment and also the local conditions of the area in which the 
clinical establishment is situated. — 
(5) Any person aggrieved by the decision of the Authority may 
prefer an appeal to the Appellate Authority within a period of forty-five 
days from the date of the said decision. : 
(6) Every appeal under sub-section (5) shall be made: in such 
form and be accompanied by such fees as may be prescribed. 
28. Disobedience of order, obstruction and refusal of information—(1) 
Whoever wilfully disobeys any direction lawfully given by the Authority, 
the Council or any person empowered under this Act to give such 
direction, or obstructs any person or the Authority or the Council in the 
discharge of any function which such person or the Authority or the 
Council is required or empowered under this Act to discharge, shall be 
liable to a monetary penalty which may extend to one lakh rupees. 
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(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 one lakh rupees. 
(3) For the purpose of adjudging under sub-sections (1) and (2), 
and for the purpose of imposing any monetary penalty, the Authority shail 
conduct an inquiry in the prescribed manner after giving any person 
concerned a reasonable opportunity of being heard. 
(4) While conducting an inquiry, the Authority shall have power 
to summon and enforce the attendance of any person acquainted with the 
facts and the 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 in 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 section 32. 
(5) While determining the quantum of monetary penalty, the 
Authority shall take into account the category, the size and the type of the 
clinical establishment and also the local conditions of the area in which the 
clinical establishment is situated. 
(6) The recovery of fine shall be as laid down under section 421 
to 424 of the Code of Criminal Procedure, 1973 (Central Act 2 of 1974). 
(7) Any person aggrieved by the decision of the Authority may 
prefer an appeal to the Appellate Authority within a period of forty-five 
days from the date of the said decision. 
(8) Every appeal under sub-section (7) shall be made in such 
form and be accompanied by such fees as may be prescribed. 
29. Penalty for minor deficiencies.—Whoever contravenes any 
provision of this Act or any rule made thereunder resulting in deficiencies 
that de not pose any imminent danger to the health and safety of any 
patient and can be rectified within a reasonable time, shall be liable to a 
monetary penalty which may extend to ten thousand rupees. 
s 
  
 
  
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30. Contravention by companies.—(1) Where a contravention under 
this Act has been committed by a company, every person who at the 
time of such contravention, 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 be proceeded against and punished accordingly: ; 
Provided that nothing contained in this sub-section shall render any 
such person liable to any punishment, if he proves that the contravention 
was without his knowledge, or that he had exercised all due diligence to 
prevent 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 been committed 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 be deemed to be guilty of that 
contravetition and shall be liable to monetary penalty. 
Explanation:—For the purposes of this section,— 
(a) “company” means any body corporate and includes firm, 
a co-operative society or other association of individuals; and 
(b) “director”, in relation to a firm, means a partner in 
the firm. 
_ 31. Offences by Government Departments.—Where an offence 
under this Act has been committed by any clinical establishment under the 
control of the Government, the officer responsible for that 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 officer 
liable to any punishment if he proves that the offence was committed 
without his knowledge or that he has exercised all due diligence to 
prevent the commission of such offence.
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CHAPTER VI 
FINANCE AND ACCOUNTS 
32. Fees, fines and penalties to be credited to separate 
account.—The amount collected by way of fees, fines and penalties by 
the Council and the Authority shall be credited to such separate account 
as the Government may, by order, specify in this behalf and shall be 
utilized for the activities connected with the implementation of the 
provisions of this Act. 
33. Eligibility for allowances.—The non-official members of the 
Council and Authority, members of the grievance redressal committee, 
assessors and members of the sub-committee shall be eligible for such 
allowances as may be prescribed. 
Cuapter VII 
APPEALS, REVISION AND GRIEVANCE REDRESSAL 
34. Appeals.—{1) The Government shall, by notification, constitute an 
Appellate Authority to receive and adjudicate the appeals against the 
decision of the Authority with the following members, namely:— 
(a) Secretary, Health and Family Welfare Department, 
(ex-officio)—Chairperson; 
(b) Additional Law Secretary, Law Department, (ex-officio)— 
Member; 
(c) Director of Medical Education, (ex-officio) Member. 
(2) Any person, aggrieved by an order of the Authority refusing | 
to grant or renew a certificate of registration or cancelling or revising a 
certificate of registration or under sub-section (1) of section 27 and 
sub-section (1) of section 28 and section 29 may prefer an appeal to the 
Appellate Authority in the manner as may be prescribed within forty five 
days of such a decision. 
(3) Every appeal under sub-section (2) shall be made in such 
form and be accompanied by such fees as may be prescribed.
  
