Sample Read
© Taxmann Price : ` 130 Law stated in this book is as updated till 20th November, 2025 Published by : Taxmann Publications (P.) Ltd. Sales & Marketing : 59/32, New Rohtak Road, New Delhi-110 005 India Phone : +91-11-45562222 Website : www.taxmann.com E-mail : sales@taxmann.com Regd. Office : 21/35, West Punjabi Bagh, New Delhi-110 026 India Printed at : Tan Prints (India) Pvt. Ltd. 44 Km. Mile Stone, National Highway, Rohtak Road Village Rohad, Distt. Jhajjar (Haryana) India E-mail : sales@tanprints.com Disclaimer Every effort has been made to avoid errors or omissions in this publication. In spite of this, errors may creep in. Any mistake, error or discrepancy noted may be brought to our notice which shall be taken care of in the next edition. It is notified that neither the publisher nor the author or seller will be responsible for any damage or loss of action to any one, of any kind, in any manner, therefrom. It is suggested that to avoid any doubt the reader should cross-check all the facts, law and contents of the publication with original Government publication or notifications. No part of this book may be reproduced or copied in any form or by any means [graphic, electronic or mechanical, including photocopying, recording, taping, or information retrieval systems] or reproduced on any disc, tape, perforated media or other information storage device, etc., without the written permission of the publishers. Breach of this condition is liable for legal action. For binding mistake, misprints or for missing pages, etc., the publisher’s liability is limited to replacement within seven days of purchase by similar edition. All expenses in this connection are to be borne by the purchaser. All disputes are subject to Delhi jurisdiction only.
Contents CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 PAGE
CHAPTER I PRELIMINARY 1. Short title, application and commencement
1
2. Definitions
3 CHAPTER II THE NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS
3. Establishment of National Council
6
4. Disqualifications for appointment as member
8
5. Functions of National Council
8
6. Power to seek advice or assistance
9
7. National Council to follow consultative process
9
CHAPTER III REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS 8. State Council of clinical establishments
9
9. Providing information to National Council
10
10. Authority for registration
11 I-5
CONTENTS
I-6 PAGE
11. Registration for clinical establishments
11
12. Condition for registration
11
13. Classification of clinical establishments
12
CHAPTER IV PROCEDURE FOR REGISTRATION 14. Application for provisional certificate of registration
12
15. Provisional certificate
17
16. No inquiry prior to provisional registration
18
17. Validity of provisional registration
18
18. Display of certificate of registration
19
19. Duplicate certificate
19
20. Certificate to be non-transferable
19
21. Publication of expiry of registration
20
22. Renewal of registration
20
23. Time limit for provisional registration
20
24. Application for permanent registration
21
25. Verification of application
21
26. Display of information for filing objections
22
27. Communication of objections
22
28. Standards for permanent registration
22
29. Allowing or disallowing of registration
22
30. Certificate of permanent registration
23
31. Fresh application for permanent registration
23
32. Cancellation of registration
24
33. Inspection of registered clinical establishments
25
34. Power to enter
26
35. Levy of fee by State Government
27
36. Appeal
27 CHAPTER V REGISTER OF CLINICAL ESTABLISHMENTS
37. Register of clinical establishments
28
38. Maintenance of State Register of clinical establishments
29
39. Maintenance of National Register of clinical establishments
29
I-7
CONTENTS PAGE
CHAPTER VI PENALTIES 40. Penalty
29
41. Monetary penalty for non-registration
30
42. Disobedience of direction, obstruction and refusal of information
32
43. Penalty for minor deficiencies
33
44. Contravention by companies
33
45. Offences by Government Departments
34
46. Recovery of fine
34 CHAPTER VII MISCELLANEOUS
47. Protection of action taken in good faith
34
48. Furnishing of returns, etc.
35
49. Power to give directions
35
50. Employees of the authority, etc., to be public servants
35
51. Power to remove difficulties
35
52. Power of Central Government to make rules
36
53. Laying of rules
37
54. Power of State Government to make rules
37
55. Laying of rules
39
56. Savings
39
SCHEDULE
39
SUBJECT INDEX
41
EPIDEMIC DISEASES ACT, 1897 1. Short title and extent 1A. Definitions 2. Power to take special measures and prescribe regulations as to dangerous epidemic disease
45 46 47
2A. Powers of Central Government
52
2B. Prohibition of violence against healthcare service personnel and damage to property
52
3. Penalty
53
CONTENTS
I-8 PAGE
3A. 3B. 3C. 3D. 3E. 4.
Cognizance, investigation and trial of offences Composition of certain offences Presumption as to certain offences Presumption of culpable mental state Compensation for acts of violence Protection to persons acting under Act
SUBJECT INDEX
55 56 56 57 57 58 59
CLINICAL ESTABLISHMENTS (CENTRAL GOVERNMENT) RULES, 2012 1. Short title and commencement
61
2. Definitions
61
3. Appointment of Secretary of the National Council by the Central Government
61
4. National Council and its sub-committees
62
5. Allowances for the members of the National Council and subcommittees
62
6. State Council or Union Territory Council representation in the National Council meeting
62
7. Common registration form for compilation of the State and National Register
63
8. District Registering Authority
63
8A. Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories)
64
9. Other conditions for registration and continuation of clinical establishments
64
SCHEDULE
65
Clinical Establishments (Registration and Regulation) Act, 2010 [23 OF 2010]1 An Act to provide for the registration and regulation of clinical establishments in the country and for matters connected therewith or incidental thereto. Whereas, it is considered expedient to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services which may be provided by them so that mandate of article 47 of the Constitution for improvement in public health may be achieved; And whereas, Parliament has no power to make laws for the States with respect to any of 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, resolutions have 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 be regulated in those States by Parliament by law; Be it enacted by Parliament in the Sixty-first Year of the Republic of India as follows:— CHAPTER I PRELIMINARY Short title, application and commencement. 1. (1) This Act may be called the Clinical Establishments (Registration and Regu lation) 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 such other State which adopts this Act by resolution passed in that behalf under clause (1) of article 252 of the Constitution. 1. Dated 18-8-2010.
