The CLINICAL ESTABLISHMENTS(REGISTRATION AND REGULATION)ACT,2010

40 f. W--(~r)o4~~0712W~-10 REGISTERED NO. DG-(N)B410007/2003-1O - mm MTRAORDINA RY mn--r - PART U Section 1 **Fmm PUBLISHED BY AUTHOW Tb 3311 fkd, WlE! 19,2010 / W W 2 8, 1932 No. 311 NEW DELFIl, THURSDAY, AUGUST 19,2010 1 SRAVANA 28,1932 ~ r ~ m ~ ~ ~ ~ - A ~ # ~ ~ ~ m ~ 6 : m ~ ~ m K d : l Separate paging is given to this Part in order that it may be filed as r separate cornpiladon. MINISTRY OF LAW AND JUSTICE (Legislative Department) New Delhi, rhe Augiist 19,20lO/Srmuna28,1932( SaRa) The following Act af Parliament received the assent of the President on the 1 8th August, 20 1 0, and is hereby published for general information:- TEE CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 20 10 No. 23 OF 2010 An Act to provide for the registration and regulation of clinical establishments in the cormtry and for matten connected therewith or incidental thereto. W ~ Sit is, co nsidered expedient to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of fkilities and services which may be provided by them so that mandate of article 47 of the Constitution for improvement in pub1 ic 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; ANDW HEREAS, in pursuance of clause (1) of rtrticle 252 ofthe Constitution, resolutions have been passed by all the Houses of the Legislatures of the States ofArumchal Mesh, Himachal Pradesh, Mizorm and S i bto the effect that tbe matters aforesaid should be regulated in those States by Parliament by law; 2 THE GAZETTE OF INDIA EXTRAORDINARY [PART11 - BEi t uuacled by Parliarnzd in the Sixty-first Year ofthe Republic of lndia as follows:- CHAPTER 1 Short titlc, I. (I) This Act may be called the Clinical Establishments (Registration and Regulation) appllcatlon Act, 201 0. and v t ( 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 ArunachaI Pradesh, Himachal Pradesh, Mimram and Skkim 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, on the date of such adoption; and any reference in this Act to the commencement ofthis 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. Definitions. 2. In this Act, unless the context otherwise requires,- (a) "authority"m eans the district registering authority set-up under section 10; (b) "certificate"m eans certificate of registration issued under section 30; (c) 'kdinical establishment" means- (9 a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institu~ionb y whatever name called that offers services, facilities requiring diagnosis, hatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system ofmedicine 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 ar part of an establishment referred to in sub-clause (11, 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 oflaboratory 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)t he Government or a department of the Government; (6) 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; Id) a local authority; and (e) a single doctor, but does not include the clinical establishments owned, controlled or managed by the Armed Forces. .hpl~natio~t.-Fort he purpose of this dause "Armed Forces" means the forces I constituted under the Army Act, 1950, the Air Force Act, 1950 and the Navy Act, 1957; 46 of 1950. 45 of 1950. 62 of 1957. 1 SEC.I ] THE GAZETTE OF MDlA EXTRAORDNARY -3 (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)p lacing the health ofthe individual or, with respect to a pregnant women, the health of the woman or her unborn child, in serious jeopardy; or (ii)s erious 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 estabIished under section 3; V) "notification"m eans a notification published in the Official Gazette; (g) "prescribed"m eans prescribed by rules made under this Act by the Central Government or, as h ec ase may be, the State Government; (h) "recognised system of medicine" means Allopathy, Yoga, Naturopathy, Ayurvedg Hornoeopathy, Siddha and Unani System of medicines or any other system of medicine as may be recognised by the Central Government; (4 "register"m eans the register maintaided 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; (13 "registration"m eans to register under section I 1 and the expression registration or registered shall be construed accordingly; (k) "rules"m eans rules made under this Act; (I) "Schedule"m eans 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 aUnion territory, means the Administrator thereof appointed under article 239 of the Constimiion; and (0) "to sbbilise (with its grammatical variations and cognate expressions)"m eans, with respect to an emergency medical condition specified in clause (4, to provide such medical treament of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result fiom ox occur during the transfer of the individual from a clinical establishment. CHAPTER II THE NATIONCAOLU NCKFO R CLTNICEASLT ABLISHMENTS 3. (1) FKih effect from such date as