CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010
NOTIFICATION
The 16th September, 2016
No. LGL.78/2013/25.- The following Act of Parliament which received the assent of the President on 18th August, 2010 and which has been adopted by passing a resolution unanimously by the Assam Legislative Assembly on 10th December, 2015, for adoption of the sa
1. Short title, application and commencement. : - (I) 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.
2. Definition :- 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-.
(1) a hospital, maternity home, nursing home, dispensary, clinic, sanatoriu
3. Establishment of National Counsel. :- (1) With effect from such date as the Central Government may, by notification appoint in this behalf, there shall be established for the purposes of this Act, a Council to be called the National Council for clinical Establishment.
(2) The National Council shall consist of-
(a) Director-General of Health Service, Ministry of Health and Family Welfare, ex officio, who shall be the chairperson;’
4. Disqualifications for appointment as member :- A person shall be disqualified for being appointed as a member of the National Council in he-
(a) has been convicted and sentenced to imprisonment for an offence which in the opinion of the Central Government, involves moral turpitude; or
(b) is an un-discharged insolvent; or
(c) is of unsound mind and stands so declared by a competent court
5. Functions of National Council : - The National Council shall-
(a) Compile and publish a National Register of clinical establishments within two years from the date of the commencement of this Act:
(b) classify the clinical establishments into different categories;
(c) develop the minimum standards and their periodic review:
(d) de
6. Power to seek advice or assistance :- The National Council may associate with itself any person or body whose assistance or advice it may desire in carrying out any of the previsions of this Act.
7. National Council to follow consultative process :- The National Council shall follow a consultative process for determining the standards and for classification of clinical establishment in accordance with such procedure as may be prescribed.
8. State Council of clinical establishments. :- (I) Every State Government shall by notification constitute a State Council for clinical establishment or the Union territory Council for clinical establishment, the case may he.
(1) The State Council or the Union territory Council, as the case may be, shall consist of the fallowing members, namely-
(a) Secretary, Health- ex officio, who shall be the Chairman;
9. Providing information to National Council : - It shall be the responsibility of the State Council for clinical establishments to compile and update the State Register of clinical establishments of the State and further to send monthly returns in digital format for updating the National Register.
10. Authority for registration : - (i) The State Government shall by notification, set-up an authority to be called the district registering authority for each district for registration of clinical establishments, with the following members, namely:-
(a) District Collector - Chairperson;
(b) District Health Officer - Convener;
(c) three members with such qualifications and on such terms an
11. Registration for clinical establishments :- No person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of this. Act.
12. Condition for registration :- (I) For regulation and continuation, every clinical establishment shall fulfil the following conditions, namely:-
(i) the minimum standards of facilities and services as may be prescribed;
(ii) the minimum requirement of personnel as may be prescribed;
(iii) provisions for maintenance of records and reporting as may be prescribed;
13. Classification of clinical establishment : - (I) Clinical establishment of different systems shall be classified into such categories as may be prescribed by the Central Government, from time to time
(2) Different standards may be prescribed for classification of different categories referred to in sub-section (1);
Provided that in prescribing the standards for clinical establishments, the Central Government shall have regard to the loc
14. Application for provisional certificate of registration : - (1) For the purposes of registration of the clinical establishment under section 10, an application in the prescribed proforma along with the prescribed fee shall be made to the authority.
(2) The application shall be filed in person or by post or online.
(3) The application shall be made in such form and shall be accompanied by such details as may be prescribed under this Act
15. Provisional certificate.The authority shall, within a period of ten days from the dale of receipt of such application, grant to the applicant a certificate of provisional registration in such form and containing such particulars and such information, as may be prescribed.
16. No inquiry prior to provisional registration. (I) The authority shall not conduct any inquiry prior to the grant of provisional remigration.
(2) Notwithstanding the grant of the provisional certificate of registration, the authority shall, within a period of forty-five days from the grants of provisional registration, cause to polished in such manner as may be prescribed. All particulars of the clinical establishment so registered provisionally.
17. Validity of provisional registration. :- Subject to the provision of section 23, every provisional registration shall be valid to the last day of the twelfth month from the date of issue of the certificate of registration and such registration shall be renewable.
18. Display of certificate of registration :- . The certificate shall be kept affixed in a conspicuous place in the clinical establishment in such manner so as to be visible to every one visiting such establishment.
19. Duplicate Certificate.: - In case the certificate is lost, destroyed, mutilated or damaged, the authority shall issue a duplicate certificate on the request of the clinical establishment and on the payment of such fees as may be prescribed.
20. Certificate to be non-transferable : - (1) The certificate of registration shall be non-transferable.
(2) In the event of change of ownership or management, the clinical establishment shall inform the authority of such manner as may be prescribed.
