be it enacted by parliament in the sixty-first year of the republic of india as follows:—  chapter i preliminary1 (/) this act may be called the clinical establishments (registration and regulation} act, 2010 short title, application and commencement, (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 {oo (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 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: 15 provided that different dates may be appointed for different categories of clinical establishments and for different recognised system of medicine definitions, 2 in this act, unless the context otherwise requires,— (a) "authority" means the district registering authority set-up under section 10; 20 (6) "certificate" means certificate of registration issued under section 30; (c) "clinical establishment" means— (i ahospital, 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 (i) aplace 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 30 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— 35 (a) the 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; (d) a local authority; and yo (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, the air force act, 1950 and the navy act, 1957;(d) "emergencymedical 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— (/) placing the health of the individual or, with respect fo a pregnant women, the health of the woman or her unborn child, in serious jeopardy; or (ii) serious impairtment 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 33 , (¢) "notification" means & 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 )5 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; ?)) "registration" means to register under section 11 and the expression registration 20 or registered shall be construed accordingly;  (a) "rules" means rules made under this act; (j "schedule" means the schedule appended fo this act; (m) "standards" means the conditions that the central government may prescribe 2s under section 12, for the registration of clinical establishments; (a) "state government", in relation to a union territory, means the administrator" thereof appointed under article 239 of the constitution; and (0) "to stabilise owith its grammatical variations and cognate expressions)" means, bo 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 il tue national council for clinical establishments3 m with effect from such date as the central government may, by notification establishment of national councilappoint 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 - @ director-general of health service, ministry of {health and family welfare, ex officio, who shall be the chairperson; yo (6) four representatives out of which one each to peelected by the— (), dental council of india constituted under section 3 of the dentists act, 1948; (i) medical council of india constituted under section 3 of the adian medical council act, 1956; 102 of 1956 (id) nursing council of india constituted under section 3 of the indian nursing council act, 1947; 48 of 1947 () pharmacy council of india constituted undersection 3 of the pharmacy ¢ act, 1948; $ 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, (@) one representative to be elected by the central council of homoeopathy {6 constituted under section 3 of the homoeopathy central council act, 1973; 359 of 1973 (©) one representative to be elected by the central council of the indian medical association; (/) one representative of bureau of the indian sandards constituted under section 3 of the bureau of indian standards act, 1986; {5 63 of 1986 (g) two representatives from the zonal council set-up under section 15 of the states reorganisation act, 1956; 37 of 1956 (4) two representatives from the north-eastern council set-up under section 3 of the north-eastern council act, 1971; 84 of 1973 (/) one representative from the tine of paramedical systems excluding systems 2 0 that have been given representation under clause (6); (/) two representatives from national level consumer group to be nominated by the central government; (4) one representative from the associations of indian systems of medicines relating to ayurveda, siddha and unani to be nominated by the central government; 25 () 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 formaximum 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: be 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, 35 (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 yo sub-committee, as it deems fit, persons, who are not members of the 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 45 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, disqualifications for appointment 4 a person shall be disqualified for being appointed as a member of the national council ifhe— as member (a) has been convicted and sentenced to imprisonment for an offence which, in the opinion of the central government, involves moral turpitude; or (6) 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 id in the council as is likely to affect prejudicially the discharge by him of his functions as amember  5, the national council shalt— functions of national couneil (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; i (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; 28 (f) perform any other function determined by the central government from time to time 6 the national council may associate with itself any person or body whose assistance power to seek - advice or assistance, or advice it may desire in carrying out any of the provisions of this act 4, 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 national council to follow consultative process  chapter ii registration and standards for clinical establishmentsstate council 8 (1) every state government shail by notification constitute a state council for clinical | of              ||-----------------|| establishments || 30              || -               || 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 officia, who shail be the chairman, (b) director of health services - ex officio member-secretary; 35 (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; yo (iif) 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; (/) one representative to be elected by the state council of the indian medical association; 5 (g) one representative from the line of paramedical systems; (4) two representatives from state level consumer groups or reputed non- governmental organisations working in the field of health (3) the nomiriated 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 forre-nomination {0 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 15 elected to the state council or the union territory council, as the case may be (3) the state council or the union territory council shall perform the following functions, namely:— (a) compiling and updating the state registers of clinical establishment; °o wv (8) sending monthly returns for updating the national register; (c) representing the state in the national council; @ 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 providing information to national council 5 it shall be the responsibility of the state council for clinical establishments to 2 5 compile and update the state register of clinical establishments of the state and further to send monthly returns in digital format for updating the national register, 10 (7) the state government shall, by notification, set-up an authority to be called the authority for registration, district registering authority for each district for registration of clinical establishments, with the following members, namely:— 20 (a) district collector _ chairperson; (4) 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 (/), for the purposes of 35 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 registration 11 no person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of this act yo for clinical establishments, condition for registration 12, (/) for registration and continuation, every clinical establishment shall fulfil the following conditions, namely:— j () the minimum standards of facilities and services as may be prescribed; 7 (i) 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 classification 13 (j) clinical establishment of different systems shall be classified into such categories, of clinical establishments as may be prescribed by the central government, from time to time fo (2) different standards may be prescribed for classification of different categories referred to in sub-section (7): provided that in prescribing the standards for clinical establishments, the central government shall have regard to the local conditions,  chapter iv1  procedure for registrationapplication 14, (/) for the purposes of registration of the clinical establishment under