Clinical Establishment Rules - Bokaro

Clinical Establishments (Registration and Regulation) Rules, 2010Draft Model Rules for StatesThese rules may be called the Name of the State Government Clinical Establishments (Registration andRegulation) Rules, 2010These rules extend to the whole of the Name of the State Government and are applicable to all the ClinicalEstablishments in the State of Name of the State GovernmentThese Rules shall come into force on the date of their publication in the Name of the State GovernmentOfficial Gazette.The Rules shall be applicable to various categories of clinical establishments in a phased manner, as maybe notified from time to time.The State / Union Territory Council for Clinical EstablishmentsEstablishment of State Council for Clinical EstablishmentsEvery State Government shall by notification constitute y State Council / Union Territory Council forclinical establishments, as the case may be.Functions of the State/ Union Territory Council:The Slate Council or the Union Territory Council shall perform the following functions, namely:—a. compiling and updating the State / Union Territory Registers of clinical establishment;b. sending monthly returns for updating the National Register (including in the digital format);c. representing the State / Union Territory in the National Council;d. hearing of appeals against the orders of the authority;e. publication on annual basis a report on the state of implementation of standards within theirrespective States and Union Territoriesf. monitor the implementation of the provisions of the Act and rules in the State;g. recommend to the Government, any modifications required in the rules in accordancewith changes in technology or social conditions;h perform any other function as may be outlined by the National council of ClinicalEstablishmentsI Any other function as may be prescribed by the Central Government.Sub-CommitteesThe State Council may at any time constitute a sub-committee consisting of any number of its member, for suchperiod, not exceeding two years, for the consideration of particular matters, at the request of the NationalCouncil and / or as determined by the Central Government.A motion for the appointment of a sub-committee shall define the functions of the subcommittee, number of themember to be appointed thereon and timeline for completion of tasks. The Chairman of every such committeeshall be appointed by the State / Union Territory Council at the time of the appointment of the committee.Any decisions taken by the sub-committee/s shall be placed before the State Council at its next meeting for itsconsideration and approval.Conduct of BusinessEvery meeting of the State / Union Territory Council shall be presided over by the ChairpersonTime & Place for Meetings of the State / Union Territory CouncilThe meetings of the State / Union Territory Council shall ordinarily be held at State / Union Territory Capital onsuch dates as may be fixed by the Council. The State/Union Territory Council shall meet every three months.Notice of Meeting

Notice of every meeting other than a special meeting shall be dispatched by the Member Secretary to eachmember of the Council not less than 15 days before the date of the meeting.Quorum, Call for Meeting, Minutes of Meetings One - third of the total number of members of theState/ Union Territory Council shall form a quorum and all actions of the Council shall be decided by amajority of the members present and voting.The notice and agenda of every such meeting of the State / Union Territory Council shall ordinarily be given15 days before the meeting by the Member Secretary of the Council.The proceedings of the meetings of the Council shall be preserved in the form of minutes which shall beauthenticated after confirmation by the signature of the Chairperson.A copy the minutes of each meeting of the State / Union Territory Council shall be submitted to theChairperson within 7 days of the meeting and after having been approved by him/her shall be sent to eachmember of the Council within 15 days of the meeting. If no objection to their correctness is received within 10days of their dispatch, any decisions therein shall be given effect to, provided that the Chairperson may,where in his opinion it is necessary or expedient so to do, direct that action be taken on the decision of themeeting.Registration and Filling of Casual VacanciesA member desiring to resign his seat on the State / Union Territory Council shall send his resignation in writingto the Chairperson and every such resignation shall take effect from the date mentioned by him in this behalf orin case no such date is mentioned, from the date of the receipt of his letter by the Chairperson afterconfirmation from the member concerned about his resignation.When a casual vacancy occurs by reason of death, resignation or otherwise of a member, a report shall bemade forthwith by the Chairperson to the Central Government which shall take steps to have the vacanciesfilled by nomination or election, as the case may be.Finance and AccountsThe Accounts of the Council shall be audited annually by a Chartered Accountant, who is to be appointed withthe prior approval of the Comptroller and Auditor General of India. Any expenditure incurred in connection withsuch audit shall be payable by the Council.The District Registering AuthorityEstablishment of District Registering AuthorityThe State Government shall, by notification under Section 10 of the Act and in accordance with the rulesframed by Central Government in this behalf set up an authority to be called the District Registering Authorityfor each district for registration of clinical establishments.Functions of the District Registering Authoritya. to grant, renew, suspend or cancel registration of any clinical establishmentsb. to enforce compliance of the provisions and rules of the Clinical Establishments (Registrationand Regulation) Act 2010c. to investigate complaints of breach of the provisions of this Act or the rules made there underand take immediate action;d. to prepare and submit on quarterly basis report containing details of related to number and nature ofprovisional and permanent registration certificates issued; included these cancelled, suspended or rejected tothe State / Union Territory Councils;e. to report to the State / Union Tenilury Council on a quarterly basis on action taken against nonregisteredclinical establishments operation in violation of the Actf. perform any other function as may be prescribed by the central government and or the stategovernment from time to time.Time and Place of and Preparation of Business for Meetings of the District Registering

AuthorityThe meetings of the District Registering Authority shall be held at least once in a month at a stipulated date andtimeConduct of BusinessEvery meeting of the District Registering Authority shall be presided over by the Chairperson.Notice of MeetingNotice of every meeting other than a special meeting shall be dispatched by the Convenor toeach member not less than 15 days before the date of the meeting.Quorum, MinutesOne - third of the total number of members of the District Registering Authority shall form a quorum and allactions of the Authority shall be decided by a majority of the members present and voting.The proceedings of the meetings of the District Registering Authority shall be preserved in the form of minuteswhich shall be authenticated after confirmation by the signature of the Chairperson.A copy the minutes of each meeting of the District Registering Authority shall be submitted to the Chairpersonby the Member Secretary within 7 days of the meeting and after having been attested by him shall be sent toeach member of the Council within 15 days of the meeting. If no objection to their correctness is received within10 days of their dispatch, any decisions therein shall be given effect to, provided that the Chairperson may,where in his opinion it is necessary or expedient so to do, direct that action be taken on the decision taken inthe meeting.Resignation and filling of casual vacanciesIf a casual-vacancy occurs in the office of any other members, whether by reason of death, resignation orinability to discharge, functions owing to illness or any other incapacity, such vacancy shall be filled by theDistrict Collector by making a fresh appointment and the member so appointed shall hold office for theremaining term of office of the person in whose place s/ he is so appointed.Registration of Clinical EstablishmentsApplication for RegistrationThe applicant shall apply to the District Registration Authority for provisional registration, either in person,or by post or through web based online facility with the necessary information as per SG1 Form underSection 14 (1) and 14 (3) of the ActThe applicant shall apply to the District Registration Authority for permanent registration, in person, or bypost or through web based online facility with the necessary information filled and with evidence of havingmet the requirements of minimum standards and personnel for different categories of ClinicalEstablishments in a form and format that shall be prescribed by the National Council under Section 24 and25 of the ActIf an establishment is offering services in more than one category as specified under the ClinicalEstablishments (Registration and Regulation) Rules (Central Government), 2010, the establishment willneed to apply for a separate provisional or permanent registration for each category of establishmentunder Section 14 (I) and Section 30 of the Act. However, if a laboratory or diagnostic center is a part of anestablishment providing out patient / inpatient care, no separate registration will be required.Acknowledgement of ApplicationThe Registration Authority, or any person in his office authorized in this behalf, shall, acknowledge receiptof the application for registration, in the acknowledgment slip provided as per SG2 Annexe immediately, ifdelivered at the office of the authority, or not later than the next working day if received by post and byonline acknowledgement to be generated automatically by the system.Grant of RegistrationThe authority shall not undertake any enquiry prior to the grant of provisional registration and shall within aperiod of ten days from the date of receipt of such application, grant to the applicant a certificate of

provisional registration containing particulars and information as per SG3 Annexe either by post orelectronically under Section 15, read with Section 17 of the ActCertificate of registrationThe District Registering Authority shall grant the applicant a certificate of permanent registration as per SG4 Annexe either by post or electronically after satisfying itself that the applicant has complied with all therequirements and criteria, including provision of minimum standards and personnel required to run theclinical establishment under Sections 28 and 30 of the ActIn case of permanent registration, under Section 29 of the Act, the authority shall pass an order within 31/2months -(a) allowing the application for permanent registration; or(b) disallowing the application:Provided that the authority shall record its justifications and reasons, if it disallows ar application, forpermanent registration.Fees to be chargedThe various fees charged for provisional and permanent registration, renewal, late application, duplicatecertificate, change of ownership, management or name o establishment is prescribed in SG5 Annexeunder Section 14 (I) read with Section 19 Section 20 (2), Section 22; Section 24, Section 35 of the Act.Clinical establishments owned, controlled and managed by the government (Central, State or localauthority) or department of government, shall be exempt from payment of fees for registration.The fees prescribed for various categories of clinical establishments may be revised by the State Councilthrough a notification issued by the State GovernmentThe fee shall be paid by a demand draft drawn / online transaction in favour of the Registration Authorityconcerned as specified under Section 14 (I) and Section 30 of the Act.The fees collected by the Authorities for registration of the Clinical Establishments shall be, deposited bythe Authority concerned in a Nationalized bank account opened in the name of the official designation ofthe Registration Authority concerned and shall be utilized by the Authority for the activities connected withthe implementation of the provisions of the Act and these rules as approved by the District RegistrationAuthority.The Accounts shall be maintained as per the Financial Code rules and shall be audited by engaging aqualified Chartered Accountant. The annual Audit reports shall be submitted to the concerned StateCouncil.In the event of any change of ownership or management, the establishment shall intimate to the DistrictRegistration in writing within one month of such change along with the fee prescribed in SG5 Annexe forissue of a revised certificate of Provisional or Permanent registration, as the case maybe, incorporating thechanges and on surrendering the old certificate under Section 20 (2) and Section 30 of the Act.In the event of certificate of registration (Provisional or Permanent) being lost or destroyed, the owner shallapply to the District Registration Authority to issue a duplicate certificate upon payment of the feeprescribed under rule (b) SG6 Annexe and the provisional certificate shall be marked "Duplicate" as perSG6 Annexe under Section 19 and Section 30 of the Act.Renewal of RegistrationThe clinical establishment shall apply for renewal of provisional registration thirty days before the expiry ofthe validity of the certificate of provisional registration. In case the application for renewal is not submittedwithin the stipulated period, the authority shall allow for renewal of registration on payment of the renewalamount as prescribed in SG5 Annexe and penalty of Rs. 100 per day till the date of application for renewalunder section 22 of the Act.For renewal of permanent registration, the clinical establishment shall apply three (3) months before expiryof the registration period of five (5) years. The renewal will be granted by the Authority within 3 months of

eceipt of the application failing which it will be deemed to have been renewed. If the clinical establishmentdoes not apply within one month of expiry of registration period, the registration will be deemed to havebeen suspended.Under Section 30 (4) of the Act the clinical establishment shall apply for renewal of permanent registrationsix months before the expiry of the validity of the certificate of permanent registration. In case theapplication for renewal is not submitted within the stipulated period, the authority will allow for renewal ofregistration on payment of the renewal amount as prescribed in SG5 Annexe and penalty of Rs. 100 perday till the date of application for renewal is accepted.Registers to be maintained, furnishing of returns and display of informationRegisters to be maintainedEvery District Registration Authority shall within a period of two years from its establishment, compile,publish and maintain in digital format a register of Clinical Establishments registered by it and it shall enterthe particulars of the certificate so issued in a register containing particulars as prescribed in CG3 Annexeunder Section 37 (1) (2) and Section 38 (1) (2) of the Act.Every District Registration Authority including any other authority set up for the registration of clinicalestablishments under the law for the time being in force shall supply in digital format to the State Council ofClinical Establishments a copy of every entry made in the District register of clinical establishments for aparticular month by the 15th day of the following month in keeping with Section 37 (2) of the Act.Display of InformationThe District Registering Authority shall, within a period of forty-five days from the grant of provisionalregistration, mandatorily cause to be published in the public domain through two local dailies and on thewebsite, which the District Registering Authority will launch, the name of the Clinical establishment,Address, Ownership, Name of Person in Charge, System of Medicine offered, Type and Nature of Servicesoffered and details of the Medical Staff (Doctors, Nurses, etc.) as under Section 16 (2) of the ActThe State council could make changes in the nature of information to be provided in the Public Domainthrough a notification, except in the case of the mandatory information to be provided under Section 16 (2)of the Act.The District Registering Authority shall, within a period of 7 days cause to be published in the public domainthrough two local dailies and on the website, which the District Registering Authority will launch, the name ofthe Clinical establishment, Address, Ownership, Name of Person in Charge, System of Medicine offered,Type and Nature of Services offered, details of the Medical Staff (Doctors, Nurses, etc) and the details andinformation related to having complied with the minimum standards and personnel prescribed for theparticular category of clinical establishment as under Section 26 of the Act.The District Registration Authority shall cause to be displayed the above information in public domain for aperiod of 30 days for filing objections before granting permanent registration.If any person has any objection to the information published regarding the clinical establishment they shallgive in writing the reasons and evidence of objection or non-compliance to the District Registration AuthorityThe District Registering Authority shall, within a period of 15 days cause to be published in the publicdomain the name of the Clinical Establishment whose (Provisional or Permanent) registration has expiredas under Section 21 and Section 30 of the Act.Information to be provided by Clinical EstablishmentsThe Clinical Establishments shall maintain medical records of patients treated by it and health informationand statistics in respect of national programmes and furnish the same to the district authorities in form ofthree monthly reports. The minimum medical records to be maintained and nature of information to beprovided by the Clinical Establishments are prescribed in CG2 Annexe as per Section 12(1) (iii) of the Act.Copies of all records and statistics shall be kept with the clinical establishment concerned for 3 vears or inaccordance with any other relevant act in force at the time under Section 12 (1) (iii) of the Act. All clinicalestablishments shall be responsible for submission of information and statistics in the time of emergency ordisaster or epidemic situation.