the Central Government may, by notification Establishment appoint in this behalf, there shall be established for the purposes ofthis Act, a Council to be National Council. called the National Council for clinical establishments. (2) The National Council shall consist of- (a) Directof-General of Health Service, Ministry of Health and Family Welfare, ex oflcio, who shall be the Chairperson; (6)f our representatives out of which one each to be elected by the- (4 Dental Council of India constituted under section 3 of the Dentists Act, 1948; 4 THE GAZETTE OF INDIA EXTRAORDINARY [PAKTII - (ii)M edical Council of India constituted under section 3 of the Indian Medical Council Act, 1 956; 102 of' 1956. (iii) Nursing Council of India constituted under section 3 of the Indian Nursing Council Act, 1947; 18 of 1937. (iv) Pharmacy Council of rndia constituted under section 3 ofthe Pharmacy Act, 1948; 8 of 1948. (c) three representatives to be elected bythc Central Council ofI ndian Medicine representing the Ayurveda, Siddha and Unani systems of medicine constituted under sectioi~3 of the Indian Medicine Central Council Act, 1970; (4 one representative to be elected by the Central Council of Homoeopathy constituted under section 3 of the Homoeopathy Central Council Act, 1973; (e) one representative 10 be elected by the Central CounciI ofthe Indian Medical Association; CrJ one representative of Bureau of the Indian Smdards constiW under section 3 of the Bureau of Indian Standards Act, 1986; (gl two representatives from the Zonal Council set-up undet sectio~1~5 of the States Reorganisation Act, 1956; (h) two representatives from the North-Eastern Council set-up under section 3 of the North-Eastern Council Act, 1971 ; (I) one representative from the line of paramedical systems excluding systems that have been given representation under clause (6); (j) two representatives from National Level Consumer Group to be nominated by the Cenzral 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; (0 the Secretary-General of the Quality Council of India, ex officio. (3)T he nominated members of the National Council shall hold ofice 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 ofice for three years, but shall be eligible for re-election: Provided that the person nominated or elected, as the case may be, shall hold ofice for such period till he holds appointment of the ofice by virtue of which he was nominated or elected to the council. (5)T he lnembers 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 byelaws 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 Natjo~lalC ouncil may be exercised notwithstnnding any vacancy therein. (10) The Central Gover~menrs hall 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 staffas the Central Government considers necessary SECI. ] THE GAZETTE OF mDIA EXTRAORDINARY 5 4. A person shall be disqualified for heing appointed as a member of the National Diqu~lificuiions Council ifhe- for appointment (a)h as been convicted and sentenced to imprisonment for an offence which, in as member. 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 ofthe Central Governmern, such financial or other interesr in the Council as is likely to affect prejudicially thedischarge by him ofhis functions as a member. 5. The National Council shalt- Functions of National (a)c ompile and publish a National Register of clinical establishments within two council. 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)d etermine within aperiod 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; perfom any other function determined by the Central Government from time to time. 6. TheNationaI Council may associate with itself any person or body whose assistance Power to seek or advice it may desire in carrying out any of the provisions of this Act. advice or assistance 7.T he National Council shdl follow a consukive process for determiningthe standads National and for classificationo fclinical establishments in accordance with such procedure as may be COuncCil to follow prescribed. consultative process. cmnaarn 8. [I) Every State Government shall by notification constitute a State Council for clinical State Council establishments or the Union territory Council for clinical establishments, as the case may be. of clinical establishments. (2) The State Council or the Union territory Council, as the case may be, shall ccnsist ofthe following members, namely:- (a) Secretary, Health - ex offcio, who shall be the Chairman; (b)D irector of Health Services -e x oflcio member-secretary; (c) Directors of different streams of Indian Systems of Medicin- oflcio members; (4 one representative each to be elected by the executive committee of- (i) State Medical Council of India; (ii) Shte Dental Council ofIndia; (iid State Nursing Council of India; (iv) State Pharmacy Council of India; 6 THE GAZETTE OF INDIA EXTRAORDINARY [PARI 11- (e)t hree 