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EXTRAORDINARY
PUBLISHEO BY AUTHORITY

ISLAMABAD, SATUR-DAY, JUNE 2,2018

PART II

Statutory Notifications (S. R. O.)

GOVERNMENTOF PAKISTAN
MINISTRY OF NATIONAL HEALTI{ SERVICES,
REGULATIONS AND COORDINATION

NOTIFICATION

Islamabad, the 29th May, 2018

S.R.O. 68f (D/20f 8.-ln

pursuance of the Honourable Supreme Court of
Pakistan's order dated the 20th March,20l8, passed in HRC No. 623-P of 2017,
the Federal Government is pleased to notiry the National lnterventional
Cardiology Board, with the following composition and term of references,
namely:-

(i) Executive Director / Head of [nterventional Cardiology of Member

Rawalpindi [nstitute of Cardiology, Rawalpindi
(ii) Chief Executive / Head of Interventional Cardiology, Punjab Member
Institute of Cardiology, Lahore

(\277)

Price : Rs. 5.00

[5983(2t) I 8)/Ex. Gaz.]

1278 THE GAZETTE OF PAKISTAN, EXTRA.' JUN_E 2, 2OIE

( iii) Head of lnterventional Caldiology of National Institute of Membcr

Cardiovascular Diseases (.r-ICVD), Karachi
(iv) tlead of Intcnentional Cardiolory of Lady Reading Member
Hospital, Peshawar
(v) l{ead of Interventional Cardiology of Bolan Medical College Member
Hospital, Quetta
(v i) Head of lnterventional Cardiolory of Pakistan Institute of Members
Medical Sciences (PIMS), Islamabad
(vii) Head Interventional Cardiology of Interventional
of Members
Cardiotogr of Federal Govemment Polyclinic (FGPC),
Islamabad
(viii) The President, Pakistan Society of lnterventional Cardiolory Member
IPSlC) or its nominee
(ix) A nominee of the Pakistan Society of
[nterventional Member
Cardiology (PSIC) from private sector Cath Labs

2. The senior most member shall act as the Chairman of National

InterventionaI Cardiology Board.

3. Primary Functions.-The National Interventional Cardiolory

Board shall perform the following functions, namely:-

(a) approve the standards and guidelines for accreditation and

operation of Cath Labs in Pakistan (Public and Private);

(b) approve the qualification standards for interventional cardiologists

to operate Cath Labs;

(c) recommend the terms ol reference and selection of independent

private operator of "Cardiac Registry of Pakistan" and regulate its
operations;

(d) recommend the medical devices of acceptable quality for use by

Cath Labs including issuance ofnegative list ofdevices;

(e) Frame rules where necessaD/ and form committees to carry out any
specific functions including but not limited to peer commitlccs to
evaluate complaints;
^tARr ltl rHE GAZETTE oF pAKtsTAN, EXTRA., JUN-E 2. 2018 t2is

(11 to design and set up Cardiac Registry of Pakistan, which shall be

thereafter handed over to selected and secure private entity for its
operations to ensure neutrality and security of the date and registry.
The operations and utilization of Cardiac Regisfy of Pakistan shall
be defined pursuant to the terms and conditions to be framed jointly
by the National lnterventional Cardiolory.Board and Pakistan
Society of lnterventional Cardiolory; and

(g) to inform the public and patients for immediate information and
verification of the list of accredited interventional cardiologists,
accredited and registered Cath Labs, approved Life Saving Medical
Devices, Pricing of Life Saving Medical Devices and charges
permissible for Cath Labs through Pakistan Society of
Interventional Cardiolory, Drug Regulatory Authority of Pakistan,
Provincial Healthcare Commissions, Hospitals and Cath Labs
websites. The website shall also provide mechanism for public and
patients to report any complaints in respect of price, services or
procedure for further reference to Peer Committees.

4. Terms of Reference.-The terms of references are as follows-

(a) the Provincial llealthcare Commissions to ensure that the

Certification Criteria for Interventional Cardiologists and Cath Lab
registration/ regulation criteria is as per the Cardiac Catheterization
Laboratory Standards and Best Practice Guidelines for Pakistan
20l7,CCL Guidelines 2017 be enforced;

(b) the accreditation of Cath Labs shall take place by a comrnittee

consisting of nominees of the National Interventional Cardiology
Board and one nominee of the relevant Provincial Healthcare
Commission;

(c) the accreditation / registration of the existing Cath Labs shall be

completed within 180 days, where after no unregistered Cath Lab
shall be permitted to operate;

(d) annual monitoring and evaluation ofeach accredited and registered

Cath Lab shall be carried out on a regular basis to ensure that each
1280 TllE GAZET'I'E OF PAKISTAN, EXTRA.. JUNE 2, 2018 IPARr I'

Cath Lab is operating itr accordance rvith the ( ardiac

Catheterization Laboratory Guidelincs, 201 7:

(e) all operators be duly certified and credentialed as per CCL

Guidelines, 2017 by a committee consisting of nominees of the
National Interventional Cardiology Boand, Pakistan Society of
Interventional Cardiolory and the College of Physicians and
Surgeons;

(f) the .r-ational Interventional Cardiology Board shall from time to

time issue a list of'life Saving Medical Devices' required for
purposes of Interventional Cardiologl. The list of Life Saving
Medical Devices is provided in Schedule "A" which, may be
amended so as to omit any entry there from, add any entry thereto
or amend entry therein by the National Interventional Cardiology
Board;

(g) the National Interventional Cardiolory Board shall issue a list of

companies whose Life Saving Medical Devices shall be considered
for procurement and used by Cath Labs on the basis of existing
experience, usage and performance after through scrutiny and
consideration;

