MINUTES OF 232ND MEETING OF CENTRAL LICENSING BOARD
HELD ON 29TH& 30THJULY 2013
232nd meeting of the Central Licensing Board (CLB) was held on 29th & 30th July,
2013 in the committee room of Ministry of National Health Services, Regulation &
Coordination, Islamabad under the Chairmanship of Mr. Faqeer Muhammad Shaikh,
Director Drug Licensing, DRAP/ Chairman CLB.
Following members attended the meeting: Sr.
#
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Name & Designation
Mr. Faqeer Muhammad Shaikh.
Director Drug Licensing, Drug Regulatory Authority of
Pakistan, Islamabad.
Mr. Ayaz Ali Khan, Chief Drugs Controller, Health
Department, Government of Punjab, Lahore.
Mr. Salim Isharat Husain, Chief Inspector of Drugs,
Health Department, Government of Sindh, Karachi.
Syed Jawed Yousaf Bukhari, expert in Drug
Manufacturing (Karachi).
Mr. Nadeem Iqbal, expert in Drug Manufacturing
(Lahore).
Dr. Ali Akbar Sial, Wafaqi Urdu University, Karachi
Mr. Khalid Yousuf, Expert in Quality Control, Karachi.
Prof. Dr. Gul Majeed Khan, Chairman Pharmacy
Department, Quaid-e-Azam University, Islamabad.
Mr. Zaheeruddin M. Baber, DDC (QC), DRAP,
Islamabad,
Representative of Directorate of Quality Assurance and
Lab Testing.
Mr. Ahmad Din Ansari.
Deputy Director General (Licensing), Drug Regulatory
Authority of Pakistan, Islamabad.
Mr. Ahsan Awan, Representative of PPMA (South).
Mr. Khalid Munir, Representative of PPMA (North).
Mr. M. Rashid Representative of Pharma Bureau
Position in CLB
Chairman CLB
Member
Member
Member
Member
Member
Member
Member
Member
Secretary CLB/
Member
Observer
Observer
Observer
The Chairman CLB welcomed the honorable members of this Apex Forum & participants
of the meeting. The Chairman briefly introduced himself and the members of the Board
also gave their introduction. The meeting started with the recitation of verses from the
Holy Quran. The Chairman apprised the members of the Board regarding the
reconstitution of the CLB and that strong responsibility devolves on the members of the
Board to conduct the proceedings of CLB in an amicable and responsible way to deliver
to the public and stake holders in a transparent and efficient manner. He further added
that all the legal and codal formalities regarding convening of the meeting has been
fulfilled. He also disclosed that the Federal Government desires to ensure transparency at
Page 1 of 78
all forums of delivery by Drug Regulatory Authority of Pakistan. The Secretary CLB
informed the honorable members of the Board that no person who is the member of CLB
can be the member of any other Board / Committee constituted under the Drugs Act,
1976 or Rules framed there under to avoid conflict of interest as provided under Section
11-A of the Drugs Act, 1976. He further added that in his opinion, giving consultancy to
Pharma Industry by a CLB member will also be contrary to these provisions of the law.
However, Mr. Khalid Yousuf, Member CLB, was of the view that if a member gives
consultancy to Pharma Industry, he/she should not participate in any discussion / decision
of the case where conflict of interest arises. Syed Jawed Yousaf Bukhari, and Mr.
Nadeem Iqbal, Members of CLB supported the version of Mr. Khalid Yousuf, and also
added that such member should not participate in discussion, proceeding, conduct
inspection of those cases and should remain impartial to avoid such conflict. Secretary
CLB presented the agenda and started proceedings of the Board. Mr. Khalid Mehmood,
DDC (Lic.), Mr. Zaheeruddin M. Baber DDC (Q.C.), Mr. Adnan Faisal Saim, DDC
(Q.A.) and Mr. Salateen Waseem Philip ADC (Lic.) DRAP Islamabad assisted the
Secretary CLB in presenting the agenda.
2. The proceedings of the Board are as follows:A.
LICENSING SECTION
Item I: - CONFIRMATION OF THE MINUTES OF 231ST MEETING
The Minutes of 231st meeting of the Central Licensing Board, held on 30-012013, were circulated to all members after getting approval of Chairman Board. Since no
objection was received from any member so the Minutes are presumed to be confirmed /
approved.
Item II: - CASES OF GRANT OF DRUG MANUFACTURING LICENSES.
The Board decided the following cases of Grant of Drug Manufacturing License in the
light of recommendations by panel of experts/inspectors.
Sr.
Name of the firm
#
1.
M/s Crystolite
Pharmaceuticals, Rawat,
Rawalpindi
Type of
License
Formulation
2.
Formulation
M/s Filix Pharmaceuticals,
Rawat, Rawalpindi.
Decision of CLB
Grant of DML to the Firm with
following six (06) Sections was
approved by CLB.
i). Tablet (General)
ii). Capsule (General)
iii). Cream/Ointment (General)
iv). Cream/Ointment (Steroidal)
v). Lotion (General)
vi). Lotion (Steroidal)
Grant of DML to the Firm with
following two (02) Sections was
approved by CLB.
i). Tablet (General)
ii). Capsules (General)
Page 2 of 78
3.
M/s Wisdom
Pharmaceutical Industry,
Peshawar
Formulation
4.
M/s Ravi Medical Supplies
(Pvt.) Ltd, Kasur.
Formulation
Item-III:
Grant of DML to the Firm with
following seven (07) Sections was
approved by CLB.
i). Dry Powder Suspension
(Cephalosporin).
ii). Capsule (Cephalosporin)
iii). Capsule (General)
iv). Liquid Syrup (General)
v). Tablet (General)
vi). Ointment/Cream Steroid.
vii). Ointment/Cream (General).
The case of grant of DML to the firm
was deferred by CLB.
The Board further decided to get the
premises re-inspected with regard to
verification of rectification of points as
identified by the panel for grant of Drug
Manufacturing License in its report
dated 08-01-2013. The Board delegated
the power to Chairman Central
Licensing Board that the case shall be
processed for constitution of panel for
grant of DML. The case shall be placed
before CLB in its next meeting after the
receipt of panel inspection report. The
FID / Panel should be directed to furnish
report
with
clear
and
candid
recommendations. The case will be
decided by CLB accordingly in the light
of fresh report by the panel of experts.
CASES OF GRANT OF ADDITIONAL SECTIONS.
The Board decided the following cases of Grant of Additional Sections of the already
licensed Pharmaceutical manufacturers in the light of recommendations by the panel of
experts/inspectors. However the sections which are not approved / deferred for reinspection are also placed under this provision of Item III.
Sr. Name of the firm
Type of
#
License
1.
M/s Hansel Pharmaceuticals (Pvt.) Formulation
Ltd, Lahore.
2.
M/s Bosch Pharmaceuticals (Pvt.) Formulation
Ltd, Karachi.
Decision of CLB
The CLB approved grant of
following two (02) additional
sections to the firm.
i). Eye Drops (General)
ii). Skin Ointment (General)
The CLB approved grant of
following four (04) additional
sections to the firm.
i). Penicillin Injectable section.
Page 3 of 78
3.
M/s Merck Pharmaceuticals (Pvt.) Formulation
Ltd, Karachi.
4.
M/s NovaMed Pharmaceuticals Formulation
(Pvt.) Ltd, Lahore.
5.
M/s Sanofi Aventis Pakistan Formulation
Limited, Korangi Industrial Area,
Karachi.
6.
M/s
Saaaf
Pharmaceutical Formulation
Industries, Risalpur.
7.
M/s WelWink Pharmaceutical, Formulation
G.T Road Gujarawala.
ii). QC Laboratory.
iii). Raw material Store.
iv). Finished goods store.
The
CLB
approved
the
following:
i). Alteration and expansion in
existing
manufacturing
and
packaging facility (Ground Floor
and First Floor).
ii). Alternation and expansion in
existing packing, Raw Material
and Finished Good ware houses
(Ground Floor).
The CLB approved grant of
following two (02) additional
sections to the firm.
i). General Liquid Injection
(Ampoule).
ii). General Liquid Injection Vial
(SVP).
The CLB approved grant of
following two (02) additional
sections to the firm.
i). Secnidal Dry Suspension
Area.
ii). Gel & Cream Area.
The case of
Psychotropic/Narcotic (Tablet
& Capsule) area was deferred
till finalization of decision on
policy of Psychotropic/Narcotic
drugs.
The CLB approved grant of
following one (01) additional
section to the firm.
i). Liquid (General) Section
During proceeding / discussion,
the Secretary, Central Licensing
Board, after perusing the firm’s
file, apprised the Board that the
case had inadvertently been
included in the agenda and as per
available record, approval of two
additional
sections
under
reference/as mentioned in agenda
i.e. Liquid Injection (General) and
Powder Sachet (General) had
already been communicated to the
Firm vide letter No. F. 1-33/2006Page 4 of 78
Lic, dated 18-02-2013 (Page93/
Corr.) by the then Secretary,
Central Licensing Board. The
Board after considering the
facts unanimously decided to
drop the agenda item / case
accordingly.
The CLB approved grant of
following two (02) additional
sections to the firm.
i). Liquid Section (Antibiotics)
ii).
Sachet Section (Non
Antibiotics)
The CLB approved grant of
following three (03) additional
sections to the firm.
i). Bolus & Granules Section.
ii). Ointment Section.
iii). Spray Section.
The CLB approved grant of
following one (01) additional
section to the firm.
1). Eye/Ear Drops (Steroidal)
8.
M/s Hamaz Pharmaceutical (Pvt.) Formulation
Ltd, Multan.
9.
M/s Zakfas Pharmaceutical (Pvt.) Formulation
Ltd, Multan.
10.
M/s
Jaens
Pharmaceutical Formulation
Industries, Lahore.
11.
M/s Elite Pharma, Lahore.
Formulation
The CLB approved grant of
following one (01) additional
section to the firm.
i). Liquid Injectable Infusion (100
ml vial)
12.
M/s S.N.B. Pharmaceuticals (Pvt.) Formulation
Ltd, Industrial Estate, Hayatabad,
Peshawar.
13.
M/s Vega Pharmaceuticals (Pvt.) Formulation
Ltd, Lahore.
The CLB approved grant of
following two (02) additional
sections to the firm.
i). Liquid syrup General
ii).Cephalosporin (Capsule & Dry
Powder Suspension)
The CLB approved grant of
following three (03) additional
sections to the firm.
i) Dry Powder for Injectable
(Cephalosporin).
ii) Dry
Powder
for
oral
suspension (Cephalosporin).
iii) Capsule (Cephalosporin).
14.
M/s Farmigea Pakistan (Pvt.) Ltd, Formulation
Lahore.
The CLB deferred the case of
grant of two (02) additional
Sections to the firm.
The Board decided to get
Page 5 of 78
15.
M/s Wellmark Pharmaceuticals, Formulation
Hattar.
16.
M/s A & K Pharmaceutical, Formulation
Faisalabad.
17.
M/s Friends Pharma (Pvt.) Ltd. Formulation
Lahore.
clarification
from
QA/QC
regarding stoppage of production
since 2008 and non-compliance
of cGMP of firm. A surprise re
inspection of the facility by a
panel of experts was desired by
the Board to check over all GMP
compliance Level of the Firm.
The Board also decided that
Provincial Governments may be
asked to check availability of
products of M/s Farmigea
Pakistan, Lahore in the market /
institution as production has been
stopped since 2008.
The CLB approved grant of
following three (03) additional
sections to the firm.
(i). Dry Suspension (General)
(ii). Sachet (General)
(iii). Dry Injection (General)
The CLB approved grant of
following one (01) additional
section to the firm.
(i). Liquid Injectable.
The CLB approved grant of
following one (01) additional
section to the firm.
(i). Cephalosporin Dry Powder
Injection.
Item-IV: CASES OF ADDITIONAL SECTIONS (NOT APPROVED)
Following case for grant of additional sections of already licensed manufacturers
inspected but not recommended by the panel of experts were decided by the Board as
follows.
S
#
1.
Name of Firm
Type of
License
M/s Pharmacare Laboratories (Pvt.) Formulation
Ltd, Kot Lakhpat, Lahore.
Grant of two additional sections i.e.
Quinolone and Capsule Section
General was not recommended by the
Panel of Inspectors as per inspection
report dated 01-03-2013.
Decision of CLB
The Board did not approve the
grant of two additional sections
to
the
firm
as
per
recommendation of panel of
inspectors in its report dated0103-2013.
Page 6 of 78
Item-V: CASES OF GRANT OF RENEWAL OF DRUG MANUFACTURING
LICENSES.
The Board approved / deferred the following cases of the grant of renewal of Drug
Manufacturing Licenses of already Licensed Pharmaceutical Manufacturers in the light of
recommendations of the respective panels of experts/inspectors subject to installation /
confirmation of HVAC system and updated deposition of CRF as admissible under the
rules.
S
#
1.
2.
3.
4.
5.
6.
7.
Name of the firm
Type of
License
Pharmaceuticals, Formulation
Decision of CLB
M/s Valor
Islamabad.
M/s Pharmacare Laboratories Formulation
(Pvt.) Ltd, Kot Lakhpat, Lahore.
M/s Saffron Pharmaceuticals Formulation
(Pvt.) Ltd, Sheikhupura Road,
Faisalabad.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
M/s MBL Pharma, Hub, Formulation
Balochistan
M/s Delux Chemical Industries, Formulation
Karachi.
The CLB approved the Renewal
of DML of Firm.
The case of Renewal of DML of
firm was deferred by the CLB.
The Board decided to get the unit
re-inspected by the same panel
along with Chief Drug Inspector
Sindh Mr. Salim Isharat Husain,
Member CLB. The case shall be
presented before the Board after
receipt of report of re-inspection
by the panel.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
However, the Board deferred
approval of layout plan and
additional section of Psychotropic/
Narcotics drugs of the firm
pending
before
Licensing
Directorate till finalization of
policy on Psychotropic/ Narcotics
Drugs and recommendations of
Ministry of Narcotics Control. The
Board also decided to send a
reference to Director Controlled
Drugs, till then the cases for
M/s Fedro Pharmaceuticals Formulation
Labs, Peshawar.
M/s Akhai Pharmaceuticals Formulation
(Pvt.) Ltd, Lasbela, Balochistan.
Page 7 of 78
8.
M/s Sanofi Aventis Pakistan Basic
Limited, Korangi Industrial Manufacture
Area, Karachi
DML NO.(000368) (By way of
basic manufacture)-
9.
M/s
Saaaf
Pharmaceutical Formulation
Industries, Risalpur
10. M/s Z-Jans Pharmaceutical
(Pvt.) Ltd, Peshawar.
11. M/s Trigon Pharmaceutical
(Pvt.) Ltd, Lahore.
12. M/s Hamaz Pharmaceutical
(Pvt.) Ltd, Multan.13. M/s Zakfas Pharmaceutical
(Pvt.) Ltd, Multan
Formulation
Formulation
Formulation
Formulation
approval of layout plan and grant
of
additional
sections
for
Psychotropic/ Narcotics Drugs are
with held.
The Board approved the
renewal of DML by way of basic
manufacture.
However, as there was no rating
given to the firm given in the
inspection report so the Board
directed that all members of this
panel should be asked to send their
recommendations in clear and
candid way on evaluation form in
future so as to ease the decision
making for CLB.
Regarding
the
issue
of
Psychotropic / Narcotic Drugs,
the Board decided to send a
reference to Director Controlled
Drugs, till then the cases for
approval of layout plan and grant
of
additional
sections
for
Psychotropic/ Narcotics Drugs are
with held.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm other than
liquid injectable section.
The Board also decided that the
matter regarding Liquid Injectable
Section should be referred to Q.C
section for collecting the reasons
of stoppage of production in the
aforesaid section on decision /
order by the Registration Board
communicated vide letter No. F.375/2010-Q.C dated 29-08-2012
and same shall be presented before
the CLB.
Page 8 of 78
14. M/s
Jaens
Pharmaceutical Formulation
Industries, Lahore.
15. M/s Saydon Pharmaceutical Formulation
Industry, Peshawar.
16. M/s BSN Medical (Pvt.) Ltd, Formulation
Karachi.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The case of Renewal of DML of
firm was deferred by the CLB.
The Board decided to get the unit
re-inspected by a new panel. The
case shall be presented before the
Board after the report of reinspection by the panel as desired
by Board is received.
17. M/s CSH Pharmaceuticals (Pvt.) Formulation
Ltd, Peshawar.
18. M/s Mediceena Pharma (Pvt.) Formulation
Ltd, Lahore.19. M/s Faisal Pharmaceutical (Pvt.) Formulation
Ltd, Faisalabad.-
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The
Board
by
majority
approved the renewal of DML of
the Firm.
The Board further decided to get
an affidavit / undertaking from the
management of the firm that they
will either purchase land / plot
very much adjacent to the existing
site (if possible) so as to
amalgamate with existing premises
to fulfill requirement of Plot size
of 2000 square yards as required
under Schedule B of Drugs (L,R&
A) Rules 1976 framed under the
Drugs Act, 1976, or they will shift
their present facility at some other
place in Industrial Area with
required land of minimum 2000 Sq
yards as per requirement of
Schedule B of Drugs (L, R & A)
Rules 1976. The process should be
completed within next two years
and detail of proposed project
should be described in the
undertaking by the Firm. However
Mr. Ayaz Ali Khan, Chief Drugs
Controller, Health Department,
Govt. of Punjab (Member CLB)
did not support renewal of DML
on existing premises of 1000 Sq.
yards which was granted on said
premises in the year 1994 prior to
Page 9 of 78
promulgation of the SRO 470
(I)/98 dated 15-05-1998 vide
which requirement of area of 2000
Sq. yards was declared medatory.
The CLB approved the Renewal
of DML of Firm.
20. M/s Medimarker
Pharmaceuticals (Pvt.) Ltd,
SITE, Hyderabad.
