The Clinical Establishments (Registration and Regulation) Act, 2010
Administered Ministry: Ministry of Health and Family Welfare / Department of Health and Family Welfare
Section
Section 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 1[under section 40, sub-sections (1) and (2) of section 41 and section 43 and sub-sections (1) and (2) of section 44], the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportunity of being heard for the purpose of imposing any monetary penalty.
(4) While holding an inquiry the authority shall have power to summon and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence or to produce any document which in the opinion of the authority, may be useful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfied that the person has failed to comply with the provisions specified in sub-sections (1) and (2), it may by order impose the monetary penalty specified in those sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8) of section 42.
(5) While determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical establishment and local conditions of the area in which the establishment is situated.
(6) Any person aggrieved by the decision of the authority may prefer an appeal to the State Council within a period of three months from the date of the said decision.
(7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed.
(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 1[under section 40, sub-sections (1) and (2) of section 41 and section 43 and sub-sections (1) and (2) of section 44], the authority shall hold an inquiry in the prescribed manner after giving any person concerned a reasonable opportunity of being heard for the purpose of imposing any monetary penalty.
(4) While holding an inquiry the authority shall have power to summon and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence or to produce any document which in the opinion of the authority, may be useful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfied that the person has failed to comply with the provisions specified in sub-sections (1) and (2), it may by order impose the monetary penalty specified in those sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8) of section 42.
(5) While determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical establishment and local conditions of the area in which the establishment is situated.
(6) Any person aggrieved by the decision of the authority may prefer an appeal to the State Council within a period of three months from the date of the said decision.
(7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed.
2. Subs by Act 8 of 2026, s. 2 and sch., for "under sub-sections (1) and (2)" (w.e.f. 22.06.2026).
Section 42 Disobedience of direction, obstruction and refusal of information.
(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 of being heard for the purpose of imposing any monetary penalty.
(4) While holding an inquiry the authority shall have power to summon and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence or to produce any document which in the opinion of the authority, may be useful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfied that the person has failed to comply with the provisions specified in sub-sections (1) and (2), it may by order impose the monetary penalty specified in those sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8).
(5) While determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical establishment and local conditions of the area in which the establishment is situated.
(6) Any person aggrieved by the decision of the authority may prefer an appeal to the State Council within a period of three months from the date of the said decision.
(7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed.
(8) The monetary penalty levied under sections 41 and 42 shall be credited to such account as the State Government may by order specify in this behalf.
(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 of being heard for the purpose of imposing any monetary penalty.
(4) While holding an inquiry the authority shall have power to summon and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence or to produce any document which in the opinion of the authority, may be useful for or relevant to the subject matter of the inquiry and if, on such inquiry, it is satisfied that the person has failed to comply with the provisions specified in sub-sections (1) and (2), it may by order impose the monetary penalty specified in those sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8).
(5) While determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical establishment and local conditions of the area in which the establishment is situated.
(6) Any person aggrieved by the decision of the authority may prefer an appeal to the State Council within a period of three months from the date of the said decision.
(7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed.
(8) The monetary penalty levied under sections 41 and 42 shall be credited to such account as the State Government may by order specify in this behalf.
Section 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 1[liable to penalty] which may extend to ten thousand rupees.
1. Subs by Act 8 of 2026, s. 2 and sch., for "punishable with fine" (w.e.f. 22.06.2026).
Section 44 Contravention by companies.
1[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 for the contravention and shall be liable for the first contravention to a penalty may extend to ten thousand rupees, for any second contravention to a penalty which may extend to fifty thousand rupees and for any subsequent contravention with penalty which may extend to five lakh rupees:
Provided that nothing contained in this sub-section shall render any such person liable to any penalty 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 penalty which may extend to ten thousand rupees for the first contravention, penalty which may extend to fifty thousand rupees for the second contravention and penalty which may extend to five lakh rupees for any subsequent contravention.
Explanation.---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 firm.
Provided that nothing contained in this sub-section shall render any such person liable to any penalty 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 penalty which may extend to ten thousand rupees for the first contravention, penalty which may extend to fifty thousand rupees for the second contravention and penalty which may extend to five lakh rupees for any subsequent contravention.
Explanation.---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 firm.
1. Subs by Act 8 of 2026, s. 2 and sch., for s. 44 (w.e.f. 22.06.2026).
Section 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 to any neglect on the part of, any officer, other than the Head of the Department, such officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
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 accordingly.
Section 46 Recovery of Penalty.
Whoever fails to pay the 1[penalty], the State Council of clinical establishment may prepare a certificate signed by an officer authorised by it specifying the 1[penalty] 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.
1. Subs by Act 8 of 2026, s. 2 and sch., for "fine" (w.e.f. 22.06.2026).
Section 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.
(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.
Section 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.
Section 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.
Section 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).
Section 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.
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.
