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Agenda for 252nd Meeting Registration Board to be held on 07-08th September, 2015.

Item No.

Detail of Item

Item No.I

Confirmation of minutes of 251st meeting Registration Board

Item No.II

Cases referred by Biological Drugs Division

Item No.III

Cases referred by Pharmaceutical Evaluation & Registration Division


Any other item with permission of Chair

Agenda 252

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Item No. I: Confirmation of minutes of 250th meeting Registration Board.


251st meeting of Registration Board was held on 12-13th August, 2015. Draft minutes were
circulated to all members (who attended the meeting) through e-mail with the request to forward
their comments (if any) within 05 days.
Dr.Khalid Khan, Director DTL, Peshawar forwarded following comments:
Agenda item No II. Case No.1 Court case of rBGH or Rbst:
Before taking the decision on safety of the rBST or rBST i shall bring in the notice of board 8
shocking facts about BGH or rBST published on Jan. 2014. since BGH received FDA approval
in 1993 three disturbing health trends have emerged
a) cancer cases continue to increases.
b) obesity has been an epidemic.
c) an early onset puberty has become norm.
RRR Division. Case No. 01 Re-registration of drugs:
Wrongly depicted the agenda item in the 251st meeting working paper as Registration instead of renewal
of expired certificate of Registration.

As mentioned in Rule 27 chapter III Registration of drugs, Drugs (L.R.&A) Rules 1976. The
certificate for registration of drugs period is five years from the date of registration of drug and
may thereafter be renewed for period not exceeding five years i.e, continuous processes till the
withdrawal of registration by firm or suspension/ cancellation by the competent forum or as the
case may be. The mod-us operandi for renewal of registration is that an application has been
made within sixty days after the expiry of the registration and when an application has been
made as aforesaid the registration shall subject to the orders passed on the application for the
renewal continue in force for the next period of five years. It was worthwhile to mention The
Rules 1976 are silent regarding fail to apply for renewal of registration of certificate in time or
expired for next five years due unfavorable circumstances or otherwise.
The article 254 of constitution of Pakistan clearly redress this issue as under:
Failure to comply with requirement as to time does not render an act invalid. When any act or thing is
required by the constitution to be done within a particular period and it is not done within that period. The
doing of the act or thing shall not be invalid or otherwise ineffective by reason only that it was not done
within that period

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Registration Board Meeting

Keeping view the essence of Article 254 all the pending applications of firms whos
failed to apply for renewal in time and expired may be reconsidered and approval may be
accorded by board with full fee as required under Law.
Submitted for consideration of Registration Board.

Item No.II:

Cases referred by Biological Drugs Division.

Case No.0 I

COURT CASE OF RECOMBINANT


HORMONE (rBST OR rBGH)

BOVINE

GROWTH

The case of rBST containing Registered Products is in the Honorable Lahore High
Court. The decision of 251st Board Meeting is as follows;
After due discussion and deliberations in Registration Board, it was decided to
continue with the registration of rBST containing products as the safety and efficacy profile of
the drug reported in the available scientific data is in acceptable limits. However, to the point
raised for more data on buffaloes, the Registration Board decided to carry out a multi-centred,
controlled trial in buffalos, particularly to ascertain the relation of rBST use with incidence of
mastitis, under supervision of the Vice Chancellors of at least three public sector Universities
of Veterinary Sciences. The trials will be completed within six (6) months and the decision can
be reviewed in the light of data generated by these studies.
2.

In light of case discussion and decision in the 251 st Meeting of Registration Board, report

was submitted before the Honorable Lahore High Court. The Court has passed following orders
on 26.08.2015;
.2.

The DRAP to convene the meeting of the Drug Registration Board on

31.08.2015 at 9:00 A.M. The objections filed by Government of Punjab which are already
pending before the DRAP should be considered by the DRAP and if the Petitioners file their
objections within time before 31.08.2015, the same may be heard as well. All the parties
including the distributors should appear before the Board on 31.08.2015 at 9:00 A.M. for
which date notices be issued to all concerned by the DRAP
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Registration Board Meeting

3.

Due to time constraints the Meeting could not be held on 31.08.2015. Further, the

Petitioners did not submit any objections or data for consideration of the Board before
31.08.2015. However, a fresh reference has been received from the Secretary (L&DD),
Government of Punjab on 25.08.2015. The meeting was scheduled on 07.09.2015 and notices of
meeting were issued to all the concerned on 31.08.2015. The report was submitted to the Lahore
High Court on 01.09.2015 explaining the position.
4.

The Secretary (L&DD), Punjab being respondent in the writ petition has submitted fresh

reference (dated 25.08.2015) which is reproduced as under;


Subject:

USE of rBST AND ASSOCIATED ISSUES.

Kindly refer to the subject cited above and directions, dated 19.8.2015, of the
Honourable Lahore High Court, Lahore in Writ Petition No. 10663/15 titled Surfraz Ahmed Vs.
FOP etc., The AG Office, Punjab vide letter No. 17124/ AG, dated 19.8.2015 (Copy enclosed at
Annex-A) communicated the directions of the Honourable Court for the Government of the
Punjab to provide:
i.
its own information;
ii.
reasons/ data,
Which formed the basis of reaching the conclusion that the drug in question is injurious and
harmful to:a.
b.

sustainable production capacity of the Livestock Sector;


harm to the human life.

PRELIMINARY OBJECTIONS:
The DRAP skipped the actual view point of the Punjab Government and did not include the
major issues raised during the proceedings of the meeting is a big question mark. The
undersigned pointed out the following:
1.

Before start of the meeting, to influence the decision making of the Registration
Board and to favor the representatives of both the companies, the CEO DRAP at the
very outset of the meeting consumed 32 minutes for propagation of the hormones in
question. The undersigned was left with no choice but to register protest on this
unethical and biased conduct, which was not even warranted by the rules of business.

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Registration Board Meeting

2.

3.

4.

5.

The Chairman committed to incorporate this episode in the minutes and report but
there is no mention of the same.
During the start of the meeting, the CEO DRAP was apprised by the undersigned that
he had held and unofficial meeting with both the companies a day before i.e. on 12 th
of August, in absence of any of the representatives of the Punjab Government.
The issue of Fish Powder was very much on the agenda but it was not discussed. So
much so that the undersigned had to remind Chairman and the Board regarding the
issue but the same has been skipped from the report.
The Registration Board was informed that 3 out of the 5 foreign representatives of
both the companies did not had approvals of use of rBST for their own countries and
how they can recommend the same for Pakistan. Furthermore, the Board was
apprised that in the US i.e. the country of origin, the rate of pasteurization/ UHT for
milk is 100% done to ensure the food safety standards as per their law. In Pakistan,
more than 96% milk reaches the consumer unprocessed i.e. it contains puss cells,
residues of anti-biotics and hormones used in animals. Hence, the comparison is only
possible when we guarantee the US processing capacity and standards.
The literature of the company (Annex-B), itself mentions that it is for healthy
lactating DAIRY COWS ONLY. It clearly mentions effects of the drugs i.e.
a.
Reduced pregnancy rates
b.
Increased days open
c.
Increased mastitis (visibly abnormal milk)
d.
Higher somatic cell count
e.
Increased body temperature not related to illness
f.
Lower body condition
g.
Disorders of hocks and foot region
h.
Reduced hemoglobin and hematocrit values
i.
Udder edema hence more therapeutic treatment and drugs use
j.
Swelling of injection sites
k.
Slaughtering prohibited till 7 days of use of injection
The involved complications ended up decline in its use even in the country of origin. The
overall percentage of cows that received rBST decreased from 22.3% in 2002 to 17.2% in
2007 (USDA APHIS VS/73) (Copy Annexed at Annex-C). The decline in use and
reaction by the EU and 90% countries of the world forced the company to dispose of it
product to some other company to get rid of it.

6.
As confessed by the companies that the said hormones are being administered mainly to
the buffalo population i.e. 90%, the Department highlighted the following facts:
a.

Agenda 252

The fate of animals of Pakistan, especially the water buffalo along with local and
exotic cows, already living in the extreme weather conditions, can be evaluated

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Registration Board Meeting

with the fact that use of this hormones adds to the misery of the animals by
further raising their body temperature unnecessarily with no solutions proposed.
7.

The companies admitted upon enquiry by the undersigned that they maintain
the data of the users, sellers and their stockists. The factual position about the sale and use of
this drug at human medical stores and by quakes administering the same to the human beings.
No explanation was extended or recorded in the report. The list of some of the human medical
stores, involved in this heinous crime was handed over to the companies and the Chair along
with copy of the FIR but the same could not find its place in the report. (Copies enclosed as
reference as Annex-D).

8.

The undersigned apprised the Board that there are rumors that after the
meeting on 12 of August, 2015 of the CEO DRAP with the companies, original record relating
to the subject drugs has been removed as an attempt to conceal facts from the Honourable
Court. The Chairman publically committed to provide copy of the same to the undersigned on
the same day so as the undersigned could frame reply but despite reminder till late night, the
Chairman confessed that the record is not traceable. This very important fact has been
concealed from the Court in the report as no such report could be generated in the absence of
such basic record. The gentleman namely Dr. Usmani who happened to be the Animal
Husbandry Commissioner for quite a long time, allegedly maneuvered the registration of a nontherapeutic hormone beyond the legal competency of the drug registering authority.
Astoundingly, he was representing one of the companies pretending himself to be their employee
but in fact he was partner of the company and reaping the associated benefit at the cost of the
poor farmers interest. This irony also not found its place in the report.
th

9.

The company representatives failed to reply the query about the devised
mechanism for the disposal of milk infected with puss and anti-biotic residues for which the
company itself recommends 72 hours as withdrawal period, meaning thereby the public under
ignorance is being forced to consume milk of animals, with higher incidence of mastitis, as
stated by Dr. Makhdooms research report page No. 2, published by PARC, which confirms
prevalence of mastitis was 57.14% higher in rBST treated animals, infested with puss and
anti-biotic residues.(Annex-E)

10.

The reports on the issue, of the Bahaudin Zakariya University Multan and
Agriculture University Faisalabad, were presented and copies handed over during the
discussion. The physiological and anatomical differences in the structure, formation and
functioning of cows and water buffalos, being distinctly different species, reported by Prof. Dr.
Masood Akhter, Dean, Faculty of Veterinary Sciences, BZU, Multan also could not find its even
mentioning in the report be it in the form of rebuttal. Reasons are not known. (Copy of the said
reports are annexed at Annex-F & G, respectively).
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Registration Board Meeting

11.

The Board was apprised about the maneuvered reports; misrepresentation of


facts of the claimed trials: one maneuvered by the ICI at Patokki and the other by the Gentleman
representing the local company. The original data and registers were presented for verification
of the wrongly stated facts but the same was also skipped conveniently. Copies of the data
showing the havoc wreck by the hormone to the animals with unprecedented mortality ratio
caused physical disorders and ultimate fate ending up in disposal of animals. The original
record will further be produced in the Court for fact finding.
OBJECTION ON THE REPORT
1.

THE SCOPE OF DRAPS REPORT


a.

FISH POWDER SKIPPED

Despite being on the agenda item, the Fish Powder was deliberately skipped. No
approval, literature on the said hormones, which is being widely used in the Punjab, was made
available by the company. Hence, the mystery surrounding the origin, nature, use and approval
of Fish Powder needs to be elaborated by the DRAP.
b.
i.

DEFECTIVE COVERAGE OF THE SCIENTIFIC DATA


Technical Details and deliberations (Pharmaceutical Dossier, Assessment, data
presented) thereon skipped;
The data presented by the undersigned, regarding defenders own quaoted studies/
trials at L&DDs Experiment Stations, depicting a heinous picture of out of the trials
of rBST on animals were deliberately skipped, posing a big question mark on the
scientific integrity of whole process of evaluation. Following trials at BRI, Pattoki
and LPRI, Bahadanagar, Okara as per claim of the paid research with maneuvered
results, the facts are preserved n the original registers/ record:
1.
BRI, Pattoki: experiment was conducted on 25 controlled and 25 treated
buffalos from 30.10.2013 to 31.05.2014. The ICI financed and paid budget
amounting to Rs. 4.43 million. The record exposes the claimed impact as
under:

ii.

a.

20 treated animals against compared with 6 controlled out of batches of 25 each,


suffered mastitis. The increased incidence is thus 80 in treated animals with
rBST and 21% n the controlled batch. (Annex-H)
15 treated animals received 2-5 services i.e. decreased conception rate. (AnnexI)

b.

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c.

The service period of 17 treated animals was 4-16 months against a normal of 3
months i.e. increased service and calving interval. (Annex-J)
After rBST trial, the birth weight reduced by 5 Kg on average, two dead births,
two teat and udder damage and ten have not yet calved after the trial. (AnnexK)
The treatment details depict the severity of mastitis in rBST treated animals as
steroids and even formalin had to be administered to control the phenomenal
infection. (Annex-L)
Interestingly the general public kept consuming the milk produced with more
puss, hormone, anti-biotic residues and FORMALIN.

d.

e.

f.

2.

The trials at LPRI, Bahadarnagar: it was a remote control trial managed by the
said Dr. Usmani, who was the Animal Husbandry Commissioner, happened to
have remained posted at the said station and succeeded in maneuvering the
shifting of trial site from Sindh Province to LPRI, Bahadarnagar, Okara, As
confirmed, he never visited the LPRI during the trial except fabricating the data
and sharing the same with another partner who was also away. The fabricated
data presented by Dr. Usmani and published thereafter is in contravention with
the original data contained in the official registers, which was duly produced in
the DRAP Boards meeting and alarms as under:

a.

The study was conducted (Annex-M) from Dec. 2004 to June 2007 at LPRI
Bahadarnagar, Okara on Nili-Ravi Buffaloes, The sample size of treated and
controlled animals was 15 each and the study titled Effect of long term use
Bovine Somatotropic Hormone (BST) on milk production, reproduction health
and physiological parameters in Nili-Ravi Buffalo. The milk production of the
treated group showed a decrease of 7,238 litters during 1 st and 2nd lactation and
10.556 liters reduction in 2nd and 3rd calving against which the controlled group
showed reduction of 4930 liters during 1st and 2nd lactation and 4,683 liters in 2nd
and 3rd lactation i.e. the impact of the rBST was observed negative in milk
production with advancing lactation as the treated group showed a decreased
production of more than 40% of milk in 2nd and 3rd lactation hence, it
diametrically opposes the claim.
The treatment record, confirms that 12 out of 15 animals
suffered foot wound, and lameness, which is 80%. The tits swelling, eye and foot
wounds, tympany, colic, increased body temperature, blood from ear, nose,
Theileriosis, RFM, tail wound, weakness, thin milk and much more remained
the hall mark of the trial due to which the Department had to suffer and
irreparable loss as even the steroids failed to ameliorate the situation. (AnnexN)

b.

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Registration Board Meeting

iii

Data regarding extra label use of the drug was not considered .
1.

Data on its use in male buffalo calves i.e. for feedlot fattening
(Annex-O)

2.

Data on its use in Sheep & Goat (Annex-P)


Data regarding the use of drug in contravention of
the Federal Law of the country of origin was skipped. The Government of the
Punjab is considering approaching the FDA regarding extra-label use of this
drug by the company and other importers to claim damages purported to poor
ill-informed farmers and dairy breeders in violation of the law of the land.
No. data regarding bio equivalent studies
etc. exists as per the mandatory clause of DRAP Act, 2012.
Misuse and mis-interpretation of data of
experiments has been proved on both the studies maneuvered by the companies.
The Department is approaching the HEC and Higher Education Department for
taking legal action against the fraudulent move.
Against the claim of the company, the OCT sale of
this hormone at human medical stores with free access by the quakes has also
been reported to the health Department. (Annex-Q)

iv.

v.
vi.

vii.

c.

ECONOMIC ASPECTS OF DRUG ON SECTOR DEVELOPMENT AND


FARMERS SKIPPED
i.

The corporate sector was forced due to the colossal damage to their livestock
after the use of this hormone in their exotic cattle during 2002-2010. This
devastation has now turned into closing of the business. The representatives of
the company even confessed that at present no corporate dairy having exotic
cattle or Military dairies is using this hormone.
Small subsistence farmers, who constitute more than 80% of the total livestock
breeders, are illiterate; cannot afford quality controls of management of disease
and environmental controls hence are at the mercy of exploitation with knock
out effect.

ii.

a.

Agenda 252

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THE LEGAL FRAMEWORK


THE PREVENTION OF CRUELTY OF ANIMALS ACT, 1890

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Registration Board Meeting

The Act explicitly stipulates up 2 years imprisonment and fine and forfeiture of
the animal to the Government if subjected to the introduction of any substance into the
female organ of a milch animal with the object or drawing off the animal any secretion of
milk. Hence, no question of using any substance can be allowed on animals for milk
secretion being in contravention of the said Act, In the presence of this already existing Law,
the Registration Board of DRAP cannot register rBST in the first place. This is extremely
important and significant aspect of animals prevention of cruelty and also as per the
admission of Dr. Glenn Kennedy, the representative of ICI, given at page 19 of DRAPs
report, the European Commission has banned the use and marketing of rBST from 1st
January 2000 on animal health and welfare ground.
b. REGISTRATION OF rBST BY REGISTRATION BOARD OF DRAP
As per oxford Advanced Learners Dictionary, therapeutic means designed to help treat
an illness. It is worth mentioning here that EU does not allow the use of rBST in animals,
besides other reasons, due to the reason that it is not therapeutic drug and the same fact was
admitted by Mr. Glenn Kenndy, the respenstative of ICI and his admission was duly
incorporated by DRAP in its very report at page seventeen. As per the DRAP Act, 2012, the
registration Board means a Registration Board to regulate the grant of registration to
therapeutic goods. Thus on this very count, DRAP s Registration to Board cannot entertain
rBST registration or renewal as the same is not being claimed to be used in animals as a
therapeutic drug rather it is a substance to enhance mild production, acting on female organ
of the dairy cows which is again illegal as per the Prevention of Cruelty of Animals Act,
1890. In short, rBST registration and renewal or its legal use in the country is neither
covered by the spirit of the DRAP Act, 2012 nor does it is permissible as per the law of the
land. In this very backdrop, India has not given permission of rBST usage despite holding of
controlled trials in 1989, 2004 and 2010.
C. THE PUNJAB PURE FOOD RULES, 2007 defines the milk as the normal,
clean and pure secretion obtained from the memory glands of a healthy cow, buffalo, goat or
sheep and mild shall not contain any . Traces of antibiotic substance and hormonal
residue. This definition needs to be evaluated on the ground that 96% milk is consumed
unprocessed in Pakistan.
d. Against the cautions of withdrawal period of 72 hours for milk and 7 days for the
consumption of meat both the companies miserably failed to present any data or document to
negate that the puss cells, antibiotic residues, hormone filled milk and meat are not being
complied or cannot be complied with in Pakistan.
3. THE ETHICAL FRAMEWORK

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Registration Board Meeting

a.

CEO is influenced the Registration Board in favour of the rBST and on objection
raised by Secretary Livestock & Dairy Deveoplment Department Punjab assured
that the very
observation pointed out shall be incorporated into the minutes
of the meeting but no such thing reflected in the report submitted in the
Honourable Court.

b.

Out of four International Experts of the ICI & Ghazi Brothers, as introduced in
the Report of DRAP, three advocating the use of use of rBST in their own
countries i.e. Australia, New Zealand and UK.

c.

The Conflict of Interest as defined under Section 18 of DRAP Act, 2012- ExAnimal Husbandry Commissioner Dr. Usmani who gave the renewal was
representing the company under the guise of employee but in fact associate. On
the presentation of the orginal record of the so called research at Bahadarnagar
and Pattoki, he was flabbergasted as the mis-interpretation of the actual data was
exposed.

VIEW POINT OF THE LIVESTOCK & DAIRY DEVELOPMENT


DEPARTMENT
1. The Legal Aspect
a. The Registration Board of DRAP lacks jurisadiction to deal with the registration/
renewal of rBST as it is not a Therapeutic drug.
b. The DRAP or the companies never moved the Punjab Government to change and amend
the pure Food and Prevention of Animals Cruetly Act, which bars the usage of such like
hormones for milk production. The wisdom of the law makers of above said laws deserve
our gratitude, having provided a steel shield to the generations from unscrupulous
elements.
2. THE LOGICAL FRAMEWORK- Situation on ground -the bare reality the Punjab
Government envisages:a. The First ever Livestock and Dairy Development Policy of 2015 of the Punjab
Government envisages:1. Paradigm Shift of L&DD Department from Curative to Preventive Regime of
Livestock Sector Government transformation its role from Provincial Disease
Attendant to Provincial Livestock Asset Manager. Accordingly, the first ever Mass
Vaccination of animals and rural birds and Cross Sectional Survey of preventable
diseases in the Punjab from village level was conducted with following:

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Registration Board Meeting

1. The shocking revelation of 60% less animal found on ground as they should have
been as per the 2006 Census; one of the major causes for the shrinking of the
livestock can safely be attributed to the indiscriminate use of hormones both
Injectable and powder form to the animals. The corporate farming has already
suffered irreparable loss due to the induced usage of the subject hormones during the
last 6-8 years. This revelation perhaps forced the Department and the Government to
create the largest database, covering over 2.9 million livestock farmers in the Punjab
so far to devise a monitoring and support mechanism. This paramount effort is in
response to the SOS call and alarms generated by the poor breeders and consumers
of Livestock products.
b. THE PUBLIC INTEREST is attached with the consumption of milk and meat.
The peri- urban areas of cities have the largest concentration of mich animals and
remained victims to sue this hormone as they were lured through marketing
gimmickries as proved and warned by the company itself, the ultimate result was
higher mastitis, more puss anti-biotic residues and hormones in the produced and
offered milk. This unprocessed fresh milk ultimately consumed as such by the urban
population with the outcome of wide spread of diseases with raised resistance level to
ani-biotic and other increasing complication physical disorders.
c. THE SECTOR DEVELOPMENT
1.
The Dairy Sector suffered an irreparable loss as the best producing
animals wre subjected to the use of rBST. The mortality of calves, weight loss, and
increase in calving period and decrease in conception rate added with reproductive
disorders played havoc to the best milch animals. The evaporated milch animal head
population requires long restoration efforts.
The foregoing facts, which form basis of the issue, should have acquired major
importance of the proceedings at DRAP, but they, unfortunately, remained neglected.
The Punjab Government, being the major stakeholder, as it has largest number of
buffalo and cattle population; chief supplier of milch and slaughtering animals to
other Provinces and even beyond; largest contributor in the production of mild and
sacrificial animals, apprehends that the SOS call of this sector has not received a
requisite matching response, which may culminate into devasting effects on the
sustainable production capacity of the sector. In view of the above proved facts, the
Livestock Department Punjab is of the firm view That:
A.

The DRAP lacks jurisdiction for approval or renewal of the hormones, including the Fish
Powder. The laws of the land do not empower any such forum to allow the use of said
products, which are NON-THEERAPEUTIC BY ALL DEFINITIONS;

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Registration Board Meeting

B. None else except the Legislature has the powers to amend the applicable provisions of Pure
Food Laws and the Prevention of Animals Cruelty Act. The definition, composition of milk
and administering of hormones for milk production will have to be changed prior to allowing
the use of such substances which are controversial world over.
C. The regime allowing use of any such substance will have to first ensue 100% processing of the
milk before its consumption like the US. The country like Pakistan consuming about 96%
unprocessed milk and 100% beef from milch animals would require guarantees for meeting
minimum standard applications as are observed in the EU and the US and other countries.
The Lust of some companies for sale of hormones on one side and antibiotics for the
treatment of animals and human beings requires quantification and comprehension in its real
context Emerging Zoonotic disease, their wide spread demonstration, the thinning strength of
cattle head are nothing but the alarms generated by the nature.
This Department humbly submits to the DRAP authorities and the Honourable
Court for reflection of the actual stance of the Department. The Honourable Members of the
DRAP should be exposed to the developed scenario, enabling them to see through the conspiracy
with better understanding of the jurisdictional constraints as envisaged by the law of the land.

5.

Presentation of the Secretary (L&DD), Punjab is placed before the board for point wise

discussion/ review and evaluation. Other stakeholders have also been invited for the meeting for
their point of view.
Matter is placed before the Board for a decision.
Case No.02:

PANEL INSPECTION OF M/S. PAKCURE PHARMA, RAWAT

The case of the company for the registration of Allergy vaccines was discussed in 242 nd
Meeting of Registration Board. The Registration Board constituted following panel for the
product specific inspection of the firm.
1. Gen (R) Karamat A Karamat
(Member Registration Board)

2. Brig (R) Muzammil H Najmi


(Member Registration Board)

3. Dr. Muhammad Arshad


(Member Registration Board)

4. A.Q. Javed Iqbal


(Ex. Director QA/LT)

5. Shaikh Ansar Ahmed

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Registration Board Meeting

Director Biological Drugs

The panel inspected the firm twice but the firm was found deficient of the facilities
required for the products for which registration is applied. The Board advised for re-inspection of
the firm. The FID coordinated for the inspection and has reported as under;

One of the member of the panel A.Q. Javed Iqbal has been transferred from the position
of Director QA/LT.
Gen. (R) Karamat A Karamat has proceeded abroad and not available for inspection.
Dr. Muhammad Arshad has refused to join for inspection till the panel is complete.
Brig. (R) Muzammil H. Najmi has also refused for inspection till panel is complete.
Shaik Ansar Ahmad showed his consent for the inspection.
The firm has requested to conduct their inspection as early as possible. Matter is placed

before the Board.

Case No.03:

PENDING CASE OF M/s. HI-TECH PHARMACEUTICALS


LAHORE FOR POULVAC SE VACCINE

The following case of the firm was discussed in 241st , 246th and 249th Meeting of
Registration Board.
Sl.# Applicant

Name and Specs

ECBD

1.

Poulvac SE Vaccine
Each 0.3ml dose
contains: Salmonella enteritidis
Phase Type 4.RP
> 1.0/dose at release.
Salmoella enteritidis
Phase Type 8
RP.>1.0/dose at
release.
Salmonella enteritidis
Phase Type 13a
RP> 1.0/dose at
release 37%

Recomme
nded

M/s
Hi-Tech
Pharmaceutical,
Lahore
Manufactured
by:
M/s Pfizer
Animal Health
(Pfizer Inc),
2000 Rockford
Road, Charles
City, Iova, USA

Agenda 252

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Registration Board Meeting

Committee
Recommendation
More data is
required

Decision
Deferred
for
clarification
from
the
application
regarding use
of
formalin
concentration
and review by
already
constituted
committee and
veterinary
expert
of
ECBD.

Formaldehyde.
Solution..0.0006ml
White oil.0.1995ml
Arlacel-830.1105ml
Tween-80
0.001105ml
Saline.q.s to 0.3ml
(For Veterinary Use)
The Registration Board in its 249th Meeting decided as under;
Registration Board decided to take the opinion from further two experts,
namely Prof. Dr. Zafar Qureshi, U.V.A.S., Lahore and Prof. Dr. Masood
Rabbani U.V.A.S., Lahore.
The expert Prof. Dr. Zafar Queshi did not exist and letter returned from the UVAS,
Lahore. Matte was placed before the Director Biologicals who approved the expert namely Prof.
Dr. Khushi Mohammad for expert opinion. The details are summarized as below;
Name and designation of Expert
Prof. Dr. Masood Rabbani
Director/ Chairman
Department of Microbiology, UVAS, Lahore

Prof. Dr. Khushi Muhammad


Dean FVS, UVAS, Lahore

Agenda 252

nd

Expert Opinion
The letter was reviewed critically and
literature related to vaccine. I have no
technical observation as Poulvac SE vaccine
is a killed vaccine. So in my opinion the
product may be registered.
I have critically gone through the literature
supplied to me with application on subject
matter,
clarification
of
Hi-Tech
Pharmaceutical Lahore of application which
indicates that dose of vaccine is 0.3ml. As per
this dose and dossier and dossier of the
vaccine, final concentration of formaldehyde
(37%) in the culture is 0.2% that is sufficient
to inactivate the bacteria. Other component of
the vaccine are also according to international
standards. The Poulvac SE vaccine may be
registered.

15
Registration Board Meeting

Further, the firm has also filed an application with request that the name of manufacturer
has been changed from Pfizer Animal Health Lowa, USA to Zoetis Inc. Lowa, USA along with
Certificate of Licensing and Inspection from U.S. Department of Agriculture Animal and Plant
Health Inspection Service, USA.
The case is placed before the Board for a decision.
Case No. 04

PENDING CASE OF M/s. POPULAR INTERNATIONAL,


KARACHI FROM 240TH MEETING OF REGISTRATION BOARD.

The following case of the firm M/s. Popular International, Karachi was considered in
240th Meeting of Registration Board.
S.
No.

Applicant

Brand name and


Composition

Demanded
Price

7.

Popular

Uman Albumin

Rs.5,775/

Internationa
l (Pvt)

Solution for Infusion

Per vial

250g/1-50ml vial

50ml

Ltd., Karachi.
M/s. Kedrion
S.p.A

contains:-

the respective
SRA of the
country of origin.

Proteins containing at

confirmation of
similar
formulation in
Pakistan

(Plasma Protein

Popular
International
(Pvt) Ltd.,
Karachi.

Agenda 252

clarification of

20.08.2011

Pascoli-Barga Albumin.12.5
(LU),
g

8.

Decision of the
Registration
Board.
Deferred for

Application date:

Castelvecchio least 95%

Italy.

upon the approval


process adopted
by

Each 50ml vial

Human Plasma

Loc. Ai
Conti,

4th ECBD
Recommendatio
n
Recommended
based

nd

Solutions (Human)
Uman Albumin

Rs.9,450/

Solution for Infusion

Per vial

200g/1-100ml vial

100ml

16
Registration Board Meeting

Recommended
based
upon the approval
process adopted

Deferred for
clarification of
confirmation of

M/s. Kedrion
S.p.A
Loc. Ai
Conti,

Each 100ml vial

by

similar

contains:-

the respective
SRA of the
country of origin.

formulation in

Human Plasma

Castelvecchio Proteins containing at

Application date:

Pascoli-Barga least 95%


(LU),
Albumin.20g

20.08.2011

Italy.

Pakistan.

(Plasma Protein
Solutions (Human).

The firm was advised to provide the evidence of similar formulation in Pakistan. The firm
has informed that the following similar formulation are available;
Reg. No.

Name of Product

007967

Plasbumin
20ml
50ml
100ml
(Old Registration letter, composition
not mentioned)
The firm provided pack having the
composition of 25 % human albumin.
Human Albumin 20% Behring
100ml vial containing at least 95%
Human Albumin

023674

020652

Albutein 20% containing at least


95% human albumin
100ml vial

Name of
Importer
Popular
International,
Karachi.

Remarks

Hakimsons,
Karachi

Human albumin is at least


95% and the firm M/s.
Popular has specification
is of at least 95%

Biotechna,
Karachi

Human albumin is same


as M/s. Popular
specification of 95%.

Exact comparison is not


possible based on the
information provided.

The case is placed before the Board for a decision.


Case NO. 05

Agenda 252

PENDING CASE OF M/s. HIVET ANIMAL BUSINESS, LAHORE

nd

17
Registration Board Meeting

The following case of the firm was discussed in 249th Meeting of Registration Board.
S.No
.

Name of
applicant and
name of
exporter

Name o f drug
and its
composition

Date of
application

Applicatio
n form and
Fee

Pack size

Shelf life

5.

Hivet Animal
Health
Business
Lahore

Emulmax ND

11.07.2013

Form 5 A

500ml
bottle

24Months

1000
doses and
10000
doses
bottle

24Months

Investigacion
Aplicada S.A.
de C.V. Puebla
Mexico.

6.

Hivet Animal
Health
Business
Lahore
Investigacion
Aplicada S.A.
de C.V. Puebla
Mexico.

Each dose
contains:Newcastle
disease
inactivated
virus La Sota
strain
Minimum titer
before
inactivate is
109.0 DIE50/ml
Biovac ND

Rs.
100,000

11.07.2013

Each dose
contains:Newcastle
disease
inactivated
virus La Sota
strain
Minimum titer
before
inactivated is
108.0 DEP/ml

Form 5 A
Rs.
100,000

The Board deferred the case for scrutinization of registration dossier and CoPP for
confirmation of license holder, manufacturing and release site.

Agenda 252

nd

18
Registration Board Meeting

The dossiers were re-checked and as per GMP certificate (Legalized and Notarized by
Embassy of Pakistan in Mexico) issued by the Health, Safety and Agro Food Quality National
Service, Directorate General of Animal Health (SAGARPA), Ministry of Agriculture, Livestock,
Rural Development, Fisheries and Food Mexico the firm M/s. Aplicada S.A. de C.V. Puebla
Mexico is GMP compliant as per their requirements. Free sale certificate issued by SAGARPA
shows the products Emulmax ND and Biovac ND are on free sale in the country of origin.
Further, the composition of above products has also been verified from provided documents.

The case is placed before the Board for a decision.


Case No. 06

CASE OF M/s. GRATON PHARMA, KARACHI FOR THE


REGISTRATION OF INTERFERON ALFA 2B 3000IU /VIAL
(LIPHERON FROM BEIJING SHANGLU, CHINA)

The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration
of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered
in any meeting till date .The firm has provided evidence of documents and fee challans submitted
by them.
The case of the firm belongs to pre devolution at the time to Drugs Control Organization,
Ministry of Health. The section tried to retrieve the application from old record but still the
record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been
provided by the company.

The matter is placed before the Board for a decision.

Agenda 252

nd

19
Registration Board Meeting

Item No.III: Cases referred by Pharmaceutical Evaluation & Registration Division.


A. RRR Division
Case No. 01: Renewal of Fakma Pharma
The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore
to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in year 2000 on their request. Subsequently, the firm
requested that either change all registration letters with new name of their firm or issue a letter to
reflect the said change in each of the registration letter, however, they did not deposit any fee for
this purpose. The case was placed before the registration Board in 164 th meeting of held on 30-72001 wherein Registration Board had decided the case as under).
The request of the firm was not acceded to and the was directed to deposit the requisite fee of
Rs. 8000/- for each product for transfer of registration in the new name
It is submitted that as per practice in vogue, in case a firm changes their name/ title, such
a firm apply for transfer of registration form previous name to new name with full registration
fee. However, the owner of the firm has the view that there is no provision in law for transfer of
registration with full fee on same premises. Further, the firm is also of the opinion that the
change of the name of company from M/s. Fakma Pharma, Lahore to M/s. Pharmawise labs (Pvt)
Ltd: Lahore on Drug Manufacturing License is deemed to be valid for all purposes contingent to
their Drug Manufacturing License.
The above position was presented before registration board in its 246 th meeting held on
10-11th December, 2014 for guidance/ orders in the matter. Registration Board decided to seek
opinion of Legal Affairs, Division, DRAP in the matter.
The opinion of legal division is as under:Facts of the case of M/s. Breez PharmaICI were different the facts of the case of M/s.
Pharmawise therefore, the two cases are not be taken on the same analogy and equated. M/s.
Pharmawise had the right of appeal under Section 9 of Drug Act, 1976 against the decision of the
Registration Board. This end needs to be checked. If the firm did not fiel any appeal, the decision
of the Registration Board is deemed to have achieved finally. Advise of the Law Division to
make the repective ruels explicit and clear may be proceeded. In the meanwhile the Registration
Board may decide the matter per applied rules.

Agenda 252

nd

20
Registration Board Meeting

Advise of the Law Division to make the respective rules exploit and clear may be
proceeded. In the meanwhile the registration Board may decide the matter as per applied rules.
Case was considered in 251st Registration Board meeting with advise to present all
relevant record in forthcoming meeting.
Submitted for consideration of Registration Board.
Case No. 02: Applications for Re-Registration of drugs
Following firms have applied for re-registration of drug as they failed to apply for
renewal of registration within due time. The cases of M/s. Ambrosia, Woodward Karachi and
M/s. Macter International Karachi were deferred in 246 th meeting for comments from stake
holders in such cases:M/s. Ambrosia Pharmaceuticals, Islamabad
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.
1.

035357

Ambrocillin
250mg
Tablets
Each tablets contains:Amoxicillin
(as
Trihydrate).250mg

18-12-2004

17-12-2009

Application
Receiving
Date for
Re-Reg.
17-10-2012

2.

035358

-do-

-do-

-do-

3.

041411

04-10-2005

03-10-2010

-do-

-do-

4.

041412

-do-

-do-

-do-

-do-

5.

041414

Ambrocillin
500mg
Tablets
Each tablets contains:Amoxicillin
(as
Trihydrate).500mg
Micozole N Ointment
Contains:Miconazole
Nitrate2%
Isozole Vag Cream
Contains:Isoconazole
Nitrate..1%
Sexatin N Cream
Each
gm
cream

(i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-do-

-do-

-do-

-do-

-do-

Agenda 252

nd

21
Registration Board Meeting

Renewal
Application
Due Date

Documents
Provided
by the firm

contains:Bufexamac50mg
Neomycin
Sulphate.2500IU
Nystatin100,000IU
6.
042917 Monorate Ointment
Contains:Mometasone
Furoate.0.1% w/w
M/s.Woodward Pakistan (Privat) LTD., Karachi.
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.

-do-

-do-

Documents
Provided
by the firm

Bactizith 500mg Capsule 07-04-2009


Each capsule contains:Azithromycin
(as
Dihydrate)..500mg
(USP Specification)
M/s Macter International Limited Karachi

06-04-2014

Application
Receiving
Date for
Re-Reg.
24-06-2014

S.
No

Reg
No.

Name of Drugs with


composition

Date of
initial
registration

Doucments
provided
by the firm

000483

Genticyn HC Cream
Each gm contains:Gentamicin
Sulphate
Hydrocotisone Acetate

6.09.2006

Renrewal
Application
Application reveiving
due date
date for
Reregistration
05-9-2011
24-11-2014

010186

Genticyn B Cream
Each gm contains:Gentamicin
Sulphate.Betamethason
e Valerate

do

do

do

(i).Form-5
(ii). Initial
Reg.letter
(iii) CRF
NOC
(IV) Fee
Rs. 20,000/Do

007701

do

do

do

Do

000497

Multigesic Cream Each


gm contains
Diethylamine
Salicylate
Genticyn Cream Each
gm contains

do

do

do

do

1.

055717

Agenda 252

nd

22
Registration Board Meeting

Renewal
Application
Due Date

(i). Initial
Reg. Letter
(ii). Fee
Rs.20,000/-

Gentamicin Sulphate
M/s Rakaposhi Pharmaceuticals Pvt Limited Peshawar
The firm has applied for registration of drug as they failed to apply for renewal of registration within
due time.
1
54681
Prozam 0.5 mg Tab
30.12.2008
30.12.2013 7-8-2015
(i).Form-5
(ii). Initial
Reg.letter
(iii) CRF
(IV) Fee
Rs. 20,000
2

54682

Pocin 25 mg Tab

do

do

do

Do

54679

Buper 0.2 mg Tab

do

do

do

Do

24218

Rixcime 400 mg Cap

12-3-2002

12-3-2012

do

Do

30303

Quell 500 mg Tab

25-4-2003

25-4-2013

do

Do

30304

Acumen 250 mg Tab

do

do

do

Do

32308

6-3-2004

6-3-2014

do

Do

24217

Rakacid Dry susp 60


ml
Urti- Care Tab

12-3-2002

12-3-2012

do

Do

30305

Acumen 500 mg Tab

25-4-2003

25-4-2013

do

Do

10

21642

Roxidin 20 mg Tab

20-5-1998

20-5-2013

do

Do

11

30301

25-4-2003

Do

33973

do

Do

13

32305

Kavaflox 500 mg tab

6-3-2004

25 42013
16 9 2014
6-3-2014

do

12

Rixcime Dry Susp 30


ml
Deasma Susp 60 ml

do

Do

14

32792

12-6-2004

12-6-2014

do

Do

15

32798

Rothin Dry Powder 15


ml/
Coxban 200 mg Cap

do

do

do

Do

16

33968

Klebro Susp

16-9-2004

16-9-2014

do

Do

Agenda 252

nd

16 9 - 2004

23
Registration Board Meeting

17

32377

Zoromed 250 mg Cap

3-8-2004

3-8-2014

do

Do

18

23013

H2bf 40 mg Tab

20-11-1999

20-11-2014

do

Do

19

32304

Kavaflox 250 mg tab

6-3-2004

6-3-2014

do

Do

20

32302

Quell 250 mg tab

do

do

do

Do

21

32307

do

do

do

Do

22

33969

Rakacid Dry Powder


25 ml
Rakazine Syp 60/ml

16-9-2004

16-9-2014

do

Do

23

32303

Lozamep 20 mg Cap

24-3-2004

24-3-2014

do

Do

24

32791

Rothin 250 mg Cap

12-6-2004

12-6-2014

do

Do

25

23014

Dectil 50mh Tab

20-11-1999

20-11-2014

do

Do

26

32800

12-6-2004

12-6-2014

do

Do

27

23012

Dompitillium 10 mg
Tab
H2 BF 20 mg tab

20-11-1999

20-11-2014

do

Do

28

33775

Dompitillium Susp

4-9-2004

4-9-2014

do

Do

29

24218

Alert 20 mg Cap

12-3-2002

12-3-2012

do

Do

30

PP Zole 20 mg Cap

11-5-2004

11-5-2014

do

Do

31

000178Ex
56325

Mudine 2 mg tab

21-3-2009

21-3-2014

do

Do

32

49227

Ostamed 70 mg tab

3-6-2008

3-6-2013

do

Do

33

34691

Atastan 10 mg tab

30-11-2004

30-11-2014

do

Do

34

58324

Rapezol 20 mg tab

21-3-2004

21-3-2014

do

Do

35

23267

Ostamed 10 mg tab

20-12-2004

20-12-2014

do

Do

36

49228

Esorok 20 mg Cap

3-6-2008

3-6-2013

do

Do

37

54673

Xcite 10 mg tab

30-12-2008

30-12-2013

do

Do

38

35628

Lomexin 200 mg tab

20-12-2004

20-12-2014

do

Do

Agenda 252

nd

24
Registration Board Meeting

39

49500

Malamether Plus tab

17-7-2008

17-7-2013

do

Do

40

32376

Rakalide 100 mg tab

3-8-2004

3-8-2014

10-8-2015

Do

41

30306

25-4-2003

25-4-2013

do

Do

42

32802

Acumen Dry Susp 30


ml
Mebamine 500 mcg tab

12-6-2004

12-6-2014

do

Do

43

32306

Rakazole 40 mg tab

6-3-2004

6-3-2014

do

Do

44

32583

Vifolix Cap

25-6-2004

25-6-2014

do

Do

45

Rakaflex 500 mgCap

29-12-2008

29-12-2013

do

Do

46

001137
Ex
32375

Rakaprofen 100 mg tab

3-8-2004

3-8-2014

do

Do

47

33972

Rakamizole Susp 60 ml 16-9-2004

16-9-2014

do

Do

48

56326

Roxbex 20 mg tab

21-3-2009

21-3-2014

do

Do

49

32310

Rakacid 500 mg tab

6-3-2004

6-3-2014

do

Do

50

32309

Rakacid 250 mg tab

do

do

do

Do

51

32790

Rakazine 10 mg tab

12-6-2004

12-6-2014

do

Do

52

54680

Sonaril 3 mg tab

30-12-2008

30-12-2013

do

Do

53

35627

Moxacin 400 mg tab

20-12-2004

20-12-2014

do

Do

54

32793

12-6-2004

12-6-2014

do

Do

55

32794

Leucon Dry susp 50


mg
Leucon Cap 150 mg

do

do

do

Do

56

32796

Kilbac 125 mg Susp

do

do

do

Do

57

32797

Kilbac 250 mg Susp

do

do

do

Do

Submitted for consideration of Registration Board.

Agenda 252

nd

25
Registration Board Meeting

Case No.03:
M/s Cherry Pharmaceuticals International, Lahore has applied for renewal of drug
registration with following details:S.
No.