Formulation
21. M/s Alpha Chemicals (Pvt.)
Multan Road, Jamber (District
Kasur).
22. M/s Raazee Therapeutics (Pvt.)
Ltd, Kasur.
23. M/s SchazooZaka (Pvt.) Ltd.
Lahore.
24. M/s Focus & Rulz
Pharmaceuticals (Pvt.) Ltd.
Islamabad.
Basic
Manufacture
The CLB approved the Renewal
of DML of Firm.
Formulation
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
The CLB approved the Renewal
of DML of Firm.
Item-VI:
Formulation
Formulation
CASES OF RENEWAL/GRANTOF DRUG MANUFACTURING
LICENSES (NOT RECOMMENDED).
Following cases were not recommended by the respective panels of experts for grant of Drug
Manufacturing Licenses/Renewal of Drug Manufacturing Licenses. The Board took the
decisions as under.
S
#
1.
Name of Firm
Type of
License
applied
M/s Umer Usman Surgical Formulation
Cotton Industries, Jhang DML
(No.000361) Formulation.
Remarks:Renewal of DML of the firm was
not recommended by panel being
unsatisfactory at the time of
inspection on 01-03-2013.
Decision of CLB
In the light of the show cause
notice served to the firm due to
violations of conditions of DML
reported by the panel vide its
report dated 01-03-2013, the firm
availed the opportunity of personal
hearing. Adnan Latif , Chief
Operating Officer appeared before
CLB along with his counsel
Muhammed Shahzad Siddiq. The
Board heard the persons in detail
and asked some questions / raised
queries related to the observations
of the panel and contraventions of
provisions of law as reported by
the panel on above said date.
After hearing the above named
persons of the firm and thorough
deliberations among the members,
Page 10 of 78
and taking into consideration the
legal
provisions,
the
CLB
unanimously decided as follows:
i). The Board did not approve
the
renewal
of
drug
manufacturing license of the
firm as the unit was declared
unsatisfactory
and
not
recommended by the panel of
inspectors / experts vide it’s
report dated 01.03.2013.
ii). The Board further decided that
the production of the firm should
be stopped immediately, as the
firm’s production In-charge and
Quality Control In-charge have not
been approved by the DRAP.
iii). The Board also decided that
the firm should recall all its stocks
from the market / institution and
distributors manufactured without
the supervision of approved
technical persons.
iv). The Board authorized the
Chairman CLB to constitute a
panel for a surprise visit /
inspection of the facility. This will
confirm / verify the firm’s
statement given before the Board
that they have rectified 90% of the
shortcomings as pointed out by the
panel on 01-03-2013 and have
upgraded their unit. The panel will
also submit in its report the record
of all recalled batches/products.
The panel inspection report shall
be presented before the Board in
its meeting as and when the same
is received.
v). In the light of presentation
made by the firm before the
Board stating that their unit /
facility was never inspected by
Page 11 of 78
2.
M/s Nortech Pharmaceuticals, Formulation
Islamabad.
Remarks:Grant of DML to the firm was not
recommended by panel being
unsatisfactory at the time of
inspection on 29-03-2013.
the area FIDs / panel of experts
for GMP and renewal purpose
in last nineteen years, the Board
took serious note of casual
behavior of FIDs / field Officers
who are not performing their
duties under the provision laid
down under The Drug (Federal
Inspectors,
Federal
Drugs
Laboratory
&
Federal
Government Analyst) Rules
1976 promulgated vide S.R.O
783(I)/76 in which Rule 4
defines the duties to be
performed
by
Federal
Inspectors.
The
Board
further
recommended that strict action
be taken against the FID / field
officers not fulfilling the duties
as per requirement of rules.
i). The Board did not approve
the grant of new Drug
Manufacturing License to the
firm as the facility was declared
unsatisfactory and was not
recommended by the panel of
inspectors / experts in its
inspection report dated 29-032013.
ii). As per decision of the CLB, the
application of the firm for grant of
DML stands rejected under Rule
10 (4) of Drugs (Licensing,
Registering, Advertising) Rules,
1976 due to the following major
critical observation of the panel
reported in inspection report dated
29-03-2013.
a) Firm has changed layout
plan in Tablet Section with
shuffling of areas. Creation
of packing material store in
place
of
Psychotropic
Injectable Section (which
was cancelled), change of
stairs place for lift.
b) Numbers of changes have
Page 12 of 78
3.
M/s Pharmedic Laboratories Formulation
(Pvt.) Ltd, 17-KM, Multan
Road, Lahore.
Remarks:Grant of DML to the firm was not
recommended by panel being
unsatisfactory at the time of
inspection on 05-03-2013.
been made in injectable area
and microbiological lab
which needs approval from
licensing section under the
Drugs
(Licensing,
Registering
and
Advertising) Rules, 1976.
c) Some equipment of Q.C like
HPLC,
UV
Spectrophotometer
and
Production Machinery were
not operational. IQ/OQ
needs to be performed.
d) HVAC system in injection
Section
needs
to
be
validated with reference to
class A, B, C & D for sterile
operations as per GMP
requirements.
iii). Due to the above said
shortcomings the unit was
declared as unsatisfactory in the
above referred report by the panel
of inspectors / experts, hence
grant of DML was not approved
by the CLB.
i). The Board did not approve
the grant of new Drug
Manufacturing License to the
firm as the facility was reported
to be unsatisfactory and not
recommended by the panel of
inspectors / experts in its report
dated 05-03-2013.
ii). As per decision of the CLB, the
application of the firm for grant of
DML stands rejected under Rule
10 (4) of Drugs (Licensing,
Registering, Advertising) Rules,
1976 due to the following
major/critical observations of the
panel mentioned in inspection
report dated 05-03-2013.
a). Change rooms were not
completed, civil work and
electricity work was going on
b). HVAC system has been
installed but not yet functional at
Page 13 of 78
the time of inspection.
c.). Q.C Lab was under
construction at the time of
inspection,
equipment
and
instruments were not available.
d). It was observed that water
treatment/purification system is
still under the process of
installation and not ready for use.
e). No staff for QA Department.
f). Area was not neat and clean.
g). No QA / QC In charges were
hired.
h). Machinery was not installed
and ready for use at the time of
inspection.
i).SOPs were not developed for
Production & QC.
Due to the aforementioned
shortcomings the unit was
declared as unsatisfactory in the
referred to report by the panel of
inspectors / experts, hence grant
of DML was not approved by
the CLB.
Item-VII:
CASE OF M/S GELCAPS (PAKISTAN) LIMITED (DML.NO. 000282
SEMI BASIC MANUFACTURE) HUB,
BALOCHISTANFOR
SUSPENSION OF DML.
Decision of CLB
The Board decided to get the unit re-inspected for cGMP compliance as well as for
renewal of their DML. The Board also decided to direct the firm not to open the factory
till the firm is inspected and panel recommends with clear and candid recommendations
in the report as well as on the evaluation form & case is accordingly decided by the CLB.
The Board further decided to suspend the production of the firm till the decision of the
case by the Board. The case shall be placed before Central Licensing Board, along with
the inspection report of the panel constituted for the purpose of verification of redressal
of shortfalls / deficiencies reported previously in panel inspection report dated 28-022011and under taking by the firm to address these shortcomings for consideration &
decision by the Board.
Page 14 of 78
Item-VIII:
MISCELLANEOUS CASES.
(a) RENEWAL OF DRUG MANUFACTURING LICENSE OF M/s NOVARTIS
PHARMA PAKISTAN LTD, KARACHI DML NO. 000193 (FORMULATION)
Mr. Khalid Yousuf excused himself from discussion / decision with regards to this case
as he disclosed that he is a Pharmaceutical Consultant for Novartis and wants to remain
impartial in deciding the matter.
Decision of CLB
In the light of detailed background of the case mentioned in agenda, thorough discussion
& deliberation among the members, the Board decided to get the firm re-inspected by
panel of experts / inspectors for verification of conditions of Drug Manufacturing License
No. 000193 (Formulation). The Board also decided that the firm may be directed to
submit formal application for grant of additional section for Capsule (General) and
application for renewal of their DML (Formulation) on Form 1A along with all necessary
enclosures as the pervious application was for renewal of DML (Re-packaging) which is
not defined in Law and Rules. The Board also decided to give three months time to the
firm for doing the needful as recommended by panel of experts in its report dated 20-062013. It was also decided that no further time will be given to the firm on the issue /
matter. The case was deferred due to aforementioned reasons and will be placed
before the Board as and when a fresh report by panel is received as mentioned
above.
(b) APPLICATION OF M/s ABBOTT LABORATORIES PAKISTAN LTD,
KARACHI FOR CANCELLATION OF THEIR DMLNO. 000005 (BASIC
MANUFACTURE).
Decision of CLB.
After hearing the firm’s representative Mr. Anis Shah, Director Plant Operation,
considering written request mentioned in agenda and thorough discussion and
deliberation among the members of the Board on the issue, the Central Licensing Board
did not accede to the request of the firm for cancellation of their DML No. 000005 (Basic
Manufacture). The board directed to get the clarification from the firm on following
issues.




Documentary evidence supported by relevant documents / information
mentioning that why this license has not been feasible to operate.
The drugs registration directorate shall be asked for clarification regarding
approval of change of source of their Aluminum Hydroxide Gel for use in their
registered products (i.e. Antacids like Dijex MP and Dijex).
The firm shall be asked to clarify that how the import of Aluminum Hydroxide
Gels had been feasible in spite of enhanced duty structure where said API is
approved for local production under the rules?
The firm shall also be asked how their Formulation Products are being
manufactured if they have changed their source after closure of their facility?
Page 15 of 78


Since, the representative of firm stated that they had been enhancing the capacity
of this plant from 500 kg to 1000 kg in the past and now how this plant is
suddenly unfeasible to run at once?
The Drug policy has given different incentives to basic / semi basic manufacture
so the firm’s request for cancellation of DML No. 000005 (basic manufacture) is
absolutely illogical / irrational that tantamount to deprive this country from an
API, being manufactured indigenously.
It was also decided that the case shall be presented before CLB in its next meeting
after getting the response / clarification from the concerned on the above stated
queries.
(c) M/S BRAND PHARMA INTERNATIONAL, KARACHI. DML NO. 000684
(FORMULATION) - CASE OF NON-COMPLIANCE OF CONDITIONS OF
DML/cGMP).
DECISION OF CLB.
The case was discussed in detail wherein Dr. Ali Akbar Sial, Mr. Salim Isharat
Husain, Syed Jawed Yousaf Bukhari and Mr. Khalid Yousuf (All Members of CLB from
Karachi / Sindh) were of the opinion that closure of the unit due to Law & Order situation
in Phase II S.I.T.E Super Highway Karachi is a lame excuse by the management as
mentioned in their reply received in DC (QA) office on 24-08-2012. These members of
CLB argued that about 20 Pharma units are operational in the same industrial area of
Karachi where M/s Brand Pharma International is located. In the light of facts narrated by
honorable members of the Board as stated above and deliberations made in the meeting,
the Board concluded and decided as under:i). The Board unanimously decided to suspend the DML No.
000684(Formulation) of the firm for a period of six months, as the firm had
contravened the conditions of DML No. 000684 (Formulation) and due to noncompliance of cGMP under Schedule B of Drugs (L, R & A) Rules 1976 and
failed to appear before the Board in spite of five show cause notices /
opportunities of personal hearing given to the firm.
ii). The Board further decided to get explanation from the panel for not submitting
inspection report in the matter as directed by the Board vide DRAP letter dated
20-05-2013. It was further decided to get the facility inspected by some other
panel for facts finding and present the report in the next meeting of the Board.
(d) CASE OF RENEWAL OF DML (NO. 000497) FORMULATION M/s
MACQUINS INTERNATIONAL, KARACHI.
DECISION OF CLB.
The Board observed that as the provision in the Rule 5[2A] of Drugs (L, R & A)
Rules 1976 is present to deal the matters regarding submitting application for renewal of
DML and rectifying the shortcomings / deficiencies therein, if any, as in the instant case
their application made by M/s Macquins International Karachi for renewal of their DML
was observed grossly deficient of requirements laid down in the said rules. Rule 5[2A] of
Drugs (L, R & A) Rules 1976 is reproduced as under:
Page 16 of 78
“On receipt of an application for renewal of a license any objection or shortcoming in
the application observed by the CLB may be notified to the applicant and he shall be
given a time period of thirty days for rectification or completion of the application. In
case he fails to rectify or complete the application within the specified period, the
application may be rejected.”
The Board also observed that in spite of two letters issued to the firm by Drug
Regulatory Authority of Pakistan on 01-03-2013 and 17-04-2013, the firm failed to
rectify the shortcomings and complete their application as provided under Rule 5[2A] of
Drugs (L, R & A) Rules 1976. In light of afore said legal provision and facts narrated, the
CLB decided as under:
“The Board took serious notice of the casual attitude of the management of the firm
in submitting/completing the application for renewal of DML despite notifying them
twice and decided to reject the application for renewal of DML of the firm.”
(e) REQUEST FOR CHANGE OF MANAGEMENT OF M/S WELLBORNE
PHARMACHEM LABS, HATTAR-DML NO. 000657 (FORMULATION) AND
DML No.000653 (SEMI BASIC MANUFACTURE) AND STANCE FOR
RETAINING OF NAME OF FIRM AS M/s WELLBORNE PHARMACHEM AND
BIOLOGICALS, HATTAR ISSUED ON DML.
Decision of CLB.
The Board acceded to the request of the firm M/s Wellborne Pharmachem and
Biologicals, Hattar DML No. 000657 (formulation) and DML No.000653 (semi basic
manufacture) for change of its management based on provision of relevant documents for
this purpose and retaining of name of firm as M/s Wellborne Pharmachem and
Biologicals, Hattar as per it’s DMLs, and also for correction of record of licensing section
as described in agenda item. Further the new management had already been the partner
(s) / share holder (s) of said firm previously. The Board further decided that if any legal
anomaly arises at later stage between partners, the sole responsibility would lie on the
deponents. The CLB and the DRAP would not be held responsible in any case.
(f) M/S SYNTEX PHARMACEUTICALS, KAMRA ROAD, ATTOCK CITY,
DML NO. 000290 (FORMULATION).
BACKGROUND
The Central Licensing Board was apprised that the Federal Inspector of Drugs
along with Mr. Ahmad Mahmood Mumtaz, DDG (E&M) Islamabad visited M/s Syntex
Pharmaceuticals, Kamra Road, Attock City, DML (No. 000290) Formulation on 30-052013 to check and verify the compliance of firm towards GMP and reported that the firm
was found closed for the time being and that the Management had informed further that
they intend to open the factory premises within a month. Thereby the firm had violated
the condition of Drug Manufacturing License under Drugs (Licensing, Registering &
Advertising) Rules, 1976.
Page 17 of 78
DECISION OF CLB.
The Board after thorough discussion / deliberation and taking into
consideration the legal provisions as laid down under Section 41 of the Drugs Act, 1976
and the rules framed there under decided as follows: 1. To issue a show cause notice to the firm as why the firm had been closed without
prior permission from or information to the Competent Authority and provide the
firm an opportunity of personal hearing in the upcoming meeting of the Board.
2. To get the unit inspected by a larger panel of experts to verify compliance of the
firm towards the conditions of DML and cGMP as required under the Drugs
(Licensing, Registering & Advertising) Rules, 1976 as reportedly by the FID, the
facility had been closed by the management at their own. The inspection report by
panel shall be placed before the Board in its next meeting for consideration /
decision.
3. The Board also desired to direct the FIDs / Field Officers to inspect such premises
in their respective area of jurisdiction for which he/she may take assistance of the
law enforcing agencies and that no stone should be left unturned to inspect such
units promptly even by follow up visits.
(g)
M/S EVEREST PHARMACEUTICALS, ISLAMABAD, DML NO. 000535
(FORMULATION).
BACKGROUND OF THE CASE
The Central Licensing Board was apprised that the Federal Inspector of Drugs,
Islamabad-I had informed that he visited M/s Everest Pharmaceuticals (Pvt) Ltd, Plot
No.124, Industrial Triangle Kahuta Road, Islamabad on 18-06-2013 for the purpose of
GMP inspection. The firm was found closed and that the security supervisor present at
the gate informed him that the owner of the property has got the possession of the
building through learned Court Order. Thereby the firm had violated the condition of
DML.
Decision of CLB
The Board after thorough discussion / deliberation and taking into consideration
the legal provisions as laid down under Section 41 of the Drugs Act, 1976 and the rules
framed there under decided as follows: a. To issue a show cause notice to the firm as why the firm had been closed without
prior permission from or information to the Competent Authority and provide the
firm an opportunity of personal hearing in the upcoming meeting of the Board.
b. To get the unit inspected by a larger panel of experts to verify compliance of the
firm towards the conditions of DML and cGMP as required under the Drugs (L, R
& A) Rules, 1976 as reportedly by the FID, the possession of the building /
Licensed Premises has been taken up by Owner of Property through some Court
Order. The inspection report by panel shall be placed before the Board in its next
meeting for consideration / decision.
c. The Board also desired to direct the FIDs / Field Officers to inspect such premises
in their respective area of jurisdiction for which he/she may take assistance of the
law enforcing agencies and that no stone should be left unturned to inspect such
units promptly even by follow up visits.
Page 18 of 78
Item-IX:- POLICY REGARDING ESTABLISHMENT OF PHARMACEUTICAL
UNITS LOCATED IN RESIDENTIAL AREAS.
The Central Licensing Board in its 228th meeting had decided to issue show cause
notices to the firms located in the residential area with the directions to shift their units to
the industrial areas. Accordingly as per directions of the Board show cause notices were
served to the M/s Bliss Industries Ltd, Karachi, M/s Cresent Cotton, Okara, M/s Soma
Laboratories, Lahore and M/s Shamsi Pharmacy, Lahore and opportunities of personal
hearing had also been given to the firms. The firms’ replies to the show cause notices
were discussed in the previous meetings of the Board. The cases were again discussed in
232ndmeeting held on 29th& 30th July 2013 of CLB too in view of decisions taken in 231st
meeting of CLB held on 31-01-2013.