The government may notify from time to time, the nature of information that needs to be furnished by theClinical Establishments including other disease notified for this purpose along with the prescribed interval.In addition to the specific provisions of the Clinical Fstablishments (Registration fl Regulation) Act 2010.all establishments shall comply and maintain information and statistics in keeping with other applicable Actsand Rules which are in force in the country.Power to EnterEntry and search of the clinical establishment can be done by the District Registering Authority or anofficer or team duly authorized by it or subject to such general or special orders as may be made by theauthority, subject to a unanimous decision by all member of the District Registration Authority for conduct ofsuch entry and search.Such entry and search of clinical establishments can be conducted if anyone is carrying on a clinicalestablishment without registration or does not adhere to the prescribed minimum standards or hasreasonable cause lo believe the CE is being used for purposes other that it is registered or contravenes any of(tie provisions or this Act & Rules, shall at all reasonable times enter and inspect any record, register,document, equipment and articles as deemed necessary under the provisions of Section 34 of the Act.The inspection team shall intimate the establishment in writing about the date of visit. The team shallexamine all portions of the premises used or proposed to be used for the clinical establishment and inspectthe equipments, furniture and other accessories and enquire into the professional qualifications of thetechnical staff employed or to be employed and shall make any such other enquires as they considernecessary to verify the statements made in the application for registration and grant of license. All personsconnected with the running of the establishment shall be bound to supply full and correct information to theinspection team.The Officer and / or inspection team so constituted by the Registering Authority shall submit a report as perSG7 Annexe within a week of the inspection to the District Registration Authority with a copy to the StateCouncil.Penalties & AppealsPenaltiesIn keeping with the provisions of Section 41 (1) (2) (3) and Section 42 (1) (2) (3) the Act, whoever carries on aclinical establishment without registration or whoever willfully disobeys any direction, or obstructs any personor authority or withholds any such information or provides false information shall be liable for a monetarypenalty.Whoever carried on a clinical establishment without registration, shall, on first contravention be liable to amonetary penalty upto fifty thousand rupees, for second contribution to a monetary penalty which mayextend to two lakh rupees and for any subsequent contravention to penalty which may extend to five lakhrupees.Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall be liableto a monetary penalty which may extend to twenty five thousand rupees.The penalty fees collected by the authorities for shall be, deposited by the Authority Goncorncd in aNationalized bank aucount opened in the name of the official designation of the State Council concerned andshall be utilized by the Council and authority for the activities connected with the implementation of theprovisions of the Act and approved by the Council.AppealsIn keeping with Section 36, 41 (4) (5) (6) (7) and Section 42 (4) (5) (6) (7), any person or clinical establishment,if aggrieved by the decision of the Authority under Sections 29 and 34 of the Act, may file an appeal to the StateCouncil within thirty (30) days from the date of receipt of such order along with prescribed fees as indicated in

SG 6 Annexe.After receipt of the appeal, the State Council shall fix the time and date for hearing and inform the same to theappellant and others concerned by a registered letter giving at least 15 days time for hearing of the case.The appellant may represent by himself or authorized person or a Legal practitioner a*nd submit the relevantdocumentary material if any in support of the appealThe State Council shall hear all the concerned, receive the relevant oral/documentary evidence submitted bythem, consider the appeal and communicate its decision preferably within 90 days from the date of filing theAppealIf the State Council considers that an interim order is necessary in the matter, it may pass such order, pendingfinal disposal of the appeal. The decision of State Council shall be final and binding.If no appeal is filed against the decision of the Registering Authority in the prescribed period (i.e.) within 30 daysfrom the date of receipt of the order, the orders of the Authority shall be final.The appeal fees collected by the authorities shall be deposited by the Authority concerned in a Nationalizedbank account opened in the name of the official designation of the State Council concerned and shall be utilizedby the Council and authority for the activities connected with the implementation of the provisions of the Act asapproved by the Council.Any other matter which is required to be or may be prescribed by the State Government

SG1 FormApplication Form for Provisional Registration of Clinical Establishments1. Name of the Establishment__________________________________________________2. Address:Village/Town:Taluka:District: State: Pin codeTel No (with STD code): Mobile: Fax ;Email ID :Website (if any):3. Year of starting:________________4. Location: Rural Urban Metropolitan5. OwnershipPublic Sector Central government State government Local government- please specify: Public Sector Undertaking Railways Employee State Insurance Corporation (ESIC) Autonomous organization Any other (please specify):/Private SectorIndividual Proprietorship Registered Partnership Registered Company Co-operative Society Trust/Charitable registered under a Central, Provincial or State Act (please specify):____________ Any other (please specify):_______________________________6. Name of the owner of Clinical Establishment:_________________________________________Educational Qualification: ______________________Address: _______________________________________________________________Village/Town.; __________________________ Taluka: __________________________District: _______________ State: _______________________ Pin code _____________Tel No (with STD code): _____________ Mobile: ____________ Fax : _______________Email ID ________________________________________________________________________7. Name of person in-charge of the Clinical Establishment: ____________________Designation: _____________________________ Educational Qualification: __________Address: _________________________________________________Village/Town: _______________________ Taluka: __________________________District: _______________ State: _______________________ Pin code _____________Tel No (with STD code): ____________ Mobile: ____________ Fax : ______________Email ID :8. Systems of Medicine offered: (please tick whichever is applicable)Allopathy Ayurveda Unani Siddha HomeopathyYoga & Naturopathy9. Type of Establishment: (please tick whichever is applicable)Providing Out Patient Care Single practitioner Polyclinic Sub-Centre Physiotherapy Clinic Occupational Therapy Infertility Dental clinic Dispensary Dialysis Centre Integrated Counseling and Testing Centre (ICTC) Wellness/fitness centreAny other (please specify):______________________________________

Providing In Patient CareHospital Nursing Home Maternity Home Primary Health Centre Community Health Centre SanatoriumAny other (please specify):^ __________________________Providing Testing & Diagnostic Services:LaboratoryPathology Haematology Biochemistry Microbiology Genetics CollectionCentre Any other (please specify):_________________________________________Diagnostic and Imaging CentreX Ray centre Mammography Bone Densitometry SonographyColor Doppler CT Scan Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET) ScanElectro Myo Graphy (EMG) Any other (please speciry):_____________________________Any other (please specify):10. Nature of Services (please tick whichever is applicable)For all Systems of MedicineGeneral Single Specialty Multi Specialty Super Specialty MobileAny other, please specify:_________________________________a) Allopathy General Practice Out-patient In-patient Day care centre Emergency / Casualty ICU ICCU Special Care Services for challenged persons Blood Bank Organ /Tissue Bank Any other please specify:_____________________________b) AyurvedaAusadh Chikitsa Shalya Chikitsa Shodhan Chikitsa RasayanaAny other please specify:Pathya Vyavasthac) UnaniMatab Jarahat Ilaj-bit-Tadbeer Hifzan-e-SehatAny other please specify:d)Slddha Maruthuvam Sirappu Maruthuvam Varmam Thokknam & Yoga Any other please specify:e) Homeopathy General Homeopathy Any other please specify:________________________________________f) Naturopiithy External Therapies with natural modalities Internal Therapies Any other please specify:_____________________________g) Yoga please specify:________________________INFRASTRUCTURE DETAILS

12. Area of the establishment (in sq. meters):a) Total Area:_______________________ b) Constructed area:____________________13. Out Patient Department:13..1 Total no. of OPD Clinics: _________________13.2 Specialty-wise distribution of OPD ClinicS.No. Specialty No. of Rooms14. In Patient Department:14.1. Total number of beds:14.2. Specialty-wise distribution of beds, please specify:S.No. Specialty No. of Beds15. Whether Clinical Waste Disposal License obtained from Panchayat/Municipality/MunicipalCorporation etc? Yes No Applied For16. Whether clearance from Pollution Control Board/Authority obtained? Yes No Applied ForHUMAN RESOURCES17. Total number of Staff (as on date of application):No. of permanent staff: _______ No. of temporary staff:____________________________Please furnish the following details:-Category of staff Name Qualification RegistrationNumber(whereapplicable)DoctorsNursing staffPara-medical staffPharmacistsSupport staffOthers, pleasespecifyNature of serviceTemporary/ Permanent*Separate annexure may be attached.*18. Payment options for Registration Fees: Online payment Demand Draft Postal Order

Any other (please specify): ________________________________________Amount (in Rs): ________________________________________Details: ________________________________________Receipt No. ________________________________________I,………………………….. on behalf of myself and the company/society/association/body hereby declarethat the statements above are correct and true to the best my knowledge and I shall abide by all the rulesand declarations under the Clinical Establishment (Registration and Regulation) Act 2010.I undertake that I shall intimate to the appropriate registering authority any change in the particularsgiven above.Place:Date:Signature of the Authorized SignatoryOffice Seal

SG2 AnnexeACKNOWLEDGEMENTREGISTRATION OF CLINICAL ESTABLISHMENTThe application in Form ___ for Grant / Renewal of Provisional / Permanentregistration of the Clinical Establishment submitted by __________________________ (Nameand address of Owner) has been received by the District Registration Authority on______________________ (date) and found to beCompleteOrIncompleteThis acknowledgement does not confer any rights on the applicant for grant or renewalof registration.Signature and Designation of Registration Authority or authorized person in theOffice of the Appropriate Authority.SEALDesignation of the Issuing Authority (ComputerGenerated)Place & Date: (Computer Generated)

SG 3 AnnexePROVISIONAL CERTIFICATE FOR REGISTRATION OF CLINICAL ESTABLISHMENTProvisional registration No: (Computer Generated)Date of issue: (Cotnwrter Generated)Valid up to: {Computer Generated]1. Name of the Clinical Establishment: ______________________________________________2. Address: ______________________________________________3. Owner of the Clinical Establishment: ______________________________________________4. Name of Person in Charge: ______________________________________________5. System of Medicine : ______________________________________________6. Type of Establishment: ______________________________________________Is hereby provisionally registered under the provisions of Clinical Establishments (Registration andRegulation) Act 2010 and the Rules made there under.This authorization is subject to the conditions as specified in the rules in force under the ClinicalEstablishments (Registration and Regulation) Act 2010 and the Rules made there under.Designation of the Issuing Authority (Computer Generated)District Registration AuthorityAddress:Place & Date: (Computer Generated)Phone number in case of Grievances

SG 4 AnnexePERMANENT CERTIFICATE FOR REGISTRATION OF CLINICAL ESTABLISHMENTPermanent registration No: (Computer Generated)Date of fssue: (Computer Generated)Valid up to: (Computer Generated)1. Name of the Clinical Establishment: _______________________________________________2. Address: _______________________________________________3. Owner of the Clinical Establishment: _______________________________________________4. Name of Person in Charge: _______________________________________________5. System of Medicine : _______________________________________________6. Type of Establishment: _______________________________________________is hereby permanently registered under the provisions of 'Clinical Establishments (Registration andRegulation) Act 2010 and the Rules made there under.This authorization is subject to the conditions as specified in the rules in force under the ClinicalEstablishments (Registration and Regulation) Act 2010 and the Rules made there under.Designation of the Issuing Authority (ComputerGenerated)Place & Date: (Computer Generated)District Registration AuthorityAddress:Phone number in case of Grievances

SG 5 AnnexeFees to be ChargedDescription Urban Rural MetroProvisional Permanent Provisional Permanent Provisional PermanentOut Patient Care 100 500 50 250 200 1000In Patient Care1 to 30 beds 30to 100 bedsAbove 100 bedsTesting & DiagnosticLaboratories Diagnostic &Imaging Centre100 500 50 250 200 1000200 1000 100 500 400 2000300 1500 150 650 600 3000200 1000 100 500 400 2000300 1500 150 650 600 3000VOther Fees• For Renewal half the amount of registration fee (Provisional / Permanent)• For Late Application the amount would be double of the registration fee (Provisional / Permanent)• For Duplicate Certificate the amount would be Rs. 200• For change of ownership, management or name of establishment would be Rs 100• For any appeal the amount would be Rs. 100* If a laboratory or diagnostic center Is a part of a establishment providing out patient / Inpatient care no separateregistration is required.