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; (fl one representative to be elected by the State Council of the Indian Medical Association; (g)o ne 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)T he nominated member ofthe State Council or the Union territory Council, as the case may be, shall hold ofice for a term of three years, but shall be eligible for re-nomination for maximum of one more term oft hree years. (I)T he elected members ofthe State Council or the Union territory Cauncil, 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)T he State Council or the Union territory Council shall perform the following Functions, namely:- (a) compiling and updating the State Registers of clinical establishment; (b)s ending monthly returns for updating the National Register; (c) representing the State in the National Council; (4 hearing of appeals against the orders of the authority; and (e) publication on annual basis a report on the state of implementatian of standards within their respective States. Providing 9. It shall be the responsibility of the State Council for clinical establishments to infurmation compile and update the State Register of clinical establishments of the State and further to to National Council. send monthly returns in digital format for updating the National Register. Authority for 10. (I)T he State Government shall, by notification, set-up an authority to be called the registration, district registering authority for each district for registration of clinical establishments, with the following members, namely:- (a) District Collector - Chairperson; (b)D istrict Health Officer - Convenor; [c) three members with such qualifications and on such terns and conditions as may he prescribed by the Cebtral Government. (2) Notwithstanding anything contained in sub-section (I), for the purposes of provisional regispation of clinical establishments under section 14, the Dislrict Health Officer or the Chief Medical OfEcer (by whatever name called) shali exercise the powers of the authority as per procedure that may be prescribed. Registration 11. No person shall run a clinical establishment unless it has been duly registered in for ciinical accordance with the provisions of this Act. establishments. Condition for 12. (1) For registration and continuation, every clinical esrablishment shall fulfil the registration. following conditions, namely:- (i) the minimum standards of facilities and services as may be prescribed: SEC1. 1 THE GAZETTE OF INDIA EXTRAORDINARY 7 (ii)t he 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 rhe staff and facilities available, such medic&[ examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical estabIishment. 13. (I)C linical establishment of different systems shall be classified into such categories, Classification as may be prescribed by the Central Government, from time to time. of clinical estahlishrnents (2) Different standards may be prescribed for classification of different categories referred to in sub-section (I): Provided that in prescribing the standards for clinical establishments, the Central Government shall have regard to the local conditions, CHAPTER n, PROCEDURE FOR REGISTRATION 14. (1) For the purposes of registration of the clinical establishment under section 10, Application an application in the prescribed profom along with fhe prescribed fee shall be made to the ~ n ~ ' ' ~ ~ ~ i ~ ' authority. regislration. (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 ofthe 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 far 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 !aw requiring registration of such establishments, even then it shalt apply for registration as referred to in sub-section (I). 15. The authority shall, within a period of ten days h m t he date of receipt of such Provisionar application, grant to the applicant a certificate of provisional registration in such form and certificate. containing such particulars and such information, as may be prescribed. 16. (1) The authority shall not conduct any inquiry prior to the grant of provisional No Inquiry registration. prior to provisional (2) Notwithstanding the grant of the provisional certificate of registration, the authority registration. shall, within a period of forty-five days from the grant of provisional regisbation, cause to be published in such manner, as may be prescribed, all particulars of the clinicaI establishment so registered provisionaIly. 