The Haryana Clinical Establishments (Registration and Regulation) Act, 2014

THE HARYANA CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2014 (HARYANA ACT NO. 6 OF 2014) Table of Contents Sections:

(1) This Act may be called the Haryana Clinical Establishments (Registration and Regulation) Act, 2014. (2) It shall apply to all the clinical establishments in the State of Haryana. (3) It shall come into force on such date, as the State Government may, by notification, appoint: Provided that different dates may be appointed for different categories of clinical establishments and for different recognized systems of medicines.

In this Act, unless the context otherwise requires,∶ (a) “Appellate Authority for Clinical Establishment” means the authority referred in section 10, to hear appeals against the orders of the State Authority for Clinical Establishment; (b) "clinical establishment" means— (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called, that offers services, facilities for diagnosis, treatment or care for illness, injury, deformity, abnormality, pregnancy or dental care in any recognized system of medicine established, administered or maintained by any person or body of persons, whether incorporated or not; or (ii) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of a disease, 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 and which is established, administered or maintained by a person or body of persons, whether incorporated or not, and shall include a clinical establishment owned, controlled or managed by– (I) the State Government; (II) a trust, whether public or private; (III) a company/corporation (including a society) registered under a Central or State Act, whether or not owned by the Central or State Government; (IV) a local authority; or (V) single or more doctors, but shall not include 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 (Central Act 46 of 1950) , the Air Force Act, 1950 (Central Act 45 of 1950) and the Navy Act, 1957 (Central Act 62 of 1957); (c) “certificate” means a provisional registration certificate issued under section 17 or a permanent certificate issued under section 26, as the case may be; (d) “District Authority for Clinical Establishment” means an authority constituted under section 13; (e) “emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) of such magnitude wherein the absence of immediate medical attention could reasonably be expected to result in– (i) placing the health of an individual or, with respect to a pregnant woman, the health of the woman or her unborn child, in serious jeopardy; or (ii) serious impairment of bodily functions; or (iii) serious dysfunction of any organ or part of the body; (f) "Indian Medicine" means the system of Indian Medicine commonly known as Ayurvedic System and Unani System supplemented or not by such modern advancements, as may be declared under the Punjab Ayurvedic and Unani Practitioners Act, 1963 (Punjab Act 42 of 1963); (g) "prescribed" means prescribed by the rules made under this Act; (h) "recognized system of medicine" means Allopathy, Yoga, Naturopathy, Homeopathy or Indian Medicine or any other system of medicine, as may be notified by the Central Government; (i) "register" means a register maintained under this Act containing the number of different kinds of clinical establishments under different recognized systems of medicines; (j) "registration" means to register under section 17 or 26 and the expression registration or registered shall be construed accordingly; (k) “State Authority for Clinical Establishments” means an authority constituted under section 11; (l) “State Council” means the State Council for Clinical Establishments constituted under section 3; (m) "State Government” means the Government of the State of Haryana; (n) “standards" means such conditions, as may be prescribed for the registration and regulation of various kinds of clinical establishments; (o) "to stabilize” (with its grammatical variations and cognate expressions) with respect to an emergency medical condition specified in clause (e) means to provide such medical treatment/First–Aid as per the best available resources in a clinical establishment with indoor facility and if so required, refer the individual to a suitable clinical establishment.

(1) The State Government shall, by notification, constitute for the purposes of this Act, a council to be called the State Council for Clinical Establishments. (2) The State Council shall consist of the following members, namely:– (i) Secretary, Health Department – Chairperson (ii) Director General, Health Services – Member Secretary (iii) one officer, not below the rank of Director, Health Services – Member (iv) Deputy Director (Policy Matters) – Member (v) Director General Ayush or his representative not below the rank of Assistant Director – Member (vi) one representative each from the – (a) Haryana Medical Council; (b) Haryana State Dental Council; (c) State Nursing Council Haryana; (d) Haryana State Pharmacy Council; (vii) one representative from the Indian Medical Association (Haryana State); (viii) two representatives from reputed non–Governmental organizations working in the field of health, to be nominated by the State Government. (3) The nominated members shall hold office for a term of three years and shall be eligible for re–nomination for one more term of three years. (4) The State Council may perform its functions notwithstanding any vacancy therein.