SG 6 AnnexeDUPLICATECERTIFICATE FOR CLINICAL ESTABLISHMENTPermanent registration No: (Computer Generated)Date of Issue: (Computer Generated)Valid up to: (Computer Generated)1. Name of the Clinical Establishment: _______________________________________________2. Address: _______________________________________________3. Owner of the Clinical Establishment: _______________________________________________4. Name of Person in Charge: _______________________________________________5. System of Medicine : _______________________________________________6. Type of Establishment: _______________________________________________is hereby permanently registered under the provisions of 'Clinical Establishments (Registration andRegulation) Act 2010 and the Rules made there under.This authorization is subject to the conditions as specified in the rules in force under the ClinicalEstablishments (Registration and Regulation) Act 2010 and the Rules made there under.Designation of the Issuing Authority (ComputerGenerated)Place & Date: (Computer Generated)District Registration AuthorityAddress:Phone number in case of Grievances

SG 7 AnnexeSuggested Format for Submission of Inspection ReportNumber of visits made with datesNames and details of members of the inspection teamName of clinical establishment visitedAddress and contact details of clinical establishment visitedProcess followed for inspection (e.g. kindly outline who was met with, what records wereexamined, etc)vSalient Observations / Findings ConclusionsSpecific Recommendations:(1) To the Clinical Establishment(2) To the District Registering Authority*ln case of lack of consensus amongst members of the inspection team, the same may be kindlyindicatedSignature (of all members of the inspection team)DatePlace

The Clinical Establishments (Registration and Regulation) Rules, 2010Draft Rules for the Central GovernmentThese rules may be called The Clinical Establishments (Registration and Regulation) Rules (CentralGovernment), 2010These rules extend to the whole of the States of Arunachal Pradesh, Himachal Pradesh, Mizoram,Slkkim and in any other State which adopts this Act under clause (1) of Article 252 of the Constitutionand the Union Territories of Chandigarh, NCT of Delhi, Dadra & Nagar Haveli, Puducherry, Andamanand Nicobar Islands, Daman and Diu and LakshadweepIt shall come into force from the date of notification of these Rules in the Official Gazette.The Rules shall be applicable to various categories of clinical establishments in a phased manner, asmay be notified from time to time.DefinitionsIn these rules, unless the context otherwise requires:a) 'Act means the Clinical Establishments (Registration and Regulation) Act 2010b) 'Rules' means the Clinical Establishments (Registration and Regulation) Rules, 2010c) 'Authority 1 means the district registering authority set up under Section 10 of the Act.d) 'Certificate' means certificate of registration issued under section 30;e) 'Clinical Establishment' means(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution bywhatever name called that offers services, facilities requiring diagnosis, treatment or carefor illness, injury, deformity, abnormality or pregnancy in any recognised system ofmedicine established and administered or maintained by any person or body of persons,whether incorporated or not; or(ii) a place established as an independent entity or part of an establishment referred to in subclause(i), in connection with the diagnosis or treatment of diseases where pathological,bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic orinvestigative services with the aid of laboratory or other medical equipment, are usually carriedon, established and administered or maintained by any person or body of persons, whetherincorporated or not, and shall include a clinical establishment owned, controlled or managedby(a)(b)(c)(d)(e)the Government or a department of the Government;a trust, whether public or private;a corporation (including a society) registered under a Central, Provincial orState Act, whether or not owned by the Government;a local authority; anda single doctor,but does not include the clinical establishments owned, controlled or managed by the Armed Forcesconstituted under the Army Act 1950, the Air Force Act 1950 and the Navy Act 1957.f) 'Emergency Medical Condition' means a medical condition manifesting itself by acutesymptoms of sufficient severity (including severe pain) of such a nature that the absence ofimmediate medical attention could reasonably be expected to result in:(i)(ii)(iii)placing the health of the individual or with respect to a pregnant women, the healthof the woman or her unborn child, in serious jeopardy;serious impairment to bodily functions; orserious dysfunction of any organ or part of a body

g) 'National Council' means the National Council for clinical establishments establishedunder section 3 of the Acth) 'Prescribed' means prescribed by rules made under this Act by the CentralGovernment or, as the case may be, the State Government;i) 'Recognised System of Medicine' means Allopathy, Yoga, Naturopathy,Ayurveda, Homoeopathy, Siddha and Unani System of medicines or any other system ofmedicine as may be recognised by the Central Government;j) 'Register" means the register maintained by the authority, State Government and theCentral Government under sections 37, 38 and 39 respectively of this Act containing thenumber of clinical establishments registered;k) 'Registration' means to register under section 11 and the expression registration orregistered shall be construed accordingly;I) 'Schedule' means the Schedule appended to this Act;m) 'Standards' means the conditions that the Central Government may prescribe under section12, for the registration of clinical establishments from time to time;n) 'State Government, in relation to a Union Territory', means the Administrator thereofappointed under article 239 of the Constitution; ando) To stabilise' (with its grammatical variations and cognate expressions) means, with respectto an emergency medical condition specified in clause (f), to provide such medical treatment ofthe condition as may be necessary to assure, within reasonable medical probability, that nomaterial deterioration of the condition is likely to result from or occur during the transfer of theindividual from a clinical establishment.The words and expressions used herein and not defined but defined in the Act shall have the samemeanings respectively assigned to them in the Act.The National Council for Clinical EstablishmentsEstablishment of the National Council for Clinical EstablishmentsThe Central Government by way of a Notification shall constitute a National Councilfor Clinical Establishments.The establishment of the National Council shall be as defined in Section 3 of the ActAppointment of Secretary of the National Council by the Central GovernmentThe Central Government shall appoint an officer of the rank of Joint Secretary dealing with the subjectof Clinical Establishments in the Ministry of Health & Family Welfare as the Secretary, National Councilunder Section 3 (10) of the Act.The term of office of Secretary of the National Council shall be for a period of 3 years.The Secretary of the council will be responsible for the control & management of the secretariat of thecouncil and supervision of the other employees of the Council and perform such other duties as may berequired of him/her by the Council for the purposes of the Act. He shall attend the meetings of theCouncil.The Central Government will provide the National Council with such other secretarial and other staffas deemed necessary by it under Section 3 (10) of the Act.The powers and duties of the other employees shall be such as may be laid down from time to time inthe standing orders as may be framed for the purposes by the National Council.Functions of the National Council for Clinical EstablishmentsThe National Council shall:x

(a)(b)(c)(d)(e)(f)Compile and publish a National Register of clinical establishments within two years from the dateof the commencement of this Act;Classify the clinical establishments into different categories;Develop the minimum standards and their periodic review;Determine within a period of two years from its establishment, the first set of standards forensuring proper healthcare by the clinical establishments;Collect the statistics in respect of clinical establishmentsPerform any other function determined by the Central Government from time to time.Sub - Committees of the National CouncilThe National Council shall at any time constitute sub-committees for such periods, not exceeding twoyears, for the consideration of particular matters related to :O Categorization of clinical establishments;O Development of minimum standards and personnel for various categories of clinicalestablishments and their periodic review;O Compilation and publication of a National Register of clinical establishments;O Collection of statistics from clinical establishments andO Any other function determined by the Central Government from time to time.A motion for the appointment of each sub-committee shall define the functions of each subcommittee,number and nature of members to be appointed thereon and timeline for completion of tasks. At the timeof formation of each sub-committee, it should be ensured that there is adequate representation fromacross the country in each committee from experts in the relevant fields across the private sector, publicsector and/its organizations, non-governmental sector, professional bodies, academia and researchinstitutions amongst others.The Chairperson of every such sub-committee shall be appointed by the National Council at the time ofthe appointment of the sub-committee.The proceedings of the meetings of the sub-committees shall be preserved in the form of minutes whichshall be authenticated after confirmation by the chairperson of the subcommittees.Any decisions taken by the sub-committee/s shall be placed before the National Council at its nextmeeting for its consideration and approval.The National Council of Clinical Establishments shall request the State / Union Territory Councils toprovide inputs for the consideration of particular matters. If required, the State / Union Territory Councilshall at the request of the National Council and / or as determined by the Central Government constitutesub-committee/s consisting of members of the state and UT council and field experts for such period notexceeding one year, for the particular matter.Determination of standards of personnel, facilities and services (including standards forpermanent registration); classification of clinical establishments by the National CouncilThe minimum standards of facilities and services and personnel for different categories of ClinicalEstablishments for permanent registration shall be submitted by the National Council to the CentralGovernment to be notified from time to time under Section 5 (c) (d) read with Section 7, Section 12 (1) (i)(ii) and Section 13 (1) (2), Section 28 of the Act.The Clinical Establishments of different systems of medicines under Section 13 (1) have been classifiedinto the categories as prescribed in CG1 Annexe and the Central Government will have the power to add,delete or modify such categories, as it deems appropriate from time to time, based on therecommendations of the National Council established under this Act.The National Council shall constitute sub-committees having adequate representation from across thecountry including experts in the relevant fields across the private sector, public sector and/its organizations,non-governmental sector, professional bodies, academia and research institutions amongst others for suchperiod, not exceeding two years, for determination of minimum standnids and personnel for differentcategories of Clinical Establishments under Section 5 (c) (d) read with Section 7, Section 12 (1) (i) (ii) andSection 13 (2) of the Act, in particular, the National Council shall have regard to local conditions whileprescribing the standards of personnel, facilities and services for different categories of clinicalestablishments.

Once the standards are developed, the National Council shall prepare the application form for permanentregistration, including format for submission of evidence that different categories of clinical establishmentshave met the requirements of minimum standards and personnel. The form and format developed shallcome into effect after notification by the Central Government.Conduct of business of meetings of the National CouncilEvery meeting of the National Council shall be presided over by the ChairpersonTime and Place of and Preparation of Business for Meetings of the National CouncilThe meetings of the National council shall ordinarily be held at Delhi or at such other place in India and onsuch dates as may be fixed by the Council, The National Council shall meet every month till such time asstandards are developed. Thereafter, the Council shall at the minimum meet every three months.Notice of MeetingNotice of every meeting other than a special meeting called shall be issued to each member of the Councilnot less than 15 days before the date of the meeting.Quorum, Call for Meeting, MinutesOne - third of the total number of members of the National Council shall form a quorum and all actions ofthe Council shall be decided by a majority of the members present and voting.The notice and agenda of every such meeting of the National Council shall ordinarily be given 15 daysbefore the meeting by the Secretary of the National Council.A copy the minutes of each meeting of the National Council shall be submitted to the Chairpersonwithin 7 days of the meeting and after having been approved by him/her shall be sent to each memberof the Council within 15 days of the meeting. If no objection to their correctness is received within 10 daysof their dispatch, any decisions therein shall be given effect to, provided that the Chairperson may,where in his opinion it is necessary or expedient so to do, direct that action be taken on the decisiontaken in the meeting.The proceedings of the meetings of the Council shall be preserved in the form of minutes which shall beauthenticated after confirmation by the signature of the Chairperson.Allowances for members of the National CouncilThe central government officials who are members of the National Council for Clinical Establishmentsunder sub-section 3 (5) of the Act shall not be paid any allowances. The travel and daily allowancefor state government officials shall be paid by the respective States / UTs. The non-officialmembers of the Council shall be paid travel and daily allowance in accordance with the rules of theCentral Government for Class I officials as applicable from time to time.Resignation and filling of casual vacanciesA member desiring to resign his seat on the National Council shall send his resignation in writing to theChairperson and every such resignation shall take effect from the date mentioned by him in this behalfor in case no such date is mentioned, fium the date of the receipt of his letter by the Chairperson afterconfirmation from the member concerned about his resignation.When a casual vacancy occurs by reason of death, resignation or otherwise of a member, a report shallbe made forthwith by the Chairperson to the Central Government which shall take steps to have thevacancy filled by nomination or election, as the case may be.Disqualification for Appointment of MemberA person shall be disqualified for being appointed as a member of the National Council ifshe/hea) has been convicted and sentenced to imprisonment for an offence which, in the opinion ofthe Central Government, involves moral turpitude: orb) is an undischarged insolvent; orc) is of unsound mind and stands so declared by a competent court; or

d) has been removed or dismissed from the service of the Government or aCorporation owned or controlled by the Government; ore) has, in the opinion of the Central Government, such financial or other interest in theCouncil as is likely to affect prejudicially the discharge by him of his functions as a member.Register of Clinical EstablishmentsEvery State Government shall maintain a State Register of Clinical Establishments in digital formatcontaining the particulars as prescribed in CG3 Annexe under Section 38 of the ActDistrict Registering AuthorityQualification and the terms and conditions for the members of the authorityThe Central Government prescribes that 3 members of the District Registering Authority underSection 10 sub-section (1) clause (c) shall be nominated by the District Collector /DistrictMagistrate and they shall include one representative from the City Police Commissioner (or his/hernominee) or SP or SSP, (as the case may be); one representative from a reputed Non-GovernmentalOrganization working in the district / State in the area o health and related issues for a minimum periodof 3 years and one representative from i professional medical association or body, having jurisdictionin the district or at the state level (as the case may be)The term of office for the representative from the NGO and the professional medica association orbody shall be for a period of 3 years.If a casual-vacancy occurs in the office of any other members, whether by reason of death,resignation or inability to discharge, functions owing to illness or any other incapacity, suchvacancy shall be filled by the District Collector/District Magistrate by making a fresh appointmentand the member so appointed shall hold office for the remaining term of office of the person inwhose place s/ he is so appointed.The State Government shall include the members in the District Registration Authority for each Districtas prescribed by the Central government in clause 52 (d) under section 10 (1) (c) of the ActProcedures under which the powers of the authority may be exercised by the District HealthOfficer or Chief Medical Officer for the purpose of provisional registration of clinicalestablishmentThe district registering authority shall have the power to grant, renew, enforce or cancelregistration of any clinical establishment in accordance with the provisions and rules of theClinical Establishments (Registration and Regulation) Act 2010 as per procedure prescribedunder Section 14 (1) (2) (3) (4) (5); Section 15; Section 16 (1) (2); Section 17; Section 19;Section 22; Section 23 (1) (2) (3); Section 24; Section 25; Section 26; Section 29; Section 30 (1)(2) (3) (4); Section 32 (1) (2) (3); Section 33 (1) (2) (3) (4); Section 34 and Section 36.The District Registering Authority shall be responsible forO Grant, renewal, suspension or cancellation of registration for any clinicalestablishmentO Enforcing compliance with the provisions and rules of the Clinical Establishments(Registration and Regulation) Act 2010O Investigation of complaints of breach to the provisions of this Act or the rules madethereunder and take immediate action;O Preparation and submission of report to the State / Union Territory C ouncil, on aquarterly basis containing details related to number and nature of provisional andpermanent registration certificates issued; included those cancelled, suspended or rejectedO Reporting to the State / Union Territory Council on a quarterly basis on action taken againstnon-registered clinical establishments operation in violation of the ActThe District Health Officer or the Chief Medical Officer (by whatever name called) shallexercise the powers of the district health authority as per procedure outlined in the Act TheConvener of the District Registering Authority may also perform such functions as maybeassigned to him / her by the Chairperson from time to time and the Rules framed by the Stategovernment.