17. Subject to the provisions ofsection23, every provisional registration shall be valid Validiry of to the last day ofthe twelfth month from the date of issue of the certificate of registration and provisional such registration shall be renewable. registat~on. 18. The certificate shalt be kept affixed in a conspicuous place in the clinical Display of establishment in such manner so as to be visible to every one visiting such establishment. Of regisfration I 19. In case the certificate is lost, destroyed, mutilated or damaged, the authority shalI Duplicate I issue a duplicate certificate an the request of the clinical establishment and on the payment cerlrficate. I of such fees as may be prescribed. I 8 THE GAZETTE OF INDIA EXTRAORDMARY [PAR1T1- -- Ccrtiticatc to 20. (I) l'he certificate of registration shall be non-transferable. bc non- transferable. (2) In the event of change of u~aershipo r management, the clinical establishment shall inform the authority of such change in such manner as may be prescribed. (3) In the evem of change of category, or location, or on ceasing to function as a clinical establishment. the certificate of registratipn in respect of such clinical establishment shall be surrendered to the authority and the clinical establishment shall appiy afresh for grant of certificate of registration. Publication of- 21. The authority shall cause to be published within such time and in such cxpiv of manner, as may be prescribed, the names of clinical establishments whose registration registratiun. has expired. Rcnewai of 22. The application for renewal of regiswarion shall be made thirty days before the expiry ofthe validity of the certificart of provisional registration and, in case the application for renewal is made after the expiry oft he provisional registration, the authority shall allow renewal of registration on payment of such enhanced fees, as may be prescribed. Tlme Ilrn~t 23. Where the clinical establishments in respect of which standards have been notified for by the Central Government, provisiondl registration shall not be granted or retiewed beyond,- provisional regis!rat~on. (0 the period of wo years h mth e date of notification ofthe standards in case of clinical establishments which came into existence before the commencement ofrhis Act; (ii) the period of two years from the date of notification of the staadards 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 rnor~thsf rom the date ofnotification ofstandards for clinical establishments which come into existence after standards have been notified. Application 24. Application for permanent registration by a clinical establishment shall be made to for the authority in such furnl and be accompanied by such fees, as may be prescribed. pcrmnnent registration. Verification of 25. The clinical establishment shall submit evidence of having complied with the a~pllcation. prescribed minimum stmdards in such manner, as may be prescribed. I>isplay of 26. As soon as the clincial establishmem submits the required evidence of having 1nfol'mation complied with the prescribed minimum standards, the authority shall cause to be displayed for filtng for information of the public at large and for filing objections, ifany, in such manner, as may objections. be prescribed, all evidence submitted by the clinical establishment of having c.omptied with thc p~escribedm inimum standards for a period of thirty days before processing for grant of permanent registratinn. Communication 27. if objections are received within the period referred to in the preceding section, objcctiofis- such objections shall be communicaied to the ciinical establishment for response within a period of forty-five days. Standards for 28. Permanent registration shall be granted only when a clinics1 establishment fulfils PCrmanent the prescribed standards for registration by the Central Government. registration. Allowing or 29. The authoriv shall pass an order immediately after the expiry of the prescribed dlsalluwing of period and within thc next thiq days thereaAer either-- registrat~on (u) allowing thc application for permanent registration; or (b)d isallowing the applicatiorr: Provided that the authu:itv shall record its reasons, if it disallows arl applicatior,, for permanent registration. SEC. I] THE GAZETTE OF WDIA EXTRAORDINARY 9 30. (1) The authority stlaIl, if it, alIows an application of the clinical establishment, Certificate of issue a certificate of permanent registration in such form and containing such particulars, as Y""!n' may be prescribed. registral~on. (2) The certificate shall be valid for a period of five years from the date of issue. (3)F or the purposes of sub-section (I), the provisions of sections 18, 19,20 and 2 t shall also apply. (4) The applications for renewal of permanent registration shatl be made within six months before the expiry of the validity of the certificate of permanent registration and, in case the application ofrenewai 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. The disallowing of an application for permanent registration shatl not debar a Fresh cIinical establishment from applying afresh for permanent registration under section 24 and a~p~pil'i~ca~ti!o~n~ n' after providing such evidence, as may be required. of having rectified the deficiences on which grounds the earlier application was disallowed. 