A person shall be disqualified for being nominated as a member of the State Council, if he– (a) has been convicted and sentenced to imprisonment for an offence which, in the opinion of the State Government, involves moral turpitude; or (b) is an undischarged insolvent; or (c) is of unsound mind; or (d) has been removed or dismissed from the service of the Central Government or the State Government or a corporation or council or board owned or controlled by the Central Government or the State Government; or (e) has, in the opinion of the State Government, such financial or other interest in the State Council, as is likely to prejudicially affect in discharge of his functions as a member.

The State Council shall perform the following functions, namely:– (a) compiling and updating the register; (b) hearing complaints; (c) determine within a period of two years from its constitution, the standards to be maintained by the clinical establishments and supervise their implementation; (d) collect the statistics in respect of clinical establishments; (e) lay down guidelines, procedures and functions for the State Authority for Clinical Establishments and the District Authority for Clinical Establishment; (f) lay down guidelines, standards, procedures etc. for different diseases under different recognised systems of medicines; and (g) any other function, as determined by the State Government, from time to time.

The non-official members of the State Council shall be entitled to such allowances, as may be prescribed.

The State Council shall frame bye–laws for regulating the procedure for the conduct of its business.

The State Council shall meet at least once in three months.

The State Council may, with the approval of the State Government, constitute sub-committees for the consideration of particular matter; and may appoint to such sub-committees, persons from relevant fields, as it deems fit, who are not members of the State Council, for a period not exceeding two years.

(1) There shall be an Appellate Authority for Clinical Establishments to hear the appeals against the orders of the State Authority for Clinical Establishment consisting of the following members, namely:– (i) Secretary, Health Department – Chairperson (ii) Director General, Health Services – Member Secretary (iii) Additional Legal Rememrbancer– – Member Cum-Special Secretary, Law and Legislative Department, Haryana (2) The Appellate Authority may, if it so desires, take the assistance of a subject specialist or professional or seek his advice on the matter in issue.

(1) The State Government shall, by notification constitute an authority to be called the State Authority for Clinical Establishment for permanent registration of the clinical establishments, to hear the appeals relating to refusal to grant or renew the provisional registration by the District Authority for Clinical Establishment, to entertain complaints and to perform any other duties, as may be assigned. (2) The State Authority for Clinical Establishment shall consist of the following members, namely:– (i) Additional Director General, Health Services – Chairman (ii) Director, Health Services (Lab) – Convener (iii) One representative of Director, Health Services(Dental) – Member (iv) One Doctor from Ayush Department – Member (v) One representative from the Indian Medical Association, Haryana – Member

The State Council or the State Authority for Clinical Establishment may, if it so desires, associate or seek advice from any person or body for carrying out any of the provisions of this Act.

(1) The State Government shall, by order, constitute an authority to be called the District Authority for Clinical Establishment for each district for provisional registration of clinical establishments. (2) The District Authority for Clinical Establishment shall consist of the following members, namely:– (a) Civil Surgeon – Chairperson (b) Deputy Civil Surgeon – Convener (be nominated rotation wise by the Chairperson) (c) one representative of the Deputy Commissioner – Member (d) one representative of Indian Medical Association, Haryana District Branch of the concerned District – Member (e) one Senior Dental Surgeon from District Government Hospital – Member (f) District Ayush officer or his representative – Member

(1) No person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of this Act. (2) Every clinical establishment existing prior to commencement of this Act, shall make an application for its provisional registration within six months from the date of the commencement of this Act. (3) Notwithstanding that a clinical establishment is already registered under any existing law requiring registration of such establishment, it shall apply for provisional registration under sub-section (2).

(1) Clinical establishments of different recognized systems of medicines shall be classified into such categories, as may be specified by the State Government, from time to time. (2) The State Government may prescribe different standards for different categories of clinical establishments.

(1) For the purposes of provisional registration of the clinical establishment, an application in such form alongwith such particulars and fee, as may be prescribed, shall be made to the District Authority for Clinical Establishment. (2) The application may be filed in person or by post or online. (3) If a clinical establishment has branches at different locations, then each branch shall apply separately for registration.

The District Authority for Clinical Establishment may, within a period of fifteen days from the date of receipt of such application, after verification of documents, grant to the applicant a provisional registration certificate in such form, containing such particulars and information, as may be prescribed.

No inspection of the clinical establishment, its building, laboratories, equipments etc. shall be conducted prior to grant of the provisional registration certificate.

Subject to the provisions of section 20, every provisional registration certificate shall be valid upto the last day of the twenty-fourth month from the date of its issue and such registration shall be renewable.

