Agenda for 247 Meeting, Registration Board to be held on 04 ...

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Agenda for 247th

Meeting, Registration Board to be held on

04th

February, 2015.

Item No. Detail of Item

Item No.I Confirmation of minutes of 246th

meeting Registration Board

Item No.II Standard Operating Procedure for preparation of agenda and minutes of

Registration Board meeting

Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division

Item No.IV Registration of drugs - Pharmaceutical Evaluation Cell

Item No.V Miscellaneous cases - Pharmaceutical Evaluation & Registration Division

Item No.VI Registration of Biological Drugs – Biological Evaluation & Research

Division

Any other item with permission of Chair

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Item No I: Confirmation of minutes of 246th

meeting Registration Board.

246th

meeting of Registration Board was held on 10-11th

December, 2014 and minutes

were circulated to all members through e-mail. Director DTL, Quetta forwarded following

comments, as follows:

a. Item No. X: (246-M) Local Manufacturing of Biological Drugs:

The Registration Board has shown their concern to the local biological manufacturer’s

for the purpose to ensure the safety, efficacy and quality of the local manufacture of the

biological drugs in the country. The local Manufacturer have agreed to all the conditions

highlighted from point a to g however in my opinion it was not decided that the data provided by

the local manufacturer shall be evaluated by the Expert Committee on Biological Drugs.

Recommendation of the committee shall be considered by the Registration Board for issuance of

registration letter.

In my opinion, if in this way the cases are referred back to committees , then I fear that

the future of local manufacturing of biological products in the country will become history

therefore as per agreed decision the registration letters of biological products may be issued in

the public interest without compromising safety, efficacy and quality of the drugs.

b. f. (246-M) Manufacturing requirement for various classes of drugs.

As in the previous meeting I have submitted my observation that as an international

practices all the steroidal preparations except topical preparations have separate manufacturing

area and the same was agreed, however the minutes received on this agenda point is added with

that “such external preparations will be on campaign manufacturing basis in general

manufacturing area with segregated dispensing booths”, therefore as far as I recall it was not

decided like this , therefore external preparations for such dosage forms may be allowed in

general area and there is no need to keep bar on the manufacturer to manufacturer such dosage

forms on campaign basis , furthermore there is no need for segregated dispensing booths ,

however the manufacturer should ensure cGMP, cleaning validation and validated HVAC

system in place .

c. Agenda Item No. IV (243-M) manufacturing requirement for various categories of

drugs.

Carbapanems are a class of Beta – Lactam antibiotics with a broad spectrum of

antibacterial activity. There was some ambiguity whether dedicated manufacturing facilities

should be required or the current practice in the country may be continued, after marathon

scientific deliberations by the Board Members finally it was decided that Carbapanems will be

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manufactured in dedicated facilities . Moreover, all manufacturers having registration of these

drugs will be informed to establish dedicated facilities within six months.

My point is this that six month period was not sufficient to establish dedicated area therefore I

recommend that further six months period may be permitted to the manufacturer to establish

dedicated area .

d. Item No. II: (243-M) Change of Brand Name of Registered Drugs:

This point was well taken up by the Board and substantial action was taken where it was required,

however on the same lines there was one case of the Company namely S.J & Fazal Ellahie (Pvt)

Ltd Karachi and in 231st meeting of CLB another company is granted registration with the name

S.Fazalilahi & Sons (Pvt) Lahore its name very closely resembles with the S.J & Fazal Ellahie

(Pvt) Ltd Karachi therefore I recommended that its name should be changed , in this matter the

registration board referred the case to Licensing Division DRAP for appropriate action at their

end but so far on ground no action is taken if it is taken then the board may be informed about the

action taken so far.

e. Transfer of Drug Registration to M/s Getz Pharma (Pvt) Limited Karachi.

The received minutes of the meeting shows that the decision taken for the grant of above

registrations in name of M/s. Getz Pharma (Pvt) Limited, Karachi is as that “Chairman,

Registration Board will permit issuance of registration letter after evaluation / completion of

Form 5A as per check list approved by Registration Board, comments of Cost & Pricing Division

about MRP of the drug and compliance of Import Policy for Finished Drugs.”

“My observation may be noted that the Product is already registered in the country and for the

last two decades it is available in Pakistan and we know it’s very important general anesthetic by

inhalation drug and essential in hospital care setting for routine operations. Re-evaluation of the

already registered product with the same source and that has the approval of EMA is an un-

substantiated decision which will make the life saving drug short in the market. This may have

deleterious consequences on the ailing society of Pakistan. The decision may be re-visited and

grant of registration may be approved.”

Chairman, Registration Board approved the minutes with direction to place points a, b, c

and e in agenda of forthcoming meeting of Registration Board.

For point d, a reference was sent to Licensing Division for further action. The later

Division advised that M/s S.J & Fazal Ellahie (Pvt) Ltd, Karachi my be advised to process their

application for this purpose.

Submitted for consideration of Registration Board.

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Item No II: Standard Operating Procedure for preparation of agenda and minutes of

Registration Board meeting.

Registration Board considers cases for following Divisions of DRAP.

Pharmaceutical Evaluation & Registration.

Biological Drugs

Medical Devices & Medicated Cosmetics

Quality Assurance & Lab Testing

Pharmacy Services

In 246th

meeting, Registration Board decided that agenda will be circulated about 07 days

before the meeting. For this purpose, Directors of above Divisions met and prepared Standard

Operating Procedure for preparation of agenda and minutes of Registration Board meeting,

which is as follows:

1. Tentative date for next meeting of Registration Board (RB) will be decided in the

preceding meeting.

2. Concerned Division will forward agenda 10 days before the meeting in any case to

Secretary, RB (hard and soft copy).

3. Secretary, RB will compile agenda received from various Divisions and will send to

members 07 days before the meeting.

4. Agenda of the meeting will be prepared on following format.

a. Text will be in Times New Roman with 12 font size.

b. Table will be inserted properly. Text of table will be Times New Roman in 11

font size.

c. Number and bullets will be inserted in proper format.

d. All cases of similar nature will be placed under one heading with sub-numbering.

5. After the meeting, respective Division will immediately prepare and forward draft

minutes (hard and soft copy) to Secretary, RB but not later than within 03 days of the

meeting.

6. After receipt of draft minutes from all Divisions, Secretary, RB will compile and then

forward draft minutes (by email) to participating members of the Board for their

comments within 03 days.

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7. Members will forward their comments (if any) by email within next 03 days to Secretary,

RB.

8. Secretary, RB will process the minutes with comments of members (if any) for approval

of Chairman, Registration Board.

9. After approval, officer(s) and Director of the concerned Division, Secretary and

Chairman, RB will sign relevant pages of the minutes. Soft copy of approved minutes

will be circulated by email to participating members of the Board, Director of relevant

Division for implementation of decision and Director MIS for uploading on DRAP’s

website within 02 days. Relevant portion of hard copy of the minutes will also be

circulated to concerned Divisions for record as well.

10. Concerned Division will take appropriate action on the minutes within 15 days on all

relevant items, accordingly.


Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division

Case No.01 Registration of a Patent Drug – Iodine Complex

M/s MTI Medical (Pvt) Limited Lahore informed that they have developed Iodine complex

molecule in their Research & Development Laboratories and the said molecule has been awarded

patent in Pakistan. The firm submitted that they have conducted preclinical studies in UVAS

(University of Veterinary & Animal sciences, Lahore) and human studies in different teaching

hospitals in Pakistan. Results of these studies have been published in international and national

journals which show that addition of iodine complex with standard therapy of Hepatitis gives

significant results.

S/N

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition, Pharmacological

Group (as submitted by the firm)

Finished product Specification

Type of Form, Initial date,

diary, Fee including

differential fee, Demanded

Price / Pack size

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The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding

and treating some deadly diseases and diseases due to iodine deficiency, therefore requested to

register the drug on fast track basis in public interest. In this regard, they have submitted registration

applications on Form-5 E in different dosage forms. Details of which are tabulated below.

1. IODIRIN Tablets

200mcg

Each tablet contains:

Iodine complex equivalent to

elemental Iodine…….200mcg

Iodine deficiency disorder/

Antithyroid

Manufacturer

Form-5E; 23-10-14 Dy. No:

1271 50,000/-

Not provided

2. IDOMARINE Capsules

50mg

Each capsule contains:


elemental Iodine…….50mg

Iodine deficiency disorder/

Antithyroid/ Immunomodulator

Manufacturer

Form-5E, 23-10-14 Dy. No:

1271 50,000/-, Not provided

3. RENESSANS Capsule

200mg




Antiviral/ Hepatic Preps/


Manufacturer

Form-5E, 23-10-14 Dy. No:

1271, 50,000/-

Not provided

4. RENESSANS

Suspension 15mg/ 5ml

Each 5ml contains:



Antiviral/ Hepatic Preps/


Manufacturer

Form-5E, 23-10-14 Dy. No:

1271, 50,000/-

Not provided

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2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following

observations have been noticed:

a. The applicant has been granted patent for the said molecule named as “Iodine Complex”

for cure against Hepatitis C. Here, the question arises that whether patent is valid for

purpose of getting the registration for a patent drug or not.

b. The application has been filed on Form 5-E for the purpose of registration of a patent

drug and currently the Pharmaceutical Evaluation Cell has no approved check list for the

said form. There are many clauses of the said form wherein the applicant is unable to

answer properly. Evaluation reports clearly depicts the same.

c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case

(being new molecule not elsewhere approved in the world). At present, the Cell for the

said purpose (especially in cases of new drug molecule), relies on the approvals by the

Stringent or Reference Drug Regulatory Agencies of the world like USFDA, EMA, TGA,

Health Canada & PMDA Japan etc. While the drug under discussion has no such approval

from any of the drug regulatory agency in the world.

5. In the light of the above observations, the case was handed over to Pharmacy Services Division,

who has taken up the case. The said Division has forwarded the submitted clinical trial data /

research publication of the applicant to the Executive Director of PMRC for the validity of the

trials / research conducted. Their reply is awaited. The case is therefore, placed for consideration

before Registration Board.

The case was discussed in the M-246th

meeting Registration Board, inwhich Dr. Muhammad

Ajmal and his team appeared and presented before the Board about development of above

formulations and results of clinical trials conducted on the above formulations. Registration

Board then directed the applicant to provide all the documents related to development of

formulations and their clinical studies for confirmation of safety and efficacy to the Prof. Dr.

Muzammil H.Najmi, Member Registration Board for further evaluation.

Comments of Prof. Dr. Muzammil Najmi, Member Registration Board is as under:

The studies and data provided by M/S MTI has been reviewed. The following

discrepancies /shortcomings have been noted in the project.

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i. The principal investigator of the clinical trial conducted on hepatitis C patients was

himself the Chairman of the Review Board granting ethical approval of the project. The

clash of interest is evident in the case.

ii. The trial was not blinded to eliminate the bias.

iii. Direct jump to phase-3 trial has been made without having sufficient data of Phase-1 & 2

studies, particularly toxicological screening.

iv. The drug has been tested in combination with already established drugs without having

the data of single drug studies.

v. The publication claimed in impact factored journal is actually an abstract published on

the basis of a presentation made in a conference.

It is concluded that the data available at present is insufficient to form the basis for

registration of Iodine complex Renessans as a drug for clinical use.

Submitted for consideration of Registration Board

Case No.02 Polio End-Game Strategies-Poliovirus Type 2 challenge study. A Five Arm

Community Based Randomized Trial, Karachi. Pakistan.

The Aga Khan University has applied for the clinical trial to be conducted in

collaboration with WHO in assistance with EPI Programme.

The key feature of the trial is as under:

Title Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

Community Based Randomized Trial, Karachi. Pakistan.

Phase III

Background Polio disease is present in only three countries including Pakistan. Since the

injectable polio vaccine has better results, WHO “Polio Endgame Strategy ”

is to slowly withdraw the current vaccines replace all oral polio vaccine with

injectable polio vaccine.

Objective The over all purpose of this study is to compare the suggested five different

polio vaccine strategies to see which produces the best immunity for Pakistani

Children and prevents the spread of polio.

Participating

Country/Sites.

Pakistan

Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,

Ibrahim Hyderi and Bhains Colony.

Number of 1000 children each study group (arm) will have 200 children.

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participants

Duration of

Trial.

One year (June 2014-15)

Study

Interventions. Oral Bivalent vaccine – Available from EPI

Oral Trivalent Vaccine – Available from EPI

Inactivated Polio Vaccine (IPV) – To be imported

Inactivated Polio Vaccine2 (IPV2) – To be imported

Oral Monovalent Vaccine2 (mOPV2) – To be imported at a later stage

in the study. An amendment and request will be sent to DRA at that

time.

Study

Outcomes To determine which vaccine best protects the children from polio

Quantity of

Drug to be

Imported.

IPV= 1510 Doses

IPV= 230 Doses

Other vaccines are already registered and standard of care. These will

be purchased from EPI.

Registration

Status of drugs

in Pakistan.

Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.

Monitor of the

Trial. Dr. Maha Mohamed Saadeldine Salama

Head Clinical Research Sector/VACSERA, Cairo Egypt.

Sponsor World Health Organization (Geneva)

Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk

components since 1994. The company has now developed an investigational monovalent high

dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication

Initiative (GPEI) and World Health Organization (WHO)’s strategic advisory group of experts

(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 D-

antigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type

2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen

should permit the one step immunization of children against type 2 polioviirus while avoiding

the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus

vaccine (OPV).

Bulk virus was initially produced in monkey kidney cells and is now produced in Vero

cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.

Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were

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also obtained for this formulation. When production of IPV was switched from sub cultured

monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were

conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to

the safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A

nonclinical toxicology study in rats showed no unexpected toxicological findings.

There are currently no clinical data with the m-IPV-HD. However, clinical studies

showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune

response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further

supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million

IPV-Vero vaccine doses distributed worldwide in close to 60 countries.

As per procedure in vogue the submitted trial was referred to three experts for expert

opinion to facilitate the decision making process by the Registration Board. The same is

summarized as under:

S.No. Expert Name Opinion

1. Syed Sohail Zahoor

Zaidi, Chief Scientist

(Virology) Head of

Department of Virology

It is hereby informed that the subject study is well planned to

determine the improved effect of vaccination with combined

formulations i.e bivalent OPV + IPV vaccines to fill-in the

gaps in immunity type 2 polioviruses among Pakistani

Children.

The study will be conducted with the financial and technical

support of WHO Head Quarters, Geneva and does not pose

any apparent burden on the GoP/National or international stake

holders providing assistance for the Polio Eradication program

in the country.

I hope that the findings and outcomes of this interventional

study will improve our understanding and help to devise

progressive recommendations for vaccination to achieve the

goal of Polio eradication.

2. Mr.Mazharullah

Memon, Principal

Scientific

Officer/Manager

Quality Control

Laboratory.

The five arms plan for End Game Polio Virus, the pattern of

dosing as described are suitable for the subject study and the

subject clinical trial is suggested in my opinion and there is no

financial burden on the Government of Pakistan.

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3. Dr. Haider Sherazi,

Neonatology, PIMS,

Islamabad.

The expert has recommended the clinical trial.

The institution has also requested for import of the following trial material to supplied by the

WHO through EPI:

Drug Name Quantity required

Inj IPV 1510 Doses

Inj IPV2 230 Doses

The case was discussed in the previous M-246th

meeting of Registration Board, wherein the

Board considered the trial for its all prons and cons keeping in view the prevalence of polio in

the country. Board after thorough deliberation deferred the case for presentation by Principal

Investigator (PI) of the trial. The PI has therefore, been called for his presentation.


Case No.03 Approval of Clinical sites for the conduction of an international randomized

double blind placebo controlled trial regarding use of tranexamic acid for the treatment of

Postpartum Hemorrhage.

The Professor Rizwana Chaudhri has been granted the permission for the said clinical trial vide

letter No.3-5/2010-ADC(CT) dated 18th

February, 2013 for the 15 approved centers / hospitals.

Now, the applicant has requested that the trial aims to recruit 20,000 patients worldwide. At the

start of this trial, other countries started to recruit before Pakistan. International countries

contributed a large proportion of patients initially. The growth of the WOMAN trial in Pakistan

during the last 18 months is fantastic. Now, the pI (Principal Investigator) desires to increase the

number the trial centers from 15 to 40 with additional recruitment of the patients. With this

modification in the trial it has becoming the highest recruiting country. For which fresh approval

from the Registration Board is required to record post-approval trial variation in the submitted

protocol.

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Sites in Pakistan are continually joining & therefore we do not have an absolute number of the

proportion of total patients that will be entered, however we predict this will be between 50-70%

in the remaining 14 months in the trial.


Item No. IV Registration of drugs - Pharmaceutical Evaluation Cell.

Case No.01. Registration applications of brand leaders products whose me-too Products are

already registered in Pakistan.

In 244th meeting of Drug Registration Board it was brought to the notice of the Board that generic

products of some molecules have been considered by the Board for new licensees but brand leader’s

products are still not scrutinized. The Drug Registration Board in its 244th meeting had advised PEC to

evaluate those pending registration applications of brand leaders on priority whose generic products have

already been considered by the Board.

Following clarifications are required from Registration Board.

i. Whether Brand leader means “Innovator” or a Firm being granted registration of a new

molecule/drug for the first time in the country.

ii. If such a molecule/drug being granted to a firm in Fast Track, additional section or in

routine, whether the Innovator/brand leader should be given priority for registration or otherwise.

Submitted for orders of the Board, please.

Case No. 02: Registration of drugs – 10 products per section.

M/s Martin Dow Ltd, (formerly M/s Roche Pakistan Ltd) Karachi has informed

that on 22nd

June, 2011 they were granted additional Psychotropic (Tablet products already

registered) Section by Central Licensing Board in its 227th

meeting. 07 Products were already

registered in the name of M/s Roche Pakistan Ltd, Karachi and accordingly these drugs were

transfer to their name. In March, 2013 they were applied following drugs for registration.

S.

No.

Name of drug(s) & Composition Proposed

Pack

Proposed

MRP

Date of

application,

Diary No. &

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Form

1. Anzolam 1mg Tablet


Alprazolam …………..1 mg

(Benzodiazepine derivative)

10’s

20’s

30’s

Rs.232.33

Rs.464.67

Rs.697.00

29-03-2013

Dy.No.200

Form-5

Rs.20,000/-

2. Anzolam XR 1mg Tablet

Each extended release tablet

contains:

Alprazolam …………..1 mg


10’s

20’s

30’s

Rs.153.27

Rs.306.53

Rs.459.80

29-03-2013

Dy.No.198

Form-5

Rs.20,000/-

3. Anzolam 0.5mg Tablet


Alprazolam …………..0.5 mg


10’s

20’s

30’s

Rs.139.33

Rs.278.67

Rs.418.00

29-03-2013

Dy.No.199

Form-5

Rs.20,000/-

M/s Martin Dow has requested to grant registration of above 03 products to

complete 10 products per section.

Case No. 03: Registration of Drugs of Public Health Urgency on Priority Basis.

UNICEF Pakistan had made a request for urgent registration of “7.1% Chlorhexidine Digluconate

Gel (4% active Chlorhexidine)” as this drug is considered an important intervention in cord care and

reported to decrease infant mortality rate by reducing the incidence of umbilical cord related infections in

neonates.

The request made by UNICEF Pakistan was forwarded to Committee for disposal of registration

applications of public health urgency which comprised of Chairperson, Policy Board DRAP, CEO, DRAP

and Mr. Abdul Latif Shaikh, Member Policy Board, DRAP. This committee has recommended to process

the registration application of “7.1% Chlorhexidine Digluconate Gel (4% active Chlorhexidine)” on

priority basis. Meanwhile, Director Programs, M/o NHSR&C has also inquired about the registration

status of the subject drug.

Following applications have been forwarded by registration sections to Pharmaceutical

Evaluation Cell for evaluation on priority basis and their status as per scrutiny of PEC is as under:

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Name and

address of

Manufactur

er /

Applicant

Brand Name

(Proprietary

name +

Dosage form +

Strength)

Composition

Pharmacologi

cal Group

Finished

product

specification

Type of

Form

Initial

date,

diary.

Fee

includin

g

different

ial fee

Demand

ed Price

/ Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)

Remarks / Observations

M/s Atco

Laboratories

Limited B-

18, S.I.T.E,

Karachi.

Umbilica Gel

Contains:

Chlorhexidine

(as

Chlorhexidine

digluconate

solution Ph.

Eur. 7.1%

W/v)...4% w/v

(Antiseptic and

disinfectant for

umbilical cord

care in

neonates)

(B.P Specs)

Form 5-

D

19-11-

2014

Rs.

50,000/-

(Dy. No .

243)

Rs. 15/

per 3g,

Rs. 105/

per 3g×7

Tubes,

Rs. 25/

per 5g,

Rs. 50/

per 10g,

Rs. 75/

per 15g,

Not available in

reference SRAs,

However

available in

WHO Model List

of Essential

Medicines for

Children and

Nepal, Nigeria.

Form 5-D

Good level of

GMP (18-06-

2014),

mentioning

cream/ointment

/gel/lotion/Enema

section.

1. Signatures are required to be verified

whether they have been done by

relevant persons (List of signatures

identification by Chief executive of the

firm).

2. Evidence of approval of section /

manufacturing facility of applied drug

from licensing section is required.

3. SOPs / procedure to record and inform

about the change of person are required.

4. Details of Reference standard (Primary

or Secondary) being used are required.

5. Undertaking of submitting before

marketing of the product, Description

of Suitability of container closure

system comprising of parameters(i)

Protection of Drug(ii) Compatibility of

Drug(iii) Safety of Drug &(iv)

Performance of Drug (Stability studies

will establish the the final suitability of

container closure system) is required.

6. Stability Studies conducted according to

ICH guidelines for Zone IV-a are

required. The data shall be supported by

relevant documents which will include

(i) Purcahse of raw material (ii)

Certificate of analysis (iii) Testing

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protocols (iv) SOPs (v) Analytical data

and (vi) Finished product sample.

7. An undertaking that before marketing of

the product the firm shall submit the

clinical trial data is required.

8. Undertaking that in case of resemblance

of brand name and packaging of applied

product, the firm will change these; is

required.

M/s.

Medisearch

Pharmacal

(Pvt) ltd, 5-

Km,

Raiwind

Manga

Road,

Lahore.

Chloro

(Chlorhexidine

) 4% Gel

Each Gram of

gel contains:-

71mg of

Chlorhexidine

Digluconate eq.

to

Chlorhexidine

(B.P)….40mg

(Antiseptic)

Form 5

23-07-

2014

Rs.

20,000/-

(Dy. No .

328)

Rs. 200/

per 3g,

Rs. 210/

per 10g

Rs. 225/

per 20g

Not available in

reference SRAs,

However

available in

WHO Model List

of Essential

Medicines for

Children and

Nepal, Nigeria.

Not confirmed

Grant of 3

additional

sections

recommended

(07-11-2013),

mentioning

Semisolid section

and external

liquid section.

1. Application is not on prescribed Form

as per Drug (Registering, Licensing and

Advertising) Rules 1976.

2. Fee required as per Schedule-F of Drugs

Act, 1976 not complete.





firm).

4. Attested Copy of valid DML / Renewal

of DML (In case of more than 5 years)

is required.




6. Complete details regarding brands

available in Pakistan like name,

strength, dosage form, name of

manufacturer, registration number etc

with reference are required if Firm

applies on Form 5.

7. Master formulation with scientific

names as present in the relevant

pharmacopoeia 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 inactive starting

materials and the Justification of their

quantities used is required. Clarification

is required for physical form of

Chlorhexidine Digluconate wether in

solid form or in solution form and

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gelling agent in Formulation.

8. Stepwise details of manufacturing

process including Precautions/Control

required to produce specified quantities

of the drug applied for registration and

demonstration of cleaning validation

procedures, Identification & description

of Critical steps which may alter the

results and tests for IPQC including

weight variation, hardness, friability,

water content, etc are required.

9. List of particular equipments (used for

production of applied product) showing

its model and capacities along with their

status of cGMP compliance is required.

10. Complete and updated Specfications of

active starting material(s) i.e., API

(Active Pharmaceutical Ingredient) with

pharmacopoeial reference are required.


inactive materials/excipients with clear


Specifications of additionl excipients

are also required if firm changes

formulation of product.

12. Specifications of finished product not

correct.

13. Reference of and complete

Specifications of finished product are

required.

14. Copy of Last GMP inspection report

(should be conducted with in six

months from the date of evaluation of

dossier and having detailed assessment

of facility in which the applied drug will

be manufactured whether it is GMP

compliant or not.) is required.

15. Complete Specifications (Physical &

Chemical Characteristics) of the

container closure system (Primary

Packaging, Secodary Packaging &

Associated components e.g., caliberated

spoon etc.) fulfilling the compendial

17

requirement are required.

16. Updated CD of the dossier alongwith

Undertaking that the CD contains the

same information / data as submitted by

the applicant in the dossier and that the

CD is in operative condition is required.

17. In case of New Molecule/Dosage Form/

combination an undertaking that before

marketing of the product the firm shall

submit the clinical trial data is required.


combination Stability Studies conducted

according to ICH guidelines for Zone

IV-a are required. The data shall be

supported by relevant documents which

will include (i) Purcahse of raw material

(ii) Certificate of analysis (iii) Testing






required.

M/s. Friends

Pharma

(Pvt.)

Limited, 31-

Km,

Ferozepur

Road,

Lahore.

Chlodin Gel

3g, 10g & 20g

Contains:-

Chlorhexidine

Gluconate B.P

7.1% eq. to

Chlorhexidine

….4%

(Antiseptic)

(B.P Spec.s)

Form 5

06-08-

2014

Rs.

20,000/-

(Dy. No .

397)

As per

SRO per

3g, 10g

, 20g

Not available in

reference SRAs,

However

available in

WHO Model List

of Essential

Medicines for

Children and

Nepal, Nigeria.

Not confirmed

Operations at the

factory premises

were compliant

to GMP and

guidelines (21-

05-2014),

mentioning

Cream/ Ointment

section but

observation that

the Firm was in










firm).




5. Clarification is required about

observation of inspection report (dated

21-05-2014), mentioning Cream/

Ointment section that the Firm was in

the process of external revalidation of

HVAC system as per SOP’s. They have

plan to shift this section within six

18

the process of

external

revalidation of

HVAC system as

per SOP’s. They

has plan to shift

this section

within six

months.

months.

6. An undertaking/commitment (on

desired format) as per decision of

Registration Board regarding the

submission of (a) Stability studies (b)

Pharmaceutical Development Studies(c)

Validation of analytical testing methods

studies (d) Process validation (e) Label

claims and prescribing information

being same as approved by reference

drug agencies e.g., FDA, TGA, MHLW,

EMA and Health Canada is required.






applies on Form 5.









quantities used is required.

Clarification is required for physical

form of Chlorhexidine Digluconate

wether in solid form or in solution form

and gelling agent in Formulation.











10. cGMP compliance status for List of

particular equipments (used for

19

production of applied product) is

required.


























required.

M/s Zafa

Pharmaceuti

cal

Laboratories

(Private

Limited L-

1/B, Block-

22, Federal

‘B’

Industrial

Area,

Karachi.

Cordiclean Gel

4%

Contains:-

Chlorhexidine

Gluconate

Solution B.P

equivalent to

Chlorhexidine

….4%

(Disinfectant)

(B.P Spec.s)

Form 5

21-07-

2014

Rs.

20,000/-

(Dy. No .

N/A)

Rs.

100/20g

Pack and

Rs.35/4g

Pack

Not available in

reference SRAs,

However

available in

WHO Model List

of Essential

Medicines for

Children and

Nepal, Nigeria.

Not confirmed

Grant of renewal

of DML

recommended

(17-12-2013),

mentioning

1. Evaluated dossier is duplicate. Each

page should be signed (original) by

authorized / approved production and

Quality Control Incharge.




3. Original bank reciept of Rs. 20,000/- or

verification of photocoy by STO is

required.






20

Cream/

Ointments

section


firm).




7. Clarification of pharmacological group

is required wehter disinfectant or

antiseptic.

8. An undertaking/commitment (on

desired format) as per decision of

Registration Board regarding the

submission of (a) Stability studies (b)

Pharmaceutical Development Studies(c)

Validation of analytical testing methods

studies (d) Process validation (e) Label

claims and prescribing information

being same as approved by reference

drug agencies e.g., FDA, TGA, MHLW,

EMA and Health Canada is required.






applies on Form 5 with same fee.









quantities used is required.










21


15. cGMP compliance status for List of

particular equipments (used for

production of applied product) is

required.


active starting material(s) i.e., API

(Active Pharmaceutical Ingredient) with



inactive materials/excipients with clear


14. Specifications of finished product not

correct/updated (not phamacopial).

Wavelength of detection in assay has

been given as 245 nm instead of 254 nm

and inj. Volum is 20 µl instead of 100

µl.


Specifications of finished product are

required.

16. Details of Reference standard (Primary

or Secondary) being used are required.

17. GMP report is not latest (should be

conducted with in six months from the

date of evaluation of dossier and having

detailed assessment of facility in which

the applied drug will be manufactured

whether it is GMP compliant or not.).

