The Sikkim Clinical Establishments (Licensing and Registration) Act, 1995

GOVERNMENT
EXTRAORDINARY
PUBLISHED BY AUTHORITY
-Gangtok Monday 13E November, 1995 No. 181
GOVERNMENT OF SIKKIM
LAW DEPARTMENT
GANGTOK.
No. 8/LD/1995. Dated: Gangtok, the 301h October. 1995-
NOTIFICATION
The following Act of the Sikkim Legislative Assembly Secretariat having received
the assent ofthe Governor on 11111 day of October, 1995 is hereby published for general
information:—
THE SIKKIM CLINICAL ESTABLISHMENTS (LICENSING AND REGISTRATION)
PWNQ9*PN?
ACT. I995.
(ACT N0. 3 OF 1995)
ARRANGEMENT 0F SECTIONS :»
Short title, extent, commencement and application-
Definitions
Constitution of a licensing and Registering Authority.
Jurisdiction and quorum.
Powers, duties and functions or the Authority.
Restriction in setting up clinical establishments.
Application for licence and for registration.
Renewal of a licence and certificate of registration.
Processing of application.
Directions.
Inspection.
Cancellation or suspension of a licence.
Appeals.
Offences and Penalties.
Ofl‘enoe by a Company-
Taking cognizance of any offence.
Chairman, Member ofrhe aulhorily and officers and persons to be public servants.
Power to remove difficulties.
Power to make rules.
2 84

THE SIICKINI CLINICAL ESTABLISHNIENTS (LICENSING AND REGISTRATION)
ACT: l995.
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.
Shun :z'xlz, l.
extent, comm—
ulcemmt and
application.
De minions, 2.
Constitution 5r 3.
a licensing and
nagnran'ng Auzbomy.
Be it enacted by the Legislature of Sikkim as in. the Forty-sixth Year of
the Republic of Indians follows :—
(1) This Act‘rnay be Called theSik kim Clinical Establishments (Licensing
and Registration) Act. 1995.
(2) It extends to the whole of Sikkin.
(3) It shall come into force onsuch date as the State Government may.
by notification 1n the Offictal Gazette, appomt.
(4) It shall apply to all clinical establishments other than clinical establi-
shments set up 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 sectlon 3;
(b) “Clinical 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.
or mentally sick, injured or infirm persons are admitted either as
in<patients or out—patients for treatment with or without the aid
of operative procedures; and
(iii) a clinic catering to radiological, biological and other diagnostics or
investigative servrces With the aid of laboratory or other medical
equlpments;
-
.
(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” means the Government of the State of Sikkim.
(l) The State Government may, by notification, constitute an authorit
to be called the Sikkim Clinicai Establishments Licensing an
Registering Authority consisting of the following persons, namely:-
(i) Director of Health and Family Welfare, Govrn-
ment of Sikkim. .
-
Chairman
(ii) Licensing Authority under the-Drugs and Cos—
metics Act, 1940, Health and Family Welfare,
Government of Sikkim.
-
Member
'
(iii) Two members from medical profession of the
Government of Sikkim.
_
-
Member
(iv) Joint Director, Health and Family Welfare,
Government of Sikkim.
'
-
Member-
Secretary.
(2) The Authority may. if it considers necessary. for dealing with any
special issue before it, invite any person to attend any meeting but
such person shall not be deemed to be a member of the Authority
nor shall he have a voting right.
(3) No act or proceeding of the Authority shall be invalid on the ground
merely of the existence of any vacancy or defect in the constitution
of the Authority.
(4) The Authority shall have an office and all correspondence and orders
emanating from the office of the Authority shall be authenficated
under the signature at the Member Secretary.
285