32. (1) if, at any time after any clinical establishment, has been registered, the authority Cancellalion of is satisfied that,- registration. (a) the conditions ofthe regiswalion are not being complied with; or (b) the person entrusted with the management ofthe 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 reaso~~abotpe portunity to the clinical establisment, 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)w here 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, afier cancellation ofregistration 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. (1) The authority or an officer authorised by it shall have the right to cause an Inspection of inspection of, or inquiry in respect of any registered clinical establishment, its building, registered laboratories and equipment and also of the work conducted or done by the clinical : ~ ~ ~ ~ h m e n E , 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 he 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 10 THE GAZETTE OF INDIA EXTRAORDIKARY [P~RII I- representaticn made by the clinical establishment, issue such directions within such ti~tlea s indicated in the direction. as that authority deems fit, and the clinical establishment shall comply with such directions. llo!\'er lu 34. The authority or an oficer authorised by it may, if there is any reason to suspect cnter. that anyone is carrying on a clinical establishment without registration, enter and search in the manner prescribed, at any ;easonable timc and the clinical establishment, shall offer reasonable facilities for inspeclion or inquiry and be entitled to be represented thereat: Provided that no such person shall cnter the clinical establishment without giving notice of his intention to do so. Lcvy of fee 35. 'The State Government may charge fees for different categories of clinical by State establishments, as may be prescribed. Government Appeal. 36. (1)Any person, aggrieved by an order ofthe registering authority refusing to grant or renew a certificate of registration or revoking a ceflificate 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 ofthe prescribed period if i! is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in time. (2) Every appeal under sub-section (I) shall be made in such form and be accompanied by such fee as may be prescribed. CHAPTER V Register of 37. (1)T he authority shall within a period oftwo years from its establishment, compile, clinical publish and maintain in digital format a register of clinical establishments, registered by it establishments 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 Govemment. (2) Each authority, including any other authority set-up for the registration of clinicai establishments under any other law for the time being in force, shall suppiy in digital format to the State Council of clinical estab\ishments a copy of every entry made in the register of clinical establishments in such manner, as may be prescribed to ensure that the Slate Register is constantly up-to-date with the registers maintained by the registering authority in the State. hlaintcnancc 38. (1)E very Stare Government shall maintain in digital and in such form and containing of State such particulars, as may be prescribed by the Central Government a register to be known as the Register of State Register of clinical establishments in respect of clinical establishments of that State. clinical establishmenls (2) Every State Government shall supply in digital format to the Central Government, a copy of the State Register of clinical establishments and shall inform the Central Government all additions to and other amendments in such register made, for a particular month by the 15th day ofthe following month. Maintenan~e 39. The Central Government shall maintain in digital format an All India Register to be of National called as the National Register of clinical establishments that shall be an amalgam of the State Register of cl~nical Register of clinical establishments maintained by the State Governments and shall cause the cstahlrshments same to be published in digital format. CHAPTER VI 40, Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere, be punishable for the first offence with fine which may extend to ten thousand SECI. ] THE GAZETTE OF INDIA EXTRAORDMARY 11 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. (1) Whoever carries on a clinical establishment without registration shalt, on first Monetary contravention, be liable to a monetary penalty up to fifty thousand rupees, for second penalty fur now contravention with a monetary penalty which may extend to two lakh rupees ,pinnlion, and for any subsequent contravention with a monetary penaliy which may extend to five lakh rupees. (2) Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall be liable to a monetary penalty which may extend to twenty-five thousand tupecs. (3) For the purpose of adjudging under