(3) In the event of change of category, or location, or on ceasing to function as a clinical establishment, the certificate of registration in respect of such clinical establishment shall be s
21. Publication of expiry of registration. :- The authority shall cause to be published within such time and in such manner, as may be prescribed, the names of clinical establishments whose registration has expired.
22. Renewal of registration: - The application for renewal of registration shall be made thirty days before the expiry of the validity of certificate of provisional registration and, in case the application for renewal is made after the expiry of the provisional registration, the authority shall allow renewal of registration on payment of such enhanced fees, as may be prescribed.
23. Time limit for provisional registration. : - Where the clinical establishment in respect of which standards have been notified by the Central Government, provisional registration shall not be granted or renewed beyond,-
(i) the period of two years from the date of notification of the standards in case of clinical establishments which came into existence before the commencement of this Act;
(ii) the period of two years from the date of n
24. Application for permanent registration :- Application for permanent registration by a clinical establishment shall be made to the authority in such from and be accompanied by such fees, as may be prescribed,
25. Verification of application : - The clinical establishment shall submit evidence of having complied with the prescribed minimum standards in such manner, as may he prescribed.
26. Display of information for filing objections : - As soon as the clinical establishment submits the required evidence of having complied with the prescribed minimum standards, the authority shall cause to be displayed for information of the public at large and for filing objections, if any, in such manner, as may be prescribed,. all evidence submitted by the clinical establishment of having complied with the prescribed minimum standards for a period of thirty days before processing for grant of permanent registration.
27. Communication of objections :- if objections are received within the period referred to in preceding sections, such objections shall be communicated to the clinical establishment for response within a period off forty-five days.
28. Standards or permanent registration : - Permanent registration shall be granted only when a clinical establishment fulfils the prescribed standards for registration by the Central Government.
29. Allowing or disallowing of registration : - The authority shall pass an order immediately after the expiry of the prescribed period and within the next thirty days thereafter either-
(a) allowing the application for permanent registration or
(b) disallowing the application.
Provided that the authority shall record its reasons, if it disallows an application, for permanent registration.
30. Certificate of permanent registration. : - (1) The authority shall, if it, allows an application of the clinical establishment, issue a certificate of permanent registration in such form and containing such particulars, as may be prescribed.
(2) The certificate shall be valid for a period of five years from the date of issue.
(3) For the purposes of sub-section (1), the provisions of section. 18, 19, 20 and 21 shall also apply.
31. Fresh application for permanent registration. :- The disallowing of an application for permanent registration shall not debar a clinical establishment from applying afresh for permanent registration under section 24 and after providing such evidence, as may be required, of having rectified the deficiencies on which grounds the earlier application Was disallowed.
32. Cancellation of registration : - (1) 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 this Act-
it may issue a notice to clinical establish
33. Inspection of registered clinical establishments. : - (1) The authority or an officer authorised by it shall have the right to cause an inspection of, or inquiry in respect of any registered clinical establishment, its building. laboratories and equipment and also of the work conducted or done by the clinical establishment, to be made by such multi-member inspection team as it may direct and to cause an inquiry to be made in respect of any other matter connected with the clinical establishment and that establishment shall be entitled to b
34. Power to enter : - The authority or an officer authorised by it may, if there any reason to suspect that anyone is carrying on a clinic establishment without registration, enter and search in the manner prescribed at any reasonable time and the clinical establishment, shall offer reasonable facilities for inspection or inquiry and be entitled to be represented thereat:
Provided that no such person shall enter the clinical establishment without giving notice of his intention to do so.
35. Levy of fee by state Government :- The State Government may charge fees for different categories of clinical establishments as may be prescribed.
36. Appeal : - (l) Any person, aggrieved by an order of the registering authority refusing to grant or renew a certificate of registration or revoking a certificate of registration may, in such manner and within such period as may be prescribed, prefer an appeal to the State Council:
Provided that the State Council may entertain an appeal preferred after the expiry of the prescribed period if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in t
37. Register of clinical establishment :- (1) The authority shall within a period of two years from its establishment, compile, publish and maintain in digital format a register of clinical establishments, registered by 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 State Government.
(2) Each authority, including any other authority set-up for the registration of clinical establishments un
38. Maintenance of State Register of clinical :- (1) Every State Government shall maintain in digital and in such form and containing such particulars, as may be prescribed by the Central Government a registers be known as the State Register of clinical establishments in respect of clinical establishments of that State.
(2) Every State Government shall supply in digital format to the Central Government, a copy of the State Register of clinical establishment and shall inform the Central Gover
39. Maintenance of National Register of clinical : The Central Government shall maintain in digital format an All India Register to be called as the National Register of clinical establishments that shall be an arnalgam of the State Register of clinical establishments maintained by the State Governments and shall cause the same to be published in digital format.
