The CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010

'*...,.. ~ !"'"=(~)04/0001l200l-10 REGISTERED NO. DL-{N)0-4I1U07J1Hl-JO I -- CfiT ~he ~a~ette tIC ~iQ I aHflill(Oj EXlRAORI>INARY "'" n- 'wq 1 PARI'U- Section1 iIflm<"it1f'I;lflnr PUBLISHED BY AUlHORITY ...311 -=rf~, ,fWft!i(](, ~ 19, 2010 I wttfOj 28, 1932 No. 31) NEWDELHI,THURSDAY,AUGUST19,1010ISRAVANA18,1931 '" "","411A'l'"'""'"(t-..nItt fiRIlt~ 'It....,'"""'It.."4_~'Il'ltI rea SeparatefllIIIGI is to 1mrarli. ordertUtlt RIa)' be0,.• a separwteCOIapUltloO. MIN1STRYOFLAWANDJUSTICE (LegislativeDepartJDeal) NewDelhi, the Augwt19, 2010lSravana28, 1932(Saka) The following Act of Parliament received die assent of the President OD the 18thAugust,2010,and isherebypublishedforgeneral information:- THECLINICALESTABLISHMENTS(REGISTRATIONAND REGULATION)ACT,2010 No. 23 OF 2010 [18thAUgW't,2010.] ADAettoprovidefortheregistrationandregulationofclinicalestablishmentsin I thecountryandfurmattersconnectedtherewithorincidentalthereto. WHEREAS, it is consideredexpedient10provide fortheregisUation lU'Id regulationof clinicalestablishmentswithaviewtoprescribeminimwnstandardsoffacilitiesandservices which may be provided by them so that mandate ofarticle 47 of the Constitution fot improvementinpublichealthmaybeachieved; AHoWKEREAS,ParliamenthzI:snopowertomakelawsfortheStaleSwithrespecttoany oftbemattersaforesaidexceptasprovided inarticles249and250oftheConstitution; ANDWHEREAS, inpursuanceofclause(I)ofarticle252oftheConstitution,resolutions havebeenpassedbyalltheHousesofthe LegislaturesoftheStatesofArunachal Pradesh, Himachal Pradesh, Mizoram and Sikkimto the effectthatthe matkrs aforesaid should be regulated inthoseStatesbyParliamentbylaw; 2 THE GAZETTE OF INDIA EXTRAORDINARY [PAltT11- BEitcna.ct~d byParliamenlintheSixty-flCstYearoflheRepublicoflndiaasfollows:- CHAPTER I PRELfMINARY .. Short title, I.(l)ThisActmaybecalledtheClinicalEstablishments(Registrationand'Regulation) Ipp , lil:ltion Act,201o. COhiCkllCalklll (2) Itapplies, in the first instance, to the wholeofttle StatesofArunachal Pradesh, Himachal Pradesh,MizoramandSikkimandtheUnionterritories; and itshallapplytosuch other State whicll adopts thisAct by resolution passed in that behalfunder clause (I) of article252oftbeConstitution. (3) It shall come into force at once in the States ofArunachal Pradesh, Himachal Pradesh.MizoramaJ:1dSikkimandtheUnionterritories,onsuchdateastheCentralGovernment may.byIlOtification,appointandinanyotherStatewtUchadoptsthisActunderclause(I)of article252 oftheConstitution,onthedateofsuchadoption;andanyreferenceinthisActto thecommencementofthisActshall,inrelationtoanyStateorUnionterritory,meanthedate on whichthisAetcomes intoforce insuchStateor Unionterritory: Provided that different dates may be appointed for different categories ofclinical establishmentsand for differentrecognisedsystems ofmedicine. DefiniliollS. 1. In thisAct, unlessthecontextoilierwiserequires,- (a) "authority" meansthe districtregisteringauthorityset-up under section 10; (b)"certifteate"meanscertificateofregistration issuedundersection30; (c)"clinicalestablishment" means- (l)ahospital,maternityhome,nursinghome,dispensaJy,clinic,sanatorium oraninstitutionbywhatevernamecalledthatoffersservices.facilitiesrequiring diagnosis,treaD1lelltorcareforillness,injury,deformity,abnonnalityorpregnancy inanyrecognisedsystemofmedicineestablishedandadministeredOfmaintained byanyperson or body ofpersons, whether incorporated or oot; or (it)aplaceestablishedasanindependententityorpartofanestablishment referred to in sub-clause (I), in connection with the diagnosis or treatment of diseases where pathological, bactt:riological, genetic. radiological, chemical, biological investigations Of other diagnostic or investigative services with the I aidoflaboratoryorothermedicalequipment.areusuallycarriedon,established I and administered or maintained by any person or body ofpersons, whether incorporated ornot, I andshall includeaclinical establishmentowned,controlled ormanaged by ., (a)lheGovernmentoradepartmentoflbeGovernment; • (b) atrust, whetherpublicorprivale; (c) acorporation(includingasociety)registered underaCenual.Provincialor StateAct, whetherornotowned bytheGovernment; (d) alocal authority;and (e)asingledoctor, butdoesootincludetheclinicalestablishmentsowned,controlledormanagedbytheArmed Fo=. up/analian.-For the purpose of this clause "Armed Forces" means the forces constitutedundertheArmyAct, 1950,theAirForceAct, 1950andtheNavyAct, 1957; 46 of 1950. 45 Df 1950. 62 of1957. I I I ,I SEC. I} THE GAZETTE OF INOlA EXTRAORDINARY 3 (d)ne:mergencymedicalcondition"ffiCamamedicalconditionmanifeslingitself byacutesymptomsofsufficientseverity(includingseverepain)ofsuchanaturethat the absence ofimmediate medical attention could reasonably be expected to result ;0- (I)placingthehealthoftheindividualor.withrespectto8 pregnantwomen, lhehealthoClhewomanorh~unbornchild, in seriousjeopardy; or (Ii)serious'impairmenttobodilyfunctions; or (iiI) serious dysfunction ofanyorgan orpan ofa body; (e) "National Council" meanstheNational Council for clinicalestablishments established under section 3; (j)"notificationMmeansanotificationpublishedintheOfficialGazette; (g) "prescribed" meansprescribed byrules made underthisActbytheCentral Governmentor.asthecaserna)'be,theStateGovernment; (h) "recognised system ofmedicine" means Allopathy, Yoga, Naturopathy, Ayurveda,Homoeopathy,SiddhaandUnaniSystemofmedicinesoranyothersystem ofmcdicincasmayberecognisedbytheCentraJ Government; (I)"register"meanstheregistermaintainedbytheauthority,StaleGovernment and the Central Government under seetioru 37, 38 and 39 respectively