1

RNI No. KARBIL/2001/47147

∞¬Òûª∞
ª∞ «Ò∏Â√¿Ê C¢üPÀÈvÀªÁV ¥ÀæPÀn¸À¯ÁzÀÄzÀÄ
«±ÉõÀ gÁdå ¥ÀwæPÉ
¨sÁUÀ–IVA ¨ÉAUÀ¼ÀÆgÀÄ, ±ÀÄPÀªÁgÀ
æªÁgÀ, ¥sɧæªÀj 9, 2018 (ªÀiÁWÀ 20,, ±ÀPÀ ªÀµÀð 193
1939) £ÀA.259
Part–IVA Bengaluru, Friday, February 9, 2018 (Magha 20, Shaka Varsha 193
1939) No.259
0¸ÀASÉå

HEALTH AND FAMILY WELFARE SECRETARIAT

NO. HFW 11 FPR 2018 BENGALURU, DATED: 09.02.2018
NOTIFICATION
The draft of the following rules further to amend the Karnataka Private Medical
Establishments Rules, 2009 which the Government of Karnataka proposes to make in exercise of
the powers conferred by said section of the Karnataka Private Medical Establishment
Establishments Act, 2007
(Karnataka Act 21 of 2007) is hereby published as required by sub-section
sub section (1), of said section, of the
said Act, for the information of all persons likely to be affected thereby and notice is hereby given
that the said draft will be taken into consideration after fifteen days from the date of its publication
in the Official Gazette.
Any objection or suggestion which may be received by the State Government from any person
with respect to said draft before the expiry of the period specified above will be considered by the
State Government. The objections and suggestions may be addressed to the Additional Chief
Secretary to Government, Department of Health and Family Welfare, Vikasa Soudha, Bengaluru
Bengaluru-560
001.
DRAFT RULES
1. Title and Commencement. - (1) These rules may be called the Karnataka Private Medical
Establishments (Amendment) Rules, 2018.
(2) They shall come into force on such date as the State Government may by notification in
the Official Gazette, may appoint.
Provided that different dates
ates may be appointed for different provisions of these rules and any
reference in any such provision to the commencement of these rules shall be construed as a
reference to the coming into force of that provision.
2. Amendment of Chapter-2.-
Chapter In Chapter-2 of the Karnataka Private Medical
Establishments Rules, 2009, (hereinafter referred as the said rules), for the heading "CATEGORIES
OF PRIVATE MEDICAL ESTABLISHMENTS" the following shall be substituted, namely: namely:-
"CATEGORIES OF PRIVATE MEDICAL ESTABLISHMENTS AND REGISTRATION"
3. Amendment to rule 3. – In rule 3 of the said rules,-
(i) for sub-rule
rule (2), the following shall be substituted, namely:-
namely:
“(2) Private medical establishments shall be further classified into the following categories,
namely:-
(i) Clinic/Polyclinic Only Consultation
(ii) Clinic/Polyclinic with Diagnostic Support
 2

(iii) Clinic/Polyclinic with Dispensary

(iv) Clinic/Polyclinic with Observation
(v) Health Check-up Centre
(vi) Integrated Counselling Centre
(vii) Hospital (Level 1A)
(viii) Hospital (Level 1B)
(ix) Hospital (Level 2)
(x) Hospital (Level 3)(Non-Teaching with Super Specialty Services)
(xi) Specialty / Super-Specialty Specific Hospital
(xii) Hospital (Level 4)(Teaching)
(xiii) Dental Lab or Clinic
(xiv) Allied Health Professional Centre
(xv) Ayush Therapy Centre
(xvi) Medical Diagnostic Laboratory
(xvii) Diagnostic Imaging Centre
Provided that the definition and scope of above categories of establishment shall be the same
as prescribed by the National Council constituted as under the Clinical establishment (Registration
and Regulation) Act 2010 (Central Act 23 of 2010).”
(ii) sub-rule (3) and (4) shall be omitted.
4. Substitution of rule 4.- For rule 4 of the said rules, the following shall be substituted,
namely:-
"CHAPTER – III
REGISTRATION OF PRIVATE MEDICAL ESTABLISHMENTS
4. Fee for processing of registration or renewal application. - (1) The non-refundable fee
payable by different categories of private medical establishments for processing of registration
application shall be as specified below,-
Sl. Category of Private Medical Registration Processing Fee
No. Establishments (in Rupees)
1 Clinic/Polyclinic Only Consultation 2500
2 Clinic/Polyclinic with Diagnostic Support 5000
3 Clinic/Polyclinic with Dispensary 5000
4 Clinic/Polyclinic with Observation 5000
5 Health Check-up Centre 5000
6 Integrated Counseling Centre 5000
7 Hospital (Level 1A) 20000
8 Hospital (Level 1B) 30000
9 Hospital (Level 2) 40000
Hospital (Level 3) (Non-Teaching with Super
10 100000
Specialty Services)
11 Specialty/Super-Specialty Specific Hospital 100000
12 Hospital (Level 4) (Teaching) 200000
13 Dental Lab/Clinic 5000
 3