sub-sections (I) and (21, the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opporhlnity of being heard for the purpose of imposing any monetary penalty. (4) While holding an inquiry the authority shall have power to summon and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence ar to produce any document which in the opinion of the authority, may be useful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfied that the person has failed to comply with the provisions specified in sub-sections(!) and (21, it may by order impose the monetary penalty specified in those sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8)o f section 42. (5) While determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical establishment and local conditions of the area in which the establishment is siruated. (6)A ny person aggrieved by the decision of the authority may prefer an appeal to the State Council within a period of three months fkom the date of the said decision. (7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed. 42. (1) Whoever wilhlly disobeys any direction lawfully given by any person or Disobedience authority empowered under this Act to give such direction, or obstructs any person or of direction. authority in the discharge of any functions which such person or authority is required or ~ ~ ~ t ~ ~ ~ ~ ~ ~ o f empowered under this Act to discharge, shall be liable to a monetary penalty which may information, extend to five lakh rupees. (2) Whoever being required by or under this Act to supply any information wilfully withholds such information or gives information which he knows to be false or which he does not believe to be true, shall be liable to a monetary penalty which may extend to five lakh rupees. (3) For the purpose of adjudging under sub-sections (I) and (21, the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportunity of being heard for the purpose of imposing any monetary penalty. (4 While holding an inquiry the authority shall have power to summon and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence or to produce any document which in the opinion of the authority, may be useful for or relevant to the subject matter ofthe inquiry and if, on such inquiry, it is satisfied that the person has failed to camply with the provisions specified in sub-sections (I)a nd (Z), it may by order impose the monetary penalty specified in those sub-sections to be deposited within thirty days ofthe order in the account referred to in sub-section (8). (5) While determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the ciinical establishment and local conditions of the area in which the establishment is situated. 12 THE GAZETTE OF' INDIA EXTRAORDINARY [PARTI I- - -- (6) Any persan aggrieved by the decision of the authority may prefer an appeal to the State Council within a period of rhree months from the date of the said decision. (7) The manner of filing the appeal referred to in sub-section (6:s hall be such as may be prescribed. (8) The monetary penalty ieviid under secti~ns4 1 and 42 shall be credited to such account as the State Government may by order specify in this behalf. Penalty for 43. Whoever contravenes any provision of this Act or any rule made thereunder rnln~r resulting in deficiencies that do not pose any imminent danger to the health and safety of deficiencies. aty patient and can be rectified within a reasonable time, shall be punishable with fine which may extend to ten thousand rupees. Contravention 44. (I) Where a person committing contravention of any of the provisions of this Aot bj' companies- or ofany rule made thereunder is a company, every person whc, at the time the contravention was committed, was in charge of, and was responsible to the company for the conduct ofthe 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 such person liable to any punishment if he proves that the contravention was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such contravention. (2) Notwithstanding anphing contained in sub-section (I), where a contravention of any of the provisions of this Act or of any rule made thereunder has been committed by a company and it is proved that the contravention has taken place with the consent or connivance of, or is attributable to any neglect on the'part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other oficer shall also be deemed to be guilty of that contravention and shall be liable to fine. Explanarion.