ofthis Act containingthe numberofclinicalestablishmentsregistered; (j)"registration"meanstoregisterundersectionIIandtheexpressionregistration or registered shall beconstrued accordingly, (k) "rules" means rules madeunderthisAct; (1) "Schedule" means the Schedule appended tothisAct; (m) -standards"meanstheconditionsthatthe-CentralGovernmentmayprescribe undersection 12,fortheregistrationofclinicalestablishments; (n)"StateGovernment",inrelationtoaUnionterritory,meanstheAdministrator thereofappointedunderanicle239 oftheConstitution;and (0) "toslabiJise(withitsgrammaticalvariationsandcognateexpressions)"means, with respect to an emergency medical condition specified in clause (d), to provide suchmedicaltreatmentoftheconditionasmaybenecessarytoassure,withinreasonable medical probability, tha.t no material deterioration ofthe condition is likelyto result fromorocc:urduringthetransferoftheindividualfromaclinicalestablimment. CHAP'ffiR 11 THEiNATIONAlCOUNCILFORCLINICALESTABLISHMENTS 3. (I) With effect from such date as the Central Government ma.y, by notification ESllbllshmeDt appointinthisbehalf,thereshallbeestablishedforthepurposesofthisAct,aCounciltobe of Nltional Council. calledtheNationalCouncilforc1inkalestablishments. (2)TheNationalCouncilshallconsistof- (a)Director-GeneralofHealtl1 Service,MinistryofHealthandFamilyWelfare, exofficio,whoshall betheChairperson; (b) four representativesout ofwflichone each to be ejected bythe-- (l) Dental Council of India constituted under seetion 3 ofthe Dentist3 16of PH8. Act,1948; 4 THE GAZETTE OF [NDIA EXTRAORDINARY [PARTIl- (ii) Medical Council of India constiOJled under seclion 3 ofthe (ndian MedicalCouncilACI, 1956; 102 of 19S6. (iiI) Nursing Council ofIndia constituted under section 3 ofthe Indian NursingCounciIAcl,1947; U or 1947. (ill)PharmacyCounciloflndiaconstitutedundersection3afmePharmacy Act, 1948; I of 19411. (c)threerepresentativestobeelectedbytheCentralCounciloflndianMedicine representingtheAyurveda, Siddha 8ndUnani systems ofmedicine constituted under section3oftheIndianMedicineCentralCouncilAct, 1970; 48 of 1970, (d) one representative to be elected by the Central Council ofHomoeopathy constituted undersection l oflheHomoeopathyCentral CouncilAct, 1973; 59 of 1973. (e)onerepresentativetobeelectedbytheCentralCounciloftheIndian Medical Association; ifJonerepresentativeof BureauoftlteJndianSandardsoonstiwtedWIdersection3of the BureauofIndianStandardsAct, 1986; 63 of 19B6. (g) two representatives from the Zonal Council set-up under section 15 ofthe SlalesReorganisationAct, 1956; J7 of 1956 (h) two representatives from the North·Eastern Councilset-up undersection J oftneNorth-EasternCouncilAct, 1971; 84 of 197J (Ij onerepresentative from the lineofparamedical systems excludingsystems that have been given representation underclause (b); (j)tworepresentativesfromNationalLevelConsumerGrouptobenominatedby theCentralGovernment; (k) one representative from the Associattons ofIndian Systems ofMedicines relatingtoAyurv.tda, Siddhaand Unani10benominated bytheCentralGovernment; (I)theSecrctal}'-GeneralofttleQualityCouncilofIndia,exofficio. (3) Thenominated members ofthe NationalCouncil shallhold office forthree years butshallbeeligibleforre-nominationformaximumofonemoretermofthreeyears. (4)Theelected membersoflheNationalCouncil shallholdofficeforthreeyears,but shallbeeligibleforre-election: Providedthatthepersonnominatedorelected,aslhecasemaybe,shallholdorftcefor suchperiod till heholdsappointmentoflheofficebyvirtueof.....llich he wasnominatedor electedto thecouncil. (5)ThemembersoflheNationalCouncilshallbeentitledforsuchallowancesasmay beprescribedbytheCentralGovernmenl. (6) The National Council may, subject to the previous approval of the Central Government, make bye·laws fixing a quorum and regulating its oYm procedure and the conduct ofall businessto be transacted by it (7)TheNationalCouncil shall metlat leastonce inthreemonths. (8) The National Council may constitute su1>-comminees and may appoint to such sub-<:omminee, as itdeems fit, persons, whoarenot membersoftheNationalCouncil, for such period, no1 exceedingtwoyears, fortheconsideration ofpanicularmatters. (9) The functions ofthe National Council may be exercised notwithstanding any vacancy therein. (to) The Central Government shall appoint such person to be the Secretary ofthe National Council as the Central Government may prescribe, and may provKle the Nalional COWlCiiwithsuchothersecretarialandotherstaff'astheCentmlGovernmentconsidersnecessary. Soc.IJ THE GAZETTE OF INDIAEXTRAORDINARY 5 4. A person shall be disqualified for being appointed as a member ofthe National DisqulllificuioO'l ro, Council ifhe-- Ippgifllmcnl (a)hasbeenconvicted andsentencedtoimprisonment for anoffencewhich. in as mcmbet-_ theopinionoftheCentralGovernment, involvesmoralturpitude;or (b) is an undischarged insolvent; or (e) isOfunSOLond mind and standssodeclared byacompetentcourt; or (d) has been removed or dismissed from the service ofthe Govemment or a I CorporationownedorcontrolledbytheGovernment;or (e)has.intheopinionoftheCentralGovernment,suchfinancialorotherinterest intheCouncilasislikelytoaffectprejudiciallythedischargebyhimofhisfunctionsas amember. 5.TheNationalCouncilshall- FLUlClioll1 of Naliontl (0)compileandpublishaNationalRegisterofclinicalestablishmentswithintwo Council. years from thedateofthecommencementofthisAct; (6)classifytheclinicalestablishments intodifferentcategories; (c)developtheminimumstandardsandtheirperiodicreview; (d)determinewithinaperiodoftwoyearsfrom itsestablishment,thefirstsetof standards for ensuringproper healthcare bythe clinical establishments; (e) collectthestatistics in respectofclinicIII establishments; (/)performanyotherfunction detenninedbytheCentralGovemmentfromtime totime. 