The cases of the individual firms in detail and the decision of the Board taken thereof in
232nd meeting are as under: -
S.#
Name of Company / Case background
1. M/s Bliss Industries Ltd, 225/2, J.M. Sadhu Naval
Rai Road, Karachi.
In response to show cause notice bearing No. F. 215/95-Lic (Vol-I) dated July 2012. M/s Bliss
Pharmaceuticals had informed that they had started
construction of their facility at new site in Korangi
as per approved layout plan. But because of law and
order situation in Korangi Karachi they could not
completed their construction timely.
Decision of CLB
The Board in its 232nd
meeting discussed the
case in the light of
decision taken in 231st
meeting of the Board in
detail. Syed Jawed
Yousaf
Bukhari
member CLB furnished
a panel report which
was asked to inspect
In compliance to the decision of CLB taken in its the new site of the firm
231st meeting a panel comprising Syed Jawed in Korangi Industrial
Yousaf Bukhari, Member CLB, Area FID and Area area.
ADC was constituted to conduct the inspection of The
Board
was
the firm. Due to delay, a reminder was also issued apprised by him that
for timely conduction of inspection of the firm to Panel tried to contact
verify progress made by the firm at the new site so Mr.
Ashraf,
far. In compliance to the decision of CLB taken in representative
/
its 231st meeting show cause notice/letter for spokesman of the firm
personal hearing dated 25thJuly 2013, was issued so that the new site
and the firm’s representative was called before the may be inspected to
Board. None of the accused/ representative of the check the progress but
firm appeared before the Board for personal hearing. the management was
not serious and that he
did not coordinate and
respond for the needful.
It was also disclosed by
the worthy member that
the panel also tried to
trace out the location of
the new site in Korangi
Page 19 of 78
Industrial area, but
failed to find out the
same.
2.
M/s Cresent Cotton, Chowk Depalpur, Okara.
A show cause notice was issued to M/s
Cresent Cotton, Okara regarding their unit located in
residential area. In response to Show Cause notice
the firm has informed that it is located in
commercial / industrial area instead of residential
area and got NOC from TMA, Okara.
2.
The Board in its 230th meeting decided to
direct the area FID to inspect the premises again and
take the necessary documents as the firm is claiming
for verification. The Board also directed to advise
the area FID to take and verify the NOC obtained
from TMA, Okara and approval from concerned
provincial Building Control Authorities (BCA).
The Board in the light
of above said report of
the panel and decision
taken in 231st meeting
of the CLB decided
that
(i) To defer the case
of firm located in the
congested residential
area of Karachi.
(ii) One more but the
last opportunity of
personal hearing be
given to the owner /
management of the
firm.
(iii) Failing to appear
before the CLB, the
license of the firm shall
be
suspended/
cancelled and case shall
be
forwarded
to
Registration Board for
cancellation
/
suspension of products
registered in the name
of firm.
The
Board
after
thorough discussion /
deliberation,
considering the report
of the FID and keeping
in view the legal
provisions decided as
under: i). The case should be
processed and actions
shall be taken as per
provisions of Schedule
B of Drug (L, R & A)
Rules 1976.
ii). Management of the
3.
Subsequently the Area FID reported that the firm be asked to shift to
facility is located on Main Adda Road. In front of some Industrial area as
the factory there is a shop of Fazal Broast, TV there is no provision of
Page 20 of 78
repairing shop, a clinic, on left there are furniture
making shops, Qamar Cotton Industries is also on
same road, and beside the industry one house has
been built above the shops. The firm has also
produced an attested copy (verified) of a letter of
Tehseel Officer TMA Okara certifying that Cresent
Cotton Industry situated at Chowk Depalpur Road is
a commercial / industrial area.
Law
&Rules
that
allows Pharma unit in
industrial/ commercial
area, as per current
status of the firm.
iii). Renewal of DML
of the firm will be
decided in the light of
4. The FID in her report concluded that the firm is commitment of firm for
located in commercial area.
shifting of their unit to
some industrial area as
per requirement of Law
5. Tehseel Officer (P&C), TMA Okara was also & Rules.
requested vide letter No. F. 1-7/84-Lic (Vol-I)
dated 20-05-2013 for verification of a separate
Industrial Area in Tehseel Okara but the reply is
still awaited.
The Board was apprised about the provisions of
Schedule “B” of Drugs (Licensing, Registering &
Advertising) Rules, 1976.
3.
The case was placed before the Board for its
consideration/ decision, keeping in view various
industrial incidents/disasters which coasted loss of
precious human lives as in case of unfortunate
incident of M/s Orient Labs, Lahore.
M/s Soma Laboratories 692-N, Samanabad,
Lahore.
A show cause notice was issued to M/s Soma
Laboratories, Lahore regarding their unit located in
residential area. In response to Show Cause Notice
the firm stated that they are not contravening the
section 41 of Drugs Act, 1976 because they got
license in 1981 while the rules for condition of
location of manufacturing was added in the year
1998. The firm was called for personal hearing in
230th meeting of CLB but they did not appear before
the Central Licensing Board. The Board took serious
notice regarding manufacturing of drugs in
residential area and decided to defer the case till
next meeting and one more opportunity for personal
hearing was granted.
Mr. Mian Ghulam Jelani appeared for personal
hearing meeting of the Central Licensing Board in
its 231st held on 30-01-2013 and committed that they
will shift their unit within one year and has
voluntarily stopped the production. The Board
The
Board
after
thorough discussion /
deliberations,
taking
into
account
commitment of the firm
before the CLB in its
previous meeting and
keeping in view the
legal
provisions
decided as under: (i). Suspension of
DML of the firm with
immediate effect for a
period of six months
so as to avoid any
industrial incident /
disaster which may cost
loss of precious human
lives as occurred in
case of M/s Orient
Page 21 of 78
decided to suspend the production for a period of Labs Lahore as the firm
three months and verification from Area FID was is located in congested
also advised.
residential area of
Samanabad
Lahore.
The area FID has submitted report dated 03-06-2013 The area FID should
stating that the firm was closed and no production ensure the closure of
activities was observed.
unit / stoppage of
production and report
The case was placed before the Board for its in this regard be
consideration/ decision, keeping in view various submitted to CLB on
industrial incidents / disasters which coasted loss of monthly basis without
precious human lives as in case of unfortunate fail.
incident of M/s Orient Labs, Lahore.
ii).The
Drug
Registration Board is
informed about the
suspension of DML of
the firm for further
necessary action.
iii). The management
be directed to shift their
unit in industrial area
and to
furnish the
progress
report
regarding the shifting
of unit as per their
commitment
made
before the CLB in its
231st meeting held on
30-01-2013.
4.
M/s Shamsi Pharmacy, Samanabad, Lahore.
A show cause notice was issued to M/s
Shamsi Pharmacy, Lahore regarding their unit
located in residential area. In response to show cause
notice the firm has replied that they are not working
in old unit since 2010. Area FID as reported that the
firm has suspended its production and it is not
operational. They also want to postpone the matter
because of their father death and some family issues.
2
The firm was called for personal hearing in
230 meeting of CLB but they did not appear before
the Central Licensing Board. The Board took serious
th
iv). Area FID be
directed to inspect the
new site and submit its
progress report.
The
Board
after
thorough discussion /
deliberation,
considering the report
of the FID, taking into
account commitment of
the firm before the
CLB in its previous
meeting and keeping in
view
the
legal
provisions decided as
under: Page 22 of 78
notice regarding manufacturing of drugs in
residential area and decided to defer the case till
next meeting and one more opportunity for personal
hearing was granted.
3. Mr. Faisal Maqbool the Son of deceased
owner appeared before the Board in 231st meeting of
CLB who committed that they are ready for
inspection at new place. The Board in 231st meeting
decided to get the inspection of the premises where
firm intends to shift their unit and decided to
suspend the production at the congested area of
Samanabad. Lahore. The board further decided to
get an inspection conducted by Area FID so as to
verify the production activity at existing site.
4. The Area FID in response to DRAP letter
dated
17-05-2013 has reported that she has
inspected the facility to check the production status
of the firm 20-06-2013 in the presence of Mr. Faisal
Maqbool Son of deceased owner of the firm. It has
been further reported that no production activity was
going on at the time of inspection. However,
finished goods were stored in large quantities in two
rooms without any temperature control. Bundles of
fresh units cottons of different products were also
store bearing manufacturing date 2009 & 2010 etc.
The FID also took samples of two products i.e. Mag.
Sulphate B.P. Batch No. 43 Manufacturing date 062011 and Kaolin Light Batch No. 30 Mfg. date 062010 for test / analysis purpose. The FID has also
stated that as per availability of sample of Mag.
Sulphate bearing Manufacturing date 06-2011 and
expiry date use within 04 years clearly show that the
firm has manufacturing the products after 2010
which is contrary to the reply of firm about the
closure of the unit since 2010. FID has also
mentioned that the products of M/s Shamsi
Pharmacy are also available in the Market bearing
manufacturing dates 2009, 2010 and 2011 etc.
(i). Suspension of
DML of the firm with
immediate effect for a
period of six months
so as to avoid any
Industrial incident /
disaster which may cost
loss of precious human
lives as occurred in
case of M/s Orient
Labs Lahore as the firm
is located in congested
residential area of
Samanabad Lahore.
ii).
The
Drug
Registration Board be
informed about the
suspension of DML of
the firm for further
necessary action.
iii). The management
be directed to shift their
unit in industrial area
and to
furnish the
progress
report
regarding the shifting
of unit as per their
commitment
made
before the CLB in its
231st meeting held on
30-01-2013.
iv). Area FID be asked
about the action taken
on
availability
of
products manufactured
in the period of closure
of firm available in the
market.
5. Now the firm has been called for personal
hearing again in 232nd meeting of CLB. None of the
representative of the firm appeared before the Board
for the said personal hearing.
Page 23 of 78
Item-X: CHANGE OF NAME OF FIRMS.
DECISION OF CLB.
The Board approved the cases for change of names of following firms on the basis
of documents submitted by firms.
S.NO
1.
2.
FROM
TO
M/s Searle Pakistan Limited, Karachi M/s
The
Searle
DML No. (000016) Formulation.
Company
Limited,
Karachi DML No.
(000016)
M/s Searle Pakistan Limited, Lahore Formulation.
DML No. (000647) Formulation.
M/s
The
Searle
Company
Limited,
Lahore DML No.
(000647)
Formulation.
Both
subject
to
provision of SECP
documents.
M/s Chas. A. Mendoza, Karachi. DML M/s LE Mendoza
No. (000140) Formulation
Pharmaceutical (Pvt.)
Ltd, Karachi. DML
No.
(000140)
Formulation
Subject to provision
of SECP documents
The Board also decided to get the facilities of M/s Searle Pakistan Limited,
Karachi at Korangi site inspected by a panel as this site is reportedly used for
manufacturing nutraceutical products as informed by Mr. Salim Isharat Chief Drug
Inspector, Sindh (Member CLB). The Board further decided to get the inspection of two
separate premises of M/s Searle Pakistan Limited in Karachi i.e. Korangi Industrial area
and S.I.T.E Karachi by panel of experts to ascertain the status of licenses of these Sites
and check production activities being carried out at these two sites.
The Board was also apprised by Mr. Salim Isharat Husain, Chief Drug Inspector,
Sindh (Member CLB) that M/s Searle Pakistan Limited is already using its new proposed
name i.e. “The Searle Company Limited” w.e.f. 04-09-2012 as observed on the
packaging components of the products of the firm manufactured by M/s Novamed
Pharma Lahore on contract basis for which explanation / clarification needs to be
obtained from both these firms for using the new name without approval from CLB.
Mr. Ayaz Ali Khan, Chief Drugs Controller, Health Department, Govt. of Punjab
(Member CLB) also reported that M/s Searle Pakistan Limited, Lahore is using two
separate buildings for their Lahore plant. The Board decided to get a verification report
by a panel regarding the status of license of the firm for these two premises and check
production activities being carried out at these two sites.
Page 24 of 78
The reports regarding the above said clarification/ queries/ issues will be
presented before the CLB after receipt of the same.
Item-XI DELEGATION OF POWERS TO THE MEMBERS OF THE BOARD.
DECISION OF CLB.
The Central Licensing Board in its 232nd meeting approved delegation of
following powers to its Chairman and Secretary for a period of one year with immediate
effect under Rule 8 (10) of the Drugs (Licensing, Registering & Advertising) Rules, 1976
in order to facilitate timely disposal of routine / day to day business of Central Licensing
Board.
Sr #
Powers
i).
Show Cause Notice regarding contravention
of any of the provisions of the Drugs Act,
1976 and rules framed there under.
ii).
Suspensions of Production
iii). Lodging of FIR
iv). Issuance of Inspection Book
Powder to be Delegated to
Chairman CLB
v).
Chairman CLB through a
committee comprising of
DDG(L&A), DDC(L&A),
DDC(Lic) and ADC (Lic)
Secretary CLB
vi).
Approval of layout plan
Approval of Technical Staff and
communication/issuance of Decisions of
Central Licensing Board.
vii). Site approval.
viii). i) Approval of change of name of an
unlicensed firm / unit (before the
approval of site).
ix). ii) Approval of change of name of a firm
for licensed units/unlicensed units (after
the site approval).
iii) Approval of drugs (molecules) for basic
and semi basic manufacturing.
iv) Implementation of decisions of
Appellate Board
v) Approval of Repacking items under
Schedule D of drugs Act 1976 and Rules
framed there under.
x).
Constitution / amendments in constitution of
panel for inspection for grant/renewal of
Drug Manufacturing License, grant of
Additional Section and verification/
checking of conditions of License etc of
firms.
xi). Extension in Sealing period of Licensed
Chairman CLB
Chairman CLB
Secretary CLB
Secretary CLB
Secretary CLB
Chairman Central Licensing
Board.
Chairman Central Licensing
Board.
Chairman Central Licensing
Page 25 of 78
xii).
manufacturers where Contravention(s) is/are Board.
of Conditions of DMLs only.
Correction of typographical error in Chairman Central Licensing
recording minutes of the meeting of the Board.
CLB.
The Central Licensing Board unanimously observed that under the rules, the matters
relating to verification / compliance of GMP requirements by the Licensed
Manufacturing Facility are dealt by the Central Licensing Board so, in order to have
uniform standards in this effect for evaluation of manufacturers both inside the country
and abroad, the matter relating to the foreign facilities inspections should also be dealt by
the same Board as such inspections are undertaken for verification of compliance towards
the GMP requirements by the Manufacturers abroad . The Central Licensing Board
directed to refer its aforementioned observation to the DRAP for its consideration /
implementation.
Item-XII:
GRANT OF CASES / LAYOUT PLANS OF ADDITIONAL
SECTIONS FOR PSYCHOTROPIC / NARCOTIC DRUGS
PENDING / DEFERRED.
The Central Licensing Board in its 227th meeting deferred the approvals of Psychotropic /
Narcotic sections of all the firms placed on the agenda till recommendation of the interministerial committee specifically constituted for Psychotropic/Narcotic Drugs. The
concerned section of Narcotic / Psychotropic / Controlled Drugs of DRAP has informed
that the subject case was placed before the
11th meeting of the committee on
allocation of the controlled drugs under Ministry of National Narcotics Control held on
6th May 2013 and forwarded the extract of the minutes of the meeting which is being
reproduced as under: “The Committee decided that CLB may consider the Licensing and approval of
additional sections for manufacture of controlled drugs/substances in the light of
relevant Act and rules. The Committee on Allocation of Controlled Drugs will consider
matter for allocation of Controlled Drugs in the light of relevant laws and rules after
registration”.
DECISION OF CLB.
The Board after taking into consideration all pros and cons of the matter and taking
in account decision of meeting of Inter-Ministerial Committee on allocation of the
controlled drugs, decided to withheld / defer the cases for approval of layout plans
and grant of additional sections for Psychotropic / Narcotics Drugs due to the
following reasons: 
The Board decided to send a reference regarding the above mentioned decision to
Director Controlled Drugs, DRAP with the recommendations of CLB to take up
the matter with Ministry of National Narcotics Control on following issues as the
Central Licensing Board is of opinion that clarification is required to be solicited
to proceed further in to the matter.
Page 26 of 78

There is no provision under the Drugs Act, 1976 and rules framed there under to
process the cases for approval of Building Layout plans & sections / additional
sections for production of Psychotropic / Narcotic drugs.

The above mentioned decision of the Inter Ministerial Committee and previous
decisions of CLB & DRB need to be revisited as most of the CLB members
attending the meeting were of view that as per international practice there is no
need of segregated / dedicated facility for manufacturing of Psychotropic /
Narcotic products.
The members of CLB namely Mr. Salim Isharat Husain, Mr. Khalid Yousuf, Syed
Jawed Yousaf Bukhari, Dr. Ali Akbar Sial and Mr. Nadeem Iqbal were of view
to grant approval of Psychotropic/Narcotic drugs in general sections since

i.
ii.
iii.



No Separate Area is required for manufacturing of Solids or Liquids
Psychotropic / Narcotics Dugs in other countries including WHO, FDA
USA, FDA India etc., hence why should we put extra burden on our
manufacturers for dedicated areas with dedicated HVACs.
Cross Contamination in the world is handled by Robust Systems and
Validation / Cleaning Validation etc. for Psychotropic / Narcotic
substances. Even the API’s of Psychotropic / Narcotics are manufactured
in General Sections in the world.
Only Beta Lactams. Cephalosporin, Anabolic Steroids, etc. requires
dedicated facilities.
