 the clinical establishments (registration and regulation) bill, 2007———— arrangement of clauses———— chapter i preliminary clauses1 short title, application and   commencement 2 definitions chapter ii the national council3 establishment of national council 4 disqualifications for appointment as member 5 functions of  national council 6 power to seek advice  or assistance 7 national council to follow consultative process chapter iii registration and standards for clinical establishments8 state registrar of clinical establishments 9 providing information to  national council10 authority for registration 11 registration for  clinical establishments 12 conditions for registration 13 classification of  clinical establishments chapter iv procedure for registration14 application for provisional  certificate  of registration 15 provisional certificate 16 no inquiry prior to provisional registration 17 validity of  provisional  registration 18 display of the certificate of registration 19 duplicate certificate 20 certificate to  be non-transferable 21 publication of expiry of registration 22 renewal of registration 23 time-limit for provisional registration 24 application for permanent registration 25 verification  of application clauses26 display of  information  for filing  objections 27 communication of objections 28 standards for permanent registration 29 allowing or disallowing of registration 30 certificate of permanent registration 31 fresh application for permanent registration 32 cancellation of registration 33 inspection of registered clinical establishments 34 power to enter 35 finance and accounts 36 appeal chapter v register of clinical establishment37 register of clinical establishments 38 maintenance of state register of clinical establishments 39 maintenance of all-india register of clinical establishments 40 penalty 41 penalty for non-registration 42 disobedience of order, obstruction and refusal of information 43 penalty for minor deficiencies 44 contravention by companies 45 offences by government departments 46 recovery of fine chapter vi miscellaneous47 protection of action taken in good faith48 furnishing of returns, etc 49 power to give directions 50 employees of the authority, etc, to be public servants 51 power to remove difficulties 52 power of central government to make rules 53 laying of  rules 54 power of  state government to make rules 55 laying of rules 56 savingsthe schedule bill no  71 of 2007 the clinical establishments (registration and regulation) bill, 2007 a billto provide for the registration and regulation of clinical establishments in the country and for matters connected therewith or incidental thereto  whereas, it is considered expedient to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services which may be provided by them so that mandate of article 47 of the constitution for improvement in public health may be achieved; and whereas, parliament has no power to make laws for the states with respect to any of the matters aforesaid except as provided in articles 249 and 250 of the constitution;and whereas, in pursuance of clause (1) of article 252 of the constitution, resolutions have been passed by all the houses of the legislatures of the states of arunachal pradesh, himachal pradesh, mizoram and sikkim to the effect that the matters aforesaid should be regulated in those states by parliament by law;be it enacted by parliament in the fifty-eighth year of the republic of india as follows:— chapter i preliminary1 (1) this act may be called the clinical establishments (registration and regulation)act, 2007short 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(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 a state or union territory: provided that different dates may be appointed for different categories of clinical establishments and for different recognised systems of medicinedefinitions2 in this act, unless the context otherwise requires,—(a) "authority" means the district registering authority designated under section 10;(b) "certificate" means certificate of registration issued under section 30; (c) "clinical establishment" means— (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities with beds requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or(ii) a place established as an independent entity or part of an establishment referred to in clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not, and shall include a clinical establishment owned, controlled or managed by,—(1) the government or a department of the government; (2) a trust, whether public or private; (3) a corporation (including a cooperative society) registered under a central, provincial or state act, whether or not owned by the government;(4) a local authority; and (5) a single doctor establishment, but does not include the clinical establishments owned, controlled or managed by the armed forcesexplanation— 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;46 of 1950 45 of 1950(d) "national council" means the national council for clinical establishments established under section 3;(e) "notification" means a notification published in the official gazette; (f) "prescribed" means prescribed by rules made under this act by the central government or, as the case may be, the state government;(g) "recognised system of medicine" means allopathy, yoga, naturopathy, ayurveda, homoeopathy, siddha and unani systems of medicines or any other system of medicine as may be recognized by the central government;(h) "register" means the register maintained by the authority, state registrar and the central government under sections 37, 38 and 39 respectively of this act containing the number of clinical establishments registered and the expressions "registered" and "registration" shall be construed accordingly;(i) "registration" means to register under section 11 and the expression registration or registered shall be construed accordingly;(j) "rules" means rules made under this act; (k) "schedule" means schedule to this act; (l) "standards" means conditions that the central government may prescribe under section 12, for the registration of clinical establishments; and(m) "state government" in relation to a union territory means the administrator