The TRIPURA CLINICAL ESTABLISHMENT (REGISTRATION AND REGULATION) ACT, 2018.

No. 1344 Registered No. N. E. 930.
  TRIPURA  GAZETTE
        Published by Authority
   EXTRAORDINARY ISSUE
  Agartala,  Thursday,  December 20,  2018  A. D.,  Agrahayana  29,  1940  S. E.
PART--III--  Acts of Tripura Legislature
20th
No. 1344 Registered No. N. E. 930.
TRIPURA GAZETTE
Published by Authority
EXTRAORDINARY ISSUE
Agartala, Thursday, December 20, 2018 A. D., Agrahayana 29, 1940 S. E.
PART—III— Acts of Tripura Legislature
GOVERNMENT OF TRIPURA
LAW DEPARTMENT
SECRETARIAT : AGARTALA
Dated, Agartala, the 20th December, 2018.
NOTIFICATION
Thefollowing Act of the Tripura LegislativeAssembly received the assentof
theGovernorofTripuraonthe18thDecember,2018andisherebypublishedfor
General information.
D.M ,Jamatia
L,R. & Secretary, Law
Government of Tripura
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
2
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
The Tripura Act No.16.
THE TRIPI RA CLINICAL ESTABLISHMENT
(REGISTRATION AND REGI LATION) ACT, 2018.
ACT
to provide for the registration and regulation of clinical establishments in the Tripura 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 theilities 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;
BE it enacted by the Tripura Legislative Assembly in the Sixty ninth year of the Republic of
India as follows:
2
CHAPTER 1
Preliminary
Short title and commencement
l. This may be called the 'Tripura Clinical Establishment (Registration and Regulation)
2018';
2. It shall come into force 011the date of its publication ill the Tripura Gazette.
3. It excludes the facility of Defense Forces,
Detinitions
In this Act, unless the context otherwise requires:-
GI) '(tlinical establishmenl't 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
recognized system Df medieme established and administered or maintamed by any person
or body of persons, whether incorporated or not, andor
(lei) a place established as an independent entity or patt of an establishment referred to in
sub-clause O), 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 Illaintained by ally
person or body of persons, whether inecnorated or not, and shall also include an
establishment, established, administered or maintained by-
(u) the Government or a department of the Government,
(b) atrust, whether Pliblie or privalet
2
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
3
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
(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 praetieing doctor,
but does not include the clinical establishments owned, controlled or managed by the Armed
Forces.
Euvplunution.=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
Aet, 1957 (62 of 1957) or any other law for the time being in force;
(b) "Clinical laboratory" means an establishment where —
i. Biological, pathological, bacteriological, radiological, virological- chemical or other
tests, examinations or analysis. or
ii. The preparation of cultures, vaccines serums or other biological or bacteriological
products, In connection with the diagnosis or treatment of diseases, are of is usually
carried on;
(c) "Maternity home" means an establishment where women are usually received or
accommodated or boih for the purpose of confinement and antenatal and posi-natål care
in connections with child — birth
(d) "Nursing home" means an establishment where persons suffering from illness injury or
infirmity whether of body or mind are usually received or accommodated or both for the
purpose of nursing and treatment and includes it maternity home ;
(e) "Collection centre" means an establishment where biological samples are usually
collected or stored for analysis from other laboratory or its own laboratory in another
area.
(0 'tPhysiea1 therapy establishment" means an eståblishment where persons are usually
treated by physical means such as message, electrotherapy; hydrotherapy; remedial
gymnastics or the like ;
(g) "Prescribed" means prescribed by rules made under this Aet ;
(h) "Qualified medical praetitioner" rneans a medical praetitioner registered in Tripura
Medical Council or MCI under a law for the registration of medical practitioner
(i) "Qualitied midwife" means a midwife registered in an state in India under a law for the
registration of midwives;
Qi) "Qualified nurse" means a nurse registered in a state in India under a law for the
registration ofnurse.
(k) eQualified pathologist" means a medical practitioner with required q»alification in
pathology registered in any state in India under a law for the registration of medical
praetitioner.
(l) "Qualified radiologist" means a medical practitioner with required qualification in
Radiologist register in a State in India under a law for the registration of medical
practitioner.
(my Qualified Microbiologistl' means a medical practitioner with required qualification in
Microbiology register in a State in India under a law for the registration of medical
practitioner.
(n) "Qualified Biochemist" means a medical practitioner with required qualification in
Biochemistry register in a Stale in India under a law for the registration of medical
practitioner.