(5) Notwithstanding anything contained in this Act. the State
Government may, at any time, reconstitute the Authority or
replace any member thereof.
jurisdiction and 4. (l) The jurisdiction of the Authority shall extend over the entire
quorum. State of Sikkim.
(2) The quorum for any meeting of the Authority shall befour
including the Chairman.
?0W¢T$,dufleiand, 5. Without derogation to any law for the time being in force and
funrtian: gfxlig
Author“ .
Nonfiction: in
raring up
clinical lumb-
Ii'di mars.
Applicaunnjor
licenrc and Jbr
ugh-Erotic".
Renewal '31"
liccnm and
«affirm: of
registration,
Processing of
application.
Directions.
Inspczi inn.
Cancellation
or msprnslan of
a fissure.
“Eta-ion! prejudice to the generality of its powers and functions, the Authority
3 a.
-
(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 he required;
(as) consider the applications and pass orders;
and
(d) 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 a valid licence granted by the
Author-it and no clinical establishment shall run wiihout it having been
registere in accordance with the provisions of this Act;
Provided that in the cause of £1 clinical establishment in existence
immediately before the date of commenceiricnt of this Act, the person who has
set it up or otherwise is the proprietor or owner of such a clinial establishment
shall. within a period ofihree monil therefrom, apply to ihe Authority for
a licence and for registration of the c l ical establishment.
Explanation: For the purpose of this section 'person’ includes a body, group
or association of individuals, an organisation, a firm or society(wh_ether regis-
tered or not) or {1 company registered under the law for the time being in force
in the State of Sikkim.
, . 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 ihe certificate ol‘ registration shall be renewed in
such manner as may be prescribed.
9. On receipt ol‘an application, the Authority-may, if it is satisfied
after causing such enquiry as may be necessary to be made and after following
the criteria as may be prescribed, grant a licence or register a clinical establish-
ment. as the case may be, or iietusc, for reasons to be recorded in writing, to
grant a licence or to register clinical establishment:
Provided that no order refusing to grant a licence or to register a
clinical establishment shall be passed unless the applicant has been given an
opportunity of being heard,
10. Authority may. from time to time. give directions in regard to
matters pertaining to clinical csmb shmcnts and the licensee as ialso the person
referred to in the proviso to secils n 6 shall comply wilh such directions.
ll. The Authority may. from lime to time, cause inspections of clinical
establishments and the record Rep-r therein to satisfy itself that the clinical est-1b-
lishmeiit is run in accordance will) terms and conditions ofihe licence and that
its directions are complied with and the licensee and the olTicer-in-charge of the
clinical establishment, by whatever name called, shall afford all reasonable
opportunity to the Authority or to any person dcpuied b it to conduct the
inspection and shall furnish all information as may he calls for.
12- (1) If the Authority is satisfied that a licensee has violated any of
the terms and conditions of the licence or any of the directions it has
given or has contravened any of the provisions of this Act or the rule
made thereunder, the Authority may order cancellation or suspension
of the licence for such period as it may ihirik fit and on such cancella-
tion the certificate of registration shall stand withdrawn.
286

Appeals.
Olfcnm and
panama.
Offend! by c
Com-Pall}
.
Taking ougni.
1mm: of an):
gffcnce.
Chaimmn,
:usnubsr y'rhe
Amharify and
Provided that before alicenoe is cancelled that licence shall be
given an opportunity to be heard.
(2) 0n the cancellation crsusoension at: the licence under sub-section (1) no
person shall be free 'y admitted in the clinical establishment either as an in;
patient or en out-patient:
_
Provided that a person already admitted in a clinical establishment
before the licence is cancelled, or suspended as the case may be, shall continue
’
he treated until heir; discharged and on the disch org: of the last of such
persons the. clinical establishment shall be closed down.
13. (1) Any gerscn aggrieved by an order of the Authority refusing to grant a
licence or [0 register a clinical establishment under section 9 or cancelling or
suspending a licence under section 12’.i may prefer an appeal to the AppellateAuthority consisting of the Secretary to the Government of Sikkim in the
Health and Family welfare DCpm’tman and two other experts in the field of
medical sci-“nee to be nominated by the State Government within such period
as may be prescribed.
(2) The Appellate Authority shall. alter considering the appeal and, if necssary.
iii-165'
hearing the aggrieved person, pass orders and its orders shall. be final and
in mg.
lilo Whoever contravenes any of the provisions of this Act or the rules framed
thereunder shall be
guilty
of an ofi’ence and in addition to his licence beingcancelled or concert ed shall be punishable for—
(a) a major offence, with a line which shall not be less than twenty thousand
rupees 'trut which may extend upto one lakh rupees and in the case of a
continuing contravention with an additional fine which may extend upto one
thousand rupees for every tiny the contravention continues, and
(b) a minor offence. with a fine which shall not. be less than five
hundred rupees but which may extend onto two thousand
rupees and in the case of a continuin contravention with an
additional line which may extend upto fty rupees for every day
contravention continues,
Explanation: “Major offence’_ and ‘minor ofi‘enco' 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 quilly cf the ot'fence and shall be liable to he proceeded against and punished
accordingly
Explanation: For the purpose of this section ‘co tnpétny’ includes a firm.
society, association or group of persons by whatever name called.
_
l6. No court shall take cognizunce of any ofi‘cnc-c punishable under this
Act except on a complaint made by the Authority or by an ofliccr or person
authorised by it in this behalf-
17. The Chairman and every member ofthe Authority and
every officer mane mun exercising his functions on its behalf shall
be a public servant within the meaning of section 2] of the indian
puma: in be P rial Code. 1860. 4.5 gftfléo‘
,mbll: sunny,
ram-r w ram-ave 18. If any difficulty arises in giving efi'ect to the provisions orthis Act.
difl'iculucr.
Fami- to mail!
ruler.
the State Government may take such steps or issue such orders not inconsis—
tent with the provisions of the Act as may appear to it to be necessary or
expedient for the purpose at removals}, such difficulty:
Provided that no such order shall be made otter the expiry of in
period of two years from the date of commencement of this Act.
19. (i) The State Government may, by notification rind subject to the corn
dition of previous publication, make rules for carrying out the purposes of this
Act.
287

(2) 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.
By Order of the Governor,
B-R. PRADHAN,
Secretary to the Govt. of Sikkim.
Law Department.
F. N0. 16 (82) LD/79—95
288

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