14 Allied Health Professional Centre 5000

15 Ayush Therapy Centre 5000
16 Medical Diagnostic Laboratory 5000
17 Diagnostic Imaging Centre 5000
18 Blood Banks 5000
Provided that the registration processing fee for the hospitals at serial numbers 7 to 9 shall
be two times of the fee mentioned in the table above, in case the hospital has more than 50 beds.
Provided further that the registration processing fee for the hospitals at serial numbers 10
and 11 shall be two times of the fee mentioned in the table above, in case the hospital has more
than 150 beds.
Provided also that the registration processing fee for a charitable establishment providing free
treatment to all patients shall be twenty-five percent of the fee specified above.
(2) The non-refundable fee for processing of renewal application shall be fifty percent of the
fee specified under sub-rule (1).
(3) The fee for processing of registration or renewal application specified under sub-rule (1)
shall stand enhanced by twenty-five percent, rounded off to nearest hundred rupees, every five years
from the date of commencement of the Karnataka Private Medical Establishments (Amendment)
Rules, 2018.
(4) The registration or renewal processing fee shall be paid online on the website
https://k2.karnataka.gov.in of Khajane 2, Integrated Financial Management System of Government
of Karnataka.
5. Amendment to rule 6. – In rule 6 of the said rules, in sub-rule (1),-
(a) for the words and letter “shall apply for registration in Form-A”, the words and letters
“shall apply online on the IT portal of Health and Family Welfare Department for registration in
Form A” shall be substituted.
(b) after sub-rule (1), so amended the following provisos shall be inserted, namely:-
“Provided that the existing establishments already holding the registration also shall provide
the details in Form A within three months from the date of commencement of the Karnataka Private
Medical Establishments (Amendment) Rules, 2018.
Provided further that Aadhaar, Mobile Number and Email details provided in Form A shall
not be put in the public domain and shall be shared only with other departments of the State
Government and Government of India.”
6. Amendment to rule 7. - In rule 7 of the said rules, in sub-rule (1) for the words and letter
“shall apply for registration in Form B”, the words and letters “shall apply online on the IT portal of
Department of Health and Family Welfare for registration in Form A” shall be substituted.
7. Insertion of new rules 7A, 7B and 7C.- After rule 7 of the said rules, the following shall
be inserted, namely:-
“7A. Renewal of Registration. – (1) A registered private medical establishment shall apply
for renewal of its registration minimum three months prior to due expiry of its five-year registration
validity period.
(2) The application for the renewal shall be made online on the IT portal of Health and Family
Welfare Department in Form B along with fee specified in rule 4.
7B. Composition of Registration and Grievance Redressal Authority.- (1) The non-
official members of the Authority of a district shall have the qualification specified below.
(a) The members representing Indian Medical Association and one more association shall
be medical professional with postgraduate degree with experience of minimum ten
years in medical profession.
(b) The woman member shall have a graduate degree with experience of minimum twenty
years in field of social work or academic profession or medical profession.
 4

