THE MIZORAM CLINICAL & HEALTH ESTABLISHMENT (REGULATION) ACT, 2007

(Act no. 8 0f 2007

[Received the assent of the Governor of Mizoram on 16th April 2007]

AN ACT

To regulate the clinical establishment to provide better provision with

respect to medical–health care of the people through these establishments

and for matters connected therewith or incidental thereto.

Preamble. Whereas it is expedient to regulate the clinical establishments to provide

better provision with respect to medical-health care of the people through

these establishments and for matters connected therewith or incidental

thereto.

It is enacted in the Fifty Eight Year of the Republic of India as follows :-

1. Short title, extent and commencement:

1) This Act may be called the Mizoram Clinical & Health Establishment

(Regulation) Act, 2007.

2) it shall extend to the whole of the state of Mizoram

Ex-125/2007 2

3) It shall come into force all such date as the State Go­vernment may, by Notification in the official Gazette, appoint.

Definitions. 2. In this Act, unless the context otherwise roquires-

a) ""'::Iinical Laboratory" means an establishment wher~ testsare carhed out for biological, pathological, micro-biological.biochemical, radiological or any other method analogous toany tests carried out for diagnosis of disease and health con­dition . .b) "Nursing Home" or "Hospibtl" or "Research Institute"means any premises or establishment used or intended to beused for the reception and admission of persons suffering fromillness, injuries or infirmity of body and providing of treatmentand nursing for them and includes a .Maternity HOme or.Psychiatric care •.

c) "Clinical Establishment" means and includes:-

i) a hospital, nursing home, polyclinic, sanatorium, maternityhome, immunization or vaccination clinic, dispensary, dentalclinic, special camps where physically or mentally sick. infirm,injured or disabled person is admitted as a patient for treat­ment, observation or care or seer as out patient.

ii) A place cat~ring topatholbgical. bacteriological. genetic,r~diolo~ic~l, biol?gical inve~ti~ations or~ther diogn()s,tic ser­vlccs'wlth the aId and aSSIstance of dOVlcesand eqUJpmentsestablished as an ind.ependentl entity or part of an establish­ment as defined in (i) above.

d) "Health authority" means State Health Authority constitutedunder Section 4.

e) "Ljcensing Authority" means State Health Authority or otherauthority. autb:oris..ed by State Government for issue. of License.

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f) "Maternity Home~' meansaJn establishment" Or premiseswhere WOmenar~usually :received or accomandated or broughtforprovidingante~natal arpo,st-mltal ..medical or health care.serviceinconnection witbpregnancy and·· childbirth.

1l)"PhYsic<t'I'l:her~JlYe.tabHIJent" onean~ art .estab1ishnlen twhcrepbysical\. th~rapy, elcctro:-therapy,hydro-therapy, ..J;'eDle­.dial gymnastics or .simHal"~ork::isus1,1a:lly .. carried·()IIJ();t,"the··.Plu'poseof treatment·J;~f·di'sease9r.· .infirD1i~y..1'01'. ... impr()V~­rnent.Qt healtb or ··.·forthe.·.pur,pos~of·· re~ax.iltlOil·or·Jo(.:~~yothetpurpose whatsoever, <whetherpI ~otanalog()us;to"·tliepUJ:pose~.he.~eill;\befQrementioned iu<thisclause; .. ;.",

3 Ex-125j2001

h) "Qualified Medical practitioner" means a person wbo po .•ssesses medical qualification as prescribed in tbe Indian Medi­cal Council Act, 1956, Indian Med~cine and Central CouncilAct, 1970 and the Homeopathic Central Council Act 1973 andwho has been registered as a medical practitioner in theregister as provided in the aforemeptioned Acts.

i) "Qualified Dentist" means a perJon posse!sing qualificationrecognised by the Dental Council Act.

j) "Qualified Nurse" means a nurst possessing any of the quali .•fications included in the scheduled to Nursing Council .Act andregistered as such under any law for the tIme being in force.

k) "Rules" means rules made under this Act.I

1) "Prescribed" means prescribed by rules made under this Act~

m) "Government" means the Government of Mizoram.