Reg.
No

Name of
Drugs with

Initial
Date of
Reg
1-12-1997

Validity of Registration

02010
9

Anticoc
super
powder

04311
2

Milicoli
Oral
Solution

24-4-2006

23-42011

-do-

-do-

04492
4

Antitox
Water
Soluble
Powder

25-1-2007

24-12012

-do-

-do-

16-8-2014

(transferre
d to
Ms/Cherry
on 17-82009

The firm has applied on 5-10-2011 for the change of manufacturers Name from M/s
Franvet, France to M/s Qalian, France. Approval to the request of firm was granted on 30-12013.
Submitted for the consideration of the Registration Board

Agenda 252

nd

26
Registration Board Meeting

B. Pharmaceutical Evaluation Cell


Case No.01: Applications for registration of new molecules
(Evaluator: In-charge Evaluation Cell)
a. Imported.
S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name + Dosage Form +
Strength)

Type of Form
Initial
diary

date,

Composition
Pharmacological Group

Fee including
differential
fee

Finished product Specification


Demanded
Price / Pack
size

Remarks on the
formulation (if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities

Remarks by Evaluator

Me-too status
GMP status as
depicted in latest
inspection report
(with date) by
the Evaluator

1.

2.

M/s
Novartis
Pharma
(Pakistan)
Limited,
15
West Wharf P.O
Box
100
Karachi.
Novartis Pharma
Stein AG, Stien,
Switzerland.

Ultibro Breezhaler
Each Capsule contains:
Indacaterol
110mcg
and
Glycopyrronium
50mcg
(143
microgram glycopyrrnium bromide
equivalent to 110 micrograms
glycopyrrnium)

M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.

Neupro 2mg/24hr
Each patch of 10cm2 contains
4.5mg Rotigotine (UCB Specs)
(Antiepileptic)

(Bronchodilator)

LTS Lohmann
TherapieSystem
AG,
Lohmannstr

Agenda 252

Form-5 (A)
Dy. No: 84
dated 22-012014
100,000/dated 22-012014
30s
Rs.6,424/Form-5 (A)
Dy. No: 386
dated 19-052014
100,000/dated 19-052014

nd

27
Registration Board Meeting

Ultibro
Breezhaler
Novartis
Europharm
Limited. EMA

COPP was issued on 2301-2015

Neupro
INC

COPP is issued on dated:


30-08-2013
Storage conditions are
not as per innovator.
Pharmacological group
wrongly mentioned.
Sole Agency Agreement
with complete contact
detail of exporter.

UCB

2,D-56626
Andernach,
Germany
3.

4.

5.

M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
LTS Lohmann
TherapieSystem
AG,
Lohmannstr
2,D-56626
Andernach,
Germany
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
LTS Lohmann
TherapieSystem
AG,
Lohmannstr
2,D-56626
Andernach,
Germany
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.

28s
Rs.7,115/-

Neupro 4mg/24hr
Each patch of 20cm2 contains
9.0mg Rotigotine (UCB Specs)
(Antiepileptic)

Neupro
INC

UCB

COPP is issued on dated:


30-08-2013
Storage conditions are
not as per innovator.
Pharmacological group
wrongly mentioned.
Sole Agency Agreement
with complete contact
detail of exporter.

Neupro
INC

UCB

COPP is issued on dated:


30-08-2013
Storage conditions are
not as per innovator.
Pharmacological group
wrongly mentioned.
Sole Agency Agreement
with complete contact
detail of exporter.

Neupro
INC

UCB

COPP is issued on dated:


30-08-2013
Storage conditions are
not as per innovator.
Pharmacological group
wrongly mentioned.
Sole Agency Agreement
with complete contact
detail of exporter.

Dy. No: 387


dated 19-052014
100,000/dated 19-052014
28s
Rs.14,225/-

Neupro 6mg/24hr
Each patch of 30cm2 contains
13.5mg Rotigotine (UCB Specs)
(Antiepileptic)

Form-5 (A)
Dy. No: 384
dated 19-052014
100,000/dated 19-052014
28s
Rs.21,340/-

Neupro 8mg/24hr
Each patch of 40cm2 contains
18.0mg Rotigotine (UCB Specs)
(Antiepileptic)

LTS Lohmann
TherapieSystem
AG,
Lohmannstr
2,D-56626
Andernach,
Germany

Agenda 252

Form-5 (A)

Form-5 (A)
Dy. No: 380
dated 19-052014
100,000/dated 19-052014
28s
Rs.28,450/-

nd

28
Registration Board Meeting

6.

7.

8.

9.

M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s
Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Germany.
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s
Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Germany.
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s
Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Germany.
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.

Vimpat film coated tablet 150mg


Tablet
Each film coated tablet contains:
Lacosamide.150mg (UCB specs)
(Antiepileptic)

Dy. No: 131


dated 20-092013

Vimpat
UCB
INC FDA
50mg, 100mg,
150mg, 200mg

Lacolep by Hilton Pharma


Karachi.

Vimpat
UCB
INC FDA
50mg, 100mg,
150mg, 200mg

Lacolep by Hilton Pharma


Karachi.

Vimpat
UCB
INC FDA
50mg, 100mg,
150mg, 200mg

Lacolep by Hilton Pharma


Karachi.

Vimpat
UCB
INC FDA
50mg, 100mg,
150mg, 200mg

Lacolep by Hilton Pharma


Karachi.

100,000/dated 20-092013
56s
Rs.40,230/Vimpat film coated tablet 50mg
Tablet
Each film coated tablet contains:
Lacosamide.50mg (UCB specs)
(Antiepileptic)

Form-5 (A)
Dy. No: 133
dated 20-092013
100,000/dated 20-092013
14s
Rs.3,352/-

Vimpat film coated tablet 100mg


Tablet
Each film coated tablet contains:
Lacosamide.100mg (UCB specs)
(Antiepileptic)

Form-5 (A)

Vimpat film coated tablet 200mg


Tablet
Each film coated tablet contains:
Lacosamide.200mg (UCB specs)
(Antiepileptic)

Form-5 (A)

M/s
Aesica
Pharmaceutical

Agenda 252

Form-5 (A)

nd

29
Registration Board Meeting

Dy. No: 128


dated 20-092013
100,000/dated 20-092013
56s
Rs.26,820/-

Dy. No: 132


dated 20-092013
100,000/dated 20-09-

The product is locally


registered in 50mg, 100mg,
150mg and 200mg.
COPP was issued on 2211-2012
GMP was issued on 27-112012

The product is locally


registered in 50mg, 100mg,
150mg and 200mg.
COPP was issued on 2211-2012
GMP was issued on 27-112012

The product is locally


registered in 50mg, 100mg,
150mg and 200mg.
COPP was issued on 2211-2012
GMP was issued on 27-112012

The product is locally


registered in 50mg, 100mg,
150mg and 200mg.
COPP was issued on 22-

10.

11.

12.

GmbH
Galileistrasse 6
08056
Zwickau
Germany.
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s
UCB
Manufacturing
Inc. 331 Clay
Road
(755
Jefferson Road)
Rochester, NY
14623 USA
M/s
AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s
UCB
Pharma
SA
Chemin
du
foriest B 1420
Braine-Alleud
Belgium
M/s
Pfizer
Pakistan
Limited,
12
Dockyard Road,
West
Wharf,
Karachi.

2013
56s
Rs.53,640/-

Vimpat Syrup 10mg/ml


Syrup
Each ml contains:
Lacosamide.10mg (UCB specs)
(Antiepileptic)

Form-5 (A)

Vimpat
10mg/ml solution for
infusion
Infusion
Each ml of solution contains:
Lacosamide.10mg (UCB specs)
(Antiepileptic)

Form-5 (A)

Xeljanz
Tablet
Each tablet contains:
Tofacitinib.5mg
(Factor Xa Inhibitor)

Form-5 (A)

Dy. No: 130


dated 20-092013
100,000/dated 20-092013
20ml
Rs.10,818/-

Dy. No: 170


dated 27-092013
50,000/dated 27-092013
Not
mentioned.

Pfizer
Manufacturing
Deutschland
GmbH
Betriebsstatte
Freiburg
Mooswaldallee
179090 Freiburg

Agenda 252

Dy. No: 129


dated 20-092013
100,000/dated 20-092013
200ml
Rs.14,268/-

nd

30
Registration Board Meeting

11-2012
GMP was issued on 27-112012

Vimpat
UCB
INC 10mg/ml
oral solution

COPP was issued on dated.


22-11-2011 by European
Medicines Agency

Vimpat
UCB
INC 10mg/ml
IV infusion

Photocopy of COPP dated.


22-11-2012

Xeljanz by PF
Prism CB

Storage conditions are not


as per innovator.
COPP is issued by
Swissmedic and does not
provide information of
manufacturing / packaging
to be done at USA.
Label shows the product is
manufactured in Ireland
while as per application it
is
manufactured
at
Germany and USA.
Last Inspection Report
conducted
by
the
concerned
Regulatory

Germany.

13.

M/s
Pfizer
Pakistan
Limited,
12
Dockyard Road,
West
Wharf,
Karachi.

Authority
for
manufacturing process at
USA.
Xeljanz
Tablet
Each tablet contains:
Tofacitinib.10mg
(Factor Xa Inhibitor)

M/s
Bayer
Pakistan (Pvt.)
Limited.
M/s
Bayer
Pharma
AG
51368
Leverkusen
Germany.

15.

M/s
Abbott
Laboratories,
Karachi.
M/s
Ferrer
Internacional.
S.A.
Joan
Buscalla
1-9
08173-Sant
Cugat del Valles
(Barcelona)

Agenda 252

Dy. No: 169


dated 27-092013
50,000/dated 27-092013
Not
mentioned.

Pfizer
Manufacturing
Deutschland
GmbH
Betriebsstatte
Freiburg
Mooswaldallee
179090 Freiburg
Germany.

14.

Form-5 (A)

Stivarga (Regorafenib) 40mg film


coated tablets.
Film coated tablets.
Each film coated tablet contains.
Regorafenib40mg
(Regorafenib is a protein kinase
inhibitor with the ATC code
L01XE21.)

Nucleo CMP Forte Capsules.


Capsules.
Each Capsule contains.
Cytidine5mg
Uridine..1.33mg
(Musculoskeletal System)

nd

31
Registration Board Meeting

Form-5 (A)
Dy. No: 370
dated 03-122013
50,000/dated 03-122013
To
be
submitted
latter.
Form-5 D
Dy. No: 314
dated 11-112013
50,000/dated 11-112013
To
be
forwarded.

Xeljanz 10mg is
not
FDA
approved.

Storage condition is not as


per innovator.
COPP is issued by
Swissmedic and does not
provide information of
manufacturing / packaging
to be done at USA.
Label shows the product is
manufactured in Ireland
while as per application it
is
manufactured
at
Germany and USA.
Last Inspection Report
conducted
by
the
concerned
Regulatory
Authority
for
manufacturing process at
USA.
GMP inspection Certificate of medicinal
conducted
product dated 18-09-2013
December 14 to issued
by
EMA
is
16, 2010 by provided.
German
Authority.

GMP issued on
February
092011,
by
Spanish
Government

COPP issued on 07-192013.


Stability studies conducted
at 30C / 60%

Spain

16.

17.

M/s
Sanofieventis Pakistan
Limited.
Plot
No.23,
Sector
No.22, Korangi
Industrial Area s
Plot
No.23,
Sector
No.22,
Korangi
Industrial Area
Karachi.
M/s
SanofiAventis
Deutschland
GmbH,
Industriepark
Hoechst 65926
Frankfurt
am
Main Germany
M/s
Sanofieventis Pakistan
Limited.
Plot
No.23,
Sector
No.22, Korangi
Industrial Area s
Plot
No.23,
Sector
No.22,
Korangi
Industrial Area
Karachi.

Lyxumia.
Solution of injection.
Each dose of 0.2 ml contains.
Lixisenatide20mg
(ATC code: A10BX10)

Form-5 A
Dy. No: 763
dated 28-062013
100,000/dated 28-062013
1s/
Rs.7506.8

Lyxumia (Sanofi
Aventis
EMA
approved)

FDA approval is delayed


sighting internal data from
cardiovascular risks study.

Lyxumia.
Solution of injection.
Each dose of 0.2 ml contains.
Lixisenatide10mg
(ATC code: A10BX10)

Form-5 A
Dy. No: 761
dated 28-062013
100,000/dated 28-062013
1s/
Rs.7506.8

Lyxumia (Sanofi
Aventis
EMA
approved)

FDA approval is delayed


sighting internal data from
cardiovascular risks study.

M/s
SanofiAventis
Deutschland
GmbH,
Industriepark
Hoechst 65926
Frankfurt
am

Agenda 252

nd

32
Registration Board Meeting

Main Germany

18.

19.

M/s
Sanofieventis Pakistan
Limited.
Plot
No.23,
Sector
No.22, Korangi
Industrial Area s
Plot
No.23,
Sector
No.22,
Korangi
Industrial Area
Karachi.
M/s
SanofiAventis
Deutschland
GmbH,
Industriepark
Hoechst 65926
Frankfurt
am
Main Germany
M/s
Novartis
Pharma
(Pakistan)
Limited
M/s
Sandoz
Onco Therapies
Limited Plot No.
284,
BommasandraJigani
Link
Road , Industrial
Area,
AnekalTaluk,
Bangalore 560,
105 India.

Lyxumia.
Solution of injection.
Lyxumia Pen-injector is available
in two different dosage strengths:
10g and 20g per 0.2ml
administration volume. Body and
cap are provided in two different
colors: green (10g) and burgundy
(20g)
(ATC code: A10BX10)

Form-5 A
Dy. No: 762
dated 28-062013
100,000/dated 28-062013
1+1=2s/
Rs.15,013.6/-

Lyxumia (Sanofi
Aventis
EMA
approved)

FDA approval is delayed


sighting internal data from
cardiovascular risks study.

Veltezom 3.5mg/Vial Powder for


Solution for Injection.
Vial Injectable.
Each Vial contains.
Brotezomib3.5mg
(Antineoplastic agent)

Form-5
Dy. No: 296
dated 31-032014
50,000/dated 25-072013
1s/
Rs.20,317/-

Velcade
Millennium
Pharms

COPP issued on dated. 0501-2013

b. Local manufactured.

Agenda 252

nd

33
Registration Board Meeting

S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name + Dosage Form
+ Strength)

Type of Form

Composition

Fee
including
differential fee

Initial date, diary

Pharmacological Group
Finished product Specification

Demanded
Price / Pack size

Remarks on the
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities

Remarks by Evaluator

Me-too status
GMP status as
depicted in latest
inspection report
(with date) by
the Evaluator

20.

21.

22.

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Esli 800mg Tablets


Each Tablet contains:
Eslicarbazepine Acetate.800mg
(Anti-epileptic)

Esli 400mg Tablets


Each Tablet contains:
Eslicarbazepine Acetate.400mg
(Anti-epileptic)

Esli 200mg Tablets


Each Tablet contains:
Eslicarbazepine Acetate.200mg
(Anti-epileptic)

Form-5-D
Dy. No: 1639
dated
27-082013
50,000/- dated
27-08-2013
Rs.825/Tab
Form-5-D
Dy. No: 1637
dated
27-082013
50,000/- dated
27-08-2013
10s,20s,30s
Rs.6,000/Rs.12,000/Rs.18,000/Form-5-D
Dy. No: 1638
dated
27-082013
50,000/-

Agenda 252

nd

34
Registration Board Meeting

dated

Aptiom 800mg
by
Sunovion
Pharms
INC
(FDA)

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Aptiom 400mg
by
Sunovion
Pharms
INC
(FDA)

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Aptiom 200mg
by
Sunovion
Pharms
INC
(FDA)

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

23.

24.

25.

26.

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Rasidon 120mg
Each Tablet contains:
Lurasidone HCl..120mg
(Antipsychotic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Rasidon 80mg
Each Tablet contains:
Lurasidone HCl..80mg
(Antipsychotic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Rasidon 40mg
Each Tablet contains:
Lurasidone HCl..40mg
(Antipsychotic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Rasidon 20mg
Each Tablet contains:
Lurasidone HCl..20mg
(Antipsychotic)

Agenda 252

nd

27-08-2013
10s,20s,30s
Rs.4,000/Rs.8,000/Rs.12,000/Form-5-D
Dy. No: 139
dated
13-022013
50,000/- dated
13-02-2013
10s,20s30s
Rs.16,000/Rs.32,000/Rs.48,000/Form-5-D
Dy. No: 141
dated
13-022013
50,000/- dated
13-02-2013
10s,20s30s
Rs.15,000/Rs.30,000/Rs.45,000/Form-5-D
Dy. No: 180
dated
13-022013
50,000/- dated
13-02-2013
10s,20s30s
Rs.14,000/Rs.28,000/Rs.42,000/Form-5-D
Dy. No: 183
dated
13-022013
50,000/- dated

35
Registration Board Meeting

Latuda
Sunovion
Pharm INC

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Latuda
Sunovion
Pharm INC

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Latuda
Sunovion
Pharm INC

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Latuda
Sunovion
Pharm INC

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

27.

28.

29.

30.

31.

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Canaglu 100mg Tablets


Each film coated Tablet contains:
Canagliflozin100mg
(Anti-Diabetic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Canaglu 300mg Tablets


Each film coated Tablet contains:
Canagliflozin300mg
(Anti-Diabetic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Dapa 10mg Tablets


Each film coated Tablet contains:
Dapagliflozin10mg
(Anti-Diabetic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Dapa 5mg Tablets


Each film coated Tablet contains:
Dapagliflozin5mg
(Anti-Diabetic)

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Apix 2.5mg Tablets


Tablet.
Each film coated Tablet contains:
Apixaban.2.5mg
(Anticoagulant)

Agenda 252

nd

13-02-2013
10s,20s30s
Rs.13,000/Rs.26,000/Rs.39,000/Form-5-D

Invokana FDA

Dy. No: 1585


dated
23-082013
50,000/- dated
23-08-2013
10s/Rs.6,500/Form-5-D

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Invokana FDA

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Farxiga
(Astrazeneca
ab) 50mg, 10mg
FDA

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Farxiga
(Astrazeneca
ab) 50mg, 10mg
FDA

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Eliquis 2.5mg,
5mg (BMS)
FDA

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Dy. No: 1582


dated
23-082013
50,000/- dated
23-08-2013
10s/Rs.7,500/Form-5-D
Dy. No: 1584
dated
23-082013
50,000/- dated
23-08-2013
10s/Rs.7,000/Form-5-D
Dy. No: 1583
dated
23-082013
50,000/- dated
23-08-2013
10s/Rs.5,500/Form-5-D
Dy. No: 400
dated
06-112013
50,000/- dated
06-11-2013

36
Registration Board Meeting

10s,20s,60s
Rs.475/tablet-

32.

33.

34.

35.

M/s
Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15,
Korangi
Industrial Area,
Karachi.

Apix 5mg Tablets


Tablet.
Each film coated Tablet contains:
Apixaban.5mg
(Anticoagulant)

M/s
Getz
Pharma,
(Private)
Limited
2930/27, Korangi
Industrial Area
Karachi.

Lansodex Capsule 60mg


Delayed Release Capsules
Each delayed release contains:
Enteric
coated
pellets
of
Dexlansoprazole.60mg
PPI (Proton Pump Inhibitor)

M/s
Getz
Pharma,
(Private)
Limited
2930/27, Korangi
Industrial Area
Karachi.

Lansodex Capsule 30mg


Delayed Release Capsules
Each delayed release contains:
Enteric
coated
pellets
of
Dexlansoprazole.30mg
PPI (Proton Pump Inhibitor)

M/s
Pharma,
(Private)
Limited

Previr
Film coated tablet.
Each film coated tablet contains:
Telaprevir750

Getz

29-

Agenda 252

nd

Form-5-D
Dy. No: 102
dated
07-022014
50,000/- dated
07-02-2014
10s,20s,60s
Rs.516.58/tabletForm-5-D
Dy. No: Not
mentioned.
dated
19-102011
Rs.15,000/dated
30-072013
Rs. 5,000/06-08-2015
Rs.30,000/14s/Rs.1680/Form-5-D
Dy. No: Not
mentioned.
dated
19-102011
Rs.15,000/dated
30-072013
Rs. 5,000/06-08-2015
Rs.30,000/14s/Rs.840/Form-5-D
Dy. No: Not
mentioned.
dated
31-08--

37
Registration Board Meeting

Eliquis 2.5mg,
5mg (BMS)
FDA

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Dexlanxilant
30mg, 60mg
Takeda Pharms
FDA.

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Dexlanxilant
30mg, 60mg
Takeda Pharms
FDA.

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Inspection.
15-12-2010
International
status not

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO

30/27, Korangi
Industrial Area
Karachi.

Anti viral (HCV serine protease


inhibitors)

36.

M/s
Getz
Pharma,
(Private)
Limited
2930/27, Korangi
Industrial Area
Karachi.

Previr
Film coated tablet.
Each film coated tablet contains:
Telaprevir375
Anti viral (HCV serine protease
inhibitors)
(Getz specs)

37.

M/s
Searl
Company
Limited.
1st
Floor
N.I.C
Building Abbasi
Shaheed Road
Off: Shahrah-EFaisal Karachi.
M/s
Searl
Company
Limited.
1st
Floor
N.I.C
Building Abbasi
Shaheed Road
Off: Shahrah-EFaisal Karachi.

Dexlans 60mg Capsule


Capsule.
Each Capsule contains:
Dexlansoprazole..60mg
(Anti Ulcerant)

38.

Agenda 252

Dexlans 30mg Capsule


Capsule.
Each Capsule contains:
Dexlansoprazole..30mg
(Anti Ulcerant)

nd

2013
15,000/Rs.35,000/dated
30-082013
10s,30s
Rs.10,000/Rs.30,000/Form-5-D
Dy. No: Not
mentioned.
dated
31-082013
15,000/Rs.35,000/dated
30-072013
10s,30s
Rs.5,000/Rs.15,000/Form-5-D
Dy. No: Not
mentioned.
Dated.
08-102013
Rs.50,000/14s,/Rs.15,000/-

confirmed

guidelines.

Incivek by
Vertex pharms
FDA:375mg
Inspection.
15-12-2010

Stability
Studies
conducted under the
Zone IV-A conditions
as per ICH / WHO
guidelines.

Dexlanxilant
30mg, 60mg
Takeda Pharms
FDA.

The innovator product is


delayed release capsule
while firm has not
applied it.

Form-5-D
Dy. No: Not
mentioned.
Dated.
08-102013.Rs.50,000/
14s,
Rs.880/-

Dexlanxilant
30mg, 60mg
Takeda Pharms
FDA.

The innovator product is


delayed release capsule
while firm has not
applied it.

38
Registration Board Meeting

S/N

Name
and Brand Name
address
of
manufacturer / (Proprietary name +
Applicant
Dosage Form +
Strength)
Composition
Pharmacological
Group

39.

M/s Martin Dow


Pharmaceuticals
(Pak),
Limited,
Plot 37, Sector 19,
Korangi Industrial
area, Islamabad.

40.

-do-

Agenda 252

nd

Type of Form

International
Remarks
status
in
Initial
date, reference drug
diary
agencies
/
authorities
Fee including
differential fee Me-too status

Demanded
GMP status as
Price / Pack depicted
in
Finished
product size
latest
Specification
inspection
report
(with
date) by the
Evaluator
EUGLUCON
Plus Form 5
Glucovance
Tablets
of
Tablets
Alphapharm Ltd
Dy. No:
NSW ( TGA
Each film coated dated
Approved)
tablet contains:
Glibenclamide.2.5 8,000/- dated Glucomet
of
mg
12-01-11
Pharmatec
Metformin
HCL
of
500mg
12000/- dated Inspection
M/s
Martin
Dow
31-07-13
Pharma Karachi
was carried out
Rs. 70/- per on 24-02-15 by
tablet, Pack of the panel of
30s
inspectors
wherein
they
unanimously
recommended
the grant of
GMP for export
purpose.
DUVEL
Tablets Form 5
Januvia of MSD
Uk
25mg
Dy. No:
Sitagen of
Each film coated dated
Ferozsons Lab
tablet contains:
Sitagliptin phosphate 8,000/- dated
MDP
eq.
to 27-01-11
Sitagliptin25mg
12000/- dated

39
Registration Board Meeting

DPP-4 Inhibitor

31-07-13

Manufacturer

41.

-do-

Rs. 600, 1200,


1800/- pack of
10, 20 ,30s
DUVEL
Tablets Form 5
Januvia of MSD
Uk
50mg
Dy. No:
Sitagen of
Each film coated dated
Ferozsons Lab
tablet contains:
Sitagliptin phosphate 8,000/- dated
MDP
eq.
to 27-01-11
Sitagliptin50mg
12000/- dated
DPP-4 Inhibitor
31-07-13
Manufacturer

42.

43.

Rs. 1000, 2000,


3000/- pack of
10, 20 ,30s
-d0DUVEL
Tablets Form 5
Januvia of MSD
Uk
100mg
Dy. No:
Sitagen of
Each film coated dated
Ferozsons Lab
tablet contains:
Sitagliptin phosphate 8,000/- dated
MDP
eq.
to 27-01-11
Sitagliptin
100mg
12000/- dated
31-07-13
DPP-4 Inhibitor
Rs. 1670, 3340,
Manufacturer
5010/- pack of
10, 20 ,30s
M/s Don Valley EZOLE Capsule
Form 5
Nexium of
a. Manufacturing method
AstraZeneca
carboscisteine capsules
Pharma, 31 Km
(USFDA)
submitted.
Revis
Ferozpur
Road, Each
capsule Dy. No: 224
manufacturing method f
Lahore
contains:
DDC
Nexum of Getz
Esomeprazole
capsu
Esomeprazole
dated
20-01need to be submitted.
Magnesium 88.8mg 2011
Inspection of the b. GMP certificate of M
equivalent
to
firm was carried
surge laboratories need
be submitted.
Esomeprazole
8,000/- dated out on 06-07-15
by
the
area
FID
20mg
20-01-2011
12000/- dated and nothing was
reported in

Agenda 252

nd

40
Registration Board Meeting

Benzimidazole
derivative
Manufacturer

44.

45.

-do-

10-03-14

violation of
GMP.

As per brand
leader/ Pack of
2x7s

M/s
Surge
Laboratories,
Sheikhupura
EZOLE Capsule
Form 5

Nexium of
a. Manufacturing method
AstraZeneca
carboscisteine capsules
(USFDA)
submitted.
Revis
Each
capsule Dy. No: 225
manufacturing
method
f
contains:
DDC
Nexum of Getz
Esomeprazole
capsu
Esomeprazole
dated
20-01need to be submitted.
Magnesium 88.8mg 2011
b. GMP certificate of M
equivalent
to
surge laboratories need
be submitted.
Esomeprazole
8,000/- dated
40mg
20-01-2011
12000/- dated
Benzimidazole
10-03-14
derivative
As per brand
Manufacturer
leader/ Pack of
2x7s
M/s
Surge
Laboratories,
Sheikhupura
M/s
Gillman PATHODIME
Form 5
Not found in
Evidence of approval of sam
reference
dosage form and strength
Pharmaceuticals,
Injection
250mg
agencies
not found in reference dr
41/2- Phase I & II, (I.M)
Dy. No: 232
agencies.
Industrial Estate
dated 24-01-11
Cefcom of
Hattar.
Each vial contains:
Barrett &
Ceftazidime
as 8,000/- dated Hodgson
pentahydrate.250m 24-01-11
Karachi
g
12000/- dated Inspection of the
firm was carried
Cephalosporin
20-07-13
out on 08-05-15
by the panel of
USP
As per SRO/ inspectors and
Pack of 1s
nothing was
observed in
violation to
GMP.

Agenda 252

nd

41
Registration Board Meeting

46.

-do-

PATHODIME
Injection 500mg (I.V)

Form 5
Dy. No: 236
dated 24-01-11

Ceftazidime 500
mg Powder for
Solution for
Injection of
Stravencon UK

Each vial contains:


Ceftazidime
as
pentahydrate.250m 8,000/- dated Cefcom of
g
24-01-11
Barrett &
Hodgson
Cephalosporin
12000/- dated Karachi
20-07-13
USP

47.

-do-

PATHODIME
Injection 1g (IV)

As per SRO/
Pack of 1s
Form 5
Ceftazidime 1g
Powder for
solution for
Dy. No: 237
dated 24-01-11 injection of
Wockhart UK

Each vial contains:


Ceftazidime
as
pentahydrate.1g
8,000/- dated Cefcom of
24-01-11
Barrett &
Hodgson
Cephalosporin
12000/- dated Karachi
USP
20-07-13

48.

-do-

As per SRO/
Pack of 1s
TERBIZOLE Tablet
Form 5
Not found in
reference
agencies
Each film coated Dy. No: 234
tablet contains:
dated 24-01-11
Lamisl of
Terbinafine
as
Novartis
HCL..125mg
8,000/- dated
24-01-11
Antifungal
12000/- dated
Manufacturer
29-07-13
As per SRO/
Pack of 1x10s

Agenda 252

nd

42
Registration Board Meeting

Evidence of approval
applied dosage form a
strength in reference dr
agencies is not submitted.

49.

-do-

APRAZOLE Tablets

Form 5

Each enteric coated


table contains:
Pantoprazole sodium
sesquihydrate
40mg

Dy. No: 234


dated 24-01-11

PPI

12000/- dated
29-07-13

8,000/- dated
24-01-11

Pantoprazole
tablets of
Takeda UK
Gastipan of
Albro

USP
As per SRO/
Pack of 14s
FOLIMAL Tablet
Form 5
Not found/ not
provided
Each tablet contains: Dy. No: 234
Iron III hydroxide dated 24-01-11 Acefer-F of
Safron
Polymaltose
Laboratories
Complex
eq.
to 8,000/- dated
elemental
Iron 24-01-11
.100mg
Folic Acid.0.35ng
12000/- dated
29-07-13
Hematinic
As per SRO/
Manufacturer
Pack of 1x10s

50.

51.

-do-

GLUCOMAX
Tablets

Form 5
Dy. No: 235
coated dated 24-01-11

Each film
tablet contains:
Glucosamine
sulphate.500mg
Chondroitin
Sulphate.400mg

8,000/- dated
24-01-11
12000/- dated
29-07-13

Glucosaminoglycan
Manufacturer

Agenda 252

nd

43
Registration Board Meeting

As per SRO/
Pack of 30s

Not found/ Not


provided
Artilage tablets
of SJ & G

a. Evidence of approval
reference drug agencies
not submitted.
b. USP specifications of t
finished
product
a
claimed however t
same were not found
the official compend
Copy
of
the
sa
monograph is required.

52.

-do-

CALCINATE Tablet
Each tablet contains:
Alendronate sodium
equivalent to
Alendronic
acid.70mg
Cholecalciferol..
70mcg
Biphosphonates
Vitamin D

53.

-do-

Manufacturer
CO-GEN Tablets
Each film coated
tablet contains:
Codergocrine
mesylate..4.5mg
Cerebral activator
ergot alkaloid
Manufacturer

54.

OSTEO-D-CA
Tablets
Each film coated
tablet contains:
Alfacalcidol
0.5mcg
Calcium carbonate
1000mg eq. to
elemental
calcium.400mg
Vitamin D Analogue
Manufacturer
RECID Tablet 20mg

55.

Each enteric coated


tablet contains:
Rabeprazole
sodium20mg

Agenda 252

nd

44
Registration Board Meeting

Form-5

Fosavance
Tablets of MSD
Dy.No:
230 UK
dated 24-01-11
Drate-D
of
8000/dated SJ&G Karachi
24-01-11
12000/- dated
29-07-13
As
per
SRO/Pack of
4s
Form-5

Not found/ Not Evidence of approval of sam


provided
generic, dosage form
Dy.No:
228
reference drug agencies ne
dated 24-01-11 Ceregin Tablets to be submitted.
of
Platinum
8000/dated Pharma Karachi
24-01-11
12000/- dated
29-07-13

As
per
SRO/Pack of
10s
Form-5
Not found/ Not a. Evidence of approval
provided
same generic, dosage fo
Dy.No:
227
and strength in referen
dated 24-01-11 Oscal-D Tablets
drug agencies is n
of
Aeries
submitted.
8000/dated Pharmaceuticals b. For Alfacalcidol stora
24-01-11
.
instructions are :
12000/- dated
Under nitrogen, in
29-07-13
airtight
contain
protected from light, at
As
per
temperature of 2 C to
SRO/Pack of
C.
2x10s
3x10s
Form-5

Pariet Tablets of
Easai UK

Dy.No:
240
dated 24-01-11 Acifix Tablets of
Aeries Pharma
8000/dated

PPI

24-01-11

Manufacturer

12000/- dated
29-07-13
As
per
SRO/Pack of
14s

56.

ALERBI Tablets
10mg
Each tablet contains:
Ebastine10mg
Antihistamine
Manufacturer

57.

M/s Barrett &


Hodgson Pakistan
(Pvt)
Limited,
F/423
SITE
Karachi

-do-

Manufacturer

Agenda 252

Dy.No:
238
dated 24-01-11 Aerius Tablets
of
Dermagen
8000/dated Pharma
24-01-11
12000/- dated
29-07-13

8,000/- dated
10-12-10

Rs. 400/- Pack


Manufacturer
of 1s
BUDECORT Nasal Form 5
Rhinocort Aqua a. Manufacturing facility f
of AstraZeneca
applied formulation nee
Spray
(MHRA)
confirmation.
Dy. No: 2180
b.
Firm
submitted that appli
Each dose contains:
R-II
Not found
drug is available as inhale
Budesonide.64mcg dated 14-12-10
in Pakistan
Anti-inflammatory
Synthetic
Corticosteroid

nd

Not found/ Not


provided

As
per
SRO/Pack of
10s
BUDECORT Nasal Form 5
Rhinocort Aqua a. Manufacturing facility f
of AstraZeneca
applied formulation nee
Spray
(USFDA)
confirmation.
Dy. No: 2181
b. Firm
submitted
th
Each dose contains:
R-II
Not found
applied drug is available
Budesonide.32mcg dated 14-12-10
inhalers in Pakistan
Anti-inflammatory
Synthetic
Corticosteroid

58.

Form-5

45
Registration Board Meeting

8,000/- dated
10-12-10
Rs. 400/- Pack
of 1s

59.

M/s Remington
Pharmaceutical
Industries, (Pvt)
Limited, 18Km
Multan Road,
Lahore.

AMIOL Tablet

Dy.No:

Each film coated


tablet contains:
Amlodipine besylate
eq. to
Amlodipine..5mg
Olmesartan
Medoxomil
40mg

8000/31-12-10
12000/- dated Omsana AM of
30-07-13
Hilton Pharma
Karachi.
Leader Price./
2x10s
Panel inspection
of the firm was
carried out on
10-06-14
and
recommended
the issuance of
GMP.
Dy.No:
845 Azor Tablets of
dated 31-12-10 Daiichi Sankyo
(USFDA)
8000/dated
31-12-10
Omsana AM of
12000/- dated Hilton Pharma
30-07-13
Karachi.

CCB/ ARB
Manufacturer
60.

-do-

AMIOL Tablet
Each film coated
tablet contains:
Amlodipine besylate
eq. to
Amlodipine..10mg
Olmesartan
Medoxomil
20mg

Leader
2x10s

Azor Tablets of
Daiichi Sankyo
dated (USFDA)

Price./

CCB/ ARB

61.

Manufacturer
M/s
Unexolabs MENTIN-OG Tablets
(Pvt)
Limited,
Fine Chemicals & Each film coated
Pharmaceutical
tablet contains:
Manufacturers, 95 Amoxicillin
as
Km, Sheikhupura Trihydrate..875mg
Road, Lahore
Clavulanic acid as
potassium
salt.125mg
Antibacterial/
Penicillin
Manufacturer

Agenda 252

nd

46
Registration Board Meeting

Form-5

Co-amoxiclav of
Blufish
Dy. No: 10760 Pharmaceuticals
dated 23-11-10 UK (MHRA)
8000/dated Zamoclav
of
23-11-10
Zafa
12000/- dated Pharmaceuticals
26-07-13
Karachi
Rs. 250/- Pack
of 6s (Blister
Pack or Glass
bottle
loose

Panel inspection
of the firm was
carried out on
16-05-14

pack)

62.

M/s Asian
Continental (Pvt)
Limited, D-32,
S.I.T.E., II Super
Highway, Karachi.

SIALIC Tablet 75mg


Each enteric coated
tablet contains:
Acetyl salicylic acid
.75mg
Analgesic,
Antipyretic

63.

M/s Caraway
Pharmaceuticals,
Plot No.12, Street
No.03, National
Industrial Zone,
Rawat, Islamabad.

CARACINE Tablet
0.25mg
Each tablet contains:
Hyoscyamine
sulphate..0.250mg
Acetylcholine
Inhibitor
USP

Agenda 252

nd

47
Registration Board Meeting

wherein
the
panel
recommended
the renewal of
DML.
Form-5
Aspirin gastro
resistant tablets
Dy.No: 1033 of Actavis UK
dated 02-011- (MHRA)
10 (DDC-RIII)
Loprin
of
8000/dated Highnoon
02-11-10
Pharma Lahore
12000/- dated
26-02-14
Inspection of the
firm was carried
As per latest out on 09th Sep
decision
of 2014 by the area
PRC/3x10s
FID
and
acceptable level
of
GMP
compliance
is
found
Form-5
Availability in
SRAs
not
Dy.No: 1033 submitted by the
dated 02-011- firm
10 (DDC-RIII)
Anapaz tablets
8000/dated of Hilton
02-11-10
12000/- dated Inspection of the
26-02-14
firm was carried
out on 26-12-14
As per PRC./ by the panel and
pack of 1x10s recommends the
2x10s
renewal of DML
3x10s
5x10s
10x10s
20x10s
50x10s
100x10s

Evidence of approval of sam


generic, dosage form
reference
agencies
required.

64.

M/s Safe
Pharmaceuticals,
Karachi

PREBALIN Capsule
75mg

Antiepileptic
Manufacturer

Name
and
address
of
manufacturer /
Applicant

Lyrica Capsules
(USFDA)

Dy.No:
Each capsule
contains:
Pregabalin 75mg

S/N

Form-5

Lyrica of Pfizer
dated Karachi

8000/10-05-10
12000/- dated Inspection of the
22-05-13
firm was carried
out on 09-05-15
As per PRC
by the area FID
and rated as
GOOD.

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group
Finished
Specification

Initial
diary

date,

Demanded Price
/ Pack size

product

Remarks on the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator

65.

M/s
Evergreen
Pharmaceuticals,
69-70/B
Main
Glaxo
Town,
Industrial Estate,
Ferozpur Road,
Lahore

Agenda 252

nd

Avinox oral Solution

Form-5

Each ml contains:
Novaminsulfon..40mg
Etileferin0.2mg
Calcium
gluconate.100mg
Magnesium
gluconate..10mg
Sodium Salicylate
7mg

Dy No:
20000/- dated 0910-13
40000/- 03-12-13
Decontrolled
/
100ml,
250ml,
500ml & 1L

48
Registration Board Meeting

Novafas
Intervac

of

Inspection of the
firm was carried
out on 17-12-14
by the area FID
and GMP is rated
as satisfactory

Recommendations
the Evaluators

by

Nicotinamide.0.3mg
Caffiene .10mg
Boric acid..10mg
Supplement to antibiotic
(Restorative)
Manufacturer

Case No.02:
S/N

Cases of Pregabalin

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group
Finished
Specification

Initial
diary

date,

Demanded Price
/ Pack size

product

Remarks on the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator

66.

M/s
Searle
Pakistan Lahore.

ALBEN Capsule 75mg

Form-5

Each capsule contains:


Pregabalin75mg

Dy No:
8000/- dated 1710-08
12000/- dated 1911-14

Antiepileptic

LYRICA
(USFDA)

Manufacturer
14.28Rs.
capsule

Agenda 252

nd

49
Registration Board Meeting

per

Lyrica of Pfizer
Karachi
GMP certificate
issued on 20-0814

Recommendations
the Evaluators

by

67.

-do-

ALBEN
100mg

Capsule

Each capsule contains:


Pregabalin100mg
Antiepileptic
Manufacturer

68.

-do-

ALBEN
150mg

Capsule

Each capsule contains:


Pregabalin150mg
Antiepileptic
Manufacturer

69.

-do-

ALBEN
300mg

Capsule

Each capsule contains:


Pregabalin300mg
Antiepileptic
Manufacturer

Agenda 252

nd

200 Rs. Pack of


14 capsules
Form-5
Dy No:
8000/- dated 1710-08
12000/- dated 1911-14
17.5Rs.
per
capsule
245 Rs. Pack of
14 capsules
Form-5
Dy No:
8000/- dated 1710-08
12000/- dated 1911-14
25Rs. per capsule
350 Rs. Pack of
14 capsules
Form-5
Dy No:
8000/- dated 1710-08
12000/- dated 1911-14
32.14Rs.
per
capsule
450 Rs. Pack of
14 capsules

50
Registration Board Meeting

LYRICA
(USFDA)
Lyrica of Pfizer
Karachi
GMP certificate
issued on 20-0814

LYRICA
(USFDA)
Lyrica of Pfizer
Karachi
GMP certificate
issued on 20-0814

LYRICA
(USFDA)
Lyrica of Pfizer
Karachi
GMP certificate
issued on 20-0814

Case No.03: Registration of applications (Routine cases)


Evaluator IV
S/N

Name and
address of
manufacturer /
Applicant

Brand Name

Type of Form

(Proprietary name +
Dosage Form +
Strength)

Initial date,
diary

Composition

Fee including
differential fee

Pharmacological
Group

Demanded
Price / Pack size

International
status in stringent
regulatory
agencies
Me-too status
GMP status as
depicted in
inspection report
(dated)

Finished product
Specification

70.

M/s
Remington
Pharmaceutica
l
Industries
(Pvt.) Ltd, 18km
Multan
Road, Lahore

Valpin H
5/160/12.5 Tablet
Each film coated
tablet contains
i.

ii.
iii.

Amlodipine (as
Besylate) B.P
..5.0 mg
Valsartan U.S.P
160.0 mg
Hydrochloroth
iazide U.S.P
12.5 mg

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2161
(02/02/2011) &
Dy. No. 9262
(30-07-2013)
Pack of
14s & 28s
Blisters Tablets
as per Leader
Price

Calcium Channel
Blocker,
Angiotensin II
Receptor
Antagonist &
Thiazide Diuretics

Agenda 252

nd

51
Registration Board Meeting

FDA approved
Tablet
Exforge
HCT (Novartis)
Tablet Valam-H
5/160/12.5 (CCL)

Remarks / Observation

71.

-do-

Valpin H
10/160/12.5 Tablet
Each film coated
tablet contains
i.

ii.
iii.

Amlodipine (as
Besylate) B.P
..10 mg
Valsartan U.S.P
160.0 mg
Hydrochloroth
iazide U.S.P
12.5 mg

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2163
(02/02/2011) &
Dy. No. 9265
(30-07-2013)

FDA approved
Tablet
Exforge
HCT (Novartis)
Tablet Valam-H
10/160/12.5
(CCL)

Pack of
14s & 28s
Blisters Tablets
as per Leader
Price

Calcium Channel
Blocker,
Angiotensin II
Receptor
Antagonist &
Thiazide Diuretics
72.

-do-

Valpin 10/320
Tablet
Each film coated
tablet contains
i.

ii.

Amlodipine (as
Besylate) B.P
..10 mg
Valsartan U.S.P
320.0 mg
Calcium Channel
Blocker &
Angiotensin II
Receptor
Antagonist

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2011
(28/01/2011) &
Dy. No. 9261
(30-07-2013)
Pack of
14s & 28s
Blisters Tablets
as per Leader
Price

52
Registration Board Meeting

FDA approved
Tablet
Exforge
(Novartis)
Tablet ValsanAM 10/320
(Hilton)

73.