thereof appointed under article 239 of the constitution chapter ii the national councilestablishment of national council3 (1) with effect from such date as the central government may, by notification, appoint in this behalf, there shall be established for the purposes of this act, a council to be called the national council (2) the national council shall consist of—(a) director general of health services, ministry of health and family welfare, central government , ex officio, who shall be the chairperson;(b) one representative each to be elected by the—16  of 1948(i) dental council of india constituted under section 3 of the dentists act, 1948;102 of 1956 (ii) medical council of india constituted under section 3 of the indian medical council act, 1956;48 of 1947 (iii) nursing council of india constituted under section 3 of the indiannursing council act, 1947;8 of 1948 (iv) pharmacy council of india constituted under section 3 of thepharmacy act, 1948;48 of 1970 (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; (d) one representative to be elected by the central council constituted undersection 3 of the homoeopathy central council act, 1973;59 of 1973 102 of 1956 (e) one representative to be elected by the central council of the indian medicalassociation constituted under section 3 of the indian medical council act, 1956;63 of 1986 (f) one representative of bureau of the indian standards constituted under section 3 of the bureau of indian standards act, 1986;37 of 1956(g) two representatives from the zonal councils set up under section 15 of the states reorganisation act, 1956;(h) two representatives from the north-eastern council set up under section 3of the north-eastern council act, 1971;84 of 1971(i) one representative from the line of paramedical systems; (j) the central government may nominate not more than three eminent representatives of other recognized systems of medicine of which no statutory regulatory authority has been set up(3) the nominated members of the national council shall hold office for one year but shall be eligible for re-nomination(4) the elected members of the national council shall hold office for three years, but shall be eligible for re-election: provided that the person nominated or elected, as the case may be, shall hold office for so long as he holds appointment of the office by virtue of which he was nominated or elected to the national council(5) the members of the national council shall be entitled for such allowances as may be prescribed by the central government(6) the national council may, subject to the previous approval of the central government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it(7) the national council may constitute sub-committees and may appoint to such sub-committee, as it deems fit, consisting of members who are not members of the council for such periods, not exceeding two years, for the consideration of particular matters(8) the functions of the natinal council may be exercised notwithstanding any vacancy therein(9) the central government shall appoint a person to be the secretary of the national council and may provide the council with such other secretarial and other staff as the central government considers necessary4 a person shall be disqualified for being appointed as a member of the national council if he—disqualifications for appointment 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(b) is an undischarged insolvent; or (c) is of unsound mind and stands so declared by a competent court; or (d) has been removed or dismissed from the service of the government or a corporation owned or controlled by the government; or(e) has, in the opinion of the central government, such financial or other interest in the council as is likely to affect prejudicially the discharge by him of his functions as a member5 the national council shall —functions of national council (a) determine the standards for ensuring proper health care by the clinical establishments; (b) classify the clinical establishments into different categories; (c) develop the minimum standards and their periodic review; (d) compile, maintain and update a national register of clinical establishments; (e) collect the statistics in respect of clinical establishments; (f) perform any other function determined by the central government, from time to time6 the national council may associate with itself any person or body whose assistance or advice it may desire in carrying out any of the provisions of this act7 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 prescribedpower to seek advice  or assistance national council to follow consultativeprocess chapter iii registration and standards for clinical establishmentsstate registrar of clinical establishments8 every state government shall, by notification, designate the director of health services (by whatever name called) or any other officer subordinate to him as the registrar of clinical establishments9 it shall be the responsibility of the registrar of clinical establishments to compile and update the state register of clinical establishments and further to send monthly returns in digital format for updating the national registerproviding information to national council authority for registration10 the state government shall, by notification, designate the district health officer or the chief medical officer (by whatever name called) as an authority to be called the district registering authority for each district for registration of clinical establishments11 no person shall carry on a clinical establishment unless it has been duly registered in accordance with the provisions of this actregistration for  clinical establishmentsexplanation— for the purposes of this section, "carry on" means to admit patients in a clinical establishment for providing treatment, diagnosis, or nursing care12  for registration and continuation, every clinical establishment shall fulfil—conditions for registration(i) the minimum standards of facilities and services as may be prescribed; (ii) the minimum qualifications for the personnel as may be prescribed;(iii) provisions for maintenance of records and reporting as may beprescribed;(iv) such other conditions as may be prescribed13 (1) clinical