Maintenance of records and reporting by clinical establishmentsEvery Clinical Establishment shall maintain medical records of patients treated by it and healthinformation and statistics in respect of national programmes and furnish the same to the districtauthorities in form of quarterly reports. The minimum medical records to be maintained and nature ofinformation to be provided by the Clinical Establishments are prescribed in CG 2 Annexe as perSection 12 (1) (iii) of the ActCopies of all records and statistics shall be kept with the clinical establishment concerned for at least 3or 5 years or in accordance with any other relevant Act in force at the time under Section 12(1) (iii)).All clinical establishments shall be responsible for submission of information and statistics in time ofemergency or disaster or epidemic situation.The Central Government may notify from time to time, the nature of information that needs to befurnished by the Clinical Establishments along with the prescribed interval.Other conditions for registration and continuation of clinical establishmentEach category of clinical establishments shall comply with the Standard Treatment Guidelines andmaintain electronic medical records of every patient as may be notified by the Central Governmentfrom time to timeEach category of clinical establishments shall charge the rates for each type of procedure and servicewithin the range of rates to be notified by the central government from time to time, for suchprocedures and services.Every Clinical Establishment shall display the rates charged for each type of service provided andfacilities available, for the benefit of the patients at a prominent place in the local dialect and as wellas in English language. The minimum list of services for which rates are to be displayed are given inCG 4 Annexe.In addition to the specific provisions of the Clinical Establishments (Registration & Regulation) Act2010, all establishments shall comply and maintain information and statistics in keeping with otherapplicable Acts and Rules which are in force in the country.Every category of clinical establishments, as may be notified by the Central Government from time totime, shall establish mechanisms for review and audit for the purpose of provision of rationalpractice and service and maintenance of high standards of quality.Each category of clinical establishments, as may be notified by the Central Government shall carryout every prescription audits every 3 months.Each category of clinical establishments, as may be notified by the Central Government from time totime, shall carry out audit to assess the cause of death including treatments given to explore betterpreventive and management strategies.

Diagnostic and Imaging Centre• X Ray centre• Mammography centre• Bone Densitometry centre• Sonography centre• Color Doppler centre• CT Scan centre• Magnetic Resonance Imaging (MRI) centre• Positron Emission Tomography (PET) Scan centre• Electro Myo Graphy (EMG) centre• Any other

CG2 AnnexeRECORDS TO BE MAINTAINED BY CLINCIAL ESTABLISHMENTSThe various medical records to be maintained by clinical establishmentOut patient Register• Inpatient Regisler• Operation Theater register• Labor room register• MTP register (if registered under the MTP Act)• Case sheets• Medico legal register• Laboratory Register• Radiology and imaging register• Discharge summary• Medical certificate in duplicate• Complaint register• Birth register (Notified to such medical officer as authorized• Death register by Government in such format as prescribed by Government/ State level authority)• Information in terms of government programmes / areas of work (eg maternal health, childhealth, immunization, family planning, Vector borne disease, NLEP, RNTCP, IDSP. NRHMinitiatives-ASHA, JSY)• Number of beds system-wise and specialty-wise in Clinical Establishments providing in patient care(e.g Genera! Med/Surg Beds; Special Care Beds)• Total Discharges:

CG3 AnnexeState / District Register for Clinical EstablishmentDetails of Information Required(A) At State/District level:Total number of establishments by- Category- System of medicine practiced- Type of service provided- Rural / urban / metro- No of bedsNumber of Clinical Establishments increased or decreasedNumber of Inspections carried out.Number of Pending applications with reasonsAction Taken against non-registered Establishments operating in violation of the ActComplaints received by the State Council under the Act and Action taken pursuant thereto(B) Detailed informationDetails of each Clinical Establishment byNameLocation containing detailsRural / Urban / MetropolitanVillage / TownTalukaDistrictStatePincodePhone NumberEmail ID:Ownership DetailsName of OwnerEducational QualificationPerson in Charge of Clinical EstablishmentEducational QualificationUrban / Rural Designation:Longitude / Latitude: Systems of Medicine offeredType of Establishments by category specified under Section ___ of the ____ rulesNature of Services provided by category specified under Section ___ of the ____ rulesNumber of beds system-wise and specialty-wise in Clinical Establishments providing in patientcare

Total Employees:Total Discharges:Average length of stay (OP / IP)Utilization StatisticsDetails of Staff with Name, Qualification, Registration number, Number temporary orpermanent

CG 4 AnnexeMinimum list of services for which rates are to be displayedName of the service Type of Service Charges (in Rs.)Room Charges:General Services(includes Room/ Bed charges, Nursing Private rooms:charges, Medical utilities charges)Semi Deluxe - SharedIntensive care units:(Charges include the ICUBed Charges, MedicalUtilities, Monitoring andNursing charges)Deluxe with ACMICU &ICUNEUROPOWNeonatal ICUPediatrics ICUVOT ChargesGeneral Anesthesia Vz HourGeneral Anesthesia 1 HourLocal AnesthesiaSurgical procedures Charges(Package) (includes Surgeon charges+Anesthetist charges* Nursing HomeCharges and Inpatient MedicineCharges)Doctor Consultation charges: OPIPEmergency VisitsEmergency care team chargesDiagnostic ChargesCommon diagnostic Tests X- ray perfilmUltra Sound, General and ObstetriccareCTScan:Multi slice/Spiral/CT scanMRI 0.5/1/1 .5(Magnetic Resonance Imaging)ECG/TMT/ECHO/EMG/EEGUpper Gl Endoscopy/ Lower GlEndoscopyLab Investigation:Random Blood sugarSerum CreatinineCBP/ESR/CUEBlood GroupBlood for MPLFTGeneral wardTwin/ Triple sharingGeneral WardTwin/ Triple sharing1 / 2 Hour1 HourGeneral SurgicalProceduresOb & Gy proceduresOrthopedicproceduresCardiacproceduresSpecialistSuper SpecialistPer VisitsPer Visits3 shift per daySurgicalSurgicalAbdomenFemale PelvicKUBBrain PlainChest/ Abdomen/ Neck/SpineBrainChestContast

Lipid profileHBSAG/VDRL/HIVElectrolytesT3, T4, TSHAny other items (not included above]Note: Other service charges for Inpatients such as drugs & disposables, investigations andconcession, if any, shall be displayed at appropriate places for the benefit of the patient

TO BE INTRODUCED IN LOK SABHABill No. 43 of 2010CLAUSESTHE CLINICAL ESTABLISHMENTS (REGISTRATION ANDREGULATION) BILL, 2010————ARRANGEMENT OF CLAUSES————CHAPTER IPRELIMINARY1. Short title, application and commencement.2. Definitions.CHAPTER IITHE NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS3. Establishment of National Council.4. Disqualifications for appointment as member.5. Functions of National Council.6. Power to seek advice or assistance.7. National Council to follow consultative process.CHAPTER IIIREGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS8. State Council of clinical establishments.9. Providing information to National Council.10. Authority for registration.11. Registration for clinical establishments.12. Conditions for registration.13. Classification of clinical establishments.CHAPTER IVPROCEDURE FOR REGISTRATION14. Application for provisional certificate of registration.15. Provisional certificate.16. No inquiry prior to provisional registration.17. Validity of provisional registration.18. Display of certificate of registration.19. Duplicate certificate.20. Certificate to be non-transferable.21. Publication of expiry of registration.22. Renewal of registration.23. Time limit for provisional registration.

(ii)CLAUSES24. Application for permanent registration.25. Verification of application.26. Display of information for filing objections.27. Communication of objections.28. Standards for permanent registration.29. Allowing or disallowing of registration.30. Certificate of permanent registration.31. Fresh application for permanent registration.32. Cancellation of registration.33. Inspection of registered clinical establishments.34. Power to enter.35. Finance and accounts.36. Appeal.CHAPTER VREGISTER OF CLINICAL ESTABLISHMENTS37. Register of clinical establishments.38. Maintenance of State register of clinical establishments.39. Maintenance of National Register of clinical establishments.CHAPTER VIPENALTIES40. Penalty.41. Penalty for non-registration.42. Disobedience of order, obstruction and refusal of information.43. Penalty for minor deficiencies.44. Contravention by companies.45. Offences by Government Departments.46. Recovery of fine.CHAPTER VIIMISCELLANEOUS47. Protection of action taken in good faith.48. Furnishing of returns, etc.49. Power to give directions.50. Employees of the authority, etc., to be public servants.51. Power to remove difficulties.52. Power of Central Government to make rules.53. Laying of rules.54. Power of State Government to make rules.55. Laying of rules.56. Savings.THE SCHEDULE

Bill No. 43 of 2010THE CLINICAL ESTABLISHMENTS (REGISTRATION ANDREGULATION) BILL, 2010ABILLto provide for the registration and regulation of clinical establishments in the countryand for matters connected therewith or incidental thereto.WHEREAS, it is considered expedient to provide for the registration and regulation ofclinical establishments with a view to prescribe minimum standards of facilities and serviceswhich may be provided by them so that mandate of article 47 of the Constitution forimprovement in public health may be achieved.AND WHEREAS, Parliament has no power to make laws for the States with respect to anyof the matters aforesaid except as provided in articles 249 and 250 of the Constitution;AND WHEREAS, in pursuance of clause (1) of article 252 of the Constitution, resolutionshave been passed by all the Houses of the Legislatures of the States of Arunachal Pradesh,Himachal Pradesh, Mizoram and Sikkim to the effect that the matters aforesaid should beregulated in those States by Parliament by law;

2BE it enacted by Parliament in the Sixty-first Year of the Republic of India as follows:—CHAPTER IPRELIMINARYShort title,applicationandcommencement.Definitions.46 of 1950.45 of 1950.62 of 1957.1. (1) This Act may be called the Clinical Establishments (Registration and Regulation)Act, 2010.(2) It applies, in the first instance, to the whole of the States of Arunachal Pradesh,Himachal Pradesh, Mizoram and Sikkim and the Union territories; and it shall apply to suchother State which adopts this Act by resolution passed in that behalf under clause (1) ofarticle 252 of the Constitution.(3) It shall come into force at once in the States of Arunachal Pradesh, HimachalPradesh, Mizoram and Sikkim and the Union territories, on such date as the Central Governmentmay, by notification, appoint and in any other State which adopts this Act under clause (1) ofarticle 252 of the Constitution, on the date of such adoption; and any reference in this Act tothe commencement of this Act shall, in relation to any State or Union territory, mean the dateon which this Act comes into force in such State or Union territory:Provided that different dates may be appointed for different categories of clinicalestablishments and for different recognised system of medicine.2. In this Act, unless the context otherwise requires,—(a) "authority" means the district registering authority set-up under section 10;(b) "certificate" means certificate of registration issued under section 30;(c) "clinical establishment" means—(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatoriumor an institution by whatever name called that offers services, facilities requiringdiagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancyin any recognised system of medicine established and administered or maintainedby any person or body of persons, whether incorporated or not; or(ii) a place established as an independent entity or part of an establishmentreferred to in sub-clause (i), in connection with the diagnosis or treatment ofdiseases where pathological, bacteriological, genetic, radiological, chemical,biological investigations or other diagnostic or investigative services with theaid of laboratory or other medical equipment, are usually carried on, establishedand administered or maintained by any person or body of persons, whetherincorporated or not,and shall include a clinical establishment owned, controlled or managed by—(a) the Government or a department of the Government;(b) a trust, whether public or private;(c) a corporation (including a society) registered under a Central, Provincial orState Act, whether or not owned by the Government;(d) a local authority; and(e) a single doctor,but does not include the clinical establishments owned, controlled or managed by the ArmedForces.Explanation.— For the purpose of this clause "Armed Forces" means the forcesconstituted under the Army Act, 1950, the Air Force Act, 1950 and the Navy Act, 1957;

3(d) "emergency medical condition" means a medical condition manifesting itselfby acute symptoms of sufficient severity (including severe pain) of such a nature thatthe absence of immediate medical attention could reasonably be expected to resultin—(i) placing the health of the individual or, with respect to a pregnant women,the health of the woman or her unborn child, in serious jeopardy; or(ii) serious impairtment to bodily functions; or(iii) serious dysfunction of any organ or part of a body;(e) "National Council" means the National Council for clinical establishmentsestablished under section 3;(f) "notification" means a notification published in the Official Gazette;(g) "prescribed" means prescribed by rules made under this Act by the CentralGovernment or, as the case may be, the State Government;(h) "recognised system of medicine" means Allopathy, Yoga, Naturopathy,Ayurveda, Homoeopathy, Siddha and Unani System of medicines or any other systemof medicine as may be recognised by the Central Government;(i) "register" means the register maintained by the authority, State Governmentand the Central Government under sections 37, 38 and 39 respectively of this Actcontaining the number of clinical establishments registered;(j) "registration" means to register under section 11 and the expression registrationor registered shall be construed accordingly;(k) "rules" means rules made under this Act;(l) "Schedule" means the Schedule appended to this Act;(m) "standards" means the conditions that the Central Government may prescribeunder section 12, for the registration of clinical establishments;(n) "State Government", in relation to a Union territory, means the Administratorthereof appointed under article 239 of the Constitution; and(o) "to stabilise (with its grammatical variations and cognate expressions)" means,with respect to an emergency medical condition specified in clause (d), to providesuch medical treatment of the condition as may be necessary to assure, within reasonablemedical probability, that no material deterioration of the condition is likely to resultfrom or occur during the transfer of the individual from a clinical establishment.CHAPTER IITHE NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS16 of 1948.3. (1) With effect from such date as the Central Government may, by notificationappoint in this behalf, there shall be established for the purposes of this Act, a Council to becalled the National Council for clinical establishments.(2) The National Council shall consist of—(a) Director-General of Health Service, Ministry of Health and Family Welfare,ex officio, who shall be the Chairperson;(b) four representatives out of which one each to be elected by the—(i) Dental Council of India constituted under section 3 of the DentistsAct, 1948;Establishmentof NationalCouncil.