section 10, for provisional certificate of registration, 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 oo fv (3) the application shail be made in such form and shall be accompanied by such details as may be prescribed under this act or rules made thereunder (4) ifany clinical establishment is in existence at the time of the commencement of this 2s 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, shail 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 (/) : 30 provisional certificate 15, the authority shall, within a period of ten days from the date of receipt of such application, grant to the applicant a certificate of provisional registration in such form and containing such particulars and such information, as may be prescribed 16 (/) the authority shall not conduct any inquiry prior to the grant of provisional registration  no inquiry prior to provisional registration, 35" (2) notwithstanding the grant of the provisional certificate of registration, the authority shail, within a period of forty-five days from the grant of provisional registration, cause to be published in such manner, as may be prescribed, all particulars of the clinical establishment so registered provisionally ' ; ' 17 subject to the provisions of: section 23, every provisional registration shall be valid validity of provisional registration yo to the last day of the twelfth month from the date of issue of the certificate of registration and such registration shalt be renewable disptay of certificate of registration 18 the certificate shalt be kept affixed in a conspicuous place in the clinical establishment in such manner su as to be visible to every one visiting such establishment 19in case the certificate is lost, destroyed, mutilated or damaged, the authority shall duplicate certificate us issue a duplicate cert:"icate on the request of the clinical establishment and on the payment of such fees as may be prescribed 20 (1) the certificate of registration shal! be non-transferable | certificate    | to             ||----------------|----------------|| be             | non-           || transferable  |                || (2)            | in             || shall          | inform         || (3)            | in             || clinical       | establishment, || shall be       | surrendered    || grant          | of             || 21,            | the            || manner,        |                || as             |                || may            |                || be             |                || prescribed,    |                || the            |                || names          |                || of             |                || clinical       |                || establishments |                || whose          |                || registration   |                || has            |                || publication    | of             || expiry         | of             || registration  |                || expired,       | :              || renewal        | of             || registration  |                || 22,            | the            || expiry         | of             || for            | renewal        || renewal        | of             || 23            | where          || time           | fimit          || by             |                || the            |                || central        |                || government,    |                || provisional    |                || registration   |                || shall          |                || not            |                || be             |                || granted        |                || or             |                || renewed        |                || beyond,—       |                || for            |                || provisional    |                || registration  |                || (i)            | the            || clinical       |                || establishments |                || which          |                || came           |                || into           |                || existence      |                || before         |                || the            |                || commencement   |                || of             |                || this           |                || act;           |                || (if the        | period         || clinical       | establishments || but            | before         || (iii)          | the            || establishments | which          || application    |                || 24,            |                || application    |                || for            |                || permanent      |                || registration   |                || by             |                || a              |                || clinical       |                || establishment  |                || shall          |                || be             |                || made           |                || to             |                || 25            |                || the            |                || authority      |                || in             |                || such           |                || form           |                || and            |                || be             |                || accompanied    |                || by             |                || such           |                || fees,          |                || as             |                || may            |                || be             |                || prescribed    |                || for            |                || permanent      |                || registration  |                || verification   | of             || application   |                || 25,            |                || the            |                || clinical       |                || establishment  |                || shall          |                || submit         |                || evidence       |                || of             |                || having         |                || complied       |                || with           |                || the            |                || prescribed     |                || minimum        |                || standards      |                || in             |                || such           |                || manner,        |                || as             |                || may            |                || be             |                || prescribed    |                || display        | of             || information    |                || 26            |                || as             |                || soon           |                || as             |                || the            |                || clincial       |                || establishment  |                || submits        |                || the            |                || required       |                || evidence       |                || of             |                || having         |                || complied       |                || with           |                || the            |                || prescribed     |                || minimum        |                || standards,     |                || the            |                || authority      |                || shall          |                || cause          |                || to             |                || be             |                || displayed      |                || for            |                || information    |                || of             |                || the            |                || public         |                || at             |                || large          |                || and            |                || for            |                || filing         |                || objections,    |                || if             |                || any,           |                || in             |                || such           |                || manner,        |                || as             |                || may            |                || for            | filing         || objections    |                || be             |                || prescribed,    |                || all            |                || evidence       |                || submitted      |                || by             |                || the            |                || clinical       |                || establishment  |                || of             |                || having         |                || complied       |                || with           |                || the            |                || prescribed     |                || minimum        |                || standards      |                || for            |                || a              |                || period         |                || of             |                || thirty         |                || days           |                || before         |                || processing     |                || for            |                || grant          |                || of             |                || permanent      |                || registration  |                || communication  |                || of            | objections    ||---------------|----------------|| 27           |                || if            |                || objections    |                || are           |                || recieved      |                || within        |                || the           |                || period        |                || referred      |                || to            |                || in            |                || the           |                || preceding     |                || section,      |                || such          |                || objections    |                || shal!         |                || be            |                || communicated  |                || to            |                || the           |                || clinical      |                || establishment |                || for           |                || response      |                || within        |                || a             |                || period        |                || of            |                || forty-five    |                || days         |                || 28           |                || permanent     |                || registration  |                || shall         |                || be            |                || granted       |                || only          |                || when          |                || a             |                || clinical      |                || establishment |                || fulfils       |                || the           |                || prescribed    |                || standards     |                || for           |                || registration  |                || by            |                || the           |                || central       |                || government   |                ||              |                || standards     | for            || permanent     |                || registration  |                |29, the authority shall pass an order immediately after the expiry of the prescribed period and within the next thirty days thereafter either— allowing or disallowing of registration (a) allowing the application for permanent registration; or (6) disallowing the application: provided that the authority shall record its reasons, if it disallows an application, for permanent registration 30 (/) the authority shail, if it, allows an application of the clinical establishment issue certificate of a certificate of permanent registration in such form and containing such particulars, as may permanent be prescribed registration, (2) the certificate shall be valid for a period of five years from the date of issue (3) for the purposes of sub-section (/), the provisions of sections 18, 19, 20 and 21 shall also apply (4) the applications for renewal of permanent registration shall be made within six months before the expiry of the validity of the certificate of permanent registration and, in lo case the application of renewal is not submitted within the stipulated period, the authority may allow renewal of registration on payment of such enhanced fees and penalties as may be prescribed 31, the disallowing of an application for permanent registration shall not debar a fresh clinical establishment from applying afresh for permanent registration under section 24 and application for permanent registration after providing such evidence, as may be required, of having rectified the deficiences on which grounds the earlier application was disallowed 32 (/) if, at any time after any clinical establishment has been registered, the authority cancellation of is satisfied that,— : registration (a) the conditions of the registration are not being complied with, or (5) the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under this act, it may issue a notice to the clinical establishment to show cause within three months' time as to why its registration under this act should not be cancelled for the reasons to be mentioned in the notice (2) ifafter giving a reasonable opportunity to the clinical establisment, the authority is as satisfied that there has been 4 breach of any of the provisions of this act or the rules made thereunder, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration (3) every order made under sub-section (2) shall take effect— (a) where no appeal has been preferred against such order immediately on the expiry of the period prescribed for such appeal; and 30 (6) where such appeal has been preferred and it has been dismissed from the date of the order of such dismissal: provided that the authority, after cancellation of registration for reasons to be recorded in writing, may restrain immediately the clinical establishment from carrying on if there is imminent danger to the health and safety of patients ast yo 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 cini shments 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 shail be entitled to be represented thereat (2) the authority shail communicate tothe 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  ys (3) the clinical establishment shall report to the authority, the action, ifany, which is proposed to be taken or has been taken upon the results of such inspection or inquiry and such report shall be furnished within such cime, as the authority may direct (4) where the clinical establishment does not, within a reasonable time, take action to 56 the satisfaction of the authority, it may, after considering any explanation furnished orrepresentation made by the clinical establishment, issue such directions within such time as indicated in the-direction, as that authority deems fit, and the clinical establishment shall comply with such directions, 34 the authority or an officer authorised by it may, if there is any reason to suspect power to enter that anyone is carrying ona clinical establishment without registration, enter and search in the manner prescribed, at any reasonable time and the clinical establishment, shall offer reasonable facilities for inspection or inquiry and be entitled to be represented thereat: provided that no such person shall enter the clinical establishment without giving notice of his intention to do so levy of fee jo 35 the state government may charge fees for different categories of clinical establishments, as may be prescribed by state governments appeal 36 (/) any person, aggreived by an order of the registering authority refusing to grant or renew a certificate of registration or revoking a certificate of registration may, in such manner and within such period as may be prescribed, prefer an appeal to the state council: 1s provided that the state council may entertain an appeal preferred after the expiry of the prescribed period if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in time (2) every appeal urider stib-section (7) shall be made in such form and be accompanied by such fee as may be prescribed  chapter v register of clinical establishments| register        | of          ||-----------------|-------------|| clinicat        |             || establishments |             || 37,             |             || (/)             |             || the             |             || authority       |             || shall           |             || within          |             || a               |             || period          |             || of              |             || two             |             || years           |             || from            |             || its             |             || establishment,  |             || compile,        |             || publish         |             || and             |             || maintain        |             || in              |             || digital         |             || format          |             || a               |             || register        |             || of              |             || clinical        |             || establishments, |             || registered      |             || by              |             || it              |             || and             |             || it              |             || shalt           |             || enter           |             || the             |             || particulars     |             || of              |             || the             |             || certificate     |             || so              |             || issued          |             || ina             |             || register        |             || to              |             || be              |             || maintained      |             || in              |             || such            |             || form            |             || and             |             || manner,         |             || as              |             || may             |             || be              |             || prescribed      |             || by              |             || the             |             || state           |             || government     |             || (2)             |             || each            |             || authority,      |             || including       |             || any             |             || other           |             || authority       |             || set-up          |             || for             |             || the             |             || registration    |             || of              |             || clinical        |             || establishments  |             || under           |             || any             |             || other           |             || lav             |             || for             |             || the             |             || time            |             || being           |             || in              |             || force,          |             || shall           |             || supply          |             || in              |             || digital         |             || format          |             || to              |             || the             |             || state           |             || council         |             || of              |             || clinical        |             || establishments  |             || a               |             || copy            |             || of              |             || every           |             || entry           |             || made            |             || in              |             || the             |             || register        |             || of              |             || clinical        |             || establishments  |             || in              |             || such            |             || manner,         |             || as              |             || may             |             || be              |             || prescribed      |             || to              |             || ensure          |             || that            |             || the             |             || state           |             || register        |             || 30              |             || is              |             || constantly      |             || up-to-date      |             || with            |             || the             |             || registers       |             || maintained      |             || by              |             || the             |             || registering     |             || authority       |             || in              |             || the             |             || state          |             || :               |             || 38             |             || (/)             |             || every           |             || state           |             || government      |             || shall           |             || maintain        |             || in              |             || digital         |             || and             |             || in              |             || such            |             || form            |             || and             |             || containing      |             || such            |             || particulars,    |             || as              |             || may             |             || be              |             || prescribed      |             || by              |             || the             |             || central         |             || governmenta     |             || register        |             || to              |             || be              |             || known           |             || as              |             || the             |             || state           |             || register        |             || of              |             || clinical        |             || establishments  |             || in              |             || respect         |             || of              |             || clinical        |             || establishments  |             || of              |             || that            |             || state          |             || maintenance     |             || of              | state       || register        | of          || clinical        |             || establishments, |             || w               |             || by              |             || (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             |             || 13th            |             || day             |             || of              |             || the             |             || following       |             || month          |             || a               | maintenance || 39,             |             || the             |             || central         |             || government      |             || shalt           |             || maintain        |             || in              |             || digital         |             || format          |             || an              |             || all             |             || india           |             || register        |             || to              |             || yo              |             || be              |             || called          |             || as              |             || the             |             || national        |             || register        |             || of              |             || clinical        |             || establishments  |             || that            |             || shall           |             || be              |             || an              |             || amalgam         |             || of              |             || the             |             || state           |             || register        |             || of              |             || clinical        |             || establishments  |             || maintained      |             || by              |             || the             |             || state           |             || governments     |             || and             |             || shall           |             || of              | national    || register        | of          || clinical        |             || establishments, |             || cause           |             || the             |             || same            |             || to              |             || be              |             || published       |             || in              |             || digital         |             || format         |             | chapter vi penaltiespenalty, ys40 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 monetary 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 penalty for nonregistration 41, (2) whoever carries on a clinical establishment without registration shall, on conviction for first offence, be punishable with a monetary penalty up to fifty thousand rupees, for second offence with monetary penalty which may extend to two lakh rupees wa "and for any subsequent offence with monetary penalty which may extend to five lakh rupees to (2) whoever knowingly serves ina clinical establishment which is not duly registered under this act, shall be punishable with monetary penalty which may extend to twenty-five thousand rupees (3) for the purpose of adjudging under sub-sections (/) and (2), 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 monetory 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 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 (2), it may by order impose the penalty specified in those sub-sections to be deposited within 20 thirty days of the order in the account referred to in sub-section (8) of 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 situated (6) any person aggrieved by the decision of the authority may prefer an appeal to the state council within a period of three months from the date of the said decision fy 4 (7) the manner of filing the appeal referred to in sub-section (5) shall be such as may be prescribed disobedience of order, obstruction and refusal of information42, (1) whoever wilfully disobeys any direction lawfully given by any person or authority empowered under this act to give such direction, or obstructs any person or authority in the discharge of any functions which such person or authority is required or empowered under this act to discharge, shall be punishable with monetary penalty