Where the clinical establishments in respect of which standards have been notified, provisional registration certificate shall not be granted or renewed beyond,– (i) the period of two years from the date of notification of the standards for clinical establishments which came into existence before such notification; and (ii) the period of one year from the date of notification of standards for clinical establishments which came into existence after such notification.

An application for permanent registration certificate by a clinical establishment shall be made to the State Authority for Clinical Establishment in such form and manner and shall be accompanied by such fee, as may be prescribed.

(1) Every clinical establishment shall fulfill the following conditions for permanent registration- (i) minimum standards of facilities and services; (ii) minimum requirement of personnel; (iii) provisions for maintenance of records; and (iv) such other conditions, as may be prescribed. (2) The clinical establishment with indoor facility shall provide within the available staff and facilities, such medical examination and treatment/First-Aid as per best available resources and as per the standards prescribed for said clinical establishment, as may be required for the emergency medical condition of any individual who comes or is brought to such a clinical establishment to stabilize such person.

The clinical establishment shall submit an undertaking alongwith evidence of having been complied with the standards, in such manner, as may be prescribed.

The State Authority for Clinical Establishment shall, within such period, as may be prescribed, pass an order– (a) granting the certificate in such form and manner, as may be prescribed; or (b) disallowing the application for grant of certificate: Provided that in case the application is disallowed, the State Authority for Clinical Establishment shall record the reasons for doing so.

The disallowing of an application for permanent registration certificate shall not debar a clinical establishment from applying afresh for permanent registration certificate, after providing such evidence, as may be required, of having rectified the deficiencies due to which the earlier application was disallowed.

Permanent registration certificate shall be granted by the State Authority for Clinical Establishment only after satisfying itself that such clinical establishment fulfils the prescribed standards and conditions required for granting permanent registration certificate.

(1) The permanent registration shall be valid for a period of seven years from the date of its issue. (2) The application for renewal of permanent registration certificate shall be made within six months before the expiry of the validity of the certificate alongwith such fee, as may be prescribed and in case the application of renewal is not submitted within the stipulated period, the State Authority for Clinical Establishment may allow renewal of registration on payment of such enhanced fee, as may be prescribed.

The State Government may prescribe different fee for registration of different categories of clinical establishments.

The certificate shall be affixed in a conspicuous place in the clinical establishment in such manner so as to be visible to everyone visiting such establishment.

In case the certificate is lost, destroyed, mutilated or damaged, the concerned authority shall issue a duplicate certificate on the request of the clinical establishment, on payment of such fee, as may be prescribed.

(1) The certificate of registration shall be non-transferable. (2) In the event of change of ownership or management, the transferor and transferee of clinical establishment shall inform the concerned issuing authority, of such change, in such manner, as may be prescribed. (3) In the event of change of category, the clinical establishment shall surrender the certificate in original and apply afresh for grant of certificate of registration alongwith such fee, as may be prescribed.

(1) The District Authority for Clinical Establishment shall compile and maintain in such format, as may be prescribed, a register of clinical establishments, provisionally registered by it and shall enter the particulars of the certificate so issued, in such form and manner, as may be prescribed.

(2) The District Authority for Clinical Establishment shall supply to the State Authority for Clinical Establishment a copy of every entry including all additions and amendment made in the register during the preceeding month by seventh day of the following month to ensure that the register is updated with the registers maintained by the State Authority for Clinical Establishment.

(1) The State Authority for Clinical Establishment shall maintain in such form and containing such particulars, as may be prescribed, a register of clinical establishments registered in the State.

(2) The State Authority for Clinical Establishment shall supply in such format, as may be prescribed, a copy of the register to the State Council and shall inform the State Council of all additions and other amendments made in such register on monthly basis.

(1) The State Authority for Clinical Establishment or the concerned District Authority for Clinical Establishment or any officer duly authorised by it shall have the right to cause an inspection of, or inquiry in respect of any registered clinical establishment, its building, laboratories, equipments etc. as also of the work conducted or done by the clinical establishment, as it may direct and to cause an inquiry to be made in respect of any other matter connected with the clinical establishment and the establishment shall be entitled to be represented therein.

(2) The State Authority for Clinical Establishment or the concerned District Authority for Clinical Establishment or an officer duly authorized by it shall give forty-eight hours notice prior to inspection of the registered clinical establishment. The inspection shall be carried out during the office hours.

(3) The State Authority for Clinical Establishment or the concerned District Authority for Clinical Establishment shall communicate to the clinical establishment its views with reference to the outcome of such inspection or inquiry and may, after obtaining the opinion of the clinical establishment thereon, advise the clinical establishment on the action to be taken.

