Ladakh Clinical Establishments (Registration and Regulations) Rules, 2022

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भारत सरकार

GOVERNMENT OF INDIA

एस.जी.-एल.डी.-अ.-01062022-119

SG-LD-E-01062022-119

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असाधारण

EXTRAORDINARY

(cid:292)ा(cid:876)धकार से (cid:292)का(cid:871)शत

PUBLISHED BY AUTHORITY

ल(cid:622)दाख, 31 मई, 2022 LADAKH, TUESDAY, MAY, 31, 2022

Part II - Section 3

के (cid:219)(cid:289)-शा(cid:871)सत (cid:292)देश ल(cid:622)दाख (cid:292)शासन ADMINISTRATION OF UNION TERRITORY OF LADAKH

DEPARTMENT OF HEALTH & MEDICAL EDUCATION, CIVIL SECRETRIAT, LEH- 194101 Phone No: 01982-257561, Email id: [email protected]

Notification S.O. No. 74, dated: 27th of May, 2022. In exercise of the powers conferred by Section 54 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010), the Lieutenant Governor of Union territory of Ladakh, hereby makes the following rules, namely,―

Part I

Preliminary

Short title, extend and commencement. ―

(1) These rules may be called the Union territory of Ladakh Clinical Establishments (Registration and Regulation) Rules, 2022.

(2) These Rules shall come into force in the Union territory of Ladakh on the date of their publication in the Official Gazette of Union territory of Ladakh.

(3) These Rules shall be applicable to various categories of clinical establishments in the Union territory of Ladakh.

Definition. ― (1) In these rules, unless the context otherwise requires―

(a) "Act" means the Clinical Establishments (Registration and Regulation) Act,2010; (b) "Administration" means Administration of Union territory of Ladakh; (c) "State Council" means the Union territory of Ladakh Council for Clinical Establishments constituted under Section 8 of the Act; and

(d) Words and expressions used herein and not defined but defined in the Act shall have the same meanings respectively assigned to them in the Act.

Part II

The Union territory of Ladakh Council for the Clinical Establishments Constitution of State Council. ― Administration of Union territory of Ladakh shall by notification constitute State Council for Clinical establishments under Section 8 of theAct. Functions. ― The State Council shall perform the following functions, namely: -

1. compiling and updating the Union Territory of Ladakh Registers of clinical establishment; 2. sending monthly returns for updating the National Register (including in the digitalformat); 3. representing the Union Territory in the National Council; 4. hearing of appeals against the orders of the authority; 5. publication on annual basis a report on the state of implementation of standards within the Union Territories of Ladakh;

6. monitor the implementation of the provisions of the Act and rules in the Union Territories of Ladakh;

7. recommend to the Administration of Union territory of Ladakh, any modifications required in the rules in accordance with changes in technology orsocial conditions;

8. perform any other function as may be outlined by the National Council ofClinical Establishments; 9. Any other function as may be prescribed by the Central Government.

Disqualification of Members. ― A person shall be disqualified for being appointed as a member of the Union territories Council if he-

(1) Has been convicted and sentenced to imprisonment for an offence which, in the opinion of the Administration of Union territory of Ladakh, involves moral turpitude; or

(2) Is an undischarged insolvent; or (3) is of unsound mind and stands so declared by a competent court; or (4) has been removed or dismissed from the service of the Government or a corporation owned or controlled by the Administration of Union territory of Ladakh; or

(5) has, in the opinion of the Administration of Union territory of Ladakh, such financial or other interest in the State Council as is likely to affect prejudicially the discharge by him of his functions as a member.

Conduct of Business. ― Every meeting of the State Council shall be presided over by the Chairperson. Time & Place for Meetings of the State Council. ― The meetings of the State Council shall ordinarily be held at Leh/Kargil on such dates as may be fixed by the State Council and shall meet at least once in three months.

Notice of Meeting. ― Notice of every meeting other than a special meeting shall be issued/dispatched by the Member Secretary to each member of the State Council not less than 15 days before the date of the meeting.

Quorum, Call for meeting, Minutes of meetings. ― (1) One - third of the total number of members of the State Council shall form a quorum and all actions of the State Council shall be decided by a majority of the members present and voting. (2) The notice and agenda of every such meeting of the State Council shall ordinarily be given 15 days before the meeting by the Member Secretary of the State Council.