-do-

Kiren 150 mg
Tablet
Each film coated
tablet contains
Aliskiren
Hemifumerate
equivalent to
Aliskiren 150mg
Renin Inhibitor

74.

-do-

(Manufacture
Specification)
Kiren 300 mg
Tablet
Each film coated
tablet contains
Aliskiren
Hemifumerate
equivalent to
Aliskiren 300 mg
Renin Inhibitor
(Manufacture
Specification)

75.

-do-

Bestegrel 5 mg
Tablet
Each film coated
tablet contains
Prasugrel
Hydrochloride
equivalent to
Prasugrel 5.0
mg
Renin Inhibitor
(Manufacture
Specification)

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 11016
(29/11/2010) &
Dy. No. 9299
(30-07-2013)

FDA approved
Tablet Tekturna
150
mg
(Novartis)
Tablet Rasilez
150 mg
(Novartis)

Pack of
1 x 07s
blisterTablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 11020
(29/11/2010) &
Dy. No. 9297
(30-07-2013)

FDA approved
Tablet Tekturna
300
mg
(Novartis)

Pack of
1 x 07s
blisterTablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2398
(29/11/2010) &
Dy. No. 9268
(30-07-2013)

FDA approved
Tablet
Effient
5mg (Elli Lilly)

Pack of
14s & 28s
Blister Tablets
as per Leader
Price

53
Registration Board Meeting

Tablet Rasilez
300 mg
(Novartis)

Tablet Prisa 5
mg (Novartis)

76.

-do-

Bestegrel 10 mg
Tablet
Each film coated
tablet contains
Prasugrel
Hydrochloride
equivalent to
Prasugrel 10 mg
Renin Inhibitor

77.

-do-

(Manufacture
Specification)
Nilol 2.5 mg Tablet
Each film coated
tablet contains
Nebivolol HCl eq
to Nebivolol 2.5
mg
Selective Beta
Blocking Agent
(Manufacture
Specification)

78.

-do-

Nilol 5 mg Tablet
Each film coated
tablet contains
Nebivolol HCl eq
to Nebivolol 5
mg
Selective Beta
Blocking Agent
(Manufacture
Specification)

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2394
(07/02/2011) &
Dy. No. 9267
(30-07-2013)

FDA approved
Tablet
Effient
10mg (Elli Lilly)
Tablet Prisa 10
mg (Novartis)

Pack of
14s & 28s
Blister Tablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2397
(07/02/2011) &
Dy. No. 9269
(30-07-2013)

MHRA approved
Tablet Nebivolol
2.5
mg
(Glenmark)

Pack of
10s & 14s
Blister Tablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2396
(10/02/2011) &
Dy. No. 9276
(30-07-2013)

MHRA approved
Tablet Nebivolol
5 mg (Glenmark)

Pack of
10s & 14s
Blister Tablets
as per Leader
Price

54
Registration Board Meeting

Tablet Nebil 2.5


mg (Getz)

Tablet Nebil 5
mg (Getz)

79.

M/s
Martin
Dow Limited,
Plot # 37,
Sector
19,
Korangi
Industrial
Area, Karachi

Lifeline 750 mg
Tablet
Each film coated
tablet contains
Levofloxacin (as
Hemihydrate)
750 mg
(USP Specification)

80.

-do-

Quinolone Group
Antibiotics
Tespral Total
Capsules 40 mg +
150 mg
Each Capsule
contains:i.
Pantoprazole
Sodium
Sesquihydrate
equivalent to
Pantoprazole
(Enteric
coated) 40 mg
ii.
Itopride (As
sustained
release pellets)
150 mg

81.

-do-

Proton Pump
Inhibitor +
Prokinetic agent
Viglip Tablet 50 mg
Each Tablet
contains:Vildagliptin 50
mg

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
10/02/2011 &
30-07-2013
Unit pack size
10,s / Rs. 500
Rs. 50.00 per
Tablet
Form 5-D
Rs. 8,000 +
12000 =
20,000/Received on
25/06/2011 &
30-07-2013
Unit pack size
10,s / Rs.
946.94

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
25/06/2011 &
30-07-2013

55
Registration Board Meeting

FDA approved
Tablet Levoquin
750 mg (OrthoMcNeil-Janssen
Pharmaceuticals)
Tablet Leflox
750 mg (Getz)
GMP compliant
vide inspection
report dated 2402-2015
Not provided

i.Source of pellets required.


ii.Legalized GMP status of the
required.
iii.Stability data of pellets require
iv.International and national avai
information
required
supported documents.
v.Full description of specificatio
analytical testing process
with photocopy of au
references.

TGA approved i. The innovators brand is not


Tablet Galvus 50
coated tablet while fir
mg (Novartis)
claimed their proposed
as film coating tablet.
Locally Galvus ii.Full description of specificat
(Novartis)
active and inactive m
required along with photo
authentic references.

82.

-do-

DiPeptide
Peptidase 4 (DPP4) inhibitors

Unit pack size


10,s / Rs.
754.30
Rs. 75.43 per
tablet

Neo-Fansidar
Tablet 40 + 320 mg

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
04/04/2011 &
31-07-2013

Each Tablet
contains:i.
Dihydroartemis
inin .. 40 mg
ii.
Piperaquine
Phosphate 320
mg

83.

M/s Genome
Pharmaceutica
ls (Pvt.) Ltd,
16/1, Phase
IV, Industrial
Estate, Hattar,
Haripur

Antiprotozoal &
anthelmintic
Norella 50 mg
Capsule
Each Capsule
contains
Milnacipran HCl
(Manufacture Spec)
Selective
Norepinephrine and
serotonin reuptake
inhibitor

Agenda 252

nd

Duo-Cotecxin by i.Full description of specificatio


Beijing Holleyanalytical processes r
Cotec
with photocopies of au
Pharmaceuticals
references for further eval
Co. Ltd, China
Artequine
(Platinum)

Unit pack size


8s / Rs. 485.00
Rs. 61 per
tablet
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 1263 (0811-2010) &
Dy. No. 29
(17/01/2014)

Unit pack 10s


as per SRO

56
Registration Board Meeting

Savella
in
Europe
by
Forest
Pharmaceuticals
Local
manufacture not
provided.

84.

-d0-

Asperam 10 mg
Chewable Tablet
Each Chewable
Tablet contains
Escitalopram (as
Oxalate) .. 10 mg
(Manufacture Spec)
5HT Reuptake
Inhibitor

85.

M/s Astellas
Pharmaceutica
l (Pvt.) Ltd,
15-C,
Industrial
Estate,
Hayattabad,
Peshawar

Astalexim 1.5 gm
Injection
Each Vial Contains
Cefuroxime
Sodium equivalent
to Cefuroxime 1.5
gm USP

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 1195 (1110-2010) &
Dy. No. 45
(17/01/2014)

Tab Fastoral by
CLL
Pharma,
Europe
Local
manufacture not
provided.

Unit pack 10s


as per SRO
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 81 (12-122014) &
Dy. No. 225
(11/02/2011)

Not Provided

1.Firm needs to provided the


IM only or IV only
Local
international availability.
manufacture by 2.Firm has mentioned R.O W
Lowitt Pharma
vial washing while require
(MARCEF)
distilled water for final rin
vials.
3.Verification of distill wate
required.

(USP Spec)

86.

-do-

Cephalosporins

Unit pack 15
ml vial as per
SRO

Astalexim 750 mg
Injection

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 228 (1202-2014) &
Dy. No. 167
(11/02/2014)

Each Vial Contains


Cefuroxime
Sodium equivalent
to Cefuroxime
750mg USP
(USP Spec)
Cephalosporins

Agenda 252

nd

Unit pack 15
ml vial as per
SRO

57
Registration Board Meeting

Not Provided

1.Firm needs to provide the d


IM only or IV only
Local
international availability.
manufacture by 2.Firm has mentioned R.O W
Lowitt Pharma
vial washing while require
(MARCEF)
distilled water for final rin
vials.
3.Verification of distill wate
required.

87.

-do-

Astedime 500 mg
Injection
Each Vial Contains
Ceftazidime
Pentahydrate
equivalent to
Ceftazidime 500mg
USP

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 226 (1202-2011) &
Dy. No. 169
(11/02/2014)

Not Provided

1.Firm needs to provide the d


IM only or IV only
Local
international availability.
manufacture by 2.Firm has mentioned R.O W
Hamaz Pharma
vial washing while require
(Bectazine)
distilled water for final rin
vials.
3.Verification of distill wate
required.

(USP Spec)
Cephalosporins

88.

-do-

Astedime 1 gm
Injection
Each Vial Contains
Ceftazidime
Pentahydrate
equivalent to
Ceftazidime 1 gm
USP

Unit pack 15
ml vial as per
SRO
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 224 (1202-2011) &
Dy. No. 70
(11/02/2014)

Not Provided

1.Firm needs to provide the d


IM only or IV only
Local
international availability.
manufacture by 2.Firm has mentioned R.O W
Hamaz Pharma
vial washing while require
(Bectazine)
distilled water for final rin
vials.
3.Verification of distill wate
required.

(USP Spec)
Cephalosporins

89.

M/s
Elite
Pharma (Pvt.)
Ltd, 9.5 km,
Sheikhupura
Road, Lahore.

Agenda 252

nd

Ciprolon I.V
Infusion
200mg/100ml
Each 100 ml Vial

Unit pack 15
ml vial as per
SRO
Form 5
Rs. 8,000 +
12000 =
20,000/Received on

58
Registration Board Meeting

MHRA approved
Ciproxin
Injection (Pfizer)
Inoquin Injection

Contains
Ciprofloxacin BP
200 mg

Dy. 9964 (2710-2010) &


Dy. No. 32
(25/11/2013)

(Barret)

(BP Spec)
Cephalosporins

90.

M/s
Elite
Pharma (Pvt.)
Ltd, 9.5 km,
Sheikhupura
Road, Lahore.

Elizole I.V Infusion


500mg/100ml
Each 100 ml Vial
Contains
Metronidazole BP
500 mg

Unit pack 100


ml vial / Rs
250
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 10995 (2212-2006) &
(25/11/2013)

(BP Spec)
Cephalosporins

Agenda 252

nd

Unit pack 100


ml vial/ Rs.
70.00

59
Registration Board Meeting

FDA approved
Metronidazole
Injection (Baxter)
Flagyl Injection
(SANOFI)

Case No. 04: Applications for registration of Sofosbuvir.


(Evaluation by: DDC (PEC-II) and Evaluator III)
S/N

Name
and Brand Name
address
of
manufacturer / (Proprietary name
+ Dosage Form +
Applicant
Strength)
Composition
Pharmacological
Group

Type
Form

of International Remarks
status
in
reference
Initial date, drug agencies
diary
/ authorities
Fee
including
differential
fee

Me-too status

GMP status
as depicted in
latest
Finished product Demanded
inspection
Specification
Price / Pack report (with
size
date) by the
Evaluator

91.

M/s
Akson LIVERSOF Tablets Form 5D
Harvoni (FDA
Approved)
Pharmaceuticals,
Pvt
Limited, Each film coated Dy No. 1720
Mirpur.
tablet contains:
dated 18-07Sofosbuvir..400
14
mg
Ledipasvir.90mg 50000/Antiviral

92.

As per SRO

Manufacturer
M/s.
Rasco HC-BUVIR
Pharma Lahore
Tablets

Form-5
Dy. No.118.
Date.4-2Each film coated 2015
tablet contains:Not
Sofosbuvir.4 mentioned/
00mg
As per SRO
Antiviral

20000/-2-022015

Manufacturer

Agenda 252

nd

Discussed in the 244 th meeting


of Registration Board. Firm
has not yet responded to the
shortcomings mentioned in the
aforesaid minutes.

60
Registration Board Meeting

a. Specifications of API and


Finished product along with
method of testing needs to
be submitted.
b. Lab scale scientifically
rationale stability data is
required.
c. Latest GMP inspection
report is required.

93.

94.

M/s. The Schazoo LAVIE Tablets


Pharma,Lahore

Form-5
Dy.No.1010
Each film coated Reg-V /116-2015
tablet contains:Rs.1190/ per
Sofosbuvir.4 tab,
00mg
Rs.33300/4x
7s
Antiviral
20,000/-2805-2015
Manufacturer
M/s.
Pharmedic HEPAVIR Tablets Form-5
Laboratories
Dy.No.238
Lahore
Each film coated Reg-V /106-2015
tablet contains:Rs.55000.00
Sofosbuvir.4 /28s
00mg
20,000/-2905-2015

a. Lab scale scientifically


rationale stability data is
required.
b. Latest GMP inspection
report is required.

a. Specifications of API along


with method of testing
needs to be submitted.
b. Lab scale scientifically
rationale stability data is
required.
c. Latest GMP inspection
report is required.

Antiviral

95.

Manufacturer
M/s.
Friends SOFOVIR
Pharma Lahore
Tablets

Form-5D
Dy. No. 133
Date.3-32015
Each film coated
As
Per
tablet contains:SRO/10s
Sofosbuvir.4
50000/-300mg
03-2015
Antiviral

Manufacturer
96.

M/s. Seatle (Pvt) ISUVIR Tablets


Ltd, Lahore

Agenda 252

Dy.No.164
Date.26-1Each film coated 2015
tablet contains:As
per
Sofosbuvir.4 brand
00mg
leader/7s,1
4s,28s
Antiviral
20000/-2301-2015

nd

61
Registration Board Meeting

a. Methylene chloride is used


as solvent in coating,
which is class II solvent as
per ICH guidelines, the
use of which restricted.
This needs to be replaced
with any other suitable
solvent.
b. Lab scale scientifically
rationale stability data is
required.
c. Latest GMP inspection
report is required
a.

Lab scale scientifically


rationale stability data is
required.
b. Latest GMP inspection
report is required

Manufacturer

97.

M/s.
English ESOVIR Tablets
Pharma Lahore

Form-5
Dy. No. 207
Each film coated date 29-42015
tablet contains:As
Per
Sofosbuvir.4 SRO/10s
00mg
20,000/- 284-2015

Accelerated stability data of


six months on three batches is
submitted. Batch size is not
provided.

Antiviral

Manufacturer
98.

-do-

LEDSOVIR
Tablets
Each film tablet
contains:Sofosbuvir.40
0mg
Ledipasvir.90mg

Form-5
Dy. No. 208
date 29-42015
As
Per
SRO/10s
20,000/- 284-2015

Accelerated stability data of


six months on three batches is
submitted. Batch size is not
provided.

Form-5D
Dy. No. 531
date 08-092014
Each film coated
As Per SRO
tablet contains:50,000/Sofosbuvir.4
00mg

a. Specifications
of API,
inactives
and
finished
product along with method
of testing are required.
b. Latest GMP inspection
report is required.
c. Lab scale scientifically
rationale stability data is
required.

Antiviral

99.

Manufacturer
M/s
Neutro NUVALDI
Pharma Lahore
Tablets

Antiviral

Manufacturer

Agenda 252

nd

62
Registration Board Meeting

100.

101.

M/s. Wilshire
Labs; Lahore

M/s. Scotmann
Pharmaceutical
Islamabad.

Ziqar Tablet
Each film coated
tablet contains:Sofosbuvir

.. 400mg

As per SRO
Form-5D
Dy. No. 469 1s, 5s, 10s,
date 25-08- 20s 50s
2014
As Per SRO
50,000/-

Hepaldi Tablet
Each film coated
tablet contains:Sofosbuvir

.. 400mg

10,000 Per tab


Form-5
Dy.
No.
387date 5- 14s, 28s

03-2015
As Per SRO

50,000/-

Copy of valid DML not


submitted.

Latest
GMP
inspection report is
required.
Lab
scale
scientifically rationale
stability
data
is
required.

Specifications of API
not submitted.
Latest inspection report not
provided.
One page accelerated
stability data of 6 months
on a batch of 500 tabs has
been provided.

Case No. 05: Applications for registration New License


S/N

Name
and Brand Name
Type of Form
address
of
Initial
date,
manufacturer / (Proprietary
name + Dosage diary
Applicant
Form + Strength)
Fee
including
Composition
differential fee

International status Remarks


in reference drug
agencies / authorities
Me-too status

GMP
status
as
depicted in latest
Pharmacological Demanded Price inspection
report
Group
/ Pack size
(with date) by the
Evaluator
Finished product
Specification

(EVALUATOR I)

Agenda 252

nd

63
Registration Board Meeting

102.

M/s
Iceberg
Pharmaceuticals
(Pvt) Ltd, Plot #
144, Nowshera
Industrial Estate,
Risalpur, KPK

Pantberg Tablet

Form-5

Each
tablet
contains
Pantoperazole
Sodium
as
sesquihydrate
40mg

17-06-2015 diary
No 224.

Proton
Inhibitor

Rs20,000

As per SRO/
Blister of 10s
Pump and 14s Pack

Manufacturers
Specifications

103.

-do-

Bixin Tablet

Form-5

Each
tablet
contains
Piroxicam
beta
Cyclodextrin
20mg

17-06-2015 diary
No 222.

NSAIDs

Rs20,000
As per SRO/
Blister of 2x10
tablets Pack

Manufacturers
specifications

Agenda 252

nd

64
Registration Board Meeting

TGA
Pirifel-D
Piroxicam 20 mg

1. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
2. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
3. International ava
is not provided.
4. Pantoperazole so
in the form of
sesquihydrate w
requires correcti
5. Description of t
is not given ente
coated or film co
6. Manufacturing m
not complete as
missing.
7. Master formulat
provided by the
8. Finished produc
specifications ar
incomplete and w
reference.
1. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
2. International ava
is not provided.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req

104.

-do-

Icepram Tablet

Form-5

BNF. Cipralex
Escitalopram
Each
tablet 17-06-2015 diary oxalate) 10 mg
contains
No 221.
Escitalopram as
Rs20,000
Oxalate 10mg
SSRIs

As per SRO/
1x10s & 1x14s
tablets Pack

Manufacturers
specifications

Agenda 252

nd

65
Registration Board Meeting

f/c,
(as

clarification.
4. Description of th
is not given ente
coated or film co
5. Manufacturing m
also not correct
firm is claiming
product as coate
in manufacturing
procedure coatin
been mentioned.
6. Master formulat
provided by the
the weight of ind
tablet is also req
justification.
7. Finished produc
specifications ar
incomplete.
1. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
2. International ava
is not provided.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Description of th
is not given ente
coated or film co
5. Approval of sect
attached.
6. In coating firm i
utilizing banned
solvents, which
to be replaced w
soluble or safe s
7. Master formulat
provided by the
the weight of ind

8.
105.

-do-

Cipberg Tablet

Form-5

BNF.
Ciprofloxacin
(as hydrochloride) 500
Each
tablet 05-06-2015 diary mg,
contains
No 206.
Ciprofloxacin HCl
Ciproxin 500mg Bayer
Rs20,000
500mg

1.

Quinolone

As
per
SRO/1x10s
tablets
blister
Pack

2.

USP
Specifications

3.

4.
5.
6.

7.
106.

-do-

Icedol Tablet

Form-5

Each
tablet
contains
Paracetamol
.500mg
Caffeine65mg
Chlorpheniramine
Maleate.2mg
500mg

05-06-2015 diary
No 209.

As per SRO/10x
10s & 10x20
tablets
blister
Pack

Manufacturers
Agenda 252

1.

2.

Rs20,000

Analgesic

nd

Require to be verified

66
Registration Board Meeting

3.

tablet requires
justification.
Finished produc
specifications ar
incomplete.
Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
International ava
is not provided.
The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
Description of th
is not given ente
coated or film co
Approval of sect
attached.
Master formulat
provided by the
the weight of ind
tablet requires
justification.
Finished produc
specifications ar
incomplete.
The firm has me
the abbreviation
which requires
clarification.
Pharmacologica
mentioned by th
wrong and incom
The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req

specifications

107.

-do-

Cipberg Tablet

Form-5

BNF.
Ciprofloxacin
(as
hydrochloride)
Each
tablet 05-06-2015 diary 250mg,
contains
No 216.
Ciprofloxacin HCl
Rs20,000
250mg
Quinolone

As per SRO/ 10s


tablets Pack

USP
Specifications

Agenda 252

nd

67
Registration Board Meeting

clarification.
4. International ava
is not provided.
5. Description of th
is not given ente
coated or film co
plain etc.
6. Approval of sect
attached.
7. Master formulat
provided by the
the weight of ind
tablet requires
justification.
8. To determine wa
hydration the fir
not have Karl Fi
apparatus.
9. Finished produc
specifications ar
incomplete only
and dissolution i
1. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
2. International ava
is not provided.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Description of th
is not given ente
coated or film co
5. Approval of sect
attached.
6. Master formulat
provided by the
the weight of ind
tablet requires
justification.

7. Finished produc
specifications ar
incomplete.

108.

-do-

Moxib Tablet

Form-5

BNF.Avelox
Tablets, f/c,
Each
tablet 05-06-2015 diary Moxifloxacin (as
hydrochloride)
contains
No 207.
400 mg,
Moxifloxacin HCl
Rs20,000
400mg
Floroquinolone

As per SRO/
1x5s
tablets
blister Pack

Manufacturers
specifications

Agenda 252

nd

68
Registration Board Meeting

1. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
2. International ava
is not provided.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Description of th
is not given ente
coated or film co
5. Approval of sect
attached.
6. Master formulat
provided by the
the weight of ind
tablet requires
justification.
7. Finished produc
specifications ar
incomplete.

109.

-do-

Levberg Tablet
Each
contains
Levofloxacin
Hemihydrate
250mg

BNF.Tavanic
Tablets, f/c,
tablet 17-06-2015 diary Levofloxacin
250 mg,
No 231.

Quinolone

Form-5

Rs20,000
As per SRO/
1x10s
tablets
blister Pack

Manufacturers
specifications

110.

-do-

Desoberg Tablet

Form-5

Dailymed.
Clarinex
Each
f/c
tablet
Each
tablet 17-06-2015 diary contains desloratidine
contains
No 219.
5mg
Desloratadine
Rs20,000
5mg
Antiallergic,
antihistamine

As per SRO/ 10s


tablets
blister
Pack

Manufacturers
specifications

Agenda 252

nd

69
Registration Board Meeting

1. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
2. International ava
is not provided.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Description of th
is not given ente
coated or film co
5. Approval of sect
attached.
6. Specifications o
material are inco
(identification as
not complete) an
specifications of
excipients are no
7. Master formulat
provided by the
the weight of ind
tablet requires
justification.
8. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
3. Description of th
is not given ente
coated or film co

111.

-do-

Agenda 252

nd

Paxetin Tablet

Form-5

BNF.Paroxetine
Tablets, paroxetine (as
Each
tablet 17-06-2015 diary hydrochloride) 20 mg,
Seroxat
contains
No 232.
Tablets, f/c, paroxetine
Paroxetine
HCl
(as hydrochloride)
Rs20,000
20mg
20 mg,
As
per
SRO/
SSRIs
1x10s
tablets
Manufacturers
blister Pack
specifications

70
Registration Board Meeting

4. The firm has me


coating in manu
while in the form
it is not mention
5. Specifications o
material are inco
(identification as
not complete) an
specifications of
excipients are no
6. Master formulat
provided by the
the weight of ind
tablet requires
justification.
7. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. The paroxetine H
complete descrip
not mentioned w
anhydrous or
hemihydrates.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Description of th
is not given ente
coated or film co
5. In coating firm i
banned organic s
which requires
justification.
6. Approval of sect
attached.
7. The firm has me
coating in manu
while in the form
it is not mention
8. Specifications o
material are inco
(identification as

9.

10.
112.

-do-

Dicloberg Capsule

Form-5

Each
capsule 17-06-2015 diary
contains
No 239.
Diclofenac
Rs20,000
Sodium 100mg
NSAID
B.P specifications

As per SRO/
2x10s & 3x10
capsules blister
Pack

Required
confirmed

to

be

1.
2.

3.

4.
5.
6.
7.

8.
9.

Agenda 252

nd

71
Registration Board Meeting

not complete) an
specifications of
excipients are no
Master formulat
provided by the
the weight of ind
tablet requires
justification.
Finished produc
specifications ar
incomplete.
International ava
is not provided.
This product is i
form of pellets,
has not submitte
source of pellets
The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
Description of th
is not given as p
Approval of sect
attached.
Specifications o
material are inco
Outline of metho
manufactuere is
incomplete and i
to the dosage.
Master formulat
provided by the
Finished produc
specifications ar
incomplete.

113.

-do-

Icepride Tablet

Form-5

Each
Tablet 17-06-2015 diary
contains Itopride No 227.
HCl 50mg.
Rs20,000
Gastroprokinetics
As per SRO/
USP
1x10
tablet
Specifications
blister pack.

114.

-do-

Levberg Tablet

Form-5

Each
Tablet
contains
Levofloxacin
Hemihydrate
500mg.

17-06-2015 diary
No 229.

Quinolone

Rs20,000
As per SRO/
1x10
tablet
blister pack.

USP
Specifications

Agenda 252

nd

72
Registration Board Meeting

1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. Role of inactive
ingredients and
justification of q
used is not provi
4. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
5. Approval of sect
attached.
6. Specifications o
material are inco
and the specifica
excipients are no
7. Master formulat
provided by the
8. Finished produc
specifications ar
incomplete.
9. International ava
is not provided.
10. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
11. Role of inactive
ingredients and
justification of q
used is not provi
12. The firm has me
Production
Manager/incharg
Iqbal in Form-5

13.
14.

15.
16.
115.

-do-

Fexoberg Tablet

Form-5

Each
Tablet 17-06-2015 diary
contains
No 223.
Fexofenadine HCl
Rs20,000
120mg.
Antiellergic
Manufacturers
Specifications

As per SRO/
1x10
tablet
blister pack.

17.
18.

19.

20.

21.
22.

23.
24.

Agenda 252

nd

73
Registration Board Meeting

DML approved
production is Mr
Ullah, which req
clarification.
Approval of sect
attached.
Specifications o
material are inco
and the specifica
excipients are no
Master formulat
provided by the
Finished produc
specifications ar
incomplete.
International ava
is not provided.
Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
Role of inactive
ingredients and
justification of q
used is not provi
The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
Approval of sect
attached.
Specifications o
material are inco
and the specifica
excipients are no
Master formulat
provided by the
Finished produc
specifications ar
incomplete.

116.

-do-

Zithberg Capsule

Form-5

Each
capsule 05-06-2015 diary
contains
No 212.
Azithromycin
Dihydrate 250mg Rs20,000
Macrolide
USP specifications

117.

-do-

Riseberg Capsule

As per SRO/
1x6s & 1x10
capsules blister
Pack

Form-5

Each
capsule 05-06-2015 diary
contains
No 213.
Omeprazole
20
Rs20,000
mg
pump As per SRO/
1x10s & 1x14
capsules blister
USP specifications Pack
Proton
inhibitor

Agenda 252

nd

74
Registration Board Meeting

25. International ava


is not provided.
26. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
27. Role of inactive
ingredients and
justification of q
used is not provi
28. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
29. Approval of sect
attached.
30. Specifications o
material are inco
and the specifica
excipients are no
31. Master formulat
provided by the
32. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. This product is i
form of pellets,
has not submitte
source of pellets
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Description of th
is not given as p
5. Approval of sect

118.

-do-

Essoberg Capsule

Form-5

Each
capsule
contains
Esomeprazole
magnesium
trihydrate 20 mg

05-06-2015 diary
No 218.
Rs20,000

As per SRO/
Proton
pump 1x10s & 1x14
capsules blister
inhibitor
Pack
Manufacturers
specifications

Agenda 252

nd

75
Registration Board Meeting

Esso 20mg (shaigan)

attached.
6. Specifications o
material are inco
7. Outline of metho
manufactuere is
incomplete and i
to the dosage.
8. Master formulat
provided by the
9. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. This product is i
form of pellets,
has not submitte
source of pellets
3. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
4. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
5. Description of th
is not given as p
6. Approval of sect
attached.
7. Specifications o
material are inco
8. Outline of metho
manufactuere is
incomplete and i
to the dosage.
9. Master formulat
provided by the
10. Finished produc
specifications ar
incomplete.

119.

-do-

Essoberg Capsule

Form-5

Each
capsule
contains
Esomeprazole
magnesium
trihydrate 40 mg

05-06-2015 diary
No 214.

Icesif Capsule

Form-5

Rs20,000

As per SRO/
Proton
pump 1x10s & 1x14
capsules blister
inhibitor
Pack
Manufacturers
specifications

120.

-do-

Each
capsule 17-06-2015 diary
contains
No 226.
Cephradine 500
Rs20,000
mg
Cephalosporin
USP specifications

Agenda 252

nd

As per SRO/ 2x6


capsules blister
Pack

76
Registration Board Meeting

Esso 40mg (shaigan)

1. International ava
is not provided.
2. This product is i
form of pellets,
has not submitte
source of pellets
3. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
4. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
5. Description of th
is not given as p
6. Approval of sect
attached.
7. Specifications o
material are inco
8. Outline of metho
manufacture is
incomplete and i
to the dosage.
9. Master formulat
provided by the
10. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
3. Approval of sect
attached.
4. Specifications o

material are inco


5. Outline of metho
manufactuere is
incomplete .
6. Master formulat
provided by the
7. Finished produc
specifications ar
incomplete.
121.

-do-

Icexib Capsule

Form-5

Each
capsule 17-06-2015 diary
contains
No 220.
Celecoxib 200 mg
Rs20,000
NSAID
As per SRO/
Manufacturers
1x10s & 2x10
specifications
capsules blister
Pack

122.

-do-

Cxime Capsule

Form-5

Each
capsule 05-06-2015 diary
contains Cefixime No 205.
trihydrate 400 mg
Rs20,000
NSAID
As per SRO/ 1x5
USP
capsules blister
Specifications
Pack

Agenda 252

nd

77
Registration Board Meeting

8. International ava
is not provided.
9. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
10. Approval of sect
attached.
11. Specifications o
material are inco
12. Outline of metho
manufactuere is
incomplete .
13. Master formulat
provided by the
14. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.

123.

-do-

Cxime Capsule

Form-5

Each
capsule 05-06-2015 diary
contains Cefixime No 205.
Trihydrate 400mg
Rs20,000
Cephalosporin
As per SRO/ 1x5
USP
capsules blister
Specifications
pack.

Agenda 252

nd

78
Registration Board Meeting

4. Approval of sect
attached.
5. Specifications o
material are inco
6. Outline of metho
manufactuere is
incomplete .
7. Master formulat
provided by the
8. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Approval of sect
attached.
5. Specifications o
material are inco
6. Outline of metho
manufactuere is
incomplete .
7. Master formulat
provided by the
8. Finished produc
specifications ar
incomplete.

124.

-do-

Icesif
Suspension

Dry Form-5

17-06-2015 diary
Each 5ml contains No 228.
Cephradine
Rs20,000
125mg
Cephalosporin

As per SRO/
60ml glass bottle.

USP
Specifications

125.

-do-

Icesif
Suspension

Dry Form-5

17-06-2015 diary
Each 5ml contains No 228.
Cephradine
Rs20,000
250mg
Cephalosporin

As per SRO/
60ml glass bottle.

USP
Specifications

Agenda 252

nd

79
Registration Board Meeting

1. International ava
is not provided.
2. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
3. Approval of sect
attached.
4. Specifications o
material are inco
5. Outline of metho
manufactuere is
incomplete .
6. Master formulat
provided by the
7. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Approval of sect
attached.
5. Specifications o
material are inco
6. Outline of metho
manufactuere is
incomplete .
7. Master formulat
provided by the
8. Finished produc

specifications ar
incomplete.

126.

-do-

Cxime
Suspension

Dry Form-5

05-06-2015 diary
Each 5ml contains No 216.
Cefixime
Trihydrate 100mg Rs20,000
Cephalosporin

As per SRO/
30ml glass bottle.

USP
Specifications

127.

-do-

Cipberg
Suspension

Dry Form-5

05-06-2015 diary
Each 5ml contains No 217.
Ciprofloxacin HCl
Rs20,000
250mg
Quinolone

As per SRO/ size


not
provided

USP

Agenda 252

nd

80
Registration Board Meeting

1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Approval of sect
attached.
5. Specifications o
material are inco
6. Outline of metho
manufactuere is
incomplete .
7. Master formulat
provided by the
8. Finished produc
specifications ar
incomplete.
1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. The firm has me

Specifications

glass bottle.

4.
5.
6.
7.
8.
128.

-do-

Cipberg
Suspension

Dry Form-5

05-06-2015 diary
Each 5ml contains No 215.
Ciprofloxacin HCl
Rs20,000
125mg
Quinolone

As per SRO/
60ml glass bottle.

USP
Specifications

1.
2.

3.

4.
5.
6.
7.
8.

Agenda 252

nd

81
Registration Board Meeting

Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
Approval of sect
attached.
Specifications o
material are inco
Outline of metho
manufactuere is
incomplete .
Master formulat
provided by the
Finished produc
specifications ar
incomplete.
International ava
is not provided.
Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
Approval of sect
attached.
Specifications o
material are inco
Outline of metho
manufactuere is
incomplete .
Master formulat
provided by the
Finished produc
specifications ar
incomplete.

129.

-do-

Zithberg
Suspension

Dry Form-5

05-06-2015 diary
Each 5ml contains No 211.
Azithromycin
Dihydrate 200mg Rs20,000
As per SRO/
15ml glass bottle.

Macrolide
USP
Specifications

Evaluator II
130.

M/s
Vetz
Pharmaceuticals
,
private
Limited, S.I.T.E
Kotri Sindh

Vetamide
Powder

Oral liquid

Frusemide.20
GM

(New Lic)

oral Form-5

Oral Powder
Each kg contains.

Sodium
Chloride..35G
M

Dy. No: 389


dated.
19-062015
20000/- dated 1806-2015
Decontrolled
Pack of 100gm,
250gm, 500gm,
1kg, 5kg, 25kg

Potassium
Chloride..4GM

Agenda 252

nd

82
Registration Board Meeting

1. International ava
is not provided.
2. Strength of activ
ingredients are g
salt form, howev
calculations for
not given in salt
which requires
justifications.
3. The firm has me
Production
Manager/incharg
Iqbal in Form-5
DML approved
production is Mr
Ullah, which req
clarification.
4. Approval of sect
attached.
5. Specifications o
material are inco
6. Outline of metho
manufactuere is
incomplete .
7. Master formulat
provided by the
8. Finished produc
specifications ar
incomplete.

Magnesium
Sulphate35GM
Calcium
Carbonate..45G
M
Maganese
sulphate..1GM
Antibacterial

131.

-do-

(Specs
provided)

not

Para
C
Powder

oral Form-5
Dy. No: 376
dated.
19-062015

Oral Powder

Each
100Gms
contains.
20000/- dated 1806-2015
Paracetamol..
2GM
Decontrolled
Pack of 100gm,
Vitamin
C 250gm, 500gm,
(Scorbic
acid) 1kg, 5kg, 25kg
.20gm
Calcium
Carbonate.4.5g
m
Potassium
Chloride4gm
Magnesium
Sulphate.3.5gm
Analgesic
(Specs
provided)

Agenda 252

nd

not

83
Registration Board Meeting

132.

-do-

Dairrhonil
Powder

oral Form-5

Oral Powder
Each
contains.

100Gm

Neomycin
sulphate.400mg
Streptomycin..4
00gm

Dy. No: 381


dated.
19-062015
20000/- dated 1806-2015
Decontrolled
Pack of 100gm,
250gm, 500gm,
1kg, 5kg, 25kg

Sulphaguanidine
..4gm
Pectin
400mg
Bismuth
sebnitrate.2gm
Vitamin A 8000
I.U
Kaolin.4mg
Antibacterial
(Specs
provided)

not

Additional Section:
(Evaluator IV)

Agenda 252

nd

84
Registration Board Meeting

S/N

Name
and Brand Name
Type of Form
address
of
date,
manufacturer / (Proprietary name Initial
+ Dosage Form + diary
Applicant
Strength)
Fee including
Composition
differential fee

International
Remarks / Observations
status
in
stringent
regulatory
agencies
Me-too status

GMP status as
Demanded
in
Price / Pack depicted
inspection
size
report (dated)
Finished product
Specification
Pharmacological
Group

133.

134.

M/s
Global
Pharmaceuticals
(Private)
Limited, Plot #
204-205,
Industrial
Triangle, Kahuta
Road,
Islamabad.
M/s
Wenovo
Pharmaceuticals
, Plot # 31 & 32,
Punjab
Small
Industrial Estate,
Taxila,
Rawalpindi

Calciferol Capsules
Each Soft Gelatin
Capsule Contains
Cholecalciferol .
5 mg (200,000 IU)
USP Specs
Vitamin
Tablet Aroxewen
20 mg
Each film coated
tablet contains
Paroxetine as HCl
Hemihydrate USP
23.28 mg
equivalent to
Paroxetine 20 mg

Form 5
20,000/Dy. No. 4278
(07/07/2015)
Pack of
10s and 30s as
per SRO

Form 5
Rs. 20,000/(20-01-2014)
Dy. No. 57
Pack of
10s / as per
policy

SSRIs
(USP Specification)

Agenda 252

nd

85
Registration Board Meeting

International
i.Nationally as well as internation
availability not
not available in the prop
provided
strength, firm may be aske
provide supported document
Sunny
-D
(Scottmann)

FDA approved
tablet paxil 20
mg (Apotex
Technologies)
Tablet Deroxat
20 mg mg
(Global)

Remaining 5 products of new sec


cases referred by R-III.

135.

-do-

Tablet Piroxiwen
20 mg.
Each tablet
contains Piroxocam
Betacyclodextrin
20 mg

Form 5
Rs. 20,000/(20-01-2014)
Dy. No. 57
Pack of
10s / as per
policy

FDA approved
tablet paxil 20
mg (Apotex
Technologies)
Tablet P-cyclo 20
mg (Global)

NSAID

136.

137.

-do-

-do-

(Manufacture
Specification)
Tablet Uricem 40
mg.

Form 5
Rs. 20,000/(03-08-2015)
Each film coated Dy. No. 4793
tablet
contains
Febuxostat 40 mg
Pack of
10s / as per
Xanthine Oxidase
policy
Inhibitors
(Manufacture
Specification)
Tablet Saveme 400
mg.

Form 5
Rs. 20,000/(03-08-2015)
Each film coated Dy. No. 4792
tablet
contains
Sevelamer HCl 400 Pack of
mg
30s / as per
policy
Phosphate Binding
Polymeric Amine
(Manufacture
Specification)

Agenda 252

nd

86
Registration Board Meeting

FDA approved
tablet uloric 40
mg(Takeda
Pharmaceuticals
America)
Tablet Zurig 40
mg (Getz)

FDA approved
tablet Renagel
400 mg (Takeda
Pharmaceuticals
America)
Tablet Renavel
400 mg
(Genome)

138.

-do-

Tablet Moxwen
400 mg.

Form 5
Rs. 20,000/(03-02-2014)
Each film coated Dy. No. 152
tablet
contains
Moxifloxacin HCl Pack of
435 mg eq to 5s / as per
Moxifloxacin 400 policy
mg

FDA approved
tablet Avelox 400
mg (Bayer)
Tablet Metoxim
400 mg
(Genome)

Flouroquinolone
Antibiotics
(Manufacture
Specification)
(Evaluator: I)
139.

140.

M/s
Ardin
Pharmaceuticals
, plot No. 56
Sector
27,
Korangi
Industrial area,
Karachi.

-do-

Gentarin
0.3%

Cream Form-5

Gentamicin
Sulphate 0.3%
Antibiotic

23-06-2015
diary No 302.
Rs20,000

USP Specifications

As per SRO/10
Gm Pack

Ardic Cream 2%

Form-5

Each gram contains 23-06-2015


Fusidic
acid.. diary No 309.
20mg
Rs20,000
Antibiotic
As per SRO/15
B.P Specifications Gm Pack

Agenda 252

nd

87
Registration Board Meeting

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Strength
requires
to
rationalized as each 1
contains 0.3 gm of genta
sulphate,
which
re
correction.

Undertaking for the stabili


product development as app
by the registration board
attached.

141.

-do-

Ardefenac Gel 1%

Form-5

Each gram contains


Diclofenac
Sodium..
10mg(require
justification)

23-06-2015
diary No 309.

Analgesic

Rs20,000
As per SRO/15
Gm Pack

B.P Specifications

142.

-do-

Sulfadin Cream 1%

Form-5

Each
gram 23-06-2015
contains:Silver diary No 311.
Sulfadiazine.10
Rs20,000
mg
Antibacterial

As per SRO/25
Gm Pack

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Firm
has
claimed
specifications
for
fi
product,
which
are
diclofenac diethylamine i
of diclofenac sodium,
requires clarification.
3. Raw material specificatio
not provided.

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Specifications of raw m
and finished product ar
provided.

Manufacturers
Specifications

143.

-do-

Neocin
Cream
Each gram contains
betamethasone as
valerate.1mg
Neomycin sulphate
.
5mg
Corticosteride/Anti
bacterial

Form-5
23-06-2015
diary No 304.
Rs20,000
As per SRO/10
Gm Pack

Manufacturers
Specifications

Agenda 252

nd

88
Registration Board Meeting

Undertaking for the stabili


product development as app
by the registration board
attached.

144.

145.

-do-

Dermazin
Gel Form-5
Each gram contains
Lignocaine HCl . 23-06-2015
diary No 303.
20mg

-do-

Local Anesthetic

Rs20,000

B.P Specifications

As per SRO/15
Gm Pack

Clomidin Cream

Form-5

Clotrimazole.1%

23-06-2015
diary No 310.

Antifungal
B.P Specifications

Undertaking for the st


and product developme
approved by the regis
board is not attached.

Undertaking for the stabili


product development as app
by the registration board
attached.

Rs20,000
As per SRO/10
Gm Pack

146.

-do-

Polydin Ointment

Form-5

Each gram contains


Polymyxin
B
Sulphate.10mg
Bacitracin Zinc
10mg

23-06-2015
diary No 307.

Antifungal

Undertaking for the stabili


product development as app
by the registration board
attached.

Rs20,000
As per SRO/20
Gm Pack

B.P Specifications

147.

-do-

Pain-Go Balm

Form-5

Each 100 gram 23-06-2015


contains
Methyl diary No 306.
Salicylate.15gm
Rs20,000
Menthol .10gm
Analgesic

As per SRO/50
Gm Pack

B.P Specifications

Agenda 252

nd

89
Registration Board Meeting

3. Undertaking for the st


and product developme
approved by the regis
board is not attached.
4. Strength
require
to
rationalized as each 1
contains 15gm methyl sal
and 10 gram menthol
requires correction.
5. The firm has mentioned
specifications but in USP
product specifications a
present,
which
re
justifications.

6. Raw material specificatio


menthol are not provided.

148.

-do-

Burnil Cream 30 Form-5


gm
23-06-2015
Each 100 gram diary No 305.
contains Euflavine
0.1gm (requires Rs20,000
justification)
As per SRO/30
Antiseptic

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Specifications for the fi
product provided by the
are incomplete and requi
be submitted with referen

Gm Pack

USP Specifications
(incorrect requires
reference)
149.

M/s
Ardin
Pharmaceuticals
, plot No. 56
Sector
27,
Korangi
Industrial area,
Karachi
(Aditional
section)

Esoprazole Capsule Form-5


40mg
23-06-2015
Each
capsule diary No 315.
contains
enteric
Rs20,000
coated
Esomeprazole
As per SRO
Magnesium pellets
eq.to Esomeprazole Source
M/s
40mg
Vision Pharma,
Islamabad.
Proton
Pump
Inhibitor

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.

Manufacturer
Specifications

150.

-do-

Agenda 252

Ardefenac Capsule Form-5


100mg
23-06-2015
Each
capsule diary No 318.
contains Diclofenac
Sodium SR pellets Rs20,000
eq.to
Diclofenac As per SRO
Sodium 100mg
Source
M/s
Vision Pharma,

nd

90
Registration Board Meeting

2. Undertaking for the st


and product developme
approved by the regis
board is not attached.
3. Finished product specific
are incomplete, all tes
required in pharmacope
not provided.

