The Clinical Establishments (Registration and Regulation) Act, 2010

Administered Ministry: Ministry of Health and Family Welfare / Department of Health and Family Welfare

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Section
Section 1 Short title, application and commencement.
(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.

(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 date1 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.

1. 1st March, 2012, vide notification No. S.O. 342(E), dated 28th February, 2012, see Gazette of India, Extraordinary, Part II, sec. 3(ii).

Section 2 Definitions.
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.

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.

Section 3 Establishment of National Council.
(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 establishments.

(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;

(b) four representatives out of which one each to be elected by the--

(i) Dental Council of India constituted under section 3 of the Dentists Act, 1948 (16 of 1948);

(ii) Medical Council of India constituted under section 3 of the Indian Medical Council Act, 1956 (102 of 1956);

(iii) Nursing Council of India constituted under section 3 of the Indian Nursing Council Act, 1947 (48 of 1947);

(iv) Pharmacy Council of India constituted under section 3 of the Pharmacy Act, 1948 (8 of 1948);

(c) three representatives to be elected by the Central Council of Indian Medicine representing the Ayurveda, Siddha and Unani systems of medicine constituted under section 3 of the Indian Medicine Central Council Act, 1970 (48 of 1970);

(d) one representative to be elected by the Central Council of Homoeopathy constituted under section 3 of the Homoeopathy Central Council Act, 1973 (59 of 1973);

(e) one representative to be elected by the Central Council of the Indian Medical Association;

(f) one representative of Bureau of the Indian Sandards constituted under section 3 of the Bureau of Indian Standards Act, 1986 (63 of 1986);

(g) two representatives from the Zonal Council set-up under section 15 of the States Reorganisation Act, 1956 (37 of 1956);

(h) two representatives from the North-Eastern Council set-up under section 3 of the North-Eastern Council Act, 1971 (84 of 1971);

(i) one representative from the line of paramedical systems excluding systems that have been given representation under clause (b);

(j) two representatives from National Level Consumer Group to be nominated by the Central Government;

(k) one representative from the Associations of Indian Systems of Medicines relating to Ayurveda, Siddha and Unani to be nominated by the Central Government;

(l) the Secretary-General of the Quality Council of India, ex officio.

(3) The nominated members of the National Council shall hold office for three years but shall be eligible for re-nomination for maximum of one more term of three years.

(4) The elected members of the National Council 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 such period till he holds appointment of the office by virtue of which he was nominated or elected to the council.

(5) The members of the National Council shall be entitled for such allowances as may be prescribed by the Central Government.

(6) The National Council may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.

(7) The National Council shall meet at least once in three months.

(8) The National Council may constitute sub-committees and may appoint to such sub-committee, as it deems fit, persons, who are not members of the National Council, for such period, not exceeding two years, for the consideration of particular matters.

(9) The functions of the National Council may be exercised notwithstanding any vacancy therein.

(10) The Central Government shall appoint such person to be the Secretary of the National Council as the Central Government may prescribe, and may provide the National Council with such other secretarial and other staff as the Central Government considers necessary.

Section 4 Disqualifications for appointment as member.
A person shall be disqualified for being appointed as a member of the National Council if 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 undischarged insolvent; or

(c) is of unsound mind and stands so declared by a competent court; or

(d) has been removed or dismissed from the service of the Government or a Corporation owned or controlled by the Government; or

(e) has, in the opinion of the Central Government, such financial or other interest in the Council as is likely to affect prejudicially the discharge by him of his functions as a member.

Section 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) determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments;

(e) collect the statistics in respect of clinical establishments;

(f) perform any other function determined by the Central Government from time to time.

Section 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 provisions of this Act.

Section 7 National Council to follow consultative process.
The National Council shall follow a consultative process for determining the standards and for classification of clinical establishments in accordance with such procedure as may be prescribed.

Section 8 State Council of clinical establishments. 1 docs
(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.

Section 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.

Section 10 Authority for registration. 1 docs
(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:--

(a) District Collector-- Chairperson;

(b) District Health Officer--Convenor;

(c) three members with such qualifications and on such terms and conditions as may be prescribed by the Central Government.

(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.

Section 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.

Section 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.

Section 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.

Section 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 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).

Section 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.

Section 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.

Section 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.

Section 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.

Section 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.

Section 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.