3
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
4
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
(o) "Register" means to register under section 8 of this Act and the expression '*registered
and "registration" construed accordingly,
(p} "Rules" rules made under this Act ;
(q} "Siq•ervising authority-v rneansthe personof authorny appointed by the state Government
by nolifieation in the Official Gazette, to all or or the functions of
supervising authority this Act,
(r) "Practicing Doctor" inany system ofMedicine,
The State Council for Establishment
Establishment of State Council
Siaie Government shall by notification constitute a SlateCouncil rorthe purposes of
this Act. Willi effect from such as may be appointed by the State
sueh ion;
State Council, Quill consist ofthe followiil menihers, namel
Secretary. Health
[Hector of Family Welfare &
Preventive Medicine
An officer, not below the
rank of a hint Director
Family Welfare Preventive
d
Ev c"fjcjo, shall be
the Chairman;
Ex Member.
Secretary;
Ex &
Slate Nk3dxl
Member
Medicine
istrur-cum,Secret
isirar
isir:ur
Branch Officer
Secretary
Duration or Sate Council
front
State Medical Council of Tri Lira
Slate Nursin Council Of Tr• uru
Council ofTTiState
Hcilijeopatliic and
of the Directorate
Of each District
Indian Medical Association,
T State Branch
{i) The Cluration of the State cooncil •.011be for a tetjii Of three
(jj) If any vacancy arises due to expiry or absence member, then
Fimjly & preventive with prior approval of
Governmem nentinate uny other of the Directorate to Ell the vacancy.
S. Function or State Council
'Jhe Statecouncil shall pecfocm functions. namely —
(o) compiling StateRegistersofclinieal establishment.
(h) sending monthly relunusfor updating the Nåtional Register,
(c} representing the Statein theNuiional Council,
hearing Of appeals against the Oj•dejsOf the authority. and
4
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
5
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
(e) publication on annual basis areport on the state of implementation of standards within
their respective States.
CIMPTER 111
The District Council for Clinical Establishment.
6. District Council for Clinical Establishment
The State Government Shall, by notification, set-up an authority to be called the district
registering authority for each district for registration and supervising of clinical
establishments, with the f0110wing members, namely:
(0) District Magistrate & Collector ofthe District or any other officer, nominated by him,
not below the rank of Addl. DM
(b) Chief Medical Officer
(c) District Health Officer
(d) District Quality Assurance Officer
Function of District Council
Chairperson;
Co-ChaWperson;
District Nodal Officer;
Member.
7.
8.
9.
The District Council shall perform the following functions, namely ----
(a) compiling and updating the District Registers of clinical establishment;
(b) sending monthly returns for updating the State Register;
(e) representing the District in the State Council;
(d) publication on annual basis a report on the District of implementation of standards
within their respective District.
(e) compilation and maintenance of the information and statistics collected from the
clinical establiShments under clinical establishment Act. every month.
Authority for Registration.
(l) 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:—
(o) Chief Medicål Officer
(b) District Health omeer
Chairperson;
Member;
(2) Notwithstanding anything contained in sub-section (l), for the purposes of provisional
registration of clinical establishments under Section 12, the Chief Medical Officer shall
exercise the powers of the authority as per procedure, as may be prescribed.
District Supervising Team.
(l) The State Government shall, by notification, set-up an authority to be called the
District Supervising Team for each district, for supervision or clinical establishments,
with the following members, namely;—
(a) District Health Officer
(b) District Family Welfare Officer
(e) District Quality Assurance Officer
(d) Any officer, as time to time
Nominated by the CMO
Chairman
Member
Member
----Member
5
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
6
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
CHAPTER IF
Registration and Standards for Clinical Establishment.
I O_Registration for Clinical Establishment
No person shall establish, maintain, manage or earw on any clinical establishment, without
being registered under this Act and except under and in accordance with the terms of
registration issued.
11. Condition for Registration.
(1) For registration or carrying on the clinical establishment, the following conditions
shall be fulfilled, namely:
i)
ii)
iii)
v)
The minimum standards of ies and services, as may be prescribed,
'ITIe minimum number required personnel* technical or non-teehnieal* as
may be prescribed.
Provision for maintenance ofreeords and reporGng, as rnay be prescribed,
Policy for providing first aid treatment to emergency medical conditions,
sexually assaulted, acid victims and Road Tramc Accident cases, and
Any other matter, as may be prescribed.