(3) The proceedings of the meetings of the State Council shall be preserved in the form of minutes which shall be authenticated after confirmation by the signature of the Chairperson.

(4) A copy the minutes of each meeting of the State Council shall be submitted to the Chairperson within 7 days of the meeting and after having been approved by him/her shall be sent to each member of the State Council within 15 days of the meeting. If no objection to their correctness is received within 10 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 of the meeting.

Resignation. ― A member desiring to resign his seat on the State Council shall send his resignation in writing to the Chairperson and every such resignation shall take effect from the date mentioned by him in this behalf or in 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.

Filling of Vacancies. ― When a casual vacancy occurs by reason of death, resignation or otherwise of a member, a report shall be made forthwith by the Chairperson to the Administration of Union territory of Ladakh which shall take steps to have the vacancies filled by nomination or election, as the case may be.

Finance and Accounts. ― The accounts of the State Council shall be audited annually by a qualified Chartered Accountant, who is to be appointed with the prior approval of the Comptroller and Auditor General of India. Any expenditure incurred in connection with such audit shall be payable by the State Council.

Part III

The District Registering Authority

Establishment of District Registering Authority. ― The Administration of Union territory of Ladakh shall, by notification under Section 10 of the Act and in accordance with the rules framed by Central Government in this behalf set up an authority to be called the District Registering Authority for the Union territory of Ladakh for registration of clinical establishments.

Functions of the District Registering Authority. ― (1) The District Registering Authority shall perform the following functions. ―

(i) to grant, renew, suspend or cancel registration of any clinical establishments; (ii) to enforce compliance of the provisions and rules of the Clinical Establishments (Registration and Regulation) Act, 2010;

(iii) to investigate complaints of breach of the provisions of the Act or the rules made there under and take immediate action;

(iv) to prepare and submit on quarterly basis report containing details of related to number and nature of provisional and permanent registration certificates issued; included those cancelled, suspended or rejected to the State Council;

(v) to report to the State Council on a quarterly basis on action taken against non- registered clinical establishments operation in violation of the Act; and

(vi) to perform any other function as may be prescribed by the Central Government from time to time. Powers of the District Registering Authority. ― (1) The District Registering Authority shall, for the purposes of discharging its functions under the Act, have the same powers as are vested in a Civil Court under the Code of Civil Procedure, 1908 in respect of the followingmatters, namely, ―

(i) summoning and enforcing the attendance of any person and examining him on oath; (ii) Requiring the discovery and production of any document or other electronic records or other material objective producible as evidence;

(iii) Receiving evidence on affidavits; (iv) Requisitioning of any public record; (v) Issuing commission for the examination of witnesses or documents; (vi) Reviewing its decisions, directions and orders; (vii)Dismissing an application for default or deciding it ex parte; and (vii) Any other matter which may be prescribed.

Time and Place of and Preparation of Business for Meetings of the District Registering Authority.― The meetings of the District Registering Authority shall be held at least once in a month at a stipulated date and time. Conduct of Business. ― Every meeting of the District Registering Authority shall be presided over by the Chairperson. Notice of Meeting. ― Notice of every meeting other than a special meeting shall be issued/ dispatched by the Convener to each member not less than 15 days before the date of the meeting. Quorum, Minutes of Meeting. ― (1) One - third of the total number of members of the District Registering Authority shall form a quorum and all actions of the Authority shall be decided by a majority of the members present and voting. (2) The proceedings of the meetings of the District Registering Authority shall be preserved in the form of minutes which shall be authenticated after confirmation by the signature of the Chairperson.

(3) A copy the minutes of each meeting of the District Registering Authority shall be submitted to the Chairperson within 7 days of the meeting and after having been attested by him shall be sent to each member of the Authority within 15 days of the meeting. If no objection to their correctness is received within 10 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 in the meeting.

Resignation.― A member desiring to resign his seat on the District Registering Authority shall send his resignation in writing to the Chairperson and every such resignation shall take effect from the date mentioned by him in this behalf or in case no such date is mentioned, from the date of the receipt of his letter by the Chairperson after confirmation from the member concerned about his resignation. Filling of Vacancies.― If a casual-vacancy occurs whether by reason of death, resignation or inability to discharge, functions owing to illness or any other incapacity of a member, such vacancy shall be filled by the Chairperson by making a fresh appointment and the member so appointed shall hold office for the remaining term of office of the person in whose place he/she is so appointed.