NSAIDs

Islamabad.

Not mentioned by
the
firm
Specifications
151.

-do-

Azin
250mg

Capsule Form-5
23-06-2015
capsule diary No 321.

Each
contains
Azithromycin
Dihydrate eq.
Azithromycin
250mg

Rs20,000
to As per SRO

Macrolide
USP Specifications

152.

-do-

Lincodin
500mg

Capsule Form-5

23-06-2015
Each
capsule diary No 317.
contains
Lincomycin
HCl Rs20,000
eq. to Lincomycin As per SRO
500mg
Antibiotic
USP Specifications

153.

-do-

Celedin
200mg

Capsule Form-5

23-06-2015
Each
capsule diary No 319.
contains Celecoxib
Rs20,000
200mg
NSAID

As per SRO

USP
Specifications(requ

Agenda 252

nd

91
Registration Board Meeting

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Finished product specific
are incomplete, all tes
required in pharmacope
not provided.
3. Calculations are provided
form, which require
justified for active.
4. In the specifications o
material identification te
firm
has
mentioned
spectrometry, while in
equipment list it is not pre

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Finished product specific
are submitted as USP bu
assay limits and other te
not same as in USP,
requires clarification.
3. Calculations are provided
form, which require
justified for active.

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. Finished product specific
are submitted as USP bu
incomplete, require refere
3. Raw material specificatio
incomplete, only assay is
complete specifications
pharmacopeia need t
submitted.

ire to be verified)

154.

-do-

Ardicam
20mg

Capsule Form-5

23-06-2015
Each
capsule diary No 318.
contains Piroxicam
Rs20,000
20mg
As per SRO

NSAID
B.P Specifications

155.

-do-

Ardium
2mg

Capsule Form-5
23-06-2015
capsule diary No 318.

Each
contains
Loperamide 2mg

Rs20,000
As per SRO

USP Specifications

Evaluator DDC )PEC-II

Agenda 252

nd

92
Registration Board Meeting

1. Undertaking for the st


and product developme
approved by the regis
board is not attached.
2. The firm has men
slugging technique in
manufacturing method,
equipment list does not c
compactor,
which
r
clarification.
3. In the specifications o
material identification te
firm
has
mentioned
spectrometry, while in
equipment list it is not pre
4. Finished product specific
are submitted as B.P b
assay limits are not correc
1. Undertaking for the st
and product developme
approved by the regis
board is not attached.
2. Pharmacological
group
wrongly
mentioned
antibiotic, require correcti
3. In the specifications o
material identification te
firm
has
mentioned
spectrometry, while in
equipment list it is not pre
4. Finished product specific
are submitted as USP b
assay limits and other te
not correct.

156.

M/s
Linta
pharmaceuticals
(Pvt)
Limited
Plot No. 03,
Stree no. S-5,
National
Industiral Zone
Rawat Islamabd.

PNK Sachet.

Form-5

Sachet

Dy. No: 1005

Each
contains:

Sachet dated
2015

16-04-

Macrogol
3350.13.125g

20000/- dated
15-04-2015

Sodium
Chloride..0.3507
g

As per SRO

Complete description of the p


/ pharmaceutical form is requi

Master formulation (excipien


not as per innovator / ref
regulatory authorities.

HVAC
details
i.e
hum
temperature, air changes, par
count, air pressure, in sachet s
is required.

Sodium
Bicarbonate
0.1785g
Potassium
Chloride
0.0466g
Laxative for the
treatment
of
constipation
and
faecal impaction
(Linta,s Specs)
157.

M/s
Linta
pharmaceuticals
(Pvt)
Limited
Plot No. 03,
Stree no. S-5,
National
Industiral Zone
Rawat Islamabd.

Airmax Sachet.

Form-5

Sachet

Dy. No: 998

Each
contains:

Sachet dated
2015

Montelukast
20000/- dated
sodium equivalent 15-04-2015
to montelukast
As per SRO
4mg
Leukotriene
receptor antagonist
(LTRA)
(Linta,s Specs)

Agenda 252

nd

16-04-

93
Registration Board Meeting

Complete description of the p


/ pharmaceutical form is requi

FPP is in the form of gr


whereas the manufacturing p
lacks granulation as a pa
manufacturing process.

HVAC
details
i.e
hum
temperature, air changes, par
count, air pressure, in sachet s
is required.

158.

M/s
Linta
pharmaceuticals
(Pvt)
Limited
Plot No. 03,
Stree no. S-5,
National
Industiral Zone
Rawat Islamabd.

Ospra Sachet.

Form-5

Product is under review.

Sachet

Dy. No: 1000

Complete description of the p


/ pharmaceutical form is requi

Each
contains:

Sachet dated
2015

16-04-

Application on form 5D requi

Omeprazole
40mg

20000/- dated
15-04-2015

Sodium
bicarbonate
1680mg

As per SRO

HVAC
details
i.e
hum
temperature, air changes, par
count, air pressure, in sachet s
is required.

Anti-ulcerants
(Proton
Pump
Inhibitors)
(Linta,s Specs)
159.

M/s
Linta
pharmaceuticals
(Pvt)
Limited
Plot No. 03,
Stree no. S-5,
National
Industiral Zone
Rawat Islamabd.

RSNK Sachet.

Form-5

Sachet

Dy. No: 1004

Each
contains:

Sachet dated
2015

Pre-cooked
Rice 20000/- dated
Powder6.0g
15-04-2015
Sodium
Citrate..0.580g

As per SRO

Sodium
Chloride.0.350
g
Potassium
Chloride
0.300g
Antidiarrhoeals
(Rehydration
Fluids)
(Linta,s Specs)

Agenda 252

nd

16-04-

94
Registration Board Meeting

Master formulation (excipien


not as per innovator / ref
regulatory authorities.

HVAC
details
i.e
hum
temperature, air changes, par
count, air pressure, in sachet s
is required.

160.

M/s
Linta
pharmaceuticals
(Pvt)
Limited
Plot No. 03,
Stree no. S-5,
National
Industiral Zone
Rawat Islamabd.

ISMEB Sachet.

Form-5

Sachet

Dy. No: 1002

Each
contains:

Sachet dated
2015

Complete description of the p


/ pharmaceutical form is requi

Master formulation (excipien


not as per innovator / ref
regulatory authorities.

16-04-

Mebeverine
20000/- dated
hydrochloride B.P 15-04-2015
.135mg
As per SRO
Ispaghula
husk
B.P3.5g
Irritable
syndrome
(Laxative)

FPP is in the form of gr


whereas the manufacturing p
lacks granulation as a pa
manufacturing process.

HVAC
details
i.e
hum
temperature, air changes, par
count, air pressure, in sachet s
is required.

bowel

(Linta,s Specs)

Case No. 06: Applications for registration of deferred applications in various meeting
(Evaluator III)
DEFERRED CASES OF M-242
Case No: i
S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name

Type of Form

(Proprietary
name
+
Dosage Form Initial
diary
+ Strength)

Composition

date,

Fee including
differential
fee

Pharmacologi
cal Group

Agenda 252

nd

95
Registration Board Meeting

Internationa
l availability
in reference
agencies

Local
availability

GMP status

Decision M-242

Remarks

Finished
product
Specification
161.

M/s. Medicraft
Pharmaceuticals,
Peshawar

Demanded
Price / Pack
size

VIT.D
Injection

Form 5
Fast Track

Each
ml
contains:Vitamin
D3..1mcg

25/3/2013 180
R&I
25/3/2013

Vitamin

(Rs. 20,000/-)
3/10/2013
Rs. 40,000/-

Not
found/
Not provided

Not
found/
provided
details
are
ambiguous

Deferred as the a.
requisite
documentation as
per Form-5 is not
complete

Revised
Form-5
is
submitted
with
following
label claim:
Each
ml
contains:
Cholecalcife
rol..5mg eq.
to
250000mg.

b. Clarification
is required
regarding
calculation
of 5mg eq.
to
250000IU.
c. Quantity of
API
submitted in
master
formulation
is
not
rational with
label claim.
d. Sterilization
method/
process of
finished
product
is
not provided
under
Manufacturi
ng method.
e. Reference of
calcitrol
(1mcg/ml)
injection is
given under
evidence of

Agenda 252

nd

96
Registration Board Meeting

availability
in reference
agencies.
f. Finished
product
specification
s
are
incomplete,
test
like
sterility,
endotoxin
limits
and
identificatio
n tests are
not
submitted.
g. Latest GMP
inspection
report
is
required.
h. Evidence of
availability
of
TOC
analyzer and
LPC.

Case No: ii.


S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name

(Proprietary
name
+
Dosage Form Initial
diary
+ Strength)

Composition

Pharmacologi
cal Group

Agenda 252

nd

Type of Form

date,

Fee including
differential
fee

Internationa
l availability
in reference
agencies

Local
availability

GMP status
Demanded
Price / Pack
size

97
Registration Board Meeting

Decision M-242

Remarks

Finished
product
Specification
162.

M/s
Bloom
Pharmaceuticals
(Pvt) Ltd. Phase I
& II Industrial
Estae, Hattar ,
KPK.

SUNMET
Cream
Each
Gm
contains:
Fluocinolone
acetonide
(U.S.P
0.01%
Hydroquinone
(U.S.P)4%
Tretinoin
(U.S.P)
0.05%

Form5
Fast Track
As
per
SRO/30grams
17-05-2013
Dy.No.426
Rs.60,000/-

Antiinflammat
ory+Depigmen
ting
agent+Keratol
ytic
Manufacturer

TRILUMA of
GAL
DERMA
LABS
(USFDA)

TRIMELASI
N(VALOR
PHARMACE
UTICALS)
[Tretinoin:0.0
5%w/w,Hydr
oquinone:4%
w/w,Fluocino
lone
(Acetonide):0
.01%w/w
cream

Deferred
for
following
(i) Clarification
of manufacturing
facility
for
steroidal section
ii) submission of
Undertakings
regarding
Pharmaceuticals
Development
studies, Stability
studies,
Validation
of
analytical testing
methods, Process
validation
and
Label claims and
prescribing
information
being same as
approved
by
reference
drug
agencies
like
FDA,
TGA,
MHLW,
EMA
and
Health
Canada.

Registration
Board in its 249th
meeting decided
that
Products
containing
steroidal topical
preparations like
eye/ear
drops,
sterile
eye
ointment,
external
preparations i.e.
cream/ointment/g
el,
lotions,
spray/aerosols,
suppositories,
vaginal
preparation, intra
oral preparations,
nasal drops etc
shall be permitted
for
manufacturing in
general
facility/area
provided
that
manufacturers
shall
have
segregated
dispensing
booths,
cleaning
validation
and
controls studies
for processes and
adequate system

Agenda 252

nd

98
Registration Board Meeting

to minimize the
potential risk of
cross
contamination.

Agenda 252

nd

99
Registration Board Meeting

DEFERRED CASES OF M-246


Case No: iii.
M/s Stallion Pharmaceuticals Lahore has informed that one of their product Flustal Injection (Amoxicillin
250mg) is deferred in the 246th meeting of Registration Board due confirmation in reference drug
agencies. The firm requested that Ampi Injection 500mg (Ampicillin) may be considered on priority basis
as per 10 products per section policy.
S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary
name + Dosage
Form + Strength)

Composition

Pharmacological
Group

Finished product
Specification
163.

M/s
Stallion
Pharmaceuticals,
(Pvt)
Limited,
581,
Sundar
Industrial Estate,
Lahore.

Type of Form

Initial
diary

date,

Fee including
differential fee

Agenda 252

Local
availability

GMP status
Demanded
Price / Pack
size

AMPI Injection Form-5


500mg
Dy. No: 853
Each
vial dated 11-02-15
contains:
Ampicillin
20000/sodium eq. to
Ampicillin..50 Rs. 42 per vial
0mg
Rs. 420 per
pack of 10
Penicillin
vials
BP

nd

International
availability
in
reference
agencies

100
Registration Board Meeting

Ampicillin
Injection
Sandoz

of

Ampin Injection
of
Bosch
Pharmaceuticals.

Remarks

DEFERRED CASES OF M-247


Case No: iv
Following products of M/s Helix Pharma (Pvt) Limited, Karachi, are deferred in the 247 th meeting of
Registration Board due to below mentioned deficiencies. The firm has now submitted reply to these
deficiencies. The evaluation report is as follow:
S/N

Name and
address of
manufactu
rer
/
Applicant

Brand Name

Type of Form

(Proprietary
name + Dosage
Form
+
Strength)

Initial
diary

Composition
Pharmacologic
al Group
Finished
product
Specification
164.

date,

Fee including
differential fee

Nogerd Total

Form 5-D

Pharma
(Pvt.) Ltd.,

Capsule

(Fast Track)

Capsule

Rs.8,000/-

Each Capsule

Not

House,
A/56,

Contains:

S.I.T.E

Pantoprazole

Manghopir

Sodium

Not

Road
Karachi.

sesquihydrate

mentioned

equivalent to

Rs.40,000/-

Pantoprazole

21-12-2012

.
40mg

Dy. No. not

(Anti
coated

Agenda 252

nd

mentioned

enteric

M-247 decision

Remarks

Local
availability

Demanded
GMP status
Price / Pack
size

M/s Helix

Hakimsons

Internationa
l availability
in reference
agencies

Rs.12,000/-

mentioned

Under evidence
of
international
availability
GANATON
TOTAL of M/s
Abbott,
has

India

been
mentioned
instead of
reference drug
agencies.

1. An
undertaking /
commitment,
on prescribed
format,
regarding the
submission of
following,
before
marketing the
product, as per
decision of the

Rs.90,000/-

Registration

pellets)

03-06-2013

Board, may be

Itopride HCL

Dy. No. not

submitted for

101
Registration Board Meeting

a. Evidence
of
approval
in
reference drug
agencies is not
submitted,
however
reference
of
GANATON
TOTAL of M/s
Abbott, India
has
been
mentioned.
b. One
page
accelerated
stability data
of 6 months on
a batch of
5000capsules
is submitted

. 150mg
(As
sustained release

mentioned

consideration

As Per

by the Board:

SRO/-10s

a) Stability

pellets)
(Gastroprokineti
c+
Proton
Inhibitors)

studies
b)
Pharmaceutical
development
studies
c) Validation of
analytical testing
methods
d)
Process
validation
e) Label claim
and prescribing
information
being
same as approved
by reference drug
agencies
e.g.,
FDA, TGA,
MHLW,
EMA
and Health
Canada.
2. Evidence of
approval of same
formulation by
stringent
regulatory
authority
e.g.,
FDA, TGA,
MHLW,
EMA
and Health

Agenda 252

nd

102
Registration Board Meeting

Canada required.
3. Prescribing
information
(PI), Patient
Information
Leaflet (PIL)
and Summary of
product
characteristics(S
mPC)
as
approved
by
Drug
regulatory
agencies or
authorities of
country of origin
or FDA, EMA,
TGA,
Health
Canada
and
MHLW (Japan).
4.
Stability
Studies
Conducted under
the Zone IV-A
conditions as
per ICH / WHO
guidelines.
5. Submission
of following
document
from source of
pellets required
along
with
balance
fee

Agenda 252

nd

103
Registration Board Meeting

(incase of
import):
i. COA
ii. Stability
studies
iii. Valid
legalized GMP
of source of
pellets.
70.

M/s Helix

Nap-X Tablets

Form 5-D

VIMOVO

undertaking /

Pharma
(Pvt.)

Tablets

(Fast Track)

20/500mg

commitment,

Each Tablet

Rs.15,000/-

(Immediate

on prescribed

Contains:

30-08-2010

release

format, regarding
the submission of

Ltd.,
Hakimsons

Naproxen USP

Not

Esomeprazole

House,
A/56,

enteric coated

mentioned

S.I.T.E

.500mg

Rs.10,000/-

Magnesium
layer

Manghopir

Esomeprazole as

21-12-2012

Road
Karachi.

magnesium

Not

coated
Naproxen

20mg

Mentioned

Sodium layer.

(Osteoarthritis
&

Rs.35,000/-

US FDA

rheumatoid

21-12-2012
Dy. No. not

arthritis,
Naproxen

mentioned

: NSAIDs,

Rs.90,000/-

Esomeprazole
Mg:

03-06-2013

Proton Pump

Dy. No. not


mentioned

Inhibitor)

Agenda 252

nd

104
Registration Board Meeting

and an enteric

following, before
marketing
the
product, as per
decision of the
Registration
Board, may be
submitted for
consideration
by the Board:
a) Stability
studies
b)
Pharmaceutical
development
studies
c) Validation of

One
page
accelerated
stability data of 6
months on a
batch of 5000
tablets
is
submitted.

As Per

analytical

SRO/-10s

testing methods
d)
Process
validation
e) Label
claim
and
prescribing g
information
being
same as approved
by reference
drug agencies
e.g.,FDA, TGA,
MHLW,
EMA
and Health
Canada.
2. Role and
justification
for proposed
quantities of
in-actives
required.
3. Stability
Studies
Conducted under
the Zone IV-A
conditions as
per ICH / WHO
guidelines.
4. Under

Agenda 252

nd

105
Registration Board Meeting

manufacturing
method firm
has mentioned
that
Esomeprazole
Magnesium
will be coated
on core tablets.
Whereas,
precautionary
steps have not
been mentioned
which would
ensure uniform
coating.

Case No: v.
S/N

Name and
address of
manufactu
rer
/
Applicant

Brand Name

Type of Form

(Proprietary
name + Dosage
Form
+
Strength)

Initial
diary

Composition

Pharmacologic
al Group

Agenda 252

nd

date,

Fee including
differential fee

Internationa
l availability
in reference
agencies

Local
availability

GMP status
Demanded
Price / Pack
size

106
Registration Board Meeting

M-247 decision

Remarks

Finished
product
Specification
165.

M/s
Novamed
Pharmaceut
icals,
Lahore

Greymerz

Form 5

Not confirmed

International

Injection

13-10-2014

Each 10ml

Rs.20,000/-

Levijon
(Sami)

Availability
reference

ampoule

(Dy. No. 29)

contains:-

Rs.

L-Ornithin
LAspartate

184.00/10ml

Amp

5gm

in

stringent
DRA,s not
confirmed.
2. Proposed

(Amino acid)

Master
formaulation
with

(Manufacturers

scientific

Spec.s)

names as
present in
the relevant
pharmacop oeia
and quantities
of all the
ingredients
including
excipients,
Batch size,
Quantities to be
used per Batch,
Source of active
and
Inactive starting
materials, Role of

Agenda 252

nd

107
Registration Board Meeting

Method testing
for specifications
of
API
and
finished product
are required.

inactive
starting
materials
and the
Justification
their

of

quantities
used is
required.
3. Clarificati
on may be asked
from
licensing
section wether
there is
one
section
ofiquid injectable
containing
vial and ampoule
products or two
separate
sections.
Inspection
reports of
the Firm
dated 21.01.14
mentions

Agenda 252

nd

108
Registration Board Meeting

General liquid
Injection
(Ampoule
Vial).

and

4. Complete
And updated
Specficati ons of
active
starting
material(s)
i.e., API (Active
Pharmaceutical
Ingredient)
with
reference
(pharmacopoeil if
any) are required.
5. Complete
And updated
Specficatiinactive
materials
/excipients
with with
reference
(pharmaco
poeial if
any) are

Agenda 252

nd

109
Registration Board Meeting

required.
6. Reference
of and complete
Specificati
ons of
finished
product are
required.
7. Evidence
and
verificatio
n of Total
Organic Testing
facility
and Liquid
particle
counter
facility by
area FID
that the said
instrument
is in functional
condition are
required.
Firm has

Agenda 252

nd

110
Registration Board Meeting

submitted
that they
willsubmit
evidence/
verificatio
n report
from area
FID before
marketing
of the product.
8. Copy of
GMP inspection
Report dated 2101-14 is
attached.
Firm has
submitted
undertaking that
they
have last
GMP report of
08-04-14 (not
provided)
they will
submit their
pending GMP
inspection

Agenda 252

nd

111
Registration Board Meeting

and

report as soon as
they got it.
8. Undertakin
g on desired
format is
required.
9. Complete
Specifications
(Physical
& Chemical
Characteristics)
of the
container
closure system
(Primary
Packaging,
Secodary
Packaging &
Associated
component
s e.g.,
caliberated
spoon etc.)
fulfilling
the compendia
l requireme

Agenda 252

nd

112
Registration Board Meeting

nt are required.
10. Undertakin
g on desired
format is
required.

DEFERRED CASES OF M-249


Case No: vi
M/s Weather Folds Pharmaceuticals Hattar have informed that one of their product Wenomet Injection
was deferred in 249th meeting of Registration Board due to review of formulation. The applied
formulation was discussed in the 250 th meeting and the Board approved the said formulation. The firm
requested to consider their product in light of said decision.
S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name

Type of Form

(Proprietary
name + Dosage
Form + Strength)
Composition
Pharmacological
Group
Finished product
Specification

166.

M/s
Weather
Folds
Pharmaceuticals,
Hattar

WENOMET
Injection 80mg

Each
contains:-

1ml

Artemether80
mg

(Ant malarial)

Agenda 252

nd

Initial
diary

date,

Fee including
differential fee

International
availability
in
reference
agencies
Local
availability
GMP status

Demanded
Price / Pack
size
Form 5

Dy. No: 502


dated
12-032015.

Rs. 20,000/-

As Per SRO /
1ml.

113
Registration Board Meeting

WHO
recommended
formulation

Artem by M/s
Hilton Pharma
Pakistan.

Remarks

(Manufacturer
Specs)
Case No: vii.
Following products of M/s Weather Fold Pharmaceuticals Hattar & & of M/s Rasco Pharmaceuticals,
Lahore are deferred in the 249 th meeting of Registration Board for confirmation of formulation in
reference drug agencies. The firms submitted that said products are available in Germany France &
Egypt. It is pertinent to mention that France and Germany are included in reference agencies approved by
Registration Board in its 249th meeting. However the applied formulation in not available in databases of
websites of aforesaid Regulatory authorities. Submitted for consideration please.

S/N

Name
and Brand Name
Type of Form
address
of
name
+ Initial
date,
manufacturer / (Proprietary
Dosage
Form
+
Strength)
diary
Applicant
Composition
Pharmacological Group
Finished
Specification

167.

M/s Weather Folds


Pharmaceuticals,
Plot No. 69/2,
Phase II, Industrial
Estate Hattar.

Agenda 252

nd

International
Remarks
status
in
reference drug
agencies
/
authorities

Fee including
differential fee Me-too status

Demanded
GMP status as
product Price / Pack depicted
in
size
latest inspection
report
(with
date) by the
Evaluator

VITA-3 Injection

Not found in
reference
Each
1ml
ampoule Dy. No: 499 agencies
contains:dated
12-03Cholecalciferol200,000 I.U 2015.
Vital D by M/s
eq. to Colecalciferol.5
Macter
mg
Rs. 20,000/International
Pakistan.
(Vitamin D3)
As Per SRO /
1mlx1s,
(Manufacturer specs)
5x1ml.

114
Registration Board Meeting

Form 5

168.

M/s Rasco Pharma


Lahore.

CALCIROL Injection 5mg

Form-5

Each 1ml ampoule


contains:
Colecalciferol BP5mg
(200,000IU)

Dy No: 2817
dated
17.4.2015

(Vitamin-D Analogue)

20,000/-

BP Specifications

As per SRO
1ml 1s

Not found in
reference
agencies
Indrop D
injection
(Neutro
Pharma)Lhr

DEFERRED CASES
S/N

Name
and Brand Name
address
of
manufacturer / (Proprietary name
+ Dosage Form +
Applicant
Strength)
Composition

Type
Form

of International Remarks
status
in
reference
Initial date, drug agencies
diary
/ authorities
Me-too status

Pharmacological
Group

Fee
including
differential
fee

AURA-D Sachet

Form 5D

Not found/
Not provided

GMP status
as depicted in
latest
Finished product Demanded
inspection
Specification
Price / Pack report (with
size
date) by the
Evaluator

169.

M/s Martin Dow


Limited Karachi

Agenda 252

nd

a. Evidence of availability in
reference drug agencies is
required.
Each
sachet Dy. No
Inspection of b. Lab scale scientifically
contains:
the firm was
rationale stability data is
Cholecalciferol.. 50000/carried out on
required.
60000IU
24-02-15 and
Rs. 40/- per panel
recommends
Vitamin
D sachet
the issuance

115
Registration Board Meeting

analogue
Manufacturer

170.

-do-

Pack of 10. of GMP for


export
20 30s
purpose.

CAL-ONE
D Form 5D
Not found/
Not provided
Chewable Tablets
Dy. No
Each
chewable
tablet contains:
8000+52000
Vitamin
+90000
D3.400IU
Ossein
Mineral Rs. 13.27/Complex.830mg per tablet
Pack of 10,
Multivitamin
& 20,30,60s
trace elements

a. Evidence of availability in
reference drug agencies is
required.
b. Lab scale scientifically
rationale stability data is
required.

Manufacturer
Case No. 07: Applications for registration of applications (Routine)

(Evaluator IV)
S/N

Name
and Brand Name
Type of Form
address
of
date,
manufacturer / (Proprietary name Initial
+ Dosage Form + diary
Applicant
Strength)
Fee including
Composition
differential fee

International
Remarks / Observations
status
in
stringent
regulatory
agencies
Me-too status

GMP status as
Demanded
in
Price / Pack depicted
inspection
size
report (dated)
Finished product
Specification
Pharmacological
Group

Agenda 252

nd

116
Registration Board Meeting

171. M/s Remington


Pharmaceutical
Industries (Pvt.)
Ltd,
18-km
Multan
Road,
Lahore

Valpin H
5/160/12.5 Tablet
Each film coated
tablet contains
iv.

v.
vi.

Amlodipine (as
Besylate) B.P
..5.0 mg
Valsartan U.S.P
160.0 mg
Hydrochloroth
iazide U.S.P
12.5 mg

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2161
(02/02/2011) &
Dy. No. 9262
(30-07-2013)

FDA approved
Tablet
Exforge
HCT (Novartis)
Tablet Valam-H
5/160/12.5 (CCL)

Pack of
14s & 28s
Blisters Tablets
as per Leader
Price

Calcium Channel
Blocker,
Angiotensin II
Receptor
Antagonist &
Thiazide Diuretics

172.

-do-

Valpin H
10/160/12.5 Tablet
Each film coated
tablet contains
iv.

v.
vi.

Amlodipine (as
Besylate) B.P
..10 mg
Valsartan U.S.P
160.0 mg
Hydrochloroth
iazide U.S.P
12.5 mg

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2163
(02/02/2011) &
Dy. No. 9265
(30-07-2013)
Pack of
14s & 28s
Blisters Tablets
as per Leader
Price

Calcium Channel
Blocker,
Angiotensin II
Receptor
Antagonist &

Agenda 252

nd

117
Registration Board Meeting

FDA approved
Tablet
Exforge
HCT (Novartis)
Tablet Valam-H
10/160/12.5
(CCL)

Thiazide Diuretics

173.

-do-

Valpin 10/320
Tablet
Each film coated
tablet contains
iii.

iv.

174.

-do-

Amlodipine (as
Besylate) B.P
..10 mg
Valsartan U.S.P
320.0 mg

Calcium Channel
Blocker &
Angiotensin II
Receptor
Antagonist
Kiren 150 mg
Tablet
Each film coated
tablet contains
Aliskiren
Hemifumerate
equivalent to
Aliskiren 150mg
Renin Inhibitor
(Manufacture
Specification)

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2011
(28/01/2011) &
Dy. No. 9261
(30-07-2013)

FDA approved
Tablet
Exforge
(Novartis)
Tablet ValsanAM 10/320
(Hilton)

Pack of
14s & 28s
Blisters Tablets
as per Leader
Price

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 11016
(29/11/2010) &
Dy. No. 9299
(30-07-2013)
Pack of
1 x 07s
blisterTablets
as per Leader
Price

118
Registration Board Meeting

FDA approved
Tablet Tekturna
150
mg
(Novartis)
Tablet Rasilez
150 mg
(Novartis)

175.

-do-

Kiren 300 mg
Tablet
Each film coated
tablet contains
Aliskiren
Hemifumerate
equivalent to
Aliskiren 300 mg
Renin Inhibitor
(Manufacture
Specification)

176.

-do-

Bestegrel 5 mg
Tablet
Each film coated
tablet contains
Prasugrel
Hydrochloride
equivalent to
Prasugrel 5.0
mg
Renin Inhibitor

177.

-do-

(Manufacture
Specification)
Bestegrel 10 mg
Tablet
Each film coated
tablet contains
Prasugrel
Hydrochloride
equivalent to
Prasugrel 10 mg
Renin Inhibitor
(Manufacture
Specification)

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 11020
(29/11/2010) &
Dy. No. 9297
(30-07-2013)
Pack of
1 x 07s
blisterTablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2398
(29/11/2010) &
Dy. No. 9268
(30-07-2013)

FDA approved
Tablet Tekturna
300
mg
(Novartis)
Tablet Rasilez
300 mg
(Novartis)

FDA approved
Tablet
Effient
5mg (Elli Lilly)
Tablet Prisa 5
mg (Novartis)

Pack of
14s & 28s
Blister Tablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2394
(07/02/2011) &
Dy. No. 9267
(30-07-2013)
Pack of
14s & 28s
Blister Tablets
as per Leader
Price

119
Registration Board Meeting

FDA approved
Tablet
Effient
10mg (Elli Lilly)
Tablet Prisa 10
mg (Novartis)

178.

-do-

Nilol 2.5 mg Tablet


Each film coated
tablet contains
Nebivolol HCl eq
to Nebivolol 2.5
mg
Selective Beta
Blocking Agent
(Manufacture
Specification)

179.

-do-

Nilol 5 mg Tablet
Each film coated
tablet contains
Nebivolol HCl eq
to Nebivolol 5
mg
Selective Beta
Blocking Agent
(Manufacture
Specification)

180. M/s Martin Dow


Limited, Plot #
37, Sector 19,
Korangi
Industrial Area,
Karachi

Lifeline 750 mg
Tablet
Each film coated
tablet contains
Levofloxacin (as
Hemihydrate) eq to
Levofloxacin
750 mg
(USP Specification)

Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2397
(07/02/2011) &
Dy. No. 9269
(30-07-2013)
Pack of
10s & 14s
Blister Tablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Dy. No. 2396
(10/02/2011) &
Dy. No. 9276
(30-07-2013)
Pack of
10s & 14s
Blister Tablets
as per Leader
Price
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
10/02/2011 &
30-07-2013
Unit pack size
10,s / Rs. 500
Rs. 50.00 per
Tablet

Quinolone Group
Antibiotics

Agenda 252

nd

120
Registration Board Meeting

MHRA approved
Tablet Nebivolol
2.5
mg
(Glenmark)
Tablet Nebil 2.5
mg (Getz)

MHRA approved
Tablet Nebivolol
5 mg (Glenmark)
Tablet Nebil 5
mg (Getz)

FDA approved
Tablet Levoquin
750 mg (OrthoMcNeil-Janssen
Pharmaceuticals)
Tablet Leflox
750 mg (Getz)
GMP compliant
vide inspection
report dated 2402-2015

181.

-do-

Tespral Total
Capsules 40 mg +
150 mg
Each Capsule
contains:iii.
Pantoprazole
Sodium
Sesquihydrate
equivalent to
Pantoprazole
(Enteric
coated) 40 mg
iv.
Itopride (As
sustained
release pellets)
150 mg

182.

-do-

Proton Pump
Inhibitor +
Prokinetic agent
Viglip Tablet 50 mg
Each film coated
tablet contains:Vildagliptin 50
mg
(Manufacture Spec)
DiPeptide
Peptidase 4 (DPP4) inhibitors

Agenda 252

nd

Form 5-D
Rs. 8,000 +
12000 =
20,000/Received on
25/06/2011 &
30-07-2013
Unit pack size
10,s / Rs.
946.94

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
25/06/2011 &
30-07-2013
Unit pack size
10,s / Rs.
754.30
Rs. 75.43 per
tablet

121
Registration Board Meeting

Not provided

vi.Source of pellets required.


vii.Legalized GMP status of the
required.
viii.Stability data of pellets require
ix.International and national avai
information
required
supported documents.
x.Full description of specificatio
analytical testing process
with photocopy of au
references.

TGA approved iii.


Tablet Galvus 50
mg (Novartis)
Locally Galvus
(Novartis)

183.

-do-

Neo-Fansidar
Tablet 40 + 320 mg

Each film coated


tablet contains:iii.
Dihydroartemis
inin .. 40 mg
iv.
Piperaquine
Phosphate 320
mg
(Manufacture spec)
Antiprotozoal &
anthelmintic
184. M/s Genome
Norella 50 mg
Pharmaceuticals Capsule
(Pvt.) Ltd, 16/1,
Phase IV,
Each Capsule
Industrial Estate, contains
Hattar, Haripur
Milnacipran HCl
(Manufacture Spec)
Selective
Norepinephrine and
serotonin reuptake
inhibitor
185.

-d0-

Asperam 10 mg
Chewable Tablet
Each Chewable
Tablet contains
Escitalopram (as
Oxalate) .. 10 mg
(Manufacture Spec)
5HT Reuptake
Inhibitor

Agenda 252

nd

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
04/04/2011 &
31-07-2013

EMA approved ii.


Tablet Eurartesim
320/40
mg
(Logix pharma
solution . UK)
Artequine
(Platinum)

Unit pack size


8s / Rs. 485.00
Rs. 61 per
tablet
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 1263 (0811-2010) &
Dy. No. 29
(17/01/2014)

Savella
in
Europe
by
Forest
Pharmaceuticals
Local
manufacture not
provided.

Unit pack 10s


as per SRO
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 1195 (1110-2010) &
Dy. No. 45
(17/01/2014)

Unit pack 10s


as per SRO

122
Registration Board Meeting

Tab Fastoral by
CLL
Pharma,
Europe
Local
manufacture not
provided.

186. M/s Astellas


Pharmaceutical
(Pvt.) Ltd, 15-C,
Industrial Estate,
Hayattabad,
Peshawar

Astalexim 1.5 gm
Injection
Each Vial Contains
Cefuroxime
Sodium equivalent
to Cefuroxime 1.5
gm USP

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 81 (12-122014) &
Dy. No. 225
(11/02/2011)

Not Provided

4.Firm needs to provided the


IM only or IV only
Local
international availability.
manufacture by 5.Firm has mentioned R.O W
Lowitt Pharma
vial washing while require
(MARCEF)
distilled water for final rin
vials.
6.Verification of distill wate
required.

(USP Spec)

187.

-do-

Cephalosporins

Unit pack 15
ml vial as per
SRO

Astalexim 750 mg
Injection

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 228 (1202-2014) &
Dy. No. 167
(11/02/2014)

Each Vial Contains


Cefuroxime
Sodium equivalent
to Cefuroxime
750mg USP

Not Provided

4.Firm needs to provide the d


IM only or IV only
Local
international availability.
manufacture by 5.Firm has mentioned R.O W
Lowitt Pharma
vial washing while require
(MARCEF)
distilled water for final rin
vials.
6.Verification of distill wate
required.

(USP Spec)

188.

-do-

Cephalosporins

Unit pack 15
ml vial as per
SRO

Astedime 500 mg
Injection

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 226 (1202-2011) &
Dy. No. 169
(11/02/2014)

Each Vial Contains


Ceftazidime
Pentahydrate
equivalent to
Ceftazidime 500mg
USP
(USP Spec)
Cephalosporins

Agenda 252

nd

Unit pack 15
ml vial as per

123
Registration Board Meeting

Not Provided

4.Firm needs to provide the d


IM only or IV only
Local
international availability.
manufacture by 5.Firm has mentioned R.O W
Hamaz Pharma
vial washing while require
(Bectazine)
distilled water for final rin
vials.
6.Verification of distill wate
required.

SRO

189.

-do-

Astedime 1 gm
Injection
Each Vial Contains
Ceftazidime
Pentahydrate
equivalent to
Ceftazidime 1 gm
USP

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 224 (1202-2011) &
Dy. No. 70
(11/02/2014)

Not Provided

4.Firm needs to provide the d


IM only or IV only
Local
international availability.
manufacture by 5.Firm has mentioned R.O W
Hamaz Pharma
vial washing while require
(Bectazine)
distilled water for final rin
vials.
6.Verification of distill wate
required.

(USP Spec)
Cephalosporins

190. M/s
Elite
Pharma (Pvt.)
Ltd, 9.5 km,
Sheikhupura
Road, Lahore.

Ciprolon I.V
Infusion
200mg/100ml
Each 100 ml Vial
Contains
Ciprofloxacin BP
200 mg

Unit pack 15
ml vial as per
SRO
Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 9964 (2710-2010) &
Dy. No. 32
(25/11/2013)

(BP Spec)
Cephalosporins

Agenda 252

nd

Unit pack 100


ml vial / Rs
250

124
Registration Board Meeting

MHRA approved
Ciproxin
Injection (Pfizer)
Inoquin Injection
(Barret)

191. M/s
Elite
Pharma (Pvt.)
Ltd, 9.5 km,
Sheikhupura
Road, Lahore.

Elizole I.V Infusion


500mg/100ml
Each 100 ml Vial
Contains
Metronidazole BP
500 mg

Form 5
Rs. 8,000 +
12000 =
20,000/Received on
Dy. 10995 (2212-2006) &
(25/11/2013)

FDA approved
Metronidazole
Injection (Baxter)
Flagyl Injection
(SANOFI)

(BP Spec)
Cephalosporins

Unit pack 100


ml vial/ Rs.
70.00

(Evaluator-I)

S/N

Name
and Brand Name
Type of Form
address
of
Initial
date,
manufacturer / (Proprietary
name
+
Dosage
diary
Applicant
Form + Strength)
Fee
including
Composition
differential fee
Pharmacological
Group

International status Remarks / Observation


in
stringent
regulatory agencies
Me-too status

GMP
status
as
depicted
in
report
Demanded Price inspection
(dated)
/ Pack size

Finished product
Specification
192.

M/s Medisearch
Pharmacal
PVT
Limited,
Raiwind Manga
Road, Lahore

Gabalin Capsule
75mg
Each Capsule
Contains:Pregabalin
75mg
(Gaba Analogue)

Form 5
8000 + 12000 =
Rs. 20,000/ dated
18-07-2009 &
dated 30-07-2013
vide dy No. 9358
Rs 800/- per 14s
Capsule Pack

(Manufacture
Specification)

Agenda 252

nd

125
Registration Board Meeting

LYRICA
Capsules (25,
50, 75, 100,
150,200, 225
and 300mg)
US FDA
GABICA
Capsules (50,
75, 100, 150 and
300mg)
Getz

Fresh inspection report i


as previous is on date
2011.

193.

-do-

Gabalin Capsule
150mg
Each Capsule
Contains:Pregabalin
150mg
(Gaba Analogue)
(Manufacture
Specification)

194.

-do-

Gabalin Capsule
300mg
Each Capsule
Contains:Pregabalin
300mg
(Gaba Analogue)

195. M/s Saydon


Pharmaceutical
Industries (Pvt.)
Ltd, 77/A,
Hayatabad
Industrial Estate,
Peshawar.

(Manufacture
Specification)
Busone Tablet 5
mg
Each Tablet
Contain
Buspirone HCl
equivalent
Buspirone 5mg

Form 5
8000 + 12000 =
Rs. 20,000/dated 18-07-2009
& dated 30-072013 vide dy No.
9358
Rs 1300/- per
14s Capsule
Pack

LYRICA
Capsules (25,
50, 75, 100,
150,200, 225
and 300mg)
US FDA
GABICA
Capsules (50,
75, 100, 150 and
300mg)
Getz

Form 5
8000 + 12000 =
Rs. 20,000/ dated
18-07-2009 &
dated 30-07-2013
vide dy No. 9358
Rs 1800/- per
14s Capsule
Pack

LYRICA
Fresh inspection report i
Capsules (25,
as previous is on date
50, 75, 100,
2011.
150,200, 225
and 300mg)
US FDA
GABICA
Capsules (50,
75, 100, 150 and
300mg)
Getz
FDA. Buspar, 5mg
1. No authentic ref
M/s Bristol Myers
clinical use and do
Squibb
2. The firm in its
dossier had dema
price as per SRO
in reply they jave d
the price Rs. 11
tablet.
3. Fresh inspection
required as previo
dated 08-07-2009.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1113)
dated 23-08-2010
& dated 11-102013
As per S.R.O

Antidepressent
nonbenzodiazepene
196.

-do-

USP Specification
Sadoquil Tablet
25 mg

Each Film
Coated tablet
contain
Quetiapine (as
fumarate) eq to
Quetiapine
25mg

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1119)
dated 23-08-2010
& dated 11-102013
As per S.R.O

Antipsycotic

Agenda 252

nd

126
Registration Board Meeting

FDA. Seroquel 25mg (


Quetiapine
(as
fumarate) ) Roxane

Fresh inspection report i


as previous is on date
2011.

1. Fresh inspection
required as prev
dated 08-07-200

USP Specification

197.

-do-

Sayzone plus
Injection -2gm

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1114)
Each Vial
dated 23-08-2010
contains
& dated 11-10Cefoperazone
Sodium USP 1 2013

gm
and
As per S.R.O
Salbactum
Sodium USP 1
gm.
Cephalosporin

198.

-do-

Manufacture
Specification
Sayzone Injection
-1gm

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1114)
Each Vial
dated 23-08-2010
contains
& dated 11-10Cefoperazone
Sodium
USP 2013

500mg
and
As per S.R.O
Salbactum
Sodium
USP
500mg.
Cephalosporin
Manufacture
Specification

Agenda 252

nd

127
Registration Board Meeting

1. No authentic ref
clinical use and do
2. Fresh inspection
required as previo
dated 08-07-2009.
3. Approval of sec
cephalosporin
provided.
4. Pharmacological
incomplete.
5. The firm has cla
finished
specifications as
which require clari

1. No authentic ref
clinical use and do
2. Fresh inspection
required as previo
dated 08-07-2009.
3. Approval of sec
cephalosporin
provided.
4. Pharmacological
incomplete.
5. The firm has cla
finished
specifications as
which require clari

199.

-do-

Zoleft Tablet
100mg

Each tablet
contains
Sertraline as HCl
eq. to Sertraline
.100mg.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1108)
dated 23-08-2010
& dated 11-102013

FDA. Tablet Zoloft


100mg ( Sertraline as
HCl eq. to Sertraline)

1. No authentic ref
clinical use and do
2. Calculations are
salt
form
internationally ca
are in base form
requires justificatio
3. Specifications
materials are pro
B.P however ass
are not same as
requires justificatio
4. Firm has submitt
product specifica
B.P
which
clarification as t
limits are incorrect
5. Fresh inspection
required as previo
dated 08-07-2009.

FDA.
Celebrex
(celecoxib)

1. No authentic ref
clinical use and do
2. Specifications
materials are prese
however, the f
provided specific
inhouse, assay lim
same as per B.P
justification.
3. In the identificatio
material IR is
which is not men
list.
4. Complete descri
finished
specifications
provided.
5. Fresh inspection
required as previo
dated 08-07-2009.

As per S.R.O

Antidepressant
B.P Specification

200.

-do-

Celecob Capsule
200mg

Each capsule
contains
celecoxib
.200mg.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1105)
dated 23-08-2010
& dated 11-102013

NSAID

As per S.R.O

Manufacturers
Specification

Agenda 252

nd

128
Registration Board Meeting

Capsule
200mg

201.

-do-

Sadoquil Tablet
100mg

Each Film
Coated tablet
contains
Quetiapine (as
fumarate) eq to
Quetiapine
100mg

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1120)
dated 24-08-2010
& dated 11-102013

FDA. Seroquel 100mg


(Quetiapine
(as
fumarate ) Roxane

1. Fresh inspection
required as prev
dated 08-07-200

As per S.R.O

Antipsycotic

202.