12. Application ror Registration.
(1) Every person intending to establisll a nevo clinical establishment shall make an
application for provisional registration, in such manner and fbrm and with such fee,
as may be prescribed, to the District Registering Authority, who on being satisfied
about the infbrmation contained in such application, may issue a provisional
registration whiéll will remalll valid for Six months, within whiCh period the District
Registering Authority shall require the District Supervising Team to make all
inspection, who will then after necessary illspeeti011, in such manner, as may be
prescribed, sübmit its report to the District Registering Authority;
(2) If the District Registering Authority is satisfied that all the required standards and
conditions are fulfilled. it may take further action according the procedure prescribed
for registration under this chapter:
(3) But if the District Registering Authority, on the basis of the report of the District
Supervising Team, is satisfied that all the required standards and conditions are not
filliilledt he may by order exQnd the period of validity of such provisional
registration for a further period of Six months and direct the applicant to take
necessary corrective measures within such date and time, as may be specified in that
order;
(4) If an applicant fails to make necessary corrections, within the extended period also,
the applicant •hall be treated as a defaulter for making any application fbr
6
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
7
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
registration for a subsequent period of one year, which shall be communicated in
writing to the applicant;
(5) All applicant, who holds a valid provisional registration and is not declared as a
defaulter according to sub-section (4), may make an application for registration, in
such manner, form and shall be accompanied by such fee, as may be prescribed;
(6) Registration of Clinical establishment issued once sluill be valid for five years in
respect of Hospitals and three years in respect of all other categories of Clinical
Establishment 011receipt of an application for registration or renewal of the same,
the District Registering Authority may require the District Supervising Team to
make an inspection, who will then after necessary inspection, in such manner, as
may be prescribed, submit its report, to the District Registering Authority and the
District Registering Authority, if satisfied that all the required standards and
conditions are fulfilled, shall forward the same to the Director, Family Welfare &
Preventive Medicine for approval;
(7) Aner the approval of the Director, Family Welfare & Preventive Medicine, the
District Registering Authority shall issuethe registration;
(8) If any application fails to fillfil the criteria during the time of inspection by the
District Supervising Team, then the establishment may be given three months more
time to fulfil the latches, after which the supervising team will inspect or examine
the latches detected during the previous inspection and if any applicant fails in the
subsequent inspection also, then his application will be treated as cancelled, but such
cancellation will not be a bar for applying for a new provisional registration, with
prescribed fee.
(9) Notwithstanding anything contained in this chapter, a clinical establishment already
holding a valid registration under the Tripura Clinical Establishment Act. 1976,
hereby repealed, shall make an application for registration under this Act, on the due
date of renewal ofllis registration under the Act, sorepealed.
13. Display of Certificate of Registration.
The registration certificate shall be kept amxed in a conspicuous place in the clinical
establishment in such manner soasto be visible to everyone visiting such establishment,
14, Display ofDistrict Registration no.
The registration number, provided to the establishment by the District Registering Authority
Shallbe displayed in the signboard, advertisement, OPD tickets, IPDtiekets, reports, bills and
private prescriptions and any other paper, document or display, by whatever style or manner.
7
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
8
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
Duplicate Certificate.
In ease the certificate is lost, destroyed, mutilated or damaged, the authority shall issue a
duplicate eertifieate on the request of the elinieal establishment and on the payment of such
fees as may be prescribed.
16, Renewål of Registration.
The application for renewal of registration shall be reached to the District Registering
Authority ninety days before the date of expiry of the vålidity ofthe registration.
Provided that, if the application is submitted aner the stipulated time, not later than three
months after the expiry of the registration, the application may be considered by the District
Registering Authority, subject to the showing of satisfactory reasons for such delay and on
the payment of such fine, as may be prescribed.
17. Cancellation of Registration.
(l) If, at any time after any clinical establishment has been registered, the authority is
satisfied that,
(a) the conditions ofthe 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 anotice 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; or
(c) ifany government doctors doing private practice in two or more districts or
(d) if monthly information & statistics as per if not submitted on due time to the
Supervising Authority.
(2) If aner giving a reasonable opportunity to the elinieal 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 etTéet—
(a) where no appeal has been preferred against suC11order immediately on the expiry
ofthe period prescribed for such appeal; and
(h) 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 establi@hment from carrying on if
there is imminent danger to the health and safety of patients.
Inspection of Registered Clinical Establishments.
(l) Tllie supervising authority or any officer empowered by it in this empowered by it in
this behalf may, subject to stib-general or special orders as may be made by the State
Government enter and inspect any premises which are used or which the supervising
authority or the officer empowered by it has reasonable cause believe to be used for the
8
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
9
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
purpose of clinical establishment and inspect records required to be kept in
accordance with the provisions of this Act.
(2) If any person refuses to allow the supervising authority or the officer empowered by
it to enter or inspect any such premises as aforesaid, or to inspect any such records as
aforesaid or Obstructs the supervising authority or the officers empowered by it in the
execution of the powers under this section, he shall be guilty of an offence under this
Act,
(3) Nodal Officer of the State (TCE Act) along with the supervising authority of the
District or any officer empowered by the supervising authority may randomly inspect the
elinieal establishment registered under this Act.
19. Levy of fee by state govermnent.
The State Government may Charge fees for different categories of clinical eståbliShments, as
may be prescribed. Any fees received or fines paid under this shall be credited to the
Consolidated Fund ofthe District through Bank Challan.
CHAPTER r
Register of Clinical Establishment.