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(4) Every appeal under sub-section (2) shall be disposed of by 
the Appellate Authority, after giving the appellant a reasonable opportunity 
of being heard, within sixty days from the date of filing the appeal. 
35. Revision.—Any person aggrieved by the order of the Appellate 
Authority may prefer revision before the High Court within sixty days 
from the date of order of the Appellate Authority. 
36. Grievance redressal.—(1) The Council shall set up a grievance 
redressal mechanism in such manner as may be prescribed, to receive 
complaints from the public regarding the violation of the provisions of this 
Act or the rules made thereunder, by any clinical establishment and shall 
give direction to the authority to take appropriate action on the complaints 
so received. 
(2) Notwithstanding anything contained in this Act, the Council shall 
have the power to give direction to the Authority to review any decision 
and proceeding or order passed, including the imposition of penalty, by the 
Authority under this Act either suo motu or on any complaint and to 
‘summon any person concerned or document, in this behalf. 
Carter VIII 
INSPECTION OF CLINICAL ESTABLISHMENTS 
37. Inspection.—(1).The Council or the Authority or the Appellate 
Authority or any officer authorised by them, shall have the right to cause 
an inspection of, or inquiry in respect of any clinical establishment, its 
building, laboratories, diagnostic facilities, equipments and also the works 
conducted or done by the clinical establishment, to be made by such 
person or persons as they may direct and to cause an inquiry to be made 
in respect of any standards or conditions of the registration, after issuing 
notice to the clinical establishment and giving a right to be represented 
thereat. 
(2) Any officer or assessor carrying out an inspection of any 
clinical establishment shall file a report, with his findings within 48 hours of 
the conclusion of inspection, with the Authority authorised for inspection. 
In case additional information have been sought for he shall file a 
preliminary report within 48 hours and file the final report within 48 hours 
after such information has been furnished to him. 
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; (3) The Council shall notify the persons qualified to conduct 
assessment of the clinical establishments. 
(4) The Council or the Authority, as the case may be, shall 
communicate to the clinical establishment the views of the Council or the 
Authority with reference to the results of such inspection or inquiry and 
may, after ascertaining the opinion of the clinical establishment thereon, 
direct that clinical establishment as to the action to be taken. 
(5) The clinical establishment shall report to the Council or the 
Authority, as the case may be, the action 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 Council or the Authority 
may direct. 
(6) Where the clinical establishment does not take action to the - 
satisfaction of the Council or the Authority, as the case may be, the. 
Council or the Authority may, after considering any explanation furnished 
or representation made by the clinical establishment, within a reasonable 
time, issue such directions as the Council or the Authority deems fit, and 
the clinical establishment shall comply with such directions. 
(7) No such inspection shall be conducted within three months 
from the date of the first inspection unless it is to verify the claim of 
clinical establishment that a defect pointed out in the report under 
sub-section (5) has been rectified and not more than two inspections shall 
be conducted without the instruction of the Council or Appellate Authority 
within one year after the defect is rectified. 
38. Power to enter and search—The Council or the Authority or 
any officer authorised by them may, if there is any reason to suspect that 
. anyone is carrying on a clinical establishment without registration, enter and 
search at any reasonable time, in such manner as may be prescribed, and 
the clinical establishment shall offer reasonable facilities for inspection or 
inquiry and be entitled to be represented thereat. 
CuapTer TX 
MISCELLANEOUS 
39. Display of the certificate of registration and other 
information by the clinical establishment.—(1) Every clinical 
establishment shall display, in a conspicuous place in the clinical 
establishment its certificate of registration, provisional or permanent. 
  
