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REGISTERED/ACKNOWLEDGEMENT
DUE
.
l ~
o Jr '
( ,~~
)
GOVERNMENT OF THE PUNJAB
,HEALTH~E:~TM::T
~"'r
Health Department
!i12---
ORDER·
No. SO(P-I)/H/4-21/03-04(Hafizabad).
~.
ar et~
ar
First Women Bank, Circular Road, Gujrat, supplied Almajax 250ml Suspension,
Batch No. JX168, manu actured
b~
M/s Medisearch
to District
Pharrna
Brief facts of the case are that M/s Pioneer
(Pvt.) Ltd., 5-Km, Raiwind
Hafizabad. The Area Drug Inspector
formation
Dated; 11.11.2014.
test/analysis
Committee
Board,
drugs were declared
no. TRA.22863
Punjab,
considered
by M/s Medisearch
held on 22.11.2014.
and statement
even after vigorous
notified vide CM office Directive
The supplied
reports
manufactured
Pharma
on Form NO.5 that Suspension
of solid cake which was not dispersible
noted by the Inquiry
Control
recorded
Manga Road, Lahore,
observed
that this was a criminal
Laboratory,
Lahore, Vide~
Provincial
250ml
Batch No. JX168, .
Suspension,
Quality
Analyst, report of Drugs Inspector
negligence
of M/s Medisearch
on part of M/s Medisearch
On the basis of test/analysis
Hence, the warranties,
& no. 5090 dated 08.01.2014,
distributor
were also •
Dated: 21.11.2014.
on Form No.5, report of CMIT and observations
human use and may cause health hazards.
(authorized
by Drugs Testing
Almajax
(PVt.) Ltd., Lahore, and gross lapse in GMP compliance.
mentioned
due to the
Pharma (Pvt.) Ltd., Lahore under Section 11 of Drugs Act, 1976, in its meeting
of the Drugs Inspector
dated 25.01.2014
Almajax is Substandard
The Board, after scrutiny of the report of the Government
DTL, observations
Hospita
shaking. Similar observations
& TRA.22864
the case of Substandard
Headquarter
No. DS(ASSEM)CMO/14/TO-4/(B)/043485~'\J
Substandard
Dated: 21.11.2014
Pharma, [an
~
reports
issued by
of PQCB, the said drug is not fit for
bearing
nO.5019 dated 21.03.2014,
nO.5010
issued by M/s Pioneer Pharma, [an Market, Circular Road, Gujrat
Pharma
on behalf of Mis Medisearch
(Pvt.) Ltd., Lahore)
Pharma
(Pvt.) Ltd., Lahore under Section 23 of Drugs Act, 1976, are proved to be false.
2.
In order to dispose
Mis Medisearch
Pharma
off the case on merit, a show cause-personal
(Pvt.) Ltd., Lahore and Mis Pioneer
even No. dated 22nd November,
2014 with the direction
at 12:00 Noon in the office of Secretary
appeared
q
'/
on behalf
of Mis
Pharma
for personal
hearing on 3rd December,
post & courier service and personally
no one appeared
record
Pioneer
Pharma,
Gujrat, Lahore were again directed
received by Mr. Na-, ced Akhtar Chaudhary,
on behalf of Mis Medisearch
Pharma
hearing.