20. Maintenance of State Register.
State Council shall maintain a State Register, containing district-wise monthly updated status.
within 20mday of thenext month, onthe basisof thereports or thedistricts, in suchformat. asmay be
prescribed.
21. Maintenance of District Register.
Every District Registering Authority shall maintain a district register containing the updated
records OT' all elinieal establishments under their respective jurisdiction, ineluding the
infbrmation and statistics, which should be sent to the State Council within 15 day of the
next month, in such manner and fOrmat, asmay be prescribed.
22. Maintenance of Clinicål Establishment Register.
Every clinical establishment will maintain the updated records of clinical establishments.
ineluding such information and statistics, in such manner and format? as may be prescribed, whiCh
Shall be submitted to the District Registering Authority, within the 07thday of the subsequent
month.
CHAPTER rl
Penalties.
23. Penalty for Non Registration.
(1)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
9
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
10
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
thousand rupees, for any second offence with fine which may extend to fifty thousand
rupees and for each subsequent offence with fine which may extend 10five lakh rupees
or six months imprisonment or both;
(2)No coun inferior to that of a Magistrate of the first class shall try any offence
punishable under this Act,
24, Penalty for Disobedience, Obstruction and Refusal of Information.
(l) The District Registering Autllority or any other person duly authorized by such
authority, within its respective jurisdiction, is empowered to make inspection of ally
establishment, at all reasonable time and the Clinical Establishments are liable to
show cause for disobedience, obstructi011 and relilsal of information for the first
instance;
(2) If no reply is received in stipulated time or the reply is not satisfactory, the District
Registering Authority, on recording of the reasons of his findings ill writing, shall
have the power to impose and realize fine, which may extend to Rs 10,000/3 with the
prior approval of the Direelort Family Welfare & Preventive Medicine;
(3) If any clinical establishment, doesn't reply to the show cause or fails to pay the fine,
within 30 days, the registration of the establishment may be cancelled, with the prior
approval of the Director, Family Welfare & Preventive Xledicine,
25 Offences by Government Departments.
Where all offence under this Aet 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 ofT1cer OTofT1cial, other than the Head of the
Department, such officer or official shall also be deemed to beguilty of that offence and shall
be liable to beproceeded against and punished accordingly
26. Recovery of Fine.
Whoever fails to pay the fine, the Stale 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 AV11iehsueh person owns any property or resides or
carries on his business and the said Collector, on receipt of such iiicate, shall proceed to
recover from such person the amount specified thereunder, as if it were an an-ear of land
revenue.
CHAPTER J'll
Miscellaneous
2Z Protection of action taken in good faith.
(4) No suit, prosecution or other legal proceedings shall lie against any authority or any
member ofthe National Council or Stale Council or any oilfieer authorized in this
10
Searchable PDF created by OCR.space (Free Version)
Tripura Gazette, Extraordinary Issue, December 20,  2018  A. D.
11
Printed at the Tripura Government Press, Agartala.
Tripura Gazette, Extraordinary Issue, December 20, 2018 A. D.
behalf in respect of anything, which is in good faith done or intended to be done in
pursuance ofthe 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 ofthis Act or any rule made thereunder;
(3) If any objection or grievance is received by the District Registering Authority, against
any establishment, such objections shall be communicated to the clinical
establishment, seeking explanation within a period of fifteen days from the date of
receipt;
(4) If no explanation is received within stipulated time or the explanation is not
satisfactory; the District Registering Authority; on recording of the reasons of his
findings in writing, shall havethe power to make an enquiry andto take action against
such establishment according to the procedures prescribed in this Ael and the rules
made thereunder,
28. Repeal and Savings
(1) existing Aet entitled " Tripura Clinical Establishment Act, 1976" (Aet No. 12 of
1976) in its application to the State of Tripura is hereby repealed;
(2) Notwithstanding such repeal, anything done or any action taken or any proceeding
instituted or any order made or any notification issued under the Act, so repealed,
shall be deemed to have been done, taken, instituted, made or issued under the
corresponding provisions of this Act;
(3) All reference in any other enactment to any of the provisions of the Acl so repealed
shall be construed asareference to the corresponding provisions ofthis Act.
29. Power to remove difficullies
(l)lf any diffeulty arises in giving effect to the provisions of this Act, after its
commencement, the State Government may; by order, published in the official
gazette, make such provisions not inconsistent with the provisions of this Act. as may
appear to be necessary for removing the difficulty ;
Provided that, no such order shall be made under this section after the expiry of two
years from the date of commencement ofthis Act.
(2)Every order made under this section, shall be laid* assoon asmay be after it is made,
before the state legislature.
JAMATIA
LR SECRETARY, LAW
GOVERNMENT OF TRIPURA
Printed at the Tripura Government Press, Agartala. 11
Searchable PDF created by OCR.space (Free Version)

‹ Prev All Tripura acts Next ›