 
  
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(2) Every clinical establishment shall display, in a conspicuous 
place in the clinical establishment in Malayalam as well as in English the 
fee rate and package rate charged for each type of service provided and 
facilities available, for the information of the patients. 
(3) All clinical establishments in the State shall display package 
rates for specific procedures. 
(4) No clinical establishment shall charge fees or package rates 
more than what is displayed. 
40. Maintenance of medical records.—Every clinical establishment 
shall maintain medical records of patients, in accordance with the laws for 
the time being in force, regarding the diagnosis, result of investigations, 
treatment given, condition at the time of discharge and advice given to the 
patients and a copy thereof shall be made available to the patient or to 
relatives free of cost. 
41. Display of Information by the Authority.—(1) The Authority 
shall, within a period of thirty days from the grant of provisional or 
permanent registration, cause to be published in such manner as may be 
prescribed, the particulars of the clinical establishment. 
(2) The Authority shall cause to be published in the website of 
Kerala Clinical Establishment Council the names’‘of clinical establishment 
whose provisional or permanent registration has expired, cancelled or | 
ceased to function. 
42. Protection of action taken in good faith.—(1) No suit, 
prosecution or other legal proceedings shall lie against any member or 
employee or any other officer authorised by the Authority or the Council 
in respect of anything, which is done in good faith or intended to be done 
in pursuance of the provisions of this Act or the rules made thereunder. 
(2) No suit or other legal proceedings shall lie against the 
Authority or the Council in respect of any loss or damage caused or 
likely to be caused by anything which is done in good faith or intended to 
be done in pursuance of the provisions of this Act or the rules made 
thereunder. 
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43. Recovery of penalties. —Penalties imposed under this Act and 
remaining unpaid shall be recovered as if it were an arrear of public 
revenue due on land. 
44. Power to give directions.—Without prejudice to the foregoing 
provisions of this Act, the Government shall have the power to give 
directions for the implementation of the provisions of the Act and to call 
for returns, statistics and other information that has relevance on public 
health and health surveillance. 
45. Employees of the Authority and Council to be public 
servants.—Every employee of the Council and the Authority while acting 
or purporting to act under the provisions of the Act or any rules made 
thereunder shall be deemed to be public servants within the meaning of 
section 21 of the Indian Penal Code, 1860 (Central Act 45 of 1860). 
46. Bar of jurisdiction of civil courts.—No civil court shall have 
Jurisdiction to settle, decide or deal with any question or to determine any 
matter or to interfere with any order which is by or under this Act 
required to be settled, decided or dealt with or to be determined or to be 
issued by the Authority or the Council or any officer authorised by them. 
47. Treatment of victims in emergencies.—(1) The clinical 
establishment shall provide, such medical examination and treatment as 
may be required and can be provided with the staff and facilities available 
in the establishment, to save the life of the patient and make the safe 
transport of the patient to any other hospital. 
(2) The Council shall notify the life saving services to be 
provided by each category of clinical establishments. 
48. Term of office, casual vacancies, resignation etc., of members 
of the Council and Authority.—(1) The term of office of non-official 
members of the Council and the Authority shall be three years from the 
date of notification of their nomination and shall not hold office for more 
than two terms. 
(2) A casual vacancy of a non-official member shall be filled by 
new nomination by the Chairperson and the member so appointed shall 
hold office for the remaining period of the term of the person in whose 
place he is nominated. 
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(3) Any member of the Council or Authority may, at any time, 
by writing under his hand addressed to the Chairperson of the Council or 
Authority as the case may be, resign his office and he shall be deemed to - 
have resigned his office legally from the date mentioned in the resign

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