The Clinical Establishments (Registration and Regulation) Act, 2010

(1) This Act may be called the ClinicalEstablishments (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 thisAct 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, Mizoramand Sikkim and the Union territories, on such date 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, onthe date of such adoption; and any reference in this Act to the commencement of this Act shall, in relationto any State or Union territory, mean the date on which this Act comes into force in such State or Unionterritory: Provided that different dates may be appointed for different categories of clinical establishments andfor different recognised systems of medicine.

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 institutionby whatever name called that offers services, facilities requiring diagnosis, treatment or care forillness, injury, deformity, abnormality or pregnancy in any recognised system of medicineestablished and administered or maintained by any person or body of persons, whetherincorporated or not; or (ii) a place established as an independent entity or part of an establishment referred to insub-clause (i), in connection with the diagnosis or treatment of diseases where pathological,bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic orinvestigative services with the aid of laboratory or other medical equipment, are usually carriedon, established and administered or maintained by any person or body of persons, whetherincorporated 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, whetheror 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 theArmy 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 acutesymptoms of sufficient severity (including severe pain) of such a nature that the absence of immediatemedical 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 thewoman 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 undersection 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, asthe 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 berecognised by the Central Government; (i) "register" means the register maintained by the authority, State Government and the CentralGovernment under sections 37, 38 and 39 respectively of this Act containing the number of clinicalestablishments registered; (j) "registration" means to register under section 11 and the expression registration or registeredshall 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 section12, for the registration of clinical establishments; (n) "State Government", in relation to a Union territory, means the Administrator thereofappointed under article 239 of the Constitution; and (o) "to stabilise (with its grammatical variations and cognate expressions)" means, with respect toan emergency medical condition specified in clause (d), to provide such medical treatment of thecondition as may be necessary to assure, within reasonable medical probability, that no materialdeterioration of the condition is likely to result from or occur during the transfer of the individualfrom a clinical establishment.

(1) With effect from such date as the Central Governmentmay, by notification appoint in this behalf, there shall be established for the purposes of this Act, aCouncil 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, whoshall 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 theAyurveda, Siddha and Unani systems of medicine constituted under section 3 of the Indian MedicineCentral Council Act, 1970 (48 of 1970); (d) one representative to be elected by the Central Council of Homoeopathy constituted undersection 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 Bureauof Indian Standards Act, 1986 (63 of 1986); (g) two representatives from the Zonal Council set-up under section 15 of the StatesReorganisation Act, 1956 (37 of 1956); (h) two representatives from the North-Eastern Council set-up under section 3 of theNorth-Eastern Council Act, 1971 (84 of 1971); (i) one representative from the line of paramedical systems excluding systems that have beengiven representation under clause (b); (j) two representatives from National Level Consumer Group to be nominated by the CentralGovernment; (k) one representative from the Associations of Indian Systems of Medicines relating toAyurveda, 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 beeligible 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 eligiblefor re-election: Provided that the person nominated or elected, as the case may be, shall hold office for such periodtill 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 prescribedby the Central Government. (6) The National Council may, subject to the previous approval of the Central Government, makebye-laws fixing a quorum and regulating its own procedure and the conduct of all business to betransacted 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, asit deems fit, persons, who are not members of the National Council, for such period, not exceeding twoyears, 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 asthe Central Government may prescribe, and may provide the National Council with such other secretarialand other staff as the Central Government considers necessary.

A person shall be disqualified for beingappointed 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 theCentral 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 orcontrolled by the Government; or (e) has, in the opinion of the Central Government, such financial or other interest in the Council asis likely to affect prejudicially the discharge by him of his functions as a member.

The National Council shall-- (a) compile and publish a National Register of clinical establishments within two years from thedate 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 forensuring 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.