establishment of different systems shall be classified into such categories, as may be prescribed by the central government, from time to timeclassification of  clinical establishments (2) different standards may be prescribed for classification of different categories referred to in sub-section (1): provided that in prescribing the standards for clinical establishments, the central government shall have regard to the local conditions chapter iv procedure for registration14  (1) for the purposes of registration of the clinical establishment under section 10, an application in the prescribed proforma along with the prescribed fee shall be furnished to the authorityapplication for provisional certificate  of registration (2) the application shall be furnished in person or by post or online (3) the application shall be made in such form and shall be accompanied by such details as may be prescribed under this act or rules made thereunder(4) if any clinical establishment is in existence at the time of the commencement of this act, an application for its registration shall be made within one year from the date of the commencement of this act(5) if any clinical establishment is already registered under any existing law requiring registration of such establishments, even then it shall apply for registration as referred to in sub-section (1)provisional certificate15 the authority shall, within a period of ten days from the date of receipt of suchapplication, grant to the applicant a certificate of provisional registration in such form and containing such particulars and such information, as may be prescribed16  (1) the authority shall not be required to conduct any inquiry prior to the grantof provisional registrationno inquiryprior to provisional registration (2) notwithstanding the grant of the provisional certificate of registration, the authorityshall, 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 proposed to be registered17 every provisional registration shall be valid to the last day of the twelfth monthfrom the date of issue of the certificate of registration and such registration shall be renewablevalidity of provisional registration18 the certificate shall be kept affixed in a conspicuous place in the clinicalestablishment in such manner so as to be visible to every one visiting such establishmentdisplay of the certificate of registration duplicate certificate19 in case the certificate is lost, destroyed, mutilated or damaged, the authority shallissue a duplicate certificate on the request of the clinical establishment and on the payment of such fees, as may be prescribedcertificate to be nontransferable20 the certificate of registration shall be non-transferable and, in the event of changeof ownership or change of category or change of management or on ceasing to function as a clinical establishment, the certificate of registration shall be surrendered to the authority and the clinical establishment shall apply afresh for grant of certificate of registrationpublication of expiry of registration21  the authority shall also cause to be published in such manner, as may beprescribed, the names of clinical establishments whose registration would be expiring within the next forty-five daysrenewal of registration22  application for renewal of registration shall be made thirty days before the expiryof the validity of the certificate of provisional registration and, in case the application for renewal is made after the expiry of the provisional registration, the authority shall allow renewal of registration on payment of such enhanced fees, as may be prescribedtime-limit for provisional registration23 where clinical establishments in respect of which standards have been notifiedby the central government, provisional registration shall not be granted or renewed beyond a period of three years from the date of notification of standards24  application for permanent registration by a clinical establishment shall be madeto the authority in such form and be accompanied by such fees, as may be prescribedapplication for permanent registrationverification of application25 the clinical establishment shall submit evidence of the clinical establishmenthaving complied with the prescribed minimum standards in such manner, as may be prescribeddisplay of information for filing objections26  as soon as the clinical establishment submits the required evidence of the clinicalestablishment 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 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 registrationcommunication of objections27  if objections are received within the period referred to in the preceding section, such objections shall be communicated to the clinical establishment for response within a period, as may be prescribed28  permanent registration shall be granted only when a clinical establishment fulfils the prescribed standards for registration by the central governmentstandards for permanent registration29 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 (b) disallowing the application: provided that the authority shall record its reasons, if it disallows an application for permanent registration30 the authority shall issue a certificate of permanent registration in such form and containing such particulars, as may be prescribed, if the authority allows an applicationcertificate of permanent registrationfresh application for permanent registration31 the disallowing of an application for permanent registration shall not debar a clinical establishment from applying afresh for permanent registration under section 24 and after providing such evidence, as may be required, of having rectified the deficiencies on which grounds the earlier application was disallowedcancellation of registration32 (1) if, at any time after any clinical establishment has been registered, the authority is satisfied that,—(a) the conditions of the registration are not being complied with; or (b) the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under this act, it may issue a show cause notice as to why its registration under this act should not be cancelled for the reasons to be mentioned in the notice(2) if after giving a reasonable opportunity to the clinical establishment, the authority