3. No person shall establish or maintain a clinical estab1i~hmentwithout registration and a licence granted thereof under this Act.

Provided that clinical establishment already in existence priorto commencement of this Act Shall have to be registered and alicence shall be obtained thereafrer. unqer this Act within a periodof 3 months from the date of promulgation of this Act.

4. (i)TheGov~rnment may, .bytlotification,constitutean autho­rityto be caned theSTATJEHEALTHIAUTHORITY.· TheHealthAuthority shall be a body corporate llavingperpetual successioDand.common seal and may sue and b~sued.

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(ii) The. Health Authority shall cons~st of eight1l1embers inclu­

din.'g the Chairman and shall beconstiltuted in the following man-ner: '.

1. Commissioner/Secretary,Health ahd Family Welfare-Chair­man.

2~....pirectorof Hospital.&Medical. Education (DHME}-Member

secretarY"'\i .........•.....,..... 1 '...." .' .....3~Director of Health Services (PHS)-Me11lber .

•.¥~d~al$l!~dnte"<lenI,N~aWldvil.n"'Pital~Me!1l~r..·.\'·S~.•i..•·.·.,.Re~r~s,entative:•.·.o~.·•.~llrsing ••.§eryi·cesl· ••·.not·.,.•.be.low t·he··r~n·k···oY••De-·,

.puty·.I)lrectortMen;lber·\ ".,''.." "', ." -, -, . ,- "-, ..

Central Act59 of 1973

Central Act102 of 1956

Central Act48 of 1970

Clinical Est­ablis·hmentnot to be es­tablishedor maintai­ned withoutregistra tionallaIicenee •

. ConstitutionofSta.teHealth Au­thorityatidits terms .

Ex-125/2007

Ivlaintenan- 5.ee of Re­gi$ter of Cli ..Lical Esta b­lisbment.

Appoint- - 6.mentof Re·{!istrar ands'taff.

Qualifica- 7.tlOn, func­tion, sa lh ry,duties and -

.allOwancesof the Regis­trar and staff.

Establish- 8,ment andmaintenanceof clinicalestablish­ment.

Application 9.for registra-

. tion andlicence.

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'6. Two eminent medical professionals to be nomina ted.by theGovernmc nt- Mern bers.

7. Representative of Indian Medic~l Association (lMA)-:Men";ber.

nq The H,:,alth I\~!~hofitv shali be c;lns~jtuted \vithin six mOD'hsfrom the dite of this Ad comes into force and thl;; names of the

membets sh:.·dl be pubJis;led in th? offich 1 GClzette.

(iv) '1 he Health Authority will be a permanent hody.

(v: The lerrn (Jf ron-otfic;ai IT.eii1bcrs v,ill be two \ ear::. from thedate 'of ,,'ppointrnent. -

{i} The Health Authority shall, as soon as may be after itsconstitution ~md not l?ter than six months hO:11 the cominginto Torce of this Act, make orders for maintenance of a

Regisl,er fer the clinic:l establishment.

(ii) The Register referred t'Ol in sub-section (1) siiall containth'e names of all the <clinical establishments and sh~ll bepublished in the official Gazette.

(Hi) The Reghter shall be maintained in such form as maybe prescribed.

The GOVernment shall appoint or designate a person as Registrarwbo shaH be the Secretary. to the Health Authority and alsoaf pO-int the staff if consider necessary fur carrying out the

purposes of this Act.

The qualification, function, duties, s::ibry and allo\vanceS andsuch other matters rdating to the Registrar anQ the stafIshallbe such as may be prescribed from time to time.

The Health Authority may, in' any part '0fMizoram within itsjurisdiction. allow to establish ,or maintdn clinical establishmenttor leception, admission, treatment and care of physically ill

• persons, pregnant .woman and carry out laboratory procedurefor di~tgnosis of healtn and disease at :mcil p laces as it thinksfit.