Latest if any is required.

18. Complete Specifications (Physical &

Chemical Characteristics) of the



Associated components e.g., caliberated

spoon etc.) fulfilling the compendial

requirement are required.







22

Submitted for further orders of the board, please.

Case No. 04: Registration applications of new licenses.

Evaluator II

Sr.

No.

Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage form +

Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form

Initial date,

diary.

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)





20. Updatd CD of the dossier alongwith

Undertaking that the CD contains the

same information / data as submitted by

the applicant in the dossier and that the

CD is in operative condition is required.

















required.

23

1. M/s Sigma

Pharma

International

(Pvt.) Limited

Plot # E-50,

N.W.I.Z., Bin

Qasim Karachi.

(Cream /

Ointment / Gel

General: No.

F.6-6/2014-Lic

(M-237 dated

17-10-2014)

Dice 10mg/g Gel

Contains:-

Diclofenac Di-

Ethyl Ammonium

Salt (B.P)

equivalent to

Diclofenac

Sodium…10mg/g

( Anti-rheumatics )

(BP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 199)

As Per DRAP

policy

/10gm,20gm,

100gm

BNF: Voltaren

Emulgel

(Novartis)

DICLORAN Gel

(Sami

Pharmaceuticals

(Pvt.) Ltd.)

New License

2. -do- Adapt 1mg/g (0.1%

w/w) Cream

Contains:-

Adapalene…1mg/g

( Retinoids )

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 209)

As Per DRAP

policy /

Pack 15gm

BNF: Differin

(Galderma)

Adapco Cream

(Atco)

New License

3. -do- Burnaid 10mg/g

Cream

Contains:-

Silver

Sulphadiazine

10mg/g

(Antibacterial)

(USP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 215)

As Per DRAP

policy /

Pack 25gm &

50gm

BNF: Flamazine

(S&N Hlth.)

DERMAZIN

Cream (Novartis)

New License

4. -do- Acnil 40mg/g

Cream

Contains:-

Benzoyl Peroxide

40mg/g

(Antibacterial-

Keratolytic )

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 202)

As Per DRAP

policy/

Pack 40gm

BNF: Brevoxyl

(GSK)

BREVOXYL

Cream (GSK)

New License

24

(USP Spec.s)

5. -do- Orgel 20mg/g Oral

Gel

Contains:-

Miconazole

20mg/g

( Anti-fungal )

(BP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 200)

As Per DRAP

policy /

Pack 10gm &

20gm

BNF: Daktarin

(Janssen)

DAKTARIN

Oral Gel(Johnson

& Johnson,

Pakistan)

New License

6. -do- Mupin 20mg/g

Ointment

Contains:-

Mupirocin 20mg/g

(Anti-bacterial)

(BP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 201)

As Per DRAP

policy /

Pack 15gm

BNF: Bactroban

(GSK)

Bactroban (GSK)

New License

7. -do- Spot Ointment

Each gram

Contains:-

Lignocaine HCl

40mg

Zinc Bacitracin 500

units

Neomycin Sulfate

equivalent to

Neomycin 3.5mg

Polymyxin B

Sulfate 5000 units

(Antibacterial /

Local anaesthetic)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 203)

As Per DRAP

policy /

Pack 15gm &

20gm

Not confirmed

XYLOAID

Ointment(Barrett

Hodgson

Pakistan (Pvt.)

Ltd)

New License

1. International availability in same

strength in reference Stringent

Regulatory Agencies not

confirmed.

8. -do- Ogel Gel

Contains:-

Form 5

17-11-2014

Not confirmed 1. International availability in same

strength in reference Stringent

25

Lignocaine…

0.6% w/w

Cetylpyridinium

Chloride…

0.02%w/w

Menthol…0.06%w/

w

Eucalyptol…0.1%v

/w

Ethanol…33%v/w

(Local Anesthetic/

Antiseptic )

(Manufacturer’s

Spec.s)

Rs. 20,000/-

(Dy. No. 207)

As Per DRAP

policy /

Pack 20gm

Somogel (Abbot

Laboratories

(Pakistan)

Limited)

New License


confirmed.

9. -do- Dagel 10mg/g Gel

Contains:-

Clindamycin

Phosphate

equivalent to

Clindamycin

10mg/g

(Antibiotic(Lincosa

mide))

(USP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 214)

As Per DRAP

policy /

Pack 10gm

FDA: Clindagel

CLINAGEL

Gel(GlaxoSmith

Kline Pakistan

Limited)

New License

10. -do- Lotrim 10mg/g

Cream

Contains:-

Clotrimazole

10mg/g

( Anti-fungal )

(BP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 208)

As Per DRAP

policy /

Pack 10gm &

20gm

BNF: Canesten

(Bayer Consumer

Care)

Clotrim (Zafa)

New License

11. M/s Oakdal

Pharma.

Plot#114

Industrial Estate

Rbezole 20mg

Tablets

Each enteric coated

tablet contains:-

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 434)

BNF: Pariet

(Janssen, Eisai)

Acifix (Aries)

26

Hayatabad,

Peshawar.

Tablet (General)

Section.

(No. F.3-

1/2006-Lic (M-

235) dated 3rd

July, 2013

Rabeprazole

Sodium…20mg

(PPI)

(USP pending)

As Per SRO/

1×10’s

Grant of DML by

way of

formulation

recommended

(10.05.14)

12. -do- Lumefen 80/480mg

Tablets

Each tablet

contains:-

Artemether

…80mg

Lumefantrine

…480mg

(Antimalarial)

(USP Salmous

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 439)

As Per SRO/

1×4’s

WHO approved

formulation

Arthejet (Getz)

Grant of DML by

way of

formulation

recommended

(10.05.14)

13. -do- Lizine 5 mg

Tablets

Each film coated

tablet contains:-

Levocetirizine

Hydrochloride…5

mg

(Antihistamine)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 435)

As Per SRO/

1×10’s

BNF: Xyzal

(UCB Pharma)

Alergocit of

Global Pharma

Islamabad.

Grant of DML by

way of

formulation

recommended

(10.05.14)

14. -do- Glimiril Tablet

3mg

Each tablet

contains:-

Glimepiride

(USP)…3mg

(Sulphonylurea)

(USP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 432)

As Per SRO/

2×10’s

BNF: Amaryl

(Sanofi-Aventis)

Amaryl

(Sanofi-Aventis)

Grant of DML by

way of

formulation

recommended

(10.05.14)

15. -do- Fexostat 40 mg

Tablets

Each film coated

tablet contains:-

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 433)

FDA: Uloric

Zurig (Getz)

27

Febuxostat…40mg

(Xanthine oxidase

inhibitor)

(Manufacturer’s

Spec.s)

As Per SRO/

2×10’s

Grant of DML by

way of

formulation

recommended

(10.05.14)

16. -do-

Tablet

(Antibiotic)

Section

Azrocin 250 mg

Tablets

Each film coated

tablet contains:-

Azithromycin

dihydrate (USP) ≡

Azithromycin

…250mg

(Antibiotic/Macroli

de)

(USP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 423)

As Per SRO/

2×6’s

International:

BNF:

Azithromycin

(Nonproprietary)

Local:

Azitor of Macter

Int

Pvt Limited

Karachi

Grant of DML by

way of

formulation

recommended

(10.05.14)

17. -do-

Moxacin 400 mg

Tablets

Each film coated

tablet contains:-

Moxifloxacin HCl

(USP) ≡

Moxifloxacin

…400mg

(Fluoroquinolone)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 422)

As Per SRO/

2×10’s

BNF: Avelox

(Bayer)

Local: Morax tab

400mg by M/s

Global

Grant of DML by

way of

formulation

recommended

(10.05.14)

18. -do-

(Capsule

(General/Antibi

otic) Section

Celbiz 200 mg

Capsule

Each capsule

contains:-

Celecoxib

(B.P)…200mg

(Cox-2 Inhibitor)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 430)

As Per SRO/

1×10’s

BNF: Celebrex

(Pharmacia)

CELBEX 200mg

Capsule Getz

Pharma

Pvt. Ltd. Karachi

Grant of DML by

way of

formulation

recommended

(10.05.14)

19. -do-

Mercin 135 mg

Capsule

Form 5

17-11-2014

Not confirmed

Not confirmed

1. International availability in

reference Stringent Regulatory

28

Each capsule

contains:-

Mebeverine HCl

(B.P)…135mg

(Antispasmodic)

(Manufacturer’s

Spec.s)

Rs. 20,000/-

(Dy. No. 428)

As Per SRO/

1×10’s

Grant of DML by

way of

formulation

recommended

(10.05.14)

Agencies not confirmed

2. Me-too status not confirmed.

20. -do-

Dulocap 20 mg

Capsule

Each capsule

contains:-

Duloxetine as

Duloxetine HCl

enteric coated

pellets…20mg

(Anti depressant)

(Manufacturer’s

Spec.s)

Source: M/s Vision

Pharmaceuticals,

Islamabad.

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 429)

As Per SRO/

1×14’s

FDA: Cymbalta

(Lillly)

Dulan (Hilton)

Grant of DML by

way of

formulation

recommended

(10.05.14)

21. -do-

Ferrocid 200/0.5

mg Capsule

Each capsule

contains:-

Ferrous Sulphate

…200mg

Folic Acid…

0.5mg

(Heamatonic)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 431)

As Per SRO/

3×10’s

Not confirmed

Ferrocap (CCL)

Grant of DML by

way of

formulation

recommended

(10.05.14)




2. Source, GMP certificate of Souce,

COA, Stability Studied conducted

according to zone IV-a conditions

and fee in case of import of pellets

are required.

22. -do-

Liquid (General)

Section

Nfacon Suspension

Each 5ml contains:-

Simethicone

(USP)…50mg

Dicyclomine HCl

(BP)… 5mg

(Antispasmodic/ant

iflatulent)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 438)

As Per SRO/

60ml

Not confirmed

Infacol (Spenser

Pharma)

Grant of DML by

way of

formulation

recommended

(10.05.14)




2. IR spectrophotometer is required

23. -do- Triconyl Syrup Form 5 Not confirmed 1. International availability in

29

Each 5ml contains:-

Terbutaline

Sulphate

(USP)…0.3mg

(Bronchodialator)

(Manufacturer’s

Spec.s)

17-11-2014

Rs. 20,000/-

(Dy. No. 434)

As Per SRO/

60ml

Tesmic (Zafa)

Grant of DML by

way of

formulation

recommended

(10.05.14)


Agencies not confirmed.

24. -do-

Ditralka Syrup

Each 5ml contains:-

Disodium

Hydrogen Citrate

…1.315gm

(Urinary

Alkaliniser)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 432)

As Per SRO/

60ml

Not confirmed

Citralka (Pfizer)

Grant of DML by

way of

formulation

recommended

(10.05.14)



Agencies not confirmed.

25. -do-

Dry Powder

Suspension

(General and

antibiotic)

section

Azrocin dry

suspension

Each 5ml contains:-

Azithromycin

dihydrate (USP) eq.

to Azithromycin

…200mg

(Antibiotic/Macroli

de)

(USP Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 424)

As Per SRO/

15ml

BNF: Zithromax

(Pfizer)

ZETRO Getz

Pharma

(Pvt.) Ltd

Karachi.

Grant of DML by

way of

formulation

recommended

(10.05.14)

26. -do-

Lumefen 15/90mg

dry suspension

Each 5ml contains:-

Artemether

…15mg

Lumefantrin…90m

g

(Antimalarial)

(Manufacturer’s

Spec.s)

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 425)

As Per SRO/

60ml

WHO

recommended

formulation

ARTHEGET

(Getz)

Grant of DML by

way of

formulation

recommended

(10.05.14)

27. -do-

Ovidale

250mg/5ml dry

suspension

Each 5ml contains:-

Ciprofloxacin

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 426)

As Per SRO/

CIPROXIN

Bayer

(Formulation is

different)

HIFLOX

1. Formulation is under review by the

review committee.

30

Hydrochloride eq.

to Ciprofloxacin

…250mg

(Fluoroquinolone)

(Manufacturer’s

Spec.s)

60ml

Hilton

Pharma (Pvt.) Ltd

Karachi

Grant of DML by

way of

formulation

recommended

(10.05.14)

28. -do-

Clarimyth

125mg/5ml dry

suspension

Each 5ml contains:-

Clarithromycin (as

taste masked

granules) …125mg

(Macrolide)

(USP Spec.s)

Source: M/s Vision

Pharmaceuticals,

Islamabad.

Form 5

17-11-2014

Rs. 20,000/-

(Dy. No. 427)

As Per SRO/

60ml

BNF . Klaricid

(Abbott)

(Klaricid

(Abbott))

Grant of DML by

way of

formulation

recommended

(10.05.14)

Evaluator III

Sr.N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Type of Form

Initial date,

diary

Fee including

differential fee

Remarks on the

formulation (if any)

including

International status

in stringent drug

regulatory agencies /

authorities

Me-too status

Remarks by Evaluator

31

Group

Finished product

Specification

Demanded

Price / Pack size

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

29. M/s Bajwa

Pharmaceuticals,

Mureedke

(Sheikhupura)

Liquid

Injectable

(General)

Aqua Pro Injection

Each ampoule

contains:

Water for

Injection……5ml

Solvent/ Diluent

BP

Form-5

Dy. No: 1671

dated 18-11-14

Rs. 650/- pack of

100ml ampoule

Water for Injection

(BNF)

The inspection of the

firm was conducted by

the panel of inspectors

recommended the grant

of DML to the form

with sections namely:

a) Liquid Injectable

(General)

The firm has submitted the

invoice of purchase of

TOC analyzer and liquid

particle counter.

30. -do- Bupirex Injection-SP

Each ml contains:

Bupivacaine

HCL…..7.5mg

Local Anesthetic

Form-5

Dy. No: 1682

dated 18-11-14

Rs. 200/- Pack

of 2ml

x100ampoules

Bupivacaine Injection

of Hospira (USFDA)

Abocain Spinal of

Abbot Karachi

32

BP

31. -do- Lignox Injection 2%

Each ml contains:

Lignocaine HCL

…….20mg

Local anesthetic

BP

Form-5

Dy. No: 1668

dated 18-11-14

Rs. 850/- Pack

of 10mlx50

ampoules

Lignocaine

Hydrochloride

injection of

Amdipharma company

UK

Xylex of Venus

Pharma Lahore

32. -do- Suxonium Injection

Each 2ml contains:

Suxamethonoium

Chloride……100mg

Skeletal Muscle

Relaxant

BP

Form-5

Dy. No: 1675

dated 18-11-14

Rs. 450/- Pack

of 2mlx5

ampoules

Anectine Injection of

GSK UK

Suxal of Global

Pharma

33. -do- Ketamine Injection

Each ml contains:

Ketamine HCL

equivalent to

Ketamine……50mg

Form-5

Dy. No: 1674

dated 18-11-14

Rs. 326.43/-

Ketalar Injection of

Pfizer UK

Ketasol Injection of

Indus Pharma Karachi

33

General Anesthesia

BP

Pack of

5mlx1ampoules

34. -do- Ketamine Injection

Each ml contains:

Ketamine HCL

equivalent to

Ketamine……50mg

General Anesthesia

BP

Form-5

Dy. No: 1680

dated 18-11-14

Rs. 130.57/-

Pack of

2mlx1ampoules

Ketalar Injection of

Pfizer UK

Ketasol Injection of

Indus Pharma Karachi

35. -do- Stigmine Injection

Each 1ml contains:

Neostigmine methyl

sulphate…..2.5mg

Anticholinesterase

BP

Form-5

Dy. No: 1678

dated 18-11-14

Rs. 410/- Pack

of

1mlx10ampoules

Neostigmine Methyl

Sulphate injection of

Hemln Pharma UK

Nestigin Injection of

Elite Pharma Lahore

36. -do- Naloxo Injection

Each ml contains:

Naloxone

Form-5

Dy. No: 1676

dated 18-11-14

Naloxone Solition for

Injection of Wockhardt

UK

Athiol Injection of Siza

34

HCL…..0.4mg

Narcotic Antagonist

BP

Rs. 1200/- Pack

of

1mlx10ampoules

International

37. -do- Beefenac Injection

Each 3ml contains:

Diclofenac

sodium……..75mg

Non Narcotic

Analgesic/ Anti-

inflammatory

Manufacturer

Form-5

Dy. No: 1676

dated 18-11-14

Rs. 130/- Pack

of

3mlx5ampoules

Voltral of Novartis UK

Amefenac Injection of

Ameer Pharma

38. -do- Frusemide Injection

Each 2ml contains:

Frusemide…….20mg

Diuretic

BP

Form-5

Dy. No: 1676

dated 18-11-14

Rs. 255/- Pack

of

2mlx50ampoules

Lasix of sanofi

Lasix of Sanofi

Case No.05: Registration Applications of New / Additional sections.

35

Evaluator II

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)


39. M/s Kohs

Pharmaceuticals

, Pvt. Ltd. P/8,

SITE, Area

Hyderabad.

Mycin

Capsule

Each capsule

contains:

Azithromycin……

……250mg

{Antibiotic

(Macrolide)}

(USP Spec.s)

Form5

6’s,10’s/Not

mentioned

28-06-2012

Dy.No.1218

Rs.8000/-

Rs.12,000/-

04-04-2013

BNF:

Zithromax

(Pfizer)

ZITAMAX

(ZITHROMAX)

PFIZER

LABORATORIE

S LTD.

Not provided

1. Signatures are required to be

verified whether they have been

done by Production Manager and

Q.C. Manager. Not Provided

2. Attested Copy of DML / Renewal

of DML (In case of more than 5

years) is required. Not Provided


manufacturing facility of applied

drug from licensing section is

required. Not Provided

4. The drug product name (proprietary,

INN or generic name,

pharmaceutical form, strength) with

relevant information is not

provided/correct. Hydrated form of

Azithromycin has not been

mentioned and calculated in

composition and formulation. Not

corrected.



pharmacopoeia 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

inactive starting materials and the

36

Justification of their quantities used

is required. Not corrected.

6. Evidence of approval of production

in-charge from licensing section is

required. Not provided

7. Complete and updated Specfications

of active starting material(s) i.e.,

API (Active Pharmaceutical

Ingredient) with pharmacopoeial

reference are required.


of inactive materials/excipients with

clear pharmacopoeial reference are



of finished product specifications

with clear pharmacopoeial


10. Details of Reference standard

(Primary or Secondary) being used

are required. Not provided

11. Evidence of approval of the persons

working in quality control from

Licensing section is required. Not

provided

12. Copy of Last GMP report not

provided(should be conducted with

in six months from the date of

evaluation of dossier and having

detailed assessment of facility in

which the applied drug will be

manufactured whether it is GMP

compliant or not.). Not provided

13. Undertaking of submitting

Description of Suitability of

container closure system

comprising of parameters(i)

Protection of Drug(ii) Compatibility

of Drug(iii) Safety of Drug &(iv)

Performance of Drug (Stability

studies will establish the the final

suitability of container closure

system.) Before marketing of the

37

product is required. Not provided

40. -do- Mycin

Capsule

Each capsule

contains:

Azithromycin……

……500mg

{Antibiotic

(Macrolide)}

(USP Spec.s)

Form5

As per SRO

28-06-2012

Dy.No.1224

Rs.8000/-

Rs.12,000/-

04-04-2013

Not confirmed

AZOUR

(MERCK

SHARP)

Not provided

1. Signatures are required to be

verified whether they have been

done by Production Manager and

Q.C. Manager. Not Provided



years) is required. Not Provided




required. Not Provided





provided/correct. Hydrated form of

Azithromycin has not been

mentioned and calculated in

composition and formulation. Not

corrected.

5. Complete details regarding

international availability especially

in FDA, EMA, Health Canada,

TGA & MHLW for same generic,

dosage form & strength with










38


is required. Not corrected.














of finished product specifications

with clear pharmacopoeial








provided








compliant or not.). Not provided











39

product is required. Not provided

41. -do- Kanzole

Capsule

Each capsule

contains:

Lansoprazole……

…..30 mg

(Antipeptic

ulcerants)

Form5

As per

SRO/10’s,14’s

28-06-2012

Dy.No.1220

Rs.8000/-

Rs.12,000/-

04-04-2013

BNF:Lansoprazol

e (Non-

proprietary)

LANSOR(PHAR

MEDIC (PVT)

LTD.)

Not provided



years) not provided. Not provided





3. Complete Description of dosage

form (e.g film coated, Bilayered ,

coblister, immediately released,

sustained released, Capsule with

enteric coated pellets, Powder for

suspension etc) of drug is required.

Not corrected properly, instead

strength has been changed to 20mg

incorrectly.





provided/correct. Lansoprazole is in

the form of enteric coated

pellets/granules for capsule dosage

form. Clarification is required. Not

corrected properly.










40

is required. In case of modification

to enteric coated pellets

formulation, revised fromulation is

required. Not corrected properly.

Formulation is incorrect again.














Specifications of finished product

are required. Clarification is

required why inhouse specifications

have been given instead of U.S.P.

Not corrected.







provided








compliant or not.) Not provided

13. Complete Specifications (Physical

& Chemical Characteristics) of the



Associated components e.g.,

41

caliberated spoon etc.) fulfilling the

compendial requirement are












product not provided. Not provided

15. In case of modification to e/c pellets

formulation, source, Valid GMP

certificate, CoA, stability studies

and in case of import of pellets fee

of additional Rs. 80,000/- are

required. Not provided.

42. -do- Omizole Kohs

Capsule

Each capsule

contains:

Omeprazole………

…….20 mg

(PPI Remedy Of

severe Acidity)

Form5

As per SRO/

10’s,14’s

28-06-2012

Dy.No.1216

Rs.8000/-

Rs.12,000/-

04-04-2013

BNF:

Losec

(AstraZeneca)

Risek (Getz)

Not provided














Not correct properly





provided/correct. Omeprazole is in




correct properly

42













required. Not correct


process including

Precautions/Control required to

produce specified quantities of the

drug applied for registration and

demonstration of cleaning

validation procedures, Identification

& description of Critical steps

which may alter the results and tests

for IPQC including weight

variation, hardness, friability, water

content, etc are required. In case of

modification to enteric coated

pellets formulation, revised

manufacturing process is required.

Quantity of active / batch is not

correct. Not correct.








reference are required.Not correct






43





Not correct



are required. Not provided.




provided
































44



43. -do- Prazole

Capsule

Each capsule

contains:

Esomeprazole as

magnesium

trihydrate..20mg

(PPI Remedy Of

severe Acidity)

Form5

As per

SRO/10’s,14’s

23-11-2011

Dy.No.380

Rs.8000/-

Rs.12,000/-

04-04-2013














Not correct properly





provided/correct. Omeprazole is in




correct properly












45




process including

Precautions/Control required to

produce specified quantities of the

drug applied for registration and

demonstration of cleaning

validation procedures, Identification

& description of Critical steps

which may alter the results and tests

for IPQC including weight

variation, hardness, friability, water

content, etc are required. In case of

modification to enteric coated

pellets formulation, revised

manufacturing process is required.

Quantity of active / batch is not

correct. Not correct.








reference are required.Not correct










Not correct



are required. Not provided.




46

provided


































44. M/s Ahad

International

Pharmaceuticals

Limited, 13KM,

Gomal University

Multan Road,

Dera Ismail Khan

Pakistan.

Ampoule Section

(General)

Lignosafe

Injection

Each ml contains:-

Lignocaine HCl

(USP)…20mg

(2%w/v).

(Local anaesthetic)

(USP Spec.s)

Form 5

04/07/2013

Dy. No. 511

Rs. 20000/-

As per

SRO/1ml×25’s

BNF: Lidocaine

(Non-proprietary)

Lignocaine (Elite

Pharma)

New Section,

Grant of renewal

of DML and

additional section

1. Undertaking on desired format is

required.

2. The Firm has applied for 1ml

ampoule while the formulation is

not available in 1ml ampoule in

Pakistan and reference stringent

DRA,s.



47

No. F.6-6/2014-

Lic (M-237)

dated 14th oct

2014.

Ampoule

(General)

recommended.

(06.09.2014)






pharmacopoeial reference are

required.


of finished product with

pharmacopoeial reference are

required. Firm has claimed USP

Spec.s while contents limits given

are 90 to 105 % instead of 95 to

105%.

6. Evidence and verification of Total

Organic Testing Facility and Liquid

Particle Counter by area FID that

the said instruments are in

functional condition are required.

45. -do- Aquasafe 5ml

Injection

Contains:-

Sterile Pyrogen

Free Water for

Injection

USP…5ml.

(Vehicle)

(USP Spec.s)

Form 5

04/07/2013

Dy. No. 508

Rs. 20000/-

As per

SRO/5ml

BNF

Water for

Injection (Getz)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.





functional condition is required.

46. -do- Diclonac-S

Injection

Each 3ml contains:-

Diclofenac Sodium

(USP)…75mg

(NSAIDs)

(Manufacturer’s

Spec.s)

Form 5

04/07/2013

Dy. No. 509

Rs. 20000/-

As per

SRO/3ml

BNF: Voltarol

(Novartis)

Voltral (Novartis)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.






48

47. -do- Dexone Injection

Each ml contains:-

Dexamethasone

Sod. Phosphate

(USP) ≡

Dexamethasone

…4mg.

(Glucocorticoids)

(USP Spec.s)

Form 5

04/07/2013

Dy. No. 513

Rs. 20000/-

As per

SRO/1ml

amp×25’s

BNF:

Dexamethasone

(Non-proprietary)

Dexamed

(Munawar)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.

2. Formulation is steroid. Section

approved is for General products.






48. -do- Ranit Injection

Each 2ml contains:-

Ranitidine HCl

(USP) ≡

Ranitidine…50mg.

(H2 receptor

Blocker)

(USP Spec.s)

Form 5

04/07/2013

Dy. No. 512

Rs. 20000/-

As per

SRO/2ml ×5’s

BNF: Zantac

(GSK)

Zantac (GSK)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.






49. -do- Artem-R Injection

Each ml contains:-

Artemether (Ph.

Int.) …80mg.

(Anti-Malarial)

(Manufacturer’s

Spec.s)

Form 5

17/11/2014

Dy. No. 437

Rs. 20000/-

As per

SRO/1ml ×6’s

International:

Artem Inj in

China

Artem Inj

by M/s Hilton

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.

2. Evidence and verification of Liquid


the said instrument is in functional

condition is required.

3. Drug Registration Board has

deferred the formulation in the light

of recommendation of National

Malaria Control programme.

49

50. -do- Dinate Injection

Each ml contains:-

Dimenhydrinate

(USP)…50mg.

(Anti-Histamine)

(USP Spec.s)

Form 5

17/11/2014

Dy. No. 443

Rs. 20000/-

As per

SRO/1ml ×25’s

FDA approved

Gravinate

(Searle)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.






51. -do- A-Fer Injection

Each 5 ml

contains:-

Iron Sucrose

(USP)…100mg.

(Hematonic)

(USP Spec.s)

Form 5

17/11/2014

Dy. No. 440

Rs. 20000/-

As per

SRO/5ml ×5’s

International:

Venofer Inj

(FDA)

Me too: Merofer

JInj by M/s

Bosch

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.






3. Label claim is not correct, as it

should be Iron Sucrose equivalent

to elemental iron 100mg.

4. Master formulation is not correct.

52. -do- Oxysone Injection

Each ml contains:-

Oxytocin (USP)…5

i.u.

(Uterotropics)

(USP Spec.s)

Form 5

17/11/2014

Dy. No. 441

Rs. 20000/-

As per

SRO/1ml ×25’s

BNF: Syntocinon

(Alliance)

Syntocinon

(Novartis)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


required.






3. Clarification is required about

source whether natural or synthetic.

4. Correct master formulation is

required.

5. Correct finished product

specifications are required. Firm

has given pH of 3.5 to 4.5 instead of

3.0 to 5.0

50

Evaluator III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack size

Remarks on the


including

International status in

stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Remarks by Evaluator

54. M/s Arson

Pharmaceutical

Industries (Pvt)

Limited, Lahore

ZANAX Tablet

0.25mg


Form-5

Dy. No:

8000/- dated 16-

Xanax of Pharmacia &

Upjohn (USFDA)

Azolam of Merck Labs

53. -do- Spasmonil

Injection

Each 4ml contains:-

Phloroglucinol

Dihydrate

(USP)…40mg.

(Antispasmodic)

Form 5

17/11/2014

Dy. No. 442

Rs. 20000/-

As per

SRO/4ml ×6’s

Not confirmed

Spasmex

(Scharper)

New Section,

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)


reference DRA,s not confirmed.


review committee.


required.






5. Correct master formulation is

required.

6. Finished product specifications with


51

Alprazolam….0.25mg

Antianxiety for

psychotropic

disorders

BP

03-11

12000/- dated

02-12-14

As per SRO/

pack of 3x10’s

Karachi


firm was conducted on

08-05-2014 by the

panel of inspectors and

recommended the

renewal of DML and

grant of additional

section of tablets

psychotropic.

