The SIKKIM CLINICAL ESTABLISHMENT (LICENSING AND REGISTRATION) ACT,1985

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GAZETTEGOVERNlVIENT
EXTRAORDINARY
PUBLISHED BY AUTHORITY
No. 181Gangtok Monday 13th November, 1995
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GOVERNMENT OF SIKKIM
LAW DEPARTMENT
GANGTOK.
No. 8fLD/1995. Dated: Gangtok, the 30th October, 1995.
NOTIFICATION
The following: Act of the Sikkim Legislative Assembly Secretariat having received
the assent of the Governor on 11th day of October, 1995 is hereby published for general
information ;-
THE SIKKIM CLINICAL ESTABLISHMENTS (LICENSING AND REGISTRATION)
ACT, 1995.
~ (ACT NO.8 OF 1995)
ARRANGEMENT OF SECTIONS :-
\
1. Short title, extent, commencement and application.
2. Definitions
3. Constitution of a licensing and Registering Authority.
4. Jurisdiction and quorum.
5. Powers, duties and functions of the Authority.
6. Restriction in setting up clinical establishments.
7. Application for licence and for registration.
8. Renewal of a licence and certificate of registration.
9. Processing of application.
10. Directions.
p 11. Inspection.
12, Cancellation or suspension of a licence.
13. Appeals.
14. Offences and Penalties.
15. Offence by a Company.
16. Taking cognizance of any offence.
17. Chairman, Member of the authority and officers and persons to be public servants.
18. Power to remove niffir.llltip<;:

2
THE SIKKIM CLINICAL ESTABLlSH;\IENTS (LICENSING AND REGISTRATION)
i\Crr. 19~}5.
ACT NO.' 8 OF 1995
AN
ACT
to provide for regulating the setting up of private hospitals, nursing homes and
other centres catering to diagnostic, investigative and other health care services
and for matters connected therewith.
Be it enacted by the Legislature of Sikkim as in the Forty-sixth Year of
the Republic; 0;"india as follows r-
Short title,
extent, comm-
encement OI1l!
application.
Difinition~. 2.
Consti tut ion c:I3.
a licensing end
'Registerina Authority.
1
1. (l) This Act maybeCalledtheSikkimClinicalEstablishments (Licensing
and Registration) Act, 1995.
(2) 11extends to the whole of Sikkin.
(3) It shall come into force on such date as the State Government may,
by notification in the Official Gazette, appoint.
(4) It shall apply to anclinical establishments other than clinical establi-
shments set IIp by the Central Government or the Government of
any State.
In this Act, unless the context otherwise requires,-
(a) "Authority'; means the Sikkim Licensing and Registering Authority
constituted under section 3;
(b) "Cl inical establishment" means and includes-
(i) a general hospital, a maternity hospital and a dispensary;
(ii) an institution or centre by whatever name called where physically
Of menially sick, injured or infirm persons are admitted either as
in-patients or out-patients for treatment with or without the aid
of o"Ar'5\t';V'" nrocedures: and.IJ. [-""'.a. •••.••~~, '""-' }. "" 'U',4.L
(iii) a clinic catering to radiological, biological and other diagnostics or
investigative services with the aid of laboratory or other medical
equipme nts ;
(c) "licence" means a licence referred to in section 7;
(d) "notification" means a notification published in the Official Gazette-. ,
(e) "prescribed" means prescribed by rules made under the Act;
(f) "State Government' 1~'l:;ailC; the Government of the State of Sikkirn.
0) The Stale Government may, by notification, constitute an authority
to be called the Sikkirn Clinical Establishments Licensing and
Registering AUlhority consisting of the following persons. namely i,
(i) Director of Health and FamilyWelfare,Govrn-
ment of Sikkirn. • Chairman
1Ql
(ii) Licensing Authority under the Drugs and Cos-
metics Act, 1940, Health and Family Welfare,
Government of Sikkim.
(iii) Two members from medical profession of the
GOVC1"111TJCrlt of Sikl,iI1l4
- Member
- Member
(iv) Joint Director, Health and Family Welfare,
Government of Sikkim. - Member-
Secretary.
'Th ,. .~, .i f d I' . h(2) 1 e Authority may) ~.r)~consicers necessary, or eamg WIt any
special issue before it, invite any person to attend any meeting but
such peL;(l~'l ::hclllnot 'bedeemed to be a member of the Authority...-._"' .. , 1.•. ~, '?l k 1.. r ••••• --' •• ....., •• _ •••• _.: _1_ •.