(2) The non-official members of the Authority of a district shall be nominated by the
Chairman in the manner specified below.
(a) The member representing Indian Medical Association shall be the nominee of the
Chapter of the Association having the largest membership in the district.
(b) The member representing another Association shall be the nominee of a registered
Association representing private medical establishments having the largest
membership in the district.
(c) The woman member of the authority relevant for purpose of grievance redressal only
shall be selected on recommendations of three-member committee consisting of
Deputy Commissioner of the district, Chief Executive Officer of the Zilla Panchayat
and Deputy Director of Women and Child Development Department.
(3) The term of each non-official member shall be two years and the incumbent shall not be
nominated again.
7C. Composition of Inspection Committee. –The inspection committee shall consist of two
medical professionals with minimum experience of ten years with one of them being in the
Government service and another being one of the two members representing the associations in the
Authority.”
8. Insertion of new Chapter-IV. – After rule 9 of the said rules, the following shall be
inserted, namely:-
"CHAPTER-IV
STANDARDS OF INFRASTRUCTURE, STAFFING PATTERN AND QUALIFICATION OF STAFF
9A. Minimum Standards in Interim Period. – Till such time the minimum standards are
prescribed by the State Government in accordance with the minimum standards as prescribed
under the Clinical establishment (Registration and Regulation) Act 2010 (Central Act 23 of 2010)
shall apply mutatis mutandis to the private medical establishments registered under the Act:
Provided that the existing establishments shall have a grace period of one year to comply
with the minimum standards as per this rule.
Provided further that the minimum standards in respect of infrastructure as per this rule
shall be optional for the existing establishments. The minimum standards in respect of other
aspects shall be mandatory with the grace period mentioned in the first proviso."
9. Insertion of new Chapters.- After the rule 11 of the said rules, the following shall be
inserted, namely:-
"CHAPTER - V
EXPERT COMMITTEES
12. Expert Committee for classification, standards of infrastructure, staffing pattern
and staff qualification.- (1) The State Government shall constitute the Expert Committee for the
purpose of section 9 and 9A of the Act, standards of infrastructure, staffing pattern and staff
qualification shall have the consisting of the following members, namely:-
(i) The Commissioner, Health and Family Welfare - Ex-officio chairman
(ii) The Director, Health and Family Welfare: - Ex-officio member
Secretary
(iii) The Director, Ayush Department - Ex-officio member
(iv) The Director, Medical Education - Ex-officio member
(v) One Representative of a tertiary care public health - Ex-officio member
institution
(vi) One Representative of the State Government from Public - Non-official Member
Health Foundation of India
(vii) One Representative of the State Government from
National Accreditation Board for Hospitals and
- Non-official Member
Healthcare Service Providers
 5

(viii) One Representative of the Private Medical Establishment

- Non-official Member
from Indian Medical Association
(ix) One Representative of the Private Medical Establishment
- Non-official Member
from a tertiary care private medical establishments
(x) One Representative of the Private Medical
Establishments from Private Hospital and Nursing - Non-official Member
Homes Association
(2) As far as possible, the committee shall use as reference the classification and minimum
standards as prescribed by the Government of India as under the Clinical establishment
(Registration and Regulation) Act 2010 (Central Act 23 of 2010).
13. Expert Committee for standard protocols for treatments, procedures and
prescription audit.- (1) The Expert Committee constituted by the State Government for
recommending standard protocols for treatments, procedures and prescription audit shall have the
following composition, namely:-
(i) The Director of a Government super-specialty hospital or - Ex-officio Chairman
medical college

(ii) One Medical specialist in allopathic system of medicine in - Ex-officio Member-

Government service. Secretary
(iii) One Medical specialist in Indian system of medicine in - Ex-officio member
Government service
(iv) One Representative of a tertiary care public health - Ex-officio member
institution
(v) One Representative of the Rajiv Gandhi University of Health - Ex-officio member
Sciences
(vi) One Representative of National Health Systems Resource - Non-official member
Center
(vii) One Representative of the State Government from Indian - Non-official member
Medical Association
(viii) One Representative of the State Government from National - Non-official member
Accreditation Board for Hospitals and Healthcare Service
Providers
(ix) One Representative of the State Government from a tertiary - Non-official member
care private medical establishment
(x) One Representative of the State Government from a - Non-official member
secondary care private medical establishment
Provided that the committee may co-opt one relevant medical specialist each from public
health institution and private medical establishment while formulating recommendations for any
specialized types of treatment.
(2) As far as possible, the committee shall use as reference the standard treatment guidelines
prescribed by the Government of India as under the Clinical establishment (Registration and
Regulation) Act 2010 (Central Act 23 of 2010).
14. Expert Committee for uniform package rates for healthcare assurance schemes in
participating establishments.- (1) The Expert Committee constituted by the State Government for
recommending uniform package rates for healthcare assurance schemes of the State Government for
participating private medical establishments shall consist of following members, namely:-
(i) The Additional Chief Secretary, Principal Secretary / - Ex-officio Chairman
Secretary to Government, Department of Medical Education
(ii) The Executive Director, SAST - Ex-officiomember
Secretary
 6

