Clinical Establishments (Registration and Regulation) Act, 2010

S.19 Duplicate certificate.

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

S.20 Certificate to be non-transferable.

(1) The certificate of registration shall be non-transferable.

(2) In the event of change of ownership or management, the clinical establishment shall inform the authority of such change in such manner as may be prescribed.

(3) In the event of change of category, or location, or on ceasing to function as a clinical establishment, the certificate of registration in respect of such clinical establishment shall be surrendered to the authority and the clinical establishment shall apply afresh for grant of certificate of registration.

S.21 Publication of expiry of registration.

The authority shall cause to be published within such time and in such manner, as may be prescribed, the names of clinical establishments whose registration has expired.

S.22 Renewal of registration.

The application for renewal of registration shall be made thirty days before the expiry of 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 prescribed.

S.23 Time limit for provisional registration.

Where the clinical establishments in respect of which standards have been notified by the Central Government, provisional registration shall not be granted or renewed beyond,--

(i) the period of two years from the date of notification of the standards in case of clinical establishments which came into existence before the commencement of this Act;

(ii) the period of two years from the date of notification of the standards for clinical establishments which come into existence after the commencement of this Act but before the notification of the standards; and

(iii) the period of six months from the date of notification of standards for clinical establishmen

S.24 Application for permanent registration.

Application for permanent registration by a clinical establishment shall be made to the authority in such form and be accompanied by such fees, as may be prescribed.

S.25 Verification of application.

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

S.26 Display of information for filing objections.

As soon as the clincial establishment submits the required evidence of having complied with the prescribed minimum standards, the authority shall cause to be displayed for information of the public at large and for filing objections, if any, in such manner, as may be prescribed, all evidence submitted by the clinical establishment of having complied with the prescribed minimum standards for a period of thirty days before processing for grant of permanent registration.

S.27 Communication of objections.

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 of forty-five days.

S.28 Standards for permanent registration.

Permanent registration shall be granted only when a clinical establishment fulfils the prescribed standards for registration by the Central Government.

S.29 Allowing or disallowing of registration.

The authority shall pass an order immediately after the expiry of the prescribed period and within the next thirty days thereafter either--

(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 registration.

S.30 Certificate of permanent registration.

(1) The authority shall, if it, allows an application of the clinical establishment, issue a certificate of permanent registration in such form and containing such particulars, as may be prescribed.

(2) The certificate shall be valid for a period of five years from the date of issue.

(3) For the purposes of sub-section (1), the provisions of sections 18, 19, 20 and 21 shall also apply.

(4) The applications for renewal of permanent registration shall be made within six months before the expiry of the validity of the certificate of permanent registration and, in case the application of renewal is not submitted within the stipulated period, the authority may allow renewal of registration on payment of such enhanced fees and penalties as may be prescribed.

S.31 Fresh application for permanent registration.

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 deficiences on which grounds the earlier application was disallowed.

S.32 Cancellation of registration.

(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 notice to the clinical establishment to show cause within three months' time as to why its registration under this Act should not be cancelled for the reasons to be mentioned in the notice.

(2) If after giving a reasonable opportunity to the clinical establishment, the authority is satisfied that there has been a breach of any of the provisions of thi

S.33 Inspection of registered clinical establishments.

(1) The authority or an officer authorised by it shall have the right to cause an inspection of, or inquiry in respect of any registered clinical establishment, its building, laboratories and equipment and also of the work conducted or done by the clinical establishment, to be made by such multi-member inspection team as it may direct and to cause an inquiry to be made in respect of any other matter connected with the clinical establishment and that establishment shall be entitled to be represented thereat.

(2) The authority shall communicate to the clinical establishment the views of that authority with reference to the results of such inspection or inquiry and may, after ascertaining the opinion of the clinical establishment thereon, advise that establishment upon the action to be taken.

(3) The clinical establishment shall rep

S.34 Power to enter.

The authority or an officer authorised by it may, if there is any reason to suspect that 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 giving notice of his intention to do so.

S.35 Levy of fee by State Government Appeal.

The State Government may charge fees for different categories of clinical establishments, as may be prescribed.

S.36 Appeal.

(1) Any person, aggrieved by an order of the registering authority refusing to grant or renew a certificate of registration or revoking a certificate of registration may, in such manner and within such period as may be prescribed, prefer an appeal to the State Council:

Provided that the State Council may entertain an appeal preferred after the expiry of the prescribed period if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in time.