-For the purpose of this section,- (a)" company" means a body corporate and indudes a fin or other association of individuals; and (6) "director", in relation to a firm, means apartner in the firm. Offences by 45. (1) Where an offence under this Act has been committed by any Department of Government Government within a period of six months after the commencement of this Act, the Head of Uepartrntnt~ the Department shall be deemed to be guilty ofthe offence and shsll be liable to be proceeded against and punished accordingly: Provided that nothing contained in this section shall render such Head ofthe Department liable to any punishment if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent rhe commission of such offence. (2) Notwithstanding anything contained in sub-section (I), where an otience under this Act has becn committed by a Department of Government and it is proved that the offence has becn committed with the consent ar connivance of, or is attributable to any neglect on the part oT, my oscer, other than the Head of the Departmerrt, such. officer shall also be deemed to be guilly ol~haotf fence and shall be liable ta be proceeded against and punished accordingly. Recovcry of 46. Whoever fails to pay rllc fine, the State Council of clinical establishment may fine prepare a certificate signed by an uificer authorised by it specifying the fine due from such person and send it to the Collector of ihe District in which such person owns any properly or resides or carries on his business and the said Collector, on receipt of such certificate, shall proceed to recover from such person thc amount specified there~nder,a s if it wcre an arrear of land revenue. SEC.I ] THE GAZETTE OF WDlA EXTRAORDMhRY 13 CHAPTER VU 47. (1)N o suit, prosecution or other legal proceedings shall lie against any authority Protect~ono f or any member of the National Council or-state Council or any oficer authorised in this act'on taken behalf in mpectof anything, which is in good faith done or intended to be done in pursuance In fa'th of the provisions of this Act or any rule made thereunder. (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 caused by anything which is in good faith done or intended to be done in pursuance of the provisions of this Act or any rule made thereunder. 48. Every clinical establishment shall, wirhin such time or within such extended time, Furnishing of as may be prescribed in that behalf, furnish to the authority or the State Council or the retUrnSe, tc. 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. Without prejudice to the foregoing provisions of this Act, the authority shall have Power to give 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. Every empiuyee ofthe authority, theNational Council and the State Council shall Employees of be deemed to, when acting or purporting to act in pursuance of any of the provisions of this the authoriry, Act, be public servants within the meaning of &ion 21 ofthe Indian Penal Code. etc., to be public servants. 51. (I)I f any difficulty arises in giving effect to the provisions of this Act, the Central Power to Government may, by order published in the Official Gazette, make such provisions not remove inconsistent with the provisions of this Act as may appear to it to be necessary or expedient difficuItics. for removal of the difficulty: Provided that no such order shall be made after the expiry of a period of two years fiom the date of commencement of this Act, (2) Every order made under this section shall, as soon as may be after it is made, be laid before each House of Parliament. 52. (I)T he Central Government may, by notification, make rules for carrying out all or Power of any of the provisions of this Act. Central Government (2) In particular and without prejudice to the generality of the foregoing power, such to make rules may provide for all or any ofthe following matters, namely:- (a)a llowances for the members ofthe National Council under sub-section (5)o f section 3; (b) appointment of such person to be the Secretary of the State Council by the Central Government under sub-section (10) of section 3; (c) the determination of standards and for classification of clinical establishments under section 7; (4t he qualification and the terms and conditions forthe members ofthe authority under clause (c) of sub-section (I) of section 10; (e) the procedure under which the powers of the authority may be exercised by the District Health Officer or Chief Medical Officer for the purpose of provisional registration of clinical establishment under sub-section (2) of section 10; 14 THE GAZETTE C)F INDIA EXTRAORDINARY [PARTi I-- the rnini~nu~snta ~~dardosf facilities and services under clause ti) of sub- section (/) of section 12; (g) the minimum number of personnel under clausc (ii)o f sub-section (I) of section 12; (h)t he maintenance ofrccords and reporting by thc clinical establishment under clause (iii) of sub-section (I) of section 12; ti) other conditions for registration and continuation of clinical establishment under clause (iv) of sub-section (,I)o f section 12; (j)cl assifica~iono f clinical csrabtishmenl under sub-section (I)o f section 13; (k) the different standards Tor classification of clinical establishments under sub-section (2) of section 13; (0 the minimum standards for permanent regisrration under section 28: (m) the form and particulars to be contained in the register to be maintained under section 38. Lay11go f rub 53. 