(iii) The Commissioner, Department of Health and family - Ex-officio member

Welfare Services
(iv) The Director, Medical Education - Ex-officio member
(v) Additional Chief Secretary / Principal Secretary / Secretary - Ex-officio member
to Government, Finance Department or his representative
not below the rank of Deputy Secretary
(vi) One Representative of a tertiary care public health - Ex-official member
institution
(vii) One Representative of the State Government from Public - Non-official member
Health Foundation of India
(viii) One Representative of the State Government from IIMB - Non-official member
(ix) One Representative of the Private Medical Establishment - Non-official member
from Indian Medical Association
(x) One Representative of the Private Medical Establishment - Non-official member
from a tertiary care private medical establishment
(xi) One Representative of the Private Medical Establishment - Non-official member
from a secondary care private medical establishments.
Provided that the committee may co-opt one relevant medical specialist each from public
health institution and private medical establishment and one cost accountant while formulating
recommendations for package rates for specific types of treatment.
(2) As far as possible, the committee shall use as reference the standard costing template
formulated by the National Council constituted as under the Clinical establishment (Registration
and Regulation) Act 2010 (Central Act 23 of 2010).
Provided that the recommended rates shall have reference to median rates notified by the
private medical establishments as per section 10 of the Act.
Provided further that the recommended rate for a treatment as per the standard treatment
guidelines shall cover the estimated cost of drugs, consumables, implants, tests, professional fee, OT
charges, bed charges in general ward, and rental expenses of the hospital, but not the cost of land
and building and debt-servicing.
15. Allowance for Members. – All non-official members shall be entitled for a sitting fee of
rupees ten thousand for each meeting of the committee in addition to travelling allowance and daily
allowance as applicable to Group-A officers of the State Government.”
"CHAPTER-VI
INFORMATION DISCLOSURE
16. Notification of Establishment Details. – (1) Every private medical establishment shall
display its details in Form C on the IT portal of the Health and Family Welfare Department and on
its own website in case the establishment has one:
Provided that the operational guidelines for the display and secured access to the IT portal
shall be provided by the department.
(2) Notwithstanding anything contained in second proviso to sub-rule (1) of rule 6, Mobile
Number and E-mail details of the establishment administrator or manager shall be available in the
public domain.
(3) Every private medical establishment shall update the details displayed as per sub-rule (1)
on monthly basis before fifth day of each month.
(4) Every private medical establishment shall display prominently at its reception area the
system of medicine which the establishment is authorized to practice.”
17. Notification of Schedule of Charges. - (1) Every private medical establishment shall
display its schedule of charges in Form D to these rules on the IT portal of Health and Family
Welfare Department and on its own website in case the establishment has one:
 7

Provided that the operational guidelines for the display and secured access to the IT portal
shall be provided by the Department.
(2) Every private medical establishment shall update the schedule of charges displayed as per
sub-rule (1) at least one week before the date on which the revision is planned to be effective.”

"CHAPTER-VII
PATIENT CHARTER AND PRIVATE ESTABLISHMENT CHARTER
18. Manner of making complaint. – (1) A complaint in respect of violation of any of the
provisions of the Patient Charter, Private Medical Establishment Charter, or these rules shall be
made online on the IT portal of the Department:
Provided that the application can be made by the patient or his near relative only.
(2) The complaint may also be made in physical form the office of the Chairman or Member-
Secretary of the Registration and Grievance Redressal Authority. It shall be obligatory for the office
to record the complaint in the IT portal in presence of the complainant, and provide a portal
generated acknowledgment at the same time.
10. Substitution of Form A, B and C.- For Form A, Form B and Form-C of the said rules,
the following shall be substituted, namely:-
"Form-A
(See sub-rule (1) of rule 6 and sub-rule (1) of rule 7)
Application for Registration of existing or eew medical Establishment1

