Chapter IV PROCEDURE FOR REGISTRATION

1. (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. (2) The application shall be filed in person or by post or online.
3. (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. (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 date of its establishment.
5. (5) If any clinical establishment is already registered under any existing law requiring registration of such establishments, even then it shall apply for registration as referred to in sub-section (1).

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.

1. (1) The authority shall not conduct any inquiry prior to the grant of provisional registration.
2. (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.

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.

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.

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.

1. (1) The certificate of registration shall be non-transferable.
2. (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. (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.

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.

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.

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,—

1. (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;
2. (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
3. (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.

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.

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

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.

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.

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

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

1. (a) allowing the application for permanent registration; or
2. (b) disallowing the application: Provided that the authority shall record its reasons, if it disallows an application, for permanent registration.

1. (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. (2) The certificate shall be valid for a period of five years from the date of issue.
3. (3) For the purposes of sub-section (1), the provisions of sections 18, 19, 20 and 21 shall also apply.
4. (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.

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.

1. (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. (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. (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.

1. (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. (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. (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. (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.

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.

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

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