6.TheNationalCouncilmayassociatewithitselfanypersonorbodywhoseassistance POwel 10 SoeC'k oradvice it maydesire incarryingoutanyoftheprovisions ofthisAct. advice or assistanec. 7.TheNationalCouncilshallfollowaconsultativeprocessfordetenniningthestandards Nlliol\l:l andforclassificationofclinicalestablishmentsinaccordancewithsuchprocedureasmaybe CoUDCill0 follow prescribed. consultAtive process. CHAPTER ill REGlsTR....nON....NDSTANDARDSFORCLINICAL ESTABLISHMENTS 8.(I)EverySweGovernmentshallbynotificationconstituteaStateCouncilforclinical S~e Council establishmentsortheUniontenitofyCouncilforclintca!establishments,asthecasemaybe. ofcliniu.1 establishments. (2)TheStateCouncilortheUnionterritoryCouncil,asthecasemaybe,shallconsist oftbefollowingmembers,.namely:- (0) Secretary.Healtt~- exoffICio. whoshallbetheChairman; (b)DirectorofHealthServices- exofficiomember-secretary; (c) DireCfOfS ofdifferent streams ofIndian Systems ofMcdicin~officio members; (d) onerepresentativeeach to beelected bytheexecutivecommitteeof (I)StateMedicalCounciloflndia; (ii)StateDentalCouncilofIndia; (iii) StateNursingCouncilofIndia; (i\I)StatePharmacyCouncilofIndia; 6 THE GAZETTE OF {NOlA EXTRAORDINARY [PARr11- (e) threerepresentativesto beelecled bythe Executiveofthe StateCouocil or the Union territoryCouncil, asthe case may be, ofIndian Medicine representingthe Ayurveda, Siddhaand Unani systemsofmedicine; (/)one representative to beel~tedbytheState Councilofthe Indian Medical Association; (g)onerepresentativefrom the lineofparamedical systems; (h) twO representatives from State level consumer groups or reputed non Governmentalorganisationsworkinginthe field afhealth. (3)ThenominatedmemberoftheStateCouncilortheUnionterritoryCouncil,asthe case:maybe.shallholdofficeforateonofthreeyears.butshallbeeligibleforre-nomination for maximumofonemoretermofthreeyears. (4)TheelectedmembersoftheStateCouncilortheUnionterritoryCouncil,asthecase maybe,shallholdofficeforthreeyears,butshallbeeligibleforre-election: Providedthatthepersonnominated Orelected,asthecasemaybe,shallholdofficefar so long ashe holds the appointment oftheoffice by vinue ofwhich he was nominated or elected10the StateCoun\;ilorthe UnionterritoryCouncil, asthecasemaybe. (.5)TheStateCouncilortheUnionterritoryCouncilshallperfonnthefollowingfunctions, namely:- (0) compilingand updatingtheState Registers ofclinicalestablishment; (b) sending monthly returns for updatingtheNational Register; (e) representingtheState in theNationalCouncil; (d) hearing ofappeals against theorders ofthe authority; and (e) publication on annual basis a report on the state of implementation of standards within their respective States. Providing 9. It shall be the responsibility ofthe State Council for clinical establishments to information compile and update the State Registerofclinical establishments ofIhe State and funher to to National Council. sendmonthlyreturns indigital formal for updatingtheNational Register. Authority (or 10.(/)TheStateGovernmentshall,bynotification.set-upanauthoritytobecalledthe re~i>!ration. districtregisteringauthorityforeachdistrictfor registr<uionofclinical establishments,with thefollowingmembers,namely:- (a) DistrietCollector Chairperson; (b)DistrictHealthOfficer Convenor; (c)threememberswithsuchqualificationsandonsuchtermsandconditionsas maybeprescribedbytheCentralGovernment. (1) Notwithstanding anything contained in sub-~ction (I), for the purposes of provisionalregistrationofclinicalestablishmentsundersection t4,theDistrictHealthOfficer or the ChiefMedical Officer (by whatever name called) shall exercise the powers ofthe authorityas perprocedurethatmaybe prescribed. Registration II. No person shall run aclinical establishment unless it has been dulyregis!ered in for clinical accordance with the provisions ofthis Act. cslllbli;hmenlS. CClldilion for 12,(I) Forregistration and continuation, everyclinical establishment shall fulfil the registration. followingconditions,namely:- (I) theminimumstandardsoffacilitiesand~rvicesasmaybeprescribed: SEC. I] THE GAZETrE OF INOlA EXTRAORDINARY 7 (il) theminimumrequirementofperwnnelasmaybeprescribed; (iii)provisionsfor maintenanceofrecordsandreportingasmaybeprescribed; (iv)suchothercondilionsas maybe prescribed. (2)Theclinicalestablishmentshall undertaketoprovidewithinthestaffandfacilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition ofany individual who comes or is brought to such clinical establishment. 13.(J)Clinicalestablishmentofdifferentsystemsshallbeclassifiedintosuchcategories. Clas.sificalion asmaybeprescribedbythoCentralGovernment.fromtimetotime. ofelinical establishments, (]) Different standards may be prescribed for classification ofdifferent categories referredto in sub-section(1): Provided that in prescribing the standards for clinical establishments. the Central Governmentshall have regard 10the local conditions. CHAPTER IV PROCEOUREFOR REGISTRATION U.(1) Forthepurposesofregistrationoftheclinicalestablishmentundersection 10, Application anapplicationintheprescribed proformaalongwiththeprescribedfee shall bemadetothe for provisional ee:nificale: of authority. n:gisl'atioll. (2)Theapplicationshall befiled in personorbypostoronline. (3) The application shall be made in such form and shall be accompanied by such details.asmaybeprescribed underthisActorrulesmadethereunder. (4)Ifanyclinicalestablishmentisinexistenceauhetimeofthecommencementofthis Act, an application for its registration shall be made within one year from the date ofthe commencement ofthisAct and a clinical establishment which comes into existence after commencement ofthis Act, shall apply for permanent registration within a period ofsix months from the dateofits establishment. (5)Ifanyclinicalestablishment isalreadyregisteredunderanyexistinglawrequiring registrationofsuch establishments, eventhen itshallapplyfor registrationasreferredto in sub-section (1). 