-do-

Manufacturers
Specification
Zoleft Tablet
25mg

Each tablet
contains
Sertraline as HCl
eq. to Sertraline
.25mg.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. -------)
dated 23-08-2010
& dated 11-102013
As per S.R.O

Antidepressant
B.P Specification

203.

-do-

Hapirol Injection
5mg

Each 1ml
ampoule
contains
Haloperidol as
Decanoate eq. to
Haloperidol
.5mg.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. 1116)
dated 23-08-2010
& dated 11-102013
As per S.R.O

(Butyrophenone)

Agenda 252

nd

129
Registration Board Meeting

FDA. Tablet Zoloft


25mg ( Sertraline as
HCl eq. to Sertraline)

1. No authentic ref
clinical use and do
2. Calculations are
salt
form
internationally ca
are in base form
requires justificatio
3. Specifications
materials are pro
B.P however ass
are not same as
requires justificatio
4. Firm has submitt
product specifica
B.P
which
clarification as t
limits are incorrect
5. Fresh inspection
required as previo
dated 08-07-2009.

1. No authentic ref
clinical use and do
2. Firm has claim
product as B.P ho
B.P the active is in
haloperidol as lacta
requires clarificatio
3. Active
specifications als
justification.
4. Approval of se
required from the l
5. Calculations are

salt
form
internationally ca
are in base form
requires justificatio
6. Fresh inspection
required as previo
dated 08-07-2009.

B.P Specification

204.

-do-

Nupain Injection
10mg

Each 1ml
ampoule
contains
Nalbuphine HCl
.10mg.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No. )
dated 23-08-2010
& dated 11-102013
As per S.R.O

(Narcotic
Analgesic)

205.

-do-

Manufacturers
Specification
Nupain Injection
20mg

Each 1ml
ampoule
contains
Nalbuphine HCl
.20mg.

Form 5
8000 + 12000 =
Rs. 20,000/- vide
(Dy. No.1106)
dated 23-08-2010
& dated 11-102013
As per S.R.O

(Narcotic
Analgesic)
Manufacturers
Specification

Agenda 252

nd

130
Registration Board Meeting

1. No authentic ref
clinical use and do
2. Photocopies of fee
have been submitt
to be verified.
3. Approval of se
required from the l
4. Fresh inspection
required as previo
dated 08-07-2009.

1. No authentic ref
clinical use and do
2. Approval of se
required from the l
3. Fresh inspection
required as previo
dated 08-07-2009.

C. Miscellineous Cases.
Registration-I
Case No.01

SURGICAL SUTURES- M/S. 3 M SURGICALS, SARWAR ROAD,


RAWALPINDI.

(a)

Registration Board in its 248th meeting deferred following products for expert opinion.

S.
No.

Name of
Indenter/
Manufacturer

Name of drug (s)/


Composition
& Therapeutic Group

Demanded
Price/Pack

Shelf
Life

1.

M/s. 3 M
Surgicals,
Sarwar Road,
Rawalpindi. /
M/s. Peters
Surgical Z.I. Les
Vignes 42, rue
Benoit Frachon
Bobigny Cedex,
France.
M/s. 3 M
Surgicals,
Sarwar Road,
Rawalpindi. /
M/s. Peters
Surgical Z.I. Les
Vignes 42, rue
Benoit Frachon
Bobigny Cedex,
France.
M/s. 3 M
Surgicals,
Sarwar Road,
Rawalpindi. /
M/s. Peters
Surgical Z.I. Les
Vignes 42, rue
Benoit Frachon
Bobigny Cedex,
France.
M/s. 3 M
Surgicals,
Sarwar Road,

Cardioxyl Non-absorbable
Surgical Sutures, Coated
Polyester Braid
(Surgical Sutures).

As per SRO

05
years

Date of
application
receiving &
fee.
19-08-2013
Rs.100000/-

Cardioflon Non-absorbable
Surgical Sutures Coated
Polyester Braid.
(Surgical Sutures).

As per SRO

05
years

19-08-2013
Rs.100000/-

Acier Non-absorbable
Surgical Sutures, Stainless
Steel Monofilament.
(Surgical Sutures).

As per SRO

05
years

19-08-2013
Rs.100000/-

Corolene Non-absorbable
Surgical Sutures,
Polyproplene Monofilament

As per SRO

05
years

19-08-2013
Rs.100000/-

2.

3.

4.

Agenda 252

nd

131
Registration Board Meeting

Rawalpindi. /
M/s. Peters
Surgical Z.I. Les
Vignes 42, rue
Benoit Frachon
Bobigny Cedex,
France.

(Surgical Sutures).

Accordingly products were referred for views. Comments are as under:Prof. Dr. Abdul Waheed,
Head/Professor Cardiac
Surgery,
Punjab Institute of
Cardiology (PIC),
Lahore.

Col. Dr. Kamal Saleem,


Professor of Cardiac Surgery.
Armed Forces Institute of
Cardiology, (AFIC),
Rawalpindi.

Dr. Sulaiman B. Hasan,


Head, Section of
Cardiothoracic Surgery,
Department of Surgery, The
Agha Khan Hospital and
Medical College Foundation,
Karachi.

We have used the sutures


supplied by you and found them
of good quality with relation to
needle behavior, thread and
knot ability etc.

I have found them satisfactory in


every respect regarding needle
behavior, thread strength and
knotting characteristics. Peters
suture is one of the best sutures
in the world and is used in many
centers all over Europe and North
America.

We
have
sampled
the
polypropylene and polyester
suture as well as stainless steel
wire suture manufactured by M/s.
Peters Surgical distributed by 3M
Surgicals. We find that it is of
acceptable quality for use in
cardiovascular procedures. The
7-0 Polypropylene suture is
especially suited for distal
anastomosis
in
CABG
procedures and is of superior
quality.

(b)

The Registration Board in its 243 rd meeting of Registration Board deferred the case of the sutures

of M/s. 3M Surgical, Rawalpindi for expert opinion as per following details.


S.
No.

Name of
Indenter/
Manufacturer

Agenda 252

nd

Name of drug (s)/


Composition
& Therapeutic Group

132
Registration Board Meeting

Demanded
Price/Pack

Shelf
Life

Date of
application
receiving &
fee.

1.

2.

M/s. 3 M
Surgicals,
Sarwar Road,
Rawalpindi. /
M/s. Peters
Surgical Z.I. Les
Vignes 42, rue
Benoit Frachon
Bobigny Cedex,
France.
M/s. 3 M
Surgicals,
Sarwar Road,
Rawalpindi. /
M/s. Peters
Surgical Z.I. Les
Vignes 42, rue
Benoit Frachon
Bobigny Cedex,
France.

Optime Absorbable Surgical


Sutures, Coated Polyglycolic
Acid Braid
(Surgical Sutures).

As per SRO

05 years

19-08-2013
Rs.100000/-

Optime-R Absorbable
Surgical Sutures, Coated
Polyglycolic Acid Braid with
Fast Resorption.
(Surgical Sutures).

As per SRO

05 years

19-08-2013
Rs.100000/-

Accordingly products were referred for views. Comments are as under:Maj. Gen.
Muhammad Ahmed,
(D.G. Surgery)
Combined Military Hospital,
Rawalpindi
Quality of sample sutures
provided is satisfactory and they
are recommended for purchase.

Prof. Dr. Imran Skindar,


Head Department Orthopedic
Surgery,
Pakistan Institute of Medical
Sciences,
Islamabad
We have done the sample testing
of all the sutures mentioned and
found to be satisfactory as to
knotting thread strength and
needle behavior.

Dr. Moeed. I. Qureshi,


Head, Department of Surgery,
Sheikh Zayed Hospital,
Lahore.
Awaited.

Subsequently the Registration Board in its 248th meeting deferred the above mentioned
products for expert opinion from Ophthalmologists on observations of a member. Accordingly
products were referred for views. The comments are as under:Prof. Dr. Wajid Ali Khan,
Chief Consultant/Dean),
Shifa Eye Trust Hospital,
Rawalpindi.

Agenda 252

nd

Col. For Comdt.


Rana Intisar Ul Haq,
Armed Forces Institute
Ophthalmology, (AFIO),
Rawalpindi.

133
Registration Board Meeting

Dr. Anwar Ali,


Associate Professor,
of Head
of
Ophthalmology,
Pakistan Institute of Medical
Sciences (PIMS),
Islamabad.

These sutures are used in


general surgery which is not
my domain to comment upon.
I would suggest to contact
some general Surgeon for his
input on these sutures.

Case No.02.

Sample sutures provided to this


Institute are for general surgery
use and are not used in
ophthalmic surgery.

We received the samples of


Optime and Optime-R
follow our view for the sutures.
These sutures are not relevant
to ophthalmology procedures.

Drugs deferred by Registration Board.

Registration Board in its 225th meeting held on 15-06-2010 & 16-06-2010 defer the under
mentioned drugs for import policy with India. Now the firm has deposited the differential fee Rs.85,000 x
2 = 170,000/-. M/s. Hakimsons (Impex) (Private) Ltd., Karachi has submitted valid original CoPP attested
by Pakistan Embassy.

S.No

Name of
Manufacturer /
Importer.
M/s. Hakimsons
(Impex) (Pvt) Ltd.,
Karachi. /
M/s. Cadila
Healthcare Ltd,
India.
M/s. Hakimsons
(Impex) (Pvt) Ltd.,
Karachi /
M/s. Cadila
Healthcare Ltd,
India

Name of Drug (s)


Composition &
Therapeutic Group.

Demanded
Price &
Pack Size.

Mycophenolate Mofetil
Tablets 500mg
Each tablet contains: Mycophenolate Mofetil Ph.
Eur..500mg
(Immunosuppressant )

Rs.7500 /
Pack 50s

2 years Deferred
for import
policy with
India.

Azathioprine Tablets UPS


50mg
Each tablet contains: Azathioprine USP.50mg
(Immunosuppressant)

Rs.1350 /
Pack of 100
Tablets

2 years Deferred
for import
policy with
India.

Shelf
Life

Decision

As per import policy 2012-15 Immunosuppressants are not included in the list of items not
importable from India.

Case No.03.

Agenda 252

Registration application of M/s. Medipak Ltd. Lahore for Nephrotect injectable.

nd

134
Registration Board Meeting

Registration Board in its 238th meeting held on 05-06th August, 2013 deferred below
mentioned drugs for expert opinion by the following experts:(i) Lt. Col. Dr. Zahid Farooq Baig, Armed Forces Institute of Urology, Rawalpindi,
(ii) Head of Urology Department, SIUT, Civil Hospital, Karachi.
(iii) Dr. Sohail Sabir, Military Hospital, Rawalpindi.
S.No.

Name of Drug (s).

1.

Nephrotect Injectable
Each 1000ml contains: Isoleucine.5.80g
Leucine.12.8g
Lysine acetate...16.9g
(12.0 g Lysine)
Methionine....2g
Phenylalanine.. 3.50g
Threonine.8.20g
Tryptophan....3g
Valine...8.70g
Arginine...9.80g
Alanine.6.20g
Acetylcysteine..0.54g
(0.40g cystenine)
Glycine.5.31g
Praline..3.00g
Serine...7.60g
Tyrosine...0.60g
Glycyl tyrosine3.16g (0.99g
glycine and 2.40g tyrosine)
(Amino Acids)

Demanded
Price.
Rs.1670/
250ml
Rs.2580/
500ml

Name of Indentor/
Manufacturer.
M/s. Medipak Ltd
Lahore /
M/s. Fresenius Kabi Austria
GmbH, 8055 Graz, Austria

Lt. Col. Dr. Zahid Farooq Baig, Armed Forces Institute of Urology, Rawalpindi has
recommended the product for registration for patient acute and chronic renal failure including
patients on hemodialysis. The other two experts did not respond despite four reminders.
Case No.04.

Agenda 252

Registration of drugs under Drugs Act, 1976.

nd

135
Registration Board Meeting

Registration Board in its 249th meeting held on 18th and 19th May, 2015 approved under
mentioned veterinary drugs subject to inspection of manufacturer abroad as per import policy,
verification of storage facilities etc where applicable.
While proceeding further it was noticed that the packs size and shelf life was not
mentioned due to typographic mistake. The missing information i.e. packs size and shelf life are
now also mentioned against each product for Board consideration/approval.
S. No.
1.

2.

3.

4.

Name of Importer/

Manufacturer.

Name of Drug
(s)/Composition.

Pack Sizes.

Shelf Life

Decision

M/s. Ghazi Brothers,


Karachi-75350 /
Product License
Holder:M/s. Agrovet Market S.A.,
San Luis, Lima, Peru.
Manufacturer Under
Product License Holder:M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3-Peru.
M/s. Ghazi Brothers,
Karachi-75350 /
Product License
Holder:M/s. Agrovet Market S.A.,
San Luis, Lima, Peru.
Manufacturer Under
Product License Holder:M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3-Peru.
M/s. Ghazi Brothers,
Karachi. /
M/s. Vetanco S.A. Buenos
Aires, Argentina.

Metri-CEF 3 Intrauterine
Suspension
Each 30ml contains:Cephalexin monohydrate
(Base)600mg
Neomycin sulfate (Base)
1.02gm
Cloxacillin benzathine
1.50gm
Vitamin A30.000 IU

Decontrolled
30ml Prefilled syringe

03 years

Approved

Catofos B9 + B12 Injectable


Solution
Each ml contains:Butaphosphan100mg
Vitamin B9 (Folic Acid)
15mg
Vitamin B12
(Cyanocobalamin)0.05mg
(Vitamin and Mineral).

Decontrolled
10ml
20ml
50ml
100ml
250ml
500ml

03 years

Approved

Ketoxilen Injection
Each 100ml contains:Oxytetracycline..20gm
Ketoprofen..3gm
(Antibiotic/Antiinflammatory).

Decontrolled
40ml
50ml
100ml
250ml
500ml

2 years

Approved

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-Si,
Gyeonggi-Do, Korea.

Geslong Injection
Each ml of solution contains:Metoclopramide
HCI.5mg
(Antiemetic/ Gastroprokinetic).

Decontrolled
2ml
10ml
20ml
50ml

02 years

Approved

Agenda 252

nd

136
Registration Board Meeting

5.

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-Si,
Gyeonggi-Do, Korea.

Cheil Tonocomp Injection


Each ml of solution contains:Toldimfos sodium200mg

6.

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-Si,
Gyeonggi-Do, Korea.

Seletoco Injection
Each ml of solution contains:Vitamin E acetate100mg
Sodium Selenite1mg
(Nutritional additive).

7.

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-Si,
Gyeonggi-Do, Korea.

8.

M/s. Ghazi Brothers,


Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co. Ltd.,
Shijiazhuang City, Hebei
Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co. Ltd.,
Shijiazhuang City, Hebei
Province, China.

9.

10.

11.

M/s. Ghazi Brothers,


Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co. Ltd.,
Shijiazhuang City, Hebei
Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co. Ltd.,
Shijiazhuang City, Hebei
Province, China.

Agenda 252

nd

100ml vials
Decontrolled
50ml
100ml
200ml
250ml
500ml vials

02 years

Approved

Decontrolled
10ml
20ml
50ml
100ml vials

02 years

Approved

Procillin-LA Injection
Each ml contains:Pencillin G
Benzathine 1,00,000 IU
Penicillin G Procaine
1,00,000 IU
Dihydrostreptomycin sulfate
200mg
(Antibacterial).
Cefquin Suspension for
Injection
Each ml contains:Cefquinome (as sulfate)
...25mg
(Antibiotic).
Isomedium Powder for parental
administration
Each sachet contains:Isometamedium chloride
hydrochloride.1g
(Antiprotozoal).

Decontrolled
20ml
50ml
100ml vials

02 years

Approved

Decontrolled
50ml
100ml

03years

Approved

Decontrolled
1 gm sachet

03years

Approved

Oxybiotic LA 30% Solution for


Injection
Each ml contains:Oxytetracycline (as dihydrate)
.300mg
(Antibiotic).
Bupaquone Solution for
Injection
Each ml contains:Buparvaqone.50mg
(Antiprotozoal).

Decontrolled
50ml
100ml

03years

Approved

Decontrolled
50ml
100ml
500ml

03 years

Approved

137
Registration Board Meeting

12.

M/s. Orient Animal Health


(Pvt) Ltd., Karachi. /
M/s. Univet Ireland Ltd.
Tullyvin, Cootehill, Co.
Cavan, Ireland.

Unimox LA Injection
Each ml contains:Amoxicillin (as Amoxicillin
Trihydrate) Ph. Eur...150mg
(Antibacterial).

13.

M/s. Marush (Pvt) Ltd.,


Lahore. /
M/s. Univet Ltd. Tullyvin,
Cootehill, Co. Cavan,
Ireland.

Ubroloxin Intramammary
Suspension
Each 1 injector with 10g
(12ml) contains:Cefalexin
monohydrate..200mg
Kanamycin
monosulfate133mg
(Corresponds to 100,000 I.U).
(Pharmaceuticals).

14.

M/s. U.M. Enterprises,


Karachi-74900/
M/s. Qilu Animal Health
Products Co. Ltd., Jinan,
Shandong, China.

Flumeglu 5gm Injection


Each 100ml contains:Flunixin Meglumine equivalent
to 5.0g of Flunixin.
(Non-steriod, Antinflammatory drug).

M/s. U.M. Enterprises,


Karachi-74900/
M/s. Qilu Animal Health
Products Co. Ltd., Jinan,
Shandong, China.
16. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal Health
Products Co. Ltd., Jinan,
Shandong, China.

15.

Decontrolled
10ml
30ml
50ml
100ml
250ml
500ml
Decontrolled
10 x 10g

03 years

Approved

12 months

Approved

Decontrolled
50ml
100ml

24 months

Approved

Cefent 1gm Injection


Each 25ml vial contains:Ceftiofur Sodium equivalent to
1.0g Ceftiofur.
(B.Lactum Antibiotics).
Cefent 4gm Injection
Each 100ml vial contains:Ceftiofur Sodium equivalent to
4.0g Ceftiofur.
(B.Lactum Antibiotics).

Decontrolled
1gm/25ml

24 months

Approved

Decontrolled
4gm/100ml

24 months

Approved

17.

M/s. U.M. Enterprises,


Karachi-74900/
M/s. Qilu Animal Health
Products Co. Ltd., Jinan,
Shandong, China.

Ceftihyde 5gm Injection


Each 100ml contains:Ceftiofur Hydrochloride
equivalent to 5.0g Ceftiofur.
(B.Lactum Antibiotics).

Decontrolled
50ml
100ml

24 months

Approved

18.

M/s. Siddiqui Pharma


(Pvt) Ltd., Multan. /
M/s. KBNP, INC, Dugokri, Sinam, Yesan,
Chungnam, Korea.

Kenoxin 10% Oral Solution


Each Liter contains:Enrofloxacin100g
(Antibiotics).

Decontrolled
50ml
100ml
250ml
500ml
1 Liter

02 years

Approved

Agenda 252

nd

138
Registration Board Meeting

19.

M/s. Mustafa Brothers


Faisalabad. /

M/s. Laboratorio
Centrovet Santiago,
Chile.

Cefalexine Injectable
Suspension 15%
Each 10ml contains: Cefalexine .150/ml
(Beta lactam Antibiotic)

Decontrolled
20ml
50ml
100ml
250ml

02 years

Approved

20.

M/s. Mustafa Brothers


Faisalabad. /
M/s. Laboratorio
Centrovet Santiago, Chile.

Ceftiofur Hydrochloride
Injectable Suspension 5%
Contains:
Ceftiofur
Hydrochloride...50mg
(Antibiotic)

Decontrolled
20ml
50ml
100ml
250ml

02 years

Approved

21.

M/s. Seignior Pharma


Karachi. /

Ceftiofur LPU Injectable


Each 100ml vial contains: Ceftiofur HCL50mg
Excipients..100ml
(Antibiotic)

Decontrolled
100ml vial

2 years

Approved

Florfenicol 30% Rosenbusch


Injectable
Each 100ml vial contains:Florfenicol.....30gm
Excipients q.s....100ml
(Antibiotic)

Decontrolled
100ml vial

2 years

Approved

Decontrolled
100ml
200ml
250ml
450ml
500ml
1000ml
Decontrolled
100ml
250ml
500ml
1 Liter
2.5 Liter
Decontrolled
100g
250g
500g
1 Kg
5 Kg
10 Kg

02 years

Approved

02 years

Approved

02 years

Approved

M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
22. M/s. Seignior Pharma,
Karachi. /
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
23.

M/s. Bio-Labs (Pvt) Ltd.,


Islamabad.

Coliflox 20% Liquid


Each 100ml contains:Enrofloxacin20gm
Colistin Sulphate..50,000,000
i.u.
(Quinolones).

24.

M/s. Intervac (Pvt)


Limited, Lahore.

Amprobit Liquid
Each liter contains:Amprolium HCI250gm
Ethopabate.16gm
(Anticoccidial).

25.

M/s. Attabak
Pharmaceutical,
Islamabad.

Spiralinc-B Powder
Each 100gm powder contains:Lincomycin HCI5g
Spectinomycin HCI.7.5g
Spiramycin adipate..........2.5g
Bromhexine HCI..0.5g
(Antibacterials).

Agenda 252

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Registration Board Meeting

25 Kg

Case No.05. Drugs deferred by Registration Board.


Following drugs were deferred by the Drug Registration Board in its 243 rd meeting held
08-09th May, 2014 for confirmation of approval status in FDA:S.#

Name of Importer /
Manufacturer.

1.

M/s.
RG
Pharmaceutica (Pvt)
Ltd., Karachi /
M/s. Genewel Co.
Ltd.,
Seongnam-si,
Gyeonggi-do, Korea.
Marketed by (Sole
Exclusive Supplier:
M/s. Trasen, Bisandong,
Dongan-gu,
Anyang City, Korea.
M/s. RG
Pharmaceutica (Pvt)
Ltd., Karachi /
M/s. Genewel Co.
Ltd., Seongnam-si,
Gyeonggi-do, Korea.
Marketed by (Sole
Exclusive Supplier:
M/s. Trasen, Bisandong, Dongan-gu,
Anyang City, Korea.

2.

Name of Drug (s) /


Composition & Therapeutic
Group.
Guardix-Sol 5.0g Injection.
Each 5ml contains:Sodium hyaluronate12.50mg.
Sodium
Carboxymethyl
Cellulose....25.00mg.
Water For injection..5.0ml
NaCI40.0mg
KCI1.0mg
KH2PO4.1.0mg
Na2HPO4..5.75mg
(Wound Dressing).
Guardix-Sol 1.5g Injection.
Each 1.5ml contains:Sodium hyaluronate..3.75mg
Sodium Carboxymethyl
Cellulose..7.50mg.
Water For injection1.50ml
NaCI12.0mg
KCI..0.30mg
KH2PO4...1.73mg
Na2HPO4..5.75mg
(Wound Dressing).

Demanded
Price & Pack
Size.

Shelf
Life.

Rs.17480/
Per 5.0gm
Prefilled
Syringe

24
months

Rs.8740/
Per 1.5gm
Prefilled
Syringe

24
months

Accordingly, the firm M/s. RG Pharmaceutica (Pvt.) Ltd., was advised to provide the
same the in response firm has claimed that the drug is approved as Seprafilm adhesive barrier by
US FDA and furnished following comparison of Guardix-sol with Seprafilm:Topic

Agenda 252

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Registration Board Meeting

Detail

Active Ingredients

Both Guardix-sol and Seprafilm contain the same ingredients i.e


(Sodium Hyaluronate (HA) and Carboxy Methyl Cellulose (CMC).

Indication

Both products are recommended as adhesive barriers in same


indication e.g. General and orthopedic surgery.

Presentation

Guardix Sol is formulated as viscous solution (gel) which is


applied easily and absorbed quickly while Seprafilm becomes
gel within 24 hours after application*.

Case No.06. Change in company name from M/s. Bayer Schering Pharma AG to
M/s.Bayer Pharma AG.
M/s. Medipharm (Private) Limited, Lahore have informed that due to a Bayer Groupwide initiative to change the name of the pharmaceutical company, they have requested to
approved the change of the manufacturer name of their following registered imported drug as
follows:Reg. No.

012367

Name of Drug.

Progyluton
Tablets.

Current Name of
Manufacturing Site.
M/s. Bayer Schering Pharma
AG, Germany.

Proposed Name of
Manufacturing Site / Source of
Import
Manufactured by:
M/s. Bayer Weimar GmbH und
Co. KG, Weimar, Germany.
Source of Import:
M/s. Bayer Pharma AG, 13342
Berlin, Germany.

M/s. Medipharm (Private) Limited, Lahore have deposited fee Rs.100000/- and
supporting documents including ,Notarized Declaration from their Principal regarding the Name
Change from Bayer Schering Pharma AG to Bayer Pharma AG, Original legalized CoPP
Progyluton Tablets etc.
In the registration letter the manufacturer/ source of import was mentioned as M/s. Bayer
Schering Pharma AG, Germany, while the firm claimed that the manufacturer even at that time
was the same i-e M/s. Bayer Weimar GmbH und Co. KG, Weimar, Germany.
M/s. Medipharm (Private) Limited, Lahore was advised to clarify the following:-

Agenda 252

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Registration Board Meeting

i)

As per CoPP the product is neither has valid license to be


placed on market nor freely available in the country of origin
as its Re-registration was not granted, being manufactured by
the exporting country which need clarification.

ii)

Brand name is different on CoPP as registered in Pakistan.

In response, M/s. Medipharm (Private) Limited, Lahore has submitted the following
clarification:

Product is already approved by competent authorities and available in Switzerland


(Approval submitted with letter No. BHC-DRAP-14-075).

They have already submitted Notarized Declaration which state that


product has never withdrawn not due to safety of efficacy reason in
Germany.
They have provided CPP from Germany where this product is
manufactured and GMP inspections are conducted.
The current request from authorities is only for Name Change the
manufacturing site is same as registered with the authorities.
The Drug Registration Board in its 245th meeting held on 29-30th September, 2014
deferred the case due to non-availability in the country of origin i.e. Germany.
Now the firm has again requested to consider their case for change of
manufacturer site / source of import as the DRB in its 249th meeting recommended that
products approved by USFDA, Health Canada, EMA, TGA Australia and PMDA Japan
along with the regulatory authorities of United Kingdom, Germany, France, Switzerland,
Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in at least three
European Union countries will also be taken as reference for consideration of
Registration Board for approval.
The firm claimed that the product is available in Switzerland and provided CoPP
from Switzerland in local language the firm . No authenticated translation is provided.

Case No.07. Change of products names from generic to brand, change of manufacturing
site and exemption in labeling information of product name in Urdu,

Agenda 252

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Registration Board Meeting

registration number and MRP on the label of inner most container i.e. Foil of
the products.
M/s. Sind Medical Stores, Karachi has made following requests in respect of their below
mentioned registered imported surgical sutures:S#

Reg. No.

Old Generic Names.

New Proposed Brand Names.

1.

069558

DemeTech Rapid (PGR)


Absorbable Surgical Sutures.

DemeQUICK

2.

069560

DemeTech Surgical Stainless


Steel Nonabsorbable Sutures.

DemeSTEEL

(a) To approve the change of product name from generic to brand name as mentioned
above.
(b) Change of address of the manufacturer from M/s. DemeTECH Corporation, 3530
NW 115 Ave, Miami, FL, 33178, USA to M/s. DemeTECH Corporation, 14175
NW 60th Ave., Miami Lakes, FL, 33014, USA.
(c) Exemption in labeling information of product name in Urdu, Registration Number and
MRP on the label of inner most container i.e. Foil of the products. One pack of
DemeTech Sutures contains 12 foils in a box which then further enveloped with
cellophane. Due to sterilized nature of the product and insufficient space on blister of the
foil, Ink jet printing of product name in Urdu, Registration No and MRP on the label of
inner most container i.e. Foil of the product, carry the risk of compromising product
sterility.
M/s. Sind Medical Stores, Karachi have deposited required fee Rs.100000x2 =200000/and submitted following supporting documents:i)
ii)
iii)
iv)
v)
vi)
vii)
viii)

Agenda 252

Original Agency Agreement Certification by US Commercial Services, Islamabad


for the Exclusive Authorization Letter to M/s. Sind Medical Stores, Karachi from
M/s. DemeTECH Corporation, USA for their products.
Original Notarized (Florida Notary Assn. Inc) NOC / TO WHOM IT MAY
CONCERN about the change of products name by their principal.
Notarized (Florida Notary Assn. Inc) copy of US FDA FSC with the new brand
names of the products.
Notarized (Florida Notary Assn. Inc) copy of CE certificate.
Notarized (Florida Notary Assn. Inc) copy of ISO certificate.
Copy of Product Registration Certificate.
Original undertaking on stamp paper.
Original US-FDA Free Sale Certificate.

nd

143
Registration Board Meeting

ix)
x)
xi)
xii)
xiii)

Case No.08.

Principal company authorization letter in favour of M/s. Sind Medical Stores,


Karachi for applying the said change to the DRAP on behalf of the principal.
Principal company announcement letter for change of address.
FSC with the new address issued by US FDA duly notarized.
ISO with the new address of the principal company.
CE Certificate with the new address of the principal company.

Transfer of registrations of imported veterinary drugs.

M/s. ICI Pakistan Limited, Karachi have requested for transfer of registration of the
under-mentioned registered imported veterinary drugs from the name of previous importer M/s.
Genome Pharma, Islamabad to their name as a result of agreement between M/s. Norbrooke
Laboratories Limited, Northern Ireland & M/s. ICI Pakistan Limited, Karachi: S. No.

Reg. No.

Name of Drugs.

1.

048145

Moxyl-LA Injection.

2.
3.

048146
048147

Strepcilin Injection.
Lynox Injection.

4.

048148

Clavon Injection.

5.

048149

Masticlox IMM.

6.

048150

Onyx Aerosol.

7.

048151

Multivor Injection.

M/s. ICI Pakistan Limited, Karachi have deposited required


Rs.100000x7=700000/- and submitted following supporting documents:i)
ii)

Applications on Form-5 (A).


Authorization certificate from manufacturer abroad.

iii)

No Objection Certificate from previous importer M/s. Genome Pharma,


Islamabad.

iv)

Termination letter with previous importer.

v)

Copy of registration letters.

vi)

Renewal status of drugs.

vii)

Approval of change of brand names.

Agenda 252

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144
Registration Board Meeting

fee

M/s. ICI Pakistan Limited, Karachi was advised to submit fresh legalized CoPP of
the products referred above. In response, the firm informed that the UK authorities no
longer provide FSCS and all documents are called Export Certificates Defra 1, Defra 2 &
Defra 3. An informed request for these to be supplied on company headed Paper (Norbrook
headed paper) was advised in July 2013 through Veterinary Medicines Guidance Note No. 19
(Export Certificate Scheme). The firm has provided the original legalized copy of the Export
Certificates.

Case No.09.

Import of veterinary drugs by m/s. Zoic international, lahore.

Dr. Muhammad Aslam Niazi of Lahore vide a complaint

alleged that M/s. Zoic

International, Lahore has got registration of number of veterinary/poultry medicines of M/s.


Tithebarn Limited UK illegally by submitting fake and forged documents. The complainant
further alleged that M/s. Tithebarn Limited UK is not a manufacturer of medicines.
As per record, following drugs of M/s. Tithebarn Limited UK were registered for import
by M/s. Zoic International, Lahore:-

S. No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.

Reg. No.
021297
021298
021299
021300
021301
023422
049580
049581
049582
049583
057176
057177

Name of Drug (s).


Cocostop 20% Water Soluble Powder.
Quincure 20% Liquid.
Quintril 20% Liquid.
Quintril 10% Liquid.
Grow More Water Soluble Powder.
Premix PL300 Powder.
Tithedox Water Soluble Powder.
Tithemox Injection.
Tithemox Water Soluble Powder.
Enrobarn Water Soluble Liquid.
Tithemycin Water Soluble Powder.
Tithechlore 20% Water Soluble Powder.

M/s. Zoic International, Lahore was given a show cause notice to clarify their position
with regard to the complaint. The firm, in response, denied the allegations stating that their
Agenda 252

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145
Registration Board Meeting

principle M/s. Tithebarn Limited UK abroad is a manufacturer. M/s. Zoic International, Lahore
was again directed to submit fresh original latest approval letter for the products (CoPP) / Defra
I&II issued by Regulatory Authority of United Kingdom, within 7days, failing which it will be
presumed that they have nothing to offer in their defence and an ex-party decision will be took
against them.
In response M/s. Zoic International, Lahore vide letter dated 15-06-2015 informed that in
order to submit fresh documents from concern / issuing department i.e VMD UK (Veterinary
Medicine Directorate) they may require 42 to 56 days. The firm has further given undertaking
that they will immediate stop any further import of these products until the matter is resolved.

Case No.10. Approval for one-time importation of finished packs without unit carton of
registered product Sevorane Volatile Liquid for Inhalation 250ml (Reg.
No.027374).
M/s. Getz Pharma (Pvt) Ltd., Karachi have requested for approval of one-time importation
for import of 3960 finished packs without unit carton of their registered product Sevorane
Volatile Liquid for Inhalation 250ml (Reg. No.027374) as the manufacturer abroad observed a
printing error in registration number on the unit cartons at their manufacturing facility.
Sevorane is a US-FDA and EMA approved product and is indicated for induction and
maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient
surgery. In order to ensure its continuous supply in Pakistan for needy patients, their principle
Abbvie, UK have requested to allow them the importation of Sevorane commercial shipment
without carton. The firm has further submitted that there is no change in the primary packaging,
product label and patient insert of the product.

Case No.11: Cancellation of the Registration of Drug Formulation(s) Containing


Chloramphenicol for Veterinary Use.
In pursuance of 239th Drug Registration Boards meetings (held on 12th September, 2013)
recommendations for banning the Chloramphenicol containing veterinary drugs formulations,

Agenda 252

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146
Registration Board Meeting

Show Cause Notices were issued to the following firms for cancellation of drugs containing
chloramphenicol in oral dosage form:S. No.

Name of Firm.

1.

M/s. Symans Pharmaceuticals (Pvt.) Ltd, Lahore.

2.

M/s. Star Laboratories (Pvt.) Ltd, Lahore.

3.

M/s. Farm Aid Group Pakistan, Hattar, Haripur.

4.

M/s. Epla Laboratories (Pvt.) Ltd, Karachi.

5.

M/s. Kaligon Agro Industries (Pvt) Ltd, Hub, Baluchistan.

6.

M/s. Venus Pharma, Lahore.

7.

M/s. S.J. & G. Fazul Ellahie (Pvt) Ltd, Karachi.

8.

M/s. Nawan Laboratories (Pvt) Ltd, Karachi.

9.

M/s. Leads Pharma (Pvt) Ltd, Islamabad.

10.

M/s. Elko Organization (Pvt) Ltd, Karachi.

11.

M/s. Rex Pharmaceutical Pakistan, Karachi.

12.

M/s. Vetcon Pharmaceuticals (Pte) Ltd, Bhimbaer, AJK.

13.

M/s. Manhattan Pharma, Karachi.

14.

M/s. Alina Combine Pharmaceuticals (Pvt) Ltd, Karachi.

15.

M/s. Mehran International, Karachi.

16.

M/s. Atzan Pharmaceuticals (Pvt) Ltd, Sargodha.

17.

M/s. Class Pharam Pakistan, Lahore.

18.

M/s. Vety-Care (Pvt) Ltd, Rawalpindi.

19.

M/s. Vigilant Veterinary Services (Pvt) Ltd, Lahore.

20.

M/s. Global Veterinary & Technical Services (Pvt) Ltd, Multan.

21.

M/s. Aims Traders, Lahore.

From responses received from a few firms following points were highlighted:(i)

Beside oral dosage form the chloramphenicol is also available in injectable and spray

form.
(ii)

The use of chloramphenicol should be restricted in food consuming animals.

Agenda 252

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147
Registration Board Meeting

The next step after Show Cause is the personal hearing by the DRB. However, the matter
of inclusion of injectable and spray dosage form in these Show Cause Notices require
clarification.
Submitted for consideration of Registration Board.

Case No.12. Request of M/s. Sanofi-Aventis Pakistan Limited, Karachi for change of
shelf life of Taxotere 80mg/4ml Concentrate for Solution for Infusion
(Reg.
No.066090) from 24 months to 36 months.
M/s. Sanofi-Aventis Pakistan Limited, Karachi have requested to approve the extension
of shelf life of their registered imported drug Taxotere 80mg/4ml Concentrate for Solution for
Infusion (Reg. No.066090) from 24 months to 36 months. The proposed extension of shelf-life is
based on 36 months real time stability data obtained from three primary stability batches of each
presentation. The firm have deposited required fee Rs.5000/- and submitted following supporting
documents:i)

Copy of approved Release and shelf life.

ii)

Copy of registration letter of Taxotere 80mg/4ml Concentrate for Solution for Infusion
(Reg. No.066090).

iii)

Stability Summary and Conclusions.

iv)

Stability Data.
The case was referred to three experts for views. The comments received are summarized

as under:S.
No.

Name of Expert.

Opinion

1.

Prof. Dr. Mahmood Ahmad, Dean, Faculty


of Pharmacy & Alternative Medicine, The
Islamia University of Bahawalpur.

The requested extension in shelf-life of the


product may be granted provisionally and
the firm may be requested to provide
updated stability data.

2.

Muhammad Jamil Anwar,

The results are acceptable as per


information / data provided. It is
recommended that firm may be allowed to
change the shelf life of the product from

Director, Drugs Testing Laboratory,

Agenda 252

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148
Registration Board Meeting

Government of the Punjab, Lahore.

3.

24 months to 36 months.

Dr. Khalid Khan,

Awaited

Director, Drugs Testing Laboratory,


Government of Khyber Pakhtoonkhawa,
Peshawar.

Submitted for consideration of Registration Board.


Case No.13. Request of M/s. PharmEvo (Private) Limited, Karachi for change of
manufacturing site of registered imported drugs.
M/s. PharmEvo (Private) Limited, Karachi have requested to approve the change of
manufacturing site of their following registered imported drugs form M/s. Jiangsu Hansoh
Pharmaceutical Co., Ltd, Economic & Technical Development Zone, Lianyungang City, Jiangsu,
China to M/s. Jiangsu Hansoh Pharmaceutical Co., Ltd, No.5, Dong Jin Road Economic &
Technical Development Zone, Lianyungang City, Jiangsu, China:S.
No.

Reg. No.

Name of drug(s) & Composition.

1.

072538

Trugem 1gm Injection.


Each vial contains: Gemcitabine Hydrochloride USP
equivalent to Gemcitabine
1gm.

2.

072539

Trugem 0.2gm Injection.


Each vial contains: Gemcitabine Hydrochloride USP
equivalent to Gemcitabine
0.2gm.

M/s. PharmEvo (Private) Limited, Karachi have deposited required fee of


Rs.100000x2=200000/- and submitted supporting documents including Legalized Certificate of

Agenda 252

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149
Registration Board Meeting

Pharmaceutical Products, GMP Certificate of M/s. Jiangsu Hansoh Pharmaceutical Co., Ltd,
China, Credential of the Manufacturer, Applications on Form 5-A, stability data etc.
Submitted for consideration of Registration Board.

Case No.14. REQUEST OF M/S. PFIZER PAKISTAN LIMITED, KARACHI FOR


CHANGE OF MANUFACTURING SOURCE / SITE AND NAME
OF
PACKAGING SOURCE / SITE OF THEIR REGISTERED
IMPORTED
DRUGS.
M/s. Pfizer Pakistan Limited, Karachi have requested to approve the change of
manufacturing source / site and name of packaging source / site of their following registered
imported drugs:S#

Reg.

Name of Product.

No.

Existing

New Manufacturing

Manufacturing

Source / Site.

Source / Site.
1.

041196

Zeldox 40mg

M/s. Heinrich-Mack

Bulk Manufacturing &

Capsules.

Nachfolger GmbH,

Testing Site:-

Each capsule
contains:-

Heinrich-Mack-Str. 35,
89257 Illertissen,
Germany.

M/s. Pfizer Ireland


Pharmaceuticals, Little
Connell, Newbridge, Co.

Ziprasidone

Kildare, Ireland.

hydrochloride
monohydrate 40mg.

Packaging and labeling,


testing and batch release
Site:M/s. R-Pharm Germany
GmbH, Heinrich-MackStrasse 35, D-89257
Illertissen, Germany.

2.

045682

Agenda 252

nd

Zeldox 60mg

150
Registration Board Meeting

-do-

-do-

Capsules.
Each capsule
contains:Ziprasidone
hydrochloride
monohydrate 60mg.

M/s. Pfizer Pakistan Limited, Karachi have deposited required fee Rs.200000/- and
submitted following supporting documents:i)

Copies of initial registration letters of the products.

ii)

Copy of transfer of registration letter from M/s. Parke-Davis & Company


Limited, Karachi to M/s. Pfizer Pakistan Limited, Karachi.

iii)

Copy of NOC for CRF.

iv)

Original and legalized Certificate of Pharmaceutical Product of each


strength.

v)

Original and legalized GMP Certificates.

vi)
vii)

Applications on Form-5 (A).


Site Master File.

Submitted for consideration of Registration Board.

Registration-II

Case No.15: Combo pack Osmolar ORS (Reg. No.0454416) with Zincat-OD Syrup (Reg.
No.053094) M/s Atco Laboratories, Karachi
Registration Board in 247th and 249th meeting considered request of M/s Atco
Laboratories Ltd, Karachi for provision of following two registered drugs in one Combo pack as
per following details:-

Agenda 252

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151
Registration Board Meeting

S. No.

Reg. No.

1.

045416

2.

053094

Name of drug(s) & Composition


Osmolar ORS
Each sachet contains:Sodium Chloride BP .1.3g
Potassium Chloride BP .0.75g
Sodium Citrate BP 1.45g
Glucose Anhydrous . 6.75g
Zincat OD Syrup
Each 5ml contains:Elemental Zinc (as Zinc Sulphate
Monohydrate USP) .20mg

Quantity in
Combo Pack
Two sachets

One pack of 60ml

Firm has submitted following justifications to support their request:

The reason for making combo pack is that if both products are being used simultaneously
by the patient for management of diarrhea then it will ultimately reduce the use of
antibiotics and intravenous fluids for treatment of diarrhea.
It also helps malnourished children to recover more quickly from diarrhea.
Recent studies suggest that administration of Zinc along with low osmolarity oral
rehydration solution / salts (ORS) can reduce the duration and severity of diarrheal
episodes for up to three months.
According to WHO, Zinc and low osmolarity ORS are critical for the reduction of
diarrhea mortality.
They have also furnished following documents:i.
ii.
iii.
iv.
v.
vi.
vii.

copy of registration letter with last renewals


two copies of proposed art work of combo pack duly singed by QC & Production
inchange
Packaging specifications of combo pack
Reference, indicting that the prescribing information is in line with information
approved by the international regulatory authority.
copy of valid DML, NOC for CRF
Undertaking
Variation fee of Rs.5000/- for the purpose.

Registration Board in 249th meeting deferred the case and advised firm to provide
information including Countries where same combo pack is available for similar indication and
Specific recommendations of WHO regarding combo pack.

Agenda 252

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Registration Board Meeting

In response to decision of Registration Board in 249th meeting the firm has stated that this
combination pack is an urgent requirement of patients, especially in summer season. And further
delay in the approval of subject matter will definitely affect the population suffering form severe
diarrhea during the summer season because it is quite obvious that the spread of diarrhea is more
in summer season as compare to other seasons.
The case is placed before Registration Board.
Case No.16: Registration from M/s Johnson & Johnson (Pvt) Ltd to M/s Aspin Pharma
(Pvt) Ltd, Karachi.
Registration Board in 249th meeting deferred case for registration Sporanox Capsule
100mg, Registration No. 012647 from M/s Johnson & Johnson (Pvt) Ltd to M/s Aspin Pharma
(Pvt) Ltd, Karachi (DML No. 000045 Formulation) and advised firm to submit source of
itraconazole pellets along with legalized GMP certificate, stability data and certificate of analysis
and remaining fee upto Rs.100000/-. Now firm has deposited remaining fee and submitted
referred documsnts.
Submitted for consideration of Registration Board.
Case No.17: Change of formulation - Sodium Carbonate from inactive to API
M/s GSK Karachi has informed that due to global formulation harmonization
process they are including Sodium Carbonate in the API list from Inactive of existing
formulation for following products.
1. Eno Fruit Salt Regular (Reg No. 000180)
2. Eno Fruit Salt Lemon (Reg No. 016868)
3. Eno Fruit Salt Orange (Reg No. 019645)
Firm has submitted following documents:

Fee @ Rs. 5000/- for each product.