which may extend to five lakh rupees : hai (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 punishable with monetary penalty which may extend to ww five lakh rupees (3) for the purpose of adjudging under sub-sections (/) and (2), 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 monelory penalty (4) while holding an inquiry the authority shall have power to summon and enforce yo 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 of the inquiry and if, on sugh inquiry, it is satisfied that the person has failed to comply with the provisions specified in sub-sections (/) and (2), it may by order impose the penalty specified in those sub-sections to be deposited within thirty days of the 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 clinical establishment and local conditions of the area in which the establishrnent is situated, (6) any person aggrieved by the decision of the authority may prefer an appeal to the state council within a period of three months from the date of the said decision, (7) the manner of filing the appeal referred to in sub-section (5) shall be such as may be prescribed, (8) the monetary penalty levied under sections41 and 42 shall be credited to such account as the state government may by order specify in this behalf, | penalty        | for        ||----------------|------------|| minor          |            || deficiencies,  |            || 43,            |            || whoever        |            || contravenes    |            || any            |            || provision      |            || of             |            || this           |            || act            |            || or             |            || any            |            || rule           |            || made           |            || thereunder     |            || resulting      |            || in             |            || deficiencies   |            || that           |            || do             |            || not            |            || pose           |            || any            |            || imminent       |            || danger         |            || to             |            || the            |            || health         |            || and            |            || safety         |            || of             |            || any            |            || patient        |            || and can        |            || be             |            || rectified      |            || within         |            || a              |            || reasonable     |            || time,          |            || shall          |            || be             |            || punishable     |            || with           |            || fine           |            || which          |            || may            |            || extend         |            || to             |            || ten            |            || thousand       |            || rupees,        |            || fo             |            || contravention  |            || by             | companies, || 44, (7)        |            || where          |            || a              |            || person         |            || committing     |            || contravention  |            || of             |            || any            |            || of             |            || the            |            || provisions     |            || of             |            || this           |            || act            |            || or             |            || ofany          |            || rule           |            || made           |            || thereunder     |            || is             |            || a              |            || company,       |            || every          |            || person         |            || who,           |            || at             |            || the            |            || time           |            || the            |            || contravention  |            || was            |            || committed,     |            || was            |            || in             |            || charge         |            || of,            |            || and            |            || was            |            || responsible    |            || to             |            || the            |            || company        |            || for            |            || the            |            || conduct        |            || of             |            || the            |            || business       |            || of             |            || the            |            || company,       |            || as             |            || well           |            || as             |            || the            |            || company,       |            || shall          |            || be             |            || deemed         |            || to             |            || be             |            || guilty         |            || of             |            || the            |            || contravention  |            || and            |            || shall          |            || be             |            || liable         |            || to             |            || fine:          |            ||               |            || is             |            || 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, |            || 20             |            |(2) notwithstanding anything contained in sub-section (j), where a contravention of any of the provisions of this act or of any rule made thereunder has been committed bya 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 2s or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that contravention and shall be liable to fine, explanation—for the purpose of this section,— (a) "company" means a body corporate and includes a firm or other association of individuals; and (6) "director", in relation to a firm, means a partner in the firm, 36 offences by government departments, 45, (1) where an offence under this act has been committed by any department of government within a period of six months after the commencement of this act, the head of the department shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly: provided that nothing contained in this section shall render such head of the department 3 tiable to any punishment if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence (2) notwithstanding anything contained in sub-section (j), where an offence under yo this act has been committed by a department of government and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any officer, other than the head of the department, such officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly recovery of fine, 46 whoever fails to pay the fine, the state councit of clinical establishment may prepare a certificate signed by an officer authorised by it specifying the fine due from such person and send it to the collector of the district in which such person owns any property ysor resides or carries on his business and the said collector, on receipt of such certificate, shall proceed to recover from such person the amount specified thereunder, as if it were an arrear of land revenue,  chapter vii miscellaneous47, (1) no suit, prosecution or other legal proceedings shall lie against any authority protection of action taken in good faith or any member of the national council or state council or any officer authorised in this behalf in respect of 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 (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 jo 48 every clinical establishment shall, within such time or within such extended time, furnishing of retums, etc as may be prescribed in that behalf, furnish to the authority or the state council or the 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 power to give directions 49 without prejudice to the foregoing provisions of this act, the authority shall have 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 employee of the authority, the national council and the state council shall 2° be deemed to, when acting or purporting to act in pursuance of any of the provisions of this act, be public servants within the meaning of section 21 of the indian penal code 45 of 1860 | employces     | of         ||---------------|------------|| the           | authority, || etc,          | to         || public        |            || servants     |            || power         | to         || remove        |            || difficulties, |            |§1 (/) ifany difficulty arises in giving effect to the provisions of this act, the central government may, by order published in the official gazette, make such provisions not inconsistent with the provisions of this act as may appear to it to be necessary or expedient