55. -do- ZANAX Tablet

0.5mg


Alprazolam….0.5mg

Anti anxiety for

psychotropic

disorders

BP

Form-5

Dy. No:

8000/- dated 16-

03-11

12000/- dated

02-12-14

As per SRO/

pack of 3x10’s


Upjohn (USFDA)


Karachi

56. -do- ZANAX Tablet 1mg


Alprazolam….1mg

Anti anxiety for

psychotropic

disorders

Form-5

Dy. No:

8000/- dated 16-

03-11

12000/- dated

02-12-14

As per SRO/


Upjohn (USFDA)


Karachi

52

BP pack of 3x10’s

ADDITIONAL SECTION (VETERINARY) –

Evaluator III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded Price

/ Pack size

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

Recommendations by the

Evaluators

57. M/s Univet

Pharmaceuticals,

14-Km Adyala

Road, Post Office

Daghal,

Rawalpindi

THIAVET Suspension

Each 100ml contains:

Thiabendazole…..13.3g

m

Anthelmintic

Form-5

Dy. No. 169

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

Vetyzole of Leads

Pharma

Inspection of the

firm was

conducted on 17-

11-14 by the panel

of inspectors and

recommended the

grant of additional

section namely

“Oral Liquid

53

Manufacturer HPDE Bottles of

50,100, 250, 500

and 1000ml

Section Veterinary

(General)”.

58. -do- OXYZAN Suspension


Oxfendazole….2.265g

Oxyclozanide….6.25g

Anthelmintic

Manufacturer

Form-5

Dy. No. 170

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

Pronide of Hilton

Pharma

59. -do- NOWORM Suspension


Albendazole…..10g

Closental…..2g

Anthelmintic

Manufacturer

Form-5

Dy. No. 171

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

Albacol

suspension of

Intervac

60. -do- AMLOCIN Liquid


Enrofloxacin

Form-5

Dy. No. 171

Me too status

submitted needs

confirmation

54

HCL…20gm

Colistin sulphate….7gm

Amantadine

HCL….8gm

Antibiotic

Manufacturer

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

61. PROCOX Suspension


Toltrazuril…..5g

Anticoccidial

Form-5

Dy. No. 175

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

Toltrasheph Oral

solution of

Shephard

Transnational

Lahore

62. LEVAMIN-T

Suspension


Triclabendazole….5g

Levamisole…..3.75g

Anthelmintic

Form-5

Dy. No. 175

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

Trimisole Oral

Liquid of Sanna

Labs Faislabad

55

Manufacturer

HPDE Bottles of

50,100, 250, 500

and 1000ml

63. FLOTIN Liquid


Enrofloxacin

HCL…..20gm

Colistin

Sulphate…..20MIU

Antibiotic

Manufacturer

Form-5

Dy. No. 174

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

Enro C liquid of

Leads Pharma

Islamabad

64. CIPEX Liquid


Ciprofloxacin……20gm

Bromhexine….0.5gm

Quinolone &

Expectorant

Manufacturer

Form-5

Dy. No. 174

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

Me too status

needs

confirmation.

Evidence of availability in

local market needs

confirmation. Moreover

formulation also contains

ciprofloxacin and such

formulation are banned by

the DRAP due their

potential of developing

resistance against Quinolone

in humans.

65. -do- FENICOL Liquid


Form-5

Dy. No. 178

Flotin Liquid of

D- Marson

Pharmaceuitcals

56

Florfenicol…..23gm

Colistin

sulphate….50MIU

Antibiotic

Manufacturer

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

66. LEVAMIN Liquid


Levamisole

HCL…..1.5gm

Anthelmintic

Form-5

Dy. No. 178

dated : 01-12-14

20000/- dated :

28-11-14

Decontrolled /-

HPDE Bottles of

50,100, 250, 500

and 1000ml

Levax of Epla

Labs Karachi

Evaluator - V

Sr.

No.

Name and address

of Manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage form +

Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of

Form

Initial date,

diary.

Fee

including

differential

fee

Demanded

International

status in stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection report

(dated)


57

Price / Pack

size

67. M/s Decent Pharma,

Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Liquid Injection

General (Vet.)

granted vide letter

No. F. 6-2/2013-Lic

(M-233) dated 3rd

February, 2013.

Gentasol Injection

Liquid Injection

Each ml Contains:

Gentamycin (as

Sulphate)

B.P……100mg

(Anti biotic)

Form 5

Rs.20,000/-

03-10-2014

Dy. No. 18

Decontrolled/

100ml

GENTOCIN INJ

100mg

Canada

GENTAJECT 10%

Gentamicin As

Sulphate

100ml

International

Champharma,

Lahore.

Inspection report

dated 11-06-2014.

Company found

complying GMP.

TOC analyzer and particle

counter not available as

per equipment list.

However, firm has

submitted test for

oxidisable substances as

an alternative and

informed that TOC will be

purchased at a later stage

and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Diatril Injection

Liquid Injection

Each ml Contains:

Enrofloxacin….100mg

(Quinolone

Antibactrial)

Form 5

Rs.20000/-

03-10-2014

Dy. No. 19

Decontrolled/

100ml

BAYTRIL 100

USA

ENROSAL

100ml

Zakfas, Multan

Inspection report

dated 11-06-2014.

Company found

complying GMP.



per equipment list.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Spel Injection

Liquid Injection

Each ml Contains:

Spectinomycin (as

sulphate) …

……..100mg

Lincomycin (as HCL)

………………….

50mg

(Antibiotic)

Form 5

Rs.20000/-

03-10-2014

Dy. No. 20

Decontrolled/

100ml

L.S Injection

100/50mg (eq. to

base)

Holland

LINCOJECT S INJ

100mg / 50mg (eq.

to base)

Intl. Chempharma,

Lhr

Inspection report

dated 11-06-2014.

Company found

complying GMP.



per equipment list.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Trodec L.A Injection

Liquid Injection

Form 5

Rs.20000/-

TRODAX 34%

Merial, UK



per equipment list.

58

Industrial Zone

Rawat.

Each ml Contains:

Nitroxinil….340mg

(Antiparasitic)

03-10-2014

Dy. No. 21

Decontrolled/

100ml

FASCIONIX 34%

Inj

340mg/ml

Better Traders

Inspection report

dated 11-06-2014.

Company found

complying GMP.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Combi-4 Injection

Liquid Injection

Each ml Contains:

Tylosin tartrate

B.P.......................150m

g

Gentamycin sulphate

B.P………………..60

mg

Chlorpheniramine…7.5

mg

Dexamethasone…2.65

mg

(Antibiotic/Anti

inflammatory)

Form 5

Rs.20,000/-

03-10-2014

Dy. No. 17

Decontrolled/

100ml

TYLO-

COMBISONE

15/6/0.0265/0.075g

/ 100ml

Agrovet

Peru, Albani,

Ecuador etc.

TYLO-

COMBISONE

15/6/0.0265/0.75g /

100ml

Mustafa Brothers

Inspection report

dated 11-06-2014.

Company found

complying GMP.



per equipment list.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Titan Injection

Liquid Injection

Each ml Contains:

Tylosin (as tartrate)

B.P..........100mg

Gentamycin (as

sulphate)

B.P……..50mg

(Antibiotec)

Form 5

Rs.20000/-

03-10-2014

Dy. No. 16

Decontrolled/

100ml

PRI-

MACROGENT

INJ

100/50mg (eq. to

base)

Prix

Pharmaceutical

Inspection report

dated 11-06-2014.

Company found

complying GMP.



per equipment list.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Bomec LA Injection

Liquid Injection

Form 5

Rs.20000/-

BOVIMEC LA

Agrovet, Peru

59

Industrial Zone

Rawat.

Each ml Contains:

Ivermectin……10mg

Vitamin

A…….25000IU

Vitamin D3….3750IU

Vitamin E……25mg

(Antiparasitic)

03-10-2014

Dy. No. 15

Decontrolled/

50ml

BOVIMEC INJ

Leads Pharma

Inspection report

dated 11-06-2014.

Company found

complying GMP.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Ectin-C Injection

Liquid Injection

Each ml Contains:

Ivermectin……10mg

Closental……..125mg

(Antiparasitic)

Form 5

Rs.20000/-

03-10-2014

Dy. No. 14

Decontrolled/

100ml

CLOSIVET

5 / 125mg

Ireland

CLOXANTEL

PLUS INJ

Leads Pharma

Inspection report

dated 11-06-2014.

Company found

complying GMP.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

Tide Injection

Liquid Injection

Each ml Contains:

Tylosin

tartrate…..50mg

Colistin

Sulphate…10mg

Streptomycin..100mg

(Antibiotic)

Form 5

Rs.20000/-

03-10-2014

Dy. No. 13

Decontrolled/

100ml

COLISTREP-T INJ

Attabak

Inspection report

dated 11-06-2014.

Company found

complying GMP.



per equipment list.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.


Plot No.30, Street

No.SS-3, National

Industrial Zone

Rawat.

OxytopInjection

Liquid Injection

Each ml Contains:

Oxytetracycline

Hydrochloride

B.P...50mg

(Antibiotic)

Form 5

Rs.20000/-

03-10-2014

Dy. No. 12

Decontrolled/

50ml

ONYX 50 INJ

Breeze Pharma

Inspection report

dated 11-06-2014.

Company found

complying GMP.



per equipment list.

However, firm has

submitted test for


an alternative and



and DRAP will be

informed.

77. M/s Semos

Pharmaceutical (Pvt)

Ltd., Plot No. 11,

Duroxil Capsule 500mg

Capsule

Form 5

Rs.20,000/-

CEFADROXIL

500mg Caps

USFDA

60

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Each capsule Contains:

- Cefadroxil (as

monohydrate) ……

500mg

(Anti bacterial 1st

Generation oral

Cephalosporin’s)

Dy.

No.152R&I)

03-11-2014

As per SRO

NEUCEF

500mg Capsule

Sami

78. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Sedox Capsule 100mg

Capsule

Each Capsule Contains:

-

Cefpodoxime (as

Proxetil)

………………. 100mg

(Anti bacterial Agents

3rd

Generation

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy. No. 244

(R&I)

19-11-2014

As per SRO

Tablet

internationally

CEFPORITE

100mg Caps

Sharooq

79. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Selexin Capsule 250mg

Capsule


Cephalexin (as

monohydrate) …..

250mg

(Anti bacterial Agents

1st Generation

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy.

No.247(R&I)

19-11-2014

As per SRO

KEFLEX

250mg Caps

USFDA

CEPOREX

250mg Caps

Gsk

80. Selexin Capsule 500mg

Capsule


-

Cephalexin (as

monohydrate)

…500mg

(Anti bacterial 1st

Generation oral

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy. No. 248

(R&I)

19-11-2014

As per SRO

KEFLEX

500mg Caps

USFDA

CEPOREX

500mg Caps

Gsk

61

81. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Duroxil 125mg/5ml

Dry Powder

Suspension

Dry Powder

Suspension

Each 5ml Contains:

Cefadroxil (as

monohydrate) …….

125mg

(Anti bacterial 1st

Generation

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy.

No.154R&I)

05-11-2014

As per SRO

CEFADROXIL

125mg/5ml

USFDA

DEXEF

125mg/5ml

Spadix

82. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Duroxil 250mg/5ml

Dry Powder

Suspension

Dry Powder

Suspension

Each 5ml Contains:

Cefadroxil (as

monohydrate) ……

250mg

(Anti bacterial 1st

Generation

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy. No.152

(R&I)

05-11-2014

As per SRO

CEFADROXIL

250mg/5ml

USFDA

DEXEF

250mg/5ml

Spadix

83. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Selexin Dry Powder

Suspension

Dry Powder

Suspension

Each 5ml Contains.

Cephalexin (as

monohydrate) ….. 125

(Anti bacterial 1st

Generation

Form 5

Rs.20,000/-

Dy.

No.246(R&I)

19-11-2014

As per SRO

CEPHALEXIN

125mg/5ml

USFDA

CEPHCARE

125mg/5ml

CSH

62

Cephalosporin’s)

84. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Selexin Dry Powder

Suspension 250/5ml

Dry Powder

Suspension

Each 5ml Contains.

Cephalexin (as

monohydrate) …... 250

(Anti bacterial 1st

Generation

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy.

No.245R&I)

19-11-2014

As per SRO

CEPHALEXIN

250mg/5ml

USFDA

CEPHCARE

250mg/5ml

CSH

85. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Sedox Dry Powder

Suspension 40mg/5ml

Dry Powder

Suspension

Each 5ml Contains.

Cefpodoxime (as

proxetil) ……………

40mg/5ml

(Anti bacterial 1st

Generation

Cephalosporin’s)

Form 5

Rs.20,000/-

Dy.

No.249R&I)

19-11-2014

As per SRO

CEFPODOXIME

PROXETIL

40mg/5ml (eq. to

base)

MHRA

EPODOX

40mg

Polyfine

86. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Axone IV 250mg Dry

Powder Injection

Each vial Contains.

Ceftriaxone (as

Sodium) ……………...

250mg

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy. No.146

(R&I)

05-11-2014

As per SRO

CEFTRIAXONE

250mg IM/IV

USFDA

ROCEPHIN

250mg IV

Roche

87. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Axone IV 500mg Dry

Powder Injection

Each vial Contains.

Ceftriaxone (as

Sodium)……..500mg

Form 5

Rs.20,000/-

Dy.

No.148(R&I)

05-11-2014

CEFTRIAXONE

500mg IM/IV

USFDA

ROCEPHIN

500mg IV

Roche

63

(3rd

Generation

Cephalosporin Anti-

bacterial)

As per SRO

88. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Axone IV 1g Dry

Powder Injection

Each vial Contains

Ceftriaxone (as

Sodium) ……. 1000mg

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy. No.145

(R&I)

05-11-2014

As per SRO

CEFTRIAXONE

1g IM/IV

USFDA

ROCEPHIN

1g IV

Roche

89. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Axone IM 250mg Dry

Powder Injection

Each vial Contains: -

Ceftriaxone (as

Sodium)….. 250mg

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy.

No.147(R&I)

05-11-2014

As per SRO

CEFTRIAXONE

250mg IM/IV

USFDA

AVENTRIAX

250mg IM

Sanofi

90. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

SepRime 500mg Dry

Powder Injection

Each vial Contains:-

Cefepime (as Hcl) and

L-Arginine eq. to

Cefepime ……..500mg

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy. No.149

(R&I)

05-11-2014

As per SRO

MAXIPIME

500mg

USFDA

ZEPIM

500mg IM/IV

Global

91. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Taxy 1gm Dry Powder

for Injection (IM/IV)

Each vial Contains

Cefotaxime (as sodium)

……. 1gm

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy.

No.139(R&I)

05-11-2014

As per SRO

CEFOTAXIME

1g

USFDA

NOVOSEF

1g

Himont

64

92. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Sebact 1gm Dry

Powder Injection

(IV/IM)


Cefoperazone (as

sodium)…500mg

Sulbactum (as sodium)

………….…. 500mg

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy.

No.143(R&I)

05-11-2014

As per SRO

CEBAC

500/500mg

Bosch

Evidence of approval by

reference regulatory

authorities e.g., FDA,

TGA, MHLW, EMA and

Health Canada has not

been submitted. However,

Board has approved same

formulation in its previous

meetings.

93. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Sebact 2g

Dry Powder Injection


Cefoperazone (as

sodium) ……….… 1g

Sulbactum

(as sodium) ……. 1g

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy.

No.144(R&I)

05-11-2014

As per SRO

CEBAC

1/1g

Bosch

Evidence of approval by

reference regulatory

authorities e.g., FDA,

TGA, MHLW, EMA and

Health Canada has not

been submitted. However,

Board has approved same

formulation in its previous

meetings.

94. M/s Semos


Ltd., Plot No. 11,

Sector 12-A, North

Karachi Industrial

Area, Karachi.

Cefdim 1g Dry Powder

Injection (IM/IV)

Each vial Contains: -

Ceftazidime (as

Sodium)………….

1gm

(3rd

Generation

Cephalosporin Anti-

bacterial)

Form 5

Rs.20,000/-

Dy.

No.150(R&I)

05-11-2014

As per SRO

CEFTAZIDIME

1g Vial

USFDA

UTAZID

1g

Bosch

65

Case No. 06: Grant of additional sections to the firms already possessing same manufacturing

areas in the same dosage form- Registrations thereof.

M/s Sami Pharmaceuticals, Karachi has been granted 12 additional sections by CLB which may be in

addition to their existing sections in the same dosage form. Firm has also been granted registrations in

246th meeting of registration board. Moreover, following applications have been further evaluated.

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)


95. M/s Sami

Pharmaceuticlas

(Pvt.) Limited,

F-95, S.I.T.E.

Karachi-

Pakistan

Tablet (General)

Section (No.

F.6-5/2014-Lic

(M-236) dated

8th Sep, 2014.

Enier 24mg Tablet

Each tablet

contains:

Betahistine

dihydrochloride

(B.P)….24mg

(Antihistamine, anti

vertigo)

(B.P Spec.s)

Form 5

06-08-2014

Dy.No.123

Rs.20,000/-

As per PRC

Health Canada:

Serc (Abbot)

Serc (Abbot)

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)

96. -do- Breeky 50mcg

Tablet

Each tablet cotains:

Misoprostol(as 1%

dispersion in

HPMC)…50 mcg

(Prostaglanding

(PGE1) analogue)

(Manufacturer’s

Spec.s)

Form-5

27-08-2014

Dy.No.179

Rs.20,000/-

As per DPC

Not confirmed

Mite (Genix)

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)



Agencies not confirmed, however

the Firm has provided various

research articles for support of the

formulation.

66

97. -do- Solfy 10mg Tablets

Each film coated

tablet contains:-

Solifenacin

Succinate…10mg

(Muscarinic

antagonist)

(Manufacturer’s

Spec.s)

Form 5

21-10-2014

(70)

Rs. 20,000/-

As per PRC

BNF: Vesicare

(Astellas)

Fenaso

(Highnoon)

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)

98. -do- Apandol XR

200mg Tablet

Each extended

release tablet

contains:

Tapentadol HCl eq.

to Tapentadol...200

mg

(Analgesic)

(Manufacturer’s

Spec.s)

Form 5-D

06-08-2014

Dy.No.122

Rs.20,000/- +

Rs. 30,000/-

dated 06-01-15

Rs.2400/-Per

10’s

FDA: Nucynta

ER (Janssen)

Form 5-D

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)

1. The Firm had applied on Form-5,

after evaluation of application the

Firm was asked to provide evidence

of Me-too status of formulation or

apply on Form 5-D. In reply the

Firm has submitted Rs. 30,000/-

additional Fee and submitted Form

5-D.

2. The firm has submitted clinical

justification data against

observation regarding clinical trial

data or undertaking regarding

clinical trial data submission before

marketing of the product.

3. Firm has submitted stability study

data that needs clarification that

whether it should be evaluated after

finalization of stability studies

guidelines/SOPs or Firm shall

submit stability studies according to

ICH/WHO guidelines.

99. -do- Apandol XR

150mg Tablet

Each extended

release tablet

contains:

Tapentadol HCl eq.

to Tapentadol...150

mg

(Analgesic)

(Manufacturer’s

Spec.s)

Form 5-D

06-08-2014

Dy.No.121

Rs.20,000/- +

Rs. 30,000/-

dated 07-01-15

Rs.1800/-Per

10’s

FDA: Nucynta

ER (Janssen)

Form 5-D

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)








5-D.




67










ICH/WHO guidelines.

100. Apandol IR 75mg

Tablet

Each film coated

tablet contains:

Tapentadol HCl eq.

to

Tapentadol……..75

mg

(Analgesic)

(Manufacturer’s

Spec.s)

Form 5-D

06-08-2014

Dy.No.120

Rs.20,000/-+

Rs. 30,000/-

dated 06-01-15

Rs.862.50/- per

10’s

FDA: Nucynta

(Janssen)

Form 5-D

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)








5-D.













ICH/WHO guidelines.

101. -do-

(Oral Liquid

General Section)

Gasicol Advance

Suspension

Each 10ml of

suspension

contains:

Sodium Alginate

BP..1g

Potassium

Bicarbonate

BP………………2

00 mg

(Antacid.)

(Manufacturer’s

Spec.s)

Form 5

25-03-14

Dy.No.137

Rs.20,000/-

Rs.175/-

Rs.350/-

120ml

240ml

BNF : Gaviscon

Advance (Reckitt

Benckiser)

Gaviscon

Advance (Reckitt

Benckiser)

Very good, Panel

recommends all

the additional

sections as per

approved layout

68

plan. (24-06-14)

102. -do- Bisleri-F

100mg/400mcg

Syrup

Each 5ml contains:

Iron (III)

Hydroxide

Polymaltose

complex eq. to

Elemental

Iron...100 mg

Folic Acid…….400

mcg

(Anti anemic Iron

preparations)

(Manufacturer’s

Spec.s)

Form 5-D

24-9-2014

Dy.No.309

Rs.20,000/-/-+

Rs. 30,000/-

dated 06-01-15

As per brand

leader

Not Confirmed

Form 5-D

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)


reference DRA,s not confirmed and

not provided by the Firm. The Firm

has submitted that same formulation

has been considered for M/s

Pharmactech Karachi and the Board

was agreed to expert opinions. The

registration of said formulation is

pending for stability studies data

provision by M/s Pharmactech.




of Me-too status of formulation. In

reply the Firm has submitted Rs.

30,000/- additional Fee and

submitted Form 5-D.







ICH/WHO guidelines.

103. -do- D-Tres 5mg/ml

Drops

Each ml contains:

Cholecalciferol

(Vitamin D3) Ph.

Eur………5 mg

(Vitmain D3

analogue)

(Manufacturer’s

Spec.s)

Form-5

19-9-2014

Dy.No.289

Rs.20,000/-

As per DPC

Not Confirmed

DRU (Genix

Pharma Karachi)

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)


reference DRA,s not confirmed and

not provided by the Firm.

69

Orders of the board are solicited as to whether such additional sections be treated as new sections and 10

products per sections be granted as per policy of the board.

Case No. 07: Remaining Registration Applications of New / Additional sections.

The Registration Board has been granting 10 products per section to newly approved sections. Following

are the remaining products of the applicants as per above policy.

Evaluator – II

104. -do- Sitip 1mg/5ml

Syrup

Each 5ml contains:

Cinitapride acid

tartrate eq. to

Cinitapride……..1

mg

(Gastroprokinetic)

(Manufacturer’s

Spec.s)

Form-5

19-08-14

Dy.No.151

Rs.20,000/-

As per DPC

Not Confirmed

Cidine

(Highnoon)

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)


reference DRA,s not confirmed,

however Firm has claimed that he

formulation is available in Spain.


Review Committee.

105. -do-

Sachet (General)

Section

Doctile 3gm Sachet

Each sachet

contains:

Dioctahedral

smectite…………3

gm

(Antidiarrheal)

Form-5

19-08-14

Dy.No.152

Rs.20,000/-

As per DPC

Not Confirmed

Smecta (Atco)

Very good, Panel

recommends all

the additional

sections as per

approved layout

plan. (24-06-14)


reference DRA,s not confirmed,

however Firm has claimed that he

formulation is available in China,

France, Hungry, Malaysia, Polant,

Russia & South Africa.


Review Committee.

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)


70

106. M/s Ahad

International

Pharmaceuticals

Limited, 13KM,

Gomal University

Multan Road,

Dera Ismail Khan

Pakistan.

Safesol NS

Infusion

Each 5ml contains:-

Sodium Chloride

(USP)…45mg.

(Electrolytes and

Water replacement)

(USP Spec.s)

Form 5

04/07/2013

Dy. No. 510

Rs. 20000/-

As per

SRO/100ml

FDA Approved

Sterifluid NS

(FDL Hattar)

Grant of renewal

of DML and

additional section

Ampoule

(General)

recommended.

(06.09.2014)



drug (Infusion section) from

licensing section is required.


required.

3. Evidence of verification of Total





107. M/s. Caliph

Pharmaceuticals,

(Pvt) Ltd., Plot

No. 17 S.I.Z.

Risalpur,

Nowshera.

Khyber

Pakhtoonkhwa

(Tablet General )

Calflox 250mg

Tablets

Each film coated

tablet contains:-

Ciprofloxacin (as

HCl)

USP…250mg

(Quinolone)

(USP Spec.s)

Form 5

14/06/2012

Dy. No. 508

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per SRO

Ciproxin (Bayer)

Ciproxin (Bayer)

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

area FID.

108. -do- Calflox 500mg

Tablets

Each film coated

tablet contains:-

Ciprofloxacin (as

HCl) USP…500mg

(Quinolone)

(USP Spec.s)

Form 5

14/06/2012

Dy. No. 516

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per SRO

Ciproxin (Bayer)

Ciproxin (Bayer)

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

area FID.

71

109. -do- Calicin 250 Tablets

Each film coated

tablet contains:-

Levofloxacin (as

hemihydrate)

USP…..250mg

(Quinolone)

(Authorized USP

pending Spec.s)

Form 5

14/06/2012

Dy. No. 531

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per SRO

BNF: (Tavanic

(Sanofi-Aventis)

Tavanic (Sanofi-

Aventis)

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

area FID.

110. -do- Calicin 500mg

Tablets

Each film coated

tablet contains:-

Levofloxacin (as

hemihydrate)

USP……500mg

(Quinolone)

(Authorized USP

pending Spec.s)

Form 5

14/06/2012

Dy. No. 505

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per SRO

BNF: (Tavanic

(Sanofi-Aventis)

Tavanic (Sanofi-

Aventis)

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

area FID.

111. -do-

(Liquid Syrup

General)

Calpro Liquid

Suspension

Each 5ml contains:-

Ibuprofen

(USP)………….10

0mg

(NSAID,

Analgesic/Antipyre

tic)

(USP Spec.s)

Form 5

14/06/2012

Dy. No. 515

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per

SRO/90ml

BNF: Brufen

Syrup

Brufen Abbott

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

72

area FID.

112. -do- Calzole Liquid

Suspension

Each 5ml contains:-

Metronidazole (as

benzoate)

(B.P)...200mg

(anti-amoebic)

(B.P Spec.s)

Form 5

14/06/2012

Dy. No. 518

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per

SRO/90ml,120

ml

BNF 61 (Flagyl S

(Winthrop)

Flagyl (Sanofi)

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

area FID.

113. -do- Calfam liquid

Suspension

Each 5ml contains:-

Famotidine

(USP)………..10m

g

(Anti Ulcerent)

(Manufacturer’s

Spec.s)

Form 5

14/06/2012

Dy. No. 512

Rs. 8000/- +

04/11/2013 Rs.

12000/-

As per

SRO/60ml,120

ml

PEPCID (FDA)

is dry powder for

suspension. USP

also mentions it

Powder for Oral

suspension

Polypep (Wilson)

No conclusion,

however no

major

observations

some minor

observations (05-

09-2014) GMP

certificate dated

12-03-13 has

been issued by

area FID.

Formulation is under review by the

review committee.

73

114. M/s Umema

Pharma, Plot No.

M-28, Hub

Industrial Estate,

Balochistan

U-Fem 18mcg

Capsules

Each Capsule

contains:-

Tiotropium (as

bromide)

USP…18mcg

(Anti-asthma)

Form 5

25/09/2014

Dy. No. 322

Rs. 20000/-

As per PRC

BNF: Spiriva

(Boehringer

Ingelheim)

Tiovair

(Highnoon)

Grant of DML

recommended

(19-09-2013)


required.

2. Proposed Master formulation is not

correct.




Ingredient) with reference are

required. Specification of

Tiotropium has been claimed as

USP. Monograph from USP with

Edition and Page No. of USP is

required. No reply provided and

again claimed USP.



are required. Firm has claimed

USP spec.s for formulation for

which no evidence has been

provided.

5. Copy of Last GMP inspection report

is of 19.09.13 for grant of DML.

6. Undertaking that in case of

resemblance of brand name and

packaging of applied product, the

firm will change these; is required.

115. M/s Weather

Folds

Pharmaceutical

Plot No 69/2

Phase 2

Industrial Estate

Hattar.

( Oral Dry

Powder

Suspension

section

(Cephalosporin)

No. F.3-8/2007-

Lic dated

11.10.2008)

Weclor 125mg Dry

Suspension

Each 5ml contains:-

Cefaclor

Monohydrate (USP)

equivalent to

Cefaclor…125mg

(Second generation

Cephalosporin

antibiotic)

(USP Spec.s)

Form 5

14-03-2014

Rs.20,000/-

(Dy. No. 116)

As per policy

of MOH/90ml

bottle

BNF: Distaclor

(Flynn)

Ceclor (AGP)

Panel has

recommended

renewal of DML.

(19.06.14)

1. Evidence of approval of technical

staff from licensing section is

required.

2. CLB has defered the renewal of

DML and decided to re-inspect the

firm. Firm has filed an appeal in

appellate board against this

decision.

74

116. -do-

Weclor 250mg Dry

Suspension

Each 5ml contains:-

Cefaclor

Monohydrate (USP)

equivalent to

Cefaclor…250mg

(Second generation

Cephalosporin

antibiotic)

(USP Spec.s)

Form 5

14-03-2014

Rs.20,000/-

(Dy. No. 119)

As per policy

of MOH/90ml

bottle

BNF: Distaclor

(Flynn)

Ceclor (AGP)

Renewal of DML

recommended.