(2) Every appeal under sub-section (1) shall be made in such form and be accompanied by such fee as may be prescribed.

S.37 Register of clinical establishments.

(1) The authority shall within a period of two years from its establishment, compile, publish and maintain in digital format a register of clinical establishments, registered by it and it 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 Government.

(2) Each authority, including any other authority set-up for the registration of clinical establishments under any other law for the time being in force, shall supply in digital format to the State Council of clinical establishments a copy of every entry made in the register of clinical establishments in such manner, as may be prescribed to ensure that the State Register is constantly up-to-date with the registers maintained by the registering authority in the State.

S.38 Maintenance of State Register of clinical establishments.

(1) Every State Government shall maintain in digital and in such form and containing such particulars, 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 State.

(2) Every State Government shall supply in digital format to the Central Government, a copy of the State Register of clinical establishments and shall inform the Central Government all additions to and other amendments in such register made, for a particular month by the 15th day of the following month.

S.39 Maintenance of National Register of clinical establishments.

The Central Government shall maintain in digital format an All India Register to be called as the National Register of clinical establishments that shall be an amalgam of the State Register of clinical establishments maintained by the State Governments and shall cause the same to be published in digital format.

S.40 Penalty.

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 rupees.

S.41 Monetary penalty for non-registration.

(1) Whoever carries on a clinical establishment without registration shall, on first contravention, be liable to a monetary penalty up to fifty thousand rupees, for second contravention with a monetary penalty which may extend to two lakh rupees and for any subsequent contravention with a monetary penalty which may extend to five lakh rupees.

(2) Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall be liable to a monetary penalty which may extend to twenty-five thousand rupees.

(3) For the purpose of adjudging under sub-sections (1) and (2), the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportunity of being heard for the purpose of imposing any monetary penalty.

(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 liable to a monetary penalty 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 liable to a monetary penalty which may extend to five lakh rupees.

(3) For the purpose of adjudging under sub-sections (1) and (2), the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportunity

S.43 Penalty for minor deficiencies.

Whoever contravenes any provision of this Act or any rule made thereunder resulting in deficiencies that do not pose any imminent danger to the health and safety of any patient and can be rectified within a reasonable time, shall be punishable with fine which may extend to ten thousand rupees.

S.44 Contravention by companies.

(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 t

S.45 Offences by Government Departments.

(1) Where an offence under this Act has been committed by any Department of Government within a period of six months after the commencement of this Act, the Head of the Department shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this section shall render such Head of the Department 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

S.46 Recovery of fine.

Whoever fails to pay the fine, the State Council of clinical establishment may prepare a certificate signed by an officer authorised by it specifying the fine due from such person and send it to the Collector of the District in which such person owns any property 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.

S.47 Protection of action taken in good faith.

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

(2) No suit or other legal proceedings shall lie against a State Government or the Central Government in respect of any loss or damage caused or likely to be caused by anything which is in good faith done or intended to be done in pursuance of the provisions of this Act or any rule made thereunder.

S.48 Furnishing of returns, etc.

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 Council or the National Council such returns or the statistics and other information in such manner, as may be prescribed by the State Government, from time to time.

S.49 Power to give directions.

Without prejudice to the foregoing provisions of this Act, the authority shall have the power to issue such directions, including furnishing returns, statistics and other information for the proper functioning of clinical establishments and such directions shall be binding.

S.50 Employees of the authority, etc., to be public servants.

Every employee of the authority, the National Council and the State 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 Code (45 of 1860).

S.51 Power to remove difficulties.

(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 Parliament.

S.52 Power of Central Government to make rules.

(1) The Central Government may, by notification, make rules for carrying out all or any of the provisions 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) allowances for the members of the National Council under sub-section (5) of section 3;

(b) appointment of such person to be the Secretary of the State Council by the Central Government under sub-section (10) of section 3;

S.53 Laying of rules.

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 rule.

S.54 Power of State Government to make rules.

(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 52.

(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 proforma and the fee to be paid for registration under sub-section (1) of section 14;

(b) the form and details of application under sub-section (3) of section 14;

S.55 Laying of rules.

Every rule made by the State Government under this section shall be laid, as soon as may be after it is made, before each House of the State Legislature where it consists of two Houses, or where such Legislature consists of one House, before that House.

S.56 Savings.

(1) The provisions of this Act shall not apply to the States in which the enactments specified in the Schedule are applicable:

Provided that the States in which the enactments referred to in sub-section (1) are applicable, and such States subsequent to the commencement of this Act, adopts this Act under clause (1) of article 252 of the Constitution, the provisions of this Act shall, subsequent to such adoption, apply in that State.