for removal of the difficulty: as provided that no such order shall be made after the expiry ofa period oftwo years from 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 bo power of centrat government 52, (1) the central government may, by notification, make rules for carrying out all or any of the provisions of this act, to make rules (2) in particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely: - (a) allowances for the members of the national council under sub-section (5) of section 3; 3g (6) 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; ho (d) the qualification and the terms and cénditions for the members of the authority under clause (c) of sub-section (/) 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; () the minimum standards of facilities and services under clause (i) of subsection (/) of section 12; (g) the minimum number of personnel under clause (i) of sub-section (/) of section 12; (a) the maintenance of records and reporting by the clinical establishment under clause (i) of sub-section (7) of section 12; (/) other conditions for registration and continuation of clinical establishment under clause (év) of sub-section (/) of section 12; (/) classification of clinical establishment under sub-section (j) of section 13; (4) the different standards for classification of clinical establishments uider so sub-section (2) of section 13; (a the minimum standards for permanent registration under section 28; (i) the form and particulars to be contained in the register to be maintained under section 38, laying of rates ss53 every rule made by the central government'under this act shall be laid, as soon as -cay 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 fotlowing 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 thereafler have effectonly 20 in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule 54 (7) the state government may, by notification, make rules for carrying out in | power      | of     ||------------|--------|| government | to     || make       | rules, |respect of matters which do not fall within the purview of section 52, as (2) in particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:— (@) the proforma and the fee to be paid for registration under sub-section (7) of section 14; (6) the form and details of application under sub-section (3) of section 14; 3° (c) the particulars and information contained in certificate of provisional registration under section 15; (d) the manner of publication of all particulars of the clinical establishment proposed to be registered under sub-section (2) of section 16; (e) the fees to be paid to issue a duplicate certificate under section 19; 35 (/) the change of ownership or management to be informed by the clinical establishment to the authority under sub-section (2) of section 20; (g) the manner in which the authority shal! publish the names of the clinical establishments whose registration expired under section 2 i; (a) the enhanced fees to be charged for renewal after expiry of the provisional = yo registration under section 22; (@ the form of the application and fees to be charged by the state government under section 24; (/) the manner of submitting evidence of the clinical establishments having complied with the minimum standards under section 25; y s (k) the manner of displaying information of the clinical establishments having complied with the minimum standards for filing objection under section 26; : (p the expiry of period specified in section 29; (m) the form and particulars of the certificate of registration under section 30; w (n) the period within which an appeal shall be preferred under clause (a) of sub-section (3) of section 32; (o) the 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; to (q) the manner and the period within which an appeal may be preferred to the state council under sub-section (j) of section 36; (vy 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 (/) of section 37; 15 () 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 41 and 42; (v) the manner of finding the appeal under sub-section (7) of sections 41and 42; 20 gy) the manner and the time within which the information is to be furnished to the authority 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 of laying tules 25 55, every rule made by the state government under this section shall be laid, as soon as may be after it is made, before each house of the state legislature where it consists of two houses, or where such legislature consists of one house, before that house savings 56 (1) the provisions of this act shall not apply to the states in which the enactments specified in the schedule are applicable: 30 provided that the states in which the enactments referred to in sub-section (/) are applicable, and such states subsequent to the commencement of this act, adopts this act - under clause (/) of article 252 of the constitution, the provisions of this act shall, subsequent to such adoption, apply in that state : (2) the central government may, as and when consider necessary, by notification 345 amend the schedule  the schedule[see section 56] 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 the manipur homes and clinics registration act, 1992 6 the nagaland health care establishments act, 1997, 7 the orissa clinical establishments (control and regulation) act, 1990, 8, the punjab state nursing home registration act, 1991 9 the west bengal clinical establishments act, 1950  statement of objects and reasonsat 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 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 establishment (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 introduced 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:— (/ 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 setup under the states reorganisation act, 1956, the north-eastern council, etc; (i) 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 makeenquiry 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 maybe 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 registeation 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; (xii) 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 monetory penalty for violation of the provisions of sections 41 and 42 of the proposed bill; (xv) any person aggrieved by the decision of authrity may prefer an appeal to the state council 7, legislation in respect of "public health and sartitation, hospitals and dispensaries" are relatable to entry 6 of list 1 - state list inthe seventh schedule to the constitution and parliament has no power to make a law in the state (apart from the provisions of articles 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 new delhi, ghulam nabi azad the \0 march, 2010  president's recommendation under article 117) of the constitution of india(copy of letter no z2801 5/48/2000-h dated the 15th march, 201 0 from shri ghulam nabi azad, minister of health and family welfare to the secretary-general, lok sabha the president, having been informed of the subject matter of the proposed clinical establishments (registration and regulation) bill, 2010, recommends to the house the consideration of the bill under article 1 17(3) of the constitution(ii) the period of six months from the date of notification of standards for clinical establishments which come into existence after standards have been notified clause 24,—-this clause provides procedure for making application for permanent registration it provides that an application to the authority shall be made in the form and accompanied by such fees as may be provided by rules by the state government clause 25—this clause provides that every clinical establishment shall submit evidence of having complied with the prescribed minimum standards in such manner, as may be provided by rules by the state government, clause 26—this clause provides that as soon as the clinical establishment submits the required evidence of having complied with the prescribed minimum standards, the authority shall display the same for information of the public for filing objections, if any, for a period of thirty days before processing for grant of permanent registration, clause 27—this clause provides for communication of objections received by the authority within the period refetred to in clause 26 to the clinical establishment for response within a period of forty-five days  clause 28—this clause provides that permanent registration shall be granted only when a clinical establishment fulfils the standards for registration as may be provided by tules by the central government clause 29—this clause provides time limit to the authority for allowing or disallowing of registration and record its reasons for disallowing the application clause 30—this clause provides