(4) The clinical establishment shall report to the concerned authority regarding the action, if any, which is proposed to be taken or has been taken in pursuance to the results of such inspection or inquiry and such report, shall be furnished within such time, as the concerned authority may direct.

(5) Where the clinical establishment does not, within a reasonable time, take action to the satisfaction of the concerned authority, it may, after considering any explanation furnished or representation made by the clinical establishment, issue such directions and the clinical establishment shall comply with such directions, within such time as indicated therein.

(1) If, on a complaint or otherwise, at any time after any clinical establishment has been registered, the State Authority for Clinical Establishment or the concerned District Authority for Clinical Establishment is satisfied that,– (a) the conditions of the registration are not being complied with; or (b) there is such grave contravention of any of the standards or the provisions of this Act or the rules made thereunder; as may be prescribed, it may issue a notice to the clinical establishment to show cause, within a period of one month, as to why its certificate may not be cancelled for the reasons mentioned in the notice.

(2) If after giving a reasonable opportunity to the clinical establishment, the District Authority for Clinical Establishment is satisfied that there has been a breach of any of the provisions of this Act or the rules made thereunder, it may recommend cancellation of its registration to the State Authority for Clinical Establishment.

(3) The State Authority for Clinical Establishment shall on a complaint or otherwise or in the cases referred to in sub–section (2), if satisfied, may cancel the registration after giving an opportunity of hearing to the concerned clinical establishment.

(4) Every order made under sub–section (3) shall take effect– (a) where no appeal has been preferred against such order then immediately on the expiry of the period prescribed for such appeal; and (b) where such appeal has been preferred and it has been dismissed then from the date of the order of such dismissal: Provided that the State Authority for Clinical Establishment, after cancellation of the registration for reasons to be recorded in writing, may immediately restrain the clinical establishment to continue as such, if there is an imminent danger to the health and safety of patients.

(1) The State Authority for Clinical Establishment or the concerned District Authority for Clinical Establishment or an officer authoried by it may, if there is any reason to suspect that anyone is carrying on a clinical establishment without registration or after cancellation of registration or after restrain orders under the proviso to sub-section (4) of section 35 or on complaint or otherwise, enter and search in such manner, as may be prescribed to cause an inquiry to be made in respect of such matter or any other matter connected with that clinical establishment at any reasonable time and the clinical establishment shall, offer reasonable facilities for inspection or inquiry and shall be entitled to be represented thereat.

(2) If after enquiry by the State Authority for Clinical Establishment or on report of the District Authority for Clinical Establishment or an officer authorized in this behalf, the State Authority for Clinical Establishment is satisfied that the said clinical establishment is unregistered or carrying on after cancellation of registration or after passing restrain orders, it shall pass orders for immediate closure of such clinical establishment alongwith a fine which may extend to fifty thousand rupees.

(3) Any person who continues to run a clinical establishment after the order of closure under sub-section (2), shall be punished with simple imprisonment for a term which may extend to two years and with fine which may extend to five lac rupees.

(1) The State Government may prescribe such contraventions and fine thereof, not exceeding five lac rupees, for which no fine has been provided in the Act.

(2) Whoever knowingly serves in a clinical establishment not duly registered under this Act, shall be punished with fine which may extend upto one month’s gross salary or Rs. 25,000, whichever is less.

(3) Whoever wilfully disobeys any direction lawfully given by any person or authority empowered under this Act to give such direction, shall be punished with fine which may extend to one lac rupees.

(4) Whoever being required by or under this Act to supply any information, willfully withholds such information or gives information which he knows to be false or which he does not believe to be true, shall be punished with fine which may extend to two lac rupees and shall also be liable to be prosecuted under the Indian Penal Code, 1860 (Central Act 45 of 1860).

(5) For the purpose of adjudging under sub–sections (3) and (4), the State Authority for Clinical Establishment shall hold an inquiry in the prescribed manner after giving the person concerned a reasonable opportunity of being heard for the purpose of imposing any fine.

(6) While holding an inquiry, the State Authority for Clinical Establishments 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

Save as otherwise provided, the State Authority for Clinical Establishment shall be the competent authority to impose the fine.

On the failure to pay the fine, the State Authority for Clinical Establishment shall prepare a certificate signed by an officer authorized 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 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 in accordance with the provisions of the Punjab Land Revenue Act, 1887 (Punjab Act 17 of 1887), as if it were an arrear of land revenue.