The request
(Pvt.) Ltd., Lahore
was received, through
was acceded
2014 at 10:00 AM. Once again, Mis Medisearch
Gujrat, failed to appear lattend the personal
the firms and they were directed
hearing. Subsequently,
to appear for personal
Secretary
Health alongwith
written
appeared
on behalf of Mis Medisearch
defense
Pharma
2014
(if any). No one
through
Gujrat. Mis
to appear
registered
Advocate High Court, on behalf
Pharma (Pvt.) Ltd., Lahore and Mis Pioneer Pharrna, Gujrat, on 1st December,
the date of personal
December,
and requisite
and Mis
letter of
on 28th November,
hearing
2014 at 12:00 Noon. The said notices were dispatched
instead a letter from Mr. Naveed Akhtar Chaudhary
extend
defense
(Pvt.) Ltd., Lahore
(Pvt.) Ltd., Lahore and Mis Pioneer Pharma,
Medisearch
of Mis Medisearch
Pharma
written
notice was issued to
Gujrat, vide this department's
to appear for personal
Health alongwith
Medisearch
Pharma,
hearing
2014. Yet again,
and Mis Pioneer
Pharma,
courier service, requesting
to. The personal
hearing
Gujrat,
therein to
was fixed on 9th
(Pvt.) Ltd., Lahore and Mis Pioneer Pharma,
Final Personal
Hearing Notice was issued to
hearing on 11th March, 2015 at 11:00 AM in the office of
and all relevant
record
(if any). Mr. Uzair Nagra & Raja Junaid
Lahore & Mis Pioneer Gujrat. Special Secretary
Health was appointed
as
. Page 10f4
.
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Hearing Officer who heard the representatives
case from Secretary
PQCB & EDO (Health)
of the firms in detail and for want of more clarifications
Hafizabad,
it was decided
re-fixed for 8th April, 2015 at 11:00 AM. The accused
informed
Pioneer
Gujrat
Special Secretary
Health/Hearing
Hafizabad & Secretary
point of EDO(Health)
M/s Medisearch
who supplied
Pharama
itself proves
Lahore supplied
& supplying
mechanism
to store different
drugs from extreme
humidity
the
Department,
Government
atmospheric/storage
of Punjab.
compliance
to him. The drug in question
when
supplied
to the respective
drug is totally out of question
They further
added that the stores/warehouses
M/s
They
of the patient
further
Gujrat,
was sent to
Pharma
contented
that
this
hence the
of Hafizabad
were present
Lahore
& as a gesture
institution,
which
as Drug Testing Laboratory
season. No dehumidifiers
Mediserach
that
to protect
were present
voluntarily
had no
the
to control
offered
for the
of good will with the Health
is a well
proven
fact that
the
always affect the drug very badly.
PQCB, briefed
Board that the Drug Inspector
M/s Pioneer Pharma
Sub-standard
for the benefit
conditions
Secretary,
condition
store/warehouses.
of the said drug
4.
leveled against their firms. They contended
drugs as per their label claim. No air conditioners
replacement
were
Lahore & M/s
quality vide TRA No. 232 Dated 03-01-2p14
heat which prevails in Punjab in summer
inside
Hafizabad
of the firms in detail. View
drug to their distributor,
as of standard
that the Drug was in perfect
Lahore is a part of Health Department.
the
the particular
Lahore and was declared
of manufacturing
hearing was
PQCB was also heard in detail.
it to DHQ Hospital Hafizabad as per rate contract awarded
Drug Laboratory
allegation
on behalf of M/s Medisearch
Officer heard the representatives
Mr. Uzair Nagra & Mr. Raja Junaid denied the allegations
3.
the case. Personal
PQCB & EDO (Health)
firms, Secretary
Mr. Uzair Nagra & Raja [unair' appeared
accordingly.
to adjourn
of the
about the history
of the proceeding
of the case in Provincial
Tehsil Hafizabad vide letter dated 21-11-2014
with the directions
of the E.D.O (Health)
Hafizabad
inspected
reported
Qual!ty Control
that he, on 17-11-2014,
in
Main Medicine Store of DHQ Hospital
Hafizabad and took samples of the following drugs:
Name of Drug
Almajax
250
ml
Batch No.
Manufacturer
-IX 168·
Parma (Pvt.)
M!s Mcdisearch
Raiwind Manga Road, Lahore
Suspension
He informed
that Drug Inspector
the office of E.D.O (Health)
Government
Sr.
No
Q
/'
Name of Drug
Almajax Suspension
.Almajax I Suspension
Drug
The samples,
Analyst Drug Testing Laboratory
1
Inspector,
recovered/seized
250 ml
Name of Drug
1
Almajax
Suspension
ml
DTL Report
No. & Date
JX 11'·8
22863/DTL;
22864/DTL;
again
inspected
Batch No.
I JX 168
250
Batch No.