15.The authority shall, within aperiod often days from the date ofreceipt ofsuch Provisional appltcation. granl 10 theapplicantacertificateofprovisional registration insuchform and ce:rtificate:. containingsuch particularsandsuch mformation, asmaybeprescribed. 16.(1)The authorityshall notconduct any inquirypriorto the grantofprovisional No ioquiry prrof to registration. provisional (2)Notwithstandingthegrantoftheprovisionalcertificateofregistration,theauthority re:gistration. shall,withinaperiodofforty-fivedaysfromthegrantofprovisionalregistration,causetobe publishedinsuchmanner,asmaybeprescribed,allparticularsoftheclinicalestablishment soregisteRd provisionally. 17.Subjecttotheprovisionsofsection23,everyprovisionalregistrationshallbevalid Validfry of tothelastdayofthetwelfthmonlhfromthedaleofissueofthecertificateofregistrationand provisional re:l;isITllion. such registration shallberenewable. 18. The certificate shall be kept affixed in a conspicuous place in the clinical DispIIY of establishment in such manner so asto be visible to every one visiting such establishment. ce:rtifieale: of re:gislration 19.incasethecertificaleis lost,destroyed, mutilatedordamaged,theauthorityshall Duplicate: issueaduplicatecertificateontherequestoftheclinicalestablishmentandonthepayment ec:n,ficalc. ofsuch fees as may beprescribed. 8 THEGAZETTE OF INDIA EXTRAORDINARY [PART1I- Ccnifkalc 10 20. (/)Theceniricaleofregisl1"ation shall benon-rransferable. be non lunsfe:rabJe. (2) 10 the event ofchange ofo"l1ership or management, the clinical escablishment shall inform the authorityofsuch change in suchmanner as maybe prescribed. (3) In the eveO! ofchange ofcategory. or location, or on ceasing to function as a clinicalestablishment.thecertificateofregistrati9n inresj>t:ctofsuchclinicalestablishmenl shall be surrendered to the authority and the clinical establishment shall apply afresh for granlofcertificateofregistralion. Publica.ion of 21. The authority shall cause to be published within such timt and in such e:lIpiry of manner,asmay beprescribtd, the namesofclinical estabIishmentswhose registration rcgis;tr'liun. hasexpired. Renewal of 22. The application for renewal ofregistration shall be made thirty days before the regISlr.lioll.. expiryofthevalidityofthecertificateofprovisionalregistrationand,incasetheapplication forrenewal ismadeafterIheexpiryoftheprovisional registration,theauthorityshall allow renewal ofregislration on paymentofsuch enhanced fees. as may be prescribed. Time: IImll 23.WheretheclinicalestablishmentsinrespectofwhichstandardshavebeennOlified r" bytheCentralGovernment,provisionalregistrationshallnotbegrantedorrenewedbeyond.- provision.l rcgiuration. (I)theperiodoftwoyearsfromthedateofnotificationoflhestandardsincaseof clinicalestablishmentswhichcameintoexistencebeforethecommencemenlofd1isAct; (ii) the period oftwo years from the dale ofnOlification ofthe sta.,dards for cliniealestablishmentswhichcomeintoexistenceafterthecommencementofthisAct but before Ihe no~ifieation ofthe standards; and (iii)theperiodoFsixmOllthsfromthedateofootificationofstandardsforclinical establishments whichcome intoexislence afterstandardshave been notified. Application 24. Applicationforpermanentregistrationbyaclinicalestablishmentshallbemadeto r., theauthorily in such form and beaccompanied bysuch fees. asmaybe prescribed. pClmllntnl regiSll.Hon. VerifiClllon of 25. The clinical establishmenl shall submit evidence ofhaving complied with the .pplitllion. prescribedminimumstandards insuch manner,asmaybeprescribed. Display of 1.6. As soon as the c1incial establishment submits the required evidence ofhaving ioformlllion oomplied with the prescribedminimum standards,the authorityshall causetobedisplayed for filing for informationorlhepublicatlargeandforfilingobjections, ifany.insuchmanner,asmay objection!. beprescribed,allevidencesubmittedbytheclinicalestablishmentofhavingcompliedwith theprescribed minimumstandardsfora period ofthirtydaysbeforeprocessingfor grantof perm::menlregistralion. C_~ion 27. Ifobjections are received within the period referred to inthe precedingsection. ofobjC:Cliclls. such objeclions shall be communicated to the clinical establishment for respome within a period offorty-fivedays. Standards (or 28. Permanentregistrationshallbegranted onlywhenac1inic:!1 establishment fulfils pClml\nenl the prescribed standards for registration bytheCentral Government. rcgiUralion. Allowinll or 29. The authority shall pass an order immediately after the expiry ofthe prescribed dISallowing of periodand withinth.:- next thinydaysthereaftereither-- rCr;iSlrillOn (0)allowingthe-application forpermanentregistration;or (b)disallowingtheapplication: Provided that theauthorirvshall record itsreasons. jfit disallowsan application, for permanent registration. SEC. I] mE GAZETTE OF INDIA EXTRAORDINARY 9 30. (1) The authority shall, ifii, allows an application ofthe clinical establishment, Cerrificale (If issueacertificateofpermanentregistrationinsuchform andcontainingsuchparticular!