(l)Eveiyapplication for registration in any ciinic,d establish-·ment and for. lhe grant thereof shaH b~ made to HealthAu'thority. The application shall contain such particulars andshall be accompalli~d by such fees as may be prescribed.

5 Ex~125/2007

Terms and. conditions

lof' granti­.riglieences .

(2) The Health AuthQrity. if <nttsfbd that the appliclnt andthe clinic;llestablishment fulfillcondition~ specified underSection 10, shall register theapqlicant in respect of suchestablishment and shall grant a licence thereof within 45 daysftom the date of application for registration and licence. Theregistration and the license shall be valid for a period ofthree years.

(3) Th,e,:Heallh Autnorityshall rej~ct an anplicati(),n within 45days -from the. date of receipt of the applica tiOG if it is satis·fiedtha~ .

(a) The applicant or the clinical establishment does not ful·fill the conditions specified under section 10.

o ' .•

(h) There are nead-equate provisions for maintaining properbiomedical waste management under existing rules.

(c) In the case of·nursinghome other thana maternity homethat such nursing homeis notu ndtr the cha rge of a qual ifiedmedical practitioner resident therein round the clock and thatthe nursing of persons received. admitted and accommodatedtherein is not under the superintendence of a ql!alified nurseresIdent therein round.. th. clock; orI

(d) In the case of a materoity home that such maternityhome is not under the cha~ge of a qualified medical practitia·ner resident therein round the clo9k ~nd. that the attendan.ceon every woman before at, or aftercblldblrth or on any chIldborn is not und er the superintendence of a qualified MidWife

resident therein round the clock. I

(4) Where the application is rejected under sub section (3), theHealth Authority shall be record the reason for such rej.~ction'indo noapplication shall be rejected unless tbe applicant hasbeen given an opportunity of showing cause in support of his

application ..... I1O~Everylicensegrabteduncier, ·..sub·s~cti()n (2) ,of section 9 shall

be subject to the terms and conditi;onl. Dlimely;. .... ,

(a) That the clinicaLcstablishment shaU not be used forimmoral purposes.,... I ......- ... ,.-: .... _- .. ',,' .' :.'

(b) That adequatemeasurcSl1alJ betaken to keep the clinicalestablishmellt in perfectly,hygienic ~nd sanit~ry conciition.

~ .... "". ,:., ....'. ,."., I

(c).Tli~tadequate1l1e~sure shaUlbetaken to dispose of the.' .garbagesincluding .•disp(}~able syringFs•.needles, .·etc.conforming,toe~istil1gRuIesandR •• tllatiousmad.bY tb..Government ..~,-"," '-," ' ,-.". ,,-':' . -', .-':.:' ~." .' ':, .

Ex-125/2007

t·

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(d) That every person keeping or carrying on 3- clinicalestablishment shall, submit an immediate report to the HealthAuthority as soon ,as it comes to his notice tha;: ':;;y personwho has been admttted as an outdoOr or indoor pH'1'nt in theclinical establishment is suffering from or has b::~ attackedwith notifiable diseJses as specified by the Gov(,:! i; :',cnt fromtime to time ..

(e) That every clinical establishment records shad 0::: kept insuch from and report submitted to the Health A,,'jthority insuch form, in such manner and at such interv,ds~ :1:) lILay beprescribed, containiBg-

(i) The name' and other particulars of each pcr',on who isreceived, admitted or accommodated at the CIIUichi c:ic.blishment

~s an outdoor or _indoor patient.

(ii) The name of any of the pIescribed diseases for \viich suchperson is treated.'

(iii) The name and other particulars of the qualiikd medicalpractitioner who attends bim.

(iv) The amount: paid by each person admit{ed aLa treatedtowards the costs of:-

(a) boarding and lodging, if any, aad

(b) treatment;

(0) birth, death and miscarriage, if any, that takes place inthe clinical establishment during the period to which the reportrelates, and

(f) any other terms and conditions \\-hich may be f'"es~ribed.