(19.06.14)



required.

117. -do-

( Capsule

section

(Cephalosporin)

No. F.3-8/2007-

Lic dated

11.10.2008)

Weclor 375mg

Capsule

Each capsule

contains:-

Cefaclor

Monohydrate (USP)

equivalent to

Cefaclor…375mg

(Second generation

Cephalosporin

antibiotic)

(USP Spec.s)

Form 5

14-03-2014

Rs.20,000/-

(Dy. No. 117)

As per policy

of MOH/2×6’s

Not confirmed

Not confirmed

Renewal of DML

recommended.

(19.06.14)


reference stringent DRA,s not

confirmed and not provided by the

Firm.

2. Me-too status not confirmed and

not provided by the Firm.



required.

118. -do-

Weclor 500mg

Capsule

Each capsule

contains:-

Cefaclor

Monohydrate (USP)

equivalent to

Cefaclor…500mg

(Second generation

Cephalosporin

antibiotic)

(USP Spec.s)

Form 5

14-03-2014

Rs.20,000/-

(Dy. No. 118)

As per policy

of MOH/2×6’s

BNF: Distaclor

(Flynn)

Ceclor (AGP)

Renewal of DML

recommended.

(19.06.14)



required.

75

119. M/s NovaMed

Pharmaceuticals

(Pvt.) Ltd 28-km

Ferozepur Road,

Lahore

O-Quine Infusion

Each 100ml

infusion contains:-

Ofloxacin

(USP)…200mg

(Flouroquinolones

Antibiotics)

(Manufacturer’s

Spec.s)

Form 5

22-10-2014

Rs.20,000/-

(Dy. No. 1270)

Rs.

768.77/100ml

Infusion

BNF: Tarivid

(Sanofi-Aventis)

Tarivid (Sanofi-

Aventis)

No conclusion,

but no negative

observations in

inspection report

for grant of GMP

certificate dated

15 and 21-01-14

1. The reference originator’s

formulation Tarivid (Sanofi-

Aventis) contains HCl as an

ingredient and BNF mentions the

formulation Ofloxacin as HCl.

Firm has not mentioned HCl in their

formulation.

2. Clarification may be asked from

licensing section wether there is one

section of liquid injectable

containing vial and ampoule

products or two separate

sections.Inspection reports of the

Firm dated 21.01.14 mentions

General liquid Injection (Ampoule

and Vial).

3. Finished product spec.s of

Ciprofloxacin inj has been given

that contains lactic acid not present

in formulation.


Organic Testing facility and Liquid

particle counter facility by area FID

that the said instrument is in


Firm has submitted that they will

submit evidence/ verification report

from area FID before marketing of

the product.

5. Copy of GMP inspection report

dated 21-01-14 is attached. Firm

has submitted undertaking that they

have last GMP report of 08-04-14

(not provided) and they will submit

their pending GMP inspection

report as soon as they got it.








76

required.


required.

120. -do- Greymerz Injection

Each 10ml ampoule

contains:-

L-Ornithin L-

Aspartate…5gm

(Amino acid)

(Manufacturer’s

Spec.s)

Form 5

13-10-2014

Rs.20,000/-

(Dy. No. 29)

Rs.

184.00/10ml

Amp

Not confirmed

Levijon (Sami)

No conclusion,

but no negative

observations in

inspection report

for grant of GMP

certificate dated

15 and 21-01-14


reference stringent DRA,s not

confirmed.

2. Proposed Master formulation with

scientific names as present in the

relevant pharmacopoeia 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 inactive

starting materials and the


is required.

3. Clarification may be asked from

licensing section wether there is one

section of liquid injectable

containing vial and ampoule

products or two separate

sections.Inspection reports of the

Firm dated 21.01.14 mentions

General liquid Injection (Ampoule

and Vial).




Ingredient) with reference

(pharmacopoeial if any) are

required.



with reference (pharmacopoeial if

any) are required.


77


are required.


Organic Testing facility and Liquid

particle counter facility by area FID

that the said instrument is in


Firm has submitted that they will

submit evidence/ verification report

from area FID before marketing of

the product.

8. Copy of GMP inspection report

dated 21-01-14 is attached. Firm

has submitted undertaking that they

have last GMP report of 08-04-14

(not provided) and they will submit

their pending GMP inspection

report as soon as they got it.


required.








required.


required.

78

Case No. 08: Routine/ Pending Registration Applications.

Evaluator – II

S/N Name and

address of

manufacturer

/ Applicant

Brand Name

(Proprietary

name + Dosage

Form + Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size


stringent regulatory

agencies

Me-too status

GMP status as depicted

in inspection report

(dated)


121. M/s S.J. & G.

Ellahie (Pvt)

Limited. E-46,

S.I.T.E,

Karachi-

75700.

Cartikon Tablets

Each film coated

Tablet contains:-

Glucosamine

Sulphate

Potassium

Chloride (USP)

equivalent to

Glucosamine

Sulphate …750mg

Chondroitin

Sulphate

(USP)…600mg

(Health

Supplement for

the management

of Osteoarthritis)

(USP Spec.s)

Form-5

05-07-

2010(63)Rs.8,000/-

+Rs. 12,000 (20-

05-2013)

Rs. 450/20’s

Not confirmed

Cartigen Plus (Getz

Pharma)

Good level of GMP

compliance (26.09.14)

mentioning Tablet Non-

antibiotic, antibiotic

section.

1. Evidence of approval of

section / manufacturing

facility of applied drug

from licensing section is

required. Firm has

submitted cGMP

certificate dated 18.11.14

mentioning Tablet (Non-

antibiotic, Antibiotic,

Cephalosporin) Section

and routine GMP

inspection report (dated

26.09.14) mentioning

Tablet Non-antibiotic,

antibiotic section.

2. Label/composition is not

correct, as Glucosamine

should be calculated in

base form.

3. Calculation of quantity of

Glucosamine Sulphate

Potassium Chloride is not

correct.

4. International availability

in reference stringent

79

DRA,s not confirmed.

Firm has provided

literature of some

products taken from

internet stating that

formulation has not been

evaluated by the FDA and

the product is not

intended to diagnose,

treat , cure, or prevent any

disease.

5. Master formulation with

scientific names as

present in the relevant

pharmacopoeia 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

inactive starting materials

and the Justification of

their quantities used is

required.

122. M/s OBS

Pakistan (Pvt)

Limited C-14,

S.I.T.E.,

Manghopir

Road,

Karachi-75700

V-Fill 2.5 mg

Tablets

Each film coated

Tablet contains:-

Vardenafil HCl ≡

Vardenafil

…2.5mg

(Erectile

Dysfunction)

(Manufacturer’s

Spec.s)

Form 5-D

13-07-2010

Rs.15,000/ (136)

+Rs. 35000 (14-

05-2013)

Rs.1000/10’s

FDA Approved

New Application

Satisfactory GMP




section.

1. Drug Registration Board

has deferred formulations

for Erectile Dysfunction

in its 237th meeting.

2. Stability studies data

according to zone IV-a

and Before marketing of

the product an

undertaking that the firm

shall submit the clinical

trial data are required.

123. -do- V-Fill 5 mg

Tablets

Each film coated

Tablet contains:-

Vardenafil HCl ≡

Form 5-D

13-07-2010

Rs.15,000/ (128)

+Rs. 35000 (14-

FDA Approved

New Application

Satisfactory GMP






80

Vardenafil …5mg

(Erectile

Dysfunction)

(Manufacturer’s

Spec.s)

05-2013)

Rs.2000/10’s




section.



the product an





Tablets

Each film coated

Tablet contains:-

Vardenafil HCl ≡

Vardenafil

…10mg

(Erectile

Dysfunction)

(Manufacturer’s

Spec.s)

Form 5-D

13-07-2010

Rs.15,000/ (136)

+Rs. 35000 (14-

05-2013)

Rs.1000/10’s

FDA Approved

New Application

Satisfactory GMP




section.








the product an





Tablets

Each film coated

Tablet contains:-

Vardenafil HCl ≡

Vardenafil

…20mg

(Erectile

Dysfunction)

(Manufacturer’s

Spec.s)

Form 5-D

13-07-2010

Rs.15,000/ (134)

+Rs. 35000 (14-

05-2013)

Rs.4000/10’s

FDA Approved

New Application

Satisfactory GMP




section.








the product an




126. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi

Hipride-Met SR

1/500 Tablets

Each Bilayered

Tablet contains:-

Glimepiride (as

Immediate

release)…1mg

Metformin HCl

(as extended

release) …500mg

(Antidiabetic)

(Manufacturer’s

Spec.s)

Form 5

11-11-2010

Rs.8,000/ (82)

+Rs. 12000 (28-

11-2013)

Rs.100/10’s

Rs.140/14’s

Rs.200/20’s

Rs.280/28’s

Rs.300/30’s

Not confirmed

Amaryl M SR 1mg

(Sanofi)

Grant of renewal of DML

recommended

(06.11.2014)





required. Inspection

report dated 06.11.2014

mentions Tablet General

section.


of formulation in

reference Stringent


confirmed. Firm has

81

given international

availability of India.

3. Proposed Master

formulation with

scientific names as


pharmacopoeia and







materials, Role of




required. Firm has given

undertaking that they will

submit the same before


4. Stepwise details of

manufacturing process

including

Precautions/Control

required to produce

specified quantities of the

drug applied for

registration and

demonstration of

cleaning validation

procedures, Identification

& description of Critical

steps which may alter the

results and tests for IPQC

including weight

variation, hardness,

friability, water content,

etc are required. Firm has

given undertaking that

they will submit the same

before marketing of the

product.

82

5. Evidence and verification

of Bilayered compression

Machine by area FID is

required.

6. Complete and updated

Specfications of active

starting material(s) i.e.,

API (Active

Pharmaceutical

Ingredient) with

pharmacopoeial reference

are required. No reply


Specfications of inactive

materials/excipients with

clear pharmacopoeial

reference are required. No

reply

8. Details of Reference

standard (Primary or

Secondary) being used


127. -do- Hipride-Met SR

2/500 Tablets

Each Bilayered

Tablet contains:-

Glimepiride (as

Immediate

release)…2mg

Metformin HCl

(as extended

release)…500mg

(Antidiabetic)

(Manufacturer’s

Spec.s)

Form 5

11-11-2010

Rs.8,000/ (83)

+Rs. 12000 (28-

11-2013)

Rs.180/10’s

Rs.252/14’s

Rs.360/20’s

Rs.504/28’s

Rs.540/30’s

Not confirmed

Amaryl M SR 2mg

(Sanofi)


recommended

(06.11.2014)








section.


of formulation in

reference Stringent


confirmed. Firm has

given international


3. Proposed Master

formulation with

scientific names as


pharmacopoeia and


83






materials, Role of










including

Precautions/Control

required to produce


drug applied for

registration and

demonstration of

cleaning validation





including weight







product.




required.




API (Active

84

Pharmaceutical

Ingredient) with








reply






1/1000 Tablets

Each Bilayered

Tablet contains:-

Glimepiride (as

Immediate

release)…1mg

Metformin HCl

(as extended

release)…1000mg

(Antidiabetic)

(Manufacturer’s

Spec.s)

Form 5

11-11-2010

Rs.8,000/ (80)

+Rs. 12000 (28-

11-2013)

Rs. 12/Tablet

Rs.120/10’s

Rs.168/14’s

Rs.240/20’s

Rs.336/28’s

Rs.360/30’s

Not confirmed

Not confirmed


recommended

(06.11.2014)








section.


of formulation in

reference Stringent


confirmed. Firm has

given international


3. Me-too status not

confirmed. No reply by

the Firm however Firm

has submitted photocopy

of differential fee challan

of Rs. 30,000/- dated

13.05.14 which shows

that Firm has submitted

fee for application on

Form 5-D.

4. Proposed Master

formulation with

scientific names as


85

pharmacopoeia and







materials, Role of










including

Precautions/Control

required to produce


drug applied for

registration and

demonstration of

cleaning validation





including weight







product.




required.



86


API (Active

Pharmaceutical

Ingredient) with








reply






2/1000 Tablets

Each Bilayered

Tablet contains:-

Glimepiride (as

Immediate

release)…2mg

Metformin HCl

(as extended

release)…1000mg

(Antidiabetic)

(Manufacturer’s

Spec.s)

Form 5

11-11-2010

Rs.8,000/ (81)

+Rs. 12000 (28-

11-2013)

Rs. 20/Tab

Rs.120/10’s

Rs.168/14’s

Rs.240/20’s

Rs.336/28’s

Rs.360/30’s

Not confirmed

Not confirmed


recommended

(06.11.2014)








section.


of formulation in

reference Stringent


confirmed. Firm has

given international


3. Me-too status not

confirmed. No reply by

the Firm however Firm

has submitted photocopy

of differential fee challan

of Rs. 30,000/- dated

13.05.14 which shows

that Firm has submitted

fee for application on

Form 5-D.

4. Proposed price on

covering letter is similar

87

to Hipride-Met SR

1/1000 Tablets for which

clarification is required.

No reply by the Firm

5. Proposed Master

formulation with

scientific names as


pharmacopoeia and







materials, Role of










including

Precautions/Control

required to produce


drug applied for

registration and

demonstration of

cleaning validation





including weight






88


product.




required.




API (Active

Pharmaceutical

Ingredient) with








reply





89

Evaluator III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name + Dosage

Form + Strength)

Composition

Pharmacological Group

Finished product Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Remarks on the


including


stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report (with

date) by the Evaluator

Remarks by

Evaluator

130. M/s Opal

Laboratories

(Pvt) Limited,

Karachi

FEXHEAL-D Tablet


contains Fexofenadine HCl…60mg

Pseudoephedrine HCl…120mg

Antihistamine, Systemic

Manufacturer

Form 5

Dy No 1463

dated 28/07/10

8000+12000

Pack of 10’s/

As per DRAP

Policy

Allegra-D of Sanofi

Aventis (USFDA)

Fexet-D of Getz Karachi

Inspection of the firm

was conducted on 28-

01-14 by the area FID

and the firm was fairly

complying the GMP

requirements.

131. -do- SASTOR Tablet

Each film coated tablet contains

Amlodipine as besylate….5mg

Atorvastatin calcium….10mg

Form-5

Dy No 1466

dated 28/07/10

8000+12000

Caduet Tablet of Pfizer

Cadwin Tablets of Getz

Pharma

90

Calcium channel antagonist+ Statin

Manufacturer

Pack of 20’s/

As per SRO

132. -do- SASTOR Tablet


Amlodipine as besylate….10mg

Atorvastatin calcium….10mg

Calcium channel antagonist+ Statin

Manufacturer

Form-5

Dy No 1472

dated 28/07/10

8000 + 12,000

Pack of 20’s/

As per SRO


Cadwin Tablets of Getz

Pharma

133. -do- LETRAWIN Tablets 500mg


Levetiracetam…….

500mg

Antiepileptic

Manufacturer

Form-5

Dy No 1467

dated 28/07/10

8000 + 12000

Pack of 30’s/

As per PRC

Keppra Tablets of GSK

UK

Keppra of GSK Karachi

134. -do- LETRAWIN Tablets 250mg


Levetiracetam…….

250mg

Form-5

Dy No 1474

dated 28/07/10

Keppra Tablets of GSK

UK

Keppra of GSK Karachi

91

Antiepileptic

Manufacturer

8000 + 12000

Pack of 30’s/

As per PRC

135. -do- PRASUGREL Tablet 5mg


Prasugrel as Hydrochloride ….5mg

Anti platelet agent

Manufacturer

Form 5

Dy No 1468

dated 28/07/10

8000+12000

Pack of 14’s/

As per SRO

Efient* 5 mg film-

coated tablets. Of Eli

Lilly company

Prisa of Getz Pharma

Karachi

136. -do- PRASUGREL Tablet 10mg


Prasugrel as Hydrochloride

….10mg

Anti platelet agent

Manufacturer

Form 5

Dy No 1468

dated 28/07/10

8000+12000

Pack of 14’s/

As per SRO

Efient* 10 mg film-

coated tablets. Of Eli

Lilly company

Prisa of Getz Pharma

Karachi

137. M/s Genix

Pharma Private

Limited Karachi

LUKOSIL Capsule 50mg

Each Capsule contains:

Sunitinib Malate….50mg

Form-5

Dy. No: 1894

dated 29-10-

10

Sutent of Pfizer

(USFDA)

Sutent Capsule of Pfizer


The specifications of

the active substance

include identification

by (FT-IR

Spectroscopy,

particle size by Laser

Diffraction Light

method), residual

92

Antineoplastic

Manufacturer

8,000/-

12,000/ dated

23-09-13

Rs. 150,000/-

Pack of 10’s

Rs. 225,000/-

Pack of 15’s

Rs. 4,50,000/-

Pack of 30’s



and overall GMP was

found “GOOD”

solvents by GC-FDI.

Confirmation of

availability above

mentioned testing

equipment/ facilities

is required.

138. -do- LUKOSIL Capsule 37.5mg


Sunitinib Malate….37.5mg

Antineoplastic

Manufacturer

Form-5

Dy. No: 1911

dated 29-10-

10

8,000/-

12,000/ dated

23-09-13

Rs. 125,000/-

Pack of 10’s

Rs. 187,000/-

Pack of 15’s

Rs. 375,000/-

Pack of 30’s

Sutent of Pfizer

(USFDA)





by (FT-IR

Spectroscopy,


Diffraction Light

method), residual

solvents by GC-FDI.

Confirmation of

availability above

mentioned testing


is required.

139. -do- LUKOSIL Capsule 25mg Form-5 Sutent of Pfizer

(USFDA)




93


Sunitinib Malate….25mg

Antineoplastic

Manufacturer

Dy. No: 1895

dated 29-10-

10

8,000/-

12,000/ dated

23-09-13

Rs. 125,000/-

Pack of 10’s

Rs. 187,000/-

Pack of 15’s

Rs. 375,000/-

Pack of 30’s


by (FT-IR

Spectroscopy,


Diffraction Light

method), residual

solvents by GC-FDI.

Confirmation of

availability above

mentioned testing


is required.

140. -do- LUKOSIL Capsule 12.5mg


Sunitinib Malate….12.5mg

Antineoplastic

Manufacturer

Form-5

Dy. No: 1913

dated 29-10-

10

8,000/-

12,000/ dated

23-09-13

Rs. 50,000/-

Pack of 10’s

Rs. 75,000/-

Sutent of Pfizer

(USFDA)





by (FT-IR

Spectroscopy,


Diffraction Light

method), residual

solvents by GC-FDI.

Confirmation of

availability above

mentioned testing


is required.

94

Pack of 15’s

Rs. 150,000/-

Pack of 30’s

141. -do- Dulux Capsules 20mg


Duloxetine HCL enteric coated

pellets (17.5%) equivalent to

Duloxetine…….20mg

Antidepressant

Manufacturer

Source: Alphamed Formulations

(Pvt) Limited, Survey No. 225,

Sampanbole Village, Shamirpat

Mandal, Ranga Reddy district

500078, A.P. India

Form-5

Dy.No: 1901

dated 29-10-

10

8,000/- dated

29-10-10

12,000/- dated

23-09-13

80,000/- dated

08-12-14

Rs. 250/- Pack

of 10’s

Rs. 350/- Pack

of 14’s

Yentreve of Eli Lilly

Company UK

Yentreve of Sharooq

Pharma, Lahore

Documents of enteric

coated pellets are

provided however

master formulation

submitted if of

duloxetine HCL

powder. Exact master

formulation with

quantity of pellets per

capsule and batch

along with batch size

is required.




pellets equivalent to

Duloxetine…….30mg

Form-5

Dy.No: 1898

dated 29-10-

10

8,000/- dated

Cymbalta of Elilliy UK

Yentreve of Sharooq

Pharma, Lahore


coated pellets are

provided however

master formulation

submitted if of

duloxetine HCL


formulation with


capsule and batch

95

Antidepressant

Manufacturer





500078, A.P. India

29-10-10

12,000/- dated

23-09-13

80,000/- dated

08-12-14

Rs. 330/- Pack

of 10’s

Rs. 462/- Pack

of 14’s


is required.





Duloxetine……60mg

Antidepressant

Manufacturer





500078, A.P. India

Form-5

Dy.No: 1903

dated 29-10-

10

8,000/- dated

29-10-10

12,000/- dated

23-09-13

80,000/- dated

08-12-14

Rs. 660/- Pack

Cymbalta of Elilliy UK

Yentreve of Sharooq

Pharma, Lahore


coated pellets are

provided however

master formulation

submitted if of

duloxetine HCL


formulation with


capsule and batch


is required.

96

of 10’s

Rs. 924/- Pack

of 14’s

144. -do- Calif-D Tablet

Each film coated tablet contains:

Calcium citrate equivalent to

elemental calcium……252mg

Calcitrol…..0.25mg

Calcium Supplement

Manufacturer

Form-5D

Dy. No: 1907

dated 29-10-

10

8,000/- dated

29-10-10

12,000/- dated

23-09-13

80,000/- dated

08-12-14

Rs. 1000/-

Pack of 10’s

Rs. 3000/-

Pack of 14’s

Not available in SRA’s

however the firm

submitted reference of

availability in India.

a. Evidence of

approval of same

generic, dosage

form and strength

in USFDA, TGA,

MHLW, EMA and

Health Canada is

not submitted by

the firm. However

the firm submitted

reference of

availability in India

(CitroMacalvit of

Novartis India)

which is uncoated

tablet however the

applied product is

coated.

b. Stability data

required as per

ICH/ WHO

guidelines.

145. -do- Lesker A Tablet


Aliskerin hemifumerate equivalent

to Aliskerin…..150mg

Valsartan…….160mg

Form-5

Dy. No: 1910

dated 29-10-

10

8,000/- dated

29-10-10

Valturna of Novartis

(USFDA)

Alevia-V of Atco Labs

Karachi

97

Antihypertensive

Manufacturer

12,000/- dated

23-09-13

Rs. 795/- Pack

of 7’s

Rs. 1590/-

Pack of 14’s

146. -do- Lesker A Tablet


Aliskerin hemifumrate equivalent to

Aliskerin…..300mg


Antihypertensive

Manufacturer

Form-5

Dy. No: 1905

dated 29-10-

10

8,000/- dated

29-10-10

12,000/- dated

23-09-13

Rs. 1582/-

Pack of 7’s

Rs. 3164/-

Pack of 14’s

Valturna of Novartis

(USFDA)

Alevia-V of Atco Labs

Karachi

147. -do- Lesker V Tablet


Aliskerin hemifumrate equivalent to

Aliskerin…..300mg

Form-5

Dy. No: 1902

dated 29-10-

10

International availability

in SRA’s is not

provided.

Me too staus needs

confirmation

a. Evidence of

approval of same

dosage form and

strength in

stringent SRA’s in

FDA, EMA,

USFDA, MHLW

Japan and Health

98


Hydrochlorthiazide….12.5mg

Antihypertensive

Manufacturer

8,000/- dated

29-10-10

12,000/- dated

23-09-13

Rs. 1540/-

Pack of 7’s

Rs. 3080/-

Pack of 14’s

Canada is required

b. Me too status

needs

confirmation.

148. -do- Lesker V Tablet


Aliskerin hemifumerate equivalent

to Aliskerin…..300mg


Hydrochlorothiazide….25mg

Antihypertensive

Manufacturer

Form-5

Dy. No: 1902

dated 29-10-

10

8,000/- dated

29-10-10

12,000/- dated

23-09-13

Rs. 1540/-

Pack of 7’s

Rs. 3080/-

Pack of 14’s


in SRA’s is not

provided.

Me too staus needs

confirmation

c. Evidence of

approval of same

dosage form and

strength in

stringent SRA’s in

FDA, EMA,

USFDA, MHLW

Japan and Health

Canada is required

d. Me too status

needs

confirmation.

149. -do- Pire Chewable Tablets

Each chewable tablet contains:

Form-5

Dy. No: 1912

dated 29-10-

Availability in SRA’s

needs confirmation,

moreover formulation is

applied formulation is

also not recommended

a. Evidence of

approval of same

generic, dosage

form and strength

in USFDA, TGA,

MHLW, EMA

and Health

99

Rifampicin……60mg

Isoniazid……30mg

Antituberclosis

Manufacturer

10

8,000/- dated

29-10-10

12,000/- dated

23-09-13

Rs. 300/- Pack

of 30’s

by WHO.

Me too status needs

confirmation

Canada is

required.

b. Me too status

needs to be

submitted.

150. M/s Genome

Pharmaceuticals,

Hatta

PRIMAQUIN Tablets 7.5mg


Primaquine as Phosphate……7.5mg

Antimalarial

USP

Form-5

Dy. No. 28

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 30’s

Primacin Tablets of

Boucher & Muir Pty Ltd

(TGA approved as

uncoated tablet)

Me too status is not

provided

GMP/ Panel inspection

report is required as firm

submitted product

specific inspection

report of dated 17-07-14

of URO-K Tablets.

Firm has also submitted

GMP certificate issued

on dated 12-11-14 for

export purpose.

a. Applied

formulation is

approved as

uncoated tablet in

TGA however

formulation of

film coated tablet

is submitted.

b. Me too status

needs to be

submitted.

151. -do- CYLORIN Capsules 10mg

Form-5

Dy. No. 43

Neoral soft gelatin

capsules of Novartis

UK

a. Applied product is

approved as soft

gelatin capsules in

stringent SRA’s

however the

100

Each capsules contains:

Cyclosporin…..10mg

Immunosuppressant

USP

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 10’s

Neoral soft gel capsules

of Novartis Karachi

applied product is

in hard gelatin

capsules.

b. Applied product is

also available

locally as soft

gelatin capsule (

Neoral of

Novartis)

152. -do- CYLORIN Capsules 25mg

Each capsules contains:

Cyclosporin…..25mg

Immunosuppressant

USP

Form-5

Dy. No. 35

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 10’s

Neoral soft gelatin

capsules of Novartis

UK

Neoral soft gel capsules

of Novartis Karachi

a. Applied product is

approved as soft

gelatin capsules in

stringent SRA’s

however the

applied product is

in hard gelatin

capsules.

b. Applied product is

also available

locally as soft

gelatin capsule (

Neoral of

Novartis)

153. -do- GENOVIN Tablets 500mg


Griseofulvin…..500mg

Form-5

Dy. No. 28

dated : 08-11-

10

Griseofulvin Tablets of

Sandoz

Gryso of Platinum

Pharmaceuticals Karachi

101

Antifungal

USP

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 14’s

154. -do- FRANCO Capsules


Olanzapine….6mg

Fluoxetine…..25mg

Antipsychotic/ SSRI

Manufacturer

Form-5

Dy. No. 38

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 10’s

Olanzapine And

Fluoxetine

Hydrochloride Of Teva

Pharma (USFDA)

Me too status not

provided

Evidence of local

availability of

applied formulation

is not submitted by

the firm.

155. -do- FRANCO Capsules


Olanzapine….3mg

Fluoxetine…..25mg

Form-5

Dy. No. 24

dated : 08-11-

10

8000/- dated :

Olanzapine And

Fluoxetine

Hydrochloride Of Teva

Pharma (USFDA)

Me too status not

provided

Evidence of local

availability of

applied formulation

is not submitted by

the firm.

102

Antipsychotic/ SSRI

Manufacturer

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 10’s

156. -do- GENDOL Tablets 5mg

Each tablet contains

Haloperidol……5mg

Antipsychotic

USP

Form-5

Dy. No. 36

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 100’s

Haldol of Janssen Cilag

Doskik of Adamjee

157. -do- GENDOL Tablets 1.5mg

Each tablet contains

Haloperidol……1.5mg

Antipsychotic

Form-5

Dy. No. 37

dated : 08-11-

10

8000/- dated :

08-11-10

Haldol of Janssen Cilag

Dosik of Adamjee

103

USP

12000/- dated:

17-01-14

As per SRO/

Pack of 100’s

158. -do- DOXURA Tablet 2mg


Doxazosin as mesylate….2mg

Selective Alpha-1 Blocker

USP

Form-5

Dy. No. 34

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 20’s

Cardura of Pfizer

(USFDA)

Cardura of Pfizer

Karachi

Product is approved

in SRA’s as uncoated

tablet however the

firm submitted

master formulation

and manufacturing

details of film coated

tablet.

159. -do- DOXURA Tablet 4mg


Doxazosin as mesylate….4mg

Selective Alpha-1 Blocker

USP

Form-5

Dy. No. 32

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

Cardura of Pfizer

(USFDA)

Cardura of Pfizer

Karachi

Product is approved


tablet however the

firm submitted

master formulation

and manufacturing


tablet

104

17-01-14

As per SRO/

Pack of 20’s

160. -do- PROVASC Tablet 5mg


Amlodipine as besylate……5mg

Calcium Antagonist

USP

Form-5

Dy. No. 29

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 20’s

Amlodipine besylate

tablets of Aurobindo

Pharma UK

Ampress of Barrett

Hodgson Karachi

Product is approved


tablet however the

firm submitted

master formulation

and manufacturing


tablet

161. -do- ARTEMIN Tablets (Co Blister

Pack)


Artesunate……50mg


Sulfadoxine…..500mg

Pyremethamine…..25mg

Form-5

Dy. No. 32

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

WHO recommended

formulation

Me too status needs

confirmation

Evidence of local

availability submitted

needs confirmation.