>,as pc'mancnt fcgislralion. maybeprescribed. (1)Thecertificateshallbevalid fora periodoftiveyears fromthedateofissue. me (3) for purposesofsub-section(I), theprovisionsofseclions 18, 19,20 and 21 shallalsoapply. (4)Theapplicalions for renewal ofpermanem regislnition shall be made within six months before the expiry ofthe validity ofthe certificate ofpennanent registralion and, incasetheapplicationofrenewal isnotsubmittedwithintheslipulatedperiod,theauthority mayallowrenewalofregistrationonpaymentofsuchenhancedfeesandpenaltiesasmaybe prCS'::ribed. 31. The disallowing ofan application for permanent registration shall not debar a Frcsll clinicalestablishmentfrom applyingafreshfor permanentregistrationundersection24and application after providing such evidence, as may be required, ofhaving rectified the deficienccs on for permanenl rctiuraliCln. whichgroundstheearlierapplicationwasdisallowed. 31.(1)If,atanytimeafteranyclinicalestablishmenthasbeenregisltred,theauthority Ca"CClblion of is satisfied that,- n::!islration. (a) theconditionsoftheregistration arenotbeingcompliedwith;or (b) thepersonentrustedwiththemanagementoftheclinicalestablishment has beenconvictedofan offencepunishable underthisAct, itmayissueanOlicetotheclinicalestablishmenttoshowcausewithinIhreemonths'timeas (0whyitsregistrationunderchisAclshouldnotbecancelledforIhereasons10bemenlioned inthenotice. (2)Ifaftergivingareasonableopportunity10theclinicalestablismeot,theauthorityis satisfied thatthere has beena breachofanyofthe provisionsofthisActOftherulesmade thereunder, itmay,byanorder.withoutprejudicetoanyotheractionthatitmaytakeagainst such clinical establishment, cancel its registration. (3)Everyordermadeundersub-section(2)shalltakeeffect- (a) where no appeal has beenpreferred againstsuch order immediately onthe expiryoflhe periodprescribed for suchappeal; Ilnd (b) where such appeal has been preferred and it has been dismissed from the dateoftheorderofsuch dismissal: Providedthattheauthority,aftercancellationofregistrationforreasonstoberecorded in writing, may restrain immediatelythe clinical establishment from carrying on ifthere is imminentdangerto thehealthand safety ofpatients. 33. (I) The authority or an officer authorised by it shall have Ihe right to cause an Inspection of inspection of, or inquiry in respect ofany regislered clinical establishment, its building, rc&istercd clinical laboratories and equipment and also ofthe work conducted or done by the clinical cstablisllmcnts. establishment, to be made by such multi-member inspei:tion team as it may direcl and to cause an inquiry to be made in respect ofany other matter connected wilh the clinical establishment and that establishment shall be entitled to be representedthereat. (1) The authorityshall communicate10 the clinical establishmenf theviews ofthat authoritywithreferenet;totheresullSofsuchinspectionorinquiryandmay,afterascertaining theopinionofIheclinicalestablishmentthereon.advisethatestablishmentupon theaction 10be laken. (3)Theclinicalestablishmentshallreporttotheauthority,theaction, ifany, which is proposed to be taken or has been taken upon the results ofsuch iospt(:tion or inquiry and suchreponshall be furnished within suchtime. astheauthority maydirect. (.f)Wheretheclinicalestablishmentdoesnot, withinareasonablelime,takeactionto the satisfaction ofthe authority, it may, after considering any explanation furnished or • 10 THE GAZETTE OF iNDIA EXTRAORDINARY [P.'\RT11- representation made bytheclinical establishment, issue suchdirectionswithin suchtimeas indicated in the direclion, as thai aUlhority deems fit. and the dinical establishment shall cumply with suchdirections. I'ower ((J 34. The authority or an officerauthorised by it may, ifthere is anyreason to suspect eAlcr. thaianyone iscarryingona c1iJ;lical eSlablishment without registration. enter and search in the manner prescribed, at any reasonable time and the clinical establishmt=nt, shall offer reasonablefacilities for inspection orinquiryand beentitled toberepresented thereat: Provided that no such person shall enter the clinical establishment without giving notice ofhis intention 10do so_ lev)' of fee 35. The State Government may charge fees for different categories of clinical by Slate establishments, as may be prescribed. (Jo\'crnmenl Ap~~l. 36.(1)Anyperson,aggrievedbyanorderoftheregisteringauthorityrefusingtogrant or renew a certificate ofregistration or revoking a cenificate ofregistralion may. in such mannerand within suchperiodasmaybeprescribed,preferan appeal to the StateCouncil: ProvidedthattheStateCouncilmayentertainanappealpreferredafterIheexpiryofthe prescribed period ifil issatisfied Ihallhcappellant wasprevented bysufficientcause from preferringlheappealintime. (2)Everyappealundersub-section(I)shallbemadeinsuchformandbeaccompanied bysuch fee asmaybe prescribed. CHAPTER V REGISTEROfCLlNlCALESTABLtSl-8.IE!'lTS ReliMerof 37.(I)Theauthorityshallwithinaperiodoftwoyearsfrom itsestablishment,compile. d.nical publish and maintain in digital format a register ofclinical establishments, registered by it esubHs~tS_ and ilshallenterIhepanicularsoflhecertificateso issued ina registerto bemaintained in such form andmanner. asmaybe prescribed bytheStateGovernment. (2)Each authoril)'. inCludinganyotherauthoritySCi-UpforIheregislrationofclinical establishmentsunderanyother law for Ihetimebeingin force, shall supplyindigital format tothe State Councilofclinicalestablishmentsa copyofeveryentrymade inthe registerof clinicalestablishmentsinsuchmanner,asmaybeprescribedtoensurethattheStateRegister is constantly up-to-date with the registers maintained by Ihe registering authority in the Stare. MaIntenance 38.