PART IV

Registration of Clinical Establishment

Application for Registration.― (1) The applicant shall apply to the District Registering Authority for provisional registration, either in person, or by post or through web based online facility with the necessary information as per SG-I Form; (2) The applicant shall apply to the District Registering Authority for permanent registration, in person, or by post or through web based online facility with the necessary information filled and with evidence of having met the requirements of minimum standards and personnel for different categories of Clinical Establishments in a form and format that shall be prescribed by the National Council under section 24 and section 25 of the Act;

(3) If an establishment is offering services in more than one category as specified under the Clinical Establishments (Central Government) Rules, 2012, the establishment will need to apply for a separate provisional or permanent registration for each category of establishment under sub- section(1) of section 14 and section 30 of the Act. However, if a laboratory or diagnostic center is a part of an establishment providing outpatient / inpatient care, no separate registration will be required.

Acknowledgement of Application.― The District Registering Authority, or any person authorized in this behalf, shall, acknowledge receipt of the application for registration, in the acknowledgment slip provided as per SG-2 form immediately, if delivered at the office of the authority, or not later than the next working day if received by post and by online acknowledgement to be generated automatically by the system. Grant of Registration.― The District Registering Authority shall not undertake any enquiry prior to the grant of provisional registration and shall within a period 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 SG-3 form either by post or electronically under section 15, read with section 17 of the Act.

Certificate of registration.― The District Registering Authority shall grant the applicant a certificate of permanent registration as per format developed by National Council as per SG-4 form either by post or electronically after satisfying itself that the applicant has complied with all the requirements and criteria, including provision of minimum standards and personnel required to run the clinical establishment. In case of permanent registration, under Section 29 of the Act the authority shall pass an order within 3 1/2 Months-

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 an application, for permanent registration, Change in ownership/management of clinical establishment.― (1) In the event of any change of ownership or management, the clinical establishment shall intimate to the District Registering Authority in writing within one month of such change along with the fee prescribed as per SG-5 form for issue of a revised certificate of Provisional or Permanent registration, as the case may be, incorporating the changes and on surrendering the old certificate under sub-section(2) of section 20 and section 30 of the Act. (2) In the event of certificate of registration (Provisional or Permanent) being lost or destroyed, the owner shall apply to the District Registering Authority to issue a duplicate certificate upon payment of the fee prescribed in form SG-5 and the provisional certificate shall be marked "Duplicate" as per SG-6 form under section 19 and section 30 of the Act.

Renewal of Registration.― (1) The clinical establishment shall apply for renewal of provisional registration thirty days before the expiry of the validity of the certificate of provisional registration. In case the application for renewal is not submitted within the stipulated period, the authority shall allow for renewal of registration on payment of the renewal amount as prescribed in (Annexure SG-5) and penalty of Rs. 100/-( one hundred ) per day till the date of application for renewal under section 22 of the Act. (2) For renewal of permanent registration, the clinical establishment shall apply three

months before expiry of the registration period of five (5) years. The renewal will be granted by the Authority within 3 months of receipt of the application failing which it will be deemed to have been renewed. If the clinical establishment does not apply within one month of expiry of registration period, the registration will be deemed to have been suspended.

(3) The clinical establishment shall apply for renewal of permanent registration under sub-section of section 30 of the Act six months before the expiry of the validity of the certificate of permanent registration. In case the application for renewal is not submitted within the stipulated period, the authority will allow for renewal of registration on payment of the renewal amount as prescribed in SG-5 form and penalty of Rs. 100/- (one hundred) per day till the date of application for renewal is accepted.

Fees to be charged. ― (1) The various fees charged for provisional and permanent registration, renewal, late application, duplicate certificate, change of ownership, management or name of establishment is prescribed in form SG-5 under sub- section (1) of section 14 read with section 19, sub- section (2) of section 20, section 22, section 24, and section 35 of the Act. (2) Clinical establishments owned, controlled and managed by the Administration of Union territory of Ladakh (Central, State or local authority) or department of Administration of Union territory of Ladakh, shall be exempted from payment of fees for registration.