is satisfied that there has been a breach of any of the provisions of this act or the rules made thereunder, it may, without prejudice to any other action that it may take against such clinical establishment, cancel its registration (3) every order made under sub-section (1) 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 (b) where such appeal has been preferred and it has been dismissed from the date of the order of such dismissal: provided that the authority, 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 patientsinspection of registered clinical establishments33  (1) the authority or an officer authorised by it, shall have the right to cause an inspection of, or inquiry in respect of any clinical establishment, its building, laboratories and equipment and also of the work conducted or done by the clinical establishment, to be made by such person or persons as it may direct and to cause an inquiry to be made in respect of any other matter connected with the clinical establishment and that establishment shall be entitled to be represented thereat (2) the authority shall communicate to the clinical establishment the views of that authority with reference to the results of such inspection or inquiry and may, after ascertaining the opinion of the clinical establishment thereon, advise that establishment upon the action to be taken (3) the clinical establishment shall report to the authority, the action, if any, which is proposed to be taken or has been taken upon the results of such inspection or inquiry and such report shall be furnished within such time, as the authority may direct (4) where the clinical establishment does not, within a reasonable time, take action to the satisfaction of the authority, it may, after considering any explanation furnished or representation made by the clinical establishment, issue such directions, as that authority deems fit, and the clinical establishment shall comply with such directionspower to enter34 the authority or an officer authorised by it may, if there is any reason to suspectthat anyone is carrying on a 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 givingnotice of his intention to do sofinance and accounts35 (1) the state government may charge fees for different categories of clinicalestablishments, as may be prescribed(2) the state government shall remit two per cent of the fees collected from theclinical establishments for registration and renewal to the national council(3) it shall be the responsibility of the registrar of clinical establishments to ensurethat the amount referred to in sub-section (2), is remitted to the national council, on timeappeal36 (1) any person, aggrieved by an order of the registering authority refusing togrant 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 government:provided that the state government 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 under sub-section (1) shall be made in such form and be accompanied by such fee as may be prescribed chapter v register of clinical establishments37  (1) the authority shall maintain in digital format a register of clinical establishments, registered by it and it shall enter the particulars of the certificate so issued in a register to be maintained in such form and manner, as may be prescribed by the state governmentregister of clinical establishments(2) each authority, including any other authority set up for the registration of clinicalestablishments under any other law for the time being in force, shall supply in digital format to the state registrar 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 is constantly up-to-date with the registers maintained by the registering authority in the state38 (1) every state shall maintain in digital and in such form and containing suchparticulars, as may be prescribed by the central government, a register to be known as the state register of clinical establishments in respect of clinical establishments of that statemaintenance of state register of clinical establishments(2) every state shall supply in digital format to the central government, a copy of thestate register of clinical establishments and shall inform the central government without delay of all additions to and other amendments in such register made, from time to time39 the central government shall maintain in digital format an all-india register tobe called as the national register of clinical establishments that shall be an amalgam of the state register of clinical establishments maintained by the state governmentsmaintenance of all-india register of clinical establishmentspenalty40 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 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 rupeespenalty for non-registration41 (1) whoever carries on a clinical establishment without registration shall, on conviction for first offence, be punishable with a fine up to fifty thousand rupees, for second offence with fine which may extend to two lakh rupees and for any subsequent offence with fine which may extend to five lakh rupees (2) whoever knowingly serves in a clinical establishment which is not duly registered under this act, shall be punishable with fine which may extend to twenty-five thousand rupeesdisobedienceof 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 fine which may extend to five lakh rupees(2) whoever being required by or under this act to supply any information wilfully withholds such information or gives information which he knows to be false or which he does not believe to be true, shall be punishable with fine which may extend to five lakh rupeespenalty for minor deficiencies43 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 rupeescontravention by companies44  (1) where a person committing contravention of any of the provisions of this act or of any 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:provided that nothing contained in this sub-section shall render any such person liable to any punishment if he proves that the contravention was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such contravention (2) notwithstanding anything contained in sub-section (1), where a contravention of any of the provisions of this act or of any rule made thereunder has been