Chapter III
REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS
8. State Council of clinical establishments.
8. State Council of clinical establishments.—(1) Every State Government shall by notification constitute a State Council for clinical establishments or the Union territory Council for clinical establishments, as the case may be.
(2) The State Council or the Union territory Council, as the case may be, shall consist of the following members, namely—
(a) Secretary, Health—ex officio, who shall be the Chairman;
(b) Director of Health Services—ex officio member-secretary;
(c) Directors of different streams of Indian Systems of Medicine—ex officio members;
(d) one representative each to be elected by the executive committee of—
(i) State Medical Council of India;
(ii) State Dental Council of India;
(iii) State Nursing Council of India;
(iv) State Pharmacy Council of India;
(e) three representatives to be elected by the Executive of the State Council or the Union territory Council, as the case may be, of Indian Medicine representing the Ayurveda, Siddha and Unani systems of medicine;
(f) one representative to be elected by the State Council of the Indian Medical Association;
(g) one representative from the line of paramedical systems;
(h) two representatives from State level consumer groups or reputed non-Governmental organisations working in the field of health.
(3) The nominated member of the State Council or the Union territory Council, as the case may be, shall hold office for a term of three years, but shall be eligible for re-nomination for maximum of one more term of three years.
(4) The elected members of the State Council or the Union territory Council, as the case may be, shall hold office for three years, but shall be eligible for re-election:
Provided that the person nominated or elected, as the case may be, shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the State Council or the Union territory Council, as the case may be.
(5) The State Council or the Union territory Council shall perform the following functions, namely—
(a) compiling and updating the State Registers of clinical establishment;
(b) sending monthly returns for updating the National Register;
(c) representing the State in the National Council;
(d) hearing of appeals against the orders of the authority; and
(e) publication on annual basis a report on the state of implementation of standards within their respective States.
| Other Contents of Clinical Establishments (Registration and Regulation) Act, 2010 |
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| Sections 1 to 7 Sections 8 to 36 Sections 37 to 56 and Schedule |
9. Providing information to National Council.
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.
10. Authority for registration.—(1) 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—
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(a) District Collector |
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Chairperson; |
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(b) District Health Officer |
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Convenor; |
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(c) three members with such qualifications and on such terms and conditions as may be prescribed by the Central Government. |
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(2) Notwithstanding anything contained in sub-section (1), for the purposes of provisional registration of clinical establishments under Section 14, the District Health Officer or the Chief Medical Officer (by whatever name called) shall exercise the powers of the authority as per procedure that may be prescribed.
11. Registration for clinical establishments.
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.
12. Condition for registration.—(1) For registration 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;
(iv) such other conditions as may be prescribed.
(2) The clinical establishment shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment.
13. Classification of clinical establishments.
13. Classification of clinical establishments.—(1) 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 local conditions.
Chapter IV
PROCEDURE FOR REGISTRATION
14. Application for provisional certificate of registration.
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 pro forma 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 or rules made thereunder.
(4) If any clinical establishment is in existence at the time of the commencement of this Act, an application for its registration shall be made within one year from the date of the commencement of this Act and a clinical establishment which comes into existence after commencement of this Act, shall apply for permanent registration within a period of six months from the date of its establishment.
(5) If any clinical establishment is already registered under any existing law requiring registration of such establishments, even then it shall apply for registration as referred to in sub-section (1).
15. Provisional certificate.
15. Provisional certificate.—The authority shall, within a period of ten days from the date 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.
16. No inquiry prior to provisional registration.—(1) The authority shall not conduct any inquiry prior to the grant of provisional registration.
(2) Notwithstanding the grant of the provisional certificate of registration, the authority shall, within a period of forty-five days from the grant of provisional registration, cause to be published in such manner, as may be prescribed, all particulars of the clinical establishment so registered provisionally.
17. Validity of provisional registration.
17. Validity of provisional registration.—Subject to the provisions 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.
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.
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.
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 change in 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 surrendered to the authority and the clinical establishment shall apply afresh for grant of certificate of registration.
21. Publication of expiry of registration.
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.
22. Renewal of registration.—The application for renewal of registration shall be made thirty days before the expiry of the validity of the 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.
23. Time limit for provisional registration.—Where the clinical establishments 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 notification of the standards for clinical establishments which come into existence after the commencement of this Act but before the notification of the standards; and
(iii) the period of six months from the date of notification of standards for clinical establishments which come into existence after standards have been notified.
24. Application for permanent registration.
24. Application for permanent registration.—Application for permanent registration by a clinical establishment shall be made to the authority in such form and be accompanied by such fees, as may be prescribed.
25. Verification of application.
25. Verification of application.—The clinical establishment shall submit evidence of having complied with the prescribed minimum standards in such manner, as may be prescribed.
26. Display of information for filing objections.
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.
27. Communication of objections.—If objections are received within the period referred to in the preceding section, such objections shall be communicated to the clinical establishment for response within a period of forty-five days.
28. Standards for permanent registration.
28. Standards for 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.
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.
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 Sections 18, 19, 20 and 21 shall also apply.
(4) The applications for renewal of permanent registration shall be made within six months before the expiry of the validity of the certificate of permanent registration and, in case the application of renewal is not submitted within the stipulated period, the authority may allow renewal of registration on payment of such enhanced fees and penalties as may be prescribed.
31. Fresh application for permanent registration.
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.
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 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.
(2) 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 thereunder, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration.
(3) Every order made under sub-section (2) 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.
33. Inspection of registered clinical establishments.
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 be represented thereat.
(2) The authority shall communicate to the clinical establishment the views of that authority with reference to the results of such inspection or inquiry and may, after ascertaining the opinion of the clinical establishment thereon, advise that establishment upon the action to be taken.
(3) The clinical establishment shall report to the authority, the action, if any, which is proposed to be taken or has been taken upon the results of such inspection or inquiry and such report shall be furnished within such time, as the authority may direct.
(4) Where the clinical establishment does not, within a reasonable time, take action to the satisfaction of the authority, it may, after considering any explanation furnished or representation made by the clinical establishment, issue such directions within such time as indicated in the direction, as that authority deems fit, and the clinical establishment shall comply with such directions.
34. Power to enter.
34. Power to enter.—The authority or an officer authorised by it may, if there is any reason to suspect that anyone is carrying on a clinical 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.
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.
36. Appeal.—(1) 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 time.
(2) Every appeal under sub-section (1) shall be made in such form and be accompanied by such fee as may be prescribed.
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