(1) Name of Establishment

(2) Address of Establishment
(3) GIS Coordinates
(4) Category of Establishment (See rule 3)2
(a) System of medicine
(b) Number of beds
(c) Details of specialties or super-specialties
(5) Current Status: Already functioning/To be started
(6) Date of starting the Establishment/Proposed date of starting
(7) Nature of Ownership (Proprietary/Partnership/Company/Society/Trust/LLP)3
(8) Details of proprietor / partners/directors/executive committee members/trustees,-
(a) Name
(b) Sex and Age
(c) Aadhaar Number
(d) Contact details: Mobile / email
(9) Details of Administrator or Manager,-
(a) Name

(b) Sex and Age

(c) Aadhaar Number

(d) Photograph

(e) Contact details: Mobile / email

 8

(10) Contact details of the Establishment,-

(a) Email
(b) Phone
(11) Details of Infrastructure,-
(a) Land Area
(b) Building Area (total built-up area)
(c) Floor plans4
(d) Front view photograph5
(e) Occupancy certificate6,7
(f) Fire safety certificate8,9
(12) Details of Staff,-
(i) Details of medical staff,-
(a) Name
(b) Qualification
(c) Sex and Age (optional)
(d) Aadhaar Number
(e) Photograph
(f) Contact details: Mobile / email
ii. Details of para-medical staff (service head only, e.g., nursing, pharmacy,
diagnostic, etc),-
(a) Name
(b) Qualification
(c) Sex and Age (optional)
(d) Aadhaar Number
(e) Photograph
(f) Contact details: Mobile / email
(13) Internal Grievance Redressal Mechanism – Brief description and contact details of grievance
redressal person
(14) Details of fee paid – Challan Number, Date and Amount
Form-B
(See sub-rule (2) of rule 7A)
Application for Renewal of Registration of Existing Medical Establishment23
(1) Registration Number12
(2) Name of Establishment
(3) Address of Establishment
(4) GIS Coordinates
(5) Category of Establishment (See rule 3)13
(a) System of medicine
(b) Number of beds
(c) Details of specialties or super-specialties
(6) Date of expiry of current registration
 9

(7) Nature of Ownership (Proprietary / Partnership / Company / Society / Trust / LLP)14

(8) Details of proprietor / partners / directors / executive committee members / trustees,-
(a) Name
(b) Sex and Age
(c) Aadhaar Number
(d) Contact details: Mobile / email
(9) Details of Administrator or Manager,-
(a) Name
(b) Sex and Age
(c) Aadhaar Number
(d) Photograph
(e) Contact details: Mobile / email
(10) Contact details of the Establishment,-
(a) Email
(b) Phone
(11) Details of Infrastructure,-
(a) Land Area
(b) Building Area (total built-up area)
(c) Floor plans15
(d) Front view photograph16
(g) Occupancy certificate17,18
(h) Fire safety certificate19,20
(12) Details of Staff,-
(i) Details of medical staff,-
(a) Name
(b) Qualification
(c) Sex and Age (optional)
(d) Aadhaar Number
(e) Photograph
(f) Contact details: Mobile /email
iii. Details of para-medical staff (service head only, e.g., nursing, pharmacy,
diagnostic, etc),-
(a) Name
(b) Qualification
(c) Sex and Age (optional)
(d) Aadhaar Number
(e) Photograph
(f) Contact details: Mobile / email
(13) Internal Grievance Redressal Mechanism – Brief description and contact details of grievance
redressal person
(14) Details of fee paid – Challan Number, Date and Amount
 10

Form C
(See sub-rule (1) of rule 16)
Establishment Details for Display to the Public
(1) Name of Establishment
(2) Address of Establishment
(3) GIS Coordinates
(4) Category of Establishment (See rule 3)21,-
(a) System of medicine
(b) Number of beds
(c) Details of specialties or super-specialties
(5) Details of Administrator or Manager,-
(a) Name
(b) Sex and Age
(c) Photograph
(d) Contact details: Mobile / email
(6) Contact details of the Establishment,-
(a) Email
(b) Phone
(7) Infrastructure,-
(a) Land Area
(b) Building Area (total built-up area)
(c) Floor plans22
(d) Front view photograph 23