for issuing certificate of permanent registration in such form and containing such particulars as may be provided by rules by the state government, it further provides that the certificate issued under the said clause shall be valid for a period of five years from the date of issue it also provides for renewal of permanent registration and procedure therefor however, the provisions of clauses 18, t 9,20 and 21 also apply to permanent registration _ clause 31,—this clause provides for applying fresh application for permanent registration if the earlier application for permanent registration is disallowed, clause 32—this clause provides for issuing a show cause notice for cancellation of registration if the conditions of the registration are not complied with; or the person entrusted with the management of the clinical establishment has been convicted ofan offence punishable under this proposed legistation it also provides that the authority after giving a reasonable opportunity to the clinical establishment satisfied that there has been a breach of any of the provision of the proposed legislation or the tules; it may by an order cancel its registration and every such cancellation order shall take effect if no appeal has been preferred, on the expiry of the period prescribed for such appeal and if any appeal has been preferred and dismissed, from the date of the order of such dismissal it further provides that such cancellation of registration shall be effective immediately if there is an imminent danger to the health and safety of general public clause 33—this clause provides for inspection or inquiry in respect of any registered clinical establishment, its buildings, laboratories and also of the work conducted or done by it and intimating the inspection report to the clinical establishment and advise that establishment upon the action to be taken, it also provides that the clinical establishment shall report to the authority, the action, if any, has been taken upon the results of such inspection if no action is taken to the satisfaction of the authority, it may issue directions and the clinical establishment shalt comply with such directions, clause 34—this clause provides that the registering authority or an officer authorised by it after giving prior notice, may enter and search any clinical establishment suspecting of not being registered under the provisions of proposed legislation in the manner as may be provided by rules by the state government, however, the clinical establishments shall offer reasonable facilities for such inspection or enquiryclause 35—this clause provides that fees may be charged for different categories of  clinical establishments as inay be provided by rules by the state government, clause 36-—this clause contains provisions for appeal any person aggrieved by an order of the registering authority refusing to grant or renew acertificate of registration or revoking a certificate, can appeal to the state council within such period and in such form accompanied by such fees as may be provided by rules by the state government however, the state council may entertain an appeal after expiry of the period as said above, if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in time clause 37-—this clause provides that the authority shall within a period of two years from its establishment, compile, publish and maintain in digital format a register of clinical establishments in such form and manner as may be provided by rules by the state government it also provides that every authority set up for the registration of the clinical establishments shall in digital format supply to the state council a copy of every entry made in the register of clinical establishments to ensure maintenance of up-to-date registers clause 38—this clause provides that every state government shall maintain state register of clinical establishments in digital and in such form and containing such particulars, as may be prescribed by the central government it also provides that every state shall supply a copy of the state register of clinical establishments in digital format to the central government, clause 39—this clause provides for maintenance of national register of clinical establishments in digital format by the central government it also provides that the said register shall be an amalgam of the state register of clinical establishments and shall cause to be published in digital format clause 40—this clause contains provisions for penalties for contravention of any provisions of the proposed legislation, if no penalty is provided elsewhere it provides punishment for the first offence with fine which may extend to ten thousand rupees; for 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 clause 41—this clause contains provisions for monetary penalties for nonregistration of clinical establishments it provides punishment for the first offence with a monetary penalty which may extend to fifty thousand rupees, for second offence with monetary penalty which may extend to two lakh rupees and for any subsequent offence with monetary penalty which may extend to five lakh rupees it farther provides that if a person knowingly serves ina clinical establishment which is not duly registered under the proposed legislation, shall be punishable with monetary penality which may extend to twenty-five thousand rupees it also provides that for the purpose of adjudging the monetary penalty under this clause, the authority shall hold an inquiry after giving feasonable apportunities to the person concerned it also provides that in determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical estalishment and local conditions of the area in which the establishment is situated it also provides that any person aggrieved by the decision of the authority - may prefer an appeal to the state council the nionetary penalty levied under this clause shall be credited to such account as the state governments may by order specify clause 42—this clause provides for monetary penalty for disobeying any direction given by any person or authority empowered under the proposed legislation or obstructs any person or authority ia discharge of any functions which that person or authority is required or empowered undez the proposed legislation to discharge it provides a monetary penalty which may extend to five lakh rupees it also provides that for the purpose of adjudging the monetary penalty under this clause, the authority shall hold an inquiry after giving reasonable apportuniities to the person concerned it also provides that 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 situated it also provides that any person aggrieved by the decision of the authority may prefer an appeal to the state council the monetary penalty levied under this clause shall be credited to such account as the state governments may by order specify clause 43—this clause provides for penalty for contravention of any provisions of the proposed legislation or any rule resulting in deficiencies that do not pose any imminent danger to the health and safety of any patient and can be rectified within a reasonable time it provides punishment with fine which may extend to ten thousand rupees clause 44,—this clause contains provisions for contravention of any of the provisions of the proposed legistation or any rule by companies it provides that a contravention under the proposed legislation has been committed by a company, every person directly in charge of, and responsible to, the company for the conduct of its business at the time of committing contravention shall be deemed to be guilty of the contravention and shail be hable to fine unless he provides that the contravention was committed without his knowledge or that he exercised all due diligence to prevent the commission of contravention, it also provides that where any contravention under the proposed legislation has been committed with the consent or connivance of, or attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also deemed to be guilty of that contravention and shall be liable to fine the explanation to the clause seeks to define the terms "company" and "director" clause 45-—this clause contains provisions for offences by government departments, it provides that where an offence under the proposed legislation has been committed by any department of the government within a period of six months after commencement of this act, the head of the department shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly clause 46—~this clause provides forrecovery of fines as an arrear of land revenue it provides that the state council of clinical establishments may prepare a certificate specifying the fine due from such person and send it to the collector of the district in