The Clinical Establishments (Registration and Regulation) Act, 2010
Administered Ministry: Ministry of Health and Family Welfare / Department of Health and Family Welfare
Section
Section 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.
Section 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.
Section 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 establishments which come into existence after standards have been notified.
(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 establishments which come into existence after standards have been notified.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
Section 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.
(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.
Section 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.
(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.
Section 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.
Section 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 this Act or the rules made thereunder, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration.
(3) Every order made under sub-section (2) shall take effect--
(a) where no appeal has been preferred against such order immediately on the expiry of the period prescribed for such appeal; and
(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 patients.
(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 this Act or the rules made thereunder, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration.
(3) Every order made under sub-section (2) shall take effect--
(a) where no appeal has been preferred against such order immediately on the expiry of the period prescribed for such appeal; and
(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 patients.
Section 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 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 within such time as indicated in the direction, as that authority deems fit, and the clinical establishment shall comply with such directions.
(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 within such time as indicated in the direction, as that authority deems fit, and the clinical establishment shall comply with such directions.
Section 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.
Provided that no such person shall enter the clinical establishment without giving notice of his intention to do so.
Section 35 Levy of fee by State Government Appeal.
The State Government may charge fees for different categories of clinical establishments, as may be prescribed.
Section 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.
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.
Section 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.
(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.
Section 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.
(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.
Section 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.
Section 40 Penalty.
Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere, be 1[liable for the first contravention to penalty which may extend to ten thousand rupees, for any second contravention to penalty which may extend to fifty thousand rupees, and for any subsequent contravention with penalty which may extend to five lakh rupees].
1. Subs by Act 8 of 2026, s. 2 and sch., for certain words (w.e.f. 22.06.2026).