Section 52 Power of Central Government to make rules. 2 docs
(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;
(c) the determination of standards and for classification of clinical establishments under section 7;
(d) the qualification and the terms and conditions for the members of the authority under clause (c) of sub-section (1) of section 10;
(e) the procedure under which the powers of the authority may be exercised by the District Health Officer or Chief Medical Officer for the purpose of provisional registration of clinical establishment under sub-section (2) of section 10;
(f) the minimum standards of facilities and services under clause (i) of sub-section (1) of section 12;
(g) the minimum number of personnel under clause (ii) of sub-section (1) of section 12;
(h) the maintenance of records and reporting by the clinical establishment under clause (iii) of sub-section (1) of section 12;
(i) other conditions for registration and continuation of clinical establishment under clause (iv) of sub-section (1) of section 12;
(j) classification of clinical establishment under sub-section (1) of section 13;
(k) the different standards for classification of clinical establishments under sub-section (2) of section 13;
(l) the minimum standards for permanent registration under section 28;
(m) the form and particulars to be contained in the register to be maintained under section 38.
(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;
(c) the determination of standards and for classification of clinical establishments under section 7;
(d) the qualification and the terms and conditions for the members of the authority under clause (c) of sub-section (1) of section 10;
(e) the procedure under which the powers of the authority may be exercised by the District Health Officer or Chief Medical Officer for the purpose of provisional registration of clinical establishment under sub-section (2) of section 10;
(f) the minimum standards of facilities and services under clause (i) of sub-section (1) of section 12;
(g) the minimum number of personnel under clause (ii) of sub-section (1) of section 12;
(h) the maintenance of records and reporting by the clinical establishment under clause (iii) of sub-section (1) of section 12;
(i) other conditions for registration and continuation of clinical establishment under clause (iv) of sub-section (1) of section 12;
(j) classification of clinical establishment under sub-section (1) of section 13;
(k) the different standards for classification of clinical establishments under sub-section (2) of section 13;
(l) the minimum standards for permanent registration under section 28;
(m) the form and particulars to be contained in the register to be maintained under section 38.
Section 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.
Section 54 Power of State Government to make rules. 1 docs
(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;
(c) the particulars and information contained in certificate of provisional registration under section 15;
(d) the manner of publication of all particulars of the clinical establishments proposed to be registered under sub-section (2) of section 16;
(e) the fees to be paid to issue a duplicate certificate under section 19;
(f) the change of ownership or management to be informed by the clinical establishment to the authority under sub-section (2) of section 20;
(g) the manner in which the authority shall publish the names of the clinical establishments whose registration expired under section 21;
(h) the enhanced fees to be charged for renewal after expiry of the 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 expiry of period specified in section 29;
(m) the form and particulars of the certificate of registration under section 30;
(n) the period within which an appeal shall be preferred under clause (a) of sub-section (3) of section 32;
(o) the manner of entry and search of clinical establishment under section 34;
(p) the fees to be charged by the State Government for different categories of clinical establishments under section 35;
(q) the manner and the period within which an appeal may be preferred to the State Council under sub-section (1) of section 36;
(r) the form and the fee to be paid for an appeal under sub-section (2) of section 36;
(s) the form and the manner in which the register to be maintained under sub-section (1) of section 37;
(t) the manner of supply to the State Council in digital format the entry made in the register of clinical establishment under sub-section (2) of section 37;
(u) the manner of holding an inquiry by the authority under sub-section (3) of sections 41 and 42;
(v) the manner of filing the appeal under sub-section (7) of sections 41 and 42;
(w) the manner and the time within which the information is to be furnished to the authority or the State Council or the National Council as the case may be, under section 48;
(x) any other matter which is required to be or may be prescribed by the State Government.
(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;
(c) the particulars and information contained in certificate of provisional registration under section 15;
(d) the manner of publication of all particulars of the clinical establishments proposed to be registered under sub-section (2) of section 16;
(e) the fees to be paid to issue a duplicate certificate under section 19;
(f) the change of ownership or management to be informed by the clinical establishment to the authority under sub-section (2) of section 20;
(g) the manner in which the authority shall publish the names of the clinical establishments whose registration expired under section 21;
(h) the enhanced fees to be charged for renewal after expiry of the 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 expiry of period specified in section 29;
(m) the form and particulars of the certificate of registration under section 30;
(n) the period within which an appeal shall be preferred under clause (a) of sub-section (3) of section 32;
(o) the manner of entry and search of clinical establishment under section 34;
(p) the fees to be charged by the State Government for different categories of clinical establishments under section 35;
(q) the manner and the period within which an appeal may be preferred to the State Council under sub-section (1) of section 36;
(r) the form and the fee to be paid for an appeal under sub-section (2) of section 36;
(s) the form and the manner in which the register to be maintained under sub-section (1) of section 37;
(t) the manner of supply to the State Council in digital format the entry made in the register of clinical establishment under sub-section (2) of section 37;
(u) the manner of holding an inquiry by the authority under sub-section (3) of sections 41 and 42;
(v) the manner of filing the appeal under sub-section (7) of sections 41 and 42;
(w) the manner and the time within which the information is to be furnished to the authority or the State Council or the National Council as the case may be, under section 48;
(x) any other matter which is required to be or may be prescribed by the State Government.
Section 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.
Section 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.
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.