However members of CLB, Mr. Ayaz Ali Khan, Chief Drugs Controller, Health
Department, Govt. of Punjab, Prof. Gul Majeed Khan, and Mr. Ahmad Din
Ansari, Secretary CLB were of view that there must be some more deliberations
on the subject issue and policy of dedication / segregation of Psychotropic /
Narcotic drugs may not be discontinued with one pen stroke. Furthermore
CL&RB in its 184th meeting held on 23-08-2004 “decided to allow the firms upto
31st December 2005 to establish segregated facilities for Psychotropic / Narcotic
Drugs. However, during this period they may manufacture both categories of
drugs in their previous facilities but after this period complete shift over to
segregated facilities shall be mandatory otherwise they have to surrender their
registrations for these drugs”.
It is further decided that every member of CLB will send his recommendations
supported by documentary evidence for revisiting policy decision sent by the
Directorate of Controlled Drugs in collaboration with Ministry of National
Narcotics Control accordingly.
The representatives from PPMA and Pharma Bureau also agreed to issue
approvals of the deferred cases / sections of Psychotropic/ Narcotic Drugs after
receiving the fresh reference from Directorate of Controlled Drugs as stated
above.
Item-XIII.
ACQUISITION OF LICENSED PREMISES OF M/s BREEZE
PHARMA (Pvt.) LTD, DML No. 000659 (FORMULATION) BY M/s
ICI PAKISTAN LIMITED ON LEASE HOLD RIGHTS.
Page 27 of 78
DECISION OF CLB
The Board decided to defer the case and desired personal hearing from the owners /
directors of M/s ICI Pakistan Ltd and M/s Breeze Pharma (Pvt.) Ltd to update the CLB
on their request regarding acquisition of licensed premises on lease agreement rights as
there is no provision in Law & Rules to acquire licensed Pharma unit on lease hold rights.
Item-XIV.
ACQUISITION OF LICENSED PREMISES OF M/s MAC & RAINS
(PVT.) LTD, LAHORE DML No. 000586 (FORMULATION) BY M/s
SEARLE LABORATORIES(PVT.) LIMITED ON LEASE HOLD
RIGHTS
DECISION OF CLB
The Board decided to defer the case and desired personal hearing from the owners /
directors of M/s Mac & Rains (Pvt.) Ltd, Lahore and M/s Searle Laboratories (Pvt.) Ltd
to update the CLB on their request regarding acquisition of licensed premises on lease
agreement rights as there is no provision in Law & Rules to acquire Licensed Pharma
unit on lease hold rights.
Item-XV.
REQUIREMENT OF PLOT SIZE UNDER SCHEDULE “B” OF
THE DRUGS LICENSING, REGISTERING AND ADVERTISING
RULES, 1976
DECISION OF CLB
The Board decided to reject the application of M/s Mediflow Pharmaceutical Pvt. Ltd.,
Karachi for verification of Site for establishment of Pharmaceutical Unit on the basis that
area of the plot acquired (1955 square yards) was not meeting the requirement as laid
down under section 1 of Para 1.3 of Schedule B of the Drugs (L, R & A) Rules 1976
framed under the Drugs Act, 1976. The Board desired that the provisions of rules shall be
strictly adhered to and no relaxation could be granted on the request of the firm.
Item-XVI
NOTICE FROM DRUG COURT MULTAN FOR SUSPENSION OF
DRUG MANUFACTURING LICENSE OF M/S LAWRANCE
PHARMA, LAHORE
BACKGROUND OF THE CASE
 A notice was issued by Chairman, Drug Court Multan in Case bearing
No.259/2011 under Section 23/27 of the Drugs Act, 1976 of M/s Lawrence
Pharma (Pvt) Ltd, 10-KM, Sheikhupura Road, Lahore was received to the Drug
Licensing Authority, Islamabad in the aforementioned case in which following
directions have been passed by the court.
“The Drug Licensing Authority, Islamabad in the above said case is directed
to suspend the Drug Manufacturing License of M/s Lawrence Pharma,
Lahore and its report be submitted to Court by 12.7.2013”.
Page 28 of 78
 No supplementary / supportive documents or orders of conviction or decision of
The Drug Court Multan, on contravention of any of the provisions of The Drugs
Act 1976 and Rules made there under have been provided / attached with the
above said Notice.
 As provided under Section 41 of the Drugs Act, 1976 and Rule 8(4) and Rule 12
of the Drugs (Licensing, Registering and Advertising) Rules 1976, the
cancellation and suspension of Drug Manufacturing License comes under the
domain of Central Licensing Board, Drug Regulatory Authority of Pakistan. The
Board may cancel or suspend the Drug Manufacturing License on the
contravention of such provisions of the Drugs Act, 1976 and Rules framed there
under which are likely to endanger the public health and availability of sufficient
evidence if a firm is involved in the manufacturing / sale of spurious drugs.
Moreover, serving of a Show Cause Notice and giving of an opportunity of
personal hearing to the firm / person prior to cancellation or suspension of Drug
Manufacturing License is also mandatory under the aforesaid provisions of law /
rules.
 As no documentary evidence(s) has been provided regarding the
contraventions of provisions of The Drugs Act, 1976 and Rules framed there
under as required for the above said desired action under the relevant law /
rules, so the matter was placed before the Central Licensing Board for
consideration, to seek its wisdom and decision.
DECISION OF CLB
The Board unanimously decided that the matter may be referred back to
Drug Court Multan for Provision of Supporting documents regarding the
case so as to proceed further accordingly. The Boar authorized the Chairman
CLB to decide the case as per relevant provisions of law/ rules in the light of
the documents / information provided by the relevant Court.
Item-XVI. The Standard Operating Procedures (SOPs) for Licensing Section along
with the requirements of documents as per Law/Rules and Practice in Vogue.
DECISION OF CLB.
The Standard Operating Procedures (SOPs) for Licensing Section along with the
requirements of documents as per Law/Rules and practice in vogue were placed
before the Central Licensing Board for its consideration and vetting. All the Board
members appreciated the effort vetted and approved the said SOPs and the
requirements of documents/pre-requisites for different purposes/ activities being
performed by the Licensing Section of DRAP. The Board also desired that these
SOPs etc so approved by the Board shall be posted on official website of DRAP and
be implemented for efficient and transparent working of the Licensing Directorate.
Page 29 of 78
A. SOP OF WORKING IN THE LICENSING DIVISION
Sr.
#
1.
Activity and Standard Operating Procedure
Site Verification:
 Application for verification of a site for its suitability to
establish a Pharmaceutical Manufacturing Unit
submitted by the firm or a person is scrutinized by
Licensing Division for the fulfillment of following prerequisites as required under rules/practice in vogue:
i.
Proper application made on covering letter / letter
head.
ii. Copy of Challan of Rs.5,000/- as fee for site
verification duly attested / endorsed by the
Statistical Officer, DRAP and original challan
retained by Statistical Officer, DRAP.
iii. Disclosure of status of firm: proprietorship,
partnership, public limited or private limited etc.
iv.
In case of partnership, copy of Partnership deed
duly executed in the court of competent
jurisdiction/registrar of the firms.
v.
Copy (ies) of CNIC of Chief Executive Officer /
Managing Director /Directors/ Partners of the
firm.
vi.
Copy of Certificate of Registration with Registrar
of Firms in case of a registered firm.
vii.
In case if firm is Private Limited, the Certificate
of Incorporation with SECP, Memorandum of
Article of Association, Form-A and Form-29
should also be furnished.
viii. Complete documents of proposed land / plot
(purchase document of land/plot, allotment letter,
transfer letter/ possession letter, Fard, copy of site
map or Aks Shajrah etc.) whatever is applicable.

In case of shortcomings in the above said required
documents the applicant is informed in writing for doing
the needful.

On completion of the application, the field officer
(DDG/FID/ADC) is asked for site verification with a
copy of the letter to the Director of the firm for
coordination with the concerned officers of the DRAP.
Time period
required for
Activity
15 days
Page 30 of 78
02.
03.
04.
Inspection for site verification by the field officer:
 The field officer (DDG/FID/ADC) inspects the site of the
proposed pharmaceutical unit to check / verify the
requirements for suitability of site as laid down under the
Drugs Act, 1976 and Schedule B of the Drugs (L, R &
A) Rules 1976 framed under the Drugs Act,1976.
 The field officer then sends the report to Licensing
Division, in either case (positive or negative report) in
the light of provision of schedule B of the Drugs
(Licensing, Registering and Advertising) Rules, 1976
either recommending or not recommending the site for
establishment of Pharmaceutical Manufacturing Unit.
Approval of the site by the Authority:
 At present the Competent Authority for granting
approval of Site for the establishment of a
pharmaceutical unit is Secretary, Central Licensing
Board as per delegation of powers approved by CLB
under the Rules.
 In case field officer recommends the site for
establishment of Pharmaceutical Unit, the case/file is
initiated / processed by the desk Officer for approval of
Secretary CLB and same is communicated to the
applicant/person/company.
 In case of adverse report by the field officer the proposed
site is rejected by the competent authority and
communicated
to
the
applicant/person/company
accordingly.
 In case of approval of the site, the firm is advised to
submit the layout plan of the proposed pharmaceutical
unit.
 The firm is informed accordingly in either case as
applicant may file an appeal before Appellate Board
under the Law against the decision of CLB.
Approval of the building layout plan by the Authority:
 At present the Competent Authority for granting
approval of building layout plan of a pharmaceutical unit
is Chairman CLB through a committee comprising of
DDG (L & A), DDC (L & A)/ DDC (Lic.), ADC (Lic.)
as per delegation of powers approved by the CLB.
 The firm submits in the Licensing Division the layout
plan of the proposed pharmaceutical unit or desired
changes therein. The request of the firm is scrutinized for
completion of the already defined pre-requisites for the
purpose.
 The layout plan is scrutinized by the scrutiny committee
as per cGMP guidelines. The Chairman of the Central
Licensing Board also performs function of Chairman of
the scrutiny committee for layout plan. The Layout Plan
30 days
10 days
30 days
Page 31 of 78
05.
06.
is approved by the committee in case it is found
compliant to the requirement of cGMP as per facilities
being constructed and drawn on the proposed layout
plan.
 In case of major shortcomings in the layout plan, the
observations are communicated to the applicant or a
technical expert or representative of the firm is asked to
discuss the layout plan with the licensing directorate.
However, the minor shortcomings are rectified by the
licensing directorate in the joint meeting.
 After approval, the duly signed and stamped layout plan
is sent to the firm for construction of the unit as per
approved layout plan and further necessary action.
However if approval is granted, the applicant is
informed/advised to construct proper building structure
with proper provision of safety exits under intimation /
seek approval of the relevant building control authorities
too.
Application for grant of Drug Manufacturing License
and panel constitution:
 The firm applies for the grant of Drug Manufacturing
License on prescribed Form 1, after completion of
construction of the unit as per approved layout plan,
installation of machinery, equipment, HVAC system,
engagement of the required technical personnel and
completing other requirements as per the Drugs Act,
1976 and Rules framed there under.
 The application is scrutinized by the licensing division
and if found same in order, it is processed further and as
per delegation of powers, a panel of experts is constituted
by the Chairman, Central Licensing Board for inspection
of the unit and evaluation of the provided facilities as
required under the rules.
 The field officer (DDG/FID) is advised for coordinating
with the other members of the panel and the firm’s
representative and conduct the panel inspection of the
firm as per checklist / evaluation form and submit the
report of inspection thereof.
 If there is any shortcoming in the application, the same is
communicated to the applicant for doing the needful in
the light of observation made by the concerned officer (s)
as per requirement of Rules. As the required information
/ documents are provided the case is processed as stated
above.
Inspection for grant of Drug Manufacturing License by
the panel:
 The panel of experts / inspectors inspects the proposed
pharmaceutical unit and carries out detailed evaluation of
the requirements as laid down as per criteria/checklist
20 days
Page 32 of 78
07.
under the Drugs Act, 1976, rules framed there under and
practice in vogue.
 In case of having all the required facilities made
available and in order, the panel recommends the grant of
Drug Manufacturing License for its approval by the
Central Licensing Board and vice versa.
 The field officer then sends the report to Licensing
Division, in either case.
Meeting of the Central Licensing Board:
 The Central Licensing Board constituted under Section 5
of the Drugs Act, 1976 consists of technical
experts/personnel from Federal and Provincial
Governments, representative of Law and Justice Division
& Academia in addition to the observers from Pharma
Bureau and PPMA.
 Meeting of the Board is held on need basis depending
upon the number of cases of grant and renewal of drug
manufacturing licenses or additional section etc. or the
other agenda items or on directions of the Federal
Government to consider and dispose off any specific
case/assignment.
 The report of the panel of experts (in either case) is
presented before the Board for consideration and
decision.
 If the rep0ort of the panel is negative, the Board rejects
the application and no application shall be entertained
within next three months of rejection but the applicant
may apply for re-inspection after removal of
shortcomings before expiry of 06 months period.
 Minutes of the meeting are prepared and signed by all the
members and the Chairman. Decisions of CLB are
communicated/ sent to all concerned after approval by
the Competent Authority.
 The certificate of Drug Manufacturing License is
prepared on prescribed Form-2 and signed by the
Secretary Licensing Board and its Chairman as provided
under the Rules and communicated to the concerned
firm.
 In case of negative panel inspection report and
subsequent rejection by the Board, the applicant can
prefer an appeal to the Appellate Board within a period
of 60 days of rejection against the decision of Central
Licensing Board.
20 days
30-45 days
DOCUMENTS / INFORMATION REQUIRED FOR SITE VERIFICATION FOR
ESTABLISHMENT OF A PHARMACEUTICAL UNIT
Following listed documents / information required for processing the request / application
i). Proper application on covering letter on letter head.
Page 33 of 78
ii). Copy of Challan of fee i.e. Rs.5,000/- for site verification deposited for
verification of site for establishment of Pharmaceutical Manufacturing Unit under
the following head of account. Original challan is duly retained by Statistical
Officer, DRAP. The Statistical Officer, DRAP endorses receipt of original challan
which is retained for this office record.
A/C No. 0010008463-100018 Allied Bank Limited
iii). Disclosure of status of firm: proprietorship, partnership, public limited or private
limited etc.
iv). Copy of Partnership deed duly executed in the court of competent
jurisdiction/registrar of the firms in case of partnership.
v). Copy (ies) of CNIC of Chief Executive Officer / Managing Director /Directors/
Partners.
vi). Copy of Certificate of Registration with Registrar of Firms in case of a registered
firm.
vii). Complete documents of proposed land / plot (purchase document of land/plot,
allotment letter, transfer letter/ possession letter, Fard, copy of site map or
AksShajrah etc.)
viii). In case if firm is Private Limited, the Certificate of Incorporation with SECP,
Memorandum and Article of Association, Form-A and Form-29 should also be
furnished.
ix). All documents submitted should be duly attested by Notary Public
/SECP/Registrar of firm’s office as the case may be.
*As per requirement of paragraph 1.1 of Schedule B under the Drugs (Licensing,
Registering and Advertising) Rules 1976, the proposed site shall be located
preferably in Industrial area and in any case not in any Residential or commercial
area and as per paragraph 1.3 of schedule ‘B’, the size of plot shall not be less
than 2000 Sq. Yards.
C.
DOCUMENTS / INFORMATION REQUIRED FOR APPROVAL OF
BUILDING LAY OUT PLAN FOR GRANT OF DML, ADDITIONAL SECTION
OR ANY DESIRED CHANGES/RELOCATION(s).
i). Proper application building covering letter on letter head clear mentioning these
in purpose of submission of layout. In case of relocation of certain section or post
of section in already approved building layout, the shifting of area/section from
where the area/section and layout plan from where the area/section is shifted.
ii). Two (02) copies of proposed layout plan for approval in terms of paragraph 2 of
section 1 of Schedule-B, under the Drug (Licensing, Registering & Advertising)
Rules 1976. The layout plan may be drawn to comply with the requirement of
Good Manufacturing Practices as laid down under the aforesaid rules.
iii). Provision of HVAC system may be given in the layout plan.
iv). Schedule of section wise covered areas be given. The minimum requirement of
area for different sections is provided in Schedule B-I of the Drugs (Licensing,
Registering and advertising) Rules 1976.
v). Fee @ of Rs 5,000/- per section as may be proposed in the layout plan to be
deposited under the following head of account and submit attested copy of
challan. Original duly retained by Statistical Officer, DRAP and its endorsement
made by Statistical Officer, DRAP for Licensing Division.
Page 34 of 78
A/C No. 0010008463-100018 Allied Bank Limited
vi). If there is any addition in already approved layout plan or any sort of revision is
desired then copy of previously approved layout plan along with newly proposed
LOP (properly highlighted new proposed areas or changes) should also be
submitted.
vii).
All documents submitted should be duly attested.
D. DOCUMENTS/INFORMATION REQUIRED FOR APPROVAL OF
TECHNICAL PERSONNEL/STAFF OF A PHARMACEUTICAL UNIT
1. Copies of academic degrees, as under the Drugs (Licensing, Registering and
Advertising) Rules, 1976.
2. Appointment letter by the employer on the letter head of the company duly signed
by the CEO or authorized person of the Company.
3. Job acceptance letter by the appointee.
4. Experience Certificate as per requirement under the Drugs (Licensing, Registering
and Advertising) Rules, 1976.
5. Copy of Computerized National Identity Card (s).
6. Registration certificate from Pharmacy Council in case of appointment of a
pharmacist.
7. Duly signed Resignation or termination letter regarding earlier approved
Production / QC In-charge.
8. Undertaking by the newly employed Production In-charge /Q.C In-charge stating
that he /she is a whole time employee in the firm as per requirement of rules and
that he/she is not working anywhere else.
9. Undertaking by the employer that the newly employed Production In-charge / Q.C
In-charge is the whole time employee of the firm as per requirement of rules and
that he/she is not working anywhere else.
10. All documents submitted should be duly attested and stamped by
CEO/MD/Director / Owner / Proprietor of the employing firm.
i).