Formulations as per details for label claim along with current and proposed claim.
complete batch formulation containing API and inactive, specification and stability data.

Agenda 252

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153
Registration Board Meeting

Registration Board in 249th meeting advised firm to provide scientific and medical
justification in support of their request for consideration of Registration Board. Now firm has
submitted that there is no change in existing formulation with respect to ingredients and
quantities. Sodium carbonate has similar antacid role as citric acid and sodium bicarbonate is
doing. Globally it is considered as API inactive due to its role.
Submitted for consideration of Registration Board.
Case No. 18: Cases deferred for scrutinization of registration applications.
a.

Registration from M/s Elko Organization, Karachi to M/s Sante (Pvt) Ltd.,
Karachi.
M/s Sante (Pvt.) Ltd, 97-A, S.I.T.E, Super Highway, Karachi has requested for

transfer of registration of following products from M/s Elko Organization, Karach to their new
name.
S.
No.
1.

2.

3.

4.

021611 Blephapred
Sterile Each ml contains:
Ophthalmic Suspension Sulfacetamide Sodium 100mg,
Prednisolone Acetate 2.0mg,
Phenylepherine HCl 1.2mg
030356 Dexoptic Ophthalmic Each gm contains:
Ointment
Dexamethasone USP 1.0mg
032591 Santodex Ophthalmic Each gm contains:
Ointment
Tobramycin 3.0mg
Dexamethasone 1.0mg
032595 Dexoflox Ophthalmic Each ml contains:
Suspension
Ofloxacin 3.0mg

5.
6.

7.

Agenda 252

Reg.
Name of product(s)
Composition
No.
020248 Santodex
Sterile Each ml contains:
Ophthalmic Suspension Tobramycin 3mg
Dexamethasone 1mg
021606 Blephapred Sterile
Each gm contains:
Ophthalmic Ointment
Sulfacetamide Sodium 100mg,
Prednisolone Acetate 2.0mg
021607 Optopred
Sterile Each ml contains:
Ophthalmic Suspension Prednisolone Acetate 10mg

nd

154
Registration Board Meeting

S.
No.

Reg.
No.

Name of product(s)

Composition

Dexamethasone 1.0mg
039797 Santirol
Ophthalmic Each gm contains:
Ointment
Dexamethasone (as Sodium)
1.0mg
Neomycin (as Sulphate) 3.5mg
Polymyxin B Sulfate 6000units
067534 Comox Eye Drops
Each ml contains:
Dexamethasone as Sodium
Phosphate 1mg
Moxifloxacine as HCl 5mg

8.

9.

The firm have provided following documents with support:


1)
2)
3)
4)

Application with form 5 and requirement fee amounting to Rs. 20,000/- each.
Copy of registration letter with renewal status
Copy of approved Section by Central Licensing board.
NOC from existing manufacturer/registration holder permitting for transfer of
product.

Registration Board in 249th meeting deferred the case for scrutinization of registration
applications, which has been done and submitted for consideration of Registration Board.

b.

Registration from M/s OBS Pakistan, Karachi to M/s AGP (Pvt) Ltd., Karachi.
M/s AGP (Pvt) Ltd., Karachi has requested for transfer of registration of

following products from M/s OBS Pakistan, Karachi to their new name. Registration Board in
249th meeting deferred the case for scrutinization of registration applications.
S.
No.
1.

Reg. No.

2.

Agenda 252

055574

076211

nd

Name of product(s) & composition


Vicopin 500mcg Tablet
Each tablet contains:
Mecobalamin500mcg
(Manufacturers specifications)
Vicopin 500mcg/ml Tablet

155
Registration Board Meeting

Renewal Validity
30.03.2019

28.01.2019

S.
No.

Reg. No.

Name of product(s) & composition

Renewal Validity

Each ml contains:
Mecobalamin500mcg
(Manufacturers specifications)
The firm have provided following documents with support:
1)
2)
3)

Application with form 5 and requirement fee amounting to Rs. 20,000/- each.
Copy of registration letter with renewal status
NOC from existing manufacturer/registration holder permitting for transfer of
product.

Now applications have been scrutinized and submitted for consideration of Registration Board.
c.

M/s Nawan Laboratories (Pvt) Ltd, Karachi.


Registration Board in 209th meeting approved following products for reason recorded in

last column as follows:


Name of Drug & composition

Maltose Tablet
Each tablet contains:
Iron Hydroxide Polymaltose
complex equivalent to Elemental
Iron100mg
(Haematinic)

Maltose Syrup

Agenda 252

nd

Pack size &


MRP
demanded
1s/Rs.8.00

5ml/ Rs.7.90
156
Registration Board Meeting

Decision of 209th meeting

Approved subject to quality


assessment dossiers for stability
studies and validation of non
pharmacopeial testing methods as
per policy.
Comparative dissolution profiles
with the innovative products
supported with the evidences
and qualified staff subject to
inspection by the of experts
consisting of
i. Mr. Sheikh Faqeer Muhammad
Sheikh ( DDG Pricing),
ii. Obaid Ali (ADC)
iii. Sh. Rashid Ahmed, FID
-do-

Each 5ml contains:


Iron Hydroxide Polymaltose
complex equivalent to Elemental
Iron50mg
(Haematinic)
Maltose-F Tablet
Each tablet contains:
Iron Hydroxide Polymaltose
complex equivalent to Elemental
Iron100mg
Folic Acid U.S.P0.350mg
(Haematinic)
Levocin 250mg Tablets
Each tablet contains:Levofloxacin..250mg
(Broad Spectrum Antibiotic)
Levocin 500mg Tablets
Each tablet contains:Levofloxacin..500mg
(Broad Spectrum Antibiotic)
Cefdir Capsule
Each capsule contains:Cefdinir..100mg
(Antibacterial)
Cefdir Suspension
Each 5ml contains:Cefdinir..50mg
(Antibacterial)
Gabix Capsules
Each capsule contains:Gabapentin100mg
(Anti-epileptic)

1s/ Rs.8.00

-do-

10s; Rs.
20.00/
Per tab

-do-

10s; Rs.
30.00/
Per tab

-do-

10s; Rs.
40.00/
Per cap

-do-

60ml / Rs.
250.00

-do-

10s; Rs.
5.50/
Per cap

-do-

Now firm has informed that above panel could not inspect the facility and during this time
above sections have been inspected many times and declared as good. The firm has paid fee up
to Rs. 20,000/- for each product and have submitted new Form 5 as per check list approved by
Registration Board and requested for approval of above drugs.

Agenda 252

nd

157
Registration Board Meeting

Registration Board in 249th meeting deferred above applications for scrutinization of


registration applications. These applications have been checked and submitted for consideration
of registration Board.
d.

M/s. Pliva Pakistan (Pvt) Ltd, Karachi.


i.

Following product is registered for M/s Mehran International, JM 798/D, Hume

Road, Quaideen Colony Opposite: World Map, Near 3 Star Hall, Karachi Pakistan for import
from M/s. Pliva Zagreb Croatia, Yogoslavia and now M/s. Pliva Pakistan (Pvt) Ltd, Karachi have
requested for transfer of registration of the following registered imported drug from the name of
aforementioned agent for local manufacturing.
S. No.

Reg. No.

1.

008620

Name of Products
Amoxicillin Injection 1gm
Each vial contains:
Amoxicillin as sodium Salt 1gm

The applicant M/s. Pliva Pakistan (Pvt) Ltd. Karachi has submitted following documents:i
ii
iii
iv
v

Copy of registration letter and renewal status


NOC from M/s Mehran International, Karachi for manufacturing of Amoxycillin
Injection 1gm (Reg No 008620).
NOC from M/s Pilva Zagreb, Croatia for Amoxycillin Injection 1gm (Reg No
008620).
Form 5
Copy of last inspection report

Registration Board in 249th meeting deferred the application for scrutinization, which has
been checked and submitted for consideration of the Board.
ii.

Following product is registered for M/s Shaheen Agency, Karachi for import from M/s.

Chongqing Medicines and Health Products Chongqing China and now M/s. Pliva Pakistan (Pvt)
Ltd, Karachi have requested for transfer of registration of the following registered imported drug
from the name of aforementioned agent for local manufacturing.

Agenda 252

nd

158
Registration Board Meeting

S. No.

Reg. No.

1.

013262

Name of Products
Ampicloxacillin Sodium Injection 500mg
Each vial contains:
Amicillin Sodium eq to Ampicillin 250mg
Cloxacillin Sodium eq to Cloxacillin 250mg

The applicant M/s. Pliva Pakistan (Pvt) Ltd. Karachi has submitted following supporting
documents:i
ii
iii
iv
v
vi

Request for transfer of registration along with prescribed fee for each
product amounting to Rs. 20,000/- for each product.
NOC from M/s Shaheen Agency for manufacturing of Ampicloxacillin
Sodium Injection 500mg (Reg No. 013262).
NOC from Chongqing Medicine and Health Product Chongqing China for
Ampicloxacillin Sodium Injection 500mg (Reg No. 013262).
Registration letter and renewal status
Form 5.
Copy of last inspection report.

Registration Board in 249th meeting deferred the application for scrutinization, which has
been checked and submitted for consideration of the Board.

Transfer of registration from bulk import to local manufacturing of


registered products.

e.

Following products of M/s. Genix Pharma Private Limited, Karachi are registered for
bulk import from M/s Vitabiotechs Ltd, England and repacked locally. Now firm has requested
for manufacturing of these registered products at its own facility. Details are as follows:
S.#
1.

Product Name
Perfectial Capsules

Agenda 252

nd

159
Registration Board Meeting

Registratio
n No.
024940

Proposed brand
name
Perficap Capsules

Each Capsule contains:


Vitamin D (100IU)..2.5mg
Vitamin E.40mg
Vitamin C....30mg
Vitamin B1...10mg
Vitamin B2 .5mg
Nicotinamide 18mg
Vitamin B620mg
Folic Acid.500ug
Vitamin B12 9ug
Biotin..45ug
Pantothenic acid40mg
Iron 12mg
Magnnesium..15mg
Zinc200ug
Magnese...2mg
Copper..2mg
Silicon .3mg
Silinium.100ug
Chromimum..500ug
Cystin.10mg
Betacarolene....5mg
PABA.30mg
Echinacea extract .195mg
Bordock extract..80mg
2.

Diabetone Capsules
Each capsule contains:
Vitamin A.700ug
Vitamin D ..5ug
Vitamin E.30mg
Vitamin B1...15mg
Vitamin B2 .5mg
Niacin. 45mg
Vitamin B625mg
Folic Acid.500ug
Vitamin B12 9ug
Biotin..200ug
Pantothenic acid..40mg
Iron 8mg
Magnnesium..100mg
Zinc15mg
Magnese2mg
Copper..1mg
Silinium.100ug

Agenda 252

nd

160
Registration Board Meeting

024942

Diacare Capsules

Chromimum gft..200ug
Iodine.1000ug
3.

Visionace Capsules
Each capsule contains:
Vitamin A.300ug
Betacarotene.3mg
Vitamin D3 ..2.5ug
Vitamin E..60mg
Vitamin B1......7.6mg
Vitamin B2 .5mg
Vitamin C160mg
Vitamin D3.2.5uug
Folic Acid.250ug
Vitamin B6..2mg
Vitamin K1.100ug
Vitamin B12 4.5ug
Pantothenic acid...10mg
Iron .3mg
Magnnesium...50mg
Nicotinamide8mg
Bhioflavonoids (Citrus).16mg
Bilberry powdered exract 60mg
Zinc7.5mg
Magnese2mg
Copper..1mg
Silinium.100ug
Chromimum gft..50ug
Iodine.100ug

024943

Visocare Capsules

The applicant has submitted following documents:i)


ii)
iii)

Copy of registration letter and renewal status


Form 5
Copy of last inspection report

Registration Board in 249th meeting deferred the application for scrutinization, which has
been checked and submitted for consideration of the Board.
f.

M/s. Pharmatec Pakistan, Karachi.

Agenda 252

nd

161
Registration Board Meeting

M/s. Pharmatec Pakistan, Karachi applied for transfer of registration Maltofer Tablet
(Iron III Hydroxide Polymaltos Complex) containing 100mg Iron as Iron (III)-Hydroxide
Polymaltose Complex bearing registration No. 028696 from M/s Getz Pharma (Pvt) Ltd,
Karachi. The firm has informed that they have manufacturing facility for the product. The firm
has provided following documents in support: i)

Application with Form 5-A and required fee as per relevant SRO.
i.e. 20,000/- and other relevant documents.

Registration Board in 248th meeting deferred the application for scrutinization, which has
been checked and submitted for consideration of the Board.
g.

M/s OBS Pakistan (Pvt), Ltd., C-14 Manghopir.


Registration Board in 249th meeting deferred following products of M/s OBS, Karachi for

extension in contract manufacturing and change of contract manufacturer to M/s AGP, Karachi.
1.

OBS
Pakistan
(Pvt), Ltd.,
C-14
Manghopir
Road,
Karachi.

M/s Macter
International,
Karachi.

057942

M-Span Dry
Suspension 100mg
Each 5ml contains:Cefixime.100mg/5
ml

07.04.2015
Form-5
Rs.50,000/07.04.2015

2.

OBS
Pakistan
(Pvt), Ltd.,
C-14
Manghopir
Road,
Karachi.

M/s Macter
International,
Karachi.

057943

M-Span Dry
Suspension 200mg
Each 5ml contains:Cefixime.200mg/5
ml

07.04.2015
Form-5
Rs.50,000/07.04.2015

3.

OBS
Pakistan
(Pvt), Ltd.,
C-14
Manghopir
Road,
Karachi.

M/s Macter
International,
Karachi.

057944

M-Span Capsules
400mg
Each Capsule
contains:Cefixime.400mg as
trihydrate400mg

07.04.2015
Form-5
Rs.50,000/07.04.2015

Agenda 252

nd

162
Registration Board Meeting

30.06.2015.
Firm
has
requested for
change
of
contract
manufacturer
to M/s AGP,
Karachi
30.06.2015.
Firm
has
requested for
change
of
contract
manufacturer
to M/s AGP,
Karachi
30.06.2015.
Firm
has
requested for
change
of
contract
manufacturer
to M/s AGP,
Karachi

Case was deferred for scrutinization of Form-5, which has been done. Submitted for
consideration of Registration Board.
h.

M/s Bosch Pharmaceutical (Pvt) Ltd., PlantII (DML No. 000707).


M/s Bosch Pharmaceutical (Pvt) Ltd., Karachi has requested for transfer of registration

from M/s Bosch Pharmaceuticals (Pvt) Ltd., Karachi DML No. 000350 to Bosch Pharmaceutical
(Pvt) Ltd., PlantII Situated at Plot No. 209, Sector 23, Korangi Industrial Area, Karachi having
DML No. 000707:S.
No.
1.

2.

3.

4.

5.

6.

7.

Product for registration with generic name


Tariflox 200mg Infusion
Each 100ml contains:
Ofloxacin USP..200mg
(Manufacturers Specification
Quinoflox 100mg Infusion
Each 50ml vial contains
Ciprofloxacin Lactate M.S. eq. to 100mg Ciproflxacin USP
Sodium Chloride..450mg
(USP Specification)
Quinoflox 200mg Infusion
Each 100ml vial contains:
Ciprofloxacin Lactate M.S. eq. to 200mg Ciproflxacin USP
Sodium Chloride..900mg
(USP Specification)
Quinoflox 400mg Infusion
Each 200ml vial contains:
Ciprofloxacin Lactate M.S. eq. to 400mg Ciproflxacin USP
(USP Specification)
Quinoflox DS 400mg/100ml Infusion
Each 100ml vial contains
Ciprofloxacin Lactate M.S. eq to 400mg Ciproflxacin
USP.400mg
(USP Specification)
Troz 500mg IV Infusion
Each 100ml vial contains:
Metronidazole USP.50mg
(USP Specification)
Qumic 500mg Infusion

Agenda 252

nd

163
Registration Board Meeting

Reg. No.
021506

Renewal
up to
15.05.2018

023020

03.03.2019

023021

03.03.2019

039583

16.09.2015

048489

08.02.2018

034856

07.12.2019

024244

13.06.2017

8.

9.

Each 100ml vial contains:


Levofloxacin Hemihydrate USP 512.46mg
levofloxacin.500mg
(Manufacturers Specification)
Qumic 750mg /150ml Infusion
Each 150ml vial contains:
Levofloxacin (as Hemihydrate)750mg
levofloxacin.500mg
(Manufacturers Specification)

eq

eq

to

061073

02.12.2019

061075

02.12.2019

to

Qumic 250mg/50ml Infusion


Each 50ml contains Levofloxacin (as Hemihydrate)
.250mg
(Manufacturers Specification)

The firm have provided following documents with support:


1)
2)
3)
4)
5)
6)

Application with form 5 and requirement fee amounting to Rs. 20,000/- each.
Copy of registration letter with renewal status
Copy of approved Section by Central Licensing board.
Copy of NOC for CRF Clearance.
Copy of last inspection report.
NOC from Existing Manufacturer/registration holder, permitting for transfer of
product.

Registration Board in 249th meeting deferred the application for scrutinization, which has
been checked and submitted for consideration of the Board.

Case No.19: Registration of drugs for M/s Hirani, Karachi.


M/s Hiranis Pharmaceuticals (Pvt) Ltd., Karachi has requested for registration of
following products in their name from M/s Opal Pharma, Karachi. submitted GMP certified from
M/s Vision Pharma, Islamabad for following products as pending for transfer of registration from
M/s Opal Pharma to their name:
S.
No.
1.

Agenda 252

nd

Name
of
Drug(s), Registratio
Composition with
n number
Enlon Capsule 20mg
067059

164
Registration Board Meeting

Date
of
registration
12.11.2010

Each capsule contains:


Duloxetine HCl enteric coated
pellets
eq. to Duloxetine . 20mg
(Manufacturers Specification)
2.

Enlon Capsule 30mg


067060
Each capsule contains:
Duloxetine HCl enteric coated
pellets
eq. to Duloxetine . 30mg
(Manufacturers Specification)

12.11.2010

The firm has provided following documents in support:


i)
Form-5 (evaluated by PEC)
ii)
NOC from M/s Opal, Karachi.
iii)
COA and stability Data of pellets.
iv)
GMP certificate issued by M/s Vision Pharmaceutical, Islamabad.
Submitted for consideration of Registration Board.
Case No.20: Cases deferred by Registration Board.
a.

M/s Elko Organization, (Pvt.) Ltd, Karachi.


Registration Board in 245th meetings deferred following registration application of M/s

Elko Organization, (Pvt.) Ltd, Karachi for reason mentioned in last column.
S/N

Name and
address of
manufacturer/
Applicant

Agenda 252

Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacological
Group

Type of
Form
Initial
date, diary
Fee
including
differentia
l fee
Demanded
Finished product Price /
Specification
Pack size
nd

165
Registration Board Meeting

Decision
in Remarks on Decision
previous meeting the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/

authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
M/s Elko
Organization
(Pvt.) Ltd. Plot
No. 27 & 28,
Sector 12-B,
North Karachi
Industrial Area,
Karachi

Agenda 252

nd

Cefopar
Injection
Each vial contains
Cefoperazone
Sodium USP eq
to Cefoperazone
500 mg
Sulbactum
sodium USP eq to
Sulbactum 500
mg
Antibiotic

Form 5
Fast Track
1 1 +
sterile
water for
injection
Rs
400/
vial
28-10-13
28-10-13
Rs 60,000/-

166
Registration Board Meeting

Deferred
for Reference to
completion
of finished
Form 5 (M242 product
RB)
specifications
is required.
For
Studies
like
provide
process
validation,
stability
studies,
pharmaceutica
l development
studies
&
validation of
analytical
methods,
an
undertaking
may
be
submitted
regarding the
provision of
the
same
before
marketing of
said product.
For Summary
of
Product
Characteristics
(SmPC),
Patient
information
leaflet (PIL)

Deferred for
final reminder
for
rectificarion of
following
observation.
1. Reference to
finished
product
specifications
is required.
2. For Studies
like
provide
process
validation,
stability
studies,
pharmaceutica
l development
studies
&
validation of
analytical
methods,
an
undertaking
may
be
submitted
regarding the
provision of
the
same
before
marketing of
said product.
3.
For

Prescribing
Information
(PI), you may
submit
an
undertaking
that
said
information
would be same
as approved by
reference drug
agencies like
FDA,
TGA,
MHLW, EMA
and
Health
Canada.
According to
inspection
report dated
09-05-12 firm
is operating at
good level of
compliance
International:
Not approved
by stringent
regulatory
agencies but
present in
China
Local:
Winbact Inj by
M/s Winsfield

Summary of
Product
Characteristics
(SmPC),
Patient
information
leaflet (PIL)
Prescribing
Information
(PI), you may
submit
an
undertaking
that
said
information
would be same
as approved by
reference drug
agencies like
FDA,
TGA,
MHLW, EMA
and
Health
Canada.
4. Latest GMP
inspection
report

Now the firm has provided following documents:


1. Reference to finished product specification.
2. Undertaking regarding Process of Validation, stability studies, pharmaceutical
development studies and analytical methods.
3. Undertaking regarding the provision of the same before marketing of said product.
4. Latest CGMP certificate.
The case is placed before the Drug Registration Board for decision please.

Agenda 252

nd

167
Registration Board Meeting

b)

M/s. Hilton Pharmaceutical, Karachi


Registration Board in 235th meetings deferred following registration application of M/s.

Hilton Pharmaceutical, Karachi, for reason mentioned in last column.


S.#
01

Name of
firm(s)
M/s. Hilton
Pharmaceuti
cal, Karachi

02

-do-

Name of Drug(s) &


Composition
Hilyte fruit sachet
Each sachet contains:
Sodium chloride...0.47gm
Potassium chloride.0.3gm
Sodium acid citrate....0.53gm
Dextrose monohydrate..3.56 gm
(Oral rehydration solutions)
Hilyte orange sachet
Each sachet contains:
Sodium chloride.0.47gm
Potassium chloride...0.3gm
Sodium acid citrate0.53gm
Dextrose monohydrate..3.56gm
(Oral rehydration solutions)
Prasu Plus 5/75mg Tablet
Each tablet contains:Prasugrel HCl eq. to
Prasugrel5mg
Aspirin ..75 mg
(Inhibitor of platelet activation)

Proposed
Pack Size
10s

Demand
Remarks
Price
As per PRC Deferred for
review
of
formulation

10s

As per PRC Deferred for


review
of
formulation

14s
28s

Rs.1302/Rs.2604/-

Deferred.
Clinical data
of
single
ingredient
Prasugrel
tablet
provided.
Formulation
needs to be
re-examined.
Deferred.
Clinical data
of
single
ingredient
Prasugrel
tablet
provided.
Formulation
needs to be
re-examined.
Deferred.
Clinical data
of
single

03

M/s. Hilton
Pharmaceuti
cal, Karachi

04

-do-

Prasu Plus 5/150mg Tablet


Each tablet contains:Prasugrel HCl eq. to
Prasugrel5mg
Aspirin ..150mg
(Inhibitor of platelet activation)

14s
28s

Rs.1358/Rs.2716/-

05

-do-

Prasu Plus 10/75mg Tablet


Each tablet contains:Prasugrel HCl eq. to

14s
28s

Rs.2548/Rs.5096/-

Agenda 252

nd

168
Registration Board Meeting

Prasugrel10mg
Aspirin ..75mg
(Inhibitor of platelet activation)

06

-do-

Prasu Plus 10/150mg Tablet


Each tablet contains:Prasugrel HCl eq. to
Prasugrel10mg
Aspirin .150mg
(Inhibitor of platelet activation)

14s
28s

Rs.2604/Rs.5208/-

ingredient
Prasugrel
tablet
provided.
Formulation
needs to be
re-examined.
Deferred.
Clinical data
of
single
ingredient
Prasugrel
tablet
provided.
Formulation
needs to be
re-examined.

The case is presented before Registration Board.


c.

M/s Tabros Pharma, (Pvt) Ltd., Karachi.


Registration Board in its 241st meeting deferred the following application of Predheal

Ointment 0.1% M/s Tabros Pharma, (Pvt) Ltd., Karachi for the reasons mentioned in the last
column.
M/s Tabros Pharma Predheal Ointment 0.1%
(Pvt) Ltd., Karachi. Each gram contains:Methyl Prednisolone
Aceponate.0.1%
(Corticosteroid)

5gm
10gm

Rs.122/Rs.230/-

Deferred
for
confirmation of
steroidal section

The firm has requested that in view of Registration Boards decision taken in M-248 th
meeting regarding requirement of segregate steroidal section they should be granted the
registration of above product.
Submitted for consideration of Registration Board
d.

M/s Pharmatec Pakistan Karachi.

Agenda 252

nd

169
Registration Board Meeting

Registration Board in its 239th meeting discussed registration of following product of M/s
Pharmatec Pakistan Karachi and decided as recorded in last column

M/s
Pharmatec
Pakistan
Karachi

Reltus Forte Cough


Expectorant
Each 5ml contains:
Ammonium
chloride.100mg
Ephedrine
Hydrochloride7 mg
Chlorpheniramine
maleate..2 mg
(Cpigj ex[ectprant)

120ml

As per
PRC

07-06-2013
Dy.No.640
Form-5
Rs.60,000/-

Deferred
being
controlled
Drug

Firm submitted that segregated area is required for narcotic drugs and psychotropic
substances and Reltus Forte Cough Expectorant contains Ephedrine Hydrochloride which is a
precursor, hence they segregated area for manufacturing is not required.
The case is placed before the Drug Registration Board for decision please

e. M/s Reign Pharma, Karachi.


Registration Board in 239th meeting deferred following products for reason recorded in
last column.
Name of firm(s)

Irofer-F Syrup
Each 5ml contains:

Name of
Drug(s)
&
Composit
ion
As per
PRC

Proposed
Pack Size

Demand
Price

Remarks

As per
PRC

21-05-2013

Deferred
for PSI by
Director
DTL,
Karachi and
area FID

Iron (III) Hydroxide


polymaltose complex eq.t
o elemental iron ..50mg
Folic acid0.35 mg

Agenda 252

nd

170
Registration Board Meeting

Dy.No.541
Form-5
Rs.20,000/-

(For iron deficiency


anemia, haematinic)
Irol-F Syrup

As per
PRC

Each 5ml contains:

As per
PRC

Iron Polysacharide
complex eq.t o elemental
Iron ..100 mg

21-05-2013
Dy.No.538
Form-5
Rs.20,000/-

Folic Acid..0.35
mg
(For iron deficiency
anemia, haematinic)

Deferred
for
confirmatio
n of me too
status and
PSI
by
Director
DTL,
Karachi and
area FID

Panel comprising of Mr.Abdul Razaq Director DTL, Karachi and Abdul Rasool Shaikh,
FID inspected the firm on 06.02.2014 and recommended grant of registration.
Submitted for consideration of registration Board.
f.

M/s PharmEvo, Karachi.

Registration Board in its 242nd meeting deferred following product of M/s PharmaEvo,
Karachi and decided as recorded in last column
M/s
PharmEvo
, Karchi

1.Duzalta
2.Capsule
3.Each delayed release
capsule contains:
Duloxetine 30 mg
4.Anti Depressant

1. Form-5
2.Fast Track
3.
Rs.325/7s
Rs.415/10s
Rs.600/14s
4. 21-062011
Dy.No. 253
Rs.8000/(Original)
17-5-2013

Agenda 252

nd

171
Registration Board Meeting

1. Manufacturers
specifications
2. Capsule section
available as per
inspection report
dated 20/03/2013.
3. Inspection report
dated 29/03/2011
&
20/03/2013
provided.

Deferred
for
submission
of
certificate
of
analysis
of
pellets,
valid
GMP certificate
of
source,
stability data and
requisite balance
fee as the firm has
proposed
M/s
Alphamed, India
as
source
of
pellets.

Rs.52,000/Now the firm has submitted the required documents and submitted for consideration of
registration Board.
Case No.21: Cases deferred for expert opinion.
Registration Board in 250th meeting decided to consider approval of by regulatory
agency of any of the reference country viz. USFDA, Health Canada, EMA, TGA Australia,
PMDA Japan, MHRA United Kingdom, Germany, France, Switzerland, Netherlands, Austria,
Denmark, Sweden and Norway (in same dosage form and strength). However Registration Board
can take views / opinion of experts (if requires) regarding safety and efficacy parameters of the
drug under domestic circumstances / practices, risk-benefit ratio in light of existing therapies etc
Following products are deferred for expert opinion in various meetings.

S/N

Name
and
address
of
manufacturer/Ap
plicant

1. Brand Name
2. Dosage Form
3. Composition
4. pharmacological
group

01

M/s
GlaxoSmithKline
Pakistan limted, F268
S.I.T.E.,
Karachi

Panadol Sinus Caplets

Agenda 252

nd

Each Caplet Contains:


Paracetamol500mg
Phenylephrine Hcl. 5.00mg

172
Registration Board Meeting

1.Type of Form
Remarks
2. Type of
application
3. Demanded Price
/ Pack size
4. Initial date,
diary.
5. Date on which
fee becomes
complete
according to type
of application /or
Form (total Fee)
Form 5-D (Fast
BENYLIN
Track)
COLD
&
SINUS
Rs.8,000/500/5mg
09-12-2010
Health Canada
Dy. No. not
mentioned
Inspection dated
07-01-2014, 21Rs.60,000/01-2014 & 1920-03-2013
02-2014. Well
Dy. No. not
maintained
/

Decision

Deferred fo
evaluation
of stabilit
data whic
should b
performed
at
th
applicants
site
&
expert
opinion b

mentioned
Rs.82,000/19-11-2013
Dy. No. not
mentioned
Rs.300/-100s

Agenda 252

nd

173
Registration Board Meeting

retained
unit
reported. Tablet
section
mentioned
in
report.

the
following:
1.Brig.Asla
m
2.Dr.Shazli
Manzor
1. In terms of 3.Dr.Rehan
Prescribing
Kauser,
information
PIMS
(PI),
Patient
Information
Leaflet
(PIL)
and Summary
of
product
characteristics
(SmPC)
as
approved
by
Drug regulatory
agencies
or
authorities
of
country
of
origin or FDA,
EMA,
TGA,
etc., firm has
submitted
international
data sheet for
the product.
2.
Data
of
stability studies
conducted on
three
pilot
batches
at
25C/60%RH,
30C/60%RH,
30C/75%RH
and
40C/75%RH.
However, it is
pertinent
to
mention that the
batches
were
manufactured in
Sydney,
Australia as the

02

M/s Genix Pharma


(Pvt) Ltd.
44, 45-B, Korangi
Creek Road,
Karachi.

03

-do-

04

-do-

05

M/s Helix Pharma


Pvt.
Ltd.,
Hakimsons House,
A-56,
SITE,
Manghopir, Road,
Karachi

1. Lalap
2. Syrup
3. Each ml contains
Lacosamide MS 10 mg
4. Anti- Epileptic

Azartan Tablet
Each
tablet
contains
Azilsartan Kamedoxomil
MS eq. to Azilsartan
Medoxomil 80mg

raw
material
and
pharmaceutical
development
was carried out
in firms R&D
center
in
Australia
1. Form 5 D
1. Manufacturer Deferred fo
2. Fast Track
2.
expert
3. Pack of 100 ml 3. 21-12-12
opinion
Rs 1000/Overall GMP
242nd
Pack of 200 ml Rs compliance is
2000/good
4. 14-11-12
5. Not mentioned
Rs. 150,000/-

1. Form 5 D
2. Fast Track
3. 14s Rs. 1400/28s Rs 2800/4. 05-12-13
5. 05-12-13
Rs 150,000/Azartan Tablet
1. Form 5 D
Each
tablet
contains 2. Fast Track
Azilsartan Kamedoxomil 3. 14s Rs. 1120/eq.
to
Azilsartan
28s Rs 2240/Medoxomil 40mg
4. 05-12-13
5. 05-12-13
Rs 150,000/1.Mirabon
2.Oral Tablet
3.Each film coated extended
release tablet contains:
Mirabegron ...50 mg
4.OAB/ Antispasmodic.

1. Manufacturer
2.
3. 18-12-2013

Deferred ti
expert
opinion
242nd

1. Manufacturer
2.
3. 18-12-2013

Deferred ti
expert
opinion
242nd

1. Form-5D
1.
2.Fast Track
Manufacturers
3. As per PRC/- 2. FDA:
10s, 30s
MYRBETRIQ
4.03-10-2013
(MIRABEGRO
Rs.150,000/N ) TABLET,
Dy.No.878
EXTENDED
(Original)

RELEASE;OR
AL; 50MG by
APGDI

Agenda 252

nd

174
Registration Board Meeting

Deferred
for expe
opinion o
Gen
(R
Tasawr
(FFMC),
Prof.Umer
RMC an
Dr.Javed
Butt
242nd

06

1.Mirabon
2.Oral Tablet
3.Each film coated extended
release tablet contains:
Mirabegron . 25 mg
4.OAB/ Antispasmodic.

-do-

07

-do-

1. Form-5D
1.
2.Fast Track
Manufacturers
3. As per PRC/- 2. FDA:
10s, 30s
MYRBETRIQ(
4.03-10-2013
MIRABEGRO
Rs.150,000/N ) TABLET,
Dy.No.877
EXTENDED
(Original)

Rozerem Tablet

04-06-2013

Each film coated tablet


contains:

Dy.No.633

Ramelteon..8 mg
(Hypnotics)

Form-5D
Rs.150,000/10s
30s
As per PRC

Deferred
for expe
opinion o
Gen
(R
Tasawr
(FFMC),
Prof.Umer
RELEASE;OR
RMC an
AL; 25MG by Dr.Javed
APGDI
Butt
242nd
Deferred fo
i.
Confirmati
n for
approval by
USFDA,
EMA,
regulatory
body of
Japan or
Australia.
iii. Expert
opinion by
Brig.
M.H.Najmi
Dr.Rizwan
Taj, PIMS

Dr.Saleem
Jehangeer,
MH
Rawalpindi
239th RB

Case No. 22 Correction in composition.


M/s. Braun Pakistan (Pvt) Ltd., Karachi has granted permission for contract
manufacturing of Braun RLD Infusion (Reg No. 053855). Firm identified some typographical

Agenda 252

nd

175
Registration Board Meeting

mistakes in composition of Drug i.e. Braun RLD Infusion (Reg No. 053855) as per following
details; Approved details as per letter
I
B. Braun RLD Infusion
Each 100ml contains:
Sodium Chloride.0.600gm
Sodium Lactate..0.32gm
Potassium Chloride.0.040gm
Calcium Chloride 2H2O0.027gm
Dextrose Anhydrous for
Parenteral.5.5gm

Correct details
II
B. Braun RLD Infusion
Each 100ml contains:
Sodium Chloride.0.600gm
Sodium Lactate..0.32gm
Potassium Chloride.0.040gm
Calcium Chloride 2H2O0.027gm
Dextrose Anhydrous for
Parenteral..5.0gm

The firm has stated that at the time of initial registration on 21.08.2009 they were granted
formulation as per column (I) and later on they got approval for change of formulation as per
column (II). Stance of the firm was confirmed that product was registered vide letter No.F. 32/2009-Reg-I (M-210) dated 21.08.2009 with glucose monohydrate 5.5gm and later on
formulation was changed as Dextrose Anhydrous 5gm due to change by principles company.
Registration board in 250th meeting extended contract manufacturing permission for next 05
years and rectification in composition.

Agenda 252

nd

176
Registration Board Meeting

Registration-III
Case No. 23: Cases for extension in contract manufacturing permission.

S. No.

Contract
manufacturer

Reg. No.

Name of drug(s) & Composition

Date of
application,
Diary No.

Quaper (Pvt)
Ltd., Sargodha

Mediate
Pharmaceutical
Karachi

054065

Rayxime 100 mg Dry Suspension


Each 5ml contains:Cefixime Trihydrate
Cefixime100 mg
(Cephalosporin)

2.

-do-

-do-

054067

3.

-do-

-do-

054073

1.

Applicant

Agenda 252

nd

Category

Contract
permission
valid up till
and
Registration
Board Meeting
of previous
approval

03.08.2015
DyNo.1857
Rs.50,000/03.08.2015

Import to
local contract
manufacturin
g

30.06.2015
Meeting 246th

Rayxime 400 mg Capsule


Each capsule contains:Cefixime Trihydrate
Cefixime400 mg
(Cephalosporin)

03.08.2015
DyNo.1857
Rs.50,000/03.08.2015

-do-

-do-

Cefein 250 Injection IV


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..1g

03.08.2015
DyNo.1857
Rs.50,000/03.08.2015

-do-

-do-

177
Registration Board Meeting

(Cephalosporin)
4.

Quaper (Pvt)
Ltd., Sargodha

Mediate
Pharmaceutical
Karachi

054077

Cefein 500 Injection IV


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..500 mg
(Cephalosporin)

03.08.2015
DyNo.1857
Rs.50,000/03.08.2015

-do-

-do-

5.

-do-

-do-

054069

Cefein 250 Injection IV


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..250 mg
(Cephalosporin)

03.08.2015
DyNo.1857
Rs.50,000/03.08.2015

-do-

-do-

6.

Kohs
Pharmaceutical,
Karachi

Mediate
Pharmaceutical,
Karachi

070704

30.06.2015
Meeting 238th

-do-

-do-

070703

-do-

-do-

8.

-do-

-do-

070702

-do-

-do-

9.

-do-

-do-

070701

-do-

-do-

10.

-do-

-do-

070699

03.08.2015
DyNo.1854
Rs.50,000/03.08.2015
03.08.2015
DyNo.1854
Rs.50,000/03.08.2015
03.08.2015
DyNo.1854
Rs.50,000/03.08.2015
03.08.2015
DyNo.1854
Rs.50,000/03.08.2015
03.08.2015
DyNo.1854

-do-

7.

Acxone Injection
Each vial contains:
Ceftriaxone as
Sodium..1000 mg
Acxone Injection
Each vial contains:
Ceftriaxone as
Sodium..500 mg
Acxone Injection
Each vial contains:
Ceftriaxone as
Sodium..250 mg
Macxime Suspension
Each 5ml contains:
Cefixime..200 mg

-do-

-do-

Agenda 252

nd

Macxime Capsule
Each capsule contains:

178
Registration Board Meeting

Cefixime..400 mg
11.

-do-

-do-

070700

Macxime Suspension
Each 5ml contains:
Cefixime..100 mg

12.

Medicure
Laboratories,
Karachi

Mediate
Pharmaceutical,
Karachi

044270

13.

-do-

-do-

053382

14.

-do-

-do-

044269

Injexone 250mg Injeciton


Each vial contains:
Ceftriaxone as
Sodium..250 mg
Injexone 500mg Injeciton
Each vial contains:
Ceftriaxone as
Sodium..500 mg
Injexone 1gm Injeciton
Each vial contains:
Ceftriaxone as
Sodium..1 gm

Rs.50,000/03.08.2015
03.08.2015
DyNo.1854
Rs.50,000/03.08.2015
03.08.2015
DyNo.1855
Rs.50,000/03.08.2015
03.08.2015
DyNo.1855
Rs.50,000/03.08.2015
03.08.2015
DyNo.1855
Rs.50,000/03.08.2015

-do-

-do-

-do-

30.06.2015
Meeting 238th

-do-

-do-

-do-

-do-

Case No.24: Case for extension and change in manufacturing site.

S.No.

Applicant

Agenda 252

nd

Existing
contract
Manufacturer

Proposed
contract
manufacturer

Reg.
No.

Name of drug(s) &


Composition

Date of
application,
Diary No.

Category

Contract
permission valid
up till and
Registration
Board Meeting
of previous
approval
179

Registration Board Meeting

1.

Medicure
Laboratories,
Karachi

Envoy
Pharmaceutical,
Multan Lahore.

Mediate
Pharmaceutical,
Karachi

050412

Bacnel 400mg Capsule


Each capsule contains:
Cefixime..400 mg

2.

-do-

-do-

-do-

050411

Bacnel 100mg
Suspension
Each 5ml contains:
Cefixime..100 mg

Agenda 252

nd

03.08.2015
Dy. No. 1858
Rs. 20,000/03.11.2014
03.08.2015
Dy. No. 1858
Rs. 20,000/03.11.2014

-do-

30.06.2015
Meeting 238th

-do-

-do-

180
Registration Board Meeting

Case No.25. Applications for extension in Contract Manufacturing Permission.

S. No.

1.

Name of Applicant

Name of
Contract
manufacturer

Reg.
No.

M/s Warafana
Pharmaceuticals
Islamabad.

M/s Salus
Pharmaceutical
s Rawalpindi

021057

Name of drug(s) &


Composition

Date of
application,
Diary No. &
Form

Category

Contract
permission valid up
till and Registration
Board Meeting of
previous approval

Salxone 250mg Injection

25-06-2015

Extension

30-06-2015

Each vial contains:-

Dy.No.1485

Ceftriaxone as (Sodium)
USP..250mg

Rs.50,000/=

M-239

(USP Specs.)
2.

-do-

-do-

021059

Salxone 500mg Injection

25-06-2015

Each vial contains:-

Dy.No.1484

Ceftriaxone as (Sodium)
USP..500mg

Rs.50,000/=

Extension

30-06-2015
M-239

(USP Specs.)
3.

-do-

Agenda 252

nd

-do-

021058

Salxone 1gm Injection

25-06-2015

Each vial contains:-

Dy.No.1486

Ceftriaxone as (Sodium)
USP..1gm

Rs.50,000/=

Extension

30-06-2015
M-239

181
Registration Board Meeting

(USP Specs.)
4.

M/s Drugs Inn


1-I, Parkview Plaza,
Markaz F-10,
Islamabad

M/s EG
Pharmaceutical
s, 13-A,
Industrial
Triangle,
Kahuta Road,
Islamabad.

022619

Prezone 250mg Injection


IM
Each vial contains:Ceftriaxone Sodium eq.
to Ceftriaxone
..250mg
(USP Specs.)

22-06-2015

Extension

30-06-2015

Dy.No.1631

M-239

Rs.50,000/=

The firm got


approval with two
different brand
name Prezone &
Kefcef for
Ceftriaxone IV 250,
500 & 1gm.
The firm has
requested for
Perzone 250mg
from IV to IM.

5.

6.

-do-

-do-

Agenda 252

nd

-do-

-do-

023168

022654

Prezone 500mg Injection


IV
Each vial contains:Ceftriaxone Sodium eq.
to Ceftriaxone
500mg
(USP Specs.)
Prezone 1gm Injection IV
Each vial contains:Ceftriaxone Sodium eq.
to Ceftriaxone
1gm

22-06-2015

Extension

Dy.No.1630

30-06-2015
M-239

Rs.50,000/=

22-06-2015
Dy.No.1629

Extension

30-06-2015
M-239

Rs.50,000/=
182

Registration Board Meeting

(USP Specs.)
7.

-do-

8.

-do-

9.

-do-

10.

11.

