Chapter III
Procedure for Registration
APPLICATION FOR REGISTRATION

16.
i. For the purpose of registration of the clinical establishment, an application in the prescribed Performa along with the prescribed fee shall be submitted to the prescribed authority.
ii. The prescribed authority shall facilitate online submission of applications so as to minimise the interface between the authority and the applicant.
iii. The application shall be made in such form and shall be accompanied with such details as may be prescribed under this Act or rules/regulations made there under.
iv. 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.
v. If any clinical establishment is already registered under any existing law requiring registration of such establishments, even then it would have to apply for registration as prescribed at (i) above.

CERTIFICATE OF REGISTRATION
17. 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.

NO ENQUIRY PRIOR TO PROVISIONAL REGISTRATION
18.
i. The authority shall not be required to conduct any enquiry prior to the grant of provisional registration.
ii. 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 proposed to be registered.

VALIDITY OF PROVISIONAL REGISTRATION
19. Every provisional registration shall be valid up to the last day of the twelfth month from the date of issue of the certificate of registration and such registration shall be renewable.

DISPLAY OF THE CERTIFICATE OF REGISTRATION
20. The Certificate shall be kept affixed in a conspicuous place in the clinical Establishment in such a manner so as to be visible to every one visiting such establishment.
21. In case the certificate is lost, destroyed, mutilated or damaged, the authority will issue a duplicate certificate on the request of the Clinical Establishment and on the payment of such charges as may be prescribed.

CERTIFICATE TO BE NON TRANSFERABLE
22. The Certificate of registration shall be non-transferable. In the event of change of ownership or change of management or on ceasing to function as a Clinical Establishment, the Certificate of registration shall be surrendered to the Authority and the Clinical Establishment shall apply fresh for grant of Certificate of Registration.

RENEWAL OF REGISTRATION
23. The prescribed authority shall also cause to be published in such manner as may be prescribed the names of clinical establishments whose registration would be expiring within the next forty-five days.
24. The authority shall also cause to be sent either electronically or by post to every registered clinical establishment a computer generated notice forty-five days prior to the expiry of the registration.
25. Application for renewal of registration shall be made thirty days before the expiry of the validity of the certificate of provisional registration.
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.

PERMANENT REGISTRATION
26. Permanent registration shall be granted only after the central government has prescribed minimum standards for the registration of clinical establishments.
27. Clinical Establishments in respect of which standards have been notified by the Central Government, provisional registration shall not be granted/renewed beyond a period of three years from the date of notification of standards.

APPLICATION FOR PERMANENT REGISTRATION
28. Application for permanent registration shall be made to the prescribed authority in such form and be accompanied with such fees as may be prescribed.

VERIFICATION OF THE APPLICATION
29. The applicant shall have to submit evidence of the clinical establishment being compliant of the prescribed minimum standards in such manner as may be prescribed in the rules.
30. As soon as the applicant submits the prescribed evidence of the clinical establishment being compliant with the prescribed minimum standards, the authority shall cause to be displayed in such manner as may be prescribed all such evidence submitted by the applicant for a period of thirty days before processing for grant of permanent registration.
31. If no objections are received within thirty days from the date of publication by the authority, permanent registration shall be granted.
32. If any objections are received within the prescribed period, these shall be communicated to the applicant for response within a period as may be prescribed.
33. Immediately after the expiry of the prescribed period and within the next thirty days thereafter, the authority shall pass an order:
allowing the application for permanent registration;
disallowing the application.
34. If the authority allows the application, it shall issue a certificate of permanent registration in such form and containing such particulars as may be prescribed.
35. If the authority disallows the application for permanent registration it would have to clearly state the grounds on which the application was disallowed.
36. The disallowing of an application for permanent registration shall not debar a clinical establishment from applying afresh for permanent registration under section 19 and after providing such evidence as may be prescribed, of having rectified the deficiencies on which grounds the earlier application was disallowed.

REVOCATION OF REGISTRATION
37. i. 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. any of the grounds that would have entitled the Authority to reject the application for registration was suppressed at the time of the application; or
c. the person entrusted with the management of the clinical Establishment has been convicted of an offence punishable under this Act;
it may issue a show cause notice as to why its registration under this Act should not be cancelled for the reasons mentioned in the notice. 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 there under, it may, without prejudice to any other action that it may take against such clinical Establishment, cancel its registration.

ii. Every order made under sub section (i) 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 the
Clinical Establishment from carrying on if there is imminent danger to the health and safety of patients.

INSPECTION OF REGISTERED CLINICAL ESTABLISHMENTS
38.
i. The authority or an officer authorised by it, shall have the right to cause an inspection of, or inquiry in respect of any clinical establishment, its buildings, laboratories and equipment and also of the work conducted or done by the clinical establishment, to be made by such person or persons 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 there at.
ii. 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.
iii. 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. Such report shall be furnished within such time as the authority may direct.
iv. Where the clinical establishment does not, within a reasonable time, take action to the satisfaction of the authority that authority may, after considering any explanation furnished or representation made by the clinical establishment, issue such directions as that authority deems fit and the clinical establishment shall comply with such directions.

INSPECTION OF UNREGISTERED CLINICAL ESTABLISHMENTS
39. 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 and or inquiry and be entitled to be represented thereat.

APPEALS
40. All appeals against the orders of the registering authority shall lie to the Divisional Commissioner having jurisdiction over the Zila Parishad.