1.
2.
3.
E. DOCUMENTS / INFORMATION REQUIRED FOR GRANT OF DRUG
MANUFACTURING LICENSE.
Properly filled in application on prescribed Form-1 along-with pro-forma and all
other required documents as per schedule A of the Drugs (Licensing, Registering
& Advertising) Rules 1976. The prescribed FORM-1 see Drugs (Licensing,
Registering & Advertising) Rules 1976 is reproduced as below:
I/we …………… of …………………hereby apply for the grant of a license to
manufacture Drugs by way of……………….on the premises situated at
……………………….
The drug (s) or class (es) of drugs intended to be manufactured: (I)
Class (es) of drugs
(II)
Dosage form(s) of drugs.
(III)
Name of drug (s).
I enclose: i.
Particulars regarding legal status of the applicant (i.e. in case of
Proprietorship the name(s) of proprietors and their address(es), in case of
firm the name and names and addresses of its partners and in the case of
company the name and address of the company and its directors).
Page 35 of 78
ii.
iii.
iv.
Details of the premises including layout plan of the factory.
Details of the section-wise equipment and machinery for manufacture and
quality control.
Names and qualifications of the Production In-charge and Quality Control
In-charge for supervising manufacturing processes and Quality Control
Department, and other technical staff working in these departments.
4. The premises and plant will be ready for inspection on ……………….. or are
ready for inspection.
Dated………………………
Signed………………………………
Place ………………………
Name, Designation & Address……..
ii). Pro-forma as per above referred Schedule A.
iii). Copy of Challan of Fee original duly retained by Statistical Officer DRAP as per
following schedule to be deposited under the following head of account
A/C No. 0010008463-100018 Allied Bank Limited
i.
Fee of Rs. 100,000/- for Grant of DML by way of Formulation.
ii. Fee of Rs. 30,000/- for Grant of DML by way of Basic and Semi Basic
Formulation.
iii. Fee of Rs. 60,000/- for Grant of DML by way of Repacking.
iv.
Fee of Rs. 5,000/- per Drugs specified in Schedule D for repacking.
iv). All documents submitted should be duly attested.
F. DOCUMENTS / INFORMATION REQUIRED FOR RENEWAL OF
DRUG MANUFACTURING LICENSE
i). Properly filled in application made to CLB/Licensing Division well before expiry of
DML on Form 1-A as prescribed vide schedule A of Drugs (Licensing, Registering &
Advertising) Rules 1976 along-with all required documents. The prescribed Form 1A is reproduced as below:
FORM-1A
1.
The drug (s) or class (es) of drugs intended to be manufactured: (I)
(II)
(III)
2.
Class (es) of drugs
Dosage form(s) of drugs.
Name of drug (s).
There have been / have not been any change in respect of: -I enclose: i.
ii.
iii.
iv.
Name of the proprietor (s) / directors (s)/ partner (s).
Details of the premises including layout plan of the factory.
Details of the section-wise equipment and machinery for manufacture and
quality control.
Names and qualifications of the Production In-charge and Quality Control
In-charge for supervising manufacturing processes and Quality Control
Department, and other technical staff working in these departments.
Page 36 of 78
3.
Statement of the Central Research Fund.
Following statement, as per audited accounts/ based on Income Tax Return for the
last five years:-
Year
Investment
1
2
Turn-over*** CRF due
3
4
C.R.F. ** paid as per
Col.4.
5
*If there is any change it should be furnished.
**(Original Challan attached).
***Central Research Fund at the rate of 1% of gross profit before deduction of
income tax.
(a) Attested copies of the last two income tax assessment order of the Income Tax
Department attached.
Dated………………………
Signed………………………………
Place ………………………
Name Designation & Address……..
ii). Copy of Challan of Fee original duly retained by Statistical Officer DRAP as per
following schedule, to be deposited under the following head of account:
A/C No. 0010008463-100018 Allied Bank Limited
1) Fee of Rs. 50,000/- for renewal of DML by way of Formulation.
2) Fee of Rs. 15,000/- for renewal of DML by way of Basic and Semi Basic
Formulation.
3) Fee of Rs. 30,000/- for renewal of DML by way of Repacking.
4) Fee of Rs. 5,000/- per Drugs specified in Schedule D for repacking.
iii). All documents submitted should be duly attested.
**************
Page 37 of 78
B. CASES OF QUALITY CONTROL SECTION
ITEM I:
CONFIRMATION OF THE MINUTES OF 231st MEETING
The Minutes of 231st meeting of the Central Licensing Board, held on 30-012013, were circulated to all members after getting approval of Chairman Board. Since no
objection was received from any member so the Minutes are presumed to be confirmed /
approved.
ITEM II:
S
No
1
New Cases
Title of Firm/ Medical
Store & Accused Name
(i)
M/s Surat Khan
Medical Store, Brewery
Road,
Opp
B.M.C
Complex, Quetta
(ii) Surat Khan, Proprietor
of M/s Surat Khan Medical
Store, Brewery Road, Opp
B.M.C Complex,Quetta.
(iii) Muhammad Aslam
Shah, Qualified Person of
M/s Surat Khan Medical
Store, Brewery Road, Opp
B.M.C Complex, Quetta.
(iv) Snaullah, (person
present at the time of visit
at M/s Surat Khan Medical
Store,)
(v) M/s Medicine Point,
Jinnah Road, Quetta
(vi) ArshadMehmood S/O
Sultan Mehmood of M/s
Medicine Point, Jinnah
Road, Quetta.
(vii) Mehmood Hassan.
Qualified Person of M/s
Medicine Point, Jinnah
Road, Quetta.
(F. No. 3-37/2010-DDC
(QC-I)
Offence
Manufacture /
Saleof Spurious,
Drugs
Section
23(1)(a)(i),
23(1)(a)(x),
23(1)(c) of Drug
Act, 1976,
Brief of the Case / Decision of
CLB
 Samples of Amoxi-Clave,
Batch
No
AE5475,
claimed
to
be
manufactured by M/s
Sandoz GmbH Austria,
(marketed by Sandoz
Division,
Novartis
Pharma Karachi), drawn
from M/s Surat Khan
Medical Store, Brewery
Road, Quetta, by FID
Quetta, on 18-06-2010
were declared Spurious
by F.G Analyst vide Test
Report No.R-646/2010,
dated
08-07-2010.M/s
Surat Khan Medical
Store, could not provide
the valid warranties/ bill
in respect of the drug
 FIR No. 14/2010 dated
06-07-2010 was lodged
against accused persons
with FIA, Crime Circle,
Quetta,
with
the
permission of Chairman
Central Licensing Board.
The FIA in its Challan
has nominated Surat
Khan, Muhammad Aslam
Shah,
Snaullah,
ArshadMehmood
as
accused in its Challan.
The FID later also
included
name
of
Mehmood
Hassan
Page 38 of 78



(Qualified person of
Medicine Point) in list of
accused and requested
permission for lodging
prosecution against all
the accused.
Show cause notices were
issued to accused on 0905-2013 and they were
called
for
personal
hearing before the Board
on 29-07-2013.
None of the accused
appeared
before
the
Board. However a person
namely
Asadullah,
claimed to be brother of
one of the accused
Snaullah, appeared before
the Board and informed
that the Surat Khan
medical store has already
furnished warranty of the
medicine point in respect
of the drug in question to
FID Quetta. He further
stated that the accused
Snaullah could not come
for personal hearing
because of the hearing of
the case in Drug Court on
30th July, 2013.
Since Asadullah failed to
produce any document /
identity in support of his
claimed
of
being
representative of the
accused Snaullah, so the
Board was doubtful about
his authenticity of his
statement.
DECISION OF CLB:
The Board, however,
decided to give final
opportunity of personal
hearing to the accused in
its next meeting and
Page 39 of 78
accordingly
case.
2.
i. Saif Medicine Company,
Medicine Whole Sale
Market, Ghanta Gharr,
Multan
ii. Muhammad Arshad
Khan,
Saif
Medicine
Company, Medicine Whole
Sale Market, Ghanta Gharr,
Multan.
iii. Nayab Cotton Products,
Maouza Alamgir, Old
Shujaabad Road, Multan.
iv.. Samih Aziz Khan,
Nayab Cotton Products,
MaouzaAlamgir,
Old
Shujaabad Road, Multan.
Manufacture &
Sale of
Unregistered drug
Section 23
(1)(a)(i), (v)(vii),
23 (b), (c)
Section 23
(1)(a)&(b)

(F. No. 3-39/2010-QC)


defer
the
Samples of Kotax Care
Crape Bandage(B.No
00018),Fine
Quality
Cotton Bandge (B No
00016), Fine Quality
Cotton Bandge(B No
00015), Export Quality
Absorbant
Cotton
Wool(B No 00015)
purported
to
be
manufactured by M/s
Nayab Cotton Multan
in 2012, drawn by FID
Lahore III, from Saif
Medicine
Company,
Multan on 12-04-2010,
were declared SubStandard
by
CDL
Karachi. On further
investigation by FID, it
was reveled that Drug
Manufacturing
Licensing on the firm
was declared invalid in
March, 1997.
FIR No. 74/2011 dated
12-04-2010 was lodged
against the five accused
with
FIA
Multan
Circle. The FIA its
Challan No. 298DD/M
dated 21-01-2013 has
nominated
Arshad
Khan, the owner of Saif
Medicine
Company,
and Samih Khan, of
Nayab Cotton Products
as accused and guilty.
Show cause notices
were issued to accused
on 18-03-2013 and they
along with firms were
calledfor
personal
hearing.
Sami
Aziz
Khan
Page 40 of 78


personally appeared on
behalf of M/s Nayab
Cotton Products Multan
while
Rana
M.
MaqsoodAfzal
Advocate represented
Muhammad
Arshad
Khan of Saif Medicine
Company, Multan.
Sami Aziz Khan denied
the charges claiming
that the Nayab Cotton
Products Multan was
not in operation since
1997. He further stated
that someone else was
manufacturing
the
products in question in
the name of Nayab
Cotton. He also termed
the FIR against him as
false and concocted.
Rana M. Maqsood
Advocate stated that
bill/warranty of the
products in questions
was given by the Sami
Aziz Khan to his client.
He further claimed /
alleged that M/s Nayab
Cotton
Products,
Multan remained in
operation despites its
Drug
Manufacturing
License
declared
invalid in March 1997
and a number of cases
has been filed against
the firm in Drug Courts
for manufacturing of
products
after
its
manufacturing licenses
being declared invalid.
DECISION OF CLB:
The Board in view of
personal hearing and after
thorough consideration of the
Page 41 of 78
available record and facts of
the case, including the
Challan furnished by FIA,
decided to allow FID to
prosecute all the accused of
the firm viz M/s Nayab
Cotton Products, Multan and
M/s Saif Medicine Company,
Multan and the firms through
their Managing Directors in
Drug Court Multan.
ITEM III MISCELLANEOUS CASES
Case No. 1
Manufacturing of Drugs without valid Drug Manufacturing License
by M/s Alfalah Pharma (Pvt.) Ltd, Shaikupura Road, Lahore. (F. No.
3-03/2012-QC)
During proceeding of the case Board was informed that in January, 2012, when
the initial reports of deaths / serious reactions in patients taking medicine from Punjab
Institute of Cardiology (PIC) were received, the FID Lahore drew samples of Alfagrel
Tablets 75mg, Batch No.034, from premises of M/s Alfalah Pharmaceuticals Ltd., Lahore
on 13-01-2012, for being one of the suspected drug and also an FIR was lodged against
the firm on 23rd January, 2011.
Later the FID, on finding that the firm at that time was operating without valid
Drug Manufacturing License, sealed the firm. The aforementioned sample of Alfagrel
Tablets was also declared substandard by Federal Government Analyst, Central Drug
Laboratory Karachi, on the basis of description. The firm, in response to FID’s letter,
calling for explanation, requested Appellate Testing of the sample under Section 22(4) of
Drugs Act, 1976.However, since at that time the subject of “Drugs and Medicine” was
devolved to the provinces under 18th Constitutional Amendment so, the FID handed over
the case along with case property to the Provincial Health Authorities, Punjab. The
Provincial Quality Control Board, Punjab later referred back the case to FID, Lahore,
pointing out various lacunas and the fact that DRAP had become functional and therefore
competent to consider the matter.
The FID Lahore, while reporting the above matter has also forwarded an
incomplete Challan, furnished by FIA, wherein after describing the above position, it is
stated that the investigation is yet to be completed.
Though, subsequently, it was learned that the drug Alfagrel Tablet of M/s Alfalah
Pharma Lahore, may not be associated with the death incidences relating to PIC,
however, from perusal of record, following violations appear to be committed by M/s
Alfalah Pharma.


Manufacturing drug without valid drug manufacturing license
Manufacturing of substandard drug Alfagrel Tablets.
Page 42 of 78
The Board was also informed in its 231st meeting that the Drug Manufacturing
License of the firm has already been re-granted in 230th meeting of CLB held on 31-082012. The Board after review of the available record and facts of the case, inter alia,
decided to issue Show cause notice to the firm. Accordingly the show cause notice dated
19th February 2013, was issued and the firm’s representative called for personal hearing
before the Board. None of the accused/ representative of the firm appeared before the
Board for personal hearing.
DECISION OF CLB:
The Board after detail deliberation of the case decided to defer the case till next
meeting in order to provide final opportunity of personal hearing to the accused / firm.
Case No. 2
Appeal by M/s Reko Pharmecal & M/s Ethical Labs Against Decision
of Central Licensing Board regarding Suspension of License of their
Oral Liquid / Syrup Sections, Taken in its 231st Meeting held on 3001-2013. (F. No. 3-29/2012-QC)
The Board was informed that the Central Licensing Board in its to 231st meeting
considered the recommendations of Provincial Quality Control Board Punjab for
cancellation of Drug Manufacturing license of M/s Reko Pharmecal (Pvt.) Ltd Lahore
and M/s Ethical laboratories (Pvt.) Ltd., Lahore for utilizing substandard
Dextromethorphan raw material for manufacturing of their cough syrups, which resulted
in death of number of patients. The Board took following decisions.
i.
ii.
iii.
iv.
v.
vi.
Import of any raw material / drug form M/s Konduskar India is banned
forthwith.
WHO Pakistan may be approached with the request to take up the matter with
the Indian authorities through WHO India.
Suspension of License of Oral Liquid / Syrup Section of M/s Reko
Pharmaceuticals for one year or till completion of investigation and decision
by the competent forum, whichever is earlier.
Suspension of License of Oral Liquid / Syrup Section of M/s Ethical Labs for
one year or till completion of investigation and decision by the competent
forum, whichever is earlier.
Recommendations to the Drug Registration Board for Cancellation of
Registration of Tyno SF Syrup of M/s Reko Pharmaceuticals and
Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs
Detail panel GMP inspection of the M/s Reko Pharmaceuticals and M/s
Ethical Labs
The Board further decided to take up the matter again after completion of
investigation by the relevant quarters
Action has been taken on the above decisions. A seven member expert committee
under the Chairmanship of Mr. Sultan Ghani (Former Director Health Canada) was
constituted by CEO, DRAP having following members.
Page 43 of 78
i.
Syed Shahid Nasir,
Ex-Member Central
Licensing Board
iv.
Dr. Riaz Bhatti,
Head of Pharmacy,
JPMC, Karachi
ii. Prof. Dr. Mahmood Ahmed,
Dean, Faculty of
Pharmacy & Alternate
Medicine, Islamia
University, Bahwalpur
iii. Dr. Mohammad S
Iqbal,
Professor,
Department of
Chemistry,
FC
Collage, Lahore
v. Prof.
Dr.
Muhammad vi. Dr.
Iftikhar
Sualeh,
Jaffery,
Head of Pharmacognosy,
Sr. Director/Head
Federal Urdu University,
of
Karachi
Technical
Division, Pfizer,
Pakistan
vii. Dr. Obaid Ali, DDC
(Training& Pharmacy
Services) DRAP,
Islamabad (Secretary /
Coordinator)
The Secretary / Coordinator committee vide an email has informed that the
committee started work in beginning of April 2013, but could not move forward because
of no availability of funds for TA/DA for members.
The Board was further informed that M/s Reko Pharmecal Lahore and Ethical
Laboratory (Pvt.) Ltd., Lahore have filed Appeals, through their attorney, before the
Central Licensing Board for reconsideration / recall of the aforementioned orders /
decisions and for de-sealing of the Oral Liquid / Syrup Section of these firms. The firms
in their appeal claimed that before passing such orders an inquiry should be conducted to
fix the responsibility as number of initial reports in respect of raw material and finished
Cough syrups issued by Federal Government Analyst CDL Karachi and DTL Lahore
were of standard quality and the later substandard reports issued were based on guess and
surmises because the government analyst has no facilities to perform the quantitative test
of levomethorphan in Pakistan. Moreover as per their claim there in no evidence to prove
that the syrup in question was the cause of death as the Secretary Health Punjab in its
report has mentioned that the all victims were narcotics addicts and were also using other
addictions materials.
While submitting the aforementioned appeals for consideration of the Central
Licensing Board, it was further informed that M/s Reko Pharmecal Lahore and M/s
Ethical Laboratory (Pvt.) Ltd Lahore had also filed Writ Petitions No. 2132/2013 &
2131/2013 respectively before the Islamabad High Court, Islamabad against the
aforementioned decision of the Board. The Court vide its order dated 21-05-2013
directed the Central Licensing Board (Respondent No. II) to decide the representation of
the Petitioners with in a period of one month from the receipt of the copy of the order.