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, the rule shall thereafter have effect only in such modified form or be of no effect. as the case may be; so, however, that any such modification or annulment shall be wjrhout prejudice to the validiv of anything previously done under that rule. Power of Statc 54. (1) The State Government may, by notification, make rules for carrying out in lo respect of matters which do not fall within the purview of section 52. make rules (2) In particular and without prejudice to the generality of Ble foregoing power, such rulcs may provide for all or any ofthe following matters, namely:- (a) the profor~naa nd the fee to be paid for registration under sub-section (I) of section 14; (b) the form and details of application under sub-section (3) of section 14; (c) the particulars and informalion contained in certificate of provisional registration under section 15; (4 the manner of publication of all particulars of rhe clinical establishments proposed to be registered undcr sub-section (2) of section 16; (c) the fees to be paid to issue a duplicate certiticafe under section 19; fl the change of ownership or management to be informed by rhr clinical establishment to the authority under sub-section (2) of section 20; (g)th e manner in which the authority shall publish the names of rhe clinical establishments whose registration expired under section 21; (h) the enhanced fees to be charged for renewal after expiv ofthe provisional registration undcr section 22; (i)t he form of the applicarion and fees to be charged by the State Government under section 24; (i) the manner of submining evidence of the clinical establishments having cornplied with the minimum standards under section 25; SEC. 11 THE GAZETTE OF INDIA EXTRAORDINARY 15 (A) the manner of displaying information of the clinical establishments having complied with the minimum standards for fifing objection under section 26; (I)t he expiry of period specified in section 29; (m)t he form and particulars ofthe certificate of registration under section 30; (n) the period within which an appeal shall be preferred under clause (a) of sub-section (3) of section 32; (o)t he manner of entry and search of clinical establishment under section 34; (p) the fees to be charged by the State Government for different categories of clinical establishments under section 35; (q) the manner and the period within which an appeal may be preferred to the State Council under sub-section (I)o f section 36; (r) the form and the fee to be paid for an appeal under sub-section (2) of section 36; (s) the form and the manner in which the register to be maintained under sub-section (I) of section 37; (I) the manner of supply to the State Council in digital format the entry made in the register of clinical establishment under sub-section (2) of section 37; (u) the manner of holding an inquiry by the authority under sub-section (3) of sections 4 1 and 12; (v) the manner of filing the appeal under sub-section (7) of sections 41 and 42; (w) the manner and the time within which the information is to be furnished to the authoriry or the State Council or the National Council as the case may be, under section 48; [x) any other matter which is required to be or may be prescribed by the State Government. 55. Every rule made by the State Government under this section shall be laid, as soon Lay~ng of as may be after it is made, before each House of the State Legistature where it consists of two rules. Houses, or where such Legislature consists of one House, before that House. 56. (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 (I) are applicable, and such States subsequent to the commencement of this Act, adopts this Act under clause (1) ofarticle 252 of the Constitution, the provisions of this Act shall, subsequent to such adoption, apply in rhat State. (2) The Central Government may, as and when consider necessq, by notification amend the Schedule. I6 THE GAZETTE OF INDIA EXTRAORDWARY [ Part 11-Sec. I] ?'HE SCHEDULE [See section 5 61 1. The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002. 2. The Bombay Nursing Homes Registration Act, 1949. 3. The Delhi Nursing Homes Registration Act, 1953. 4.

The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue (Ragistrikaran Tatha Anugyapan) Adhiniyam, 1973. 5.T he Manipur Homes and Clinics Registration Act, 1992. 6.T he Nagaland Health Care EstablishmentsA ct, 1997. 7. The Orissa Clinical Estabt ishments (Control and Regulation) Act, 1990. 8. The Punjab State Nursing Home Registration Act, 199 1. 9. The West Bengal Clinical Establishments Act, 1950. V,K . BHASIN, Secy, to the Gavt. of India. PRINTED BY THE GENERAL MANAGER GOVT OF lNDIA PRESS,M INT0 ROAD. NEW DELHl AND PUBLISIiED BY THE CONTROLLER OF PURLlCATIONS. DELHI-2010.