105

Antimalarial

Manufacturer

As per SRO/

Pack of 9’s

(One blister of

artesunate

tablets 9’s &

one blister of

sulfadoxine

and

pyrimethamine

tablets 3’s)

162. -do- NUCLEOID Tablet 5mg


Lamivudine…….100mg

NRTI

BP

Form-5

Dy. No. 25

dated : 08-11-

10

8000/- dated :

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 14’s

Lamivudine 100mg film

coated tablet of Apotex

Inc (USFDA tentative

approval)

Zeffix of GSK, Karachi

Evidence of

availability of FTIR

is required as under

BP specifications,

identification test is

by the aforesaid

testing equipment/

facility.

163. -do- NORELLA Capsules 25mg


Milnacipran…….25mg

Selective nor epinephrine and

Form-5

Dy. No. 27

dated : 08-11-

10

8000/- dated :

JONICA Capsules of

Pierre Fabre Australia

Pty Ltd (TGA

Appeoved)

Local availability not

provided by the firm

Evidence of local

availability of

applied product is not

provided by the firm.

106

serotonin reuptake inhibitor

Manufacturer

08-11-10

12000/- dated:

17-01-14

As per SRO/

Pack of 10’s

164. M/s Fynk

Pharmaceuticals,

19 KM GT

Road, Kalashah

Kaku, Lahore

Alvil Syrup

Each 5ml contains:

Pheniramine meleate…..15mg

Antihistamine

Manufacturer

Form-5

Dy. No. 9667

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 60ml

& 120ml

Avil of Aventis Pharma

(MHRA Approved)

Avil of Sanofi Karachi

165. -do- Metoplaxil Syrup

Each 5ml contains:

Metoclopramide HCL….5mg

Antiemetic

Form-5

Dy. No. 9660

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

Metoclopramide Oral

Solution (BNF 61)

Metoclop of Munawar

Pharma

107

USP 31-07-13

As per SRO/

Pack of 50ml

166. -do- Endzole Suspension

Each 5ml contains:

Albendazole (USP)……100mg

Anthelmintic

USP

Form-5

Dy. No. 9663

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 10ml


in SRA’s needs

confirmation.

Zentel of GSK Karachi

167. -do- Fyzole Suspension

Each 5ml contains:

Mebendazole……100mg

Anthelmintic

Manufacturer

Form-5

Dy. No. 9677

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 30ml

Ovex Suspension of

McNeil Products UK

Bedzol of Rakaposhi

Pharma

108

168. -do- Itrip Tablets


Itopride HCL…..50mg

Gastroprokinetic

Manufacturer

Form-5

Dy. No. 9664

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 10’s

Not available in SRA”s

Ganaton of Abbott Labs

Karchi

Molecule is under

review by the

Registration Board.

169. -do- Fynkofate Suspension

Each 5ml contains:

Sucralfate……1gm

Antiulcerant

Manufacturer

Form-5

Dy. No. 9679

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 60ml

Antepsin Oral

Suspension of Chugai

Pharma UK

Cidifen of Libra Pharma

170. -do- N-T Laria Suspension

Each 5ml contains:

Form-5

Dy. No. 9668

dated 14-10-

Formulation is not

recommended by WHO

Fansidar syrup of

109

Sulfadoxine……500mg

Pyrimethamine…..25mg

Antimalarial

Manufacturer

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 15ml

Martin Dow Karachi

171. -do- Dramin/ Granie Syrup

Each 4ml contains:

Dimenhydrinate……12.5mg

Antiemetic

Manufacturer

Form-5

Dy. No. 9666

dated 14-10-

10

8,000/- dated

14-10-10

12000/- dated

31-07-13

As per SRO/

Pack of 60ml

Dimenhydrinate Oral

liquid (USFDA

Approved but marketing

status is discontinued)

Dymin of Stanley

Pharma

172. M/s Remington

Pharmaceutical

Industries,

Lahore

BONAID Tablets 10mg


Alendronate Sodium USP

equivalent to Alendronic

acid……10mg

Form-5

Dy.No: 290

dated 10-12-

10

8000/- dated:

10-12-10

Fosamax Tablets of

Merck Sharp & Dome

UK

Darte tablets of SG&J

Fazul Elahi



110

Biphosphonates

USP

12000/- dated:

26-07-13

Leader price/

Pack of 10’s

PVC-Alu

Blister

Packing

Pack of 10’s

Alu-Alu

Blister

packing

06-14 by the panel of

inspectors, found the

firm operating at GOOD

level of GMP

compliance and


of GMP certificate for

export purpose.

173. -do- BONAID Tablets 70mg




acid……70mg

Biphosphonates

USP

Form-5

Dy.No: 292

dated 10-12-

10

8000/- dated:

10-12-10

12000/- dated:

26-07-13

Leader price/

Pack of 1x4’s

PVC-Alu

Blister

Packing

Pack of 1x4’s

Alu-Alu

Blister

packing

Alendronic Acid 70 mg

Tablets of Actavis UK.

Darte tablets of SG&J

Fazul Elahi

174. -do- BONAID PLUS D Tablets 70mg Form-5 FOSAVANCE 70

mg/2800 IU tablets of

111




acid……70mg

Cholecalciferol…..70mcg

Biphosphonates

USP

Dy.No:

8000/- dated:

10-12-10

12000/- dated:

26-07-13

Leader price/

Pack of 1x4’s

PVC-Alu

Blister

Packing

Pack of 1x4’s

Alu-Alu

Blister

packing

Merck Sharp & Dome

UK

Darte Plus D tablets of

SG&J Fazul Elahi

175. -do- AMITEL Tablets


Amlodipine as besylate…..5mg

Telmisartan…..80mg

CCB & ARB

Manufacturer

Form-5

Dy.No: 11025

dated 30-11-

10

8000/- dated:

10-12-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

Twynsta (bilayered

tablet) of Boehringer &

Inghelheim (USFDA)

Amtas of Getz Karachi

112





CCB & ARB

Manufacturer

Form-5

Dy.No:

8000/- dated:

10-12-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

Twynsta (bilayered


Inghelheim (USFDA)






CCB & ARB

Manufacturer

Form-5

Dy.No: 11013

dated 30-11-

10

8000/- dated:

10-12-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

Twynsta (bilayered


Inghelheim (USFDA)


113





CCB & ARB

Manufacturer

Form-5

Dy.No:

8000/- dated:

10-12-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

Twynsta (bilayered


Inghelheim (USFDA)


179. -do- COKIREN Tablet


Aliskiren hemifumerate as

equivalent to Aliskiren…….300mg

Hydrochlorothiazide….25mg

Renin Inhibitor & Diuretic

Manufacturer

Form-5

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x10’s

Alu-Alu

Blister

packing

Tekturna HCT of

Novartis

Co Kiren of Tabros

Pharma Karachi

180. -do- COKIREN Tablet Form-5 Tekturna HCT of

Novartis

114




Hydrochlorothiazide…..….12.5mg


Manufacturer

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x10’s

Alu-Alu

Blister

packing

Co Kiren of Tabros

Pharma Karachi





Hydrochlorothiazide…..25mg


Manufacturer

Form-5

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x10’s

Alu-Alu

Blister

packing

Tekturna HCT of

Novartis

Co Kiren of Tabros

Pharma Karachi


Form-5

Tekturna HCT of

Novartis

115




Hydrochlorothiazide……12.5mg


Manufacturer

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x10’s

Alu-Alu

Blister

packing

Co Kiren of Tabros

Pharma Karachi

183. -do- TELMETAN-H Tablets


Telmisartan……80mg

Hydrochlorothiazide…..12.5mg

ARB & Thiazde diuretic

Manufacturer

Form-5

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

MICARDIS-HCT

bilayered tablet of

Boheringer Inghelheim

(USFDA)

Co-Telsan of Hilton

Pharma Karachi



Form-5

Dy.No:

MICARDIS-HCT

bilayered tablet of


(USFDA)

116




Manufacturer

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

Co-Telsan of Hilton

Pharma Karachi




Hydrochlorothiazide…..25mg


Manufacturer

Form-5

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 2x7’s

Alu-Alu

Blister

packing

MICARDIS-HCT

bilayered tablet of


(USFDA)

Co-Telsan of Hilton

Pharma Karachi

186. -do- TIZMER Tablet 2mg


Tizanidine HCL equivalent to

Tizanidine……2mg

Form-5

Dy.No:

8000/- dated:

Tizanidine of Actavis

UK

Movax of Sami Pharma

Karachi

117

Muscle relaxant

Manufacturer

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 1x10’s

PVC-Alu

Blister

packing

Pack of 1x10’s

Alu-Alu

Blister

packing

187. -do- TIZMER Tablet 4mg


Tizanidine HCL equivalent to

Tizanidine……4mg

Muscle relaxant

Manufacturer

Form-5

Dy.No:

8000/- dated:

27-11-10

12000/- dated:

30-07-13

Leader price/

Pack of 1x10’s

Alu-Alu

Blister

packing

Tizanidine of Actavis

UK

Movax of Sami Pharma

Karachi

188. -do- ULCIRAB Tablets 10mg

Each enteric coated tablet contains:

Form-5

Dy.No: dated

Pariet Tablet of Eiasi

Ltd

Rabecid Tablets of

118

Rabeprazole sodium…..10mg

PPI

Manufacturer

8000/-

dated10-12-10

12000/- dated:

30-07-13

Pack of 1x10’s

Alu-Alu

Blister

packing

highnoon

189. -do- ULCIRAB Tablets 20mg


Rabeprazole sodium…..20mg

PPI

Manufacturer

Form-5

Dy.No: 291

dated 10-12-

10

8000/-

dated10-12-10

12000/- dated:

30-07-13

Pack of 1x10’s

Alu-Alu

Blister

packing

Pariet Tablet of Eiasi

Ltd

Rabecid Tablets of

highnoon

190. -do- AMIOL


Amlodipine as besylate……5mg

Olmesartan Medoxomil……20mg

Form-5

Dy.No

8000/-

dated31-12-10

12000/- dated:

Amlodipine Besylate;

Olmesartan Medoxomil

tablets of Matrix Labs

(USFDA)

Omsana AM of Hilton

Pharma

119

CCB & ARB

Manufacturer

30-07-13

Pack of 2x10’s

Alu-Alu

Blister

packing

191. -do- OLMY-H Tablets


Olmesartan Medoxomil…..20mg

Hydrochlorothiazide……25mg

ARB & Thiazide Diuretic

Manufacturer

Form-5

Dy.No

8000/-

dated31-12-10

12000/- dated:

30-07-13

Pack of 2x10’s

Alu-Alu

Blister

packing

Olmetec plus tablets of

Diachi Sankyo

Omsana DIU tablets of

Hilton Pharma

192. -do- OLMY-H Tablets


Olmesartan Medoxomil……10mg

ARB & Thiazide Diuretic

Manufacturer

Form-5

Dy.No

8000/-

dated28-12-10

12000/- dated:

30-07-13

Pack of 2x7’s

Alu-Alu

Blister

packing

Olmetc Tablets of

Diiachi Sankyo UK

Omsana tablet of Hilton

Pharma

120

193. M/s Getz

Pharma Karachi

Lotass Plus Tablets


Losartan Potassium…..50mg


Antihypertensive

Manufacturer

Form-5

Dy. No: 1840/

25-10-10

8000/- dated

25-10-10

12,000/- dated

30-07-13

Rs. 900/- Pack

of 30’s

Hyzaar of Merck sharp

Dhome (USFDA)

Hyzaar of Merck

Karachi


firm was carried out on

11-12-14 by the area

FID and he advised the

management to remain

in adaptation and up

gradation phase to cater

all the requirements of

cGMP.

194. -do- Lotass Plus Tablets


Losartan Potassium…..100mg

Hydrochlorothiazide……..25mg

Antihypertensive

Manufacturer

Form-5D

Dy. No: 1840/

25-10-10

15,000/- dated

25-10-10

5,000/- dated

30-07-13

Rs. 900/- Pack

of 30’s

Hyzaar of Merck sharp

Dhome (USFDA)

Hyzaar Tablets of

Merck (FDA)

195. M/s Paramount

Pharmaceuticals,

Islamabad

ACLOVIR Tablets

Form-5

Aciclovir Tablets of

Actavis UK.

a. Applied

formulation is

approved as

uncoated tablet in

121


Aciclovir………800mg

Antiviral

Manufacturer

Dy. No. 1266

dated : 05-11-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 320/- Pack

of 10’s

Acylex Tablets of

Ferozsons Labs




and the compliance to at

time of inspection was

acceptable to the limit or

standards

SRA’s however

formulation of

film coated tablet

is submitted.

b. Finished product

specifications are

incomplete.

Details like assay

method and

reference of

specifications are

not provided.

196. -do- LEVETAM Tablets 250mg


Levetiracetam…….250mg

Antiepileptic

Manufacturer

Form-5

Dy. No.

110260 dated :

05-11-10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 1050/-

Pack of 30’s

Levetiracetam Milpharm

250 mg film-coated

tablet of Aurobindo

Pharma

Keppra of UCB Pharma

Incomplete

specifications of API

and finished product

are submitted.

197. -do- LEVETAM Tablets 500mg

Each film coated tablet

contains:

Levetiracetam…….500mg

Form-5

Dy. No. 11261

dated : 05-11-

10

8000/- dated :

Levetiracetam Milpharm

250 mg film-coated

tablet of Aurobindo

Pharma

Keppra of UCB Pharma

Incomplete



are submitted

122

Antiepileptic

Manufacturer

05-11-10

12,000/- dated:

22-07-13

Rs. 1740/-

Pack of 30’s

198. -do- LEVOSID Tablet 25mg


Levosulpiride……25mg

Gastroprokinetic

Manufacturer

Form-5

Dy. No. 11258

dated : 05-11-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 191/- Pack

of 20’s


Levopraid of Pacific

Pharma Lahore

a. Molecule is

already under

review.

b. Incomplete

specifications of

API and finished

product are

submitted

199. -do- LEVOSID Tablet 50mg


Levosulpiride……50mg

Gastroprokinetic

Manufacturer

Form-5

Dy. No. 11259

dated : 05-11-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13


Levopraid of Pacific

Pharma Lahore

a. Molecule is

already under

review.

b. Incomplete

specifications of

API and finished

product are

submitted

123

Rs. 191/- Pack

of 20’s

200. -do- BISOLOL Tablet 5mg


Bisoprolol Fumarate…..5mg

Beta Blocker

Manufacturer

Form-5

Dy. No. 173

dated : 06-12-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 131/- Pack

of 14’s

Emcor of Merk

Serno UK

Concor of Merck

Pharmacopieal

specifications are not

provided as

formulation is

included in official

compendia (USP).

Moreover the

manufacturer specs


are also incomplete.

201. -do- ZIPRA Capsules 40mg


Ziprasidone as HCL……40mg

Atypical Antipsychotic

Manufacturer

Form-5

Dy. No. 11263

dated : 05-11-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 1680/-

Pack of 14’s

Geodon of Pfizer

(USFDA)

Zeldox of Pfizer Karachi

Incomplete



are submitted

202. -do- ZIPRA Capsules 60mg

Form-5

Geodon of Pfizer

(USFDA)

Incomplete



124


Ziprasidone as HCL……60mg

Atypical Antipsychotic

Manufacturer

Dy. No. 11262

dated : 05-11-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 2380/-

Pack of 14’s

Zeldox of Pfizer Karachi

are submitted

203. -do- Osetron Tablets 8mg


Ondansetron as

Hydrochloride……8mg

5HT3 Receptor Antagonist

Manufacturer

Form-5

Dy. No. 11264

dated : 05-11-

10

8000/- dated :

05-11-10

12,000/- dated:

22-07-13

Rs. 3795/-

Pack of 10’s

Zofran of GSK UK

Zofran of GSK Karachi

Pharmacopieal


provided of API and

formulation is

included in official

compendia (USP).

Moreover the

manufacturer specs


are also incomplete

204. -do- Thioside Capsules


Thiocolchicoside…..4mg

Form-5

Dy. No. 11265

dated : 05-11-

10

8000/- dated :


Mucoril of Searle

Pakistan Karachi

Molecule is already

under review.

Specifications of API


are incomplete.

125

Muscle Relaxant

Manufacturer

05-11-10

12,000/- dated:

22-07-13

Rs. 514/- Pack

of 20’s

205. -do- Diclomis Tablets


Diclofenac Sodium…..50mg

Misoprostol….200mcg

Cytoprotectant

Manufacturer

Form-5

Dy. No: 9969/

27-10-10

20,000/-

Rs. 275/- Pack

of 20’s

Arthrotec of Pfizer

Arthrotec of Pfizer


submitted are

incomplete and

without reference,

moreover firm has

submitted that they

use plain misoprostol

in formulation. The

Registration Board in

246th meeting

approved the applied

formulation with

misoprostol with 1%

HPMC.

Finished product


submitted by the firm

206. -do- Gaspro Tablet


Itopride HCL……50mg

Gastroprokinetic

Manufacturer

Form-5

Dy. No: 9969/

27-10-10

20,000/-

Rs. 375/- Pack

of 10’s

Not approved in SRA’s


Molecule is under

review


submitted are

incomplete

Finished product


submitted by the

firm.

126

207. M/s UDL

Pharmaceuticals,

Karachi

(Former M/s

Allied Medical

Supplies, North

West Industrial

Zone, Port

Qasim Karachi).

ZIXOFEN DS Suspension

Each 5ml contains:

Cefixime as Trihydrate……200mg

Antibiotic Cephalosporin

Manufacturer

Form-5

Dy.No: 272

8000/- dated

30-11-10

Rs. 350/ Pack

of 30ml

SUPRAX of Lupin

Pharms (USFDA)

Cebosch suspension of

Bosch Pharmaceuticals

Karachi


was conducted by the

panel of inspectors 09-

09-13 and recommended

the grant of additional

sections namely, Dry

suspension (general),

Capsule (general),

Inspection of the firm by

the provincial inspector

of drugs Karachi on 06-

05-14 and reported

nothing in violation of

GMP.

208. M/s Macter

International

(Pvt) Limited,

Karachi

Macticort Nebulizing Solution

Each 2ml vial contains:

Beclomethasone

dipropionate…….0.8mg

Anti-inflammatory Corticosteroid

Manufacturer

Form-5

Dy.No: 135

8000/- dated

18-08-10

12000/- dated

11-05-13

As per PRC/

5mono dose

vials per pack


in SRA.s needs

conformation.

Me too status submitted

also needs confirmation


was carried out by the

panel of inspectors on

06-11-14 by the panel of

inspectors and

recommends the

renewal of DML.

Manufacturing

facility for steroidal

solutions needs

confirmation.

127

209. -do- TINICID Tablet


Terbinafine as HCL….125mg

Antifungal

USP

Form-5

Dy.No: 199

8000/- dated

30-08-10

12000/- dated

11-05-13

As per PRC/

pack of 10’s

Terbinafine Tablets of

Dr Reddy Labs UK

(MHRA Approved)

Lamisil tablets of

Novartis Karachi

210. -do- TINICID Cream

Each gm contains:

Terbinafine as HCL….10mg

Antifungal

USP

Form-5

Dy.No: 199

8000/- dated

20-07-10

12000/- dated

11-05-13

As per PRC/

pack of 10gm

Lamisil Cream of

Novartis UK

Lamisil cream of

Novartis Karachi

211. -do- ALOZIN-XR Tablets


contains:

Ranolazine….500mg

Form-5

Dy.No:

Rs. 198/ pack

of 14’s

Ranexa 500 mg

prolonged-release

tablets of Menarini

Farmaceutica

Internazionale (MHRA

Approved)

Razin ER of Getz

128

Antianginal

Manufacturer

Pharma Karachi

212. -do- MCLINE Injection

Each 5ml ampoule contains:

Sodium Chloride……45mg

Solvent

Manufacturer

Form-5

Dy. No. 10

dated : 02-11-

10

8000/- dated :

02-11-10

As per PRC/

5ml ampoule

Soride of Bosch


The FID reported the

availability of TOC

analyzer however the

availability of liquid

particle counter

requires

confirmation.

213. -do- MACDRONIC Infusion

Each 100ml solution contains:

Zoledronic acid as

monohydrate…..5mg

Osteoclastic Inhibitor

Manufacturer

Form-5

Dy.No: 85

dated: 11-11-

10

8000/- dated:

08-11-10

12,000/- dated

31-07-13

24,000/- Pack

of 100ml

Aclasta of Novartis UK

Reclast of Novartis

Karachi


availability of TOC



particle counter

requires

confirmation.

214. -do- MACDRONIC Injection

Form-5

Zoledronic acid 4 mg/5

ml concentrate for

solution for infusion of


availability of TOC


129

Each 5ml contains:

Zoledronic acid as

monohydrate…..4mg

Osteoclastic Inhibitor

Manufacturer

Dy.No: 84

dated: 11-11-

10

8000/- dated:

08-11-10

12,000/- dated

31-07-13

16150/- Pack

of 5ml

Intrapharm Labs UK.

Reclast of Novartis

Karachi


particle counter

requires

confirmation.

215. -do- MACTOSIN Cream

Each gram contains:

Futicasone propionate…..0.5mg

Corticosteroid

Manufacturer

Form-5

Dy.No: 87

dated: 11-11-

10

8000/- dated:

08-11-10

12,000/- dated

31-07-13

As per SRO/-

5gm tube

Cutivate Cream of GSK

UK

Cutivate Cream of GSK,

Karachi

216. -do- DELICORT Cream

Each 100 gm contains:

Hydrocortisone…….1gm

Form-5

Dy.No: 87

dated: 11-11-

10

8000/- dated:

Ala-cort Cream 1% of

Crown Labs (USFDA)

Cortival of Valor

Pharma

130

Corticosteroid

Manufacturer

08-11-10

12,000/- dated

31-07-13

As per SRO/-

5gm tube

217. -do- DELICORT Cream

Each 100 gm contains:

Hydrocortisone…….2.5gm

Corticosteroid

Manufacturer

Form-5

Dy.No: 88

dated: 11-11-

10

12,000/- dated

31-07-13

8000/- dated:

08-11-10

As per SRO/-

5gm tube

Anusol HC 2.5% Cream

of Salix Pharms

(USFDA)

Cortival of Valor

Pharma

218. M/s Saydon

Pharmaceuticals

Industries (Pvt)

Limited,

Peshawar

Clopix Tablet 2mg


Zuclopenthixol as HCL

(B.P)……2mg

Tranquilizer (Thioxanthane)

BP

Form-5

29-09-2010

Dy. No. 69

20,000/-

As per SRO

Pack of 50’s in

sealed blister

of Al. Foil and

Clopixol of Lundbeck

UK


Pakistan Karachi




and he found certain

issues/ shortcomings

during inspection

131

PVC or in

glass bottle

219. -do- Clopix Tablet 10mg



(B.P)……10mg


BP

Form-5

29-09-2010

Dy. No. 68

20,000/-

As per SRO

Pack of 50’s in

sealed blister

of Al. Foil and

PVC or in

glass bottle


UK


Pakistan Karachi

220. -do- Clopix Tablet 25mg



(B.P)……25mg


BP

Form-5

29-09-2010

Dy. No. 67

20,000/-

As per SRO

Pack of 50’s in

sealed blister

of Al. Foil and

PVC or in

glass bottle


UK


Pakistan Karachi

221. -do- Remedon Tablet 30mg

Form-5

Mirtazapine of Actavis

UK.

132


Mirtazapine…..30mg

Antidepressant

Manufacturer

29-09-2010

Dy. No. 67

20,000/-

As per SRO

Pack of 10’s in

sealed blister

of Al. Foil and

PVC or in

glass bottle.

Rameron of OBS

Karachi

222. -do- Mashenil Tablet-80


Artemether….80mg

Lumefantrine….480mg

Antimalarial

USP (Salmous)

Form-5

29-09-2010

Dy. No. 67

20,000/-

As per SRO

Pack of 6’s in

sealed blister

of Al. Foil and

PVC or Alu-

Alu blister

Mirtazapine of Actavis

UK.

Rameron of OBS

Karachi

223. -do- Saydazole Infusion 500mg/ 100ml

Each 100 ml vial contains:

Metronidazole…..500mg

Form-5

29-09-2010

Dy. No. 72

20,000/-

Metronidazole Infusion

of Claris Life sciences

USFDA (plastic PVC

container)

Flagyl of Sanofi Karachi

Evidence of

availability of TOC

analyzer and liquid

particle counter is not

provided by the firm.

133

Amoebicide

USP

As per SRO

Pack of 1’s,

glass vial of

100ml USP

Type-I

224. M/s Rasco

Pharma, Lahore

Nilclot DS Tablet


Clopidogrel as hydrogen

sulphate……75mg

Asprin……150mg

Antiplatelet

Manufacturer

Form-5

Dy. No. 1128

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

As per SRO/

Pack of 10’s

Not available in

Stringent SRA’s

Clodrel Plus of Macter

International Karachi

The inspection of firm

was carried out on 03-


inspectors and

recommended the

renewal of DML and

additional section

namely Liquid Injection

General (Small Volume

Vial)

Firm submitted the

reference of Coplavix

Tablets (Aspirin

100mg &

Clopidogrel 75mg).

225. -do- Nilclot Plus Tablet


Clopidogrel as hydrogen

sulphate……75mg

Asprin……75mg

Antiplatelet

Form-5

Dy. No. …..

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

Cplavix of Sanofi

Aventis (TGA

Approved)

Clodrel Plus of Macter

International Karachi

134

Manufacturer

As per SRO/

Pack of 10’s

226. -do- Colast DS Tablet


Amodipine as besylate…..10mg

Atorvastatin as calcium

hydrate……20mg

Calcium Antagonist/ Statin

Manufacturer

Form-5

Dy. No. 1128

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

As per SRO/

Pack of 10’s


(USFDA)

Am Descol of Nabi

Qasim Karachi

227. -do- Colast Plus Tablet


Amodipine as besylate…..5mg

Atorvastatin as calcium

hydrate……10mg

Calcium Antagonist/ Statin

Manufacturer

Form-5

Dy. No……..

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

As per SRO/

Pack of 10’s


(USFDA)

Am Descol of Nabi

Qasim Karachi

228. -do- Dimyril DS Tablet Form-5 Not available in SRA’s Evidence of

availability in

135


Glimepiride USP…..2mg

Metformin HCL……500mg

Antidiabetic

Manufacturer

Dy. No……..

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

As per SRO/

Pack of 3x10’s

Amaryl M SR tablets of

Sanofi Pakistan

stringent SRA’s is

not submitted by the

firm.

The formulation

available locally as

bilayered tablet

contains, as active

ingridients,

Glimepiride 2mg and

Metformin

hydrochloride (as

sustained release).

However the applied

formulation is

compressed tablet

and contains the

aforesaid ingredients

as immediate release

229. -do- Dimyril Plus Tablet


Glimepiride USP…..1mg

Metformin HCL……500mg

Antidiabetic

Manufacturer

Form-5

Dy. No……..

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

As per SRO/

Pack of 3x10’s


Amaryl M SR tablets of

Sanofi Pakistan

Evidence of

availability in



firm.

The formulation

available locally as

bilayered tablet

contains, as active

ingridients,

Glimepiride 2mg and

Metformin

hydrochloride (as

sustained release).

However the applied

formulation is

compressed tablet

and contains the

aforesaid ingredients

as immediate release

230. -do- Az-Ko Capsules Form-5 Not available in SRA’s Evidence of

availability in

136


Azithromycin as

dihydrate……500mg

Macrolide

Manufacturer

Dy. No……..

dated 02-11-

10

8,000/- dated

02-11-10

12000/- dated

30-07-13

As per SRO/

Pack of 1x6’s

Azocam of Chas. A

Mendoza



firm.

231. M/s Convell

Laboratories,

Swat

CIP Tablets 750mg


Ciprofloxacin as HCL……750mg

Fluoroquinolone

BP

Form-5

30-09-2010

Dy. No.123

20,000/-

Rs: 29.90/- per

tablet

Pack of 10’s

Cipro of Bayer

Healthcare (USFDA)

Nafcin of Global

Pharmaceuticals,

Islamabad




inspectors and


of DML.

232. -do- Azit Suspension 200mg

Each 5ml contains:

Azithromycin as

dihydrate……200mg

Form-5

30-09-2010

Dy. No.128

20,000/-

Zithromax of Pfizer

(USFDA)

Zithromax of Pfizer

Karachi

137

Macrolide Antibacterial

Manufacturer

Rs: 175/- per

bottle

Pack of 1’s

233. -do- CIDOL-L Tablets


Levocetirizine dihydrochloride

…..5mg

H1- Receptor Blocker

Manufacturer

Form-5

30-09-2010

Dy. No.125

20,000/-

Rs: 6.50/- per

tablet

Pack of 1x10’s

Xyzal Tablet f/c (BNF)

Belair of Bayer

HealthCare Karachi

234. -do- FEZET Tablets


Fexofenadine HCL …..60mg

H1- Receptor Blocker

Manufacturer

Form-5

30-09-2010

Dy. No.126

20,000/-

Rs: 6.20/- per

tablet

Pack of 1x10’s

Fexofenadine HCL

Tablets of Teva

(USFDA)

Fexet of Getz Pharma

Applied formulation

is approved as film

coated tablet in

SRA’s however firm

submitted

formulation of

uncoated tablet.