40. Penalty :- Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere, be punishable for the first offence with offence which may extend to ten thousand rupees, for any second offence with fine which may extend to fifty thousand rupees and for any subsequent offence with fine which may extend to five lakh rupees.
41. Monetary penalty fur no-registration :- (1) Whoever carries on a clinical establishment without registration shall, on first contravention, be liable to a monetary penalty up to fifty thousand rupees, for second contravention with a monetary penalty which may extend to two lakh rupees and for any subsequent contravention With a monetary penalty which may extend to five lakh rupees.
(1) Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall
42. Disobedience of direction obstruction and refusal of information :- (1) Whoever wilfully disobeys any direction lawfully given by any person or authority empowered under this Act to give such direction, or obstructs any person or authority in the discharge of any functions which such person or authority is required or empowered under this Act to discharge, shall be liable to a monetary penalty which may extend to five lakh rupees.
(2) W
43. Penalty for minor deficiencies :- Whoever contravenes any provision of this Act or any rule made there under resulting in deficiencies that do not pose any imminent danger to the health and safety of any patient and can be rectified within a reasonable time, shall be punishable with fine which may extend to ten thousand rupees.
44. Contravention by companies.:- (1) Where a person committing contravention of any of the provisions of this Act or 'of any rule made there under is a company, every person who at the time the contravention was committed, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the contravention and shall be liable to fine:
Provided that nothing contained in this sub-section shall render any
45. Offences by Government Departments : - (1) Where an offence under this Act has been committed by any Department of Government within a period of six months after the commencement of this Act, the Head of the Department shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly;
Provided that nothing contained in this section shall render such Head of the Department liable to any punishment if he proves that the offence was commi
46. Recovery of fine :- Whoever fails to pay the fine, the State Council of clinical establishment may prepare a certificate signed by on officer authorised by it specifying the fine due from such person and send it to the Collector of the District in which such person owns any property or resides or carries on his business and the said Collector, on receipt of such certificate, shall proceed to recover from such person the amount specified there under, as if it were an arrear of land revenu
47. Protection of action taken in good faith :- No suit, prosecution or other legal proceedings shall lie against any authority or any member of the National Council or State Council or Intended to be done in pursuance of the provisions of this Act or any rule made there under.
(2) No suit or other legal proceedings shall lie against a State Government or the Central Government in respect of any loss or damage caused or likely to be
48. Furnishing of returns etc. :- Every clinical establishment shall, within such time or within such extended time, as may be prescribed in that behalf, furnish to the authority Or the State Council or the National Council such returns or the statistics and other information in such manner, as may be prescribed by the State Government, from time to time.
49. Power to give direction. :- Without prejudice to the foregoing provisions of this Act, the authority shall have the power to issue such directions, including furnishing returns, statistics and other information for the proper functioning of clinical establishments and such directions shall be binding.
50. Employees of the authority etc. to public servants :- Every employee of the authority, the National Council and the State Council shall be deemed to, when acting or purporting to act in pursuance of any of the provisions of this Act, (45 of 1860) be public servants within the meaning of section 21 of the Indian Penal Code.
51. Power to remove difficulties. :- (1) If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order published in the Official Gazette, make such provisions not inconsistent with the provisions of this Act as may appear to it to be necessary or expedient for removal of the difficulty:
Provided that no such order shall be made after the expiry of a period of two years from the date of commencement of this Act.
52. Power of central Government to make rules. :- (1) The Central Government may, by notification, make rules for carrying out all or any of the provisions of this Act.
(2) In particular and without prejudice to the generality of the foregoing power, such rule may provide for all or any of the following mailers, namely:-
(a) allowances for the members of the National Council under sub-sect
53. Laying of rules :- Every rule made by the Central Government under this Act shall be laid, as soon as may be after it is made, before each House of parliament while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, rule shall thereafter have
54. Power of state Government to make rules :- (1) The State Government may, by notification, make rules for carrying out in respect of matters which do not fall within the purview of section 52.
(2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely;-
(a) the proforma and the fee to be paid for registration under sub-section (1) of section 14;
55. Laying of rules :- Every rule made by the State Government under this section shall be laid, as soon as may be after it is made, before each House of the State Legislature where it consists of two rules. Houses, or where such Legislature consists of one House, before that House.
56. Saving (1) The provisions of this Act shall not apply to the States in which the enactments Savings specified in the Schedule are applicable:
Provided that the States in which the enactments referred to in sub-section (1) are applicable, and such States subsequent to the commencement of this Act, adopts this Act under clause (1) of article 252 of the Constitution, the provisions of to is Act shall, subsequent to such adoption, apply in that State.
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