committed by a company and it is proved that the contravention has taken place with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that contravention and shall be liable to fineexplanation— for the purposes of this section,— (a) "company" means a body corporate and includes a firm or other association of individuals; and (b) "director", in relation to a firm, means a partner in the firmoffences by government departments45  (1) where an offence under this act has been committed by any department of government, 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 liable 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 (1), where an offence under 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 accordinglyrecovery of fine46 whoever fails to pay the fine, the registrar of clinical establishment may preparea certificate signed by him specifying the fine due from such person and send it to the collector of the district in which such person owns any property or 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 vi miscellaneousprotection of action taken in good faith47 (1) no suit, prosecution or other legal proceedings shall lie against any authorityor any member of the national 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 thecentral 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 thereunderfurnishing of returns, etc48  every clinical establishment shall, within such time or within such extended time,as may be prescribed in that behalf, furnish to the authority or the state registrar 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 timepower to give directions49 without prejudice to the foregoing provisions of this act, the authority shall havethe power to issue such directions, including furnishing returns, statistics and otherinformation for the proper functioning of clinical establishments and such directions shall be binding50 every employee of the authority and the national council shall 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 codeemployees of the authority, etc, to be public servants45 of 1860power to remove difficulties51  (1) if any 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: provided that no such order shall be made after the expiry of a period of two 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 parliament52 (1) the central government may, by notification, make rules for carrying out all or any of the provisions of this actpower of central government 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) ofsection 3; (b) the determination of standards and for classification of clinicalestablishments under section 7;(c) classification of clinical establishment under sub-section (1) of section 13;(d) the different standards for classification of clinical establishments undersub-section (2) of section 13; (e) the minimum standards for permanent registration under section 28;(f) the form and particulars to be contained in the register to be maintainedunder section 38laying of rules53  every rule made by the central government under this act shall be laid, as soon as may be after it is made, before each house of parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both houses agree in making any modification in the rule or both houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule54  (1) the state government may, by notification, make rules for carrying out in respect of matters which do not fall within the purview of section 52power of state government 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) the conditions for registration under section 12;(b) the proforma and the fee to be paid for registration under sub-section (1) ofsection 14;(c) the form and details of application under section 14(3);(d) the particulars and information contained in certificate of provisionalregistration under section 15;(e) the manner of publication of all particulars of the clinical establishmentproposed to be registered under section 16(2);(f) the fees to be paid to issue a duplicate certificate under section 19; (g) the manner in which the authority shall publish the names of the clinicalestablishments whose registration would be expiring under section 21;(h) the enhanced fees to be charged for renewal after expiry of provisional registration under section 22;(i) the form of the application and fees to be charged by the state government under section 24;(j) the manner of submitting evidence of the clinical establishments having complied with the minimum standards under section 25;(k) the manner of displaying information of the clinical establishments having complied with the minimum standards for filing objection under section 26;(l) the period within which the objections to be communicated to the clinical establishment under section 27;(m) the expiry of period specified in section 29; (n) the form and particulars of the certificate of registration under section 30;(o) the manner of entry and inspection of clinical establishment under section34;(p) the fees to be charged by the state government for different categories of clinical establishments under sub-section (1) of section 35;(q) the manner and the period within which an appeal may be preferred to the state government under sub-section (1) of section 36;(r) the form and the fee to be paid for an appeal under sub-section (2) of section36;(s) the form and the manner in which the register to be maintained under subsection (1) of section 37;(t) the manner of supply to the state registrar in digital format the entry made in the register of clinical establishments under sub-section (2) of section 37;(u) the manner and the time within which the information is to be furnished under section 48;(v) any other matter which is required to be or may be prescribed by the state governmentlaying of rules55  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 housesavings56  (1) the provisions of this act shall not apply to the states in which the enactments specified in the schedule are applicable(2) the central government may, as and when consider necessary, by notification amend the schedule the schedule (see section 56)1the andhra pradesh private medical care establishments (registration and regulation) act, 20022the bombay nursing homes registration