CLINICAL ESTABLISHMENTS
3.
6.
7.
8.
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
38. Maintenance of State Register of clinical establishments
39. Maintenance of National Register of clinical establishments
EPIDEMIC DISEASES ACT, 1897
3A. Cognizance, investigation and trial of offences
3B. Composition of certain offences
3C. Presumption as to certain offences
3D. Presumption of culpable mental state
3E. Compensation for acts of violence
4. Protection to persons acting under Act
CLINICAL ESTABLISHMENTS (CENTRAL GOVERNMENT) RULES, 2012
1. Short title and commencement 61
2. Definitions
3. Appointment of Secretary of the National Council by the Central Government
4. National Council and its sub-committees
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
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 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 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.
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: Arunachal Pradesh, Himachal Pradesh, Mizoram and 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: Uttar Pradesh, Uttarakhand, Rajasthan, Bihar, Jharkhand, Assam and 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: The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002.
The Delhi Nursing Homes Registration Act, 1953.
The Bombay Nursing Homes Registration Act, 1949
The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue (Ragistrikaran Tatha Anugyapan) Adhiniyam, 1973.
2. With effect from 1-3-2012.
CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 S. 2
The Manipur Homes and Clinics Registration Act, 1992.
The Nagaland Health Care Establishments Act, 1997.
The Orissa Clinical Establishments (Control and Regulation) Act, 1990.
The Punjab State Nursing Home Registration Act, 1991.
The West Bengal Clinical Establishments Act, 1950. [Section 56(1)]
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.
S. 2 CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 4
Explanation.— For the purpose of this clause “Armed Forces” means the forces constituted under the Army Act, 1950 (46 of 1950) , the Air Force Act, 1950 (45 of 1950) and the Navy Act, 1957 (62 of 1957);
(d) “emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) of such a nature that the absence of immediate medical attention could reasonably be expected to result in—
(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 impairment to bodily functions; or
(iii) serious dysfunction of any organ or part of a body;
(e) “National Council” means the National Council for clinical establishments established 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 Central Government 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 system of medicine as may be recognised by the Central Government;
(i) “register” means the register maintained by the authority, State Government and the Central Government under sections 37, 38 and 39 respectively of this Act containing the number of clinical establishments registered;
(
j) “registration” means to register under section 11 and the expression registration or 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 prescribe under section 12, for the registration of clinical establishments;
(n) “State Government”, in relation to a Union territory, means the Administrator thereof 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 provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a clinical establishment.
CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 S. 2
COMMENTS
SECTION NOTES
2.1 Clinical establishments which are outside the purview of this Act
FAQ No.4 in http://www.clinicalestablishments.gov.in/cms/Home.aspx clarifies as under:
“4. Are there any specific clinical establishments that would be outside purview of the Act?
The clinical establishments owned, controlled or managed by the Armed Forces are not covered under this Act.
Also those categories of Clinical Establishment exempted by the state Government and Clinical Establishments located in the States/UTs mentioned in the schedule to the Act; unless these States/UTs repeal their existing Act and adopt Clinical Establishments Act.”
2.2 “Clinical establishment”:
The term “Clinical establishment” means any institution, private or public, that provides diagnosis, treatment, or care for illnesses or injuries.
The term “Clinical establishment” includes hospitals, maternity homes, nursing homes, dispensaries, and clinics.
The term excludes institutions owned or managed by armed forces.
FAQ No. 2 clarifies the term “clinical establishment” as follows
“2. What does ‘clinical establishment’ mean?
A clinical establishment means a hospital, maternity home, nursing home, dispensary, clinic, sanatorium, or any other institution that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicine. It also includes laboratory and diagnostic centre or any other place where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other services with aid of laboratory or other medical equipment are carried out. (Please refer to the Definition in the CEA 2010.)”
[See http://www.clinicalestablishments.gov.in/cms/Home.aspx]
2.3 “Emergency medical condition”
A sudden health issue or injury needing immediate medical attention to prevent serious harm or death.
2.4 “Recognized system of medicine”:
The term includes various medical systems such as Allopathy, Ayurveda, Yoga, Naturopathy, Homeopathy, Siddha, and Unani, which are recognized by law.
2.5 “Standards”
Standards are Minimum qualifications, infrastructure, staffing, and equipment that a clinical establishment must meet, as defined under this Act.
2.6 “Treatment”
Any medical or surgical care given to individuals for their health conditions, injuries, or diseases.
2.7 “To stabilise”
“to stabilise (with its grammatical variations and cognate expressions)” means, with respect to an emergency medical condition specified in clause (d), to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a clinical establishment.
ACT 2010 WITH RULES – BARE ACT WITH SECTION NOTES
AUTHOR : TAXMANN’S EDITORIAL BOARD
PUBLISHER : TAXMANN
DATE OF PUBLICATION : JULY 2025
EDITION : 2025 EDITION
ISBN NO : 9789371261876
NO. OF PAGES : 84
BINDING TYPE : PAPERBACK
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 2025 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, updated to 2025
• [Latest Amendments] Includes all legislative and regulatory amendments, notifications, and judicial developments up to 2025
• [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