Jurisdiction and 4.
quorum.
(5) Notwithstanding anything contained in this Act, the State
Government may, at any time, reconstitute the Authority or
replace any member thereof.
(1) The jurisdiction of the Authority shall extend over the entire
State of Sikkim.
(2) The quorum for any meeting of the Authority shall be four
including the Chairman-
Without derogation to any law for the time being in force and
prejudice to the generality of its powers and functions, the Authority
Powers, duties and, 5.
junctions ojthe without
Authori~. shall-
i~.
Restrictions in
setting lip
clinical estob-
lishments .
Application Jar
licence and Jor
resistru tion,
Keneva! ?}'a
licence and
certifi cote ?}'
reqistr atioti,
Processing cf
application.
Directions,
Inspection.
(a) receive applications for grant of licence and for registration of
clinical establishments;
(b) scrutinize the applications and call for further information or
particulars from the applicants or from any other person or
authority as may be required;
(c) consider the applications and pass orders;
and
do such other things as are necessary or incidental for the
purpose of this Act.
6, On and from the date of commencement of this Act, no person shall
set up any clinical establishment except under !1 valid licence granted by the
Authority and no clinical establishment Sh,1J1run without it having been
registered in accordance with the provisions of this Act;
(d)
Provided that in the else of a clinical establi-hmcnt in existence
immediately before "thedate of comruenc..mcnt of this Act, the person who has
set it UP or otherwise is the proprietor or OW,Wf of such a clinical establishment
shall. within a period of three mon.h., therefrom, apply to the Authority for
a licence and for registration of the clinical establishment.
Explanation: For the purpose of this section 'person' includes a body, group
or association of individuals. an organisation, a firm or socieryiwhether regis-
tered or not) or a company registered under the law for the time being in force
in the State of Sikk im.
7. An application for grant of a licence, and for registration of a clinical
establishment shall be made in such form and manner as may be prescribed.
8. The licence and the certificate of registration shall be renewed in
such manner as may be prescribed.
9. On receipt of art application, the Authority may, if it is satisfied
after causing such enquiry as may be necessary 1:) be made and after following
the criteria as may be prescribed, grant a licence or register a clinical establish-
ment, as the case m~lybe, or '.;:;1use, fur reasons to be recorded in writing, to
grant a licence or to register clinical establishmen: :
Provided that no order refusing to grant a licence or to register a
clinical esta biishment shall be passed unless the app lican t Ins been given an
opportunity of being heard.
10. Authority may, from time to time, give direst ions in regard to
matters pertaining to clinical establishments and the licencee as also the person
referred to in the proviso to seer.on 6 shall comply with such directions.
11. The Authority 1113y.from 1.tIT1(: to time, cause inspections of clinical
establishments and the 1": cord k·;p therein to satisfy itself that the clinical cs.ab-
lishment is run in accordance with terms and conditions of the licence and that
its directions ure r.nlY1nli<-,,! ,,,;th '>nri,h .;> ];"r._"~,, ,,-,-, .'-- -(.,-
/

Appeals.
OJfences and
penalties.
O)fence by cJ
Cotnpriny,
4
Provided that before a licence is cancelled that licence shan be
given an opportunity to be heard.
(2) On the cancellation or suspension of the licence under sub-section (1) no
person shall be freshly admitted in the clinical establishment either as an in-
patient or an out-patient:
Provided that a person already admitted in a clinical establishment
before the-licence is c incellcd, or suspended as the case may be. shall continue
to he treated until he is discharged and on the disch arge of the last of such
persons the cJinical esta blishmen t shall be closed down.
13. 0) AllY person aggrieved by an order of the Authority refusing to grant a
licence or to register a clinical establishment under section 9 or cancelling or
suspending a licence under section ]2, may prefer an appeal to the Appellate
Authority consisting of the Secretary to the Government of Sikkirn in the
Health and Family welfare Department and two ether experts in the field of
medical sc.rncc to be nominated by the State Government within such period
as may be prescribed.
(2) The Appellate A uthori ty shall, after considering the appeal and, if necssary,
after hearing the aggrieved person, pass orders and its orders shall be final and
binding.
14. Whoever contravenes any of the provisions of this Act or the rules framed
thereunder shall be quilty of an offence and in adduion to his licence being
cancelled or suspended shall be punishable for-
(a) a major offence, with a fine which shalt not be less than twenty thousand
rupees but which may extend upto one lakh rupees and in the case of a
continuing contraveuuon with an additional fine which may extend upto one
thousand rupees for every d.iy the contravention continues, and
(b) <1 minor offence, with a fine which shall not be less than five
hundred rupees but which may extend upto two thousand
rupees and in the case of a .continuing contravention with an
additional fine which may extend upto fifty rupees for every day
contravention conunues.
Explanation: 'Major offence' and 'minor offence' shall have
the meanings as may be prescribed,
15. Where an offence has been committed by a company every person
who at the time the offence was committed were directly in charge of or were
responsible to the company for the conduct of Its business shall be deemed to
be quilty of the offence and shall be liable to be proceeded against and punished
accordingly,
Explanation: For the purpose of this section 'company' includes a firm,
society, association or group of persons by whatever name called.
16. No court shall take cognizance of any offence punishable under this
Act except on a complaint made by the Authority or by an officer or person
authorised by it in this behalf.
17. The Chairman and every member of the Authority and
every officer or person exercising his functions on its behalf shall
be a public servant within the meaning of section 2i of the Indian
Penal Code, 1860. 45 oj1860,
Takin8 =r-zance if an)'
1fence•
Chairman,
member 1the
Authoriry a-id
persons to be
p1lblic servants,
Powerto remove 18. If any difficulty arises i:1 giving effect to the provisions of this Act,
difficulties. the State Government may take such steps or issue; such orders not inconsis-
tent with the provisions of the Act as may app;:;ar to it to be necessary or
expedient for the purpose vI' removing such difficulty:
Provided that no such order shall be made after the expiry of ar- .f· •
"

(.L) In particular and without prejudice to the generality of the foregoing powers, such rules
,,",may provide for all or any of the following matters, namely :-
(a) the principles and criteria for granting a licence or for registration of a clinical
establishment;
(b) the terms and conditions of a licence;
(c) the form of application for a licence and for registration of a clinical establish-
ment;
(d) the form of the periodical returns and statistics to be submitted by the licensee
to the Authority;
(e) the mode of holding meeting and the conduct of business by the Authority;
(f) the fees payable for applying for a licence and for registration of a clinical
establishment and for renewal of the same;
and
(g) any other matters which are to be and may be prescribed.
s
By Order of the Governor,
B·R. PRADHAN,
Secretary to the Govt. of Sikkirn,
Law Department.
F. NO. 16 (82) LD/79-95
PR1NTED AT THE SIKKlM GOVERNMENT PRESS, GANGTOK.
1.;

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