(1)EveryStaleGovernmentshallmaintain indigitalandinsuchformandcontaining ofSlalc suchpaniculars.asmaybeprescribedbytheCenualGovernmentaregisterCobeknownasthe Register of StateRegisterofc/inicalestablishments10respectofclinical establishmentsofthatState. clinical establishmc.nt~, (2)EveryStateGovernmentshallsupplyindigitalfonnattotheCentralGovernment,a copyoftheSlateRegisterofclinicaleslablisltmt:ntsandshall infonnIheCentralGovernment all additions to and other amendments in such register made, for aparticular month bythe 15thdayofthe following month. Mainlenance 39.TheCentralGovernmentshallmaintainindigitalformatanAlllndiaRegistertobe ofNation.' calledastheNationalRegisterofclinicalestablishmentsthatshallbeanamalgamoftheState Rtj,islcc of ,hnical RegisterofclinicalestablishmentsmaintainedbylheStateGovernmentsandshallcausethe estahllshments sametobe published in digilal format. CHAPTER VI PESALTIES 40. Whoever contravenes any provision ofthisAct shall. ifno penalty is provided elsewhere. be punishable for Ihe first offence with fine which mayextend10 len thousand SEC. IJ mEGAZElTE OF INDIA EXTRAORDINARY " rupees, for anysecond offencewith fine which mayextendto fiftythousand rupees and for an)'subsequent offencewith fine whichmayelCtend10five takh rupees. 41.(1) Whoevercarnesonaclinicalestablishment....titholl!registrationshall,on first Munc:tll.l)· penalty fUl contravention, be liable to a monetary penalty up to fifty thousand rupees, for second nOli contravention with a monetary penalty which may extend 10 twO lakh rupees rc:gistrUion. and for any subsequent contravention With a monetary penalty which may extend to five lakhrupees. (2)Whoeverknowinglyservesinaclinicalestablishmentwhich isnOIdulyregistered under this ACI. shall be liable to a monetary penalty which may extend to twenty-five thousand rupees_ (3) For thepurpose ofadjudging under sub-sections (I) and (1), the authority shaH hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportuni[y ofbeing heard for the purpose ofimposinganymonetarypenalty. (4) While holdingan inquiry the authorityshall have powerto summon and enforce the anendance ofany person acquainted with the facts and circumstances ofthe case to givc= evidc=nce or to produce any document which in the opinion ofIhe authority, may be usefulfororrelevanltothesubjectmaneroftheinquiryandif,onsuch inquiry, ilissatisfied thatthepersonhasfailed tocomplywiththeprovisionsspecifiedinsub-sections(I)and(2), iImaybyorderimposethemonetarypenaltyspecified inthosesub-sectionstobedeposited withinthirtydaysoftheorder inthe account referredto insub-section(8)ofsection42. (5) While decenniningthe quantumofmonetarypenalty. the authorityshall take into accountthecategory,sizeandtypeoftheclinicalestablishmentand localcondilionsofthe area in which theestablishment issituated. (6)Anypersonaggrieved bythedecisionoftheauthoritymaypreferanappeal tothe StueCouncilwithina periodoflhreemonlhsITomthedateofthesaiddecision. (7)Themanneroffiling Iheappealreferredtoinsub--section(6)shallbesuchasmay beprescribed. 42. (I) Whoever wilfully disobeys any direction lawfully given by any person or Disobtdic:n~ authority empowered undc=r this Act to give such direction, or obstructs any person or ofdirectioll. obstruction authority in Ihe discharge ofany functions which such person or authority is required or and refusal of empowered underthisAct to discharge, shall be liable to a monetary penalty which may informahon. extendtofive lakhrupees. (1) Whoever being required byorunder IhisAct to supply any infonnation wilfully withholds such infonnation or gives information which he knows to be false or which he doesnotbelievetobeU'Ue,shall be liabletoa mone1al')'penaltywhich mayextendto five 1akhrupees. (3) For the purpose ofadjudging under sub-sections (1) and (2), the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportunity ofbeing heard for the purpose ofimposinganymonetarypenalty. (4) Whileholdingan inquirythe authorityshall have powertosummon and enforce the attendance ofany person acquainted with the facts and circumstances ofthe case to give evidence or to produce any document which in the opinion ofIlle authority, may be usefulfororrelevanttothesubjectmaileroftheinquiryandif,onsuchinquiry,itissatisfied thatthepersonhasfailedtocomplywiththeprovisionsspecified insub-sections(I)and(2), itmaybyorderimposethemoMtarypenaltyspecifiedinthosesub-sectionstobedeposited withinthirtydaysofthe orderin theaccountreferredto in sub-section (8). (5) Whiledeterminingthe quanrumofmonetarypenalty,the authority shalltake into accountthecategory,size and typeofthedinicalestablishmentand local condi1ionsofthe area inwhich the establishment is situated. • \2 THE GAZEn'E OF INDIA EXTRAORDNARY (PAlI:T11- (6)Anypersonaggrieved by thedecisionoftheaUlhoritymaypreferanappeal tothe State Councilwithinaperiodofthreemonths from thedaleofthesaiddecision. (7)Themanneraflilingtheappeal referredto insub-seelion(6)shall besuch asmay be prescribed. (8) The monetary penalty levied underseclions 41 and 42 shall be credited to such accountas theState Government maybyorderspedfy inthisbehalf. I'clI.lly fo, 43. Whoever contravenes any provision of this Act or any rule made thereunder minor resulting in deficiencit:S that do not pose any imminent danger to the health and safety of ddiciend~. anypatientandcanberectifiedwithinareasonabletime,shallbepunishablewithfinewhich may ex.tend to ten thousand rupees. Conlr.vention 44. (J) Whereaperson comminingcontraventionofanyoftheprovisionsofthisAct by compuies. orofanyrulemadethereunderisacompany,everypersonwho.atthetimethecontravention wascommitted,wasinchargeof,andwasresponsibletothecompanyfortheconductofthe business ofthe company, as well as the company, shall be deemed to be guilty of the contraventionandshallbe liableto finc; Provided that nothing contained in this