(3) The fees prescribed for various categories of clinical establishments may be revised by the State Council through a notification issued by the Administration of Union territory of Ladakh.

(4) The fee shall be paid by a demand draft drawn / online transaction in favor of the District Registering Authority concerned as specified under sub-section (1) of section 14 and section 30 of the Act. (5) The fees collected by the Authority for registration of the Clinical Establishments shall be, deposited by, the Authority in a Nationalized bank account opened in the name of official designation of the District Registering Authority and shall be utilized by the Authority for the activities connected with the implementation of the provisions of the Act and these rules as approved by the District Registering Authority.

Constitution of Fund, Finance Rules, Audit. ― (1) There shall be constituted a fund called Union territory Council for Clinical Establishment Fund and the District Registering Authority shall credit two percent of the total amount collected by it by way of fees and penalties. (2) The Accounts shall be maintained as per the Financial Code and shall be audited by a qualified Chartered Accountant who is to be appointed with the prior approval of the Comptroller and Auditor General of India. The annual Audit reports shall be submitted to the State Council.

Part V

Registers to be maintained, furnishing of returns and display of information

Registers to be maintained― (1) The District Registering 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 enter the particulars of the certificate so issued in a register to be maintained in such form and manner, as may be prescribed by the Administration of Union territory of Ladakh. (2) The District Registering Authority including any other authority set up for the registration of clinical establishments under the law for the time being in force shall supply in digital format to the State Council a copy of every entry made in the District register of clinical establishments for a particular month by the 15th day of the following month in keeping with the provisions of sub- section (2) of section 37 of the Act.

(3) The District Registering Authority shall, within a period of forty-five days from the grant of provisional registration, mandatorily cause to be published in the public domain either through two local dailies /newspaper or on the website, 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 Services offered and details of the Medical Staff (Doctors, Nurses, etc.) as under sub-section(2) of section 16 of the Act.

(4) The State Council could make changes in the nature of information to be provided in the Public Domain through a notification, except in the case of the mandatory information to be provided under sub-section (2) of section 16 of the Act.

(5) The District Registering Authority shall, within a period of 7 days cause to be published in the public domain either through two local dailies/newspaper or on the website, 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 Services offered, details of the Medical Staff (Doctors, Nurses, etc.) and the details and information related to having complied with the minimum standards and personnel prescribed for the particular category of clinical establishment as under section 26 of the Act.

(6) The District Registering Authority shall cause to be displayed the above information in public domain for a period of 30 days for filing objections before granting permanent registration as per SG-4 form. If any person has any objection to the information published regarding the clinical establishment they shall give in writing the reasons and evidence of objection or non- compliance to the District Registering Authority.

(7) The District Registering Authority shall, within a period of 15 days cause to be published in the public domain the name of the Clinical Establishment whose (Provisional or Permanent) registration has expired as under section 21 and section 30 of the Act.

Information to be provided by Clinical Establishments. ― (1) The Clinical Establishments shall maintain medical records of patients treated by it and health information and statistics in respect of national programmes and furnishes the same to the District Registering Authority in form of three- monthly reports. The minimum medical records to be maintained and nature of information to be provided by the Clinical Establishments. (2) Copies of all records and statistics shall be kept with the clinical establishment concerned for 3 years or in accordance with any other relevant act in force at the time under clause(iii) of sub-section (1) of section 12 of the Act. All clinical establishments shall be responsible for submission of information and statistics in the time of emergency or disaster or epidemic situation.

(3) The Administration of Union territory of Ladakh may notify from time to time, the nature of information that needs to be furnished by the Clinical Establishments including other disease notified for this purpose along with the prescribed interval.

(4) In addition to the specific provisions of the Clinical Establishments (Registration and Regulation) Act, 2010 all establishments shall comply and maintain information and statistics in keeping with other applicable Acts and Rules which are in force in the country.