act, 19493the madhya pradesh upcharya griha tatha rujopchar sambandhi sthapnaye (ragistrikaran tatha anugyapan) adhiniyam, 19734the manipur homes and clinics registration act, 19925the nagaland health care establishments act, 19976the orissa clinical establishments (control and regulation) act, 19907the punjab state nursing home registration act, 19918the 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 negligence2 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 judiciary3 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 resolutions4 the salient features of the proposed legislation, inter alia, are as follows:—(i) the proposed legislation provides for the constitution of a national council consisting of representatives of the dental council of india, the nursing council of india, the pharmacy council of india, the indian medicines representing the ayurveda, siddha, unani and homoeopathy systems, the indian medical associations, the bureau of indian standards, the zonal councils set up under the states reorganisation act, 1956, the north eastern council, etc;(ii) the function of the national council shall be to determine the standards for clinical establishments, 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 concerned state government shall designate the director of health services or any other officer subordinate to him as the registrar of clinical establishments the state registrar of clinical establishments shall compile and update the state  register of clinical establishments and further send the same in digital format for updating the national register;(iv) the concerned state government shall, by notification, designate the district health officer or the chief medical officer as district registering authority for registration of clinical establishments;(v) no person shall carry on a clinical establishment unless it has been registered in accordance with the provisions of the proposed bill the legislation would not apply to the clinical establishments of the armed forces;(vi) it is proposed that clinical establishments already in existence may be allowed for provisional registration to carry out their business there shall be no prior enquiry for provisional registration but the authority shall have power to make enquiry in accordance with such rules as may be prescribed;(vii) the clinical establishment having provisional registration shall fulfil the standards which may be notified for the purpose the provisional certificate shall not be granted or renewed beyond a period of three years from the date of notification of standards;(viii) any clinical establishment may apply for permanent registration in such form and shall pay such fee as may be prescribed by the state government a detailed procedure for permanent registration is being provided in the proposed legislation;(ix) the authority shall have power to cancel the registration of the clinical establishment which fails to comply with the conditions prescribed by the central government the authority shall have power to inspect a registered clinical establishment any person aggrieved by an order of the registering authority shall prefer an appeal to the state government;(x) there shall be register of clinical establishments at the district level, state level and the national level;(xi) 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 5 legislation in respect of "public health and sanitation, hospitals and dispensaries"are relatable to entry 6 of list ii-state list in the seventh schedule to the constitution and parliament has no power to make a law in the state (apart from the provisions of 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 territories6 the bill seeks to achieve the above objective new delhi;the 7th august, 2007anbumani ramadoss ———— president's recommendation under article 117 of the constitution of india[copy of  letter no z28015/48/2000-h, dated the 22nd august, 2007 from dr anbumani ramadoss, 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, 2007 recommends to house the consideration of  the bill under article 117(3) of the constitution notes on clausesclause 1—this clause provides for the short title of the proposed legislation, its extent and commencement the proposed legislation shall first come into force at once in the states of arunachal pradesh, himachal pradesh, mizoram and sikkim which have already passed resolutions under article 252 of the constitution and the union territories and also in any other state which may adopt the act by a resolution as aforesaid different dates may be appointed for different categories of clinical establishments and for different recognised system of medicine to come into forceclause 2—this clause seeks to define certain expressions used in the bill the definitions of the terms - "authority", "certificate", "clinical establishment", "national council", "notification", "prescribed", "recognised system of medicine", "register" "registration", "rules", "schedule", "standards" and "state government" are given in the clauseclause 3—this clause provides for establishment of a council to be called the national council consisting of the director general of health services who shall be the chairperson and one representative each of the (i) dental council of india, (ii) medical council of india, (iii) nursing council of india, (iv) pharmacy council of india, (v) ayurveda, (vi) siddha, (vii) unani, (viii) homoeopathy, (ix) indian medical association, (x) bureau of the indian standards, (xi) line of paramedical and two representatives each of the (i) zonal councils and (ii) north eastern councilclause 4—this clause provides for the disqualifications for appointment of a person as a member of the national council if he—(a) has been convicted and sentenced to imprisonment for an offence which, in the opinion of the central government, involves moral turpitude; or(b) is an undischarged insolvent; or (c) is of unsound mind and stands so declared by a competent court; or (d) has been removed or dismissed from the service of the government or a corporation owned or controlled by the government; or(e) has, in the opinion of the central government, such financial or other interest in the council as is likely to affect