Renewal. It. A license may be renewed from time to time on an ~;ppIicationmade to the Healt.h Authority in such form and accompaniedby such fees asinay be prescribed and every' such 'applicationhe rnade- ;' j

• t .~

(a). in caSe of nursing. home, maternity home or· Hospita;}'motless than, ninety days In advance;

(b) in case of c1.inica!laboratory. physiotherapy e;:;L blishment,thirty days in ad vance; ,

(c) in case o( any ,other. clinical establishment, not less thansix~y days in ~dvance;' ..

Provided that the' renewal off a liceasemay be r~fu .•ed if theHealth Authority is .satisfied that .••

"", J"'

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0) the licensee is not in a" position to provide the minimumfarilities pre~cribed tor the admission, treatment or care and

" dAagnost~~"Sfr~ices t~;ferein of patients, pregri~nt women; or

Oi) the licensee is Eot in a position to provide a qualifiedmedical practitioner Wi10 is qualified to takt charge of thenursing home or Ho:-,pital, mat~rnity home, clinical fabof;ttoryand, physioth~rapy establishment; Or

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(iii) the' .lice!{~ee'h~s contravened any of the provisions ofthis Act or,1 allrrtll~s 'mad~ thereunder.' ,

12...- (1) The He~tfl1,',Aht4orit~ may, ~uo moto or on complaint forany breach <?f-Jhe" pr,?v1310ns ot the, Act, the rul~s or theregulations ,by "i(P-Y" cIinica~ eStablishment', issue notice to it toS?OW cause. , wi~rlf~,;~ite;:~,~~ys a:s 'to why its registration audlIcense ShOUld not be su'Spehded or 'canceUed for the reasonsmentioned III the D;9Ppe":fl", .•,. '".,!

(2) On receipt of the' show cause ,and after gl vmg a reasOna­ble opportunity of being 'heard 'to U~e clinical establishment, ifthe Health AuthoritY' is satisfIea r-h'at there has been a breachof the proviSIOns 01 the ACt. or the rules or the regulations Itmay, without prejudice 1.0 the cnminal actIOn that l[ may takeagainst such c!imcal estaQlishmerit," suspend Its registration andlicense for sucn period as it may thmk. fit,' or cancel its regIS­tration or license, as the case may be'...

,l3. fI) Any person aggtieved by an order of tbe Health Authorityrefusing to grant or renew a license orsuspetldmg or cancel­ling a lIcense, may in such manner and Within luch period asmay be prescribed prefer an appeal to the GoyernmenI:

"Cancella­

tion or SUS-'

pension of.registrationandlicense.

Appeal

Order forclosure ofthe clInicalestablish­'ment

Provided that the Government may entertain an appealafter the eXF>iryof ,tile pre&cribed periOd if it is satisfied thatthe appellant was .prevented by suftIcient cause from preterringthe appear in time.

(2) Every appeal under sub-section (1) shall be, made in SUChtorm and be accompanieC1 by SU~l1 lee as may 'pe prescribed_

(3) Any order 'passed on appeal shall be final and shall notbe questioned in any cour~.

14. If the appeal.p~eferred under sectiOn 13 is rejected by theGOVernment In respect of any cllIilcal establIshment, the HealthAuthority shaH thereafter lssue order, for closure of the clinicalest~blishment Wl~~ the. approv.alot the ,Government and the cHill­calestabliShm~h,t 8,4",11 remamclosed for ~uch periOd till the sus­penslpn 9rder is .w:ithdrawn or ,a. 'fresb. registratIon and license 18

ira~~e4 1n re$pe~t 'of tb.atesta b~lS.atneht,. '

15•. The Government shall a ppoint' District Medical SuperintendentChief 1fedical Officer (District can~erned) as In~pecting Officer forthe purpose of inspecting the clinical .stablishmest.

Ex-l~5/20b7

Appoint­ment oflnspectingofficer andhis powerof entry.

Penalty for 16...~estab1ishm~nt,

or fv1aintenanceof Clinical Es­ta blisluuent incontraventionof the. provision

, of this Act and. the rules madethere under.

