Provides for registration and regulation of clinical establishments in India.
Clinical Establishments (Registration and Regulation) Act, 2010
[Act 23 of 2010] [18th August, 2010]
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 in 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—
Statement of Objects and Reasons.—(1) At present, the supervision and regulation of the quality of services provided by the health care delivery system to the people by both public and private sectors has largely remained a contentious and therefore, unresolved issue. The current structure of the health care delivery system does not provide enough incentives for improvement in efficiency. The private sector health care delivery system in India has remained largely unregulated and uncontrolled. Problems range from inadequate and inappropriate treatment, excessive use of higher technologies, and wasting of scarce resources to serious problems of medical malpractice and negligence.
2. Despite many State Legislatures having enacted laws for regulating health care providers, the general perception is that current regulatory process for health care providers in India is inadequate or not responsive to ensure health care services of acceptable quality and prevent negligence. Concerns about how to improve health care quality have continued to be frequently raised by the general public and a wide variety of stakeholders, including Government, professional associations, private providers, agencies financing health care, National Human Rights Commission and also by judiciary.
| 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 |
3. Accordingly, a need has long been felt for a central legislation for ensuring uniform standards of facilities and services by the clinical establishments throughout the State where the Legislative Assemblies have passed resolutions under Article 252 of the Constitution and the Union territories and the States which may adopt the legislation by such resolutions.
4. In view of the above, the Clinical Establishments (Registration and Regulation) Bill, 2007 was introduced in Lok Sabha on the 30th August, 2007 and the same was referred to the Department Related Parliamentary Standing Committee on Health and Family Welfare which made certain recommendations on the provisions of the said Bill. However, the said Bill was lapsed due to dissolution of the Fourteenth Lok Sabha.
5. It is now proposed to introduce the Clinical Establishments (Registration and Regulation) Bill, 2010 on the lines of above Bill incorporating therein certain recommendations made by the Department Related Parliamentary Standing Committee on Health and Family Welfare.
6. The salient features of the proposed legislation, inter alia, are as follows—
(i) the proposed legislation provides for the constitution of a National Council consisting of representatives of Medical Council of India, Dental Council of India, Nursing Council of India, the Pharmacy Council of India, the Indian Systems of Medicines representing Ayurveda, Siddha, Unani and Homoeopathy systems, the Indian Medical Association, the Bureau of Indian Standards, the Zonal Councils set-up under the States Reorganisation Act, 1956, the North-Eastern Council, etc.;
(ii) the function of the National Council shall be to determine the standards for the clinical establishment, classify the clinical establishment into different categories, develop the minimum standards and their periodic review, compile, maintain and update a National Register of clinical establishments, perform any other function determined by the Central Government, from time to time;
(iii) the function of the State Council shall be to compile, maintain and update the State Registers of clinical establishments and to send monthly returns for updating the National Registers. The State Councils shall also publish reports on the implementation of standards within their respective States, annually;
(iv) the concerned State Governments shall, by notification, set-up an authority to be called the district registering authority under the chairmanship of District Collector for registration of clinical establishments;
(v) no person shall carry on a clinical establishment unless it has been registered in accordance with the provisions of the proposed Bill. The legislation would not apply to the clinical establishments of the Armed Forces;
(vi) it is proposed that clinical establishments already in existence may be allowed for provisional registration to carry out their business. There shall be no prior enquiry for provisional registration. But the authority shall have power to make enquiry in accordance with such rules as may be prescribed;
(vii) the clinical establishment having provisional registration shall fulfil the standards which may be notified for the purpose. The provisional certificate shall not be granted or renewed beyond a period of two years from the date of notification of standards;
(viii) any clinical establishment may apply for permanent registration in such form and shall pay such fee as may be prescribed by the State Government. A detailed procedure for permanent registration is being provided in the proposed legislation;
(ix) the authority shall have power to cancel the registration of the clinical establishment which fails to comply with the conditions prescribed by the Central Government. The authority shall have power to inspect a registered clinical establishment. Any person aggrieved by an order of the registering authority shall prefer an appeal to the State Council;
(x) the clinical establishments 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;
(xi) the certificate of permanent registration issued by the authority is valid for a period of five years from the date of issue;
(xii) there shall be register of clinical establishment at the district level, State level and the National level;
(xiii) if any person contravenes any provisions of the proposed legislation or any rules made thereunder, he shall be punished with fine. The maximum penalty being provided is Rupees Five lakh;
(xiv) conferring power upon an authority to levy monetary penalty for violation of the provisions of Sections 41 and 42 of the proposed Bill;
(xv) any person aggrieved by the decision of authority may prefer an appeal to the State Council.
7. Legislation in respect of “Public health and sanitation; hospitals and dispensaries” are relatable to Entry 6 of List II—State List in the Seventh Schedule to the Constitution and Parliament has no power to make a law in the State (apart from the provisions of Article 249, 250 and 252 of the Constitution) under Article 252 of the Constitution where the Legislatures of two or more States pass resolutions in pursuance of Article 252 of the Constitution empowering Parliament to pass the necessary legislation on the subject, a Bill may be introduced in Parliament. The Legislatures of the States of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim have passed such resolutions. The Bill is intended to give effect to the resolutions passed by the Legislatures of the aforesaid States and to make also provisions in respect to Union territories.
8. The Bill seeks to achieve the above objectives.
Chapter I
PRELIMINARY
1. Short title, application and commencement.
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 date[i] 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.
2. Definitions.
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.
Chapter II
THE NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS
3. Establishment of National Council.
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 Standards 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 one 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.
4. Disqualifications for appointment as member.
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.
5. Functions of National Council.
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.
6. Power to seek advice or assistance.
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.
7. National Council to follow consultative process.
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.
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