4(ii) Medical Council of India constituted under section 3 of the IndianMedical Council Act, 1956;(iii) Nursing Council of India constituted under section 3 of the IndianNursing Council Act, 1947;(iv) Pharmacy Council of India constituted under section 3 of the PharmacyAct, 1948;(c) three representatives to be elected by the Central Council of Indian Medicinerepresenting the Ayurveda, Siddha and Unani systems of medicine constituted undersection 3 of the Indian Medicine Central Council Act, 1970;(d) one representative to be elected by the Central Council of Homoeopathyconstituted under section 3 of the Homoeopathy Central Council Act, 1973;(e) one representative to be elected by the Central Council of the Indian MedicalAssociation;(f) one representative of Bureau of the Indian Sandards constituted undersection 3 of the Bureau of Indian Standards Act, 1986;(g) two representatives from the Zonal Council set-up under section 15 of theStates Reorganisation Act, 1956;(h) two representatives from the North-Eastern Council set-up under section 3of the North-Eastern Council Act, 1971;(i) one representative from the line of paramedical systems excluding systemsthat have been given representation under clause (b);(j) two representatives from National Level Consumer Group to be nominatedby the Central Government;(k) one representative from the Associations of Indian Systems of Medicinesrelating to Ayurveda, Siddha and Unani to be nominated by the Central Government;(l) the Secretary-General of the Quality Council of India, ex officio.(3) The nominated members of the National Council shall hold office for three yearsbut shall be eligible for re-nomination for maximum of one more term of three years.(4) The elected members of the National Council shall hold office for three years, butshall be eligible for re-election:Provided that the person nominated or elected, as the case may be, shall hold office forsuch period till he holds appointment of the office by virtue of which he was nominated orelected to the council.(5) The members of the National Council shall be entitled for such allowances as maybe prescribed by the Central Government.(6) The National Council may, subject to the previous approval of the CentralGovernment, make bye-laws fixing a quorum and regulating its own procedure and theconduct of all business to be transacted by it.(7) The National Council shall meet at least once in three months.(8) The National Council may constitute sub-committees and may appoint to suchsub-committee, as it deems fit, persons, who are not members of the Council, for such period,not exceeding two years, for the consideration of particular matters.(9) The functions of the National Council may be exercised notwithstanding anyvacancy therein.(10) The Central Government shall appoint such person to be the Secretary of theNational Council as the Central Government may prescribe, and may provide the NationalCouncil with such other secretarial and other staff as the Central Government considers necessary.102 of 1956.48 of 1947.8 of 1948.48 of 1970.59 of 1973.63 of 1986.37 of 1956.84 of 1971.

54. A person shall be disqualified for being appointed as a member of the NationalCouncil if he—(a) has been convicted and sentenced to imprisonment for an offence which, inthe opinion of the Central Government, involves moral turpitude; or(b) is an undischarged insolvent; or(c) is of unsound mind and stands so declared by a competent court; or(d) has been removed or dismissed from the service of the Government or aCorporation owned or controlled by the Government; or(e) has, in the opinion of the Central Government, such financial or other interestin the Council as is likely to affect prejudicially the discharge by him of his functions asa member.5. The National Council shall—(a) compile and publish a National Register of clinical establishments within twoyears from the date of the commencement of this Act;(b) classify the clinical establishments into different categories;(c) develop the minimum standards and their periodic review;(d) determine within a period of two years from its establishment, the first set ofstandards for ensuring proper healthcare by the clinical establishments;(e) collect the statistics in respect of clinical establishments;(f) perform any other function determined by the Central Government from timeto time.6. The National Council may associate with itself any person or body whose assistanceor advice it may desire in carrying out any of the provisions of this Act.7. The National Council shall follow a consultative process for determining the standardsand for classification of clinical establishments in accordance with such procedure as may beprescribed.CHAPTER IIIREGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTSDisqualificationsforappointmentas member.Functions ofNationalCouncil.Power to seekadvice orassistance.NationalCouncil tofollowconsultativeprocess.8. (1) Every State Government shall by notification constitute a State Council for clinicalestablishments or the Union territory Council for clinical establishments, as the case may be.(2) The State Council or the Union territory Council, as the case may be, shall consistof the following members, namely:—(a) Secretary, Health — ex officio, who shall be the Chairman;(b) Director of Health Services — ex officio member-secretary;(c) Directors of different streams of Indian Systems of Medicine—ex officiomembers;(d) one representative each to be elected by the executive committee of—(i) State Medical Council of India;(ii) State Dental Council of India;(iii) State Nursing Council of India;(iv) State Pharmacy Council of India;State Councilof clinicalestablishments.

6Providinginformationto NationalCouncil.Authority forregistration.(e) three representatives to be elected by the Executive of the State Council orthe Union territory Council, as the case may be, of Indian Medicine representing theAyurveda, Siddha and Unani systems of medicine;(f) one representative to be elected by the State Council of the Indian MedicalAssociation;(g) one representative from the line of paramedical systems;(h) two representatives from State level consumer groups or reputed non-Governmental organisations working in the field of health.(3) The nominated member of the State Council or the Union territory Council, as thecase may be, shall hold office for a term of three years, but shall be eligible for re-nominationfor maximum of one more term of three years.(4) The elected members of the State Council or the Union territory Council, as the casemay be, shall hold office for three years, but shall be eligible for re-election:Provided that the person nominated or elected, as the case may be, shall hold office forso long as he holds the appointment of the office by virtue of which he was nominated orelected to the State Council or the Union territory Council, as the case may be.(5) The State Council or the Union territory Council shall perform the following functions,namely:—(a) compiling and updating the State Registers of clinical establishment;(b) sending monthly returns for updating the National Register;(c) representing the State in the National Council;(d) hearing of appeals against the orders of the authority; and(e) publication on annual basis a report on the state of implementation ofstandards within their respective States.9. It shall be the responsibility of the State Council for clinical establishments tocompile and update the State Register of clinical establishments of the State and further tosend monthly returns in digital format for updating the national register.10. (1) The State Government shall, by notification, set-up an authority to be called thedistrict registering authority for each district for registration of clinical establishments, withthe following members, namely:—(a) District Collector — Chairperson;(b) District Health Officer — Convenor;(c) three members with such qualifications and on such terms and conditions asmay be prescribed by the Central Government.(2) Notwithstanding anything contained in sub-section (1), for the purposes ofprovisional registration of clinical establishments under section 14, the District Health Officeror the Chief Medical Officer (by whatever name called) shall exercise the powers of theauthority as per procedure that may be prescribed.Registrationfor clinicalestablishments.Condition forregistration.11. No person shall run a clinical establishment unless it has been duly registered inaccordance with the provisions of this Act.12. (1) For registration and continuation, every clinical establishment shall fulfil thefollowing conditions, namely:—(i) the minimum standards of facilities and services as may be prescribed;

7(ii) the minimum requirement of personnel as may be prescribed;(iii) provisions for maintenance of records and reporting as may be prescribed;(iv) such other conditions as may be prescribed.(2) The clinical establishment shall undertake to provide within the staff and facilitiesavailable, such medical examination and treatment as may be required to stabilise theemergency medical condition of any individual who comes or is brought to such clinicalestablishment.13. (1) Clinical establishment of different systems shall be classified into such categories,as may be prescribed by the Central Government, from time to time.(2) Different standards may be prescribed for classification of different categoriesreferred to in sub-section (1):Provided that in prescribing the standards for clinical establishments, the CentralGovernment shall have regard to the local conditions.CHAPTER IVPROCEDURE FOR REGISTRATIONClassificationof clinicalestablishments.14. (1) For the purposes of registration of the clinical establishment under section 10,an application in the prescribed proforma along with the prescribed fee shall be made to theauthority.(2) The application shall be filed in person or by post or online.(3) The application shall be made in such form and shall be accompanied by suchdetails as may be prescribed under this Act or rules made thereunder.(4) If any clinical establishment is in existence at the time of the commencement of thisAct, an application for its registration shall be made within one year from the date of thecommencement of this Act and a clinical establishment which comes into existence aftercommencement of this Act, shall apply for permanent registration within a period of sixmonths from the date of its establishment.(5) If any clinical establishment is already registered under any existing law requiringregistration of such establishments, even then it shall apply for registration as referred to insub-section (1).15. The authority shall, within a period of ten days from the date of receipt of suchapplication, grant to the applicant a certificate of provisional registration in such form andcontaining such particulars and such information, as may be prescribed.16. (1) The authority shall not conduct any inquiry prior to the grant of provisionalregistration.(2) Notwithstanding the grant of the provisional certificate of registration, the authorityshall, within a period of forty-five days from the grant of provisional registration, cause to bepublished in such manner, as may be prescribed, all particulars of the clinical establishmentso registered provisionally.17. Subject to the provisions of section 23, every provisional registration shall be validto the last day of the twelfth month from the date of issue of the certificate of registration andsuch registration shall be renewable.18. The certificate shall be kept affixed in a conspicuous place in the clinicalestablishment in such manner so as to be visible to every one visiting such establishment.19. In case the certificate is lost, destroyed, mutilated or damaged, the authority shallissue a duplicate certificate on the request of the clinical establishment and on the paymentof such fees as may be prescribed.Applicationfor provisionalcertificate ofregistration.Provisionalcertificate.No inquiryprior toprovisionalregistration.Validity ofprovisionalregistration.Display ofcertificate ofregistration.Duplicatecertificate.

8Certificate tobe nontransferable.Publication ofexpiry ofregistration.Renewal ofregistration.Time limitforprovisionalregistration.Applicationforpermanentregistration.Verification ofapplication.Display ofinformationfor filingobjections.Communicationof objections.Standards forpermanentregistrationAllowing ordisallowing ofregistration.20. (1) The certificate of registration shall be non-transferable.(2) In the event of change of ownership or management, the clinical establishmentshall inform the authority of such change in such manner as may be prescribed.(3) In the event of change of category, or location, or on ceasing to function as aclinical establishment, the certificate of registration in respect of such clinical establishmentshall be surrendered to the authority and the clinical establishment shall apply afresh forgrant of certificate of registration.21. The authority shall also cause to be published within such time and in suchmanner, as may be prescribed, the names of clinical establishments whose registration hasexpired.22. The application for renewal of registration shall be made thirty days before theexpiry of the validity of the certificate of provisional registration and, in case the applicationfor renewal is made after the expiry of the provisional registration, the authority shall allowrenewal of registration on payment of such enhanced fees, as may be prescribed.23. Where the clinical establishments in respect of which standards have been notifiedby the Central Government, provisional registration shall not be granted or renewed beyond,—(i) the period of two years from the date of notification of the standards in case ofclinical establishments which came into existence before the commencement of this Act;(ii) the period of two years from the date of notification of the standards forclinical establishments which come into existence after the commencement of this Actbut before the notification of the standards; and(iii) the period of six months from the date of notification of standards for clinicalestablishments which come into existence after standards have been notified.24. Application for permanent registration by a clinical establishment shall be made tothe authority in such form and be accompanied by such fees, as may be prescribed.25. The clinical establishment shall submit evidence of having complied with theprescribed minimum standards in such manner, as may be prescribed.26. As soon as the clincial establishment submits the required evidence of havingcomplied with the prescribed minimum standards, the authority shall cause to be displayedfor information of the public at large and for filing objections, if any, in such manner, as maybe prescribed, all evidence submitted by the clinical establishment of having complied withthe prescribed minimum standards for a period of thirty days before processing for grant ofpermanent registration.27. If objections are recieved within the period referred to in the preceding section,such objections shall be communicated to the clinical establishment for response within aperiod of forty-five days.28. Permanent registration shall be granted only when a clinical establishment fulfilsthe prescribed standards for registration by the Central Government.29. The authority shall pass an order immediately after the expiry of the prescribedperiod and within the next thirty days thereafter either—(a) allowing the application for permanent registration; or(b) disallowing the application:Provided that the authority shall record its reasons, if it disallows an application, forpermanent registration.

930. (1) The authority shall, if it, allows an application of the clinical establishment issuea certificate of permanent registration in such form and containing such particulars, as maybe prescribed.(2) The certificate shall be valid for a period of five years from the date of issue.(3) For the purposes of sub-section (1), the provisions of sections 18, 19, 20 and 21shall also apply.(4) The applications for renewal of permanent registration shall be made within sixmonths before the expiry of the validity of the certificate of permanent registration and, incase the application of renewal is not submitted within the stipulated period, the authoritymay allow renewal of registration on payment of such enhanced fees and penalties as may beprescribed.31. The disallowing of an application for permanent registration shall not debar aclinical establishment from applying afresh for permanent registration under section 24 andafter providing such evidence, as may be required, of having rectified the deficiences onwhich grounds the earlier application was disallowed.32. (1) If, at any time after any clinical establishment has been registered, the authorityis satisfied that,—(a) the conditions of the registration are not being complied with; or(b) the person entrusted with the management of the clinical establishment hasbeen convicted of an offence punishable under this Act,it may issue a notice to the clinical establishment to show cause within three months’ time asto why its registration under this Act should not be cancelled for the reasons to be mentionedin the notice.(2) If after giving a reasonable opportunity to the clinical establisment, the authority issatisfied that there has been a breach of any of the provisions of this Act or the rules madethereunder, it may, by an order, without prejudice to any other action that it may take againstsuch clinical establishment, cancel its registration.(3) Every order made under sub-section (2) shall take effect—(a) where no appeal has been preferred against such order immediately on theexpiry of the period prescribed for such appeal; and(b) where such appeal has been preferred and it has been dismissed from thedate of the order of such dismissal:Provided that the authority, after cancellation of registration for reasons to be recordedin writing, may restrain immediately the clinical establishment from carrying on if there isimminent danger to the health and safety of patients.33. (1) The authority or an officer authorised by it shall have the right to cause aninspection of, or inquiry in respect of any registered clinical establishment, its building,laboratories and equipment and also of the work conducted or done by the clinicalestablishment, to be made by such multi-member inspection team as it may direct and tocause an inquiry to be made in respect of any other matter connected with the clinicalestablishment and that establishment shall be entitled to be represented thereat.(2) The authority shall communicate to the clinical establishment the views of thatauthority with reference to the results of such inspection or inquiry and may, after ascertainingthe opinion of the clinical establishment thereon, advise that establishment upon the actionto be taken.(3) The clinical establishment shall report to the authority, the action, if any, which isproposed to be taken or has been taken upon the results of such inspection or inquiry andsuch report shall be furnished within such time, as the authority may direct.(4) Where the clinical establishment does not, within a reasonable time, take action tothe satisfaction of the authority, it may, after considering any explanation furnished orCertificate ofpermanentregistration.Freshapplicationfor permanentregistration.Cancellation ofregistration.Inspection ofregisteredclinicalestablishments.