(2) The Central Government may, as and when consider necessary, by notification amend the Schedule.

S.1 Short title, application and commencement.

(1) This Act may be called the Clinical Establishments (Registration and Regulation) Act, 2010.

(2) It applies, in the first instance, to the whole of the States of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim and the Union territories; and it shall apply to such other State which adopts 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 date¹ 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

S.2 Definitions.

In this Act, unless the context otherwise requires,--

(a) "authority" means the district registering authority set-up under section 10;

(b) "certificate" means certificate of registration issued under section 30;

(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of

S.3 Establishment of National Council.

(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 for clinical establishments.

(2) The National Council shall consist of--

(a) Director-General of Health Service, Ministry of Health and Family Welfare, ex officio, who shall be the Chairperson;

(b) four representatives out of which one each to be elected by the--

(i) Dental Council of India constituted under section 3 of the Dentists Act, 1948 (16 of 19

S.4 Disqualifications for appointment as member.

A person shall be disqualified for being appointed 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

(d) has been removed or dismissed from the service of the Government or a Corporation owned or controlled by the Government; or

The National Council shall--

(a) compile and publish a National Register of clinical establishments within two years from the date of the commencement of this Act;

(b) classify the clinical establishments into different categories;

(d) determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments;

(e) collect the

S.6 Power to seek advice or assistance.

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 Act.

S.7 National Council to follow consultative process.

The National Council shall follow a consultative process for determining the standards and for classification of clinical establishments in accordance with such procedure as may be prescribed.

S.9 Providing information to National Council.

It shall be the responsibility of the State Council for clinical establishments to compile and update the State Register of clinical establishments of the State and further to send monthly returns in digital format for updating the National Register.

S.10 Authority for registration.

(1) The State Government shall, by notification, set-up an authority to be called the district registering authority for each district for registration of clinical establishments, with the following members, namely:--

(a) District Collector-- Chairperson;

(b) District Health Officer--Convenor;

(c) three members with such qualifications and on such terms and conditions as may be prescribed by the Central Government.

(2) Notwithstanding anything contained in sub-section (1), for the purposes of provisional registration of clinical establishments under section 14, the District Health Officer o

S.11 Registration for clinical establishments.

No person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of this Act.

S.12 Condition for registration.

(1) For registration and continuation, every clinical establishment shall fulfil the following conditions, namely:--

(i) the minimum standards of facilities and services as may be prescribed;

(ii) the minimum requirement of personnel as may be prescribed;

(iii) provisions for maintenance of records and reporting as may be prescribed;

(iv) such other conditions as may be prescribed.

(2) The clinical establishment shall undertake to provide within the staff and facilities available, such medical examin

S.13 Classification of clinical establishments.

(1) Clinical establishment of different systems shall be classified into such categories, as may be prescribed by the Central Government, from time to time.

(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.

S.14 Application for provisional certificate of registration.

(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 made to the authority.

(2) The application shall be filed in person or by post or online.

(3) The application shall be made in such form and shall be accompanied by such details as may be prescribed under this Act or rules made thereunder.

(4) If any clinical establishment is in existence at the time 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 and a clinical establishment which comes into existence after commencement of this Act, shall apply for permanent registration within a period of six months from the da

S.15 Provisional certificate.

The authority shall, within a period of ten days from the date of receipt of such application, grant to the applicant a certificate of provisional registration in such form and containing such particulars and such information, as may be prescribed.

S.16 No inquiry prior to provisional registration.

(1) The authority shall not conduct any inquiry prior to the grant of provisional registration.

(2) Notwithstanding the grant of the provisional certificate of registration, the authority shall, within a period of forty-five days from the grant of provisional registration, cause to be published in such manner, as may be prescribed, all particulars of the clinical establishment so registered provisionally.

S.17 Validity of provisional registration.

Subject to the provisions of section 23, every provisional registration shall be valid to the last day of the twelfth month from the date of issue of the certificate of registration and such registration shall be renewable.

S.18 Display of certificate of registration.

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

S.8 State Council of clinical establishments.

(1) Every State Government shall by notification constitute a State Council for clinical establishments or the Union territory Council for clinical establishments, as the case may be.

(2) The State Council or the Union territory Council, as the case may be, shall consist of the following members, namely:--

(a) Secretary, Health--ex officio, who shall be the Chairman;

(b) Director of Health Services--ex officio member-secretary;