sub-section shall render any such person liable to any punishment ifhe proves that the contravention was committed without his knowledge or that he had exercised all due diligence to prevent the commission ofsuch contravention. (2) Notwithstanding anythingcontainedinsub-section(l), where a contraventionof any ofthe provisions ofthisAct or ofany rule made thereunderhas been commined bya company and il is proved that the contravention has tak.en place with the consent or connivanceof,orisanributabletoanyneglectonthe·partof,Mydirector,manager,secretary orotherofficerofthecompany,suchdirector.manager,secretaryorotherofficershallalsobe deemed tobeguiltyofthatcontravention andshallbe liableto fine. Exp/anmion,-For the purpose oflhis seaion,- (a)"company"meansIIbodycorporateand includesa Iirmorotherassociation ofindividual.;;; and (b)"director", inrelationtoa firm.meansapannerinthefirm. OlTeJtCC$ by 45. (I) Where an offence under this Act has been committed by anyDepartment of Gove'nmerll Governmentwithinaperiodofsi"monthsafterthecommencementofthisAct,the Headof DeparlmeJlI~ theDepartmentshallbedeemedtobeguiltyoftheoffenceandshallbeliabletobeproceeded against and punished accordingly: ProvidedthatnothingcoJntainedinthissectionshallrendersuchHeadaftheDepartment liabletoanypunishmentifheprovesthattheoffencewascommittedwithouthisknowledge orthaiheexercisedallduediligenceto preventthecommissionofsuch offence. (2) Notwithstanding anything contained in sub-section (f), where an offence under this Act has been committed by a Department ofGovernment 3nd il is proved that Ihe offence has been committed with the consent or connivance of, or is attributable to any neglectonthepartof,:myofficer,olherIhanthe Headafthe Department,suchofficershall also bedeeme<j to i)eguiltyOflhiltoffence and shall be liable to be proceeded againstand punished accord:ngly. Recover)' of 46. Whoever fails to pay lh~ fine, the State Council ofclinical establishment may fillc prepareacertificatesigned by:mufficer authorisedby itspecifyingthe fine duc from such personand send it 10the Collectorofthe District inv.ttich such person owns any property or resides orcarries on tlis business and Ihe said Collector, on receipt ofsuch certificate, shallproceed to recoverfrom such prrsontheamountspecified thereunder, as ifil were an arrearoflandrevenue. - ...:-..... 1 SEC.1J THE GAZETTE OF INDiAEXTRAORDINARY 1l CHAPTER VU MISCEI,.\"ANEOL:S 47. (J)Nosuit, prosecutionorother '.egal proceedings shall lie againstanyauthority Pfoltclion or or any member ofthe National Councilor State Council or anyofficer authorised in this lCf;on liken in good faiL"_ behalfinrespectofanything,whichisingoodfaithdoneorintendedtobedoneinpursuance oftheprovisionsofthisActorany rulemadethereunder. (l) No suit or other legal proceedings shall lie against a State Government or the Central Government in respect ofany loss or damage caused or likely to be caused by anythingwhich is ingood failh doneor intended tobedone inpursuanceoftheprovisions orthisActoranyrotemadethereunder. 48. Everyclinicalestablishmentshall,withinsuchtimeorwithinsuchextendedtime, Furnishing of as may be prescribed in that behalf. furnish to the authority or the State Councilor the K!ums. elc. NationalCouncilsuchreturnsorthestatisticsandotherinformation insuchmanner,asmay beprescribedbytheStaleGovernment.fromlimetotime. 49. WithoutprejudicetotheforegoingprovisionsofthisAct.theauthorityshall have Power 10 Sive the power to issue such directions, including furnishing returns, statislics and other directiol'ls. informationfortheproperfunctioningofclinicalestablishmentsandsuchdirectionsshallbe bindinc· SO.Every-employeeoftileauthority,theNationalCouncilandtheStateCouncilshall Employees of bedc=c=mc=dto.whenactingorpurportingtoactinpursuanceofanyoftheprovisionsofthis the authority. ·n or 1160. Act.bepublicservantswithinthemeaningofsection21 oftileIndianPenalCode. I:Ic.• 10 be public servanu. SI.(1)Ifanydifficultyarises ingivingeffecttotheprovisionsofthisAct,theCentral Pov.er to Government may, by order published in the Official Gazette. make such provisions not remove difficulties. inconsistentwiththeprovisionsOflhisActasmayappearto ittobenecessaryorexpedient forremovalofthedifficulty: Providedthatnosuchordershallbemadeaftertheexpiryofaperiodoftwoyearsfrom thedateofcommencementofthisAct. (l)Everyordermadeunderthissectionshall,assoonasmaybeafteritismade,belaid beforeeachHomeofPuliament. 52.{I}TheCentralGovernmentmay,bynotification.makerulesforcanyingoutallor Po\tol;r of any oftheprovisions ofthisAct. Cenlral Government (2) Inparticularandwithout prejudicetothegeneralityofthe foregoing power. such to mllke rilles. rulesmayprovideforalloranyofthefollowingmatters.namely:- {a}allowancesforthemembersoFtheNationalCouncilundersub-section{5}of section 3; {b} appointmentofsuchpersontobethe Secretaryofthe State Council bythe CentralGovernmentundersub-section(10)ofsection3; (c)thedeterminationofSlandardsandforclassificationofclinicalestablishments underseclion 7; (d)thequalifICationandthetermsandconditionsforthemembersoftheauthority underclause(e) ofsub-section (I) ofsection 10; {e} theprocedureunderwhichthepowersoftheauthoritymaybeexercisedby the District Health Officer or ChiefMedical Officer for the purpose ofprovisional registration ofclinical establishmentundersub-section(2) ofsection 10; -~--'---~~-'-=--"==.