10Powerenter.toLevy of feeby StateGovernmentsAppeal.representation made by the clinical establishment, issue such directions within such time asindicated in the direction, as that authority deems fit, and the clinical establishment shallcomply with such directions.34. The authority or an officer authorised by it may, if there is any reason to suspectthat anyone is carrying on a clinical establishment without registration, enter and search inthe manner prescribed, at any reasonable time and the clinical establishment, shall offerreasonable facilities for inspection or inquiry and be entitled to be represented thereat:Provided that no such person shall enter the clinical establishment without givingnotice of his intention to do so.35. The State Government may charge fees for different categories of clinicalestablishments, as may be prescribed.36. (1) Any person, aggreived by an order of the registering authority refusing to grantor renew a certificate of registration or revoking a certificate of registration may, in suchmanner and within such period as may be prescribed, prefer an appeal to the State Council:Provided that the State Council may entertain an appeal preferred after the expiry of theprescribed period if it is satisfied that the appellant was prevented by sufficient cause frompreferring the appeal in time.(2) Every appeal under sub-section (1) shall be made in such form and be accompaniedby such fee as may be prescribed.CHAPTER VREGISTER OF CLINICAL ESTABLISHMENTSRegister ofclinicalestablishments.Maintenanceof StateRegister ofclinicalestablishments.Maintenanceof NationalRegister ofclinicalestablishments.37. (1) The authority shall within a period of two years from its establishment, compile,publish and maintain in digital format a register of clinical establishments, registered by itand it shall enter the particulars of the certificate so issued in a register to be maintained insuch form and manner, as may be prescribed by the State Government.(2) Each authority, including any other authority set-up for the registration of clinicalestablishments under any other law for the time being in force, shall supply in digital formatto the State Council of clinical establishments a copy of every entry made in the register ofclinical establishments in such manner, as may be prescribed to ensure that the State Registeris constantly up-to-date with the registers maintained by the registering authority in theState.38. (1) Every State Government shall maintain in digital and in such form and containingsuch particulars, as may be prescribed by the Central Government a register to be known as theState Register of clinical establishments in respect of clinical establishments of that State.(2) Every State Government shall supply in digital format to the Central Government, acopy of the State Register of clinical establishments and shall inform the Central Governmentall additions to and other amendments in such register made, for a particular month by the15th day of the following month.39. The Central Government shall maintain in digital format an All India Register tobe called as the National Register of clinical establishments that shall be an amalgam of theState Register of clinical establishments maintained by the State Governments and shallcause the same to be published in digital format.CHAPTER VIPENALTIESPenalty.40. Whoever contravenes any provision of this Act shall, if no penalty is providedelsewhere, be punishable for the first offence with fine which may extend to ten thousand

11rupees, for any second offence with fine which may extend to fifty thousand rupees and forany subsequent offence with fine which may extend to five lakh rupees.41. (1) Whoever carries on a clinical establishment without registration shall, onconviction for first offence, be punishable with a monetary penalty up to fifty thousandrupees, for second offence with monetary penalty which may extend to two lakh rupeesand for any subsequent offence with monetary penalty which may extend to five lakhrupees.(2) Whoever knowingly serves in a clinical establishment which is not duly registeredunder this Act, shall be punishable with monetary penalty which may extend to twenty-fivethousand rupees.(3) For the purpose of adjudging under sub-sections (1) and (2), the authority shallhold an inquiry in the prescribed manner after giving any person concerned a reasonableopportunity of being heard for the purpose of imposing any monetory penalty.(4) While holding an inquiry the authority shall have power to summon and enforcethe attendance of any person acquainted with the facts and circumstances of the case togive evidence or to produce any document which in the opinion of the authority, may beuseful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfiedthat the person has failed to comply with the provisions specified in sub-sections (1) and (2),it may by order impose the penalty specified in those sub-sections to be deposited withinthirty days of the order in the account referred to in sub-section (8) of section 42.(5) While determining the quantum of monetary penalty, the authority shall take intoaccount the category, size and type of the clinical establishment and local conditions of thearea in which the establishment is situated.(6) Any person aggrieved by the decision of the authority may prefer an appeal to theState Council within a period of three months from the date of the said decision.(7) The manner of filing the appeal referred to in sub-section (5) shall be such as maybe prescribed.42. (1) Whoever wilfully disobeys any direction lawfully given by any person orauthority empowered under this Act to give such direction, or obstructs any person orauthority in the discharge of any functions which such person or authority is required orempowered under this Act to discharge, shall be punishable with monetary penalty whichmay extend to five lakh rupees.(2) Whoever being required by or under this Act to supply any information wilfullywithholds such information or gives information which he knows to be false or which hedoes not believe to be true, shall be punishable with monetary penalty which may extend tofive lakh rupees.(3) For the purpose of adjudging under sub-sections (1) and (2), the authority shallhold an inquiry in the prescribed manner after giving any person concerned a reasonableopportunity of being heard for the purpose of imposing any monetory penalty.(4) While holding an inquiry the authority shall have power to summon and enforcethe attendance of any person acquainted with the facts and circumstances of the case togive evidence or to produce any document which in the opinion of the authority, may beuseful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfiedthat the person has failed to comply with the provisions specified in sub-sections (1) and (2),it may by order impose the penalty specified in those sub-sections to be deposited withinthirty days of the order in the account referred to in sub-section (8) .(5) While determining the quantum of monetary penalty, the authority shall take intoaccount the category, size and type of the clinical establishment and local conditions of thearea in which the establishment is situated.Monetarypenalty fornonregistration.Disobedienceof order,obstructionand refusal ofinformation.

12(6) Any person aggrieved by the decision of the authority may prefer an appeal to theState Council within a period of three months from the date of the said decision.(7) The manner of filing the appeal referred to in sub-section (5) shall be such as maybe prescribed.(8) The monetary penalty levied under sections 41 and 42 shall be credited to suchaccount as the State Government may by order specify in this behalf.Penalty forminordeficiencies.Contraventionby companies.Offences byGovernmentDepartments.Recovery offine.43. Whoever contravenes any provision of this Act or any rule made thereunderresulting in deficiencies that do not pose any imminent danger to the health and safety ofany patient and can be rectified within a reasonable time, shall be punishable with fine whichmay extend to ten thousand rupees.44. (1) Where a person committing contravention of any of the provisions of this Actor of any rule made thereunder is a company, every person who, at the time the contraventionwas committed, was in charge of, and was responsible to the company for the conduct of thebusiness of the company, as well as the company, shall be deemed to be guilty of thecontravention and shall be liable to fine:Provided that nothing contained in this sub-section shall render any such personliable to any punishment if he proves that the contravention was committed without hisknowledge or that he had exercised all due diligence to prevent the commission of suchcontravention.(2) Notwithstanding anything contained in sub-section (1), where a contravention ofany of the provisions of this Act or of any rule made thereunder has been committed by acompany and it is proved that the contravention has taken place with the consent orconnivance of, or is attributable to any neglect on the part of, any director, manager, secretaryor other officer of the company, such director, manager, secretary or other officer shall also bedeemed to be guilty of that contravention and shall be liable to fine.Explanation.—For the purpose of this section,—(a) "company" means a body corporate and includes a firm or other associationof individuals; and(b) "director", in relation to a firm, means a partner in the firm.45. (1) Where an offence under this Act has been committed by any Department ofGovernment within a period of six months after the commencement of this Act, the Head ofthe Department shall be deemed to be guilty of the offence and shall be liable to be proceededagainst and punished accordingly:Provided that nothing contained in this section shall render such Head of the Departmentliable to any punishment if he proves that the offence was committed without his knowledgeor that he exercised all due diligence to prevent the commission of such offence.(2) Notwithstanding anything contained in sub-section (1), where an offence underthis Act has been committed by a Department of Government and it is proved that theoffence has been committed with the consent or connivance of, or is attributable to anyneglect on the part of, any officer, other than the Head of the Department, such officer shallalso be deemed to be guilty of that offence and shall be liable to be proceeded against andpunished accordingly.46. Whoever fails to pay the fine, the State Council of clinical establishment mayprepare a certificate signed by an officer authorised by it specifying the fine due from suchperson and send it to the Collector of the District in which such person owns any propertyor resides or carries on his business and the said Collector, on receipt of such certificate,shall proceed to recover from such person the amount specified thereunder, as if it were anarrear of land revenue.

13CHAPTER VIIMISCELLANEOUS45 of 1860.47. (1) No suit, prosecution or other legal proceedings shall lie against any authorityor any member of the National Council or State Council or any officer authorised in thisbehalf in respect of anything, which is in good faith done or intended to be done in pursuanceof the provisions of this Act or any rule made thereunder.(2) No suit or other legal proceedings shall lie against a State Government or theCentral Government in respect of any loss or damage caused or likely to be caused byanything which is in good faith done or intended to be done in pursuance of the provisionsof this Act or any rule made thereunder.48. Every clinical establishment shall, within such time or within such extended time,as may be prescribed in that behalf, furnish to the authority or the State Council or theNational Council such returns or the statistics and other information in such manner, as maybe prescribed by the State Government, from time to time.49. Without prejudice to the foregoing provisions of this Act, the authority shall havethe power to issue such directions, including furnishing returns, statistics and otherinformation for the proper functioning of clinical establishments and such directions shall bebinding.50. Every employee of the authority, the National Council and the State Council shallbe deemed to, when acting or purporting to act in pursuance of any of the provisions of thisAct, be public servants within the meaning of section 21 of the Indian Penal Code.51. (1) If any difficulty arises in giving effect to the provisions of this Act, the CentralGovernment may, by order published in the Official Gazette, make such provisions notinconsistent with the provisions of this Act as may appear to it to be necessary or expedientfor removal of the difficulty:Provided that no such order shall be made after the expiry of a period of two years fromthe date of commencement of this Act.(2) Every order made under this section shall, as soon as may be after it is made, be laidbefore each House of Parliament.52. (1) The Central Government may, by notification, make rules for carrying out all orany of the provisions of this Act.(2) In particular and without prejudice to the generality of the foregoing power, suchrules may provide for all or any of the following matters, namely:—(a) allowances for the members of the National Council under sub-section (5) ofsection 3;(b) appointment of such person to be the Secretary of the State Council by theCentral Government under sub-section (10) of section 3;(c) the determination of standards and for classification of clinical establishmentsunder section 7;(d) the qualification and the terms and conditions for the members of the authorityunder clause (c) of sub-section (1) of section 10;(e) the procedure under which the powers of the authority may be exercised bythe District Health Officer or Chief Medical Officer for the purpose of provisionalregistration of clinical establishment under sub-section (2) of section 10;Protection ofaction takenin good faith.Furnishing ofreturns, etc.Power to givedirections.Employees ofthe authority,etc., to bepublicservants.Power toremovedifficulties.Power ofCentralGovernmentto make rules.

14(f) the minimum standards of facilities and services under clause (i) of subsection(1) of section 12;(g) the minimum number of personnel under clause (ii) of sub-section (1) ofsection 12;(h) the maintenance of records and reporting by the clinical establishment underclause (iii) of sub-section (1) of section 12;(i) other conditions for registration and continuation of clinical establishmentunder clause (iv) of sub-section (1) of section 12;(j) classification of clinical establishment under sub-section (1) of section 13;(k) the different standards for classification of clinical establishments undersub-section (2) of section 13;(l) the minimum standards for permanent registration under section 28;(m) the form and particulars to be contained in the register to be maintainedunder section 38.Laying of rules.Power of StateGovernment tomake rules.53. Every rule made by the Central Government under this Act shall be laid, as soon asmay be after it is made, before each House of Parliament, while it is in session, for a totalperiod of thirty days which may be comprised in one session or in two or more successivesessions and if, before the expiry of the session immediately following the session or thesuccessive sessions aforesaid, both Houses agree in making any modification in the rule orboth Houses agree that the rule should not be made, the rule shall thereafter have effect onlyin such modified form or be of no effect, as the case may be; so, however, that any suchmodification or annulment shall be without prejudice to the validity of anything previouslydone under that rule.54. (1) The State Government may, by notification, make rules for carrying out inrespect of matters which do not fall within the purview of section 52.(2) In particular and without prejudice to the generality of the foregoing power, suchrules may provide for all or any of the following matters, namely:—(a) the proforma and the fee to be paid for registration under sub-section (1) ofsection 14;(b) the form and details of application under sub-section (3) of section 14;(c) the particulars and information contained in certificate of provisionalregistration under section 15;(d) the manner of publication of all particulars of the clinical establishmentproposed to be registered under sub-section (2) of section 16;(e) the fees to be paid to issue a duplicate certificate under section 19;(f) the change of ownership or management to be informed by the clinicalestablishment to the authority under sub-section (2) of section 20;(g) the manner in which the authority shall publish the names of the clinicalestablishments whose registration expired under section 21;(h) the enhanced fees to be charged for renewal after expiry of the provisionalregistration under section 22;(i) the form of the application and fees to be charged by the State Governmentunder section 24;(j) the manner of submitting evidence of the clinical establishments havingcomplied with the minimum standards under section 25;