(h) the National Interventional Cardiolory Board may also prepare and
issue a Negative List of Life Saving Medical Devices from time to
time which should be prohibited for import and usage in Pakistan.
The list shall be forwarded to Drug Regulatory Authority of
Pakistan to ensure that such Life Saving Medical Devices are not
registered and are cancelled ifregistered;

(D life Saving Medical Devices must be supplied directly to the

accredited and registered Cath Labs and shall not be sold to patients
or at hospital premises directly by distributors, retailers or their
representatives to ensure that they are not sold above the regulated
prices;

O the Drug Regulatory Authority of Pakistan shall setup and make

operational the National Medical Device Registry on an urgcnt
basis rvith a mandatory condition that all Life Saving Medical
PARTIIi THE GAZETTE OF PAKISTAN, EXTRA., JUNE 2,2018 I28I

Devices are duly entered into the Medical Device Registry

^-ational
frorn the time of entry into Pakistan and tracked right until use in a
procedure upon a patient in a Cath t^abs;

(k) a pricing committee consisting of nominee of Drug Regulatory

Authority of Pakistan, all Provincial Healthcare Commissions,
Federal Government, National Interventional Cardiology Board and
of Interventional Cardiolory be constituted to set
Pakistan Society
maximum prices of different categories of Life Saving Medical
Devices based on average procurement prices obtained through the
central procurement;

(l) the National Interventional Cardiologr Board hall issue an advisory

price for charges that may be imposed by a Cath Lab for providing
the professional services of a Cath Lab excluding costs charged by
a hospital for services directly to a patient outside the scope of the
Cath t ab;

(m) lists of accredited Cath Labs, accredited Interventional

Cardiologists, approved Life Saving Medical Devices and prices of
approved Life Saving Medical Devices be available on the websites
of Pakistan Society of Interventional Cardiology, Drug Regulatory
Authority of Pakistan, all Provincial Healthcare Facilities including
a central link to submit complaints to the National lnterventional
Cardiology Board in terms of pricing, services and procedures with
such complaints simultaneously being also brought to the
knowledge of the relevant Provincial Healthcare Commission and
Drug Regulatory Authority of Pakistan;

(n) the Drug Regulatory Authority of Pakistan, Ministry of National

Health Services and Provincial Healthcare Commissions would act
on the recommendations and directions of National lnterventional
Cardiology Board in enforcing the guidelines and standards set by
National Interventional Cardiology Board pursuant to the respective
regulatory functions ofthe said authorities;

(o) the Drug Regulatory Authority of Pakistan shall notiry and publish
the Benchmark Pricing of Life Saving Medical Devices in
consultation rvith National lnterventional Cardiologr Board, the
1282 TI{E GAZETTE OF PAKISTAN, EXTRA., JUND 2,20I8 II'ARTII

Provincial Hcalthcare Commissions and Pakistan Societr of

Interventional Cardiology;

(p) the Drug Regulatory Authority of Pakistan shall regulate

registration of Life Saving Medical Devices pursuant to the criteria
and Negative List as notified by the National Interventional
Cardiologl Board from time to time. All registrations of Life
Saving Medical Devices shall be completed rvithin one week of all
necessary documentation having been provided by an importer;

(q) the Drug Regulatory Authority of Pakistan shall at the earliest setup
and make operational the National Medical Dcvice Registry in
consultation with the National lnterventional Cardiology Board, the
Pakistan Society of Interventional Cardiology and the relevant
device importen association;

(r) all Cath Labs prior to their registration with Provincial Healthcare
Commissions must be registered with Cardiac Registry of Pakistan;

(s) provincial Healthcare Commissions to ensure the enforcement of

Certification Criteria for Interventional Cardiologists along-rvith
Cath Lab registration and regulation criteria as per the Cardiac
Catheterization Laboratory Guidelines, 201 7;

(t) the Cath Labs accreditation shall take place by a committee

consisting of nominees of the National Interventional Cardiolory
Board and one nominee of the relevant Provincial Healthcare
Commission;

(u) the accreditation and registration ofthe existing Cath Labs shall be
completed within one hundred and eighty days;

(v) annual monitoring and evaluation ofeach accredited and registered

Cath Lab shall be canied out on a regular basis to ensure that each
Cath Lab is operating in accordance with the Cardiac
Catheterization Laboratory Guidelines, 201 7;

(w) all operators be duly certified and credentialed as per Cardil.

Catheterization Laboratory Guidelines. 2017 by a committee
 PART II] THE CAZEI TE OF PAKISTAN, EXTRA.. JtrNE 2
, 2018 t283

consisting of nominees of the National Interventional

Cardiology
Board, the pakistan Society of lnterventional Cardiology
and thc
College of physicians & Surgeons; and

(x) lists of accredited Cath Labs, accredited Interventional

Cardiologists, approved Life Saving Medical Devices and
approved
prices of Life Saving Medical Devices shall be
displayed on the
websites of pakistan Society of Interventional Cardiolog;r,
the Drug
Rcgulatory Authority of pakistan, all provincial Healthcare
Facilities including a central link so as to submit complaints
to the
National Interventional Cardiolory Board in terms of pricing,
services and procedures and such complaints simultaneously
being
also brought to the knowledge of the relevant provincial Healthcare
Commission and the Drug Regulatory Authority of pakistan.

[No.F.6-2 l/20 I 8-DRAPNHS,R&C.]

SANA.UL.ISLAM,
Deputy Secretary (Aclmn).

PRI\TED BY THE MAi(ACER, PRI|\-TINC CORPORATIOI{ OF PAKISTAN PRESS, ISLAMABAD.

PUBLISHED BY THE DEPUTY COI{TROLLER. STATIO^"ERY AND FoRMs. UIiIVERSITY ROAD. KARACHL