JX 168
stocks of above-mentioned
after test/analysis,
were
declared
substandard
by the
Lahore as detailed below:
250 ml
on 21-11-2014,
Sr.
No
S-Km
also took sample of Almajax 250 ml batch no. JX168 from the stock available at
Hafizabad.
2
,
Ltd,
Main
Medicine
Report
DTL
Results'
21-11-2014
21-11-2014
Store
Substandard
Substandard
of DHQ Hospital
Hafizabad
and
drugs on Form No.5. Detail is given as under:
Manufacturer
Quantity
Seized
Reason-for Seizure
M/s Medisearch
Parma
[Pvt] Ltd. 5-Km Raiwind
Manga Road, Lahore
25084 Bottles
Substandard
(Formation of sold cake that
is not dispersible even after
vigorous Shaking)
• Page 2 of4
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The case was considered
by the PQCB under section 11 of the Drugs Act, 1967 in its meeting held on 22.11.2014.
The Board, after scrutiny of the report of Government
Drug Inspector
compliance.
observed
Secretary,
also took samples
that this is a criminal negligence
and statement
of the
and gross lapse in GMP
Gujrat and Lahore General Hospital
Suspension",
Lahore
which also after test/analysis
were
by the DTL Lahore. Detail is given below:
Batch
DTL Report
No.
& date
Results
JX 165
1616/DTL &
27-01-2015
Substandard'
Suspension
JX 167
689/DTL &
13-01-15
Substandard:
Almajax
250m]
Suspension
JX 166
22862/DTL
21-11-2014
Almajax
120ml
Almajax
120ml
Suspension
JX 155
1001/DTL &
19-01-15
Su bstandard.
Suspension'
JX 171
999/DTL &
19-01-15
Substandard
Drug
No
Inspector
1
Bhakkar
Almajax
250ml
Suspension
2
Bhakkar
Almajax
250ml
3
Bhakkar
4
Gujrat
5
LGH Lahore
Name of Drug
to the case history,
manufactured
Bhakkar,
stocks of drug "Almajax
Sr.
In addition
on part of the manufacturers
PQCB, added that Drug Inspectors
from available
declared substandard
Analyst, report of the Drug Inspector
he also informed
by M/s Medisearch
No.
DTL
Report
Su bstandard
&
that from 2009 to till date, 19 cases of Substandard
Pharma Lahore have been reported
Drugs
in PQCB. Out of these 19 cases, 7 cases are
of Almajex (Drug in Question).
5.
EDO(Health)
well ventilated
as exhaust fans are installed therein.
such incidence
of caking in any other Antacid Syrup. He stated
accused
firms has caused
provided
by the government
6.
I examined
that M/s Medisearch
!if!
Hafizabad stated that they have a big hall for the storage
detrimental
a bad name to Health
/Pharma,
on the drugs/medicines
of doubt
Pharma (Pvt.) Ltd., Lahore and M/s Pioneer Pharrna, Gujrat, Lahore have acted in a manner
or good practices.
a substandard
The GMPs were not followed at all by M/s Medisearch
drug/medicine
was not only manufactured
(Pvt.) Ltd., Lahore but also the same were supplied
Gujrat,. This indicates
of other drugs/medicines
manufactured
and lapse of quality control. This matter pertains
episode of the incidence
quality control department
to a government
health
of drugs reaction
by M/s Medisearch
Pharma
by M/s Medisearch
facility by M/s Pioneer
a complete failure of quality control and criminal negligence
supplied by M/s Pioneer Pharrna, Gujrat, cannot be truste.
.
and faith of patients
drugs by the
the available record of the instant case and it has been proved beyond any shadow
to public interest
Hence, the quality
that during his whole service, he has seen no
that supply of such Substandard
Department
which is
health facility is being removed.
(Pvt.) Ltd., Lahore. Resultantly,
Pharma
He contended
of the drugs/medicines
on part of the firms.
