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 date of its establishment.
(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).
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.
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.
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.
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.
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.
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.
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.
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
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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:
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Provided that no such person shall enter the clinical establishment without giving notice of his
intention to do so.
35. Levy of fee by State Government.—The State Government may charge fees for different
categories of clinical establishments, as may be prescribed.
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.