15(k) the manner of displaying information of the clinical establishments havingcomplied with the minimum standards for filing objection under section 26;(l) the expiry of period specified in section 29;(m) the form and particulars of the certificate of registration under section 30;(n) the period within which an appeal shall be preferred under clause (a) ofsub-section (3) of section 32;(o) the manner of entry and search of clinical establishment under section 34;(p) the fees to be charged by the State Government for different categories ofclinical establishments under section 35;(q) the manner and the period within which an appeal may be preferred to theState Council under sub-section (1) of section 36;(r) the form and the fee to be paid for an appeal under sub-section (2) of section 36;(s) the form and the manner in which the register to be maintained undersub-section (1) of section 37;(t) the manner of supply to the State Council in digital format the entry made inthe register of clinical establishment under sub-section (2) of section 37;(u) the manner of holding an inquiry by the authority under sub-section (3) ofsections 41 and 42;(v) the manner of finding the appeal under sub-section (7) of sections 41 and 42;(w) the manner and the time within which the information is to be furnished tothe authority or the State Council or the National Council as the case may be, undersection 48;(x) any other matter which is required to be or may be prescribed by the StateGovernment.55. Every rule made by the State Government under this section shall be laid, as soonas may be after it is made, before each House of the State Legislature where it consists of twoHouses, or where such Legislature consists of one House, before that House.56. (1) The provisions of this Act shall not apply to the States in which the enactmentsspecified in the Schedule are applicable:Provided that the States in which the enactments referred to in sub-section (1) areapplicable, and such States subsequent to the commencement of this Act, adopts this Actunder clause (1) of article 252 of the Constitution, the provisions of this Act shall, subsequentto such adoption, apply in that State.(2) The Central Government may, as and when consider necessary, by notificationamend the Schedule.Layingrules.Savings.of

THE SCHEDULE[See section 56]1. The Andhra Pradesh Private Medical Care Establishments (Registration andRegulation) Act, 2002.2. The Bombay Nursing Homes Registration Act, 1949.3. The Delhi Nursing Homes Registration Act, 1953.4. The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue(Ragistrikaran Tatha Anugyapan) Adhiniyam, 1973.5. The Manipur Homes and Clinics Registration Act, 1992.6. The Nagaland Health Care Establishments Act, 1997.7. The Orissa Clinical Establishments (Control and Regulation) Act, 1990.8. The Punjab State Nursing Home Registration Act, 1991.9. The West Bengal Clinical Establishments Act, 1950.16

S-1\E\BILL 2010\LAW\92LAW\92LAWSTATEMENT OF OBJECTS AND REASONSAt present, the supervision and regulation of the quality of services provided by thehealth care delivery system to the people by both public and private sectors has largelyremained a contentious and therefore, unresolved issue. The current structure of the healthcare delivery system does not provide enough incentives for improvement in efficiency. Theprivate sector health care delivery system in India has remained largely unregulated anduncontrolled. Problems range from inadequate and inappropriate treatment, excessive use ofhigher technologies, and wasting of scarce resources to serious problems of medicalmalpractice and negligence.2. Despite many State Legislatures having enacted laws for regulating health careproviders, the general perception is that current regulatory process for health care providersin India is inadequate or not responsive to ensure health care services of acceptable qualityand prevent negligence. Concerns about how to improve health care quality have continuedto be frequently raised by the general public and a wide variety of stakeholders, includingGovernment, professional associations, private providers, agencies financing health care,National Human Rights Commission and also by judiciary.3. Accordingly, a need has long been felt for a central legislation for ensuring uniformstandards of facilities and services by the clinical establishments throughout the Statewhere the Legislative Assemblies have passed resolutions under article 252 of the Constitutionand the Union territories and the States which may adopt the legislation by such resolutions.4. In view of the above, the Clinical Establishment (Registration and Regulation) Bill,2007 was introduced in Lok Sabha on the 30th August, 2007 and the same was referred to theDepartment-related Parliamentary Standing Committee on Health and Family Welfare whichmade certain recommendations on the provisions of the said Bill. However, the said Bill waslapsed due to dissolution of the Fourteenth Lok Sabha.5. It is now proposed to introduced the Clinical Establishments (Registration andRegulation) Bill, 2010 on the lines of above Bill incorporating therein certain recommendationsmade by the Department-related Parliamentary Standing Committee on Health and FamilyWelfare.6. The salient features of the proposed legislation, inter alia, are as follows:—(i) the proposed legislation provides for the constitution of a National Councilconsisting of representatives of Medical Council of India, Dental Council of India,Nursing Council of India, the Pharmacy Council of India, the Indian Systems ofMedicines representing Ayurveda, Siddha, Unani and Homoeopathy systems, theIndian Medical Association, the Bureau of Indian Standards, the Zonal Councils setupunder the States Reorganisation Act, 1956, the North-Eastern Council, etc.;(ii) the function of the National Council shall be to determine the standards forthe clinical establishment, classify the clinical establishment into different categories,develop the minimum standards and their periodic review, compile, maintain and updatea National Register of clinical establishments, perform any other function determinedby the Central Government, from time to time;(iii) the function of the State Council shall be to compile, maintain and updatethe State Registers of clinical establishments and to send monthly returns for updatingthe National Registers. The State Councils shall also publish reports on theimplementation of standards within their respective States, annually;17

18(iv) the concerned State Governments shall, by notification, set-up an authorityto be called the district registering authority under the chairmanship of District Collectorfor registration of clinical establishments;(v) no person shall carry on a clinical establishment unless it has been registeredin accordance with the provisions of the proposed Bill. The legislation would notapply to the clinical establishments of the Armed Forces;(vi) it is proposed that clinical establishments already in existence may beallowed for provisional registration to carry out their business. There shall be no priorenquiry for provisional registration. But the authority shall have power to makeenquiry in accordance with such rules as may be prescribed.(vii) the clinical establishment having provisional registration shall fulfil thestandards which may be notified for the purpose. The provisional certificate shall notbe granted or renewed beyond a period of two years from the date of notification ofstandards;(viii) any clinical establishment may apply for permanent registration in suchform and shall pay such fee as may be prescribed by the State Government. Adetailed procedure for permanent registration is being provided in the proposedlegislation;(ix) the authority shall have power to cancel the registration of the clinicalestablishment which fails to comply with the conditions prescribed by the CentralGovernment. The authority shall have power to inspect a registered clinicalestablishment. Any person aggrieved by an order of the registering authority shallprefer an appeal to the State Council;(x) the clinical establishments shall undertake to provide within the staff andfacilities available, such medical examination and treatment as may be required tostabilise the emergency medical condition of any individual who comes or is broughtto such clinical establishment;(xi) the certificate of permanent registration issued by the authority is valid for aperiod of five years from the date of issue;(xii) there shall be register of clinical establishment at the district level, Statelevel and the National level;(xiii) if any person contravenes any provisions of the proposed legislation orany rules made thereunder, he shall be punished with fine. The maximum penalty beingprovided is rupees five lakh;(xiv) conferring power upon an authority, to levy monetory penalty for violationof the provisions of sections 41 and 42 of the proposed Bill;(xv) any person aggrieved by the decision of authrity may prefer an appeal to theState Council.7. Legislation in respect of "Public health and sanitation, hospitals and dispensaries"are relatable to Entry 6 of List II — State List in the Seventh Schedule to the Constitution andParliament has no power to make a law in the State (apart from the provisions of articles 249,250 and 252 of the Constitution) under article 252 of the Constitution where the Legislaturesof two or more States pass resolutions in pursuance of article 252 of the Constitutionempowering Parliament to pass the necessary legislation on the subject, a Bill may beintroduced in Parliament. The Legislatures of the States of Arunachal Pradesh, HimachalPradesh, Mizoram and Sikkim have passed such resolutions. The Bill is intended to give

19effect to the resolutions passed by the Legislatures of the aforesaid States and to make alsoprovisions in respect to Union territories.8. The Bill seeks to achieve the above objectives.NEW DELHI;The 10 March, 2010.GHULAM NABI AZAD.————PRESIDENT'S RECOMMENDATION UNDER ARTICLE 117 (3)OF THE CONSTITUTION OF INDIA[Copy of letter No. Z.28015/48/2000-H dated the 15th March, 2010 from Shri GhulamNabi Azad, Minister of Health and Family Welfare to the Secretary-General, Lok Sabha.]The President, having been informed of the subject matter of the proposed ClinicalEstablishments (Registration and Regulation) Bill, 2010, recommends to the House theconsideration of the Bill under article 117(3) of the Constitution.

Notes on clausesClause 2.—This clause defines certain words and expressions used in the Bill including'clinical establishment', 'emergency medical condition', 'National Council', 'recognised systemof medicine', 'standards', 'to stabilise', etc.Clause 3.—This clause contains provisions for establishment of a council to becalled the National Council for clinical establishments which would consist a chairpersonand nineteen representatives drawn from the fields specified therein. The nominated or theelected members of the Council shall hold office for three years and shall be eligible for reelectionor re-nomination, as the case may be and they shall be entitled for allowances asprovided by rules to be made by Central Government. The Council, subject to the previousapproval of the Central Government, make bye-laws fixing a quorum regulating its ownprocedure and conduct of business. It also provides that the council shall meet at least oncein three months and may constitute sub-committees for consideration of particular matters.It further provides that the Central Government shall appoint a person to be the secretary ofthe council and provide other secretarial and other staff as considers necessary.Clause 4.—This clause contains provisions for disqualifications for appointment asmember of the National Council and specifies the circumstances for such disqualifications.Clause 5.—This clause specify functions of the National Council which, inter alia,includes compiling and publishing a national register of clinical establishments, classifyclinical establishments, develop minimum standards, collecting statistics in respect of clinicalestablishments, etc.Clause 6.—This clause empowers the National Council to seek advice or assistanceof any person or body in carrying out any of the provisions of this Act.Clause 7.—This clause contains provisions for consultative process to be followedby the National Council for determining the standards and for classification of clinicalestablishments.Clause 8.—This clause contains provisions for constitution of a State Council forclinical establishments or a Union territory Council for Clinical Establishments which wouldconsist of a Chairman and thirteen members drawn from the fields specified therein. It alsoprovides that the nominated or elected members of the State Council or the Union territoryCouncil shall hold office for three years and shall be eligible for renomination or re-electionas the case may be. It further provides that the State Council or Union territory Council shallperform, (a) compiling and updating the State Register of Clinical Establishment; (b) sendingmonthly returns for updating the National Register; (c) representing the State in the NationalCouncil; (d) hearing of appeals against the orders of the authority; and (e) publication onannual basis a report on the state of implementation of standards within their respectiveStates.Clause 9.—This clause fixes responsibility of the State Council for clinicalestablishments to compile and update the State register of clinical establishments and sendmonthly returns in digital format for updating the National Register.Clause 10.—This clause provides that every State shall set up an authority to becalled district registering authority for each district for registration of the clinicalestablishments which would consist of chairperson, convenor and three members as providedby rules to be made by the Central Government. It also provides that for the purpose ofprovisional registration, the District Health Officer or the Chief Medical Officer shall exercisethe powers of the authority.Clause 11.—This clause provides that no person shall run a clinical establishmentunless it has been duly registered in accordance with the provisions of this Act.20

21Clause 12.—This clause provides conditions for registration and continuation ofclinical establishment. It provides the minimum standards of facilities and services, theminimum qualifications for the personnel, provisions for maintenance of records and reporting.It also provides that every clinical establishment shall provide staff, facilities for medicalexamination and treatment as may be required to stabilise the emergency medical conditionof any individual who comes or is brought to such clinical establishment.Clause 13.—This clause empowers the Central Government to make rules to classifyclinical establishments of different systems into categories and for different standards fordifferent categories keeping in view the local conditions.Clause 14.—This clause provides procedure for making application for provisionalregistration. The application to the authority shall be in the proforma along with such fees asmay be provided by rules to be made by the State Government. It also provides that if anyclinical establishment is in existence at the time of commencement of the proposed legislation,such application shall be made within one year from the date of the commencement ofproposed legislation and a clinical establishment which comes into existence aftercommencement of this Act shall apply for permanent registration within a period of sixmonths. It further provides that if any clinical establishment is already registered under anyexisting law even then it shall apply for registration under this clause.Clause 15.—This clause provides that the authority shall within ten days from thedate of receipt of application, issue provisional certificate for clinical establishments in suchmanner as may be provided by rules by the State Government.Clause 16.—This clause provides that the authority shall not conduct any inquiryprior to the grant of provisional registration for clinical establishments. It also provides thatthe authority shall within a period of forty-five days from the grant of provisional registration,cause to be published all particulars of clinical establishments so registered provisionally.Clause 17.—This clause provides that subject to the provision of clause 23 everyprovisional registration is valid for one year and such registration shall be renewable.Clause 18.—This clause provides that every clinical establishment shall display thecertificate of registration in a conspicuous place in the clinical establishment so as to bevisible to every person visiting such establishment.Clause 19.—This clause provides for issuing duplicate certificate by the authority onthe request of the clinical establishments and on the payment of requisite fees, if the certificateis lost, destroyed, mutilated or damaged.Clause 20.—This clause provides that the certificate of registration shall be nontransferableand in case of change of ownership or management, the clinical establishmentshall inform the authority of such change. It also provides that in the event of change ofcategory or location of registration or ceasing to function as clinical establishment, thecertificate shall be surrendered to the authority.Clause 21.—This clause provides for publication of expiry of registration of clinicalestablishments by the registering authority.Clause 22.—This clause provides for application for renewal of registration andprocedure therefor.Clause 23.—This clause provides that where the clinical establishments in respect ofwhich standards have been notified by the Central Government, provisional registrationshall not be granted or renewed beyond,—(i) the period of two years from the date of notification of the standards in caseof clinical establishments which came into existence before the commencement of theproposed legislation;(ii) the period of two years from the date of notification of the standards in caseof clinical establishments which come into existence after the commencement of theproposed legislation but before the notification of the standards;

22(iii) the period of six months from the date of notification of standards for clinicalestablishments which come into existence after standards have been notified.Clause 24.—This clause provides procedure for making application for permanentregistration. It provides that an application to the authority shall be made in the form andaccompanied by such fees as may be provided by rules by the State Government.Clause 25.—This clause provides that every clinical establishment shall submitevidence of having complied with the prescribed minimum standards in such manner, as maybe provided by rules by the State Government.Clause 26.—This clause provides that as soon as the clinical establishment submitsthe required evidence of having complied with the prescribed minimum standards, theauthority shall display the same for information of the public for filing objections, if any, fora period of thirty days before processing for grant of permanent registration.Clause 27.—This clause provides for communication of objections received by theauthority within the period referred to in clause 26 to the clinical establishment for responsewithin a period of forty-five days.Clause 28.—This clause provides that permanent registration shall be granted onlywhen a clinical establishment fulfils the standards for registration as may be provided byrules by the Central Government.Clause 29.—This clause provides time limit to the authority for allowing or disallowingof registration and record its reasons for disallowing the application.Clause 30.—This clause provides for issuing certificate of permanent registration insuch form and containing such particulars as may be provided by rules by the StateGovernment. It further provides that the certificate issued under the said clause shall bevalid for a period of five years from the date of issue. It also provides for renewal of permanentregistration and procedure therefor. However, the provisions of clauses 18, 19, 20 and 21 alsoapply to permanent registration.Clause 31.—This clause provides for applying fresh application for permanentregistration if the earlier application for permanent registration is disallowed.Clause 32.—This clause provides for issuing a show cause notice for cancellation ofregistration if the conditions of the registration are not complied with; or the person entrustedwith the management of the clinical establishment has been convicted of an offence punishableunder this proposed legislation. It also provides that the authority after giving a reasonableopportunity to the clinical establishment satisfied that there has been a breach of any of theprovision of the proposed legislation or the rules; it may by an order cancel its registrationand every such cancellation order shall take effect if no appeal has been preferred, on theexpiry of the period prescribed for such appeal and if any appeal has been preferred anddismissed, from the date of the order of such dismissal. It further provides that suchcancellation of registration shall be effective immediately if there is an imminent danger to thehealth and safety of general public.Clause 33.—This clause provides for inspection or inquiry in respect of any registeredclinical establishment, its buildings, laboratories and also of the work conducted or done byit and intimating the inspection report to the clinical establishment and advise thatestablishment upon the action to be taken. It also provides that the clinical establishmentshall report to the authority, the action, if any, has been taken upon the results of suchinspection. If no action is taken to the satisfaction of the authority, it may issue directionsand the clinical establishment shall comply with such directions.Clause 34.—This clause provides that the registering authority or an officer authorisedby it after giving prior notice, may enter and search any clinical establishment suspecting ofnot being registered under the provisions of proposed legislation in the manner as may beprovided by rules by the State Government. However, the clinical establishments shall offerreasonable facilities for such inspection or enquiry.