Part VI

Inspection and search of establishment

Power to Enter.― (1) Entry and search of the clinical establishment can be done by the District Registering Authority or an officer or team duly authorized by it or subject to such general or special orders as may be made by the authority, provided that decision by majority of member of the District Registration Authority for conduct of such entryand search has been taken. (2) Such entry and search of clinical establishments can be conducted if anyone is carrying on a clinical establishment without registration or does not adhere to the prescribed minimum standards or has reasonable cause to believe the Clinical Establishment (CE) is being used for purposes other than it is registered or contravenes any of the provisions of 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.

(3) The inspection team shall intimate the establishment in writing about the date of visit and reasons for the inspection. The team shall examine all portions of the premises used or proposed to be used for the clinical establishment and inspect the equipment, furniture and other accessories and enquire into the professional qualifications of the technical staff employed or to be employed and shall make any such other enquires as they consider necessary to verify the statements made in the application for registration and grant of license. All persons connected with the running of the establishment shall be bound to supply full and correct information to the inspection team.

(4) The Officer and / or inspection team so constituted by the District Registering Authority shall submit a report as per SG-7 form within a week of the inspection to the District Registering Authority with a copy to the State Council.

(5) If, at any time after any clinical establishment has been registered, the Authority is 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 has been convicted of an offence punishable under the Act, it may issue a notice to the clinical establishment to show cause within three months' time as to why its registration under this Act should not be cancelled for the reasons to be mentioned in the notice.

(c) If after giving a reasonable opportunity to the clinical establishment, the Authority, is satisfied that there has been a breach of any of the provisions of this Act or the rules made there under, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration.

(6) Every order made under sub rule 5 above, shall take effect-

(a)where no appeal has been preferred against such order immediately on the expiry of the period prescribed for such appeal; and

(b)where such appeal has been preferred and it has been dismissed from the date of the order of such dismissal; Provided that the Authority, after cancellation of registration for reasons to be recorded in writing, may restrain immediately the clinical establishment from carrying on if there is imminent danger to the health and safety of patients.

Part VII

Penalties & Appeals

Penalties.― (1) In keeping with the provisions of sub- sections (1)(2) and (3) of section 41 and sub- sections (1)(2) and (3) of section 42 of the Act, whoever carries on a clinical establishment without registration or whoever willfully disobeys any direction, or obstructs any person or authority or withholds any such information or provides false information shall be liable for a monetary penalty. (2) Whoever carried on a clinical establishment without registration, shall, on first contravention be liable to a monetary penalty of up to fifty thousand rupees, for second contravention, to a monetary penalty which may extend to two lakh rupees and for any subsequent contravention to penalty which may extend to five lakh rupees.

(3) Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall be liable to a monetary penalty which may extend to twenty-five thousand rupees.

The penalty/fees collected by the District Registering Authority shall be, deposited by the Authority in a Nationalized bank account opened in the name of the official designation of the State Council and shall be utilized by the Council and Authority for the activities connected with the implementation of the provisions of the Act and the rules made there under as approved by the State Council. Appeals.― (1) In keeping with Section 36, sub-sections (4)(5)(6) and(7) of Section 41, and sub- sections (4),(5), (6) and (7) of section 42 of the Act, 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 as per SG-8 form to the State Council within thirty (30) days from the date of receipt of such order along with a fee of Rs.1000/-. The appeal against a public healthcare establishment shall be filed as perform SG-8 and shall be sent to the State Council by registered post or in person. Every appeal shall be accompanied by a fee of rupees one thousand. After receipt of the appeal, the State Council shall fix the time and date for hearing and inform the same to the appellant 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 and submit the relevant documentary material if any in support of the appeal. The State Council shall hear all the concerned, receive the relevant oral/documentary evidence submitted by them, consider the appeal and communicate its decision preferably within 90 days from the date of filing the appeal. If the State Council considers that an interim order is necessary in the matter, it may pass such order, pending final disposal of the appeal. The State Council will have the authority to stay the operation of the order of the District Registering Authority till such time as it deems necessary. The decision of State Council shall be final and binding.

If no appeal is filed against the decision of the District Registering Authority in the prescribed period i.e. within 30 days from the date of receipt of the order, the orders of the Authority shall be final.

The appeal fees collected shall be deposited in a nationalized bank account opened in the name of the official designation of the State Council and shall be utilized by the Council and Authority for the activities connected with the implementation of the provisions of the Act and rules made there under asapproved by the State Council. General. ― Any other matter which is required to be or may be prescribed by the Administration of Union territory of Ladakh.