DECISION OF CLB:
The Board considered both the appeals file by M/s Reko Pharmecal Lahore and
M/s Ethical Laboratory (Pvt.) Ltd Lahore and observed that firms have not given any
Page 44 of 78
additional/ new grounds in their appeals which could justify reconsideration of the earlier
decision of the Central Licensing Board taken in its 231st meeting held on 30-01-2013. It
was further observed that under Section 9 of Drugs Act 1976 the next higher forum
available for parties/persons aggrieved by any decision of Central Licensing Board in the
Appellate Board and appeals of both the Appellants are already pending before the
Appellate Board for decision/orders. The Central Licensing Board decided to uphold its
earlier decision taken in its 231st meeting.
Case No.3
Manufacture and sale of Un-Registered Capsules Ca-Ze (Batch No.
MN-05), Tablet Prosine (Batch No.AZ-08), Tablet Livogard (Batch No. SA-03),
Drugs by M/s Goldshef int’l (Pvt.) Ltd Lahore. (F. No. 4-10/2011-QC)
During proceedings of the case the Board was informed that The Central
Licensing Board in its 227th meeting held on 02-06-2011,granted permission to FID
Lahore for launching prosecution against following accused in Drug Court, Lahore for
manufacture of unregistered drugs viz Capsules Ca-Ze (Calcium, Zinc, Vit-E), Tablets
Prosense (Ginkgobiloba) and Tablets Livogard (Silymarin) by M/s Goldsheff Int’l,
Lahore.
i.
ii.
iii.
Mr. Aftab Siddiqi,
Chief Executive, M/s Goldsheff Int’l, Lahore.
Mr. Tahir Manzoor,
National Sales Manager, M/s Goldsheff Int’l,Lahore.
Mr. Azhar Farooq S/o Muhammad Siddique,
Owner of Tauheee-o-Hamd Printers.Royal Park, Lahore
It was further informed that the above accused were given show cause notices and
opportunity of personal hearing before the Central Licensing Board prior to taking
aforementioned decision in its 227th meeting.
Later the FID Lahore informed that the Departmental Prosecution Officer of Drug
Court, Lahore returned the case with the remarks that the company / firm’s names of both
the company / firms, involved in manufacturing of unregistered drugs mentioned above,
should be added in the list of accused. Accordingly, the permission of Central Licensing
Board is sought for including following names of the firms in the list of accused for
which prosecution permission has been granted by the Board.
i.
ii.
M/s Goldsheff Int’l (Pvt.) Ltd.,
Through its Chief Executive, 136-A, Canal View Housing Society,
Lahore.
M/s Tauheed-o-Hamd Printers,
Through its Owner,Royal Park, Lahore
DECISION OF CLB:
The Board after considering facts and available record of the case decided to
include names of M/s Goldsheff Int’l (Pvt.) Ltd Lahore and M/s Tauheed-o-Hamd
Printers, Lahore through their respective Chief Executives / owner, in the list of accused
to be prosecuted in the Drug Court Lahore.
Page 45 of 78
Case No.4
REFERENCE FROM PROVINCIAL QUALITY CONTROL
BOARD SINDH FOR CANCELLATION / SUSPENSION OF
LICENSE OF FIRMS FOR BEING CONVICTED BY DRUG
COURTS UNDER DRUGS ACT, 1976
The Board was informed that the Secretary Provincial Quality Control Board
(PQCB) Sindh has referred to the orders passed by Sindh High Court in Cr. Revision
Applications No. 103/2010 to 107/2010, during hearing dated 14-10-2010, wherein the
respondents were directed that, for persons convicted under Drugs Act, 1976, provision
of law and rules framed their under, which requires cancellation and or suspension of
licenses, be to complied with. The Secretary, PQCB, Sindh has forwarded following
cases of the firm convicted in the Drug Court Sindh for compliance of the High Court’s
orders.
S.No Firms Name and Case
No
1.
M/s Standard Drug Co.,
Hyderabad
Case No. 61/2011
Charges
Sentence Awarded
Counterfeit
and
Misbranded
Drug
Linobex-C
Syrup,
Batch No. LC-062
(Resemblance
with
lederplex liquid)
Sentence till rising of the
Court to Imtiaz Ahmed Haji
Muhammad,
Managing
partner and Miss Sabeen
Usman, QC in-charge and
fine of Rs 30,000 and
25,000 respectively
Sentence till rising of the
Court to Imtiaz Ahmed Haji
Muhammad,
Managing
partner and Miss Sabeen
Usman, QC in-charge and
fine of Rs 30,000 and
25,000 respectively
Sentence the firm and three
accused till rising of the
Court and fine of Rs 25,000
to each accused
2.
M/s Standard Drug Co., Counterfeit
Drug
Hyderabad
Linobex-C
Syrup,
Case No. 62/2011
Batch No. LC-022
(Resemblance
with
lederplex liquid)
3.
M/s
Z-Jans Substandard
lofsin
Pharmaceuticals
Tablets Batch No. 435
Peshawar
Case No. 14/2012
During proceeding of the case, the Chief Drug Inspector Sindh Mr. Saleem
Isharat, who is also the member of the Central Licensing Board, apprised the Board that
in cases where Drug Courts have awarded lighten sentences to the accused, the PQCB
Sindh, on directions of Supreme Court, approached the Sindh High Court, for enhancing
these sentences. The case is at present pending with the Sindh High Court However, the
Court, in its hearing dated 14-10-2010, gave the directions for cancellation / suspension
of licenses of convicts.
The Board was informed that the complete detail of cases which includes the back
ground of the case, test report and other relevant document have not been provided by the
PQCB, Sindh which are required for consideration of the matter and taking decision there
off.
Page 46 of 78
DECISION OF CLB:
Taking in to consideration of all the facts on record, the Board directed to obtain
complete details of all such cases from the PQCB Sindh for consideration of Central
Licensing Board in the next meeting. The case was accordingly deferred.
Case No. 5
Delegation of Powers
In order to facilitate timely disposal of routine / day to day business of Central
Licensing Board relating to contravention of various provisions of the Drugs Act, 1976
and DRAP Act, 2012, the Board decided to delegate following of its powers to the officer
mentioned against each for a period of one year with immediate effect under Rule 8 (10)
of the Drugs (Licensing, Registering & Advertising) Rules, 1976.
Sr
#
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Powers
Delegated to
Approval of Show Cause Notice regarding
contravention of any of the provision of Drugs Act,
1976 and rules framed there under for cases
relating to GMP and Quality Control matters
Suspensions of Production
(in case of GMP issues)
Panel Constitution (GMP Inspection)
Director Quality Assurance
and Laboratory Testing
Director Quality Assurance
and Laboratory Testing
Director Quality Assurance
and Laboratory Testing
Constitution / amendments of panel for GMP Director Quality Assurance
compliance inspections and Quality Control and Laboratory Testing
matters.
Monitoring performance and working of all field Director Quality Assurance
officers of Drug Regulatory Authority of Pakistan and Laboratory Testing
dealing with GMP inspections, clearance of
consignments of raw materials and finished drugs
and drug testing laboratories.
Issuance
of
Show
Cause
Notices
/ Deputy Drugs Controller
Circulars/Communication of Minutes / Decisions / (QA)/Deputy
Drugs
Directions of the Board to the Concerned quarters Controller (QC)
regarding GMP and Quality Control matters on
behalf of Secretary Board.
To continue custody of the seized stocks by the Director Quality Assurance
FID till decision of the case
and Laboratory Testing
To extend the period of “not to dispose off orders Director Quality Assurance
passed by FID “for three months.
and Laboratory Testing
To grant approval for sending Board’s portion of Director Quality Assurance
drug samples to the Appellate Laboratory.
and Laboratory Testing
Grant of extension in the time of testing to Federal Director Quality Assurance
Government Analyst.
and Laboratory Testing
Lodging of FIR
Director Quality Assurance
and Laboratory Testing
Page 47 of 78
The Board further observed that since matters relating to GMP inspections are
dealt by the Central Licensing Board so, in order to have uniform standards for
evaluation of manufacturers both inside the country and abroad, the matter relating to the
foreign GMP inspections should also be dealt by the same Board. The Board directed to
refer the aforementioned observation to DRAP for its consideration / implementation.
C.
CASES OF QUALITY ASSURANCE SECTION
MINUTES OF 232ND MEETING OF CENTRAL LICENSING BOARD (CLB)
QUALITY ASSURANCE SECTION CASES OF FIRMS WHOSE PRODUCTION
WAS STOPPED DUE TO NON-COMPLIANCE OF GMP AND VIOLATIONS OF
DRUGS (LICENSING, REGISTERING AND ADVERTISING) RULES, 1976
Item No. I (New Case):Karachi
M/s Rex Pharmaceuticals Pakistan Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
but no one appeared from the firm before the Board. The firm
informed telephonically that the Director of the firm had gone to
Saudi Arabia for performing Umrah and requested to defer the case
till next meeting of CLB.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd of Central
Licensing Board. The Board was apprised about the cases of firms
who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP including the
case under reference. The Board after thorough deliberations on all
the agenda items including the instant one, took the decision
accordingly on case to case basis.
Decision of CLB
The Board after thorough deliberations and taking in
consideration of the legal provisions as laid down under the
Drugs Act, 1976 rules framed there under decided as below:i. The Board decided that the production will remain stopped
till the final approval for resumption of production by the
Central Licensing Board.
ii. The case was deferred by Central Licensing Board till its next
meeting as per request of the firm and also to fulfill legal
requirement w.r.t show cause notice and personal hearing.
Page 48 of 78
Item No. 2 (New Case):-
M/s Ceicil Laboratories (Pvt) Ltd, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
25.03.2013. The case was placed before CLB in its 232nd meeting
and Mr. Waseem-ud-Din, Director of the firm appeared before the
Board wherein he requested for the resumption of production
based on recommendation of panel in its inspection report.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
The Board after taking into consideration, the recommendation of
panel comprising of Dr. Sheikh Akther Hussain, Incharge DRAP
Punjab, Mr. Asim Rauf, DDG (E&M), Lahore, Mr. Moazzam Ali
Khan, Secretary PQCB Punjab and Mrs. Majida Mujahid, FID
Lahore vide its inspection report dated 04.06.2013 and keeping in
view the relevant legal provisions/codal formalities and through
deliberations of the honorable members decided as under:i) The Board on the recommendations of the panel allowed the
provisional resumption of production, except manufacturing
of steroid containing products.
ii) Conduct the comprehensive broad based inspection by a
larger panel on approved audit Performa devised under
provisions of Schedule B-II for checking/verifying overall
GMP compliance level of firm within 30 days after the
resumption of its production.
iii) The firm was directed to submit the application to surrender
their registration of Cecidrom Injection (Dexamethasone
Sodium Phosphate) and all other steroidal products in
injectable dosage form till the provision of separate steroidal
section. It was also decided to refer the case to Registration
Board/Directorate of Registration for taking appropriate
action under the rules.
iv) Ask the firm to appoint qualified and experienced technical
personnel in stores and microbiological lab as admissible
under Rule 16th of Drug (Licensing, Registering and
Page 49 of 78
Advertising) Rules, 1976 and get approval therefore from
CLB.
Item No. 3 (New Case):-
M/s Ardin Pharmaceuticals, Karachi
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
25.03.2013. The case was placed before CLB in its 232nd meeting
and Mr. Saeed Taqi, Director of the firm appeared before the
Board, wherein he requested the Board that he needs approx 3
months time for the renovation/upgradation work as it is yet not
completed and the firm intends to improve their cGMP by
investing huge amount on the unit. The firm submitted an
undertaking to the Board in this regard that they will not resume
production activities till the rectification of shortcomings and
completion of renovation/up gradation work and directions of the
Board in this effect.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case, took the decision accordingly on case to case basis.
Decision of CLB
i)
The CLB after hearing the views of the Director of the
firm, acceded to the request of the firm for extension in
time period of three months to upgrade/renovate their
facility subject to the condition that the production will
not be resumed during up-gradation/renovation work and
till decision of the CLB after verification of rectification
of shortcomings by the panel of experts.
ii)
The firm will get the layout plan of their building/sections
approved in case of up-gradations/improvements of
existing facility if any change or alteration is made in the
existing/approved layout. The case shall be brought
before the notice of Central Licensing Board. In case of
failure to rectify the shortcomings and no further time
shall be granted and exparte decision shall be taken by
the CLB.
Page 50 of 78
Item No. 4 (New Case):Violations of Rule:-
Date of Hearing:-
Proceeding:-
Decision of CLB
M/s Lawrence Pharma (Pvt) Ltd, Lahore
Non fulfillment of conditions of relevant provisions of
Drugs (Licensing, Registering & Advertising) Rules, 1976
and gross violations of GMP as laid down under Schedule
B-II of Drugs (Licensing, Registering & Advertising)
Rules, 1976 framed under Drugs Act, 1976. Details of
violations are given as per relevant agenda item.
The firm was called for personal hearing on 30.07.2013
after issuance of show cause notice/ stop production dated
03.04.2013. The case was placed before CLB in its 232nd
meeting and Mr. Muhammad Razzaque Asadi, General
Manager and Mr. Tariq Javed, QC Manager were appeared
before the Board on 30.07.2013, wherein they requested
that their panel inspection has been conducted on
29.05.2013 and they may be allowed to resume production
in veterinary vial section and syrup section. The firm also
informed that their panel inspection has been conducted in
other areas on 29.07.2013 but the report is awaited. It was
observed by the Board that the firm does not have any
approved technical staff so the Board directed the firm to
proceed as per codal requirements for the approval of
qualified technical staff.
The members of the Board were provided with the agenda
of QA Section. The brief of case was presented before
232nd meeting of Central Licensing Board and Board was
apprised about the cases of firms who have violated the
conditions of DML, Rules and non compliance of GMP and
action taken by the DRAP. The Board after thorough
deliberations on all the agenda items including the instant
case, took the decision accordingly on case to case basis.
The Board after taking into consideration, the
recommendation of panel comprising of Mr. Asim Rauf,
DDG (E&M), Lahore, Mr. Moazzam Ali Khan, Secretary
PQCB Punjab and Mrs. Aisha Khalil, FID Lahore vide its
inspection report dated 29.05.2013 hearing the views of the
firm and keeping in view the relevant legal
provisions/codal formalities, and through deliberations of
the honorable members concluded and decided as under:i)
The Board on the recommendations of the panel
allowed the provisional resumption of production
in veterinary vial (general) section and syrup
section only.
ii)
The Board also decided to conduct the
comprehensive inspection of the entire facility on
approved audit Performa as per Schedule B-II of
Drugs Act, 1976 for monitoring/evaluation of
GMP compliance and conditions by the larger
panel within 30 days.
Page 51 of 78
iii)
Item No. 5 (New Case):Lahore
Violations of Rule:-
The Board decided to ask the firm to provide
copies of approval of technical staff by Licensing
Section i.e. Production In charge and QC In
charge to QA Section.
M/s Kakasian Pharmaceuticals (Pvt) Ltd,
Non fulfillment of conditions of relevant provisions of
Drugs (Licensing, Registering & Advertising) Rules, 1976
and of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed
under Drugs Act, 1976. Details of violations are given as
per relevant agenda item.
The firm was called for personal hearing on 30.07.2013
after issuance of show cause notice/ stop production order
dated 03.04.2013. The case was placed before CLB in its
232nd meeting and Mr. Iqbal Khan, Chief Executive
appeared before the Board, wherein he informed the Board
that they were in phase of shifting to new unit at Sunder
Industrial Estate. They further informed that machineries of
all sections except Injectable section were under the phase
of shifting. He added that, they were in process of deciding
whether the Injectable section be shifted to their new unit in
Sunder Industrial Estate or not.
The members of the Board were provided with the agenda
of QA Section. The brief of case was presented before
232nd meeting of Central Licensing Board and Board was
apprised about the cases of firms who have violated the
conditions of DML, Rules and non compliance of GMP and
action taken by the DRAP. The Board after thorough
deliberations on all the agenda items including the instant
case, took the decision accordingly on case to case basis.
Date of Hearing:-
Proceeding:-
Decision of CLB
i)
ii)
iii)
The Board after hearing the views of the Chief Executive
of the firm and facts of the case, decided as under:Directed the Licensing Section to verify whether the codal
formalities for shifting to new premises have been
observed/fulfilled by the firm or otherwise.
To conduct market survey through FIDs and Provincial
Drug Inspectors for the availability of stocks of the firm
in the market/ institutions as the firm was closed since
15.02.2012.
A panel inspection of the firm will be conducted for
verification of the improvements in existing premises to
verify the conditions of Drug Manufacturing License
including GMP under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976
framed under, Drugs Act, 1976.
Page 52 of 78
iv)
The production will remain stopped till the final decision
by Central Licensing Board after fulfillment of all legal
pre-requisites.
Item No. 6 (New Case):-
M/s N.B.S Pharma, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production dated 25.03.2013.
The case was placed before CLB in its 232nd meeting and Sheikh
Shahzad Nabi, Proprietor appeared before the Board wherein he
informed that the panel has been constituted to re-inspect the firm
but due to non-availability of one member of the panel, the
inspection is still lying pending.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case, took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board directed the QA Section of DRAP to send a
reminder to the panel to conduct the inspection at the
earliest with the advice to FID to coordinate with the
panel.
ii)
The Central Licensing Board deferred the case till receipt
of inspection report.
iii)
The production of the firm will remain stopped till the
final decision by Central Licensing Board.
iv)
The Board also took serious notice and showed its deep
concern on casual behavior/response of the field
offices/FIDs in conducting inspections for the purpose of
GMP compliance and for panel inspections for various
purposes under the Drugs Act 1976 and rules framed
there under which causes un necessary delay in
performing their duties.
Item No. 7 (New Case):Karachi
M/s Marvi Pharmaceuticals (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
Page 53 of 78
Date of Hearing:-
Proceeding:-
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting.
Mr. Faznani, (Father of the owner of the firm) along with Mr.