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(1) Any person who knowingly establishes or maintains acljnical establishment which is 'not duly registered and licensedunder this. Act or contravenes' the provisions of this Act orrules made thereundershalV, on conviction, be punishablewith imprisonment for a term which may extend to one yearof'yVith fine which may cxtel'1~to twenty thousandrupeesorwith both and in the case ofa second or subsequent offenceswith i'nprisonment for three years or fine which mayext'end to

fifty t~ousand rupees or with ~oth .

(2) Whoever after conviction under sub-section (1) continuesto, maintain a clinical establishment shall on conviction be

punishable with fine which. may extend to one thousand rupeesfor which the offence continues after conviction ..... ,- ,... !

I

GeneralProvisionfor punish~mem ofother offen­ces.

.J7. Any person, who contravenes any of the provision of thisAct or oLany rule or regulation, made thereunder for the contrawventi on of which nO penalty is expressly provided in this Act.shall on convictionJ be punishable with imprisonment which may..~xtel1.d.to six me>nths and with fine which may extend to tentbo:Qsand rupees~·

IT' fl"'·· b· • n•..) 'E;n.ce ...y 1.;1'.,

Companies.

Pc-nalty tor 1'8.' Any person who knowingly Serves in a clinical establishmentserving.in which)s not ..duly registered and li~ensed under tbis act or whichanun,licen- is,us~d for imm,oralpurposes shall . be guilty of an , offence andcedand·un~ sb,alL beptinishable with. fine which may extend to five hundredregistered rupees or with cancellation of his/her registration.cliniCal ..esta blis,hlllent.

(1) Where .an offence .under ., this ..Act . has .,.l?een committedby a coml?any,ev~ry person I. who, at the tiIne t,he offencewascom~ltted waslDchatge of, anti was responsIble·. tothecompally, for the c()lD;panyshallj be dee.rned to .~e guiltyo~ theoffen~e.·andshaJL.be hable to be proc~ededagaillstand punlsh~da~~ordingly .

.•.......... . Proyic:l¢d that n()tbingcohtaim~d' in .this sub-section' :shallrellderanysuch person li~bleio ailyypunishment if he proves .that the o~epce\~ asco~~~ttedl. wi~hout his knowledge .~r ..thathe hadexe~clsed all due dlbgellce topr~Yentll1'e COlllmlSSIon of.$uc.hoff'nce~ .... .1 •• ,' ,

9 Ex-l 25/200 7

(2) Notwithstanding anything contained in suh:-se.ction (1),wheN an offence under this Act has been committed \vithconsent or connivance of or is attributable to any neglect onthe part of any Director, Manager, Secretary or other Officerof the Company, such Director, Manager Secretary or othe rOfficer shall also be deemed to be guilty of the offence andshall be liable to be proceeded against accordingly.

EXPLANATION-

(a) For the purpose of this section, company means bodycorporate and Includes a firm or other association of individual;and

(b) 'Director' in relation to a firm means partner in the firm .. . . 1 ..

Court com. 20. No Court other than that of a. Magistrate of the First Classpetcnt to shall take cognizance of or try offence under this Act.·· .try .0ffence. Iunder thisAct andtd..eognizattcEtofofi'ence ••

Offence 21. All offence punishable under this IAct except Offences underunder this seetion 17 and 18 shall bscognizaole.Act except .sectiOM I'and 18t-obe· c:ognizat!!lJ.·

Savina

Creditolf,esalldfi.es.

22. Nothing contained in this Act, rules and regulations framedthereunder shall apply. to, clinical establishment, establIshed mainlyby the State Government, Central Government, Defense, Railwaysand ..Public Sector Undertaking. I

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23.(1) No suit, .prosecution or other leg~l proceeding shall liea.gaiJlst any person for anything which is in good faith· done ori~tended to be done in pursuance of this Act or any rules, rt:gula­tiions or order made thereunder.

(2). ~()suitor othel'. legal procejeding. shall lie against t,he99;ve~nmell.t ,for.a~Ydama,~e. 8ausedl orhk~ly to be. caused .foranythIng. whiCh 1S 1U gopd faIth done ur Intendedtobe donein pUfSl1ance. of this Act .or any .,rules, regulat~()ns or ordermi~~ t~.erounq.e~. '. j ' ..