which such person owns any property or carries on his business, clause 47— this clause contains provisions for protection of action taken in good faith under the proposed legislation it provides that no suit, prosecution or other legal proceedings shall lie against any authority or any member of the national council or state council or any officer authorised in this behalf in respect of anything done in good faith in pursuance of such proposed legislation or of any rule or order made, or direction issued, thereunder clause 48— this clause provides that every clinical establishment should furnish to _the authority or the state council or the national council such returns or the statistics and other information as provided by rules to be made by the state government clause 49— this clause empowers the authority to issue directions regarding furnishing returns, statistics and atiy other information for the proper functioning of the clinical establishments and such directions shall be binding clause 50— this clause provides that every employee of the authority and the national council and the state council shall be public servants within the meaning of section 21 ofthe indian penal code clause 51— this clause contains provisions for power to remove difficulties, it provides that if any difficulty arises in giving effect to the provisions of the proposed legislation, the central government may, by order published in the official gazette, make such provisions, not inconsistent withthe provisions of the proposed legislation, as appear to it to be necessary or expedient for removing the difficulty however, no such order can be made under this section after expiry of two years from the commencement of the proposed legislation it further provides that every order made under this section shall, as soon as may be after it is made, be laid before each house of parliament clause 52, this clause empowers the central government to make rules for carrying out the provisions of the proposed legislation in respect of the matters specified in the said clause clause 53--- this clause provides that every rule made by the central government under this act as soon as may be after it is made, laid before each house of parliament clause 54 this clause empowers the state government to make rules for carrying out the provisions of the proposed legislation which do not fall within the purview of section 52 and in particular in respect of the matters specified in the said clause, clause 55— this clause provides that every rule made by the state government shalt be laid as soon as may be after it is made, before each house of state legislature clause 56 this clause provides that the provisions of this act shall not apply to the states in which the enactments specified in the schedule are applicable however, it provides that the states in which the enactments referred to in sub-section (/) are applicable, and such states subsequent to the commencement of this act, adopts this act under clause (/) of article 252 of the constitution, the provisions of this act shall, subsequent to such adoption, apply in that state it also provides that the central government may, by notification, amend the schedule  financial memorandumclause 3 of the bill empowers the central government to establish a national council for clinical establishment it provides for payment of allowance to the members of the national council it also empowers the central government to appoint a person to be the secretary of the national council, clause 39 of the bill empowers the central government to maintain in digital format an all india register to be called the national register of clinical establishments 'the expenditure on account of procurement and maintenance of electronic equipments and setting up of network with the state government will have to be borne by the central government the bill, if enacted, could involve expenditure from the consolidated fund of india which may be of both recurring and non-recurring in nature the estimated total expenditure per ainum will be to the tune of rupees one crore  memorandum regarding delegated legislationclause 51 of the bilf empowers the central government to issue an order for removal of any difficulty which may arise in giving effect to the provisions of the proposed legislation such an order will not be inconsistent with the provisions of the legislation and would not be made after the period of two years from the date on which the proposed legislation receives the assent of the president 2 clause 52 of the bitl empowers the central government to make rules for carrying out the various provisions of the bill and regarding— (a) allowances for the members of the national council under sub-section (5) of section 3; (8) appointment of such person to be secretary of the state council by the central government under sub-section (/0) of section 3; (c) the determination of standards and for classification of clinical establishments under section 7; (a) the qualification and the terms and conditions for the members of the authority under clause (c) of sub-section (/) of section 10; (e) the procedure under which the powers of the authority may be exsercised 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; (f the minimum standards of facilities and services under clause (i) of sub-section (/) of section 12; (g) the minimum number of personne! under clause (i/) of sub-section (/) of section 12; '  (a) the maintenance of record and reporting by the clinical establishment under clause (ii/) of sub-suction (/) of section 12; , (/) other conditions for registration and continuation of clinical establishment under clause (iv) of sub-section (/) of section 12; (/) classification of clinical establishment under sub-section (/) of section 13; (4) the different standards for classification of clinical establishments under sub-section (2) of section 13; () the minimum standards for permanent registration under section 28; and (m) the form and particulars to be contained in the register to bé maintained under section 38, 3 clause 54 of the bill empowers the state governments to make rules for carrying out in respect of matters which do not fall within the purview of section 52 and regarding - (a) the proforma and the fee to be paid for registration of clinical establishment under sub-section (/) of section 14; , (6) the form and details of application under sub-section (3) of section 14; (c) the particulars and information contained in certificate of provisional registration under section 15; (d) the manner of publication of all particulars of the clinical establishment proposed to be registered under sub-section (2) of section 16; (e) the fees to be paid to issue a duplicate certificate under section 19; (a the manner in which the authority shall publish the names of the clinical establishments whose registration expired under section 21; (g) the enhanced fees to be charged for renewal after expiry of provisional registration under section 22; (h) the form of the application and fees to be charged by the state government under section 24; () the manner of submitting evidence of the clinical establishments having complied with the minimum standards under section 25; (/) the manner of displaying information of the clinical establishments having complied with the minimum standards for filing objection under section 26; (a) the expiry of period specified in section 29; (a) the form and particulars of the certificate of registration under section 30; (i) the manner of entry and search of clinical establishment under section 34; (n) the fees to be charged by the state government for different categories of clinical establishments under sub-section (/) of section 35; (0) the manner and the period within which an appeal may be preferred to the state council under sub-section (/) of section 36; (p) the form and the fee to be paid for an appeal under sub-section (2) of section 36; (%) the form and the manner in which the register to be maintained under subsection (7) of section 37; (r) 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; (s) the time and manner within which the information is to be furnished under section 48; () any other matter which is required to be or may be prescribed by the state government, 4, the rules made by the central government under clause 52 shall be laid before each house of parliament under clause 53 and the rules made by the state government under clause 54 shall be laid before the state legislature under clause 55 of the bill, 5 the matters in respect of which rules may be made are generally matters of administrative detail and procedure and it is not possible to provide for them in the bill itself, the delegation of legislative power is, therefore, of a normal character 