Abbas Hairder Jafari, Attorney of the firm appeared before the
Board. They informed the Board that they do not manufacture
herbal products and allopathic products/medicines in one premises
but they have two separate premises adjacent to each other, one for
herbal products and other is licensed premises having Drug
Manufacturing Licensing No.000148. He also claimed that the
Central Licensing Board has granted renewal of their Drug
Manufacturing License No.000148 (By way of formulation) but
they have not yet received the grant of renewal of DML certificate.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case, took the decision accordingly on case to case basis.
Decision of CLB
The Board after hearing the views of the firm, taking in to
account the case back ground as given in the agenda and
detailed deliberations by the members, decided as under:i)
Direction to the Licensing Section shall be sent to verify
the status of validity of license and its renewal status in
light of the claim of the firm.
ii)
A larger panel inspection will be conducted to
check/verify the claim of the firm about two different
premises and to check overall GMP conditions of the firm
as per Schedule B-II of Drugs (L.R.A) Rules 1976 framed
under the Drugs Act 1976 within 30 days.
iii)
The claim of the firm regarding false inspection report
was set aside by Central Licensing Board as the firm
confirmed/admitted before the Board stating that they mis
quoted about the said report and informed that the FID
had conducted inspection of their unit on 08.03.2013
which was produced before the Board. The firm however
was yet on the point that their DML +was still valid.
iv)
The Central Licensing Board directed to take/verify the
status of the Registrations of products of M/s Marvi
Pharmaceuticals (Pvt) Ltd, Karachi from Registration
Division as the area FID in his report had mentioned that
most of the registrations of Drugs had been expired..
v)
The production will remain stopped till the final approval
by Central Licensing Board on receipt of the inspection
Page 54 of 78
report of the firm by the larger panel of experts as
mentioned above.
Item No.8 (New Case):Lahore
M/s Perfect Pharmaceuticals (Pvt.) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
24.04.2013. The case was placed before CLB in its 232nd meeting
and Mr. Abdur Razzaq, Chief Executive appeared before the Board
wherein he requested for the resumption of production based on
the recommendation of panel of experts vide inspection report
dated 04.06.2013
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
The Board after taking into consideration, the recommendation of
panel comprising of Dr. Sheikh Akhter Hussain, Incharge DRAP
Punjab, Mr. Muazzam Ali Khan, Secretary PQCB Punjab, Mr.
Asim Rauf, DDG (E&M), Lahore/FID Lahore, and Ms.
Qurratulain Rana, ADC Lahore vide its inspection report dated
04.06.2013 hearing the views of the firm and keeping in view the
relevant legal provisions/codal formalities and through
deliberations of the honorable members decided as under:i)
The Board on the recommendations of the panel allowed
the provisional resumption of production.
Ii)
The Board also decided to conduct the broad based
inspection on approved audit Performa under Schedule
B-II of Drugs (Licensing, Registering and Advertising)
Rules 1976 framed under Drugs Act, 1976 for
verifying/checking the GMP compliance and conditions
of DML by the larger panel within 30 days after
resumption of production.
Item No. 9 (New Case):-
M/s Shafi Textile Faisalabad
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
Page 55 of 78
Date of Hearing:-
Proceeding:-
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production dated 23.04.2013.
The case was placed before CLB in its 232nd meeting and Mr.
Muhammad Abdullah, Owner of the firm appeared before the
Board wherein he informed that he has only government orders
and market supply is not in practice due to which the firm remains
closed mostly. He requested the Board that he has supply order
from Pakistan Defense Forces. Almost half of the supply order has
been done so he may be allowed to complete this supply order. He
also informed that a panel has been constituted with reference to
renewal of his premises but the inspection has not been conducted
by the panel yet. Moreover, the firm submitted an undertaking to
the Board that he (firm) will purchase land for new premises by
December, 2013 and also fulfill the codal formalities like site
verification, approval of layout plan etc.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case, took the decision accordingly on case to case basis.
Decision of CLB
i)
ii)
After hearing the views and request of the firm, the Board
decided that the Licensing Section may be asked to
expedite the inspection for renewal of DML immediately
and this case will be considered in the light of report of
panel inspection for renewal of DML.
The production will remain stopped till the final decision
by Central Licensing Board and in the light of report for
renewal of Drugs Manufacturing License by Licensing
Section.
Item No. 10 (New Case):-
M/s Aptcure (Pvt) Ltd, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production dated 23.04.2013.
The case was placed before CLB in its 232nd meeting and Mr.
Page 56 of 78
Proceeding:-
Muhammad Masood, Chief Executive and Raja Muhammad
Farooq, Director appeared before the Board wherein they informed
that their panel inspection has been conducted on 16.07.2013. The
report is awaited.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
The Board decided as under:i)
The Central Licensing Board deferred the case till panel
report is presented before Central Licensing Board to
enable Board to take the decision in the light of report.
ii)
The production will remain stopped till the final approval
by Central Licensing Board.
Item No. 11 (New Case):Lahore
M/s 3S Pharmaceuticals (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
and Mr. Naveed Ahmad Sindhu, Director of the firm appeared
before the Board wherein he has requested for the resumption of
their production based on the recommendation of panel in its
inspection report dated 27.06.2013.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case, took the decision accordingly on case to case basis.
Decision of CLB:
The Board after taking into consideration, the recommendation of
panel comprising of Dr. Sheikh Akhter Hussain, Incharge DRAP
Punjab, Mr. Asim Rauf, DDG (E&M)/FID, Lahore, Mr. Moazzam
Ali Khan, Secretary PQCB Punjab and Ms. Qurratulain Jamil
Rana, ADC Lahore vide its inspection report dated 27.06.2013,
hearing the views of the firm and keeping in view the relevant
Page 57 of 78
legal provisions/codal formalities and through deliberations of the
honorable members decided as under:i)
The Board on the recommendations of the panel allowed
the provisional resumption of production.
ii)
The firm shall be re-inspected in working condition by a
larger panel within 30 days time period after the
resumption of production as per provision of Schedule BII of Drugs (Licensing, Registering and Advertising)
Rules, 1976 framed under Drugs Act, 1976 specially
containing provision for GMP compliance.
Item No. 12 (New Case):Lahore
M/s
Prime
Laboratories
(Pvt)
Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
wherein Sheikh Zubair Iqbal, Director of the firm appeared before
the Board along with Mr Bashir Ahmad Advocate, Legal Advisor
of the firm wherein they informed that their panel inspection has
been conducted but QA Section informed the Board that they had
not received report till the date of Board’s meeting. During
proceedings Sheikh Zubair Iqbal used very harsh words for the
Board and exhibited very unethical and unprofessional attitude for
which all the members took serious notice and demonstrated their
immense displeasure.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board decided to defer the case and that production
of the firm will remain stopped till rectification of
shortcomings verified by the panel.
ii)
The Board desired that the decision shall be taken in light
of report of panel which will be presented in upcoming
meeting of Central Licensing Board.
iii)
Board also took extremely serious notice of the harsh,
unethical and unprofessional attitude of Sheikh Zubair
Iqbal, Director of the firm towards the Board during its
Page 58 of 78
iv)
proceedings and decided to issue warning to him to
refrain from such attitude before the Board and be
careful in future.
The Board also directed the representatives of PPMA and
Pharma Bureau to communicate, the serious concern and
displeasure of all the Board members regarding the un
professional, un ethical and harsh attitude of Sheikh
Zubair Iqbal, Director of the firm, to all their member
companies in general and the firm under reference in
particular under intimation to the Central Licensing
Board.
Item No. 13(New Case):-
M/s Crest Pharmaceuticals, Islamabad
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
Mr. Tariq Mahmood, Chief Executive of the firm called for
personal hearing but he did not appear before the CLB inspite of
the fact he came for the purpose but he left the meeting before his
case be heard.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i) The Board considering the facts of the case decided to
constitute a larger panel to inspect the firm on audit
performa for evaluation of GMP as laid down under
Schedule B-II of Drugs (Licensing, Registering and
Advertising) Rules, 1976 framed under of Drugs Act, 1976.
ii) The production will remain stopped till the final approval by
Central Licensing Board as the panel inspection is still to be
conducted for verification of rectification of shortcomings
indentified by area FID in his report. The case shall be
presented before next meeting of Central Licensing Board
after the receipt of panel inspection report.
Page 59 of 78
Item No. 14 (New Case):Lahore
M/s Xenon Pharmaceutical (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:-
Proceeding:-
Decision of CLB
The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
and Dr. Zulfiqar Malik, Chief Executive of the firm appeared
before the Board wherein he requested the Board to allow the firm
to resume production in all sections including Steroid syrup section
as the product being manufactured in this area is short in the
country.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
The Board after taking into consideration, the recommendation of
panel comprising of Mr. Asim Rauf, DDG (E&M), Lahore, Mr.
Moazzam Ali Khan, Secretary PQCB Punjab and Mrs. Aisha
Khalil, FID Lahore vide its inspection report dated 11-06-2013,
hearing the views of the firm and keeping in view the relevant
legal provisions/codal formalities and through deliberations of the
honorable members decided as under:-
The Board after hearing the views and request of the firm
decided as under:i)
ii)
iii)
The Board allowed the firm to resume production
provisionally in all their sections except in steroidal
sections as recommended by the panel.
The production of steroidal sections will remain stopped
till the provision/approval of dedicated facilities and
subsequent approval by the Central Licensing Board.
The Board also decided to conduct the inspection of the
firm by a larger panel on audit perform as laid down
under Schedule B-II in order to check/verify the GMP
compliance of the firm in working condition within 30
days after resumption of production.
Page 60 of 78
Item No. 15 (New Case):-
M/s Ambro Pharma (Pvt) Ltd, Islamabad
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.05.2013. The case was placed before CLB in its 232nd meeting
but no one from the firm appeared before the Board. However, the
firm in its reply to show cause notice requested that they are
upgrading/renovating their unit and more time is required to
complete this project/task.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board decided to defer the case till next meeting of
Central Licensing Board.
ii)
The production will remain stopped till the final decision
by Central Licensing Board as the panel inspection is still
to be conducted for verification of rectification of
shortcomings indentified by area FID in its report. The
case shall be presented before next meeting of Central
Licensing Board after the receipt of panel inspection
report.
Item No. 16 (New Case):Lahore
M/s Avicenna Laboratories (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production dated 26.04.2013.
The case was placed before CLB in its 232nd meeting and Mr.
Muhammad Shafiq, Production Manager appeared before the
Board wherein he informed that they have made improvements as
suggested by the FID and are ready for inspection.
Page 61 of 78
Proceeding:-
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
The Board decided the following:i)
The Board took serious notice that without prior approval
from or intimation to Central Licensing Board (Licensing
Section) how the firm involved in renovation of vaccine
production area for which the firm should be asked for
clarification by QA Section.
ii)
The Board further decided to direct the firm to establish a
self contained/dedicated facility for production of
Penicillin containing products/drugs and no production
activity of penicillin containing products shall be
conducted till provision of dedicated/self contained facility
as per requirement of relevant rules and same approval by
the CLB.
iii)
The Central Licensing Board decided that the production
will remain stopped till the final approval of Central
Licensing Board.
iv)
The Central Licensing Board also decided for a broad
based inspection of unit by a panel as per audit Performa
devised as per Schedule B-II of Drugs (Licensing,
Registering and Advertising) Rules 1976 framed under
Drugs Act, 1976 in order to check/verify the GMP
compliance level of the firm.
Item No. 17 (New Case):Lahore
M/s Dosaco Laboratories (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
29.04.2013. The case was placed before CLB in its 232nd meeting
and Mr. Muhammad Azeem, Quality Control In charge and Mr.
Humayoun Rashid, Production In charge appeared before the
Board wherein they requested the Board that they need more time
of approx 6 months as the renovation/upgradation work was under
process. The firm submitted an undertaking in this regard to the
Board.
Page 62 of 78
Proceeding:-
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i) After hearing the views and request of the firm, the Board
acceded to the request of the firm regarding extension in time
period for renovation/upgradation work for a period of 6 months.
However, the production of the firm will remain stopped till final
decision of CLB.
ii) The
Central
Licensing
Board
also
desired
that
instruction/information should be issued/conveyed to all FIDs
and all provincial Chief Drug Inspectors (Punjab, KPK, Sindh,
Baluchistan, Gilgit-Baltistan, ICT) regarding stoppage of
production of the firm w.e.f. 29.04.2013 with the advise to ensure
that a market/institutional survey should be conducted to check
the availability of Drugs of M/s Dosaco Laboratories (Pvt) Ltd,
Lahore manufactured after 29.04.2013, and for any action taken
under the law/rules shall be presented before the Board.
iii) The Board further decided to ask the firm to get layout plan of
the building approved for eye drops, penicillin (dedicated) and
steroidal products/drugs as required under rules.
iv) The Registration Board/Directorate of Registration will also be
appraised about the decision of CLB regarding suspension of
products/drugs i.e. eye drops, penicillin and steroids containing
products manufactured in these sections for immediate action
and compliance at their end as firm does not possess
manufacturing facilities/areas for these products as required
under the rules.
No.18 (New Case):-
M/s Elixir Laboratories (Pvt) Ltd, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
06.05.2013. The case was placed before CLB in its 232nd meeting
but no reply to show cause notice has been submitted by the firm
up till now and no one appeared before the Board for personal
hearing.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Page 63 of 78
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
ii)
iii)
The Board observed that the Appellate Board is
constituted under section 9 of Drugs Act, 1976 and rules
framed there-under to consider/decide appeals preferred
before it by the persons/firms who are aggrieved by any
decision of the CLB or the Registration Board etc. The
Board felt that the firm may approach to submit its
grievances before the said apex forum (Drug Appellate
Board) as provided under the Drugs Act, 1976 after
communication of decisions of Central Licensing Board.
The Board deferred the case being sub- judice and lying
pending before Islamabad High Court, Islamabad.
The Board further decided that the production of the firm
will remain stopped as the gross violations of Drug
(Licensing, Registering and Advertising) Rules1976 had
been committed by the firm.
Item No. 19 (New Case):-
M/s Risma Laboratories, Karachi
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
16.05.2013. The case was placed before CLB in its 232nd meeting
and Mr. Sohail Riaz, Director/GM of the firm appeared before the
Board wherein he informed that the panel has been constituted to
re-inspect the firm, but due to Holy month of Ramadan, the
inspection is still pending.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board deferred the case and decided that production
of the firm will remain stopped till panel inspection and
final decision by Central Licensing Board in the light of
panel inspection report.
Page 64 of 78
ii)
iii)
The Board directed the QA Section to send reminder to
panel for conducting the inspection expeditiously.
The Board also took serious notice and showed its deep
concern on casual behavior/response of the field
offices/FIDs in conducting inspection for the purpose of
GMP compliance and for panel inspections for various
purposes under the Drugs Act 1976 and rules framed
there under which causes un necessary delay in disposing
off cases by CLB.
Item No. 20 (New Case):-
M/s British Pharma, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
09.05.2013. The case was placed before CLB in its 232nd meeting
and Mr. Muhammad Akram, Production In charge appeared before
the Board wherein he informed that their panel inspection has been
conducted. The report is still awaited.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board deferred the case and decided that the
production of the firm will remain stopped till panel
inspection and final decision by Central Licensing Board
in the light of panel inspection report.
ii)
The Board also took serious notice and showed its deep
concern on casual behavior/response of the field
offices/FIDs in submitting inspection reports for the
purpose of GMP compliance and for panel inspections for
various purposes under the Drugs Act 1976 and rules
framed there under which causes un necessary delay in
disposing off cases by CLB.
Item No. 21 (New Case):-
M/s Medivet (Pvt) Ltd, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
Page 65 of 78
Date of Hearing:-
Proceeding:-
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
09.05.2013. The case was placed before CLB in its 232nd meeting
and Mr. Haris Saeed, Managing Director and Mr. Uzair,
Production Manager appeared before the Board, wherein they have
informed that they made improvements as suggested by the FID
and ready for inspection.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
ii)
iii)
The Board decided that the production will remain
stopped till the final decision by Central Licensing Board.
The Board also decided to get the firm re-inspected by a
panel to verify the improvements made by the firm in the
light of shortcomings indentified by the area FID.
The panel inspection report as and when received will
accordingly be presented in the meeting of CLB for
further consideration and decision by the Board.
Item No. 22 (New Case):-
M/s Oval Pharmaceuticals, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
25.03.2013. The case was placed before CLB in its 232nd meeting
and Mr. Muhammad Tahir Mahmood, Director of the firm
appeared before the Board, wherein he informed that the panel
inspection has been conducted and he submitted the copy of the
report dated 17.06.2013 by hand to the Board. The report was read
out before the Board and it was observed by the Board that this
report was a preliminary report. The panel has reported that most
of the shortcomings addressed by the firm and the panel is of
opinion to resume/recommend the production activities and the
detail report will be sent to the Board concerned.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
Page 66 of 78
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
The Board after thorough discussion decided as follows:i)
The Board observed that the panel report dated
17.06.2013 was not complete to evaluate overall GMP
compliance and rectification of shortcomings etc.
ii)
The Board decided to defer the case and place the same
in the next meeting of the Central Licensing Board in the
light of the detailed report submitted by the panel.
Item No. 23 (New Case):-
M/s Lahore Pharma, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
29.04.2013. The case was placed before CLB in its 232nd meeting
and Mr. Muhammad Saeed, Owner of the firm appeared before the
Board wherein he submitted the reply of show cause notice to the
Board and requested that they have made improvements as
suggested by the FID and ready for inspection and also requested
to withdraw the show cause notice.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board decided that the production will remain
stopped till the final decision by Central Licensing Board.
ii)
The Board also decided to get the firm re-inspected by a
panel to verify the improvements made by the firm in the
light of shortcomings indentified by the area FID.
iii)
The panel inspection report will be presented in next
meeting of CLB as and when received for further
consideration and decision by the Board.
Page 67 of 78
Item No. 24 (New Case):-
M/s Meredoa Company, Karachi
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
and the owner of the firm informed that he was intending to
perform Aitiqaf from the same evening due to which he was
unable to travel and appear personally before the Board on
30.07.201, and requested that his case may be deferred for next
meeting. The case was placed before the Central Licensing Board.