~~~~- 14 THE GAZETTE OF INDIA EXTRAORDINARY {PART1I- (f) the minimum slandards of facilities and services under clause (I) of sub· section (I)ofsection 12; (g) the minimum number ofpersonnel under clause (il) ofsub-seclion (1) of section 12; (h) themainlenanceofrecordsandreportingbytheclinicalestablishmenlunder clause(iii) ofsub·seclion(1) ofsection 12; (I) olher conditions for registration and continuation ofclinical establishment underclause(iv)ofsub-section(I) ofsection 12; (;1classification ofclinicaleSlablishmentundersuh-section(1)ofsection 13; (k) the different standards fOf classification of clinical establishments under sub-seclion(2)ofsection 13; (I) the minimum standards for permanent registration undersection28; (m) the form and paniculars to be contained in the register to be maintained undersection38. LayUlgofrules 53. EveryrulemadebytheCentralGovernmentunderthisActshaHbe laid,assoonas maybe after it is made, before each House ofParliamenl, while it is in session, for a total period oflhirtyd3YS which maybecompri~in one sessionor in two or moresucce"5ive sessions and if, before the expiry ofIhe session immediately following the session or the successivesessionsafOlesald, bOlh Housesagree inmakinganymodification in theruleor bothHousesagreeIhattheruleshouldnolbemade,lheruleshallthereafterhaveeffectonly in such modified form or be ofno eflect, as (he case may be; so, however, that any such modificationorannulmenlshallbe Wilhoul prejudice10thevalidityofanythingpreviously done underthairule. Power or Slale 54. (l) The State Government may. by notification, make rules for carrying OUI in Goyernment 10 respectofmatteeswhichdonot railwithin thepurviewofsection52. ml~C rule$ (1) In panicularand without prejudicetothegeneralityofthe foregoing power,such rulesmayprovide foralloranyofthefollowingmatters, namely:- (a) theproformaandthe fee10bepaid rorregistrationundersub-section (I) of section 14; (b) the form and detailsofapplication undersub-section(J)ofsection 14; (e) the particulars and information conlained in certificate of provisional registrationunder section 15; (4) !he manner ofpublication ofall particulars ofthe clinical establishments proposed 10 be registered undersub-section (2}ofsection 16; k) the fees tobepaid to issue a duplicatecenificate under section 19; (j) the change ofownership or managemenl 10 be informed by the clinical e1\tablishment to theamhority undersub-seclion (2) ofsection 20; (g) the manner in which the authority shall publish the names ofthe clinical eSlablishments whose registration expired under !K'Ction 21; th)the enhanced fees 10 be charged for renewal after expiryofthe provi~ional registration under section 22; (I)the form oflheapplication and fees \0 becharged bythe State Government under section 24; V) the manner ofsubmining evidence ofthe clinical establishments having compliedWilhtheminimumstandardsundersection25; SEC.II THE GAZETTE OF INDIA EXTRAORDLNARY 1S (*> the manner ofdisplaying information ofthe clinical establishments having compliedwiththeminimumstandardsfor filing objectionundersection26; (f)theexpiryofperiodspecified insection29; (m)the fonn and particularsofthecertificateofregistrationundersection30; (n) the period within which an appeal shall be preferred under clause (a) of sub-swion (1)ofscction 32; (0) themannerofentryandsearchofclinicalestablishmentundersection34; (P) the fees to be charged by the State Govemment for different categories of clinical establishments undersection 35; (q) the manner and the period within which l\n appeal maybe preferred to the StateCouncil undersub-section(J) ofsection 36; (r)thefonnandtherectobepaidforanappealunders.ub-section(2)ofsection36; ($) the form and the manner in which the register to be maintained under sub-section(l)ofsttlioo 37; (I)themannerofsupplytotheStateCouncil indigital formal theentrymadein the registerofclinical establishmentundersub-section (2) ofsectionJ7; (u) the mannerofholding an inquiry bythe authorityundersub-section (3) of sections 41 and42; (v) themanneroffilingtheappealundersub-section(7)ofsections41 and42; (w) the mannerand the time withinwhichthe information isto be furnished to the authorityorthe State CouncilortheNational Council as the casemaybe, under section 48; (x) anyother maner which is required to beor maybe prescribed bythe State Government. 55. EveryrulemadebytheStateGovernmentunderthissection shall be laid,assoon Laying of asmaybeafteritismade,beforeeachHouseoftheStateLegislaturewhere itconsistsoftwo I1lks. Houses. or where such Legislature comists ofone House, before thai House. 56.(I) TheprovisionsoflhisActshallnotapplytotheStatesinwhichtheenaClments s..viJ'lgs. specifiedintheScheduleareapplicable: Provided that the States in which the enactments ~ferredto in sub-section (I) are applicable. and such States subsequent to thecommencementofthisAct, adopts thisAct Wlderclause(I)ofarticle252oftheConslitution,theprovisionsofthisActshall,subsequent to such adoption, apply in that State. (2) The Central Government may, as and when consider necessary, by notification amendthe Schedule. 16 THE GAZEITE OF INDIA EXTRAORDrNARY [PartII-Sec. I] THFSCHEDULE [Seesection56] r 1. The Andhra Pradesh Private Medical Care Establishments (Registl1ltion and • Regulation)Act.2002. I • 2.TheBombayNursingHomes RegistrationAcl..,1949. 3.TheDelhiNursingHomesRegistrationAct.1953. 4. The Madhya Pradesh Upcharya Orilia Tatha Rujopchar Sanbabdu Sthapamaue (RagistrikaranTat~aAnugyapan)Adhiniyam, 1973. 5.TheManipurHomesandClinicsRegistrationAct, 1992. 6.TheNagaland HealthCareEstablishmentsAct, 1997. 7.TheOrissaClinicalEstablishments(ControlandRegulation)Act, 1990. 8.ThePunjabStateNursingHomeRegistrationAct, 1991. 9.TheWestBengalClinicalEstablishmentsAcl,1950. V.K. BHASIN. Sec)!. totheGovt. ofIndia. 1 I'JtINTEDBYTHE GEHERAl.MA.'1AGER.GOVT.OFL~DlAPR£SS,MMOROAD,~DElHI AHD PlillllSllEOBY'!HECQNTIt.Ou.£R OfP\JBLlc"nom.OElHI-2010.