-do-

M/s Noble
Pharmaceutical,
Office No.103, First

Agenda 252

nd

-do-

-do-

-do-

-do-

M/s EG
Pharmaceutical
s, 36-Inudstrial

022694

022695

022696

022653

023134

Kefcef 250mg Injection


IV
Each vial contains:Ceftriaxone Sodium eq.
to Ceftriaxone
250mg
(USP Specs.)
Kefcef 500mg Injection
IV
Each vial contains:Ceftriaxone Sodium eq.
to Ceftriaxone
..500mg
(USP Specs.)
Kefcef 1gm Injection IV
Each vial contains:Ceftriaxone Sodium eq.
to Ceftriaxone .1g
(USP Specs.)
Gencef 1gm Injection
IM/IV
Each Vial contains:Cefotaxime Sodium eq. to
Cefotaxime..1g
(USP Specs.)
Cefodime Injection
IM/IV
Each vial contains:

22-06-2015

Extension

Dy.No.1628

30-06-2015
M-239

Rs.50,000/=

22-06-2015

Extension

Dy.No.1627

30-06-2015
M-239

Rs.50,000/=

22-06-2015

Extension

Dy.No.1626

30-06-2015
M-239

Rs.50,000/=
22-06-2015

Extension

Dy.No.1625

30-06-2015
M-239

Rs.50,000/=

22-06-2015
Dy.No.1633

Extension

30-06-2015
M-239
183

Registration Board Meeting

Floor,
Park View Plaza,
Markaz F-10,

Triangle,
Kahuta Road,
Islamabad.

Ceftazidime Pentahydrate
eq. to Ceftazidime.
..1g
(USP Specs.)

Rs.50,000/=

Cefodime Injection
IM/IV
Each vial contains:
Ceftazidime Pentahydrate
eq. to Ceftazidime .
..250mg
(USP Specs.)

22-06-2015

Islamabad.
12.

13.

-do-

M/s Medley
Pharmaceutical,
Plot 41-A, P.S.I.E.,
Jhang Bahtar Road,
Wah Cantt.

14.

15.

-do-

-do-

Agenda 252

nd

-do-

023135

M/s.Fassgen
Pharmaceutical
s, Plot No.
67/1-A, PhaseIII, Industrial
Estate, Hattar.

030245

-do-

030246

-do-

030247

Qsef Injection 250mg


Each vial contain:Cefotaxime Sodium eq. to
Cefotxime .250mg

Qsef Injection 500mg


Each vial contain:Cefotaxime Sodium eq. to
Cefotxime .500mg
Qsef Injection 1gm
Each vial contain:Cefotaxime Sodium eq. to
Cefotxime .1gm

Extension

Dy.No.1632

30-06-2015
M-239

Rs.50,000/=

16-07-2015

Extension

Dy.No.1598

30-06-2015
M-239

Rs.50,000/=

16-07-2015

Extension

Dy.No.1598

30-06-2015
M-239

Rs.50,000/=
16-07-2015
Dy.No.1598

Extension

30-06-2015
M-239

184
Registration Board Meeting

Rs.50,000/=
16.

17.

18.

19.

20.

-do-

-do-

-do-

M/s Well Care


Pharmaceuticals A/7
PSIE, Sargodha

-do-

Agenda 252

nd

-do-

-do-

-do-

030243

030244

030241

M/s.Fassgen
Pharmaceutical
s, Plot No.
67/1-A, PhaseIII, Industrial
Estate, Hattar.

060808

-do-

060809

Kintrex 500mg Injection


I.V
Each vial contains:Ceftriaxone Sodium eq.
to. Cefriaxone.500mg
Kintrex 1gm Injection I.V
Each vial contains:Ceftriaxone Sodium eq.
to. Cefriaxone.1gm
Kintrex 500mg Injection
I.M
Each vial contains:Ceftriaxone Sodium eq.
to. Cefriaxone.500mg
Carewel 250mg Injection
IM
Each injection contains:
Ceftriaxone sodium eq to
Ceftriaxone U.S.P
50mg.
Carewel 500mg Injection
IM
Each injection contains:
Ceftriaxone sodium eq to
Ceftriaxone U.S.P

16-07-2015

Extension

Dy.No.1598

30-06-2015
M-239

Rs.50,000/=

16-07-2015

Extension

Dy.No.1598

30-06-2015
M-239

Rs.50,000/=
16-07-2015

Extension

Dy.No.1598

30-06-2015
M-239

Rs.50,000/=

16-07-2015

Extension

Dy.No.1559

30-06-2015
M-239

Rs.50,000/=

16-07-2015
Dy.No.1559

Extension

30-06-2015
M-239

Rs.50,000/=
185

Registration Board Meeting

500mg
21.

22.

-do-

M/s Glitz Pharma,


Kahuta Road,
Islamabad

-do-

M/s Linear
Pharma,

060810

050546

Rawat

Carewel 1gm Injection


IM
Each injection contains:
Ceftriaxone sodium eq to
Ceftriaxone
U.S.P.1gm
P-Zone 250mg Injection
IM
Each vial contains:-

16-07-2015

Extension

Dy.No.1559

30-06-2015
M-239

Rs.50,000/=

30-06-2015
Dy. No.306
Rs.50,000/

Extension

30-06-2015
Dy. No.306
Rs.50,000/

Extension

30-06-2015
Dy. No.306
Rs.50,000/

Extension

30-06-2015
M-238

Ceftriaxone (as Sodium)


.250mg
(USP Specs.)
23.

-do-

-do-

050545

P-Zone 500mg Injection


IM
Each vial contains:-

30-06-2015
M-238

Ceftriaxone (as Sodium)


.500mg
24.

-do-

-do-

050544

(USP Specs.)
P-Zone 1gm Injection IM
Each vial contains:Ceftriaxone (as Sodium)
.1gm

30-06-2015
M-238

(USP Specs.)
Agenda 252

nd

186
Registration Board Meeting

Case No.26. Applications for extension alongwith change in Contract Manufacturer.


M/s Medizan Laboratories (Pvt) Ltd., Islamabad have applied for extension in contract manufacturing permission alongwith
change in contract manufacturer from M/s Shawan Pharma, Plot No.37, NS-1, National Industrial Zone, Rawat to M/s Weather Folds
Pharmaceuticals, Plot No.69/2, Phase-II, Industrial Area, Hattar.

S.
No.

25.

26.

27.

Name of
Applicant

Existing
Manufacturer

New
Manufacturer

Reg. No.

M/s Medizan
Pharmaceutical,
Islamabad

M/s Shawan
Pharmaceutical,
Rawat.

M/s Weather
Folds
Pharmaceuticals
, Hattar

045067

-do-

045066

-do-

-do-

-do-

-do-

-do-

Agenda 252nd Registration Board Meeting

045068

Name of drug(s) &


Composition

Date of
application,
Diary No. &
Form

Category

Shevaz 250mg Injection


Each 5ml contains:Cefotaxime (as Sodium)
..250mg

30-06-2015

Transfer

Shevaz 1000mg Injection


Each 5ml contains:Cefotaxime (as Sodium)
..1000mg
Shevaz 500mg Injection

Dy.No.307

Contract
permission valid
up till and
Registration
Board Meeting of
previous
approval
30-06-2015
M-238

Rs.50,000/=
30-06-2015

Transfer

30-06-2015
M-238

Transfer

30-06-2015
187

Dy.No.307
Rs.50,000/=
30-06-2015

Each 5ml contains:Cefotaxime equivalent to


Cefotaxime 500mg
28.

29.

30.

31.

32.

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

Agenda 252

-do-

nd

-do-

-do-

-do-

-do-

-do-

045053

045054

045055

045056

045057

Cegrin 1000mg Injection


Each 5ml Contains:
Ceftriaxone (as Sodium)
..1000mg
Cegrin 250mg Injection
Each 5ml Contains:
Ceftriaxone (as Sodium)
.250mg
Cegrin 500mg Injection
Each 5ml Contains:
Ceftriaxone (as Sodium)
...500mg
Nosocom 1000mg
Injection
Each 5ml contains:Cefepime ( as HCl with
L-Arginine).1000mg
Nosocom 500mg
Injection
Each 5ml contains:Cefepime ( as HCl with
L-Arginine ).500mg

M-238
Dy.No.307
Rs.50,000/=
30-06-2015

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Dy.No.307
Rs.50,000/=
30-06-2015
Dy.No.307
Rs.50,000/=
30-06-2015
Dy.No.307
Rs.50,000/=
30-06-2015
Dy.No.307
Rs.50,000/=

30-06-2015
Dy.No.307
Rs.50,000/=

188
Registration Board Meeting

33.

34.

35.

36.

37.

38.

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-doAgenda 252

-dond

-do-

-do-

-do-

-do-

-do-

-do-

045058

045060

059329

059330

059331

059332

Glazidim 1gm Injection


Each 5ml contains:Ceftazidime (as
pentahydrate)
..1000mg
Glazidim 500mg
Injection
Each 5ml contains:Ceftazidime (as
pentahydrate)..500mg
Zantum 1gm Injection
Each 5ml contains:Cefoperazone (as
Sodium)...500mg
Sulbactum(as Sodium)
.500mg
Zantum 2gm Injection
Each 5ml contains:Cefoperazone (as
Sodium).1gm
Sulbactum(as Sodium)
1gm
Zanxim-400 mg capsule
Each Capsule contains:Cefixime (as trihydrate)
.400mg
Zanxim-100 mg

30-06-2015

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2015

Dy.No.307
Rs.50,000/=

30-06-2015
Dy.No.307
Rs.50,000/=

30-06-2015
Dy.No.307
Rs.50,000/=

30-06-2015
Dy.No.307
Rs.50,000/=

30-06-2015
Dy.No.307
Rs.50,000/=
30-06-2015

189
Registration Board Meeting

Suspension
Each Capsule contains:Cefixime (as trihydrate)
.100mg
39.

40.

-do-

-do-

M/s Drugs Inn


1-I, Parkview
Inn Plaza,
Markaz F-10,
Islamabad.

41.

M/s Swan
Pharmaceutical
s Islamabad

-do-

059333

M/s Paramount
Pharmaceuticals,
36 - Industrial
Triangle Kahuta
Road,
Islamabad.

M/s EG
Pharmaceuticals
, 36-Inudstrial
Triangle, Kahuta
Road,
Islamabad.

015739

M/s Fassgen
Pharmaceuticals
Hattar

M/s Bio Labs


(Pvt) Ltd.,
Islamabad

063015

Zanxim-200 mg
Suspension
Each Capsule contains:Cefixime (as trihydrate)
.200mg
Bruxicam 20mg Capsule
Each Capsule contains:Piroxicam..20mg
(USP Specs.)

Ceftriwan 250mg
Injection IV
Each vial contains:Ceftriaxone (as Sodium)
250mg
(BP Specs.)

M-238
Dy.No.307
Rs.50,000/=
30-06-2015

Transfer

30-06-2015
M-238

Transfer

30-06-2015
M-238

Transfer

30-06-2010
M-218

Dy.No.307
Rs.50,000/=

02-07-2015
Dy.No.1597
Rs.50,000

18-06-2015
Dy.No.974DDG(Reg.II)
Rs.50,000

fee Submitted in
15th April, 2013
Rs.42,000/= of
each product
29-06-2010
Rs.8000/= each
product
Registration Board

Agenda 252

nd

190
Registration Board Meeting

in M-238
Extended till
30.06.2015 with
condition that
the firm will
deposit remaininf
fee and select
either IM or IV

42.

-do-

-do-

-do-

063016

Ceftriwan 500mg
Injection IV
Each vial contains:Ceftriaxone (as Sodium)
500mg

18-06-2015

Transfer

-do-

Transfer

-do-

Transfer

-do-

Dy.No.975DDG(Reg.II)
Rs.50,000

(BP Specs.)

43.

-do-

-do-

-do-

063017

Ceftriwan 1gm Injection


IV
Each vial contains:Ceftriaxone (as Sodium)
1gm

18-06-2015
Dy.No.976DDG(Reg.II)
Rs.50,000

(BP Specs.)
44.

-do-

-do-

-do-

063018

Ceftriwan 250mg
Injection IM
Each vial contains:-

Agenda 252

nd

18-06-2015
Dy.No.970DDG(Reg.II)

191
Registration Board Meeting

Ceftriaxone (as Sodium)


250mg

Rs.50,000

(BP Specs.)

45.

-do-

-do-

-do-

063019

Ceftriwan 500mg
Injection IM
Each vial contains:Ceftriaxone (as Sodium)
500mg

18-06-2015

Transfer

-do-

Transfer

-do-

Transfer

-do-

Dy.No.979DDG(Reg.II)
Rs.50,000

(BP Specs.)

46.

-do-

-do-

-do-

063018

Ceftriwan 1gm Injection


IM
Each vial contains:Ceftriaxone (as Sodium)
1gm

18-06-2015
Dy.No.977DDG(Reg.II)
Rs.50,000

(BP Specs.)

47.

-do-

-do-

-do-

063021

Cefiwan 100mg Dry


Suspension
Each 5ml contains:Cefixime..100mg

18-06-2015
Dy.No.978DDG(Reg.II)
Rs.50,000

(USP Specs.)
Agenda 252

nd

192
Registration Board Meeting

48.

-do-

-do-

-do-

063022

Cefiwan 200mg Dry


Suspension
Each 5ml contains:Cefixime..200mg

18-06-2015

Transfer

-do-

Transfer

-do-

Dy.No.971DDG(Reg.II)
Rs.50,000

(USP Specs.)

49.

-do-

-do-

-do-

063023

Cefiwan 400mg
Capsules

18-06-2015

Each capsule contains:-

Dy.No.973DDG(Reg.II)

Cefixime..400mg

Rs.50,000

(USP Specs.)

Agenda 252

nd

193
Registration Board Meeting

Case No.27. Application for registration of drugs on contract manufacturing for export purpose only.

S.
No.
50.

Name of the
Applicant

Name of Contract
manufacturer

Name of drug(s) &


Composition

Date of
application, Diary
No. & Form

Category

M/s Metro
Pharmaceuticals
Rawat.

M/s Bio Labs (Pvt)


Ltd., Islamabad

Metxime 400mg Capsules

29-05-2015

Contract Export
purpose only

Each capsule contains:Cefixime ..400mg


(BNF-57)

51.

-do-

-do-

Metxime 100mg Dry


Suspension
Each 5ml contains:Cefixime (As Trihydrate)
100mg

Dy.No.883DDG(Reg.II)

Remarks

Rs.50,000/=
29-05-2015
Dy.No.878
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=

(anti-Biotic
(Cephalosporin)
52.

-do-

-do-

Metxime 200mg Dry


Suspension
Each 5ml contains:Cefixime (As Trihydrate)
200mg

Agenda 252

nd

29-05-2015
Dy.No.874
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=

194
Registration Board Meeting

(anti-Biotic
(Cephalosporin)
53.

-do-

-do-

Blamin 500mcg Ampoule

29-05-2015

Each ampoule contains:-

Dy.No.873
-DDG(Reg.II)

Mecobalamin.500mc
g

Contract Export
purpose only

Rs.50,000/=

(Vitamin-B)
54.

-do-

-do-

Keto 30mgAmpule
Each ampoule contains:Ketorolac
Tromethamine..30mg

29-05-2015
Dy.No.877
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=

(NSAID)
55.

-do-

-do-

Medizol 500mg Infusion

29-05-2015

Each infusion contains:-

Dy.No.880
-DDG(Reg.II)

Metronidazole.500m
g

Contract Export
purpose only

Rs.50,000/=

(Amoebicides)
56.

-do-

-do-

Esomepzole 40mg
Injection
Each vial contains:Esomeprazole (as
Sodium).40mg

Agenda 252

nd

29-05-2015
Dy.No.872
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=
195

Registration Board Meeting

(Proton Pump Inhibitor)


57.

-do-

-do-

Mepzol 40mg Injection


Each vial contains:Omeprazole (as sodium)
..40mg

29-05-2015
Dy.No.875
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=

(Proton Pump Inhibitor)

58

-do-

-do-

Metrox 250mg Injection


IM
Each vial contains:Ceftriaxone sodium eq. to
Ceftriaxone..250mg

29-05-2015
Dy.No.876
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=

(BNF)
58.

-do-

-do-

Metrox 500mg Injection


Each vial contains:Ceftriaxone sodium eq. to
Ceftriaxone.500mg

29-05-2015
Dy.No.882
-DDG(Reg.II)

Contract Export
purpose only

Rs.50,000/=

(BNF)
59.

-do-

-do-

Metrox 1gm Injection


Each vial contains:Ceftriaxone sodium eq. to

Agenda 252

nd

29-05-2015
Dy.No.881
-DDG(Reg.II)

Contract Export
purpose only

196
Registration Board Meeting

Ceftriaxone.1gm

Rs.50,000/=

(BNF)

Agenda 252

nd

197
Registration Board Meeting

Case No.28. The Registration Board in its 237th meeting deferred the following product of M/s
Danas Pharmaceuticals (Pvt) Ltd., Islamabad for confirmation of me-too status.
Brand Name / Label Claim

Demanded
Pack Size

Demanded
Price

Registration
Board Decision
M-237

Efloderm Cream 13.9%

15gm

Deferred

As Per SRO

for confirmation
of me-too status.

Each gram contains:Eflornithine Hydrochloride (as


Monohydrate).13.9%
(139mg/g)
(Antiprotozoal)

Now, the firm has submitted the evidence of me-too status of formulation with the information
that the same is already registered in the name of Valor Pharma & Hoover Pharma. The
formulation is also been found approved for M/s Crystolite in 238 th meeting of Registration
Board and also has FDA approval in 13.9%. strength in cream as under.
Eflornithine Hydrochloride anhydrous (as Monohydrate).13.9% (139mg/g)
Submitted for consideration by the Registration Board.

Case No.29. The Registration Board in its 238th meeting deferred the following product of M/s
M/s Global Pharmaceuticals (Pvt) Ltd., Islamabad for product specific inspection by Prof. Rafi U
Zaman & area FID for confirmation of manufacturing and testing facilities.
Brand Name / Label Claim

Demanded
Pack Size

Demanded
Price

Registration
Board Decision
M-238

Caltrol Injection 1mcg

Agenda 252

nd

25s

198
Registration Board Meeting

As Per SRO

Deferred for product


specific inspection
by Prof. Rafi uzamn

Each ampoule contains:-

& area FID for


confirmation of
manufacturing and
testing facilities.

Calcitriol . 1mcg/ml
(USP Specs.)
(Vit. D Analogue)

Now, the firm has submitted the inspection report conducted by the above panel for
consideration of the Registration Board. The report is accompanied with the

documents

regarding the production and testing of Injection Calcitriol 1mc/ml, SOPs (Cleaning validation,
etc) and HVAC. The panel inspected the general injection section which is the production facility
and the quality control laboratory to see the testing facilities which according to the panel were
maintained properly at the time of inspection. The panel also discussed in detail the steps
involved in the manufacturing and testing of subject product with the technical staff.
The firm requested for approval of the above product.
Submitted for consideration by the Registration Board.

Case No.30. Registration Board in its different meetings 193-A, 195-A, 202 & 229 meeting
deferred following applications of narcotics drugs.
Brand Name / Label Claim

Lortz 1mg Tablets

Demanded
Pack Size

Demanded
Price

Registration Board
Meeting &
Decision

10x10s

Rs.170.00

M-193-A

Each tablet contains:Lormetazepam.1mg


(BP Specification)

Agenda 252

nd

199
Registration Board Meeting

Deferred for Policy

(Anti-anxiety, anti-convulsants,
anti-depressants)
Glox 10mg Tablets

20s

Rs.275.00

Each tablet contains:-

M-193-A
Deferred

Zolpidem Tartrate.10mg
(Glitzs Specifications)
(Anti-anxiety, anti-convulsants
anti-depressants)
Zapiz 1mg Tablets

100s

Rs.56.00

Each tablet contains:-

M-195-A
Deferred

Lorazepam.1mg
(USP Specification)
(Anti-anxiety, anti-convulsants,
anti-depressants)
Zapiz 2mg Tablets

100s

Rs.70.00

Each tablet contains:-

M-195-A
Deferred

Lorazepam.2mg
(USP Specification)
(Anti-anxiety, anti-convulsants,
anti-depressants)
Zepam-5 Tablets

300s

Rs.960.00

Each tablet contains:-

M-202
Deferred subject to
the completion of
applications with in
30 days.

Nitrazepam Eur. Ph..5mg


(BP Specification)
(Anti-anxiety, Anticonvulsants;
Antidepressive)
Bromazep 3mg Tablets

10s

Each tablet contains:-

20s

Agenda 252

nd

200
Registration Board Meeting

As Per SRO

M-229
Deferred

Bromazepam (BP)..3mg

30s

(Glitzs Specifications)
(Anxiety and sleep disorders)

Now the firm has requested that their narcotics section was approved in June, 2010 and
they want to register these applications. The firm has deposited remaining fee Rs.12,000/= for
each product. If approved the above products may be referred to the Pharmaceutical Evaluation
Cell (PEC) for evaluation of dossiers after confirmation of approved products and decision about
above products alongwith the Fee Rs.8000/= from the official record.
Submitted for consideration of the Registration Board.
Case No.22. Drug Registration Board in its 237th meeting held on 26th February, 2013 referred
following registration application of M/s Medisynth Pharmaceuticals Islamabad to committee
comprising of following members & authorized Chairman Registration Board for the decision:a) Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board).
b) Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy,
Quaid-e-Azam University, Islamabad (Member Registration Board)
c) DDG (Reg-II)
d) Concerned DDCs

The decision of Registration Board is reproduced as under:The Registration Board referred the application (after submission of
differential fee for registration) to the committee comprising Brig (R).
Professor Dr. Muzammil Hasan Najmi (Member Registration Board), DDG
(Reg-II) and concerned DDCs / ADCs for scrutiny, verification of codal
requirements and recommendations for me-too registration applications. The
recommendations of committee will be submitted to the Chairman,
Registration Board for decision.
The above committee approved these application subject to the condition as mentioned in
second last column below. The firm has now fulfilled all the conditions & submitted the desired

Agenda 252

nd

201
Registration Board Meeting

information as mentioned in the last column below. The registration applications have now
become completed with respect to all codal formalities and decision of Registration Board.

Brand Name / Label Claim

Demanded
Pack Size

Demande
d Price

Decision of
Committee
M-237

Pirosyn-B 20mg Dispersible


Tablets
Each tablet contains:Piroxicam Beta Cyclodextrin
equivalent to Piroxicam
20mg
(Analgesic / Oxicams)

10s

As Per
SRO

Approved subject to
submission of
1. GMP of Source
2. C.O.A.

If approved, we may issue the registration letters of above products accordingly. The firm has
already deposited fee of Rs.20,000x3=60,000/= (as applied on fast track). The firm has also
submitted CRF clearance.

Submitted for consideration of the Registration Board.

Agenda 252

nd

202
Registration Board Meeting

Case No.31.
M/s Vision Pharmaceuticals, have applied for transfer of following products from its Plot
No.224, Stret No.1, I-10/3, Islamabad. (old) premises to new premises at Plot No.22-23,
Industrial Triangle, Kahuta Road, Islamabad. Previously these products were manufacturing on
contract from M/s Global Pharmaceuticals, Islamabad. Now the firm has requested for transfer of
these products from this old site to new site alongwith the change in manufacturing from contract
to manufacturing at its new site Plot No.22-23, Industrial Triangle, Kahuta Road, Islamabad
In the last meeting, these products were discussed but deferred for evaluation of due to the
reason.
S.
No
1.

2.

Name of the
Firm.

Reg.N
o.

M/s Vision
Pharmaceutic
als.
Islamabad.

033768 Artilide 100mg Tablets

-do-

Brand Name / Label Claim

Demand
ed Pack
Size
2x10s

Each tablet contains:-

Demand
ed Price

Date of
Submission

As Per
SRO

03-07-2015

Rs.20,000/=

Nimesulide..100mg
030702 Cartiofex 100mg Tablets

2x10s

Each tablet contains:

As Per
SRO

-do-

030703 Cartiofex 200mg Tablets

20s

Each tablet contains:-

As Per
SRO

-do-

033766 Citalovis 20mg Tablets

14s

Each tablet contains:-

As Per
SRO

-do-

030704 Clinex 100mg Tablets

6s

Each tablet contains:-

As Per
SRO

-do-

Agenda 252

030705 Clinex 500mg Tablets

nd

203
Registration Board Meeting

Dy.No.1526

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526
Rs.20,000/=

Clotrimazole100mg
6.

03-07-2015

Rs.20,000/=

Citalopram (HBr)20mg
5.

Dy.No.1526

Rs.20,000/=

Celecoxib..200mg
4.

03-07-2015

Rs.20,000/=

Celecoxib..100mg
3.

Dy.No.1526

1s

As Per
SRO

03-07-2015

7.

-do-

Each tablet contains:-

Dy.No.1526

Clotrimazole.500mg

Rs.20,000/=

033767 Coxyzin 10mg Tablets

1x10s

Each tablet contains:-

As Per
SRO

-do-

037574 Diclovis -K 75mg Tablets

2x10s

Each tablet contains:-

As Per
SRO

-do-

038905 Epilax 500mg Tablets

10x10s

Each tablet contains:-

As Per
SRO

-do-

038055 Esopep 20mg Capsules

Dy.No.1526

03-07-2015
Dy.No.1526
Rs.20,000/=

Divalproex Sodium
500mg
10.

03-07-2015

Rs.20,000/=

Diclofenac
Potassium.75mg
9.

Dy.No.1526
Rs.20,000/=

Cetrizine (Dihydrochloride)
10mg
8.

03-07-2015

14s

Each capsule contains:-

As Per
SRO

03-07-2015
Dy.No.1526
Rs.20,000/=

Esomeprazole (as
Esomeprazole
Manesium).20mg
11.

-do-

038056 Esopep 40mg Capsules

14s

Each capsule contains:-

As Per
SRO

03-07-2015
Dy.No.1526
Rs.20,000/=

Esomeprazole (as
Esomeprazole
Manesium).40mg
12.

-do-

033378 Feromalt 100mg Chewable


Tablets
Each tablet contains:Iron (III) Hydroxide
Polymaltose Complex

Agenda 252

nd

204
Registration Board Meeting

1x10s

As Per
SRO

03-07-2015
Dy.No.1526
Rs.20,000/=

Eq. to Elemental
Iron.100mg
13.

-do-

043938 Gerdin 40mg Tablets

1x10s

Each tablet contains:-

As Per
SRO

-do-

033763 Lapravis 30mg Capsules

14s

Each Capsule contains:-

As Per
SRO

-do-

032158 Levovis 250mg Tablets

10s

Each tablet contains:-

As Per
SRO

-do-

032159 Levovis500mg Tablets

10s

Each tablet contains:-

As Per
SRO

-do-

038129 Levozin 5mg Tablets

10s

Each tablet contains:-

As Per
SRO

-do-

041738 Lodine 10mg Tablets

10s

Each tablet contains:-

As Per
SRO

-do-

050291 Lumetrin Tablets

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526
Rs.20,000/=

Loratadine10mg
19.

Dy.No.1526

Rs.20,000/=

Levocetrizine5mg
18.

03-07-2015

Rs.20,000/=

Levofloxacin (as
Hemihydrate)500mg
17.

Dy.No.1526

Rs.20,000/=

Levofloxacin (as
Hemihydrate) 250mg
16.

03-07-2015

Rs.20,000/=

Lansoprazole.30mg
15.

Dy.No.1526
Rs.20,000/=

Famotidine.40mg
14.

03-07-2015

16s

Each tablet contains:-

As Per
SRO

03-07-2015
Dy.No.1526
Rs.20,000/=

Artemether....20mg
Lumefantrine..120mg
20.

-do-

Agenda 252

033769 Macromyd 250mg Capsules

nd

205
Registration Board Meeting

1x10s

As Per
SRO

03-07-2015

21.

-do-

Each Capsule contains:-

Dy.No.1526

Azithromycin.250mg

Rs.20,000/=

033365 Mecovis Tablets

10x10s

Each tablet contains:-

As Per
SRO

-do-

032161 Medicip 250mg Tablets

10s

Each tablet contains:-

As Per
SRO

-do-

032162 Medicip 500mg Tablets

10s

Each tablet contains:-

As Per
SRO

-do-

041731 Mytamin 500mcg Capsules

100s

Each capsule contains:

As Per
SRO

-do-

038942 Naplex 550mg Tablets

2x10s

Each tablet contains:

As Per
SRO

-do-

033756 Opepzole 20mg Capsules

14s

Each capsule contains:

As Per
SRO

-do-

033753 Osteocam 15mg Tablets


Each tablet contains:
Meloxicam15mg

Agenda 252

nd

206
Registration Board Meeting

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526
Rs.20,000/=

Omeprazole (Enteric Coated


Granules)20mg
27.

Dy.No.1526

Rs.20,000/=

Naproxen Sodium
550mg
26.

03-07-2015

Rs.20,000/=

Mecobalamin500mcg
25.

Dy.No.1526

Rs.20,000/=

Ciprofloxacin (as HCl)


500mg
24.

03-07-2015

Rs.20,000/=

Ciprofloxacin (as HCl)


250mg
23.

Dy.No.1526
Rs.20,000/=

Mecobalamin500mcg
22.

03-07-2015

1x10s

As Per
SRO

03-07-2015
Dy.No.1526
Rs.20,000/=

28.

-do-

033752 Osteocam 7.5mg Tablets

1x10s

Each tablet contains:

As Per
SRO

-do-

041730 Sebastin 10mg Tablets

10s

Each tablet contains:

As Per
SRO

-do-

032163 Visoflox 200mg Tablets

10s

Each tablet contains:

As Per
SRO

-do-

032164 Visoflox 400mg Tablets

10s

Each tablet contains:

As Per
SRO

-do-

35256

Vision DS Capsules

2mlx1s

Each capsule contains:

As Per
SRO

-do-

041732 Visobac 250mg Capsule

10s

Each capsule contains:

As Per
SRO

-do-

041737 Visobac 500mg Capsules

10s

Each capsule contains:

As Per
SRO

-do-

034849 Visodic 50mg Tablets


Each tablet contains:
Diclofenac Sodium.50mg

Agenda 252

nd

207
Registration Board Meeting

Dy.No.1526

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526

03-07-2015
Dy.No.1526
Rs.20,000/=

Ciprofloxacin HCl.500mg
35.

03-07-2015

Rs.20,000/=

Ciprofloxacin
HCl.250mg
34.

Dy.No.1526

Rs.20,000/=

Lincomycin (as HCl)


500mg
33.

03-07-2015

Rs.20,000/=

Ofloxacin400mg
32.

Dy.No.1526

Rs.20,000/=

Ofloxacin200mg
31.

03-07-2015

Rs.20,000/=

Ebastine..10mg
30.

Dy.No.1526
Rs.20,000/=

Meloxicam7.5mg
29.

03-07-2015

2x10s

As Per
SRO

03-07-2015
Dy.No.1526
Rs.20,000/=

Submitted for consideration of the Registration Board.

Case No.32. M/s Vision Pharmaceuticals, Islamabad have applied for transfer of registered
products from previous site Plot No.224, Street No.1, I-10/3, Islamabad to new site Plot
No.22-23, Industrial Triangle, Kahuta Road, Islamabad of M/s Vision Pharmaceuticals. The
case was discussed in previous meeting of Registration Board M-250 wherein it was deferred for
evaluation of dossiers. Now the dossiers have been evaluated.

S.
No
.

1.

Name of the
Firm.

M/s Vision
Pharmaceutical
s Plot No.2223, Industrial
Triangle,
Kahuta Road,
Islamabad.

Brand Name / Label


Claim

Lapravis 30mg Injection


IV

Demande
d Pack
Size

Demande
d Price

Date of
Submissio
n

N.A

As Per
SRO

28-05-2015

Each vial contains:-

Dy.No.1466
Rs.20,000/=

Lansoprazole Lyophilized
Powder..30mg
(Proton Pump Inhibitors
(PPIs).

2.

-do-

Esopep 40mg Injection IV

N.A

Each vial contains:-

As Per
SRO

28-05-2015
Dy.No.1471
Rs.20,000/=

Esomeprazole sodium eq.


to
Esomeprazole.40m
g
(Proton Pump Inhibitors)
3.

-do-

Agenda 252

nd

Virotab 20mg Injection IV

208
Registration Board Meeting

N.A

As Per
SRO

28-05-2015

Each vial contains:-

Dy.No.1470

Rabeprazole (as
Rabeprazole sodium
Lyophilized Powder)
20mg

Rs.20,000/=

(Proton Pump Inhibitors)


4.

-do-

Fitral 40mg Injection IV

N.A

Each vial contains:-

As Per
SRO

28-05-2015
Dy.No.1469
Rs.20,000/=

Pantoprazole (as
Pantoprazole Sodium
Lyophilized Powder)
..40mg
(Proton Pump Inhibitors)
5.

-do-

Nimoconil 500mg
Injection IV

N.A.

As Per
SRO

Each vial contains:-

28-05-2015
Dy.No.1468
Rs.20,000/=

Azithromycin Lyophilized
Powder.500mg
(Macrolide Anti-Infective)
6.

-do-

Rapid 40mg Injection

N.A

Each vial contains:-

As Per
SRO

28-05-2015
Dy.No.1472
Rs.20,000/=

Omeprazole Sodium
Lyophilized Powder eq. to
Omeprazole.40mg
(Proton Pump Inhibitors)
7.

-do-

Thiopental 500mg
Injection
Each vial contains:Thiopental Sodium

Agenda 252

nd

209
Registration Board Meeting

N.A

As Per
SRO

28-05-2015
Dy.No.1467
Rs.20,000/=

BP.500mg
(THiobarbiturate)

Submitted for consideration of the Registration Board.


Case No.33: M/s Grays Pharmaceuticals, Islamabad have applied for transfer of registered
products from M/s Grays Pharmaceuticals Plot No.442, Street No.7, I-9/2, Islamabad to M/s
Greays Pharmaceuticals Plot No.2, Street N-3, RCCI Rawat.

S.
No.
1.

Name of the
Firm.

Reg.
No.

Brand Name / Label


Claim

Demande
d Pack
Size

Demande
d Price

Date of
Submission

M/s Greays
Pharmaceutical
s Plot No.2,
Street

05602
3

Z-Nest 0.5mg Tablets

30s

Rs.128.00

07-05-2012

N-3, RCCI
Rawat.

Each tablet contains:-

Rs.8000/=

Alprazolam0.5mg

29-07-2015

(USP Specification)

Dy.No.1611
Rs.12,000/=

2.

-do-

05602
7

Pazam 3mg Tablets

3x10s

Rs.65.00

07-05-2012

Each tablet contains:-

Rs.8000/=

Bromazepam..3mg

29-07-2015

(USP Specification)

Dy.No.1612
Rs.12,000/=

3.

4.

-do-

03332
1

-do-

Agenda 252

03332

nd

Fungigray Cream 1%

10gm

Rs.32.00

18-12-2013

Each gram contains:-

Dy.No.3038

Clotrimazole10mg

Rs.20,000/=

Fungigray V Cream

210
Registration Board Meeting

5gm

Rs.110.00

18-12-2013

5.

-do-

03333
3

Each gram contains:-

Dy.No.3038

Clotrimazole..100mg

Rs.20,000/=

Panarodin 550mg
Tablets

2x10s

Rs.143.00

26-02-2013
Dy.No.106

Each tablet contains:-

Rs.20,000/=

Naproxen
Sodium550mg
6.

-do-

05693
6

Grazeth 250mg Tablets

1x6s

Rs.150.00

26-02-2013

Each tablet contains:-

Dy.No.106

Azithromycin (as
dihydrate)..250mg

Rs.20,000/=

(USP Specification)
7.

8.

-do-

03824
8

-do-

03824
3

Topirat 50mg Tablets

6x10s

Agenda 252

26-02-2013

Each tablet contains:-

Dy.No.106

Topiramate50mg

Rs.20,000/=

Loxaspar 100mg Tablets

10s

Rs.400.00

26-02-2013

Each tablet contains:-

Dy.No.106

Sparfloxacin.100m
g

Rs.20,000/=

Submitted for consideration of the Registration Board.

nd

Rs.1200.00

211
Registration Board Meeting

Case No.34. Application for Registration of Drugs for Export Purpose only Non Me-too.

S.
No.
1.

Name of the
Applicant.

Brand Name / Label


Claim

Demande
d Pack
Size

Demand
ed Price

Date of
Submission

Remarks

M/s Wilsons
Pharmaceuticals,
Islamabad.

Seferon 400mg Tablets

14s

19-02-2015

Each film coated tablet


contains:-

28s

Rs.10,00
0/

Export
order No.
41, 15
order
submitted
from
Afghan
Tolo
company
Private
Ltd

Dy.No.260
DDG(R.II)

Sofosbuvir.400mg

Rs.20,000/=

(HCV NS5B
Polymerase Anti-Viral)

2.

M/s Werrick
Pharmaceuticals,
Islamabad.

CELL 400mg Tablets

14s

Each film coated tablet


contains:-

28s

Sofosbuvir.400mg
(HCV NS5B
Polymerase Anti-Viral)

Agenda 252

nd

212
Registration Board Meeting

As Per
SRO

19-02-2015
Dy.No.258
DDG(R.II)
Rs.20,000/=

Export
order No.
42, 15
order
submitted
from
Afghan
Tolo
company
Private
Ltd

3.

M/s Scotmann
Pharmaceuticals,
Islamabad.

Hepaldi 400mg Tablets

14s

Each film coated tablet


contains:-

28s

Sofosbuvir.400mg
(HCV NS5B
Polymerase Anti-Viral)

Agenda 252

nd

213
Registration Board Meeting

Rs.10,00
0/

05-03-2015
Dy.No.341
DDG(R.II)
Rs.20,000/=

Export
order No.
45115
order
submitted
from
Afghan
Tolo
company
Private
Ltd

Registration-IV
Case No.35

The Following firms have requested for extension in contract manufacturing permissions
of drugs as per following details:
S.No

1.

Name of
Applicant

Name of
manufacturer

M/s. Treat
M/s. Mediate
Pharmaceutical Pharmaceuticals
s
Karachi.
Bannu

Reg.
No

Name of Drugs

07324
8

K-Xime Suspension
Each 5ml contains:Cefixime (as
Trihydrate)
..200mg
(USP Specification)

2.

-do-

-do-

07324
7

K-Xime Suspension
Each 5ml contains:Cefixime (as
Trihydrate)
..100mg
(USP Specification)

3.

-do-

-do-

07324
6

K-Xime Capsule
400mg
Each capsule contains:Cefixime (as
Trihydrate)..400mg
(USP Specification)

05657
7

Fedraxon 250 mg
Injection I.V.
Each vial contains:Ceftriaxone Sodium
Ceftriaxone.250
mg

4.

M/s. Fedro
M/s. Astellas
Pharmaceutica Pharmaceutical,
ls Peshawar
Peshawar

Agenda 252

nd

214
Registration Board Meeting

Date , Dy.
No. and
Fee.
04-082015
Dy
No.3649
Rs.50,000/
Dated 3-82015
04-082015
Dy
No.3649
Rs.50,000/
Dated 3-82015
04-082015
Dy
No.3649
Rs.50,000/
Dated 3-82015
16-072015
Dy.No.94
Rs.50,000/
Dated 30-

Date of
Expiry
30-06-2015

30-06-2015

30-06-2015

30-06-2015

(USP Specification)

06-2015

5.

-do-

-do-

Fedraxon 500 mg
Injection I.V.
Each vial contains:Ceftriaxone Sodium
Ceftriaxone..500
mg
(USP Specification)

16-072015
Dy.No.95
Rs.50,000/
Dated 3006-2015

30-06-2015

6.

-do-

-do-

Fedraxon 1 gm
Injection I.V.
Each vial contains:Ceftriaxone Sodium
Ceftriaxone....1
gm
(USP Specification)

16-072015
Dy.No.96
Rs.50,000/
Dated 3006-2015

30-06-2015

7.

M/s.
Zaynoon
Pharma
Peshawar

M/s. Synchro
Pharmaceuticals
, Lahore.

03056
9

Ofzanon Injection 250


mg I.M
Each vial contains:Ceftriaxone Sodium
Ceftriaxone.250
mg
(USP Specification)

30-062015
Dy
No.1102
Rs.50,000/
-

30-06-2015

8.

-do-

-do-

05337
0

Ofzanon Injection 500


mg I.M
Each vial contains:Ceftriaxone Sodium
Ceftriaxone...500
mg
(USP Specification)

30-062015
Dy
No.1102
Rs.50,000/
-

30-06-2015

9.

-do-

-do-

03057
0

Ofzanon Injection 1 g
I.M
Each vial contains:Ceftriaxone Sodium
Ceftriaxone ....1

30-062015
Dy
No.1102
Rs.50,000/

30-06-2015

Agenda 252

nd

215
Registration Board Meeting

gm
(USP Specification)
10.

11.

Welwrd
M/s. Wnsfeild
Pharmaceutic Pharmaceuticals
als, Hattar
, Hattar

-do-

-do-

04737
4

Xecxim Dry
Suspension
Each 5ml contains:Cefixim (as Trihydrate)
100mg
(USP Specification)

02-072015
Dy
No.1047
Rs.50,000/
-

30-06-2015

05346
7

Xecxim Capsules
Each capsule contains:Cefixim (as Trihydrate)
.100mg
(USP Specification)

02-072015
Dy
No.1047
Rs.50,000/
-

30-06-2015

Case No. 36.


Registration Board in 250th meeting deferred application for extension of toll
manufacturing period (where toll manufacturer was also changed) for dossiers evaluation. The
following applications have been evaluated as per SOP and found in order.
1

M/s Alsons
M/s. Fassgen
Pharmaceutica Pharma, Hattar
ls,
169Hayatabad
Industrial
Estate,
Peshawar

-do-

Agenda 252

-do-

nd

05297
0

Biamzone 250 mg
Injection
Each vial contains:Ceftriaxone Sodium
Ceftriaxone.250
mg
(USP Specs)

30-06-2015 30-06-2015
Dy No.3608 Firm has
Rs.50,000/ requested for
change of
contract
manufacturer
to M/s. Lowitt
Pharma,
Peshawar

05297
1

Biamzone 500 mg
Injection
Each vial contains:Ceftriaxone Sodium
Ceftriaxone..500 mg
(USP Specs)

30-06-2015 -doDy No.3609


Rs.50,000/

216
Registration Board Meeting

-do-

-do-

05297
2

Biamzone 1gm
Injection
Each vial contains:Ceftriaxone Sodium
Ceftriaxone1gm
(USP Specs)

30-06-do2015
Dy No.3610
Rs.50,000/

Case No. 37.


Registration Board in 234th meeting approved Calmol Suspension (Paracetamol
125mg/5ml (Reg. No.073398). The registration letter was issued accordingly.
Now the management of the firm requested that they applied for registration Calmol
Suspension (Paracetamol 120mg/5ml). They have requested for issuance correct formulation
and they has also deposited the correction fee of Rs. 5000/-. The firm claims regarding strength
applied (120mg/5ml) is correct.
Case No.38:
In 250th meeting, the following applications of M/s. Welmed Pharmaceuticals Gadoon
Amazai, were inadvertently

(due to typographical error,) included in the list of cases of

extension and change of toll manufacturers and the Board accordingly deferred all such cases.
12.

M/s. Welmed M/s. Welmark


Pharmaceutica
Hattar
l Gadoon
Swabi.

056235

Ze-Xim 100 mg
Suspension
Each 5ml contains:Cefixime Trihydrate
Cefixime..100 mg
(USP Specification)

30-062015
Dy No.67
Rs.50,000
/-

30-06-2015

13.

-do-

-do-

056236

Ze-Xim DS 200 mg
Suspension
Each 5ml contains:Cefixime Trihydrate
Cefixime.200
mg
(USP Specification)

30-062015
Dy No.67
Rs.50,000
/-

30-06-2015

14.

-do-

-do-

056237

Ze-Xim 400 mg Capsules


Each capsule contains:-

30-062015

30-06-2015

Agenda 252

nd

217
Registration Board Meeting

Cefixime Trihydrate
Cefixime..400
mg
(USP Specification)

Dy No.67
Rs.50,000
/-

The request/application in these cases was only for extension of toll manufacturing, while
the manufacturer was the same I. e M/s. Hisun Pharmaceuticals, Swabi.