Proceeding:-
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board decided to defer the case till next meeting of
CLB and the production will remain stopped till the final
decision by Central Licensing Board.
Item No. 25 (New Case):-
M/s Euro Pharma International, Karachi
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
23.04.2013. The case was placed before CLB in its 232nd meeting
and Mr. Asif Iqbal, Director of the firm appeared before the Board
wherein he requested that they need some more time about 2
months to rectify the shortcomings. As per statement of the
representative of firm, the firm has been sealed by the Custom
Authorities which will be de-sealed in next month.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
Page 68 of 78
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
After hearing the views of the firm and keeping in view the
relevant legal provisions/codal formalities and through
deliberations of the honorable members decided as under:i)
ii)
iii)
iv)
The production of firm will remain stopped till the
rectification of the shortcomings as identified by the panel
on 05.03.2013and final decision by the Central Licensing
Board.
The Board decided to constitute a panel to re-inspect the
unit in the light of intimation by the firm regarding
improvements made and get the firm re-inspected
accordingly.
The Board also directed the firm to provide the status of
the matter decided by the Custom Authorities to QA
Section immediately.
DDG (E&M), Karachi will be directed to coordinate and
pursue with Custom Authorities to have update of the
matter and inform to QA Section accordingly.
Item No. 26 (New Case):Hattar
M/s Shazal’s Pharmaceuticals (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
26.02.2013. The case was placed before CLB in its 232nd meeting
and Mr. Muhammad Afzal, Chief Executive and Raja Zahir,
Production In charge appeared before the Board and requested for
the resumption of production as their panel inspection has been
conducted on 06.05.2013 wherein the panel comprising area FID
Peshawar, area ADC and area Provincial Drug Inspector, Haripur
recommended for resumption of production of the firm..
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Page 69 of 78
Decision of CLB
The Board after taking into consideration, the recommendation of
panel comprising of area FID Peshawar, area ADC and area
Provincial Drug Inspector, Haripur vide its inspection report dated
06.05.2013, hearing the views of the firm and keeping in view the
relevant legal provisions/codal formalities and through
deliberations of the honorable members decided as under:i)
The Board on the recommendations of the panel allowed
the provisional resumption of production.
ii)
The Board also decided to conduct the comprehensive
inspection by the larger panel within 30 days after
resumption of production.
iii)
The persons appeared before the board also committed to
complete their application for renewal of DML and
furnish complete documents of their technical staff as
pointed out by Secretary CLB during the meeting
Item No. 27 (New Case):-
M/s
Zanctok
Pharmaceuticals
Laboratory, Hyderabad
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
07.06.2013. The case was placed before CLB in its 232nd meeting
and Mr. Feroz Ali Lasi, Director of the firm appeared before the
Board wherein he informed that panel inspection has been
conducted in which the panel is of opinion that firm has improved
their production and quality control facilities and recommended to
resume to production. The panel inspection report of the firm with
its recommendations for production resumption was however
received before meeting.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
The Board after taking into consideration, the recommendation of
panel comprising of Mr. Saleem Isharat Hussain, CDI, Sindh, Dr.
Muhamad Tanweer Alam, DDG (E&M), Karachi and Dr. Najamus-Saquid, FID Karachi vide its inspection report dated
23.07.2013, hearing the views of the firm and keeping in view the
Page 70 of 78
relevant legal provisions/codal formalities and through
deliberations of the honorable members decided as under:i)
The Board decided for provisional resumption of
production activities of the firm.
ii)
The firm shall be re-inspected in working condition by a
larger panel within 30 days time period after the
resumption of production as per provision of Schedule BII of Drugs (Licensing, Registering and Advertising)
Rules, 1976 framed under Drugs Act, 1976 specially
containing provision for GMP compliance.
Item No. 28 (New Case):-
M/s Raymond Pharmaceuticals, Lahor
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 after
issuance of show cause notice/ stop production order dated
07.06.2013. The case was placed before CLB in its 232nd meeting
and Mr. Muhammad Asif Ch. Proprietor of the firm appeared
before the Board wherein he informed that they have made
improvements as suggested by the FID and ready for inspection.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
The Board decided that the production will remain
stopped till the final decision by Central Licensing Board.
ii)
The Board also decided to get the firm re-inspected by a
panel to verify the improvements made by the firm in the
light of shortcomings indentified by the area FID.
iii)
The panel inspection report will be presented in next
meeting of CLB as and when received for further
consideration and decision by the Board.
Item No. 29 (Old Case):-
M/S. ROYAL GROUP & MARION
LABORATORIES, KARACHI.
Proceedings- The case of M/s Royal Group and M/s Marion Laboratories (Pvt) Ltd,
Karachi was presented in 231st meeting of CLB meeting held on 31.01.2013 wherein
following decisions was taken:-
Page 71 of 78
“The case was placed before the Board in its 231st meeting, wherein M/s Royal Group
and M/s Marion Laboratories (Pvt) were called for personnel hearing. After hearing
deliberated views of both the firms, the Board directed to both firms to expedite the
destruction of substandard batches “Injection Marivell-5 (Dextrose 5%) 500ml
manufactured by M/s Marion Laboratories (Pvt) Ltd, Karachi which are lying at port
Darussalam and M/s Marion Laboratories (Pvt) Ltd, Karachi had committed to the
Board for bearing the expenditures. M/s Marion Laboratories (Pvt) Ltd, Karachi has
submitted an undertaking to the Board in this regard”.
Now the Board in its 232nd meeting was apprised about the previous decision of the
Board and non compliance of M/s Marion Laboratories (Pvt) Ltd, Karachi on aforesaid
decision. The Board took serious notice of casual of approach of M/s Marion
Laboratories (Pvt) Ltd, Karachi as on one hand the reported substandard products to pose
great threat to public health and on other hand it gave a bad name/fame to Pakistan
which may greatly hamper the exports of pharmaceutical industry and tantamount to loss
of government exchequer. The Board seriously intended to hear both the parties in order
to resolve the matter amicably but unfortunately M/s Marion Laboratories (Pvt) Ltd,
Karachi adopted delaying tactics and did not appear before the Board. Even on the
direction of Board, DDC (QA) talked telephonically to Mr. Imran Saboor (Son of the
Owner/CEO) during the proceedings of the Board to inform M/s Marion Laboratories
(Pvt) Ltd, Karachi for personal hearing (as the representative of M/s Marion Lab at
Islamabad was not picking the phone) on next day i.e. 30.07.2013 of the Board’s meeting
so that their personal hearing be actualized on the evening of same day i.e. 29.07.2013,
the Chairman, CLB also talked on telephone to Mr. Imran Saboor to come for personal
hearing before the Board on 30.07.2013 as issue was of serious consequences tin
hampering exports of pharmaceuticals to the world and African region in particular and
causing bad name for the country at large. Despite all out possible efforts even talking on
telephone to Mr. Imran Saboor for attending the Board’s meeting even on its next day but
he flatly denied to attend the same.
Mrs. Mumtaz Maker, Chairperson of Royal Group appeared before the Board wherein
she has presented her matter before the Board in detail regarding the non compliance of
M/s Marion Laboratories (Pvt), Karachi and said that the other party did not stand on
decision of CLB taken in 231st meeting of the Board. She added that in case M/s Marion
Laboratories (Pvt) Ltd, Karachi did not cooperate in destroying substandard batches
referred to drug lying at Darussalam port in shortest possible time, it would badly effect
not only the exports to whole Africa Region but may also pose serious consequences for
the country if matter exploited by other countries, WHO and other international agencies.
After hearing the views of Royal Group, the Board was of serious concern as the repute
of the country is at stake and the neighboring countries like India may exploit this issue
for generating problems for exports of pharmaceuticals from Pakistan and many such
other consequences of serious impact putting repute of the country at stake.
The Board also directed the PPMA representatives of the Board to communicate to their
member companies especially M/s Marion Laboratories (Pvt.) Ltd, Karachi for its
extremely casual and irresponsible attitude towards this very important issue.
Decision of CLB
case as under:-
Then the Board in the light of fore going facts/details, decided the
Page 72 of 78
i) The Board upheld its previous decision of destruction of
substandard consignments of drugs “Injection Marivell-5
(Dextrose 5%) 500ml lying at Port Darussalam( Tanzania)
and Rwanda in a manner as has been devised/agreed upon by
both the parties in 231st meeting of CLB.
ii) The Board took serious note as why M/s Marion Laboratories
(Pvt) Ltd, Karachi did not comply with the previous order of
the Board for destruction of substandard medicines exported
from Pakistan. The Board was of the view that sanctity of
Pakistan is at risk and strict action under the Drugs Act, 1976
and rules framed there under should be initiated immediately
against M/s Marion Laboratories (Pvt) Ltd Karachi for
supply of substandard Injection Marivell-5 (Dextrose 5%)
500ml to M/s Royal Group for export purpose to Rwanda.
iii) The Board decided to suspend the Drug Manufacturing
License of M/s Marion Laboratories (Pvt) Ltd, Karachi for
period of six months for which intimation to Drug
Registration Board shall be conveyed accordingly.
iv) The Board also decided to send recommendation to the
Registration Board for cancellation/suspension of
registration of Injection Marivell-5 (Dextrose 5%) 500ml
under section 42 of Drugs Act, 1976 and rules framed there
under for manufacturing and supply of substandard drug in
the importing country.
v) Resumption of production in the facility will only be allowed
by CLB after comprehensive inspection of firm with regard to
compliance/ conformity to the conditions of DML and
compliance towards the GMP as required under the
law/rules.
Item No. 30 (New Case):Lahore
M/s Symans Pharmaceuticals (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 29.07.2013 after
issuance of stoppage of production order dated 13.03.2013. The
case was placed before CLB in its 232nd meeting and Dr. Syed
Saleem Haider, Chief Executive of the firm appeared before the
Board wherein he requested the Board for resumption of
production based on panel inspection conducted on 31.05.2013.
During course of hearing he used harsh words before the Board
and lost his temper of which the Board took very serious notice
and reminded him about his unethical and unprofessional attitude.
Page 73 of 78
Proceeding: -
.Decision of CLB
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
The Board after taking into consideration, the recommendation of
panel comprising of Mr. Asim Rauf, DDG (E&M)/FID, Lahore,
Mr. Moazzam Ali Khan, Secretary PQCB Punjab and Mrs. Aisha
Khalil, FID Lahore vide its inspection report dated 31.05.2013
hearing the views of the firm and keeping in view the relevant
legal provisions/codal formalities and through deliberations of the
honorable members decided as under:i)
The Board on the recommendations of the panel allowed
the provisional resumption of production only for nonpenicillin products.
ii)
The firm shall be re-inspected in working condition by a
larger panel within 30 days time period after the
resumption of production as per provision of Schedule BII of Drugs (Licensing, Registering and Advertising)
Rules, 1976 framed under Drugs Act, 1976 specially
containing provision for GMP compliance.
iii)
Production of sections of penicillin containing products
shall remain stopped till the provision of selfcontained/dedicated facilities by firm after approval of
layout plan by Licensing Section and subsequent
consideration/decision by CLB.
iv)
Board also took extremely serious notice of the harsh,
unethical and unprofessional attitude of Dr. Syed Saleem
Haider, Chief Executive of the firm towards the Board
during its proceedings and decided to issue warning to
him to refrain from such attitude before the Board and be
careful in future.
v)
The Board also directed the representatives of PPMA and
Pharma Bureau to communicate, the serious concern and
displeasure of all the Board members regarding the un
professional, un ethical and harsh attitude of Dr. Syed
Saleem Haider, Chief Executive of the firm, to all their
member companies in general and the firm under
reference in particular under intimation to the Central
Licensing Board.
Item No. 31 (New Case):-
M/s Alco Chemical (Pvt) Ltd, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Page 74 of 78
Date of Hearing:-
Proceeding:-
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
The firm was called for personal hearing on 29.07.2013 after
issuance of stoppage of production order dated 14.05.2013. The
case was placed before CLB in its 232nd meeting and Dr. Maria H.
Arora, Director of the firm appeared before the Board wherein she
informed that they have rectified all the shortcomings and their
firm was ready for inspection.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
ii)
The CLB after hearing the views of the firm, decided to
constitute a panel to inspect the firm to check/verify the
improvements made by the firm and also check the GMP
compliance of the firm in the light of the shortcomings
pointed out by the FID.
The Board upheld the decision of stoppage of production
till the final approval by Central Licensing Board.
Item No. 32(New Case):-
M/s Ferroza International
Pharmaceuticals (Pvt) Ltd, Lahore
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:-
Proceeding:-
The firm was called for personal hearing on 29.07.2013 before
CLB in its 232nd meeting and Mr. Usman Khalid, Director of the
firm appeared before the Board wherein he informed that they had
rectified all the shortcomings pointed out by the FID in his report
and requested to inspect the firm within 30 days.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Page 75 of 78
Decision of CLB
i)
ii)
The Board after hearing the views of the firm decided to
constitute a larger panel to inspect the firm on audit
performa schedule B-II in all sections in order to
check/verify the GMP compliance.
The production in cephalosporin section will remain
stopped till the final decision by Central Licensing Board.
Item No. 33 (New Case):Karachi
M/s Eros Pharma (Pvt) Ltd,
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 29.07.2013 after
issuance of stoppage of production order dated 26.04.2013. The
case was placed before CLB in its 232nd meeting and Mr. Khalid
Akhter, Director of the firm appeared before the Board wherein he
informed that panel inspection of their unit has been conducted and
they requested for the resumption of production in the light of
recommendation of the panel by its report dated 08.07.2013.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case, took the decision accordingly on case to case basis.
Decision
The Board after taking into consideration, the recommendation of
panel comprising of Mr. Saleem Isharat Hussain, CDI, Sindh, Dr.
Muhamad Tanweer Alam, DDG (E&M), Karachi and Dr. Shahid
Hussain, FID Karachi vide its inspection report dated 08.07.2013
hearing the views of the firm and keeping in view the relevant
legal provisions/codal formalities and through deliberations of the
honorable members decided as under:i)
ii)
The Board on the recommendations of the panel allowed
the provisional resumption of production.
The firm shall be re-inspected in working condition by a
larger panel within 30 days time period after the
resumption of production as per provision of Schedule BII of Drugs (Licensing, Registering and Advertising)
Rules, 1976 framed under Drugs Act, 1976 specially
containing provision for GMP compliance.
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Item No. 34:-
(M/s Care Pharmaceuticals, Lahore)
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 30.07.2013 and the
case was placed before CLB in its 232nd meeting and Mr. Aamir
Zulfiqar Ahmad, Director of the firm appeared before the Board
wherein he submitted that he is not involved in manufacturing of
general product i.e. (sliver sulphadiazine) in steroid section and he
also submitted an undertaking to the area FID in this regard.
Proceeding:The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
Decision of CLB
i)
To stop production of general products in steroid
manufacturing area.
ii)
The Board also decided that the firm should surrender
registration of the general product i.e. Silver
Sulphadiazine and also intimate the CLB accordingly.
iii)
The Board also decided to constitute a panel to get the
firm re-inspected on audit Performa schedule B-II in all
sections in order to check/verify the overall GMP
compliance level of the firm in addition to verification of
stoppage of production of general products (sliver
sulphadiazine) in the steroidal manufacturing area.
Item No. 35:-
M/s Pak Risen Pharmaceuticals, Hattar
Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs
(Licensing, Registering & Advertising) Rules, 1976 and gross
violations of GMP as laid down under Schedule B-II of Drugs
(Licensing, Registering & Advertising) Rules, 1976 framed under
Drugs Act, 1976. Details of violations are given as per relevant
agenda item.
Date of Hearing:The firm was called for personal hearing on 29.07.2013 after
issuance of show cause notice/ stop production dated 14.09.2012.
The case was placed before CLB in its 232nd meeting and Mr.
Sabir Khan, Managing Director of the firm appeared before the
Board wherein he apologized from the Board that he resumed the
production without proper approval from the Board and requested
Page 77 of 78
Proceeding:-
Decision of CLB
i)
ii)
iii)
iv)
v)
that the firm’s production may be allowed to be resumed properly
as the panel has recommended and allowed to resume production
some months before and subsequently FID has visited and reported
GMP compliance level of the firm as good and presented before
the Board the copies of inspection reports dated 25-06-2013 and
15-07-2013.
The members of the Board were provided with the agenda of QA
Section. The brief of case was presented before 232nd meeting of
Central Licensing Board and Board was apprised about the cases
of firms who have violated the conditions of DML, Rules and non
compliance of GMP and action taken by the DRAP. The Board
after thorough deliberations on all the agenda items including the
instant case took the decision accordingly on case to case basis.
After hearing the views, request of the firm, and considering the
reports of inspections conducted by panel on 05-12-2012, by area
FID on 28-01-2013, 25-06-2013 and 15-07-2013, the Board
decided as under:The Board allowed the firm provisionally to resume production
of their facility.
The Board also decided to constitute a larger panel to inspect the
firm on audit Performa devised as per schedule B-II of Drugs
(Licensing, Registration and Advertising) rules 1976 in all
sections in order to check/verify the GMP compliance.
Direct the firm to recall all the batches from the
market/institutions manufactured after the stoppage of
production i.e. 14.09.2012.
The firm apologized for their practice and assured the Board that
they will not repeat such practice of resumption of production at
their own in future till decision by the CLB. The Board warned
the firm to refrain such practice in future.
The Board also took serious notice and showed its deep concern
on casual behavior/response of the field offices/FIDs in
submitting
inspection reports for the purpose of GMP
compliance and for panel inspections for various purposes under
the Drugs Act 1976 and rules framed there under which causes
un necessary delay in disposing off cases by CLB.
MEETING ENDED WITH THE VOTE OF THANKS TO THE CHAIR.
************
Page 78 of 78