235. -do- CIDOL-L Syrup

Each 5ml contains:

Levocetirzine

Form-5

30-09-2010

Dy. No.124

Xyzal Oral Solution

2.5mg/ 5ml (USFDA)

Neo-Sedil of Sami

138

dihydrochloride…..2.5mg

Antihistamine

Manufacturer

20,000/-

Rs: 40/- per

bottle

Pack of 60ml

Karachi

236. M/s Irza Pharma

Sheikhupura

Gelgsic Forte Tablet


Paracetamol……650mg

Orphenadrine Citrate….50mg

Analgesic/ Central analgesic

Manufacturer

Form-5

Dy. No:……

dated 12-10-

10

8,000/- dated

12-10-10

12000/- dated

17-05-13

As per SRO/

Pack of 30’s


Nuberol of Searle

Karachi



area FID on 18-03-14

and found that firm is

complying most of

GMP guidelines except

injectable and eye drop

section which needs up

gradation and were not

in operation at the time

of inspection.

Evidence of

availability in SRA’s

is not submitted by

the firm.

237. M/s Nabiqasim

Industries (Pvt)

Limited,

Karachi

CareAll ORS Sachet

(Lemon Flavor)

Each sachet contains:

Sodium Chloride….3.5g

Sodium Citrate……2.9gm

Potassium Chloride…..1.5g

Form-5

Dy. No: 1826/

20-10-10

8,000/- dated

19-10-10

12000/- dated


Peditral ORS of Searle

Pakistan Karachi

Firm has submitted the

GMP certificate issued

on 03-06-14 by DRAP.


Formulation is not

recommended by

WHO

139

Dextrose anhydrous……20g

ORS

Manufacturer

09-09-13

As per PRC/

10’s, & 20’s,


panel of inspectors on

15-10-14 by the panel of

inspectors

recommended the

renewal of DML.

238. -do- CareAll ORS Sachet

(Orange Flavor)

Each sachet contains:

Sodium Chloride….3.5g

Sodium Citrate……2.9gm

Potassium Chloride…..1.5g

Dextrose anhydrous……20g

ORS

Manufacturer

Form-5

Dy. No: 1828/

20-10-10

8,000/- dated

19-10-10

12000/- dated

09-09-13

As per PRC/

10’s, & 20’s,


Peditral ORS of Searle

Pakistan Karachi

Formulation is not

recommended by

WHO

239. M/s Noa Hemis

Pharmaceuticals,

Plot No. 154,

Sector 23,

Korangi

Industrial area,

Karachi

ETOXIB Tablets 60mg


Etoricoxib……60mg

Analgesic, NSAID

Manufacturer

Form-5

Dy.No: 2269-

R-II dated 28-

12-10

8000/- dated

20-12-10

12,000/- dated

10-04-14

ARCOXIA® 60 mg

film-coated tablets of

Grunenthal Ltd

Arcox g Getz Pharma

Karachi


was carried out on 09-


and overall GMP was

140

As per

policy/pack of

14’s

graded as GOOD.

240. -do- ETOXIB Tablets 90mg



Analgesic, NSAID

Manufacturer

Form-5D

Dy.No: 2269-

R-II dated 28-

12-10

8000/- dated

20-12-10

12,000/- dated

10-04-14

30,000/- dated

19-01-15

As per

policy/pack of

14’s

ARCOXIA® 90 mg


Grunenthal Ltd

Submitted Form-5D

is incomplete.

241. -do- ETOXIB Tablets 120mg



Analgesic, NSAID

Manufacturer

Form-5D

Dy.No: 2269-

R-II dated 28-

12-10

8000/- dated

20-12-10

12,000/- dated

10-04-14

30,000/- dated

ARCOXIA® 120 mg


Grunenthal Ltd

Submitted Form-5D

is incomplete.

141

19-01-15

As per

policy/pack of

14’s

242. M/s MeDLey

Pharmaceuticals,

Wah Cantt,

Rawalpindi.

LINZO Tablet 600mg


Linezolid….600mg

Antibiotic

Manufacturer

Form-5

Dy. No. 875

dated : 08-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 12’s

Zyvox of Pharmacia

Limited UK

Ecasil Tablet of Sami

Pharmaceuticals,

Karachi



05-13 and GMP

compliance was found

satisfactory.

243. -do- MOXILEY Tablets


Moxifloxacin as HCL….200mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No. 870

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13


Me too not submitted

Evidence of


is not provided.

Evidence of local

availability is not

submitted by the

firm.

142

As per SRO/

Pack of 1x5’s

244. -do- PAROXI CR Tablet 25mg

Each controlled release tablet

contains:

Paroxetine as HCL…..25mg

Antidepressant

Manufacturer

Form-5

Dy. No. 871

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 100’s

Paxil CR of Apotex

Labs (USFDA

Approved)

Paraxyl CR Tablets of

CCL Labs Lahore

245. -do- DEXIMED Tablets 400mg


Dexibuprofen…..400mg

NSAID

Manufacturer

Form-5

Dy. No. 862

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 30

tablets

Seractil tablets 400mg

of Genus

Pharmaceuticals

(MHRA)

Dexifin of ICI Pakistan

246. -do- DEXIMED Suspension 100mg/5ml Form-5 Not found in SRA’s

143

Each 5ml contains:

Dexibuprofen…….100mg

NSAID

Manufacturer

Dy. No. 865

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 60ml

bottle

Tercica of Sami

Pharmaceuticals,

Karachi

247. -do- T-DOL Plus Tablets



Tramadol HCL….37.5mg

Non-opiod analgesic

Manufacturer

Form-5

Dy. No. 868

dated : 08-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 1x10’s

Tramacet tablets of

Grunenthel Pharma UK

Tonoflex-P of Sami

Karachi

248. -do- FYLO Tablets

Form-5

Not found in SRA’s

Evidence of


is not submitted by

144


Doxofylline……400mg

Antiasthmatic

Manufacturer

Dy. No. 867

dated : 08-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 1x10’s

Unifylline tablet of

Platinum Pharma

Karachi

the firm.

249. -do- IBUMED Tablets 200mg


Ibuprofen…..200mg

NSAID

BP

Form-5

Dy. No. 872

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 100’s

Amcal (Ibuprofen

200mg tablet-film

coated) of Sigma

Company (TGA

Approved)

Ifen tablets of Adamjee


250. -do- ANTIDEP XR Tablets 50mg


Form-5

Dy. No. 866

dated : 10-11-

Pristiq XR tablet of

Wyeth Pharms

Denla XR tablets of

145

Desvenlafaxine as succinate…50mg

Antidepressant

Manufacturer

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 1x5’s

semos Pharma Karachi

251. -do- LETRO Tablets 2.5mg


Letrozole……2.5mg

Non-steroidal aromatase inhibitor

USP

Form-5

Dy. No. 873

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 30’s

Femara of Novartis

(USFDA)

Femara of Novartis

Karachi

252. -do- BROMO Tablets2.5mg


Bromocriptine as

mesylate……2.5mg

Form-5

Dy. No. 869

dated : 10-11-

10

Bromocriptine tablets

2.5mg of Meda

Pharmaceuticals

(MHRA)

Brotin of Shaigan

Pharmaceuticals

146

Antiparkinsonian agent

USP

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 30’s

Islamabad

253. -do- KETO Injection 30mg/ml

Each ml contains:

Ketorolac tromethamine…..30mg

NSAID

BP

Form-5

Dy. No. 862

dated : 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

1ml glass

ampoule

Ketorolac

Tromethamine injection

of Hospira (USFDA)

Ketolac of Nimral Labs

The firm has

submitted the

invoices of purchase

of TOC analyzer and

liquid particle

counter.

254. -do- ARTELEY Injection 80mg/ml

Each ml contains:

Artemether……..80mg

Form-5

Dy. No. 864

dated : 10-11-

10

WHO recommended

formulation

Artem of Hilton


147

Antimalarial

Manufacturer

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 1mlx6

ampoules

255. -do- GENTOMED Injection 80mg/2ml

Each 2ml contains:

Gentamycin as sulphate….80mg

Aminoglycoside

USP

Form-5

Dy. No. 863

dated : 24-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of

2mlx10’s

Cidomycin Solution for

Injection of Sanofi

(MHRA)

Cidomycin of Sanofi

Karachi

.

256. -do- GENTOMED Injection 40mg/2ml

Each 2ml contains:

Gentamycin as sulphate….40mg

Form-5

Dy. No. 10812

dated : 24-11-

10

8000/- dated :


Me too needs

confirmation

.Evidence of


is not submitted by

the firm

Evidence of local

availability submitted

also requires

148

Aminoglycoside

USP

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of

2mlx10’s

confirmation.

257. -do- LINCOMED Injection 600mg/2ml

Each 2ml contains:

Lincomycin USP…..600mg

Antibiotic

USP

Form-5

Dy. No. 10816

dated : 24-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of

2mlx10’s

Lincocin of Pharmacia

& Upjohn (USFDA)

MB-Linco of MBL


258. -do- MEDCAM Injection 20mg/ml


Piroxicam…..20mg

NSAID

Form-5

Dy. No. 10810

dated : 24-11-

10

8000/- dated :

Feldene Injection of

Pfizer UK

Feldene Injection of

Pfizer Karachi

149

Manufacturer

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of

1mlx5’s

259. -do- D-WATER Injection 5ml

Each ampoule contains:

Water for Injection…..5ml

Diluent

BP

Form-5

Dy.No: 861

dated: 10-11-

10

8000/- dated :

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 5ml

ampoule

Sterile water for

injection of Pharmacia

UK

AquaBio of Biolabs

Islamabad

260. -do- M-Ject Injection 40mg/2ml


Iron as iron sucrose…….40mg

Antianemic

Form-5

Dy. No. 860

dated : 10-11-

10

8000/- dated :

Venofer 20 mg iron /

ml,of Viofer

Pharmaceuticals

(MHRA)

Me too status needs

confirmation

Evidence of

availability in local

market needs

confirmation

150

USP

10-11-10

12000/- dated:

19-07-13

As per SRO/

Pack of 2ml

ampoule

261. M/s Shawan

Pharmaceuticals,

Rawat

Islamabad

KOXIB Capsules 200mg


Celecoxib…….200mg

NSAID

Manufacturer

Form-5

Dy.No: 10835

dated: 24-11-

10

8000/- dated:

15-11-10

12000/- dated:

04-11-13

As per SRO/

Pack of 2x10’s

Celebrex of Pfizer

(MHRA)

Celbex of Getz Karachi




and GMP compliance

was found “GOOD”.

a. Quantity of API

submitted in

master

formulation is not

rational with the

batch size.

b. Pharmacopieal

specifications of

API need to be

submitted.

c. Finished product

specifications are

ambiguous.

Identification test

for cepodoxime is

submitted instead

of Celecoxib.

262. -do- KOXIB Capsules 100mg


Celecoxib…….100mg

NSAID

Form-5

Dy.No: 10834

dated: 24-11-

10

8000/- dated:

15-11-10

Celebrex of Pfizer

(MHRA)

Celbex of Getz Karachi

a. Quantity of API

submitted in

master

formulation is not

rational with the

batch size.

b. Pharmacopieal

specifications of

API need to be

submitted.

c. Finished product

specifications are

ambiguous.

151

Manufacturer

12000/- dated:

04-11-13

As per SRO/

Pack of 2x10’s

Identification test

for cepodoxime is

submitted instead

of Celecoxib.

263. -do- VIZZ DS Tablet


Artemether……80mg


Antimalarial

Manufacturer

Form-5

Dy.No: 10837

dated: 24-11-

10

8000/- dated:

15-11-10

12000/- dated:

04-11-13

As per SRO/

Pack of 1x6’s

Formulation is

recommended by WHO.

Artem Plus tablets of

Hilton Pharma Karachi

264. M/s Hilton

Pharma (Pvt)

Limited

Karachi.

Pranza Tablet


Pranlukast…….225mg

Leukotriene Receptor-1 Antagonist

Manufacturer

Form-5

Dy. No: 1815/

20-10-10

8,000/-dated

15-08-10

12000/- dated

23-10-13

As per PRC/


Me too status submitted

needs confirmation


was conducted on 21st &

22nd

August 2014 by the

panel of inspectors and

recommended the

renewal of DML.

Evidence of


is not submitted by

the firm.

Evidence of local

availability (Pankas

of CCL, Lahore) also

needs conformation.

152

10’s, 14’s,

20’s, 28’s,

30’s

265. M/s Mega

Pharmaceuticals,

Limited Lahore

DULOX Capsules 30mg




duloxetine…..30mg

Antidepressant

Manufacturer

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 20’s

Cymbalta of EliLilly

(USFDA)

Oxcym DR of Atco

Labs Karachi


firm was carried out on

22-07-14 by the area

FID regarding

rectification of

shortcommings noted on

17-05-13. The FID

reported that firm has

rectified most of the

shortcomings. Moreover

certains advises have

been made to the

management,

a. To do paint work in

some of the missing

areas.

b. To provide more

racks in warehouse

to keep goods

properly.

c. To provided new

uiforms, lab coats

and shoes for plant

staff

a. Quantity of

pellets per

capsule

equivalent to

duloxetine 30mg

and quantity per

batch is not

submitted by the

firm.

b. Source of said

pellets, their

composition,

certificate of

analysis, stability

studies as per

zone IV and in

case of import of

pellets, legalized

GMP certificate

of the source

along with the

requisite fee

under the rules is

not provided the

firm.

c. Manufacturing

process submitted

is ambiguous.

266. -do- DULOX Capsules 60mg




Form-5

Dy.No: Not

provided,

dated: 12-11-

Cymbalta of EliLilly

(USFDA)

Oxcym DR of Atco

Labs Karachi

a. Quantity of

pellets per

capsule

equivalent to

duloxetine 30mg

and quantity per

batch is not

submitted by the

153

duloxetine…..60mg

Antidepressant

Manufacturer

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 20’s

firm.

b. Source of said

pellets, their

composition,

certificate of

analysis, stability

studies as per

zone IV and in

case of import of

pellets, legalized

GMP certificate

of the source

along with the

requisite fee

under the rules is

not provided the

firm.

c. Manufacturing

process

submitted is

ambiguous.

267. -do- PERSIL Tablets 10mg

Each tablet contains;

Domperidone as meleate……10mg

Dopamine Antagonist

BP

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 50’s

Motilium of Zentiva

(MHRA)

Pelton of Global

Pharmaceuticals,

Islamabad.

The formulation is

approved in SRA’s as

film coated tablet

however the firm

applied it as

uncoated.

268. -do- MOXI Tablets 400mg


Form-5

Dy.No: Not

provided,

Avelox of Bayer

(USFDA)

Avelox of Bayer

154

Moxifloxacin as

hydrochloride…..400mg

Fluoroquinolone

Manufacturer

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 5’s

Karachi

269. -do- MEGAGESIC Forte Tablets



Orphenadrine citrate….50mg

Analgesic & skeletal muscle

relaxant

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 100’s

Not avaialbe in SRA’s

Fexodin of Remington

Pharma Lahore.

Evidence of


is not submitted by

the firm.

Finished product

specifications are

claimed as USP

however the

formulation is not

available with

aforesaid compendia

270. -do- MEGAGESIC Tablets



Orphenadrine citrate….35mg

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

Not available SRA’s

Flexar Tablet of Candid

Pharma Pasrur

Evidence of


is not submitted by

the firm.

USP specifications

are claimed by the

firm however the

applied formulation

is not available in the

155

Analgesic & skeletal muscle

relaxant

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 100’s

aforesaid compendia.

271. -do- LEOCIN Tablets 750mg


Levofloxacin as

hemihydrate….750mg

Fluoroquinolone

USP (pending)

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Levofloxacin Tablets of

Dr Reddy Lab Inc

(USFDA)

Leflox of Getz Karachi

272. -do- RITEFLOX Tablets 750mg


Ciprofloxacin as

hydrochloride….750mg

Fluoroquinolone

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

Levofloxacin Tablets of

Dr Reddy Lab Inc

(USFDA)

Leflox of Getz Karachi

156

USP 05-08-13

As per SRO/

Pack of 10’s

273. -do- OLANZ Tablets 5mg


Olanzapine as citrate…..5mg

Tranquilizer, Sedative & Hypnotic

USP (pending)

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Symbayx of Eli Lilly

(USFDA)

Olanzia of Werrick

Pharmaceuticals,

Islamabad

USP pending

monograph is

submitted for the

applied formulation

however the

submitted

specifications are

different from the

available

specifications of the

said monograph.

274. -do- OLANZ Tablets 10mg


Olanzapine as citrate…..10mg

Tranquilizer, Sedative & Hypnotic

USP(Pending)

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Symbayx of Eli Lilly

(USFDA)

Olanzia of Werrick

Pharmaceuticals,

Islamabad

USP pending

monograph is

submitted for the

applied formulation

however the

submitted

specifications are

different from the

available

specifications of the

said monograph.

Applied formulation

is approved in SRA’s

as film coated

however the firm has

157

Pack of 10’s applied the uncoated

tablet.

275. -do- PYREX Tablet 20mg


Piroxicam as beta

cyclodextrin……20mg

NSAIDS

Manufacturer

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Brexidol of Chiesi

Brexin of Chiesi

Karachi

276. -do- COLOPAN Tablets 80mg


Drotaverine as

hydrochloride……80mg

Antispasmodic & Anticholinergic

Manufacturer

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 20’s

Not available in SRA’

No-Spa of Sanofi

Karachi

Firm submitted that

formulation is

available in India and

Thailand. Evidence

of approval of the

applied drug in

SRA’s is not

submitted by the

firm.

158

277. -do- COLOPAN Tablets 40mg


Drotaverine as

hydrochloride……40mg

Antispasmodic & Anticholinergic

Manufacturer

Form-5

Dy.No: 10555,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 20’s

Not available in SRA’

No-Spa of Sanofi

Karachi

Firm submitted that

formulation is

available in India and

Thailand. Evidence

of approval of the

applied drug in

SRA’s is not

submitted by the

firm.

278. -do- MEGAFENAC-K Tablets 50mg


Diclofenac Potassium……50mg

NSAID

USP

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 20’s

Voltral Rapid of

Novartis

Artinil-K of Global

Pharma Islamabad

Product is available

in SRA’s as sugar

coated tablet

however the firm

submitted

formulation for

enteric coated tablet.

279. -do- MACROMAX Capsules 500mg


Form-5

Dy.No: Not

provided,


Azure capsules of Fynk

Evidence of


is not submitted by

the firm.

159

Azithromycin as

dihydarte……500mg

Antibiotic

BP

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Pharma Lahore

280. -do- MEGAZOLE Capsule 40mg


Omeprazole sodium enteric coated

pellets (8.5%) equivalent to

Omeprazole……40mg

PPI

Manufacturer

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 14’s

Losec capsules of

AstraZeneca

Omega of Ferozsons

Labs

a. Source of

omeprazole pellets,

their composition,

certificate of

analysis, stability

studies as per zone

IV and in case of

import of pellets,

legalized GMP

certificate of the

source along with

the requisite fee is

not submitted by

the firm.

b. Specifications of

omeprazole powder

are submitted

however the applied

formulation is with

enteric coated

pellets.

281. -do- ETOPRIDE Tablets 50mg


Itopride Hydrochloride…..500mg

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

Not avaible in SRA’s


Karachi

Molecule is already

under review.

160

Gastroprokinetic & Antiemetic

Manufacturer

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

282. -do- ARTIMEG DS Tablets


Artemether….40mg


Antimalarial

USP (pending)

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 16’s

WHO recommended

formulation (Uncoated

tablet).

Artem DS of Hilton

Pharma Karachi

Master formulation

of film coated tablet

is submitted;

however

recommended

formulation is

uncoated tablet.

283. -do- ARTIMEG Tablets


Artemether….20mg


Antimalarial

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

Riamet tablets of

Novartis (WHO

approved as uncoated

tablet)

Exafal of Novartis

Karachi

Master formulation

of film coated tablet

is submitted;

however

recommended

formulation is

uncoated tablet.

161

USP (Pending)

12,000/- dated

05-08-13

As per SRO/

Pack of 16’s

284. -do- PARAGEIS Tablets


Paracetamol…..325mg

Tramadol HCL…..37.5mg

Analgesic

Manufacturer

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Tramacet tablets of

Grunenthel Pharma UK

Zultracet of Wilshire

Labs

Master formulation

of uncoated tablet is

submitted; however

formulation in SRA’s

is film coated tablet.

285. -do- MEGAGYL Tablet 400mg


Metronidazole….400mg

Antiprotozoal

USP

Form-5

Dy.No: Not

provided,

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

Flagyl of Zentiva

Flagyl of Sanofi Karachi

Master formulation


submitted; however



162

As per SRO/

Pack of 10’s

286. -do- ETOPRIDE OD Tablets 150mg

Each sustained release tablet

contains:

Itopride hydrochloride….150mg

Antiemetic & Gastroprokinetic

Manufacturer

Form-5

Dy.No: 10540

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s


Me too status needs

confirmation

Evidence of


is not submitted by

the firm.

Under evidence of

local availability

reference of Ganaton

& Ipride 50 mg tablet

of Abbot & Wilshire

is provided.

Molecule is already

under review.

287. -do- MEGAVID Tablets 400mg


Ofloxacin…….400mg

Quinolone Antibiotic

USP

Form-5

Dy.No: 10545

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Tarivid tavlets of Sanofi

Oflobid tablets of Hilton

Pharma

288. -do- MEGAFOS Suspension 250mg/5ml

Form-5


Evidence of

availability in SRA,s

is not submitted by

163

Each 5ml contains:

Fosfomycin …250mg

Antibiotic

Manufacturer

Dy.No: 10547

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 60ml

Mifos suspension of

Remington Pharma

the firm.

289. -do- LEVEPRA Tablets 500mg


Levetiracitam…..500mg

Antiepileptic

Manufacturer

Form-5

Dy.No: 10564

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Kepra tablets of UCB

Pharma

Kepra of UCB Pharma

290. -do- LEVEPRA Tablets 250mg


Levetiracitam…..250mg

Antiepileptic

Form-5

Dy.No: 10563

dated: 12-11-

10

8000/- dated:

Kepra tablets of UCB

Pharma

Kepra of UCB Pharma

164

Manufacturer

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

291. -do- ESSE Tablets 20mg


Escitalopram as oxalate….20mg

Antidepressant

USP

Form-5

Dy.No: 10556

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 14’s

Cipralex tablets of

Lundbeck UK

Cipralex tablets of

Lundbeck Pakistan

Master formulation


submitted; however



292. -do- ESSE Tablets 10mg


Escitalopram as oxalate….10mg

Antidepressant

Manufacturer

Form-5

Dy.No: 10562

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

Cipralex tablets of

Lundbeck UK

Cipralex tablets of

Lundbeck Pakistan

Master formulation


submitted; however


is film coated tablet

165

As per SRO/

Pack of 14’s

293. -do- RITEFLOX Suspension

125mg/5ml

Each 5ml contains:

Ciprofloxacin as HCL……125mg

Antibiotic, Quinolone

Manufacturer

Form-5

Dy.No: 10543

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 60ml

Not avialble in SRA’s

Novidat of Sami

Pharmaceuticals

Applied formulation

is under review.

294. -do- MEGAFLUX Capsules 20mg


Fluoxetine as HCL….20mg

Antidepressant

USP

Form-5

Dy.No: 10561

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 10’s

Fluoxetine capsules of

Accord Healthcare UK

Alert capsules of

Rakaposhi

295. -do- DILOX DS Tablets

Form-5


Evidence of


is not submitted by

166


Diloxanide furoate…..500mg

Metronidazole…500mg

Amoebicide

Manufacturer

Dy.No: 10537

dated: 12-11-

10

8000/- dated:

12-11-10

12,000/- dated

05-08-13

As per SRO/

Pack of 15’s

Entamizole DS Tablet

of Abbot Labs Karachi

the firm

296. M/s Hilton

Pharma (Pvt)

Limited,

Karachi

FENATO Tablets 10/200


Atorvastatin Calcium equivalent to

Atorvastatin……10mg

Fenofibrate(Micronized)……200mg

Lipid Lowering Agent

Manufacturer

Form-5

Dy.No: 96

8000/- dated

13-12-10

12000/- dated

23-10-13

Rs. As per

PRC/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s


Me too needs

confirmation.

Firm has not

submitted the

evidence regarding

the availability of

applied formulation

in SRA’s as well as

in local market.

297. -do- FENATO Tablets 10/160




Form-5

Dy.No: 98

8000/- dated

13-12-10


Me too needs

confirmation.

Firm has not

submitted the

evidence regarding

the availability of

applied formulation

in SRA’s however

firm submitted that

the formulation is

registered with Cipla

167



Manufacturer

Rs. As per

PRC/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s

India

Firm further

submitted that the

formulation is

available in local

market with brand

name of Febitor of

Bryon

Pharmaceuticals, but

it needs confirmation.

298. -do- FENATO Tablets 10/67






Manufacturer

Form-5

Dy.No: 97

8000/- dated

13-12-10

Rs. As per

PRC/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s


Me too needs

confirmation

Firm has not

submitted the

evidence regarding

the availability of

applied formulation

in SRA’s however

firm submitted the

reference of Cipla

India of Atorvastain/

Fenofibrate10/160mg

formulation which is

different from the

applied.

Firm further

submitted that the

formulation is

available in local

market with brand

name of Febitor of

Bryon

Pharmaceuticals, but

it needs confirmation.

299. -do- ETIDO Tablets 400mg


Etidronate disodium……..400mg

Form-5

Dy.No: 174

8000/- dated

22-12-10

Didronel Of Warner

Chilcott UK

Etinat of Genix Pharma

Karachi

168

Bone metabolism regulator

Manufacturer

Rs 500 per

tablet/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s

300. -do- ETIDO Tablets 200mg


Etidronate disodium……..200mg

Bone metabolism regulator

Manufacturer

Form-5

Dy.No: 176

8000/- dated

22-12-10

Rs 250 per

tablet/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s

Didronel Of Warner

Chilcott UK

Etinat of Genix Pharma

Karachi

301. -do- ILOPER Tablets 1mg


Iloperidone….1mg

Antipsychotic

Manufacturer

Form-5

Dy.No: 180

8000/- dated

22-12-10

Rs 400 per

tablet/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s

Fanapt of Novartis

(USFDA)

Ilodon of Genix Pharma

Karachi


Form-5

Fanapt of Novartis

(USFDA)

169


Iloperidone….2mg

Antipsychotic

Manufacturer

Dy.No: 180

8000/- dated

22-12-10

Rs 400 per

tablet/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s


Karachi



Iloperidone….4mg

Antipsychotic

Manufacturer

Form-5

Dy.No: 182

8000/- dated

22-12-10

Rs 500 per

tablet/ Pack of

10’s, 20’s,

20’s, 28’s and

30’s

Fanapt of Novartis

(USFDA)


Karachi



Iloperidone….6mg

Antipsychotic

Form-5

Dy.No: 177

8000/- dated

22-12-10

Rs 600 per

tablet/ Pack of

10’s, 20’s,

Fanapt of Novartis

(USFDA)


Karachi

170

Manufacturer

20’s, 28’s and

30’s



Iloperidone….8mg

Antipsychotic

Manufacturer

Form-5

Dy.No: 184

8000/- dated

22-12-10

Rs 700 per

tablet/ Pack of

10’s, 14’s,

20’s, 28’s and

30’s

Fanapt of Novartis

(USFDA)


Karachi



Iloperidone….10mg

Antipsychotic

Manufacturer

Form-5

Dy.No: 175

8000/- dated

22-12-10

Rs 800 per

tablet/ Pack of

10’s, 14’s,

20’s, 28’s and

30’s

Fanapt of Novartis

(USFDA)


Karachi


Form-5

Fanapt of Novartis

(USFDA)

171


Iloperidone….12mg

Antipsychotic

Manufacturer

Dy.No: 181

8000/- dated

22-12-10

Rs 900 per

tablet/ Pack of

10’s, 14’s,

20’s, 28’s and

30’s


Karachi

172

ROUTINE (VETERINARY)

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded Price

/ Pack size

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

Recommendations by

the Evaluators

308. M/s Leads

Pharma (Pvt)

Limited,

Islamabad.

CRD SOL Oral Solution


Tylosin

Tartrate…..100gm

Doxycycline

HCL….200gm

Colistin

sulphate…450MIU

Bromohexine…..4gm

Antibiotic/ Expectorant

Form-5

Dy. No. 131

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100ml,

200ml, 250ml,

500ml & 1L

Tycodox Plus of

Attabak Pharma

Inspection of the

firm was carried

out on 27.11.2014.