Case No.39

Following firm have requested for registration of registration of drugs for the

purpose of export only:1.

M/s. Genome
, Hattar

Dapox 30 mg Tablets
Each film
contains:-

coated

Original Export
tablet

Order annexed.

Dapoxetine HCl
Dapoxetine.30 mg
2.

M/s. Weather Sofovir 400mg Tablets


Fold
Pharmaceutica Each tablet contains:ls, Hattar
Sofosbuvir..
400mg

-do-

(Weather Fold Spec)

The firm submitted all the relevant documents alongwith the fee of Rs.20000/- each and
requested for registration of drugs for export purpose only.
Submitted for consideration of Registration Board.

Agenda 252

nd

218
Registration Board Meeting

Case No.40: Registration of drugs (Change of title of manufacturer)


(i)

M/s. Araf (Pvt.) Ltd

M/s. Araf (Pvt.) Ltd; Lahore has requested for cancelation of registration from their
previous name of the firm i.e M/s. Remedy Pharmaceuticals (Pvt.) Ltd; Lahore and register in
their new name of the firm i.e M/s. Araf (Pvt.) Ltd; Lahore. The name of the firm was changed
from M/s. Remedy Pharmaceuticals (Pvt.) Ltd; Lahore to i.e M/s. Araf (Pvt.) Ltd; Lahore within
the same site:S.
No.
1.

Reg. No.

Name of Drug(s)

062747

Xemethro 250mg Capsule


Each Capsule Contain: Azithromycin (as dihydrate)250mg
(USP Specs)

2.

076810

Doxyday Capsule 100mg


Each capsule contains:Doxycycline as Hyclate 100mg
(B.P Specs)

-do-

3.

062749

Remedine 10% Solution


Each bottle Contains:Povidone Iodine 10%

-do-

4.

076809

5.

062750

(B.P Specs)
Lincody Capsule 500mg
Each capsule contains:Lincomycin (as HCl) 500mg
(USP Specs)
Nexamic 250mg Capsule
Each Capsule Contains:Tranexamic Acid.250mg

Date of
Application
21-05-2015

-do-

-do-

(USP Specs)
6.

062744

7.

062752

8.

062754

Agenda 252

nd

Remeflox Tablet
Each tablet Contains: Ofloxacin .. 200mg
(Remedys Specs)
Remedine Surgical Scrub
Each bottle Contains:Povidone Iodine ..7.5%
(B.P Specs)
Gabatin 300mg Capsule

219
Registration Board Meeting

-do-

-do-

-do-

9.

062748

10.

062753

11.

076805

12.

062751

13.

076806

14.

068175

Each Capsule Contains:Gabapentin 300mg


(Remedys Specs)
Pyrodine 7.5% Solution
Each bottle Contains:Povidone Iodine 7.5%
(B.P Specs)
Fluzole 150mg Capsule
Each Capsule Contains: Fluconazole ...150mg
(Remedys Specs)

Dulcored Tablets
Each film coated tablet contains:Bisacodyl..5mg
(B.P Specs)
Lopemide 2mg Capsule
Each Capsule Contains:Loperamide HCl .2mg

(USP Specs)
Rexipan Tablets
Each tablet contains:Hyoscine-N-butylpromide.10mg
Paracetamol..500mg
(Remedys Specs)
Sterling solution
Each contains:Chlorhexidine gluconate..0.3%
Cetrimide.3% w/v

-do-

29-07-2015

-do-

-do-

-do-

-do-

(Remedys Specs)
15.

064645

Sterling 1.5% Solution


Contains:Chlorhexidine gluconate 1.5%
Cetrimide.15%
(Remedys Specs)

-do-

16.

074289

Retaphyline Tablets
Each tablet contains:Aminophylline 100mg

-do-

17.

069292

18.

076808

(USP Specs)

Agenda 252

nd

Recutane 20mg Capsule


Each capsule contains:Isotretinoin.20mg
(BP Specs)
(Formulation under Review)
Redycam 20mg Tablets

220
Registration Board Meeting

28-01-2015

29-07-2015

19.

062759

20.

062760

Each tablet contains:Piroxicam beta cyclodextrin..20mg


(Remedys Specs)
Lopraz 30mg Capsule
Each Capsule contains:Lansoprazole (pellets) . 30mg
(Source of Pellets From Vision Pharma, Documents
for source fixation not provided)
Opizole 20mg Capsule
Each capsule contains:Omeprazole (pellets) 20mg
(Source; M/s Smilax labs, India)

29-07-2015

29-07-2015

The management of the firm has deposited fee of Rs. 20,000/- for each product at Sr. # 1 to 19
and 1,00,000/- for product at Sr. No. 20. They have provided approval of title of the firm from
Licensing Section. They have also submitted applications on Form-5 alongwith relevant
documents for this purpose. The registration of all products is valid and up-to-date.

ii.

M/s. Searle IV Solutions (Pvt.) Ltd; Lahore


M/s. Searle IV Solutions (Pvt.) Ltd; Lahore has requested to cancel the registration of

following products from the address of their previous name of the firm i.e M/s. Mac & Rains
Pharmaceuticals (Pvt.) Ltd; Lahore and register in new name i.e M/s. Searle IV Solutions (Pvt.)
Ltd; Lahore:S.
No.
1.

2.

3.

Name of Drug(s)

Macsol 5% IV Infusion
Dextrose .. 5%
(500 ml and 1000 ml)
Macsol DS IV Infusion
Dextrose 5% ,
Sodium Chloride .0.9%
(500 ml and 1000 ml)
Macsol NS IV Infusion
Sodium Chloride 0.9%

Agenda 252

nd

221
Registration Board Meeting

Reg. No.

041432

041433
041434

Initial date of
Registration
and validity
08-11-2005
Valid until
07-01-2015

Date of
Application

08-11-2005
Valid until
07-01-2015

-do-

08-11-2005
Valid until

-do-

16-06-2014

(500 ml and 1000 ml)


4. Macsolate-D I.V Infusion
(Hartmanns Plus Dextrose)
Each 100ml contains:Sodium lactate... 0.32 gm
Sodium chloride 0.6
gm
Calcium chloride
0.027gm
Potassium chloride 0.04 gm
Dextrose.. 5gm
(500 ml and 1000 ml)
5. Macsol NS IV Infusion
Each 100ml contains:
Sodium Chloride 0.9%
(50 ml and 100 ml)
6. Macsolyte-M Infusion.
Each 100ml Solution Contains :Calcium Chloride 2H2O0.022gm
Potassium Chloride0.150gm
Sodium Chloride0.216gm
Sodium acetate 3H2O.0.313gm
Dextrose anhydrous..5gm.
(500 ml and 1000 ml)
7. Macsol 25% IV Infusion
Each 100ml contains:
Dextrose
25gm
Water for injection 100ml
8. Macsol NS IV Solution
Each 100ml contains:
Sodium Chloride 0.9%
Water for injection 100ml
9. Macsol 5% IV Infusion
Each 100ml contains:
Dextrose .. 5%
Water for injection . 100ml
10. Macrin Ringers IV Infusion
Each 500ml Contains:
Calcium Chloride 2H2O0.033%,
Potassium Chloride0.03%,

Agenda 252

nd

222
Registration Board Meeting

07-01-2015
08-11-2005
Valid until
07-01-2015

-do-

041435

048044

048045

069130

069131

069132
042872

10-01-2008
Valid until
Renewal status
no attached
10-01-2008
Renewal
applied on
10-01-2013

-do-

20-01-2011
Registration is
valid.

07-07-2014

20-01-2011
Renewal not
due.

07-07-2014

20-01-2011
Registration is
valid.

16-06-2014

16-03-2006
Valid until
15-03-2016

07-07-2014

-do-

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

Sodium Chloride 0.86%


Macsol 10% IV Infusion
Contains:
Dextrose 10%
Macsol 25% IV Infusion
Contains:
Dextrose
25%
Macsol DS IV Infusion
Each 100ml contains:
Dextrose 5%,
Sodium Chloride . 0.45%
Macsol Paeds IV Infusion
Contains:
Dextrose 4.3%,
Sodium Chloride 0.18%
Macsolate Intravenous Infusion
Each 100 ml Contains
Hartmanns Solution
Sodium Lactate.
0.32gm
Sodium Chloride.
0.6gm
Calcium Chloride
.0.027gm
Potassium Chloride
0.04gm
Mactol 20% IV Infusion
Contains:
Mannitol 17.5%,
Sorbitol 2.5%
Quinorains-P I.V Infusion
Each 100 ml contains:
Pefloxacin .. 400 mg
Florains I.V Infusion
Each 100 ml contains:
Ofloxacin as HCl ...200 mg
Levomac I.V Infusion
Each 100 ml contains:
Levofloxacin.. 500 mg
Moxirains I.V Infusion

Agenda 252

nd

223
Registration Board Meeting

042873

042874

042875

042876

16-03-2006
Valid until
15-03-2016
16-03-2006
Valid until
15-03-2016
16-03-2006
Valid until
15-03-2016

16-06-2014

16-03-2006
Valid until
15-03-2016

16-06-2014

16-03-2006
Valid until
15-03-2016

16-06-2014

16-03-2006
Valid until
15-03-2016

16-06-2014

03-08-2009
Renewal status
not attached.
03-08-2009
Renewal status
not attached.
14-11-2009
Renewal status
not attached.
14-11-2009

07-07-2014

07-07-2014

16-06-2014

042877

042878

059565

059566

060631
060632

07-07-2014

07-07-2014

07-07-2014

Each 250 ml contains:


Moxifloxacin as HCl... 400 mg

Renewal status
not attached.

The management of the firm has submitted following documents:i.


ii.
iii.

Application on form-5 alongwith fee of Rs. 20,000/- for each.


Copy of initial letter of registration and renewal status.
Approval of new manufacturing facility from CLB.

Case No.41: Cases referred by Pricing Division.


Pricing Division has forwarded a case of following non-oral/surgical item to Registration
Division for clarification that whether the referred to products entail approval as additional pack
or said or said demanded packs require fresh registration. The list of products is given below:S. No.

Name of Drug(s)

1.

Ashraf Cotton Bandage Type II


Contains:(Support Bandage)
(BP Specifications)
(Reg.No.078776)

2.

Ashraf Cotton Crep Bandage


Contains:-

Agenda 252

nd

Existing price/pack
size
Rs. 35.00/5cmx4m
Rs.65.00/1.0cmx4m
Rs.93.00/15cmx4m

Rs. 65.00/3x4.5m
(Stretched)

224
Registration Board Meeting

Demanded Price/pack
size
5cmx3mtr
5cmx5mtr
5cmx6mtr
6.25cmx3mtr
6.25cmx4mtr
6.25cmx5mtr
6.25cmx6mtr7.5cmx3mt
r
7.5cmx4mtr
7.5cmx5mtr
7.5cmx6mtr
10cmx3mtr
10cmx5mtr
10cmx6mtr
15cmx3mtr
15cmx5mtr
15cmx6mtr
Demanded price as per
latest SRO
7.5cmx3mtr
10cmx3mtr

3.

3.

4.

5.

6.

Cotton 100%
(Support Bandage)
(BP Specification)
(Reg.No.078775)
Kenacomb Ointment
Each gram contains:Triamcinolone Acetonide USP 1mg
Nystatin USP
100m000units
Gramidicin USP 0.25mg
Neomycin Sulphate eq. to 2.5mg
base
(Reg.No.075189)
M/s. GlaxoSmithKline Pakistan
Ltd; Karachi.
Oralone Ointment
Each gm contains:Triamcinolone acetonide .. 1mg
(USP Specification)
(Reg.No.076512)
M/s. Hiranis Pharmaceuticals (Pvt.)
Ltd; Karachi.
Eudyna Plus Mouthwash
Each ml contains:Chlorhexidine Gluconate 0.2% w/v
Sodium Fluoride .. 0.5%w/v
(Manufacturers Specification)
M/s. Hiranis Pharmaceuticals (Pvt.)
Ltd; Karachi.
Agilona Mouthwash
Each 100ml contains:Benzydamine HCl 0.15gm
Cetylpyridinium Chloride 0.05gm
(Manuacturers Specification)
(Reg.No.076568)
M/s. Hiranis Pharmaceuticals (Pvt.)
Ltd; Karachi.
Fides Ointment
Each gm contains:Bacitracin . 500units

Agenda 252

nd

Rs. 87.00/4x4.5m
(Stretched)
Rs. 65.00/6x4.5m
(Stretched)
Rs. 42.58/10gm

15cmx3mtr
Demanded price as per
latest SRO.

Rs. 32.00/5gm

10gm

Rs. 62.00/150ml

200ml

Rs. 69.00/120ml

200ml

Rs.53.00/14gm

20mg
30gm

225
Registration Board Meeting

Rs.64.00/15gm
Rs.85.00/20gm

7.

8.

9.

10.

Neomycin as sulphate .. 3.5mg


Polymixin B Sulphate .
5000units
Lidocaine .. 40mg
(USP Specification)
(Reg.No.076573)
M/s. Hiranis Phamraceuticals (Pvt.)
Ltd Karachi.
Gen-Beta Cream
Each gram contains:Betamethasone Dipropionate 0.46
Eq. to Betamethasone ...
0.5mg
Gentamicin sulphate . 1.70mg
eq. to Gentamicin .. 1mg
(Manufacturers Specification)
(Reg.No.076518)
M/s. Hiranis Pharmaceuticals (Pvt.)
Ltd; Karachi.
Septiwel Solution
Each 5ml contains:Povidone-Iodine .. 10%w/v
(USP Specs)
M/s. Medwell Pharmaceuticals,
Lawrencepur.
Meditoll Solution
Each 5ml contains:Chloroxylenol .. 4%w/v
R/O USP qs. 5ml
(USP Specs)
(Reg.No.075325)
M/s. Medwell Pharmaceuticals,
Lawrencepur.
Kleen Enema
Each 100ml contains:Monobasic Sodium phosphate
16gm
Dibasic Sodium Phosphate . 6gm
(USP Specification)
(Reg.No.078639)

Agenda 252

nd

226
Registration Board Meeting

Rs. 45.00/10gm

15gm

Rs. 15.0060ml

50ml

Rs. 70.00/500ml

4.5 Liters

Rs. 47.00/135ml

Rs. 73.11/210ml

M/s. Ameer & Adnan


Pharmaceuticals (Pvt.) Ltd; Karachi
Ticovate Nasal Spray 50mcg
Each Nasal spray contains:Fluticasone Propionate . 50mcg
(Saffrons Specification)
(Reg.No.060353)
M/s. Saffron Pharmaceuticals (Pvt.)
Ltd; Faisalabad.
Sera-Tulle (Sterile)
Contains:Chlorhexidine Acetate 0.5%w/w
Ointment Base
(Paktexs Specs)
(Reg.No.069868)
M/s. Paktex Industries, Kamonki,
Gujranwala.

11.

12.

Rs. 215.00/60
metered sprays

120 metered sprays

Rs. 10.00/
10cmx10cmx1s
Rs. 15.00/
15cmx10cmx1s

Rs. 360.00/
15cmx1.5cm, 1roll

Case No. 42: Registration For Export Purpose Not Me too.


i.

M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of
following products for export purpose only:-

S. No
1.

2.

3.

4.

Agenda 252

Name of Products
Cardelol CR Capsule 20mg
Each capsule contains:Carvedilol (as phosphate) 20mg
Cardelol CR Capsule 80mg
Each capsule contains:Carvedilol (as phosphate) 80mg
Cardelol CR Capsule 40mg
Each capsule contains:Carvedilol (as phosphate) 40mg
Ricoxib Tablet 120mg
Each film coated tablet contains:Etoricoxib . 120mg

nd

227
Registration Board Meeting

Remarks
Intl. availability
FDA/USA
Intl. availability
FDA/USA
Intl. availability
FDA/USA
Intl. availability
EMA/UK
Sirilanka

5.

Ricoxib Tablet 30mg


Each film coated tablet contains:Etoricoxib . 30mg
Ricoxib Tablet 90mg
Each film coated tablet contains:Etoricoxib . 90mg
Vitaxon Tablet 1500g
Each tablet contains:Mecobalamin 1500mg
Glukana Tablet 100mg
Each tablet contains:Cannaglifozin as hemihydrates . 100mg
Glukana Tablet 100mg
Each tablet contains:Cannaglifozin as hemihydrates . 100mg
Apixa Tablet 2.5mg
Each film coated tablet contains:Apixabab 2.5mg
Apixa Tablet 5mg
Each film coated tablet contains:Apixabab 5mg

6.

7.

8.

9.

10.

11.

Intl. availability
EMA/UK
Sirilanka
Intl. availability
EMA/UK
Sirilanka
Intl. availability
India
Intl. availability
Invokana 300mg
USA
Intl. availability
Invokana 100mg
USA
Eliquis
UK / USA
Eliquis
UK / USA

The firm has submitted the following documents. Products from Sr. 1 to Sr. 7 is not
registered locally in Pakistan:a.
b.
c.
d.
c.
e.
ii.

Fee of Rs. 20000/- for this purpose.


Form-5.
Copy of GMP inspection.
Export orders.
NOC for CRF.
Approval of section by CLB.
M/s. Remington Pharmaceuticals Industries (Pvt.) Ltd; Lahore has requested for
registration of following products for export purpose only:-

S. No
1.

Agenda 252

Name of Products
Maxvel Sachet
Each sachet contains:Glucosamine Sulphate 2KCl equivalent to 1500
mg of Glucosamine Sulphate

nd

228
Registration Board Meeting

Remarks
Dublin

2.

Orthocox Tablets 120mg


Each film coated tablet contains:Etoricoxib . 120mg
Orthocox Tablets 90mg
Each film coated tablet contains:Etoricoxib . 90mg

3.

UK

UK

The firm has submitted the following documents. Products are not registered
locally in Pakistan:a.
b.
c.
d.
c.
e.

iii.

Fee of Rs. 20000/- for this purpose.


Form-5.
Copy of GMP inspection.
Export orders.
NOC for CRF.
Approval of section by CLB.

M/s. Pacific Pharmaceuticals Ltd; Lahore has requested for registration of following
products for export purpose only:-

S. No.
1.

Name of Drug(s)

Remarks

Dihydrocodeine 30mg Tablet

Controlled drug.

Each tablet contains:Dihydrocodeine Tartarate .. 30mg


2.

Beclofen 10mg Tablet


Each tablet contains:Beclofen .. 10mg

The firm has submitted the following documents:-

Agenda 252

nd

229
Registration Board Meeting

Export order from


England

a.
b.
c.
d.
e.

Fee of Rs. 20000/- for this purpose.


Form-5.
Export order (Beclofen 10mg).
NOC for CRF.
Approval of section by CLB for Narcotic drugs and Export order not

provided.

f.

Copy of GMP inspection.

Case No. 43: Registration of Sofosbuvir for export


Following firms have requested for registration of following products for export purpose only:S. No

Name of the firm(s)

1.

M/s. CCL
Pharmaceuticals, Lahore

2.

M/s. Wilshire Labs;


Lahore

3.

M/s. Titlis Pharma,


Lahore

Name of Products
Sofos Tablet 400mg
Each film coated tablet contains:Sofosbuvir .. 400mg
Ziqar Tablet
Each tablet contains:Sofosbuvir .. 400mg
Fusbu 400mg Tablet
Each tablet contains:Sofosbuvir .. 400mg

The firm has submitted the following documents:a.


b.
c.
d.
e.

Agenda 252

nd

Fee of Rs. 20000/- for this purpose.


Form-5.
Copy of GMP inspection.
NOC for CRF.
Approval of section by CLB.

230
Registration Board Meeting

Case No.44: Registration of Linagliptin & Linagliptin containing products.


Linagliptin & Linagliptin containing products were considered by Registration Board in
its 237th, 242nd and 245th meeting of the Board for registration. M/s. AGP Pharma, Karachi has
been granted approval of drug, however, Linagliptin of M/s. CCL Pharma, Lahore and other
companies have been deferred by Registration Board for opinion of Law & Justice Division due
to the reason that M/s. AGP, Karachi had filed a writ petition in the Sindh High Court, Karachi to
bar other applicants to obtain registration of this drug. Registration Board in its 245 th meeting has
decided to refer the case for comments of Law Division.
The case was referred to Law, Justice & Human Rights Division for direction / view in the
following Decision of Sindh High Court, Karachi:till the validity of plaintiffs patent No. 141311, 141044 and 141068, defendants is
restrained from selling Linagliptin containing products or manufacturing or making
formulating, supplying, stocking, importing, exporting, offering for sale, passing off,
advertising or otherwise enabling others to infringe or pass off, offer for sale or use in
any form in any manner which is in infringement of the claims of the petitioners patent.
Resultantly, pending application (s) is also disposed of.
Law Division has furnished legal opinion as under:In the case in hand the court categorically said that the drug has a patent registered in
Pakistan since 21.08.2002 and it has restrained the defendant from selling linagliptin.
This restriction is to the extent of defendants only and is prohibiting manufacturing or
making formulating, supplying, stocking, importing, exporting offering for sale,
advertising or otherwise enabling others to infringe or pass off, offer of sale or use in any
form or in any manger, which is in infringement of the claims of plaintiffs paten till the
validity of patens. Therefore, this makes it a right in personam. As regards consideration
of the cases for registration no such direction or injunction can be inferred from the offer
placed in the reference. Thus the injunction is regarding making, sale and selling etc., and
no such injection is directed towards the Registration Board.

Agenda 252

nd

231
Registration Board Meeting

Case No. 45: Court case for Trade mark for information
F. Hoffmann-La Roche AG, Through its authorized attorneys submitted Suit No.
881 of 2014 in Sindh High Court, Karachi wherein they have stated that a corporation organized
and existing under, The laws of Switzerland, having a place, of business at 124
Grenzacherstrasse, 4058 Basel, Switzerland versus ZamZam Pharmaceuticals (Pvt.) Ltd; Karachi
and M/s. Shrooq Pharmaceuticals (P regarding similarity of brand name Bonviva Tablet of
M/s. Roche Karachi with Bonvir Tablet (Reg. No. 069364) containing Ibandronic Acid
150mg with Bonvir Tablet containing Ibandronic Acid (Reg.No.069364) of M/s. Shrooq
Pharmaceuticals, Lahore. The contents of the suit are related to trade mark used by M/s.
ZamZam Pharmaceuticals, Karachi and M/s. Shrooq Pharmaceuticals, Lahore. However the
plaintiff firm has prayed to direct Defendant No. 3 i.e DRAP to cancel the drug registration(s)
under No. 069364) issued to Defendant No. 1 and/or Defendant No. 2 in respect of the infringing
Bonvir product, or any other mark consisting of or similar to Plaintiffs Bonviva and
Bonviva and Leaping Lady logo.
The Registration Board in 243rd meeting has approved SOP for changing of brand name
which is as under:
Registration Board decided that if brand names of two products resemble, then later registration
holder is bound to propose alternate names for approval as one of condition of registration. But
in some cases, later registration holder do not propose alternate names. The Board decided that in
such cases DRAP will issue one reminder with 15 days time period and then manufacturing of
the product will be stopped after approval of Chairman, Registration Board. Stoppage of
manufacturing will be till approval of new brand name.
Parawise comments have already been forwarded to DDG (E&M), Karachi for onward
submission in the Honourable Sindh High Court, Sindh and the matter is subjudise.
Case No.46: Expert Opinion for new drug registration
The Registration Board in its 246th meeting deferred the following products of M/s.
Servier Research and Pharmaceuticals (Pakistan) Limited Lahore for expert opinion by:i.
Agenda 252

Brig(R). Dr. Muzamil H. Najmi, Member Registration Board


nd

232
Registration Board Meeting

ii.
iii.
S.
No.
1

Dr. Shahid Nawaz, PIMS, Islamabad.


Brig. Dr. Sohail Aziz, AFIC, Rawalpindi.
Name of Drug(s) with
formulation
Natrilam 10mg Tablets
Each tablet contains:Indapamide SR..1.5mg
AmlodapineBesilate..10mg
(Antihypertensive diuretic +
Calcium antagonist)
Natrilam 5 mg Tablets
Each tablet contains:Indapamide SR..1.5mg
Amlodapineas
Besilate..5mg
(Antihypertensive diuretic +
Calcium antagonist)

Pack
size
30s

Demande
d price
Rs.72.52/
Tablet

30s

Rs.36.26/
Tablet

Fee & form


20-6-2012
Rs.8000/30-04-13
Rs. 130,000/Total Fee Rs. 150,000/Form 5-D
05-04-2011 Rs.8000/30-04-13
Rs. 130,000/Total Fee Rs. 150,000/Form 5-D

The expert has given the following opinion:Brig. Dr. Sohail Aziz
Armed Forces Institute
Cardiology, Rawalpindi

Dr. Asad Riaz Kitchlew


of Head of Department of
Cardiology PIMS, Islamabad

The drug Natrilam 10mg/1.5mg In the light of clinical evidence


is recommended for registration and clinical use of both agents,
in Pakistan.
I would recommend the
registration of Natrilam in
Pakistan for effective blood
pressure control and its
cardiovascular benefits.

Agenda 252

nd

233
Registration Board Meeting

Brig Syed Muzamil Hassan


Najmi,

Natrilam of M/s. Servier is


combination of Imdapamide and
Amlodipine intended for use in
treatment of hypertension. The
combination seems rational
pharmacologically. Indapamide,
a thiazide related diuretic has
been shown in clinical tirals to
be highly effective for reducing
blood pressure in hypertensive
patients. It can also help to
reduce the pedal edema which is
a common side effect of the
calcium channel blockers like
amlodipine. The later drug has a
well-established
place
in
treatment of hypertension and

the CCBs as a class have been


recommended as preferred
drugs for hypertension in the
JNS guidelines.
Since Natrilam is a slow release
formulation, it is advisable that
dissolution
profile
and
pharmacokinetic data of the
formulation may be evaluated
before granting registration.
Recommended for registration
after this requirement.

Case No.47: Import to Local manufacturing


M/s. The Pak Lane Pharma, Lahore Cantt. has requested for local manufacturing and
packing by M/s. Neutro Pharma (Pvt.) Ltd; Lahore:Sr. No.
1.

Name of Drug(s)
Epiglu
Each tube of 0.1gm contains:Ethyl-2-Cyanoacrylate 95.45mg

Reg. No.
069596

The firm has furnished following documents:i.


ii.
iii.
iv.
v.
vi.

vii.

Fee of Rs. 50,000/- for this purpose.


Application dossier on form-5 of M/s. Neutro Pharma, Lahore.
NOC from importer dully attested from embassy of Pakistan in Germany.
Copy of initial letter of registration & renewal status.
Contract agreement on stamp paper.
The firm has not provided any data related to packaging material specifications,
Manufacturing method and Q.C testing method and specifications of final product
even on written requests.
Approval of liquid sachet of the firm is not provided.

Case No. 48

Agenda 252

nd

234
Registration Board Meeting

M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; has requested for change of toll/contract
manufacturer from M/s. Hansel Pharmaceuticals (Pvt.) Ltd; Lahore to M/s. Lahore Chemical &
Pharmaceuticals Works (Pvt.) Ltd; Lahore:S. No.
1.

Name of Drug(s)

Reg. No.

Bamifix Tablet
Each tablet contains:Bamifyline Hydrochloride
600mg

014936

Initial date of
registration and
validity
23-02-1994
Permission was
valid until 30-062015

Date of
application
05-12-2014

The firm has submitted following documents:a

Application dossier (evaluated).

Fee of Rs. 50,000/- for this purpose.

Initial letter of registration and relevant letters.

Inspection report with recommendations (firm has fair GMP compliance).

NOC for CRF clearance.

Submitted for consideration of Registration Board.

Case No. 49
M/s. Surge Laboratories (Pvt.) Ltd; Lahore has requested for extension of contract
manufacturing of their following products through toll manufacturing by M/s. Nabiqasim
Industries (Pvt.) Ltd; Karachi:S#

Applicant

Contract
Manufactu
re

Name of Drug (S) & Reg#


Composition

M/s. Surge
Laboratori
es (Pvt.)
Ltd;
Lahore

M/s.
Nabiqasim
Industries
(Pvt.) Ltd;
Karachi

Espidone Tablets
4mg
Each tablet
contains: Risperidone ..
4mg

Agenda 252

nd

235
Registration Board Meeting

03009
0

Date of
Application/F
ee

Remarks

09-07-2015
Rs. 50,000/-

Valid
until 3006-2015
Applicati
on after
due date.

-do-

-do-

Espidone Tablets
3mg
Each film coated
tablet contains:
Risperidone Eur.P.
. 3mg

03008
9

-do-

-do-

-do-

-do-

Espidone Tablets
1mg
Each film coated
tablet contains:
Risperidone Eur.P.
. 1mg

03008
7

-do-

-do-

-do-

-do-

03008
8

-do-

-do-

-do-

-do-

02677
1

-do-

-do-

-do-

-do-

04190
3

-do-

-do-

-do-

-do-

Espidone 2mg
Tablets
Each film coated
tablet contains:
Risperidone
Eur.P.2
mg
Lisodim 50mg
Tablets
Each tablet
contains:
Diclofenac Sodium
USP...50mg
Prexa Tablets
Each film coated
tablet contains:
Excitalopram as
Oxalate
10mg
Esprol Capsule
40mg
Each capsule
contains:
Esomeprazole
magnesium
Trihydrate eq. to
Esomeprazole (in
enteric coated pellet
forms)
...40mg

04189
3

-do-

-do-

Agenda 252

nd

236
Registration Board Meeting

-do-

-do-

Esprol Capsules
20mg
Each capsule
contains:
Esomeprazole
Magnesium
Trihydrate eq. to
Esomeprazole
enteric coated pellet
forms)
20mg
Brocef Suspension
125mg
Each 5ml
suspension (after
reconstitution)
contains:
Cephradine USP .
125mg

04189
4

-do-

-do-

-do-

-do-

02676
7

-do-

-do-

10

-do-

-do-

Brocef Capsules
500mg
Each capsule
contains:
Cephradine USP .
500mg

02677
0

-do-

-do-

11

-do-

-do-

02676
9

-do-

-do-

-do-

-do-

Brocef Capsules
250mg
Each capsule
contains:
Cephradine USP .
250mg
Brocef Suspension
250mg
Each 5ml
suspension (after
reconstitution)
contains:
Cephradine USP

250mg

12

02676
8

-do-

-do-

Agenda 252

nd

237
Registration Board Meeting

13

-do-

-do-

14

-do-

-do-

15

-do-

-do-

Scavia Suspension
200mg
Each 5ml
suspension (after
reconstitution)
contains:
Cefixime USP .
200mg
Scavia Capsules
400mg
Each capsule
contains:
Cefixime USP .
400mg
Scavia Suspension
Each 5ml (after
reconstitution)
contains:
Cefixime USP
100mg

05557
8

-do-

-do-

04522
3

-do-

-do-

04522
2

-do-

-do-

Submitted for consideration of the Registration Board.

Case No. 50
M/s. Surge Laboratories (Pvt.) Ltd; Lahore has requested for extension of contract manufacturing
of their following products through toll manufacturing by M/s. Nabiqasim Industries (Pvt.) Ltd;
Karachi for export purpose only :
S.N
o
1

Reg. No

Name of drug(s) &


Composition

000911EX

Cefren 250mg Capsule


Each capsule contains:Azithromycin USP 250mg
as Azithromycin Dihydrate

07-07-2015
Fee of Rs. 50,000/- for
each product

Permission was
valid until 3006-2015

Cefren 200mg Suspension


Each 5ml contains:Azithromycin USP . 200mg as
Azithromycin Dihydrate

-do-

-do-

000913EX

Agenda 252

nd

238
Registration Board Meeting

Date of Application/Fee

Remarks

001040EX

Romycin 250mg Capsule


Each capsule contains:Azithromycin USP .. 250mg
as Azithromycin dehydrate

-do-

-do-

001106EX

-do-

-do-

00104-EX

VitCa 4 All Sachet


Each sachet contains:Calcium Lactate Gluconate
1000mg
Calcium Carbonate BP 327mg
Folic Acid .. 1mg
Vitamin C (Ascorbic Acid)
BP 500mg
Vitamin B 12 (Cyanocobalamin)
USP . 250mcg
Lipinor Tablet 10/10
Each film coated tablet
contains:Amlodipine . 10mg as
Amlodipine Besylate Ph.Eur
Atorvastatin 10 mg
as Atorvastatin Calcium
Trihydrate (MS)

-do-

-do-

001039EX

Romycin 200mg Suspension


Each 5ml contains:Azithromycin USP .. 200mg
as Azithromycin Dihydrate

-do-

-do-

001097EX

Imexium 40mg Capsule


Each capsule contains:Esomeprazole mangnesium
trihydrate eq. to Esomeprazole
(in enteric coated pellets form)
40mg

-do-

-do-

001099EX

Diatrom Tablet 80mg


Each tablet contains:Gliclazide BP .. 80mg

-do-

-do-

001095EX

Lipinor 5/10 Tablet


Each film coated tablet
contains:Amlodipine . 5mg as

-do-

-do-

Agenda 252

nd

239
Registration Board Meeting

Amlodipine Besylate Ph.Eur


Atorvastatin 10 mg
as Atorvastatin Calcium
Trihydrate (MS)
10

000844EX

11

001093EX

12

001106EX

13

001096EX

14

001044EX

15

001049EX

16

001102EX

Agenda 252

nd

Opracid Capsule 20mg


Each enteric coated capsule
contains:Omeprazole USP .. 20mg (in
enteric coated pellets form)
Cardisar 80mg Tablet
Each film coated tablet
contains:Telmisartan .. 80mg
K-Enema Solution
Each 120ml (delivered dose)
contains:Monobasic Sodium Phosphate
USP . 19.2g
Dibasic Sodium Phosphate USP
... 7.2g
Lipinor 10/20 Tablet
Each film coated tablet
contains:Amlodipine . 10mg as
Amlodipine Besylate Ph.Eur
Atorvastatin 20mg
as Atorvastatin Calcium
Trihydrate (MS)
Lumfort Syrup
Each 5ml contains:Loratadine USP 5mg
Lipinor 5/20 Tablet
Each film coated tablet
contains:Amlodipine . 5mg as
Amlodipine Besylate Ph.Eur
Atorvastatin 20mg
as Atorvastatin Calcium
Trihydrate (MS)
Clopivix Tablet 75mg
Each film coated tablet
contains:Clopdogrel USP
75mg (as Clopidogrel
240
Registration Board Meeting

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

-do-

bisulphate)
17

001100EX

Cardisar Plus Tablet


Each film coated tablet
contains:Telmisartan 40mg
Hydrochlorothiazide 12.5mg

-do-

-do-

18

001098EX

-do-

-do-

19

001103EX

-do-

-do-

20

001101EX

-do-

-do-

21

000567EX

-do-

-do-

22

001045EX

Imexium 20mg Capsule


Each capsule contains:Esomeprazole mangnesium
trihydrate eq. to Esomeprazole
(in enteric coated pellets form)
20mg
Cardisar 20mg Tablet
Each film coated tablet
contains:Telmisartan .. 20mg
Cardisar 40mg Tablet
Each film coated tablet
contains:Telmisartan .. 40mg
Lordam Tablet
Each tablet contains:Loratadine . 10mg
Lumfort Tablet
Each film coated tablet
contains:Loratadine USP .. 10mg

-do-

-do-

It is submitted that export registration permission was valid until 30-06-2015 and was
given on basis of export order at that time. If agreed export may be treated for one time and the
firms may apply a fresh for export purpose registrations.
Submitted for consideration of Registration Board.

Agenda 252

nd

241
Registration Board Meeting

Case No.51

Case deferred for confirmation of section. M/s CCL Pharma, Lahore.

Following product of M/s CCL Pharma, Lahore deferred for confirmation of section in
228th meeting of Registration Board held on 12th & 13th October 2010.
Name of Drug(s) with formulation

Pack size

Linzo Tablets 400mg


Each film coated tablet contains:Linezolid.400mg

5s
10s

Demanded
pricie
As Brand
Leader

Decision
Deferred for
the
confirmation of
section.

The firm submitted that they think decision mentioned erroneously due to copy paste as in same
meeting i.e the decision of M/s. Himont Pharma, Lahore was deferred for the confirmation of
section while the same was also written in the column of M/s. CCL Pharmaceuticals, Lahore.
However, their other products in tablet are already approved. The firm possess the relevant
facility to manufacture the above mentioned product.
The firm also submitted:
i) The requisite balance fee amounting Rs.12,000.00 for registration as per new fee
schedule.
ii) Approval of Tablet Section by Licensing Directorate.
Submitted for consideration of Registration Board.
Case No.52

Personal Hearing

Registration Board in its 249th meeting decided to call M/s. Searle IV Solutions (Pvt.)
Ltd; Lahore & M/s. The Searle Company Karachi for personal hearing regarding their joint
request that they have decided to keep all the above registrations in the name of M/s. The Searle
Company Ltd; Karachi and withdraw for shifting of registration of their following products. The
approval letter regarding the shifting of registration of 246th meeting has not been issued yet:S. No.
1.

Agenda 252

nd

Name of Drug(s)
Metronzine Injection
Each 100 ml contains:-

242
Registration Board Meeting

Reg. No.
018632

2.
3.
4.
5.
6.
7.

8.

9.
10.
11.

12.

Agenda 252

nd

Metronidazole .. 500 mg
Vaptor 20 mg Tablets
Each tablet contains:Rosuvastatin (as Calsium) .20 mg
Searl- 0.5 mcg Tablets
Each tablet contains:Alfacalcidol 0.5 mcg
Rhulef 20 mg Tablets
Each film coated tablet contains:Leflunomide . 20 mg
Gravinate Injection
Each ml contains:Dimenhydrinate 50 mg
Searl- 1 mcg Tablet
Each tablet contains:Alfacalcidol .. 1 mcg
Peditral Liquid
Each 5 ml contains:Sodium Chloride ...... 17.50 mg
Potassium Chloride 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose 100.00 mg
(Flavour: Orange)
Peditral Liquid
Each 5 ml contains:Sodium Chloride ...... 17.50 mg
Potassium Chloride 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose 100.00 mg
(Flavour: Regular)
Rhulef 10 mg Tablets
Each film tablet contains:Leflunomide . 10 mg
Searl- 0.25 mcg Tablet
Each tablet contains:Alfacalcidol .. 0.25 mcg
Co-Olesta Tablet
Each tablet contains:Olmesartan ... 20 mg
Hydrochlorothiazide .. 12.5 mg
Vaptor Tablets
Each tablet contains:-

243
Registration Board Meeting

044077
047384
047391
014408
047383
067114

067113

047390
047382
058022

044075

Rosuvastatine (as Calcium) .. 5 mg


13.

Olesta 20 mg Tablet
Each tablet contains:Olmesartan Medoxomil 20 mg

050736

14.

Olesta 40 mg Tablet
Each tablet contains:Olmesartan Medoxomil 40 mg

050737

15.

Peditral Liquid
Each 5 ml contains:Sodium Chloride 17.50 mg
Potassium Chloride .. 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose ... 100.00 mg
(Flavour: Banana)

067116

16.

Peditral Liquid
Each 5 ml contains:Sodium Chloride 17.50 mg
Potassium Chloride .. 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose ... 100.00 mg
(Flavour: Bubble gum)
Co-Olesta Tablet
Each tablet contains:Olmesartan ... 40 mg
Hydrochlorothiazide .. 12.5 mg
Simbex Tablets
Each tablet contains:Simvastatin . 10 mg
Ezetimibe 10 mg
Vaptor Tablet
Each tablet contains:Rosuvastatin (as Calcium) . 10 mg
Simbex Tablets
Each tablet contains:Simvastatin . 20 mg
Ezetimibe 10 mg
Rhulef 100 mg Tablets
Each tablet contains:Leflunomide 100 mg

067115

17.

18.

19.
20.

21.

Agenda 252

nd

244
Registration Board Meeting

058023

044048

044076
044049

047389

Both the firm i.e M/s. The Searle Company Karachi and M/s. Searle IV Solutions have been
called for personal hearing as desired by Board.
Submitted for consideration of Registration Board.
Case No.53: Registration of Nimesulide tablet 100mg, M/s Irza pharma, Lahore.
Registration Board in its 218th meeting deferred the following product of M/s. Irza
Pharma (Pvt.) Ltd; Lahore:Name of Drug(s)

Pack size

I-Nim Tablets 100mg


Each tablet contains:Nimesulide 100mg

2x10s
3x10s
5x10s

Demanded
MRP
Rs.95.00
Rs.130.00
Rs.220.00

Later on, the firm filed a writ petition No. 472/2011 before Islamabad High Court,
Islamabad for the disposal of the said application. The writ petition was disposed off by the court
on 18.02.2011 with the directions to Registration Board to decide the pending reference within
period of two months.
The firm informed that their request was not succeeded and they again approached
honorable court through Criminal original No.124/W/2011 against the then DG, Ministry of
Health but on verbal request, same was withdrawn.
Firm has provided copy of the Honourable Court orders. The firm has not submitted
differential fee for this purpose and has informed that the matter is still pending.
It is submitted that the matter of registration of Nimesulide was under review by the
Registration Board and the Board in 250th meeting decided as under:-

NIMESULIDE 100MG TABLETS


Me too status
NIMEROL of M/s
Brayon
NEMSIS of M/s

Agenda 252

Remarks
Having considered the overall submitted data provided by the MAHs in writing and in the
oral explanation, the CHMP (Committee for Medicinal Products for Human Use)
concluded:

nd

245
Registration Board Meeting

Genome
NIMS of M/s SAMI

that evidence of the clinically efficacy of nimesulide-containing products for systemic


use in the indications for short-term treatment has been shown. No unequivocal and
clinically meaningful
advantage over other NSAIDs has been demonstrated and, therefore the Committee
considered the efficacy of nimesulide to be similar to other NSAIDs available.
that nimesulide overall gastrointestinal toxicity is comparable to other NSAIDs but that
nimesulide
is associated with an increased risk for hepatotoxicity. The combined safety profile in
terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse
than some other alternative NSAIDs such as diclofenac and naproxen. Furthermore, the
limitations of the current available data lead to uncertainties on hepatotoxicity, and
concerns remain especially with prolonged use of nimesulide.
Considering the maximum duration of 15 days of treatment to minimise the risk for
hepatotoxicity
and aiming a further minimisation of the risks associated with nimesulide, the Committee
considered that nimesulide use should be restricted to acute conditions only i.e. treatment
of acute pain and primary dysmenorrhoea.
That in light of the above, considered that there is a risk of chronic use of nimesulide
in symptomatic treatment of painful osteoarthritis and concludes that the risk-benefit
balance of nimesulide-containing medicinal products for systemic use is no longer
favourable in this indication.
CHMP Recommendations:

Prescribers should no longer prescribe systemic nimesulide for


treating painful osteoarthritis

Prescribers should review treatment of patients being treated for


painful osteoarthritis with a view to choosing an appropriate
alternative treatment.

Nimesulide should only be used as a second choice, and only in the


treatment of acute pain or dysmenorrhoea.

Patient currently receiving systemic nimesulide for painful


osteoarthritis should consult their doctor in order to arrange
alternative treatment.

Patients who have any questions should speak to their doctor or


pharmacist.

The European Commission issued a decision on 20 January 2012.


(Ref: EMA Asessment Report)

Agenda 252

nd

246
Registration Board Meeting

Decision
i.
Rejected on the grounds that the drug has no clinically meaningful advantage over other NSAIDS and that
nimesulide is associated with increased risks of hepatotoxicity compared to other drugs in the class. Moreover,
the combined safety profile in terms of hepatotoxicity and GI toxicity is shown as worse than some other
alternative NSAIDS such as Diclofenac and naproxen. Hence keeping in view Risk vs benefit ratio, registration
application containing Nimesulide are rejected.
ii.
Showcause notice shall be issued for de-registration of registered drugs containing Nimesulide.

Submitted for consideration of Registration Board.

Agenda 252

nd

247
Registration Board Meeting