23Clause 35.—This clause provides that fees may be charged for different categories ofclinical establishments as may be provided by rules by the State Government.Clause 36.—This clause contains provisions for appeal. Any person aggrieved by anorder of the registering authority refusing to grant or renew a certificate of registration orrevoking a certificate, can appeal to the State Council within such period and in such formaccompanied by such fees as may be provided by rules by the State Government. However,the State Council may entertain an appeal after expiry of the period as said above, if it issatisfied that the appellant was prevented by sufficient cause from preferring the appeal intime.Clause 37.—This clause provides that the authority shall within a period of two yearsfrom its establishment, compile, publish and maintain in digital format a register of clinicalestablishments in such form and manner as may be provided by rules by the State Government.It also provides that every authority set up for the registration of the clinical establishmentsshall in digital format supply to the State Council a copy of every entry made in the registerof clinical establishments to ensure maintenance of up-to-date registers.Clause 38.—This clause provides that every State Government shall maintain Stateregister of clinical establishments in digital and in such form and containing such particulars,as may be prescribed by the Central Government. It also provides that every State shallsupply a copy of the State register of clinical establishments in digital format to the CentralGovernment.Clause 39.—This clause provides for maintenance of National Register of clinicalestablishments in digital format by the Central Government. It also provides that the saidRegister shall be an amalgam of the State Register of clinical establishments and shall causeto be published in digital format.Clause 40.—This clause contains provisions for penalties for contravention of anyprovisions of the proposed legislation, if no penalty is provided elsewhere. It providespunishment for the first offence with fine which may extend to ten thousand rupees; forsecond offence with fine which may extend to fifty thousand rupees and for any subsequentoffence with fine which may extend to five lakh rupees.Clause 41.—This clause contains provisions for monetary penalties for nonregistrationof clinical establishments. It provides punishment for the first offence with amonetary penalty which may extend to fifty thousand rupees, for second offence withmonetary penalty which may extend to two lakh rupees and for any subsequent offence withmonetary penalty which may extend to five lakh rupees. It further provides that if a personknowingly serves in a clinical establishment which is not duly registered under the proposedlegislation, shall be punishable with monetary penality which may extend to twenty-fivethousand rupees. It also provides that for the purpose of adjudging the monetary penaltyunder this clause, the authority shall hold an inquiry after giving reasonable apportunities tothe person concerned. It also provides that in determining the quantum of monetary penalty,the authority shall take into account the category, size and type of the clinical estalishmentand local conditions of the area in which the establishment is situated. It also provides thatany person aggrieved by the decision of the authority may prefer an appeal to the StateCouncil. The monetary penalty levied under this clause shall be credited to such account asthe State Governments may by order specify.Clause 42.—This clause provides for monetary penalty for disobeying any directiongiven by any person or authority empowered under the proposed legislation or obstructsany person or authority in discharge of any functions which that person or authority isrequired or empowered under the proposed legislation to discharge. It provides a monetarypenalty which may extend to five lakh rupees. It also provides that for the purpose ofadjudging the monetary penalty under this clause, the authority shall hold an inquiry aftergiving reasonable apportunities to the person concerned. It also provides that whiledetermining the quantum of monetary penalty, the authority shall take into account the

24category, size and type of the clinical establishment and local conditions of the area in whichthe establishment is situated. It also provides that any person aggrieved by the decision ofthe authority may prefer an appeal to the State Council. The monetary penalty levied underthis clause shall be credited to such account as the State Governments may by order specify.Clause 43.—This clause provides for penalty for contravention of any provisions ofthe proposed legislation or any rule resulting in deficiencies that do not pose any imminentdanger to the health and safety of any patient and can be rectified within a reasonable time.It provides punishment with fine which may extend to ten thousand rupees.Clause 44.—This clause contains provisions for contravention of any of the provisionsof the proposed legislation or any rule by companies. It provides that a contravention underthe proposed legislation has been committed by a company, every person directly in chargeof, and responsible to, the company for the conduct of its business at the time of committingcontravention shall be deemed to be guilty of the contravention and shall be liable to fineunless he provides that the contravention was committed without his knowledge or that heexercised all due diligence to prevent the commission of contravention. It also provides thatwhere any contravention under the proposed legislation has been committed with the consentor connivance of, or attributable to any neglect on the part of, any director, manager, secretaryor other officer of the company, such director, manager, secretary or other officer shall alsodeemed to be guilty of that contravention and shall be liable to fine. The explanation to theclause seeks to define the terms "company" and "director".Clause 45.—This clause contains provisions for offences by Government Departments.It provides that where an offence under the proposed legislation has been committed by anyDepartment of the Government within a period of six months after commencement of this Act,the Head of the Department shall be deemed to be guilty of the offence and shall be liable tobe proceeded against and punished accordingly.Clause 46.—This clause provides for recovery of fines as an arrear of land revenue. Itprovides that the State Council of clinical establishments may prepare a certificate specifyingthe fine due from such person and send it to the Collector of the district in which such personowns any property or carries on his business.Clause 47.— This clause contains provisions for protection of action taken in goodfaith under the proposed legislation. It provides that no suit, prosecution or other legalproceedings shall lie against any authority or any member of the National Council or StateCouncil or any officer authorised in this behalf in respect of anything done in good faith inpursuance of such proposed legislation or of any rule or order made, or direction issued,thereunder.Clause 48.— This clause provides that every clinical establishment should furnish tothe authority or the State Council or the National Council such returns or the statistics andother information as provided by rules to be made by the State Government.Clause 49.— This clause empowers the authority to issue directions regardingfurnishing returns, statistics and any other information for the proper functioning of theclinical establishments and such directions shall be binding.Clause 50.— This clause provides that every employee of the authority and theNational Council and the State Council shall be public servants within the meaning of section21 of the Indian Penal Code.Clause 51.— This clause contains provisions for power to remove difficulties. Itprovides that if any difficulty arises in giving effect to the provisions of the proposedlegislation, the Central Government may, by order published in the Official Gazette, makesuch provisions, not inconsistent with the provisions of the proposed legislation, as appearto it to be necessary or expedient for removing the difficulty. However, no such order can bemade under this section after expiry of two years from the commencement of the proposed

25legislation. It further provides that every order made under this section shall, as soon as maybe after it is made, be laid before each House of Parliament.Clause 52.— This clause empowers the Central Government to make rules for carryingout the provisions of the proposed legislation in respect of the matters specified in the saidclause.Clause 53.— This clause provides that every rule made by the Central Governmentunder this Act as soon as may be after it is made, laid before each House of Parliament.Clause 54.— This clause empowers the State Government to make rules for carryingout the provisions of the proposed legislation which do not fall within the purview of section52 and in particular in respect of the matters specified in the said clause.Clause 55.— This clause provides that every rule made by the State Government shallbe laid as soon as may be after it is made, before each House of State Legislature.Clause 56.— This clause provides that the provisions of this Act shall not apply tothe States in which the enactments specified in the Schedule are applicable. However, itprovides that the States in which the enactments referred to in sub-section (1) are applicable,and such States subsequent to the commencement of this Act, adopts this Act underclause (1) of article 252 of the Constitution, the provisions of this Act shall, subsequent tosuch adoption, apply in that State. It also provides that the Central Government may, bynotification, amend the Schedule.

S-1\E\BILL 2010\LAW\92LAW\92LAWFINANCIAL MEMORANDUMClause 3 of the Bill empowers the Central Government to establish a National Councilfor clinical establishment. It provides for payment of allowance to the members of the NationalCouncil. It also empowers the Central Government to appoint a person to be the Secretary ofthe National Council. Clause 39 of the Bill empowers the Central Government to maintain indigital format an all India Register to be called the National Register of clinical establishments.The expenditure on account of procurement and maintenance of electronic equipments andsetting up of network with the State Government will have to be borne by the CentralGovernment. The Bill, if enacted, could involve expenditure from the Consolidated Fund ofIndia which may be of both recurring and non-recurring in nature. The estimated totalexpenditure per annum will be to the tune of rupees one crore.26

MEMORANDUM REGARDING DELEGATED LEGISLATIONClause 51 of the Bill empowers the Central Government to issue an order for removalof any difficulty which may arise in giving effect to the provisions of the proposed legislation.Such an order will not be inconsistent with the provisions of the legislation and would notbe made after the period of two years from the date on which the proposed legislationreceives the assent of the President.2. Clause 52 of the Bill empowers the Central Government to make rules for carrying outthe various provisions of the Bill and regarding—(a) allowances for the members of the National Council under sub-section (5) ofsection 3;(b) appointment of such person to be Secretary of the State Council by theCentral Government under sub-section (10) of section 3;(c) the determination of standards and for classification of clinical establishmentsunder section 7;(d) the qualification and the terms and conditions for the members of the authorityunder clause (c) of sub-section (1) of section 10;(e) the procedure under which the powers of the authority may be exsercised bythe District Health Officer or Chief Medical Officer for the purpose of provisionalregistration of clinical establishment under sub-section (2) of section 10;(f) the minimum standards of facilities and services under clause (i) ofsub-section (1) of section 12;(g) the minimum number of personnel under clause (ii) of sub-section (1) ofsection 12;(h) the maintenance of record and reporting by the clinical establishment underclause (iii) of sub-suction (1) of section 12;(i) other conditions for registration and continuation of clinical establishmentunder clause (iv) of sub-section (1) of section 12;(j) classification of clinical establishment under sub-section (1) of section 13;(k) the different standards for classification of clinical establishments undersub-section (2) of section 13;(l) the minimum standards for permanent registration under section 28; and(m) the form and particulars to be contained in the register to be maintainedunder section 38.3. Clause 54 of the Bill empowers the State Governments to make rules for carrying outin respect of matters which do not fall within the purview of section 52 and regarding—(a) the proforma and the fee to be paid for registration of clinical establishmentunder sub-section (1) of section 14;(b) the form and details of application under sub-section (3) of section 14;(c) the particulars and information contained in certificate of provisionalregistration under section 15;(d) the manner of publication of all particulars of the clinical establishmentproposed to be registered under sub-section (2) of section 16;27

28(e) the fees to be paid to issue a duplicate certificate under section 19;(f) the manner in which the authority shall publish the names of the clinicalestablishments whose registration expired under section 21;(g) the enhanced fees to be charged for renewal after expiry of provisionalregistration under section 22;(h) the form of the application and fees to be charged by the State Governmentunder section 24;(i) the manner of submitting evidence of the clinical establishments havingcomplied with the minimum standards under section 25;(j) the manner of displaying information of the clinical establishments havingcomplied with the minimum standards for filing objection under section 26;(k) the expiry of period specified in section 29;(l) the form and particulars of the certificate of registration under section 30;(m) the manner of entry and search of clinical establishment under section 34;(n) the fees to be charged by the State Government for different categories ofclinical establishments under sub-section (1) of section 35;(o) the manner and the period within which an appeal may be preferred to theState Council under sub-section (1) of section 36;(p) the form and the fee to be paid for an appeal under sub-section (2) of section36;(q) the form and the manner in which the register to be maintained under subsection(1) of section 37;(r) the manner of supply to the State Council in digital format the entry made inthe register of clinical establishment under sub-section (2) of section 37;(s) the time and manner within which the information is to be furnished undersection 48;(t) any other matter which is required to be or may be prescribed by the StateGovernment.4. The rules made by the Central Government under clause 52 shall be laid before eachHouse of Parliament under clause 53 and the rules made by the State Government underclause 54 shall be laid before the State legislature under clause 55 of the Bill.5. The matters in respect of which rules may be made are generally matters ofadministrative detail and procedure and it is not possible to provide for them in the Bill itself.The delegation of legislative power is, therefore, of a normal character.

LOK SABHA————ABILLto provide for the registration and regulation of clinical establishments in the country andfor matters connected therewith or incidental thereto.————(Shri Ghulam Nabi Azad, Minister of Health and Family Welfare)GMGIPMRND—1359LS(S-1)—26-03-2010