Pharma
(Pvt)
Ltd., Lahore &
on the basis of said incidence
of criminal negligence
to 'the lives of people. The Government
cannot afford another
j
in PIC, Lahore and Shahdra as it would lead to another
of the subject firms was not playing its due role satisfactorily
disaster.
leaving masses
The
at the
:::';:".
mercy of substandard
and unhygienic
drugs. By implication,
the Government
cannot.allow.the
firms to play with
the life and health of masses any further.
7.
Under Section 23 of the Drugs Act 1976, the manufacture
Now, on the basis of the above narrated
from potential
threat of contamination
facts & perusal
from the products
& supply
of substandard
of record and in order to protect
drugs is an Offence.
the lives of the people
of the said firms, safe guard public interest.in
general,
• Page 3 of4
• __
"if
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prevent
o~~
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in future & to protect
the ,POSSWility of such incidents
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do,heri!b" debar
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.'~list and dis uali
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the public health from a source of threat to life, I
-
M s Medisearch Plwrma Pvt. Ltd. 5-KmRaiwind
,
Manga Roq4
Lah~~~!~d-';ti';r~~"~;Pioneer
Pharma, lan Marklt, Near First Women Bank. 'Circular Road, Gujrat. with
----, .""
..
immediate effect [or a period o[ One (01) year for'future participation in Governfnent of Punjab Health
'
Department's tender business under powers
.,
conferred
upon me under-Rules
Rules, 2009 & Rule 21 of Punjab Procurement
Punjab Procurement
"
of Business
2011, Rule 19 of
Rules, 2014.
GOVERNMENT
OF THE PUNJAB
NO. & DATE EVEN:
A copy is forwarded
,
Secretary,
2.
Chief Executive, Drug Regulatory
3.
All Administrative
~The
",,~
.;
Managing
~l~?
procurement
Secretaries,
of all other procuring
& Coordination,
of Pakistan,
Islamabad.
Islamabad.
of,the Punjab.
Regulatory
of the
All.Principals
,
')'
7.
All Divisional Commissioners,
of Medical & Health Institutions
8 . All Divisional Directors
Punjab, Lahore with the request
PPRA, Punjab
II~
agencies.
Authority
and
to debar
punja.!p.~,~::~~ ~~' , ..••
c£
.
~;~.
III
"", 1:;';'~'
1i!lL
'~P·'>
;& ••.""''/'
Officers in Punjab.
;~"'ft~~:~¥
. t~'·
h"
f
10. All Executive District Officers (Health) in Punjab.
.
--- -.
12. The Secretary,
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,..-
11. All Heads of Special Institutions
Provincial
of Health Department
in Punjab.
Quality Control Board Punjab, Lahore.
13, The Chief Drugs Controller,
Punjab, Lahore.
14. The General Manager, Government
15. Th:et.s~'Qn
Medical Store Depot, Guiberg-III, Lahore.
Officer (Purchase-II}j(Purchase-III}j(Drugs
Control}j(Standardization),
H~~·i~h'Department.
20. PA to Additional
Government
Government
18. PS to Special Secretary,
19. PA to Procurement
Procurement
Cell,
;
16. PSO to Chief Secretary,
17. PSO to Secretary,
l
~~~f1~i~~,'.1~
in Punjab.
Health Services, in Punj'ab.·,.!;'4.:'"
All District Coordination
<.J
.:?
for
J,y
t;.--!l-
of Health Department
the contractor
/:
I\J~.0)--
The Director General Health Services, pU~jab, Lahore.
6.
9.
Government
on the Official Website
5'
L.u:.:::-
authority
Dire,ctor, Punjab Procure~ent
j')
rn
,~
O- 0
action to the.-
Ministry of National Health, Regulation
t;,pload the same
,",,;:3.j 5.
f
necessary
1.
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for information
of the Punjab.
of the Punjab. Health Department.
Government
of th , Punjab, Health Department.
Specialist, Health Department,
Secretary
(Technical),
Lahore.
Health Department.
21. Mjs Pioneer Pharma, [an Market, Near First Women Bank, Circular Road, Gujrat,
22. Mjs Medisearch
Pharma (Pvt.) Ltd., 5-Km, Raiwind Manga Road, Lahore.
~
, Page 4 of4
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