FID has remarked

as under:

“continuous

efforts to maintain

and upgrade

production and

QC facilities is

emphasized. Most

of the

observations have

been addressed.

173

Manufacturer

309. -do- E-MAX-3 Powder

Each 100gm contains:

Sulphachloropyrazine

sodium monohydrate

(sulphcozine

sodium)…..30gm

Antibiotic

Manufacturer

Form-5

Dy. No. 126

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100, 250,

500 & 1Kg

ESB3 Powder of

Hilton Pharma

Karachi

310. -do- NC Strep Powder

Each gm contains:

Neomycin

sulphate…..60mg

Chlortetracycline…200

mg

streptomycin

sulphate…..20mg

Antibiotics

Manufacturer

Form-5

Dy. No. 126

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100ml,

250ml, 500ml &

1L

Pulmonil Powder

of Attabak

Pharmaceuticals

311. -do- DUO TA Liquid

Form-5

Dotman Liquid of

Nawal Pharma

174


Doxycycline

HCL….200gm

Tylosin

Tartrate….100gm

Amanta

dine…40gm

Antibiotic

Manufacturer

Dy. No. 129

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100ml,

250ml, 500ml &

1L

312. -do- NORCOLAM Liquid


Norfloxacin HCL….10g

Colistin sulphate…4gm

Amantadine HCL…4gm

Antibiotics

Manufacturer

Form-5

Dy. No. 129

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100ml,

200ml, 250ml,

500ml & 1L

Me too status

needs

confirmation

313. -do- LE BEN 125 Drench

Each ml contains:

Albendazole…..125mg

Form-5

Dy. No. 135

dated : 15-11-10

Albazol Drench of

Nawan Labs

175

Anthelmintic

Antibiotic

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100, 250,

500ml & 1000ml

314. -do- RESPIRE W/S Powder

Each gm contains:

Doxycycline

HCL…200mg

Tylosin

Tartrate…100mg

Bromhexine

HCL…2.5mg

Antibiotic

Manufacturer

Form-5

Dy. No. 123

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100, 250,

500ml & 1000gm

Resbro -300

Powder of Sanna

Labs

315. -do- METHAMINE Injection

Each ml contains:

Mythampyrone…..200m

g

Aminopyrine….50mg

Caffiene & Sodium

benzoate….20mg

Chlorpheiramine

meleate….2mg

Form-5

Dy. No. 120

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 10, 20,

Megapyrone of

Star Labs Lahore

176

Analgesic/ Antipyretic/

Antiallergic

Manufacturer

50 & 100ml

316. -do- VETTY HEPA Life

Liquid

Each Litre contains:

Propionic acid….200gm

Vitamin E…..25gm

Propylene

glycol…..120gm

Ammonium

propionate…..10gm

Potassium

citrate…10gm

Sorbitol….15gm

Antioxidant, Antimould,

Antimycotoxins

MAnufacturer

Form-5

Dy. No. 126

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100, 250,

500 & 1000ml

Me too status

needs

confirmation.

317. -do- VETY AMANTADOX

Liquid


Tylosin Tartrate….10gm

Form-5

Dy. No. 129

dated : 15-11-10

Me too needs

confirmation

177

Doxycycline

HCL….22gm

Amantadine

HCL….3gm

Antibiotic

Manufacturer

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100ml,

250ml, 500ml &

1L

318. -do- LE MEC10 Drench

Each ml contains:

Ivermectin…..10mg

Anthelmintic

Antibiotic

Form-5

Dy. No. 135

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Pack of 100, 250,

500ml & 1000ml

Me too needs

confirmation

319. -do- ASPER Max-C Powder

Each 1000gm contains:

Acetylcysteine…..67mg

Vitamin C…..200mg

Antibiotic

Form-5

Dy. No. 127

dated : 15-11-10

8000/- dated : 11-

11-10

Decontrolled/-

Me too needs

confirmation

178

Manufacturer Pack of 100, 250,

500ml & 1000gm

IMPORT CASES (ROUTINE)

320. Applicant

M/s Ali Gohar

& Co (Pvt)

Limited, State

Life Building

No. 1B

I.I Chundrigar

Road P.O. Box

5167 Karachi.

Manufacturer

Alcon

Laboratories,

Inc

6201 South

Freeway, Fort

Worth, Texas

76134, USA

PATADAY 0.2%

Each ml of sterile

ophthalmic solution

contains:

Olopatadine HCL 2.22mg

equivalent to

Olopatadine……..2mg

Anti-allergic

Manufacturer

Form-5A

Dy. No. 29 dated

02-03-2010

15,000/- dated

02-03-2010

35,000/- dated

26-03-13

Rs. 904/-

Pack of 4ml

Bottle containing

2.5ml of solution

Firm was asked to submit

the stability data

conducted under the Zone

IV-A conditions as per

ICH / WHO

guidelines. Only long

term study data is

provided which is

incomplete, without

chromatograms and

protocols etc. Accelerated

stability data is also

required

321. Applicant

M/s Sanofi

Aventis

Pakistan

Limited, Plot

No 23, Sector

No.22, Korangi

Industrial Area,

Karachi

Manufacturer

Solian Tablets


contains:

Amisulpride………400mg

Neuroleptic/ Antipsychotic

Form-5A

Dy. No. 94 dated

19-05-2010

15,000/- dated

19-05-2010

Rs. 904/-

a. Stability Studies data

needs to be submitted

which is conducted

under the Zone IV-A

conditions as per ICH

/ WHO guidelines.

b. Evidence of

submission of

differential fee is

required.

c. Sole agency

agreement needs to be

submitted.

179

M/s Sanofi

Whinthrops

Industries, 6

Boulevard, de

Europe, 21800,

Quetigny,

France.

Manufacturer Pack of 4ml

Bottle containing

2.5ml of solution

Evaluator V

Sr.

No.

Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage form +

Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form

Initial date, diary.

Fee including

differential fee

Demanded Price /

Pack size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection report

(dated)

Remarks /

Observations

322. M/S Uniferoz,

32/8 Sector 15,

Korangi industrial

Area, Karachi.

Dermapore

Dermapore Non

Woven Fabric

Surgical Tape for

(Surgical Dressing &

Bandage)

Form 5

10 cmx10m

5 cm x 10m

2.5 cm x10

Demanded price has

not been mentioned

Rs.8000/-

(27/07/2010)

Rs.12,000/-

(23/07/2013)

Fee challans are

duplicate

Total Rs.20,000/-

Dy. No. not

available / Duplicate

GMP inspection

report dated 15-

07-2014. Overall

GMP compliance

level rated as

good.

1. An undertaking /

commitment regarding

the submission of

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

analytical testing

methods

d) Process validation

e) Label claim and

prescribing

information being

same as approved

by reference drug

agencies e.g., FDA,

180

dossier

TGA, MHLW,

EMA and Health

Canada.

However, firm has

submitted SOP’s / data

for above mentioned

studies which require

evaluation and

verification.

2. International

availability has been

mentioned as not

applicable. Evidence of

approval of same

product by stringent

regulatory authority e.g.,

FDA, TGA, MHLW,

EMA and Health

Canada required.

3. Complete details of

brands available in

Pakistan i.e., same

generic, dosage form &

strength etc. required.

Firm has submitted two

brands as me too i.e.,

Fixomull Stretch and

OxyMax (10cm x 10M

only) both are

unregistered as

mentioned by the

applicant firm.

4. Evidence of approval

of section /

manufacturing facility

for applied drug

required.

5. Complete

specifications of

container-closure

system.

181

Case No.09: Cases deferred by Registration Board.

Evaluator – II

S/N Name and address

of manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacologic

al Group

Finished

product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Decision of

Previous Meeting

Remarks on the formulation (if

any) including International

status in stringent drug


authorities

Me-too status

GMP status as depicted in

latest inspection report (with


323. M/s Fynk

Pharmaceuticals

Sheikhupura, Lahore.

Trama 50mg

Capsule

Each capsule

contains:-

Tramadol HCl

(B.P)…50mg

(Opioid receptor

Agonist,

Analgesic)

(B.P Spec.s)

Form 5

22-02-2010

(Nil)

Rs. 8000/- +

Rs. 12000/-

(19/07/2013)

As per PRC/

10’s

Registration Board

referred above

products to

Pharmaceutical

Evaluation Cell

for scrutinization

in light of check

list approved by

Registration Board

on priority. (M-

243)

TGA: TRAMADOL ACTAVIS

( Actavis Pty Ltd )

Tramal (Searle)

Renewal of DML recommended

(01-12-14)



facility of applied drug from

licensing section is required.

Inspection report dated 01-

12-14 mentions Capsule

General Section.

2. Brand Name of Drug

Product submitted and

recoreded in previous

minutes of DRB was Trama

while it has been changed to

T-Mod.

3. Proposed Price for Pack size

of 10 capsule was recorded

Rs. 60/- in previous minutes

of DRB while it has been

changed to As per PRC in

182

new application dossier.

324. M/S Ray Pharma Pvt.

Ltd.S-58, Site,

Karachi

Clobet-G Cream

Topical

Each gm

contains:

Clobetsasol

propionate

…………….

0.5mg

Gentamicin

sulphate BP

eq.to

Gentamicin …..

1mg

Anti

inflammatory,

Antibiotic

Form 5D

New Section

03-04-2014

Dy. No. 374

R&I

Rs.50,000

15 gm/ As Per

PRC

Deferred for

confirmation of

manufacturing

facility for

steroidal

preparations and

evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

(M-245)

CLOBETAMIL-G

0.05 / 0.1% Cream

Merck Serono,

India

1) Firm has provided Cleovate-G

cream available in FDA

Philippines as an evidence of

approval in FDA

2) Confirmation of

manufacturing facility for

steroidal preparations not

provided.

325. -do-

Nadiflox 1%

w/w Cream

Topical

Each gm

contains:

Nadifloxacin

….. 10mg

Fluoroquinolone

Antibiotic

Form 5D

New Section

03-04-2014

Dy. No.378

R&I

Rs.50,000

15 gm/ As Per

PRC

Deferred for:

1) Expert opinion

2) Evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

3) Stability data

(M-245)

NADIXA

1% Cream

Ferrer International, Spain

1) Firm has submitted a

document for evidence of EMA

approval, which could not be

verified from EMA official

website.

2) No expert opinion has yet

come.

3)

Firm has submitted stability

summary reports that need

clarification that whether it

should be evaluated after

183



submit stability studies

according to ICH/WHO

guidelines.

326. -do-

Raycort Cream

Topical

Each gm

contains:

Diflucortolone

valerate

………………...

1mg

Isoconazole

Nitrate

……………...

10mg

Anti

inflammatory

and anti fungal

Form 5

New Section

03-04-2014

Dy. No. 369

R&I

Rs.20,000

15 gm/ As Per

PRC

Deferred for

confirmation of

manufacturing

facility for

steroidal

preparations and

evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

(M-245)

TRAVOCORT

0.1 / 1% Cream

Dublin

TRAVOCORT

0.1 / 1%

Schering Asia

1) Firm has submitted a

document for evidence of EMA

approval, which could not be

verified from EMA official

website.

2) Confirmation of



provided.

327. -do-

Genticyn 4

Cream

Topical

Each gm

contains:

Gentamicin as

sulphate

………………

…..1gm

Betamethasone

as Valerate

………………

….. 0.5mg

Form 5D

New Section

03-04-2014

Dy. No.387

R&I

Rs.50,000/-

15 gm/ As Per

PRC

Deferred for

confirmation of

manufacturing

facility for

steroidal

preparations and

evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

(M-245)

Quadriderm Cream

Schering-Plough

India

1) Firm has provided

Quadriderm cream available in

FDA Philippines as an evidence

of approval in FDA.

2) Confirmation of



provided.

3) quantity of Gentamicin as

sulphate is 1mg instead of 1gm

184

Tolnaftate

……… 10mg

Clioquinol

………. 10mg

Topical

corticosteroid

and anti

infectives in

combination

which is a typographic mistake

in M-245 minutes.

328. -do-

Raymox-D Eye

Drops

(0.5%+0.1%)w/

v

Sterile

Ophthalmic

Solution

Each ml

contains:

Moxifloxacin

HCl eq. to

Moxifloxacin

…… 5mg

Dexamethasone

Sodium

phosphate eq. to

Dexamethasone

phosphate

………………

….. 1mg

Anti bacterial

/steroid

combination

Form 5

New Section

03-04-2014

Dy. No. 381

Rs.20,000/-

5ml/ As Per

PRC

Deferred for

confirmation of

manufacturing

facility for

steroidal

preparations and

evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

VIGADEXA

0.5 / 0.1%

Alcon Laboratories, Brazil

OXCIN – D

Atco

1) Firm has provided Moxiblu-D

Eye drops for evidence of

availability in FDA from non-

authentic source. Stance of the

firm could not be verified from

official site of US-FDA.

2) Confirmation of



provided.

185

329. -do-

Netidex Eye

Drops

Sterile

Ophthalmic

Solution

Each ml

contains:

Dexamethasone

Sodium

phosphate eq. to

Dexamethasone

…… 1mg

Netilmicin

sulfate eq. to

Netilmicin

………….. 3mg

Anti bacterial

and anti

inflammatory

Form 5D

New Section

03-04-2014

Dy. No. 382

R&I

Rs.50,000/-

5ml/ As Per

PRC

Deferred for

confirmation of

manufacturing

facility for

steroidal

preparations and

evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

(M-245)

NATILDEX

S.I.F.I. SPA, Italia

1) Firm has provided availability

of formulation from Drugs.com

in Germany , Turkey etc.

2) Confirmation of



provided.

330. -do-

Zeebrom Eye

Drops

Sterile

Ophthalmic

Solution

Each ml

contains:

Bromfenac

Sodium

Sesquihydrate

…. 1.035mg

(eq. to

Bromfenac free

acid 0.9mg)

Non-Steroidal

anti-

inflammatory

Manufacturers

specifications

Form 5D

New Section

03-04-2014

Dy. No.379

Rs.50,000/-

5ml/ As Per

PRC

Deferred for:

1) Expert opinion

of Prof. M. Daud

Khan, Maj. Gen.

Mazhar Ishaq and

Prof. Ali Raza.

2) Stability study

data

BROMDAY

0.09% ophthalmic solution

US FDA

1) Firm has submitted stability

summary reports that need

clarification that whether it

should be evaluated after



submit stability studies

according to ICH/WHO

guidelines.

2) No expert opinion has yet

come.

186

Evaluator III

DEFERRED CASES (246TH

MEETING OF RB)

The following product of M/s Rasco Pharmaceuticals was discussed in 246th Meeting of

Registration Board and deferred because of confirmation of approval in reference SRA’s for applied

strength and volume. The case is detailed below:

331. -do-

Genticyn 4

Cream

Topical

Each gm

contains:

Gentamicin as

sulphate

………………

…..1gm

Betamethasone

as Valerate

………………

….. 0.5mg

Tolnaftate

……… 10mg

Clioquinol

………. 10mg

Topical

corticosteroid

and anti

infectives in

combination

Form 5D

New Section

03-04-2014

Dy. No.387

R&I

Rs.50,000/-

15 gm/ As Per

PRC

Deferred for

confirmation of

manufacturing

facility for

steroidal

preparations and

evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA and

Health Canada.

(M-245)

Quadriderm Cream

Schering-Plough

India

1) Firm has provided

Quadriderm cream available in

FDA Philippines as an evidence

of approval in FDA.

2) Confirmation of



provided.

3) quantity of Gentamicin as

sulphate is 1mg instead of 1gm

which is a typographic mistake

in M-245 minutes.

187

Sr. no Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacological

Group

Finished

product

Specification

Type of

Form

Initial

date, diary

Fee

including

differential

fee

Demanded

Price /

Pack size

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

Recommendations

by the Evaluator

Decision

332. M/s Rasco

Pharma, 5.5 Km

Raiwind Road,

Lahore

Liquid Injection

General (Small

Volume Vial)

LEVOFLOXA

Infusion

Each 100ml vial

contains:

Levofloxacin

hemihydarte

equivalent to

Levofloxacin

USP…..250mg

Quinolone

Form-5

Dy No: 665

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

250mg

levofloxacin

(as

hemihydarte)

in 50ml

solution

(Tavanic of

sanofi)

Levocil of

CCL Pharma

Lahore

Deferred for

confirmation

of approval

by the

reference

Stringent

Regulatory

Agencies for

this strength

/volume.

188

Manufacturer

The firm has now requested to approve the above mentioned product with 50ml vial (250mg/50ml) which

is approved by the stringent regulatory agencies and also available in local market. Submitted for

consideration of Registration Board please.

Evaluator V

Sr.

No.

Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage form +

Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form


Fee including

differential fee

Demanded Price /

Pack size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)


333. M/s Indus

Pharma (Pvt)

Ltd., Plot No. 26,

27,,64,65,66,67,

Sector-27,

Korangi

Industrial Area

Karachi-74900

Exnal Injection

10mg/ml

Injection

Each ml Contains:

Nalbuphine

Hydrochloride

……………10mg

(Opioid Analgesic)

Form 5

Rs.8000/-

17-06-2006

Dy. No. not

mentioned

Rs.12,000/-

07-06-2013

Dy. No. Not

mentioned

Rs.40,000/- (fast

track)

NUBAIN

10mg/ml

Ampoule

Health Canada

NALBIN

10mg/ml

Global

cGMP certificate

dated 11th

December, 2013.

Sterile Liquid

[Injections

(Ampoules) and

1. Firm has proposed test for

oxidizable substance and

microscopic particle count

test instead test for total

organic carbon and light

obscuration particle count

tests respectively.

189

Rs. 70/- per

Ampoule

Rs.700/- per 10’s

(1ml Ampoule)

Infusions

(Vials)].

Panel inspection

for grant of

additional

sections dated

24th February,

2014. Panel

recommended

grant of sections.

334. M/s Indus

Pharma (Pvt)

Ltd., Plot No. 26,

27,,64,65,66,67,

Sector-27,

Korangi

Industrial Area

Karachi-74900

Exnal Injection

20mg/ml

Injection

Each ml Contains:

Nalbuphine

Hydrochloride

……………. 20mg

(Opioid Analgesic)

Form 5

Rs.8000/-

17-06-2006

Dy. No. not

mentioned

Rs.12,000/-

07-06-2013

Dy. No. Not

mentioned

Rs.40,000/- (fast

track)

Rs. 85/- per

Ampoule

Rs.850/- per 10’s

(1ml Ampoule)

NUBAIN

20mg/ml

Ampoule

Health Canada

NALBIN

20mg/ml

Global

cGMP certificate

dated 11th

December, 2013.

Sterile Liquid

[Injections

(Ampoules) and

Infusions

(Vials)].

Panel inspection

for grant of

additional

sections dated

24th February,

2014. Panel

recommended

grant of sections.

1. Firm has proposed test for

oxidizable substance and

microscopic particle count

test instead test for total

organic carbon and light

obscuration particle count

tests respectively.

335. M/s Merck

(Private) Limited

7, Jail Road

Quetta, Pakistan.

Glucovance Tablets

1000mg/5mg

Tablet

Each film coated

tablet Contains:

Metformin

Hydrochloride,

ph.Eur….1000mg

Glibenclamide,

Ph.Eur ….5.00mg

Form 5D

Rs.8,000/-

20-01-2008

Dy. No. not

mentioned

Rs.52,000/-

31-01-2013

Dy. No. Not

mentioned

Evidence of

approval of same

formulation by

reference drug

agencies not

provided.

Routine GMP

inspection report

dated

14/04/2014.

1. An undertaking that in

case of resemblance /

similarity with already

registered brands the

applicant would be liable to

change the brand name.

2. An undertaking /

commitment regarding

submission of following

studies before marketing the

product has not been

190

(Oral antidiabetic)

Rs. 90,000/-

21-02-2014

Dy. No. Not

mentioned

Rs.170/-30’s

Overall GMP

compliance level

is rated as very

good.

Tablet (General

& Psychotropic)

mentioned in

cGMP certificate

dated

05/06/2014.

submitted:


b) Pharmaceutical

development studies.

Firm has mentioned

N/A without any

justification.

c) Validation of analytical

testing methods


e) Label claim and

prescribing information

being same as approved

by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA

and Health Canada.

Firm has mentioned

N/A without any

justification.


same formulation by


authority e.g., FDA, TGA,

MHLW, EMA and Health

Canada required. Firm has

mentioned N/A without any

justification.

4. Role and justification for

proposed quantities of in-

actives required.



facility for applied drug.

6. Prescribing information

(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,

Health Canada and MHLW

(Japan) required. Instead

firm has submitted package

insert for Pakistan.

7. Only 2 page stability data

for two batches has been

provided. Stability Studies

191


IV-A conditions as per ICH /

WHO guidelines required.

336. M/s Merck

(Private) Limited

7, Jail Road

Quetta, Pakistan.

Concor 5 plus

tablet

Tablet

Each film coated

tablet Contains:

Bisoprolol

fumarate Ph. EUR

……….….. 5mg

Hydrochlorothiazid

e, PH. EUR

……….… 12.5mg

(Anti-Hypertensive

agent)

Manufacturer:

Merck KGaA,

Frankfurter Strasse

250, 64293

Dramstadt,

Germany

Local Re-packager:

Merck (Private)

Limited, 7 Jail

Road, Quetta,

Pakistan

Form 5-D

Rs.15,000/-

26-07-2011

Dy. No. not

mentioned

Rs.285,000/-

Dy. No. and date is

Not mentioned

Rs. 165/- per 14’s

Concor 5 Plus

5/12.5mg

Germany

Routine GMP

inspection report

dated

14/04/2014.

Overall GMP

compliance level

is rated as very

good.

Tablet (General

& Psychotropic)

mentioned in

cGMP certificate

dated

05/06/2014.


same formulation by

Federal German Health

Office has been submitted

instead of reference

regulatory authority e.g.,

FDA, TGA, MHLW, EMA

and Health Canada.

2. Under evaluation of

stability data it is mentioned

that during long term storage

at 30C / 60% RH,

intermediate storage at 30C /

65% RH and accelerated

storage at 40C / 75% RH.

The degradation is more

pronounced (significant

changes after 5 years). It

further states that “As the

long term results at 30C /

60% RH have no relevance

for the stability evaluation

for the climatic zones I and

II these results can be

neglected”. Clarification has

not been submitted keeping

in view the prevailing

climatic conditions in

Pakistan.

3. Original and legalized

Certificate of

Pharmaceutical Product as

per WHO format for applied

product OR Original and

legalized GMP certificate of

new manufacturing site with

free sale certificate from

regulatory body of country

of origin required.

337. M/s Merck

Pharmaceuticals

(Private) Limited

F-126, S.I.T.E,

Karachi,

Pakistan.

Vitabone Capsule

1000IU

Capsule

Each soft gelatin

Capsule Contains:

Form 5-D

Rs.20,000/-

19-10-2012

Dy. No. not

mentioned

Evidence of

approval of same

formulation by

reference drug

agencies not

provided.







192

Cholecalciferol

(Vitamin D3)

………….. 1000IU

(Vitamins)

Rs. 52,000/-

01-02-2013 (Fee

submission date)

Dy. No. not

mentioned

Only copy of Rs.

90,000/- deposit

slip has been

submitted which

requires

verification.

Rs.450/-30’s

GMP inspection

report dated 09-

01-2014.

Considered to be

operating at

satisfactory level

of GMP

compliance.

Panel inspection

report dated 18-

10-2010.

Soft Gelatin

Capsule Section

mentioned in

report and GMP

certificate dated

08-02-2010.

2. An undertaking /

commitment, on prescribed

format, regarding the

submission of following,

before marketing the

product, as per decision of

the Registration Board, may

be submitted for

consideration by the Board:


b) Pharmaceutical

development studies


testing methods


e) Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA

and Health Canada.


same formulation by





mentioned N/A.



actives required.













7. Only single page stability

data has been provided.

Stability Studies conducted

193

under the Zone IV-A

conditions as per ICH /


Moreover, justification for

acceptance criteria of 95-

165% required along with

justification for

recommended storage at

25C.

338. M/s Merck

Pharmaceuticals

(Private) Limited

F-126, S.I.T.E,

Karachi,

Pakistan.

Vitabone Capsule

400IU

Capsule

Each soft gelatin

Capsule Contains:

Cholecalciferol

(Vitamin D3)

………….. 400IU

(Vitamins)

Form 5-D

Rs.20,000/-

19-10-2012

Dy. No. not

mentioned

Rs. 52,000/-

01-02-2013 (Fee

submission date)

Dy. No. not

mentioned

Only copy of Rs.

90,000/- deposit

slip has been

submitted which

requires

verification.

Rs.360/-30’s

Evidence of

approval of same

formulation by

reference drug

agencies not

provided.

GMP inspection

report dated 09-

01-2014.

Considered to be

operating at

satisfactory level

of GMP

compliance.

Panel inspection

report dated 18-

10-2010.

Soft Gelatin

Capsule Section

mentioned in

report and GMP

certificate dated

08-02-2010.







2. An undertaking /







be submitted for



b) Pharmaceutical

development studies


testing methods


e) Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA

and Health Canada.


same formulation by





mentioned N/A.



actives required.

194













7. Only single page stability

data has been provided.

Stability Studies conducted

under the Zone IV-A

conditions as per ICH /



acceptance criteria of 95-

165% required along with

justification for

recommended storage at

25C.

339. M/s Tabros

Pharma L-

20/B,F.B.

Industrial Area,

Karachi.

Allay SR Tablet

Tablet SR

Each SR tablet

contains:

Tramadol

Hydrochloride

………… 100mg

(Non Narcotic

Analgesic Agent)

Form 5

Rs.8,000/-

15-08-2009

Dy. No. not

mentioned

Rs.12,000/-

28-11-2013

Dy. No. not

mentioned

Rs.280/- 10’s

RAYZOLT

100mg Extended

Release tablet

US FDA

TRAMAL

100mg SR tablet

Searle

Tablet (General)

section approved

as per copy of

DML.

1. Under master formulation

no Sustained Release

ingredient has been claimed.

Apparently formulation is

for immediate release

formulation.

2. Under limits for

uniformity of dosage unit

merely NMT 15 mentioned.

3. Details of reference

standard being used.

4. Before marketing of the

product an undertaking to

submit comparative

dissolution profile with the

established brand and the

data shall be supported by

relevant documents to the

DRAP which will include:

a. Purchase of raw material,

b. Certificate of Analysis,

c. Testing protocols,

d. SOPs,

e. Analytical data and

f. Finished Product sample.

195

340. M/s Tabros

Pharma L-

20/B,F.B.

Industrial Area,

Karachi.

Allay Tablet 50mg

Tablet

Each film coated

Tablet Contains:

Tramadol

Hydrochloride

……….. 50.00mg

(Non Narcotic

Analgesic Agent)

Form 5

Rs.8,000/-

24-07-2009

Dy. No. not

mentioned

Rs.12,000/-

28-11-2013

Dy. No. not

mentioned

Rs.180/- 10’s

ULTRAM

50mg tablet

US FDA

TRADOL

50mg tablet

Pharmedic

Tablet (General)

section approved

as per copy of

DML.

1. Under limits for

uniformity of dosage unit

merely NMT 15 mentioned.

2. Details of reference

standard being used.

341. M/s Helix

Pharma (Pvt.)

Ltd., Hakimsons

House, A/56,

S.I.T.E

Manghopir Road

Karachi.

Nogerd Total

Capsule

Capsule

Each Capsule

Contains:

Pantoprazole

Sodium

sesquihydrate

equivalent to

Pantoprazole

…………. 40mg

(Anti enteric coated

pellets)

Itopride HCL

…….… 150mg (As

sustained release

pellets)

(Gastroprokinetic+

Proton Inhibitors)

Form 5-D (Fast

Track)

Rs.8,000/-

Not mentioned

Rs.12,000/-

Not mentioned

Rs.40,000/-

21-12-2012

Dy. No. not

mentioned

Rs.90,000/-

03-06-2013

Dy. No. not

mentioned

As Per SRO/-10’s

Under evidence

of international

availability

GANATON

TOTAL of M/s

Abbott, India has

been mentioned

instead of

reference drug

agencies.

Routine GMP

inspection report

dated 11-08-

2014.

Considered to be

operating at

satisfactory level

of GMP

compliance.

Capsule section

mentioned in

panel inspection

report dated

15/07/2010.

1. An undertaking /







be submitted for



b) Pharmaceutical

development studies


testing methods


e) Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA

and Health Canada.


same formulation by




Canada required.







196




(Japan).

4. Stability Studies



WHO guidelines.

5. Submission of following

document from source of

pellets required along with

balance fee (incase of

import):

i. COA

ii. Stability studies

iii. Valid legalized GMP of

source of pellets.

342. M/s Helix

Pharma (Pvt.)

Ltd., Hakimsons

House, A/56,

S.I.T.E

Manghopir Road

Karachi.