By order of the Lieutenant Governor.

(Dr. Pawan Kotwal) IAS Principal Secretary, Health & Medical Education Department, UT

Ladakh No:- Dated:-27.05.2022 Copy to the:-

1. 1.Joint Secretary (JKL), Ministry of Home Affairs, Government of India. 2. Drugs Controller General, (I), FDA Bhawan, Kotta Road, New Delhi. 3. 3.Commissioner/Secretary, General Administration Department. 4. Secretary, Department of Law and Justice. 5. Registrar-cum-Secretary, Pharmacy Council of India. 6. Mission Director, National Health Mission, UT of Ladakh. 7. District Collector/ CEO, LAHDC, Leh/Kargil. 8. Drugs Inspector, UT of Ladakh. 9. Director, Social Welfare, UT of Ladakh. 10. Director Health Services, UT of Ladakh. 11. Chief Medical Officer, Leh /Kargil. 12. Medical Superintendent SNM Hospital. 13. Medical Superintendent District Hospital Kargil. 14. OSD with Hon'ble Lieutenant Governor, for kind information of the Hon'ble Lieutenant Governor.

15. Private Secretary to Advisor, UT Ladakh for kind information of the Advisor. 16. Incharge Website. 17. SO file/Office file.

SG1 Form

Application Form for Provisional Registration of ClinicalEstablishments

1. Name of the Establishment

2. Address:

Village/Town: Taluka: District: State/Union territory: Pin code Tel No (with STD code): Mobile: Fax ; Email ID : Website (if any):

3. Year of starting: 4. Location:  Rural  Urban  Metropolitan 5. Ownership Public Sector Central government  State government//Union territory  Local government- please specify: Public Sector Undertaking  Railways  Employee State Insurance Corporation (ESIC) Autonomous organization  Any other (please specify): Private Sector Individual 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/Union territory: Pin code Tel No (with STD code): Mobile: Fax : Email ID 7. Name of person in-charge of the ClinicalEstablishment: Designation: Educational Qualification: Address: Village/Town: Taluka: District: State/Union territory: 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  Homeopathy  Yoga & Naturopathy 9. 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 Centre Any other (please specify):

Providing In Patient Care Hospital  Nursing Home  Maternity Home  Primary Health Centre Community Health Centre  Sanatorium Any other (please specify):^ Providing Testing & Diagnostic Services: Laboratory Pathology  Haematology  Biochemistry Microbiology  Genetics  Collection Centre  Any other (please specify): Diagnostic and Imaging Centre X Ray centre  Mammography  Bone Densitometry Sonography Color Doppler  CT Scan  Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET) Scan Electro Myo Graphy (EMG) Any other (please specify): Any other (please specify): Nature of Services (please tick whichever is applicable)

For all Systems of Medicine General Single Specialty Multi Specialty Super Specialty  Mobile Any other, please specify: 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: Ayurveda Ausadh Chikitsa Shalya Chikitsa Shodhan Chikitsa  Rasayana  Pathya  Vyavastha Any other please specify: Unani Matab  Jarahat  Ilaj-bit-Tadbeer Hifzan-e-Sehat Any other please specify: Slddha Maruthuvam  Sirappu Maruthuvam  Varmam Thokknam & Yoga Any other please specify: Homeopathy General Homeopathy Any other please specify: Naturopathy External Therapies with natural modalities  Internal Therapies Any other please specify: Yoga  please

specify:

INFRASTRUCTURE DETAILS

Area of the establishment (in sq. meters):

a) Total Area: ____________________ b) Constructed area: ___________________________ Out Patient Department:

1. Total no. of OPD Clinics: 2. Specialty-wise distribution of OPD Clinic

In Patient Department: Total no. of beds: Specialty-wise distribution of beds, please specify:

Whether Clinical Waste Disposal License obtained from Panchayat/Municipality/Municipal Corporation etc.? Yes  No  Applied For Whether clearance from Pollution Control Board/Authority obtained? Yes  No  Applied For HUMAN RESOURCES

Total number of Staff (as on date of application): No. of permanent staff: No. of temporary staff: Please furnish the followingdetails:-

Separate annexure may beattached.* 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 declare that the statements above are correct and true to the best my knowledge and I shall abide by all the rules and 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 particulars given above.