1
S. 1
CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010
2
(3) It shall come into force at once in the States of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim and the Union territories, on such date2 as the Central Government may, by notification, appoint and in any other State which adopts this Act under clause (1) of article 252 of the Constitution, on the date of such adoption; and any reference in this Act to the commencement of this Act shall, in relation to any State or Union territory, mean the date on which this Act comes into force in such State or Union territory: Provided that different dates may be appointed for different categories of clinical establishments and for different recognised systems of medicine. COMMENTS SECTION NOTES
1.1 Not applicable to the whole of India-applicable specified states only A. This Act applies to all the Union Territories except the NCT of Delhi. [Section 1(2) read with Section 56(1) and Schedule to the Act] B. This Act also applies to the following states: u
Arunachal Pradesh,
u
Himachal Pradesh,
u
Mizoram and
u
Sikkim [Section 1(2)]
C. Other states have the option to adopt this Act by resolution passed on that behalf under clause (1) of article 252 of the Constitution. D. The Act also applies to the following States which have adopted it by passing resolutions under Article 252(1) in their respective State assemblies: u
Uttar Pradesh,
u
Uttarakhand,
u
Rajasthan,
u
Bihar,
u
Jharkhand,
u
Assam and
u
Haryana
[See http://www.clinicalestablishments.gov.in/cms/Home.aspx] E. The Act does not apply to the States in which the following enactments are applicable: u
The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002.
u
The Delhi Nursing Homes Registration Act, 1953.
u
The Bombay Nursing Homes Registration Act, 1949
u
The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue (Ragistrikaran Tatha Anugyapan) Adhiniyam, 1973.
2. With effect from 1-3-2012.
3
CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 u
The Manipur Homes and Clinics Registration Act, 1992.
u
The Nagaland Health Care Establishments Act, 1997.
u
The Orissa Clinical Establishments (Control and Regulation) Act, 1990.
u
The Punjab State Nursing Home Registration Act, 1991.
u
The West Bengal Clinical Establishments Act, 1950. [Section 56(1)]
S. 2
F. This Act shall apply to any State in which any of the enactments referred to in E above are applicable; if such State adopts this Act under clause (1) of article 252 of the Constitution [Section 56(1)] Note: All clinical establishments in the States and Union Territories mentioned in A, B, and D above must register under this Act.
Definitions. 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, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine 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 sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated 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 or State 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 Armed Forces.
CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT 2010 WITH RULES – BARE ACT WITH SECTION NOTES AUTHOR : PUBLISHER : DATE OF PUBLICATION : EDITION : ISBN NO : NO. OF PAGES : BINDING TYPE :
Taxmann's Editorial Board Taxmann December 2025 2026 Edition 9789371261944 84 Paperback
Rs. 130 DESCRIPTION
Clinical Establishments (Registration and Regulation) Act 2010 with Rules [Bare Act with Section Notes] by Taxmann is a comprehensive statutory reference for the registration, regulation, and governance of clinical establishments in India. This thoroughly updated Edition consolidates the latest text of the principal Act, Clinical Establishments (Central Government) Rules 2012, and allied legislation such as the Epidemic Diseases Act 1897. Enhanced with section-wise notes, commentary, judicial summaries, and government notifications, this volume provides practical guidance for compliance and licensing across all systems of medicine. This book is intended for the following audience: • Hospital Administrators, Owners, and Healthcare Entrepreneurs • Medical Practitioners & Professionals • Legal Professionals, Compliance Officers, and Consultants • Regulatory Authorities, Policymakers & Health Officials • Students, Academicians & Researchers The Present Publication is the 2026 Edition, covering the amended and updated text of the Clinical Establishments (Registration and Regulation) Act [Act No. 23 of 2010] and Rules, with the following noteworthy features: • [Comprehensive Coverage] Verbatim text of the Clinical Establishments (Registration and Regulation) Act 2010, Clinical Establishments (Central Government) Rules 2012, and the Epidemic Diseases Act 1897 • [Latest Amendments] Includes all legislative and regulatory amendments, notifications, and judicial developments up to date • [Pre-amendment Provisions] Contains prior versions of amended provisions for historical context and comparative reference • [Section-wise Notes] Each provision features editorial notes, interpretative guidance, compliance checklists, and FAQs for practical application • [Judicial Analysis] Summaries of key Supreme Court and High Court judgments interpreting major provisions • [FAQs and Practice Guidance] Includes official FAQs and guidance notes on registration, renewal, classification, compliance, and emergency standards • [Statutory Commentary] Detailed explanations of definitions, applicability, exceptions, and interplay between central and state laws • [Reference Tools] Includes subject index, schedules, notifications, and specimen forms for easy compliance • [User-friendly Format] Optimised for quick reference and daily professional use • [Practical Guidance] Summarises checklists, forms, renewal timelines, and compliance requirements for every clinical establishment • [Authoritative Source] Trusted by legal professionals, healthcare administrators, and policymakers for clarity and completeness
Buy Now