(1) Any person aggrieved by an order of the District Authority for Clinical Establishment refusing to grant or renew a provisional registration certificate may prefer an appeal to the State Authority for Clinical Establishments.

(2) Any person aggrieved by an order under sub–section (1) passed by the State Authority for Clinical Establishment may file an appeal to the Appellate Authority for Clinical Establishments.

(3) Any person aggrieved by an order of the State Authority for Clinical Establishment refusing to grant or renew a certificate of permanent registration or cancellation of a certificate of provisional or permanent registration or closure of a clinical establishment may prefer an appeal to the Appellate Authority for Clinical Establishment.

(4) Every appeal under sub–sections (1), (2) or (3) shall be made within such period, in such form and accompanied by such fee, as may be prescribed.

(5) The Appellate Authority for Clinical Establishments or State Authority for Clinical Establishment 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.

(6) The decision of the Appellate Authority for Clinical Establishments shall be final.

(1) No court shall take cognizance of an offence under this Act except on a complaint made by the State Authority for Clinical Establishment or an officer authorized in this behalf by the State Authority for Clinical Establishment, as the case may be.

(2) An offence under this Act shall be triable by a Judicial Magistrate First Class.

No suit, prosecution or other legal proceedings shall lie against any authority or any member of such authority or any officer authorised in this behalf, in respect of anything, which is done in good faith or intended to be done in pursuance of the provisions of this Act or any rule made thereunder.

Without prejudice to the foregoing provisions of this Act, the State Authority for Clinical Establishment shall have the power to issue directions to the clinical establishments regarding furnishing returns, statistics or any other information to it or the District Authority for Clinical Establishment, as it may require.

Every clinical establishment shall, within such time or within such extended time, furnish to the concerned District Authority for Clinical Establishment or State Authority for Clinical Establishment, such returns or the statistics and other information in such manner, as may be prescribed.

Every member of the State Council, the State Authority for Clinical Establishment and the District Authority for Clinical Establishment, shall be deemed to be public servant within the meaning of section 21 of the Indian Penal Code, 1860 (45 of 1860), while acting or purporting to act in pursuance of any of the provisions of this Act.

For the purpose of proceedings under this Act, the Appellate Authority for Clinical Establishments, the State Authority for Clinical Establishment and the District Authority for Clinical Establishment shall have all the powers of a Civil Court under the Code of Civil Procedure, 1908 (Central Act 5 of 1908), in respect of the following matters, namely:– (a) summoning and enforcing attendance of any person and examining him on oath; (b) requiring the discovery and production of any document or any other material which is produceable as evidence; (c) requisitioning any public record or copy thereof from any court or office; (d) issuing commissions for the examination of witnesses or documents; (e) such other matters, as may be prescribed.

No Civil Court shall have the jurisdiction to entertain or proceed with a suit, settle, decide or deal with any matter which under this Act, is required to be settled, decided or dealt with by an authority under this Act.

If any difficulty arises in giving effect to the provisions of this Act, the State 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.

(1) The State Government may, by notification, make rules for carrying out the purposes of this Act. (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 form to be filed alongwith details of application and the fee to be paid for provisional registration; (b) the form to be filed alongwith details of application and fee to be paid for permanent registration; (c) the particulars and information contained in certificate of provisional registration; (d) the particulars and information contained in certificate of permanent registration; (e) the fees to be paid to issue a duplicate certificate; (f) the change of ownership or management to be informed by the clinical establishment to the authority; (g) the fee to be paid for renewal of provisional registration certificate; (h) the enhanced fee to be charged for renewal after expiry of the provisional registration certificate; (i) the fee to be paid for renewal of permanent registration certificate; (j) the enhanced fees to be charged for renewal after expiry of the permanent registration; (k) the manner of submitting evidence by the clinical establishments having complied with the standards; (l) different fee for registration for different categories of clinical establishments; (m) the manner of entry and search of clinical establishment; (n) the form, fee, manner and the period within which an appeal may be preferred before different authorities; (o) the form and the manner for maintaining the register; (p) the manner of holding an inquiry; (q) the manner and the time within which the returns and information is to be furnished; (r) allowances for non–official members; (s) the determination of standards for clinical establishments; (t) maintenance of records and reporting; (u) the powers of civil court; (v) any other matter which is required to be or may be prescribed. (3) Every rule made by the State Government under this section shall be laid, as soon as may be, after it is made, before the State Legislature.