Place: Signature of the Authorized Signatory Date: Office Seal SG2 Annexe

ACKNOWLEDGEMENT

REGISTRATION OF CLINICAL ESTABLISHMENT

The application in Form for Grant / Renewal of Provisional / Permanent registration of the Clinical Establishment submitted by

(Name and address of Owner) has been received by the District Registration Authority on (date) and found to be

Complete Or Incomplete

This acknowledgement does not confer any rights on the applicant for grantor renewal of registration.

Signature and Designation of Registration A u t h o r i t y o r a u t h o r i z e d person in the Office of the Appropriate Authority.

SEAL

Designation of the Issuing Authority (Computer Generated) Place & Date: (Computer Generated) SG 3 Annexe

PROVISIONAL CERTIFICATE

FOR REGISTRATION OF CLINICAL ESTABLISHMENT

Provisional 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 provisionally registered under the provisions of Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

This authorization is subject to the conditions as specified in the rules in force under the Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

Designation of the Issuing Authority (ComputerGenerated)

Place & Date: (ComputerGenerated) District Registration Authority Address:

Phone number in case of Grievances SG 4 Annexe

PERMANENT CERTIFICATE FOR REGISTRATION OF CLINICAL EST A BLISHM EN T

Permanent registration No: (Computer Generated) Date of issue: (Computer Generated) Valid up to: (Computer Generated) Name of the Clinical Establishment: ___________________________________________________________ Address: _______________________________________________________________________________ Owner of the Clinical Establishment: ___________________________________________________________ Name of Person in Charge: _________________________________________________________________ System of Medicine: ________________________________________________________________________ Type of Establishment: _________________________________________________________________

is hereby permanently registered under the provisions of 'Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

This authorization is subject to the conditions as specified in the rules in force under the Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

Designation of the Issuing Authority (Computer Generated) Place & Date: (Computer Generated) District Registration Authority Address:

Phone number in case of Grievances SG 5 Annexe Fees to be charged (in rupees)

SG 6 Annexe

DUPLICATE CERTIFICATE FOR CLINICAL E S T A B L I S H M E N T

Permanent registration No: (Computer Generated) Date of Issue: (Computer Generated) Valid up to: (Computer Generated) Name of the Clinical Establishment: __________________________________________________________ Address: ______________________________________________________________________________ Owner of the Clinical Establishment: __________________________________________________________ Name of Person in Charge: _________________________________________________________________ System of Medicine: ________________________________________________________________________ Type of Establishment: _________________________________________________________________

is hereby permanently registered under the provisions of 'Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

This authorization is subject to the conditions as specified in the rules in force under the Clinical Establishments (Registration and Regulation) Act 2010 and the Rules made there under.

Designation of the Issuing Authority (Computer Generated) Place & Date: (Computer Generated) District Registration Authority Address:

Phone number in case of Grievance SG 7 Annexe Suggested Format for Submission of Inspection Report

Number of visits made with dates

Names and details of members of the inspection team

Name of clinical establishment visited

Address and contact details of clinical establishment visited

Process followed for inspection (e.g. kindly outline who was met

with, what records were examined, etc.)

Salient Observations / Findings Conclusions Specific Recommendations:

1. To the Clinical Establishment

2. To the District Registering Authority

*ln case of lack of consensus amongst members of the inspection team, thesame may be kindly indicated

Signature (of all members of the inspection team) Date: Place:

SG 8 Annexe Application for appeal

To,

The UT Council Administration of

Sir, I, Dr………………………… of had applied for registration/ is a valid license holder with registration number................. under Clinical Establishment Act, 2010 for my ………………. Located at………………………

I was communicated by the District Authority as per letter No……………… dated That either;

I) That my application is rejected II) That my application canceled III) That I am restrained from carrying on with the running of Clinicalestablishment IV) That I am charged with a penalty for an offence under the Act V) Any other…………….

That above decision of the District Authority appears to be not valid. I request you to consider my application as per the justification mentioned below: -

I) ………………………. II) ………………………. III) ………………………

I am willing to appear before you for a personal hearing, if necessary. I am enclosing herewith a Draft of Rs. 1000/-.

Thanking you,

Place Signature

Date Name

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