prejudicially the discharge by him of his functions as a member clause 5—this clause seeks to specify the functions of the national council clause 6—this clause empowers the national council to seek advice or assistance of any person or body while carrying out any of the provisions of this actclause 7—this clause provides that the national council shall follow a consultative process for determining the standards and classification of clinical establishmentsclause 8—this clause provides that every state shall designate the director of health services (by whatever name called) or any other officer subordinate to him as the registrar of clinical establishmentsclause 9—this clause seeks to provide the responsibility of the registrar of clinical establishments to collect and update the state register of clinical establishmentsclause 10—this clause provides that every state shall designate the district health officer or the chief medical officer (by whatever name called) as the district registering authority for each district for registration of clinical establishmentsclause 11—this clause provides that no person shall carry on a clinical establishments unless it has been duly registered in accordance with the provisions of this actclause 12—this clause provides that every clinical establishment shall fulfil—(i) the minimum standards of facilities and services as may be prescribed; (ii) the minimum qualifications for the personnel as may be prescribed; (iii) provisions for maintenance of records and reporting as may be prescribed; (iv) such other conditions as may be prescribedclause 13—this clause provides for classification of clinical establishments into different categories and their standardsclause 14—this clause provides for application for provisional certificate of registration for clinical establishmentsclause 15—this clause provides for a time-limit within which provisional certificate for clinical establishment is to be issuedclause 16—this clause provides for conditions for issuing provisional registration for clinical establishmentclause 17—this clause provides for the validity of provisional registration for clinical establishmentclause 18—this clause provides that every clinical establishment should display the certificate of registration in a conspicuous place in the clinical establishmentclause 19—this clause seeks to provide for issuing duplicate certificate on the request of the clinical establishments and on the payment of requisite fees if the certificate is lost, destroyed, mutilated or damagedclause 20—this clause provides that the certificate of registration shall be nontransferable and in case of change of ownership, category, management or ceasing to function as clinical establishment the certificate shall be surrendered to the authorityclause 21—this clause provides for publication of expiry of registration by the registering authorityclause 22—this clause provides for application for renewal of registration and procedure thereforclause 23—this clause provides that a provisional certificate shall not be granted or renewed beyond a period of three years where the clinical establishments in respect of which standards have been notifiedclause 24—this clause provides for application for permanent registration for clinical establishmentsclause 25—this clause provides for verification of applications for registration of clinical establishmentsclause 26—this clause provides for display of information for filing objections, if any, within a stipulated timeclause 27—this clause provides for communication of objections received by the authority to the clinical establishmentsclause 28—this clause provides that registration shall be granted only when a clinical establishment fulfils the standards for grant of permanent registrationclause 29—this clause provides for time-limit of allowing or disallowing of registration for clinical establishmentsclause 30—this clause provides for issuing certificate of permanent registration if the application for registration of clinical establishment is allowedclause 31—this clause provides for applying fresh applications by clinical establishments for permanent registration if the earlier application for permanent registration is disallowedclause 32—this clause provides for issuing a show cause notice for cancellation of registration if—(a) the conditions of the registration are not being complied with; or (b) the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under this act clause 33—this clause provides for inspection of registered clinical establishments by the registering authority or an officer authorised by it and intimating the inspection report to the clinical establishmentclause 34—this clause provides that the registering authority or an officer authorised by it may enter and search any clinical establishment suspecting of not being registered under the provisions of this actclause 35—this clause provides for fees to be charged from the clinical establishments by the registering authority and remittance of its two per cent to the national councilclause 36—this clause provides for an appeal to the state government by any person aggrieved by an order of the registering authorityclause 37—this clause provides for maintenance of registers of clinical establishments in digital formats by the registering authorityclause 38—this clause provides that every state shall maintain register of clinical establishments in digital or in such other form and supply of information to central governmentclause 39—this clause provides for maintenance of national register for clinical establishments in digital format by the central governmentclause 40—this clause provides for penalty for contravention of any of the provisions of this actclause 41—this clause provides for penalty for non-registration of clinical establishments and also to any person who serves in such clinical establishmentclause 42—this clause provides for penalty for disobeying any direction given by any person or authority empowered under this act and any person who withholds any information is required by or under this actclause 43—this clause provides for penalty for contravention of any provision of this act 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 