(e) Occupancy certificate 24,25

(f) Fire safety certificate 26,27

(8) Details of Staff,-

(i) Details of medical staff,-
(a) Name
(b) Qualification
(c) Sex and Age (Optional)
(d) Photograph
(e) Contact details: Mobile / email
(ii) Details of para-medical staff (service head only, eg, nursing, pharmacy,
diagnostic, etc),-
(a) Name
(b) Qualification
(c) Sex and Age (Optional)
(d) Photograph
(e) Contact details: Mobile / email
9. Internal Grievance Redressal Mechanism – Brief description and contact details of grievance
redressal person
 11

10. Number of Patients and major treatments during the Year and Month (..........),-
(a) Outpatients
(b) Inpatients
(c) Major Surgeries
(d) Minor Surgeries
11. Date of last update
11. Insertion of Form D.- After Form-C so substituted, the following new Form shall be
inserted at the end, namely:-
"Form D
(See sub-rule (1) of rule 17)
Schedule of Charges4 for Display to the Public
(1) Name of the Establishment
(2) Registration Number
(3) Date of effect of the Schedule of Charges
Schedule of Charges 29

Sl.No. Item30 Code Charge (in Rupees.)

1 Consultation Fee31
2 Surgery Fee32
3 Treatments33
4 Diagnostic tests34
5 Hospital Charges

Foot Notes
1. Detailed application form and guidelines shall be available on the IT portal of the
department.
2. Provide details of specialties or super-specialties and diagnostic facilities
3. Upload supporting document
4. Upload plan for each floor in A4 size
5. Upload photograph of front view of the building taken as per operational guidelines
6. Upload the occupancy certificate
7. Occupancy certificate is optional for existing establishments
8. Upload the fire safety certificate
9. Nature of fire safety requirement in respect of existing establishments to be notified
separately
10. Detailed application form and guidelines shall be available on the IT portal of the
department
11. In case the establishment has already updated the information on the portal as under
proviso to sub-rule (1) of rule 6, the information for items at serial numbers 2 to 14 shall
be auto-populated based on the registration number entered at serial number 1. The
establishment may further update the information, if required, in the auto-populated
Form-B.
12. Upload certificate copy
 12

13. Provide details of specialties or super-specialties and diagnostic facilities

14. Upload supporting document
15. Upload plan for each floor in A4 size
16. Upload photograph of front view of the building taken as per operational guidelines
17. Upload the occupancy certificate
18. Occupancy certificate is optional for existing establishments
19. Upload the fire safety certificate
20. Nature of fire safety requirement in respect of existing establishments to be notified
separately
21. Provide details of specialties or super-specialties and diagnostic facilities
22. Upload plan for each floor in A4 size
23. Upload photograph of front view of the building taken as per operational guidelines
24. Upload the occupancy certificate
25. Occupancy certificate is optional for existing establishments
26. Upload the fire safety certificate
27. Nature of fire safety requirement in respect of existing establishments to be notified
separately
28. Charges for all medical services to be provided
29. Add rows for each item as required
30. Treatment description and code shall be as per standards formulated by the National
Council constituted under the Clinical Establishment (Registration and Regulation) Act
2010 (Central Act 23 of 2010)
31. For each medical staff, if uniform fee is not followed
32. For each surgeon, if uniform fee is not followed
33. Major treatments shall be listed ahead of others
34. Major tests shall be listed ahead of others

BY ORDER AND IN THE NAME OF

THE GOVERNOR OF KARNATAKA

K. NARAYANA
ADDITIONAL SECRETARY TO GOVERNMENT
HEALTH AND FAMILY WELFARE DEPARTMENT

¸ÀPÁðj ªÀÄÄzÀæuÁ®AiÀÄ, «PÁ¸À ¸ËzsÀ WÀlPÀ, ¨ÉAUÀ¼ÀÆgÀÄ. (¦8) ¥Àw

æ UÀ¼ÀÄ: 100