. . <' ....•...........••.••..• ;......•.......••.• ·T·· ..24.l).ny . fees,re~eIVci<i ()f .fin~s paldl!nderth~8 Act andrulesfrattled ·.·thereunder .shall.be credHc4tolthe consolidated Fuud ofthe Stat".

Ex-125j20n7 10

Expenses of 25. All eXpenses incurred by the Health Au'thority under this Actthe Healtl1 and rules made thereunder shall be met out' of the Consolida-Autbority. ted Fund of the State. " '.

Submission 26.of report tothe HealthAuthority.

(1) Any person in charge of the clinical establishment shallas soon as may be after any disease which is included underthe notifiable di ')ease of the Govunment, cases of burns.poisoning or any other cases I sU,spected to; be of medicoleg~Jnature make a report of the cases to the Health Authority.

(2) Any ,person in charge~' .of the clinical esttblishment shallreport all death and birth. still birth as per the rules laiddown.

i.'.

Power tomake rules.

27. (1) The ,Gov~rnment may, make rules, for carryi,ng.,..oul thepurposes of thIs Act.

(2) In particular and without prejudice to gentral1ty';o['theforego~ng power, SUCD rules may provide for all or,a:ny' of thefollowIllg matters, namejy;- ,',,'". , '

(a) the nature or type of patients or perseA to whom 'liteclinical establishment shaH render serVices;

(b) the form in whieh-'

(i) an application may be made for grant or ren~wal ofalicense and a fee payable in respect thereof underJs'~ction'9an d 11; , ' .. - "

(ii) a license may be granted' for the health . establishmentunder section 9.

(c) the manner in whiCh ,an ord~r refusing to grant or can·ceIling a Jic~nse shaH be commullIcated under section 9, ~~, asthe case may be under section 12; . ;""', .'

(d) the manner in which a report may be made to the HealthAuthority under clause (e) of section 10;' .

(e) the minimum facilities/standard required for treatment ofpatients in the clinical establishment in~luding:

(i) Doctor-patient relation;(ii) other medical and paramedical staff eligible

dering services III the clinical est~blishMent;(iii) space requi.re~.e~t;(iv) tre~tment tacllltles; andtV) equlpmeuts

for ren-

,', :

11 Ex-l 25j2007

Power tor~move del1bts'aile fliA1cwtiu

(f) the manner in ",hich and the condition under which nur­sing home and Hospital, clinical laeoratory, physiotherapycentre shall be maintained;

(g) the form and manner in which and the period witbinwhich an aggriev~d person can appeal against tile r..:fJsal tJgrant licence or renewal of licence or rhe fee pJyab\c inrespe.;t of thereof under section 13;

(h) the form and manner in which record..; sh aU be iTaintainedunder cla use (f) of section 10;

(i) the qualification of person who ;:nay be appointed as Ins­pecting Officer and his function salary, erc.

(j) the standards of quality of air, water and pollution con·trol devices;

(k) the procedure and safeguards of handling bazardoussu bstances;

(1) the procedure to conduct tests whether Pathoicf,ical,Chemical, biologkal, radiological, bacteriological gene,ic inves·tigations and olhers;

(m) any other manner which is required to be or may beprescribed.

28. If any doubt or difficulty arifes in giving effect to tbeprovisions of tbis Act, the Government may as occasions mayrequire, by order to anything not inconsistent with tbe provi­sion of thi:; Act or tbe rules made thereund~r, which appearsnecessary for the purpose of removing doubt or difficulty.

Provided that nO order shall be issued under this sectionafter the expiry of a period of two years from the date ofcommencement of this Act.

P.Chakraborty,Secretary to the Govt. of Mizoram,

Law, Judl. & Par. Affairs,Aizawl.

Pu•••• ed and issued by the Controller, .Printing &. Stati~nefY, MizmamPl:wlW at ~ Mizonun (iovL PIty. &awL ()-;.850