timeclause 44—this clause provides for fixing responsibility for contravention of any of the provisions of this act by companiesclause 45—this clause provides for punishment of offences committed by government departmentclause 46—this clause provides for recovery of fines imposed under the act as an arrear of land revenueclause 47—this clause protects any authority or any member of the national council or any officer authorised in this behalf of having taken actions in good faithclause 48—this clause provides that every clinical establishment should furnish such returns or the statistics and other information as may be prescribed by the state governmentclause 49—this clause empowers the authority to issue directions regarding furnishing returns, statistics and any other information for the proper functioning of the clinical establishmentclause 50—this clause provides that every employee of the authority and the national council shall be public servants within the meaning of section 21 of the indian penal codeclause 51—this clause empowers the central government to issue orders published in the official gazette making such provisions not inconsistent with the provisions of the proposed legislation for removing difficulties in giving effect to its provisions such orders could be issued within two years from the date of commencement of the proposed legislation it also provides for laying of such orders before each house of parliamentclause 52—this clause empowers the central government to make rules for carrying out the provisions of the proposed legislationclause 53—this clause provides that every rule made by the central government under this act shall be published in the official gazette and be laid before each house of parliamentclause 54—this clause confers powers on the state government to make rules for carrying out any of the provisions of the proposed legislation which do not fall within the purview of section 52clause 55—this clause provides that every rule made by the state government shall be published in the official gazette of the state and be laid before the state legislatureclause 56—this clause seeks to empower the central government to amend the schedule to the act as per legislative competence of parliament financial  memorandumclause 3 of the bill empowers the central government to establish a national council for clinical establishments it provides for allowance for the member 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 governments 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 annum will be to the tune of rs 60 lakhs memorandum regarding delegated legislationclause 51 of the bill 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 president2 clause 52 of the bill empowers the central government to make rules for carrying out various provisions of the bill and regarding—(a) allowances for the members of the national council under sub-section (5) of section 3;(b) the determination of standards and for classification of clinical establishmentsunder section 7;(c) classification of clinical establishment under sub-section (1) of section 13;(d) the different standards for classification of clinical establishments undersub-section (2) of section 13;(e) the minimum standards for permanent registration under section 28;(f) the form and particulars to be contained in the register to be maintained undersection 383 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 conditions for registration under section 12; (b) the proforma and the fee to be paid for registration of clinical establishmentunder sub-section (1) of section 14;(c) the form and details of application under sub-section (3) of section 14;(d) the particulars and information contained in certificate of provisionalregistration under section 15;(e) the manner of publication of all particulars of the clinical establishment proposed to be registered under  sub-section (2) of section 16;(f) the fees to be paid to issue a duplicate certificate under section 19; (g) the manner in which the authority shall publish the names of the clinical establishments whose registration would be expiring under section 21;(h) the enhanced fees to be charged for renewal after expiry of provisional registration under section 22;(i) the form of the application and fees to be charged by the state government under section 24;(j) the manner of submitting evidence of the clinical establishments having complied with the minimum standards under section 25;(k) the manner of displaying information of the clinical establishments having complied with the minimum standards for filing objection under section 26;(l) the period within which the objections to be communicated to the clinical establishments under section 27;(m) the expiry of period specified in section 29; (n) the form and the particulars of the certificate of registration under section 30; (o) the manner of entry and inspection of clinical establishment undersection 34;(p) the fees to be charged by the state government for different categories of clinical establishments under sub-section (1) of section 35;(q) the manner and the period within which an appeal may be preferred to the state government under sub-section (1) of section 36;(r) the form and the fee to be paid for an appeal under sub-section (2) of section36;(s) the form and the manner in which the register to be maintained under subsection (1) of section 37;(t) the manner of supply to the state registrar in digital format the entry made in the register of clinical establishments under sub-section (2) of section 37;(u) the manner and the period within which the information is to be furnished under section 48;(v) any other matter which is required to be or may be prescribed by the state government 4 the matters with respect to which rules may be made under the aforesaid provisions are procedure and detail and it is not possible to provide for them in the bill itself the delegation of legislative power is, therefore, of a normal character———— a billto provide for the registration and regulation of clinical establishments in the country and for matters connected therewith or incidental thereto————(shri anbumani ramadoss, minister of  health and family welfare)mgipmrnd—3355ls(s1)—22-08-2007