Nap-X Tablets

Tablets

Each Tablet

Contains:

Naproxen USP

enteric coated

……….500mg

Esomeprazole as

magnesium

………… 20mg

(Osteoarthritis &

rheumatoid

arthritis, Naproxen

: NSAIDs,

Esomeprazole Mg:

Proton Pump

Inhibitor)

Form 5-D (Fast

Track)

Rs.15,000/-

30-08-2010

Not mentioned

Rs.10,000/-

21-12-2012

Not mentioned

Rs.35,000/-

21-12-2012

Dy. No. not

mentioned

Rs.90,000/-

03-06-2013

Dy. No. not

mentioned

As Per SRO/-10’s

VIMOVO

20/500mg

(Immediate

release

Esomeprazole

Magnesium layer

and an enteric

coated Naproxen

Sodium layer.

US FDA

Routine GMP

inspection report

dated 11-08-

2014.

Considered to be

operating at

satisfactory level

of GMP

compliance.

Tablet section

mentioned in

panel inspection

report dated

15/07/2010.

1. An undertaking /







be submitted for



b) Pharmaceutical

development studies


testing methods


e) Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA

and Health Canada.



actives required.




WHO guidelines.

4. Under manufacturing

197

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.

343. M/s Pharmatec

Pakistan (Pvt).

Limted. D-86/A,

S.I.T.E., Karachi

Morease OD Tablet

Tablet

Each film coated,

delayed-release

tablet Contains:

Doxylamine

Succinate

…………… 20mg

Vitamin B6

……..….. 20mg

(Anti-nauseant and

anti-vomiting)

Form 5 (Fast

Track)

Rs.20,000/-

25-10-2012

Dy. No. not

mentioned

Rs.40,000/-

20-11-2012

Dy. No. not

mentioned

Rs.90,000/-

23-09-2013

Covering letter not

attached

As Per SRO/-10’s

Routine GMP

inspection report

dated 10-10-

2014. Firm

considered to be

operating at good

level of GMP

compliance.


same formulation by





submitted evidence of FDA

approval of 10mg / 10mg

dosage form instead of

applied formulation.

2. Dichloromethane has been

proposed as a film coating

solvent which is

recommended to be replaced

with a safer solvent.


the proposed quantities of

in-actives has not been

submitted.

3. Both sustained release and

delayed release have been

claimed. Whereas, the

reference international brand

in delayed release.



facility for applied drug.

However, capsule section

mentioned in approval for

change of technical staff and

FID routine inspection

report.










198

(Japan).




WHO guidelines after

clarification of formulation

i.e., Delayed Release or

Sustained Release.

Sr.

No.

Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

form + Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of

Form

Initial date,

diary.

Fee including

differential

fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)

Decision of

previous

meeting

Remarks /

Observations

344. M/s Genome

Pharmaceuticals

(Pvt) Ltd., 16/1,

Phase-IV,

Industrial Estate,

Hattar.

Parawomen tablets

Tablet

Each film coated

tablet contains: -

Paracetamol

………….. 500mg

Pamabrom

…………… 25mg

NSAID /

Antidiuretic

Manufacturers

specifications

Form 5

Rs.8,000/-

82 R&I

07-03-2009

Rs. 12,000/-

115 R&I

13-03-2014

As Per SRO

10’s

Not mentioned

FEBROL - C

Strength Caplets

Barrett Hodgson

Reg. No. 061445

Panel inspection

report dated 27-

12-2013. Panel

recommended

grant of GMP.

Tablet General /

Antibiotic

mentioned in

panel report.

Registration

Board referred

products to

Pharmaceutical

Evaluation Cell

for scrutinization

as per checklist.

1. Evidence of

approval of same

formulation by

stringent

regulatory

authority e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada required.

2. Firm has

proposed tablet

dosage form

while me too

brand is in caplet

(capsule shaped

tablet) form.

3. Latest GMP

inspection report

has not been

submitted.

However, GMP

certificate for

export purpose

dated 12-11-2014

199

has been

submitted.

4. Incorrect

pharmacological

group has been

mentioned.

Correction

required.

345. M/s Genome

Pharmaceuticals

(Pvt) Ltd., 16/1,

Phase-IV,

Industrial Estate,

Hattar.

Alciron C tablets

Tablet

Each uncoated

tablet contains: -

Alfacalcidol

……….. 0.5mcg

Calcium

Carbonate

………… 1000mg

Calcium

supplement along

with Alfacalcidol

Manufacturers

specifications

Form 5

Rs.8,000/-

Dy. No. not

mentioned

13-02-2009

Rs. 12,000/-

Fee challan

not attached

Rs. 20,000/-

Dy. No. 127

R&I

25-03-2014

As Per SRO

10’s

Arthropil

Sifam Health

Care (Pvt) Ltd.,

India

Bone Care - C

Schazoo Zaka

0.5mcg / 1000mg

(eq. to 400mg

elemental

calcium)

Reg. No. 062790

Panel inspection

report dated 27-

12-2013. Panel

recommended

grant of GMP.

Tablet General /

Antibiotic section

mentioned in

panel report.

Registration

Board referred

products to

Pharmaceutical

Evaluation Cell

for scrutinization

as per checklist.

The firm

requested for

correction in

formulation

Calcium

Carbonate 500mg

to Calcium

Carbonate

1000mg which is

equivalent to

elemental

calcium 400mg

due to

typographic

mistake. The firm

deposited revised

form 5 and fee

(Rs. 20,000/-) for

this purpose and

requested for

early registration.

Note: Revised

Form 5 has been

evaluated and

request of the

firm for revision

of formulation /

strength is

submitted for

consideration.

1. Rs. 20,000/-

fee for

Alfacalcidol

0.5mg instead of

0.5mcg has been

submitted.

2. Evidence of

approval of same

formulation by

stringent

regulatory

authority e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada required.

3. Label claim to

be revised as per

me too

formulation e.g.,

calcium

carbonate eq. to

400mg elemental

calcium.

4. Storage

conditions of 2-8

°C have been

mentioned for

Alfacalcidol API,

therefore,

verification of

suitable storage

facility etc.,

required along

with

manufacturing

precautions.

5. Latest GMP

inspection report

has not been

submitted.

200

However, GMP

certificate for

export purpose

dated 12-11-2014

has been

submitted

Case No.10: Deferred Cases of Pregablin: -

Evaluator V

Sr.

No.

Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage form +

Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form


Fee including

differential fee

Demanded Price /

Pack size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)


346. M/s Lisko Pakistan

(Pvt.) Ltd. L-10-D

Block-21 Shaheed

Rashid Minhas

Road Karachi.

Preline Capsule

50mg

Capsule for oral

use

Each Capsule

Contains:

Pregabalin …50mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

25-04-2009

Dy. No. Not

mentioned

Rs.12000/-

06-05-2014

Dy. No. Not

mentioned

Rs.17.50/Capsule

14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

GMP inspection

report dated

02/12/2013

submitted overall

compliance rated

as good.

1) An undertaking /

commitment (on letter head)

regarding the submission of

following, before marketing

the product, as per decision

of the Registration Board,

may be submitted for


i. Stability studies

ii. Pharmaceutical

development studies

iii. Validation of analytical

testing methods

iv. Process validation

v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.

201

2) Batch size of only

30,000/- capsules has been

proposed which is very

small keeping in view the

capacity of production

equipment (300kg mixer

etc.), source of active and in-

actives along with their role

and justification for quantity

used has not been submitted.

3) Only assay method has

been submitted which is

arbitrary. Details of all tests

including assay,

identification, disintegration,

weight variation etc., and

acceptance criteria along

with appropriate references

for each required.

4) Details of reference

standard required.

5) Evidence of approval of

capsule section required.

6) Latest GMP inspection

report required.


technical staff required.


(Pvt.) Ltd. L-10-D

Block-21 Shaheed

Rashid Minhas

Road Karachi.

Preline Capsule

75mg

Capsule for oral

use

Each Capsule

Contains:

Pregabalin

………..…75mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

25-04-2009

Dy. No. Not

mentioned

Rs.12000/-

06-05-2014

Dy. No. Not

mentioned

Rs.23/Capsule 14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

GMP inspection

report dated

02/12/2013

submitted overall

compliance rated

as good.

1) An undertaking /









ii. Pharmaceutical

development studies


testing methods


v. Label claim and



by reference drug

agencies e.g., FDA,

202

TGA, MHLW, EMA and

Health Canada.














including assay,





for each required.


standard required.




report required.




(Pvt.) Ltd. L-10-D

Block-21 Shaheed

Rashid Minhas

Road Karachi.

Preline Capsule

150mg

Capsule for oral

use

Each Capsule

Contains:

Pregabalin

………… 150mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

25-04-2009

Dy. No. Not

mentioned

Rs.12000/-

06-05-2014

Dy. No. Not

mentioned

Rs. 32.50/-Capsule

14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

GMP inspection

report dated

02/12/2013

submitted overall

compliance rated

as good.

1) An undertaking /









ii. Pharmaceutical

development studies


testing methods


v. Label claim and



203

by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.














including assay,





for each required.


standard required.




report required.




(Pvt.) Ltd. L-10-D

Block-21 Shaheed

Rashid Minhas

Road Karachi.

Preline Capsule

100mg

Capsule for oral

use

Each Capsule

Contains:

Pregabalin

………..100mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

25-04-2009

Dy. No. Not

mentioned

Rs.12000/-

06-05-2014

Dy. No. Not

mentioned

Rs.28.50/-Capsule

14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

GMP inspection

report dated

02/12/2013

submitted overall

1) An undertaking /









ii. Pharmaceutical

development studies


testing methods


v. Label claim and

204

compliance rated

as good.



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.














including assay,





for each required.


standard required.




report required.



350. M/S S.J.&G.

Fazul Ellahie (Pvt)

Limted. E-46,

S.I.T.E., Karachi-

75700.

Prelin

Capsule

Each Capsule

Contains:

Pregabalin……25

mg

(Anti-epileptic)

Manufacturers

specifications

Form 5

26-08-2008

Rs.8000/-

Dy. No. Not

mentioned

02-05-2014

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier /

14’s/ As per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Report of routine

GMP inspection

205

conducted on

26/09/2014

submitted.

Considered to be

operating at good

level of GMP

compliance.

Capsule section

mentioned in

GMP certificate

dated

18/11/2014.

351. M/S S.J.&G.

Fazul Ellahie (Pvt)

Limted. E-46,

S.I.T.E., Karachi-

75700.

Prelin

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anti-epileptic)

Form 5

26-08-2008

Rs.8000/-

Dy. No. Not

mentioned

02-05-2014

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier /

14’s/ As per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Report of routine

GMP inspection

conducted on

26/09/2014

submitted.

Considered to be

operating at good

level of GMP

compliance.

Capsule section

mentioned in

GMP certificate

dated

18/11/2014.

352. M/S S.J.&G.

Fazul Ellahie (Pvt)

Limted. E-46,

S.I.T.E., Karachi-

75700.

Prelin

Capsule

Each Capsule

Contains:

Pregabalin……200

Form 5

26-08-2008

Rs.8000/-

Dy. No. Not

mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

206

mg

(Anti-epileptic)

Manufacturers

specifications

02-05-2014

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier /

14’s/ As per SRO

SYNGAB

Capsules

(200mg)

Atco

Report of routine

GMP inspection

conducted on

26/09/2014

submitted.

Considered to be

operating at good

level of GMP

compliance.

Capsule section

mentioned in

GMP certificate

dated

18/11/2014.

353. M/S S.J.&G.

Fazul Ellahie (Pvt)

Limted. E-46,

S.I.T.E., Karachi-

75700.

Prelin

Capsule

Each Capsule

Contains:

Pregabalin……225

mg

(Anti-epileptic)

Manufacturers

specifications

Form 5

26-08-2008

Rs.8000/-

Dy. No. Not

mentioned

02-05-2014

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier /

14’s/ As per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

Me too status

requires

confirmation

Report of routine

GMP inspection

conducted on

26/09/2014

submitted.

Considered to be

operating at good

level of GMP

compliance.

Capsule section

mentioned in

GMP certificate

dated

18/11/2014.

1) Evidence of me too status

required. In case of non-me

too strength, firm to submit

application on form 5D

along with balance fee.

207

354. M/S CSH

Pharmaceuticals-

North (Pvt.) Ltd.

38-A, Industrial

Estate, Hayatabad,

Peshwar.

Neurelief 100mg

Tablet / capsule

Tablet

Each Tab / capsule

Contains:

Pregabalin……100

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

09-03-2009

Dy. No. 100

Rs.12000/-

08-03-2013

Dy. No. 1249

10’s Rs.50/-

Not mentioned

Not mentioned

Routine GMP

inspection report

dated

29/04/2014.

Tablet and

capsule section

mentioned in

panel report for

renewal of DML.

Firm had initially applied for

registration of tablet dosage

form now the firm has

submitted revised

application for capsule

dosage form. Similar

registration application of

M/s Glitz was rejected in the

246th meeting of the

Registration Board.

1) An undertaking /

commitment regarding the


before marketing the product

has not been submitted on

prescribed format:


ii. Pharmaceutical

development studies


testing methods


v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.


same formulation / strength

and dosage form by

reference drug agencies e.g.,

FDA, TGA, MHLW, EMA

and Health Canada required.


of tablet dosage form

required. In case of non me

too product, application on

form 5D along with balance

fee required.


standard required.

208

355. M/S CSH

Pharmaceuticals-

North (Pvt.) Ltd.

38-A, Industrial

Estate, Hayatabad,

Peshwar.

Neurelief 300mg

Tablet / Capsule

Each Tab / Capsule

Contains:

Pregabalin……300

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/- (for

tablet)

09-03-2009

Dy. No. 100

Rs.12000/- (for

tablet)

08-03-2013

Dy. No. 1249

14’s Rs.1,470/-

Routine GMP

inspection report

dated

29/04/2014.

Tablet and

capsule section

mentioned in

panel report for

renewal of DML.




submitted revised






Registration Board.

1) An undertaking /





prescribed format:


ii. Pharmaceutical

development studies


testing methods


v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.



and dosage form by


FDA, TGA, MHLW, EMA







fee required.


standard required.

209

356. M/S CSH

Pharmaceuticals-

North (Pvt.) Ltd.

38-A, Industrial

Estate, Hayatabad,

Peshwar.

Neurelief 200mg

Tablet / Capsule

EachTab / Capsule

Contains:

Pregabalin……200

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/- (for

tablet)

13-03-2009

(Section)

Dy. No. not

mentioned

Rs.12000/- (for

tablet)

08-03-2013

Dy. No. 1249

1x14’s Rs.980/-

Routine GMP

inspection report

dated

29/04/2014.

Tablet and

capsule section

mentioned in

panel report for

renewal of DML.




submitted revised






Registration Board.

1) An undertaking /





prescribed format:


ii. Pharmaceutical

development studies


testing methods


v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.



and dosage form by


FDA, TGA, MHLW, EMA







fee required.


210

standard required.

357. M/S Panacea

Pharmaceuticals,

Plot#4, Street#S-6,

National Industrial

Zone Rawat

Islamabad.

Pyrica 75mg

Capsule

Oral

Each Capsule

Contains:

Pregabalin……75

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

15-11-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated.16-07-2014

Dy. No. 1607

14’s Rs. 245/- and

As per PRC

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 03-06-

2014. As per

report company

found complying

GMP. Capsule

section

mentioned in FID

report.

1) Source of API required.


section by Licensing section.

3) Rs. 8,000/- fee challan not

attached however, copy of

covering letter for fee Rs.

8,000/- endorsed by STO

submitted.

358. M/S Panacea

Pharmaceuticals,

Plot#4, Street#S-6,

National Industrial

Zone Rawat

Islamabad.

Pyrica 150mg

Capsule

Oral

Each Capsule

Contains:

Pregabalin……150

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

15-11-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated.16-07-2014

Dy. No. 1606

2x7’s Rs.350/- and

As per PRC

Duplicate Dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 03-06-

2014. As per

report company

found complying

GMP. Capsule

section

mentioned in FID

report.








submitted.

359. M/S Panacea

Pharmaceuticals,

Plot#4, Street#S-6,

Peegab 300mg

Capsule

Capsule

Form 5

Rs.8000/-

LYRICA

Capsules (25, 50,

75, 100,




211

National Industrial

Zone Rawat

Islamabad.

Each Capsule

Contains:

Pregabalin……300

mg

(Gaba Analogue)

Manufacturers

specifications

17-11-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated.16-07-2014

Dy. No. 1608

2x7’s As Per SRO

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 03-06-

2014. As per

report company

found complying

GMP. Capsule

section

mentioned in FID

report.





submitted.

360. M/S Swan

Pharmaceuticals,

Private Limited,

Plot #11-E

Industrial Triangle

Kahuta Road

Islamabad.

Pregab 50mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

13-07-2010

Dy. No.6223

Rs.12000/-

Dated.10-06-2014

Dy. No. 630

Rs. 175/- per 2x7’s

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Routine

inspection report

dated 09-12-

2014. Some

observations

made by the FID.

Capsule section

granted vide

letter No. F. 1-

82/2005-Lic

dated

03/07/2009.


technical staff from

Licensing Section required.

However, firm has submitted

copy of application for

change of Q.C Manager on

26-01-2015.

361. M/S Swan

Pharmaceuticals,

Private Limited,

Plot #11-E

Industrial Triangle

Pregab 300mg

Capsule

Capsule

Each Capsule

Form 5

Rs.8000/-

13-07-2010

Dy. No. 6219

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)






212

Kahuta Road

Islamabad.

Contains:

Pregabalin

……….… 300mg

(Gaba Analogue)

Manufacturers

specifications

Rs.12000/-

Dated.10-06-2014

Dy. No. 627

14’s; As per SRO

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Routine

inspection report

dated 09-12-

2014. Some

observations

made by the FID.

Capsule section

granted vide

letter No. F. 1-

82/2005-Lic

dated

03/07/2009.


26-01-2015.

362. M/S Swan

Pharmaceuticals,

Private Limited,

Plot #11-E

Industrial Triangle

Kahuta Road

Islamabad.

Pregab 75mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin

……….…75mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

13-07-2010

Dy. No.6222

Rs. 12000/-

Dated. 10-06-2014

Dy. No. 631

2x7’s; Rs. 200/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Routine

inspection report

dated 09-12-

2014. Some

observations

made by the FID.

Capsule section

granted vide

letter No. F. 1-

82/2005-Lic

dated

03/07/2009.







26-01-2015.

363. M/S Swan

Pharmaceuticals,

Private Limited,

Plot #11-E

Pregab 100mg

Capsule

Capsule

Form 5

Rs.8000/-

13-07-2010

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and





213

Industrial Triangle

Kahuta Road

Islamabad.

Each Capsule

Contains:

Pregabalin

…………100mg

(Gaba Analogue)

Manufacturers

specifications

Dy. No.6221

Rs.12000/-

Dated.10-06-2014

Dy. No. 632

2x7’s; Rs.245/-

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Routine

inspection report

dated 09-12-

2014. Some

observations

made by the FID.

Capsule section

granted vide

letter No. F. 1-

82/2005-Lic

dated

03/07/2009.



26-01-2015.

364. M/S Swan

Pharmaceuticals,

Private Limited,

Plot #11-E

Industrial Triangle

Kahuta Road

Islamabad.

Pregab 150mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin

……….…150mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

13-07-2010

Dy. No.6220

Rs.12000/-

Dated.10-06-2014

Dy. No. 626

2x7’s; Rs. 350/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Routine

inspection report

dated 09-12-

2014. Some

observations

made by the FID.

Capsule section

granted vide

letter No. F. 1-

82/2005-Lic

dated

03/07/2009.







26-01-2015.

365. M/s Ambrosia

Pharmaceuticals

Plot No.18 Street

Gabalin 100mg

Capsule

Capsule

Form 5

Rs.8000/-

LYRICA

Capsules (25, 50,

75, 100,

1) An undertaking (on letter

head) that in case of

resemblance / similarity with

214

No.9, Rawat

Industrial Estate,

Islamabad.

Each Capsule

Contains:

Pregabalin

……100mg

(Analgesic and

Anticonvulsants

Activity)

Manufacturers

specifications

26-02-2010

Dy. No.499

Rs.12000/-

15-07-2014

Dy. No.1527

14’s/As Per SRO

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Copy of follow

up panel

inspection dated

24-04-2013. Firm

rectified most of

the observations.

Capsule

(General) section

granted vide

letter No. F. 1-

22/2002-Lic

dated

24/03/2007.

already registered brands the



2) An undertaking /





prescribed format:


ii. Pharmaceutical

development studies


testing methods


v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.

3) Quantity of API in master

formulation is incorrect i.e.,

50mg / capsule. Source of

in-actives has been

mentioned as local,

clarification required along

with justification for

proposed quantities.

4) Tests such as

disintegration, dissolution,

weight variation etc., are non

specific.


standard required.

366. M/s Ambrosia

Pharmaceuticals

Plot No.18 Street

No.9, Rawat

Industrial Estate,

Islamabad.

Gabalin 75mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin

……75mg

(Analgesic and

Anticonvulsants

Form 5

Rs.8000/-

26-02-2010

Dy. No.500

Rs.12000/-

15-07-2014

Dy. No.1526

14’s/As Per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)







2) An undertaking /




215

Activity)

Manufacturers

specifications

Getz


prescribed format:


ii. Pharmaceutical

development studies


testing methods


v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.

3) Quantity of API in master

formulation is incorrect i.e.,

50mg / capsule. Source of

in-actives has been

mentioned as local,




4) Tests such as



specific.


standard required.

367. M/s Ambrosia

Pharmaceuticals

Plot No.18 Street

No.9, Rawat

Industrial Estate,

Islamabad.

Gabalin 50mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin

……50mg

(Analgesic and

Anticonvulsants

Activity)

Manufacturers

specifications

Form 5

Rs.8000/-

26-02-2010

Dy. No. 495

Rs.12000/-

15-07-2014

Dy. No.1528

14’s/As Per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz







2) An undertaking /





prescribed format:


ii. Pharmaceutical

development studies


testing methods

216


v. Label claim and



by reference drug

agencies e.g., FDA,

TGA, MHLW, EMA and

Health Canada.

3) Source of in-actives has

been mentioned as local,




4) Tests such as



specific.


standard required.

Case No. 11: Change in formulation of cough syrup.

Drug Registration Board had deferred following request of change of formulation of M/s. Star

Laboratories (Pvt.) Ltd; Lahore for their following drug as they wanted to replace Ephedrine HCl to

Aminophyline for provision of required data on Form-5:-

Reg. No. Name of Drug with existing formulation. Name of Drug with demanded formulation.

038488 Alvenol Cough Syrup

Each 100ml contains:-

Chlorpheniramine Maleate …. 100mg

Terpin Hydrate ……………… 200mg

Potassium Bicarb ………...…… 2mg

Ammonium Chloride ……….. 500mg

Tr. Senega …………………… 1ml

Menthol ……………………… 20mg

Ephedrine HCl ………………. 100mg

Potassium Guaiacol Sulph. ….. 100mg

Potassium Citras ……………... 2mg

Tr. Ipecac …………………….. 0.5ml

Ext. Glycyrrhiza ……………… 2ml

Alvenol Syrup

Each 5ml contains:-

Chlorpheniramine Maleate …. 120mg

Aminophylline ……………… 768mg

Ammonium Chloride ……….. 600mg

Menthol ……………………… 24mg

Terpin Hydrate ……………… 240mg

Potassium Guaiacol Sulfonate .. 120mg

Potassium Bicarbonate ……… 2.400mg

Potassium Citrate ………..…. 2.400mg

Ext. Glycerrhiza …………….. 2.400ml

Ipecac Tincture ……………… 0.600ml

Senega Tincture ……………… 1.200ml

The Firm has submitted Form 5 for formulation as under:-

217

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacological

Group

Finished

product

Specification

Type of

Form

Initial

date,

diary

Demande

d Price /

Pack size

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


1 M/s. Star

Laboratories

(Pvt.) Ltd. 23-

Km, Multan

Road, Lahore

Alvenol Syrup

Each 5ml

contains:-

Chlorpheniramin

e Maleate ….

5mg

Aminophylline

…32mg

Ammonium

Chloride .. 25mg

Menthol … 1mg

Terpin Hydrate

… 10mg

Potassium

Guaiacol

Sulfonate .. 5mg

Potassium

Bicarbonate

…0.1mg

Potassium Citrate

…0.1mg

Ext. Glycerrhiza

…0.1ml

Ipecac Tincture

…0.025ml

Senega Tincture

…0.05ml

(Expectorant)

(Manufacturer’s

Spec.s)

Form 5

15-10-

2014

(1176)

Fee

already

submitted

(M-243)

As Per

SRO

Not confirmed

Pulmonol (CCL)

Good level of GMP compliance. (26.03.13)

1. Evidence of approval of section / manufacturing facility

of applied drug from licensing section is required.

Inspection report dated 26.03.13 mentions oral liquid

section.

2. Strengths of active ingredients applied are different from

those considered in M-243 of Drug Registration Board.

However latest formulation requested by Firm is placed

on this table.

3. International availability of formulation in reference

Stringent Regulatory Agencies not confirmed and not

provided by the Firm.

4. Stepwise details of manufacturing process including

Precautions/Control required to produce specified

quantities of the drug applied for registration and

demonstration of cleaning validation procedures,

Identification & description of Critical steps which may

alter the results and tests for IPQC including weight

variation, hardness, friability, water content, etc are

required.

5. Status of cGMP compliance of equipments (used for

production of applied product) is required.

6. Copy of GMP inspection report dated 26.03.13 is

218

attached.

7. Types of container / packaging not correct. Firm in reply

has given Aluminium Foil, PVC, Unit Carton and

Leaflet.

8. Complete Specifications (Physical & Chemical

Characteristics) of the container closure system

(Primary Packaging, Secodary Packaging & Associated

components e.g., caliberated spoon etc.) fulfilling the

compendial requirement are required.

9. Undertaking of submitting before marketing of the

product, Description of Suitability of container closure

system comprising of parameters(i) Protection of

Drug(ii) Compatibility of Drug(iii) Safety of Drug &(iv)

Performance of Drug (Stability studies will establish the

the final suitability of container closure system) is

required.

219

Registration-I

Case No.01. Drugs deferred by Registration Board for expert opinion.

a. Foscan 1ml/Ml Solution For Injection 3ml Vial & 6ml Vial

Registration Board in its 245th

meeting deferred following products for expert

opinion. Accordingly products were referred for views. Comments are as under:-

S.

No.

Name of Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

fee.

1. M/s. Allmed

Laboratories,

Karachi. /

M/s. Haupt Pharma

AG Pfaffenrieder

Str. Wolfratshausen,

Germany.

For Biolitec Pharma,

Dublin, Ireland.

Foscan 1ml/ml Solution

for injection 3ml vial

Each ml of solution

contains:-

Temoporfin……….1mg

(Photosensitizing agent).

Rs.700,000/

Per 3ml vial

5

years

21-02-2013

Rs.50,000/-

2. M/s. Allmed

Laboratories,

Karachi. /

M/s. Haupt Pharma

AG Pfaffenrieder

Str. Wolfratshausen,

Germany.

For Biolitec Pharma,

Dublin, Ireland.

Foscan 1ml/ml Solution

for injection 6ml vial

Each ml of solution

contains:-

Temoporfin…….1mg

(Photosensitizing agent).

Rs.1200,000/

Per 6ml vial

5

years

21-02-2013

Rs.50,000/-

Brig. Naeem Naqi,

Professor of Medicine

Consultant Medical

Oncologist,

Combined Military Hospital,

Lahore.

Dr. Abdul Hameed,

Consultant

Haematologist/Oncologist,

Head of Medical

Oncology Department,

Shaukat Khanam Cancer

Hospital & Research

Centre,

Lahore.

Maj. Gen. Iftakhar,


Rawalpindi.

1. Foscan has been approved by Not recommended. Because Awaited.

220

EU in the symptom palliation in

advanced Head and neck cancer

only after radiotherapy and

systemic chemotherapy has

failed or they cannot be given.

Only a 22% response rate was

observed in the study quoted.

Price of Foscan being

demanded is PKR 700,000/-

(Pak Rupee Seven hundred

thousand only) per 3ml vial.

Cost benefit ration does not

justify its approval. Temoporfin

also failed to receive approval

by FDA for use in USA.

2. Foscan requires use in a

specialized centre with

specialized equipment and

trained doctors for

photodynamic therapy. Such

facility at the moment does not

exist to my knowledge in

Pakistan.

3. Foscan has side effects,

rendering patient photosensitive

for considerable duration (from

2 weeks to six months) apart

from apart from other side

effects.

Foscan is therefore not

recommended to for approval.

of absence of large scale

randomized control trials,

low safety margins (high

cost, infrastructure….?) and

limitations in the quality of

life and resource outcome

reporting.

Temoporfin is marketed in

the European Union under

the brand name Foscan. The

US FDA deemed Foscan

non-approvable in 2000. The

EU approved its use in June,

2001.

Additionally, safety studies

with the complete final

formulation is lacking.


b. Surgical Suture M/s. 3 M Surgicals, Sarwar Road, Rawalpindi.

Registration Board in its 243rd

meeting deferred following products for expert opinion.

Accordingly products were referred for views. Comments are as under:-

S.

No.

Name of Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

221

fee.

1. M/s. 3 M Surgicals,

Sarwar Road,

Rawalpindi. /

M/s. Peters Surgical

Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Premio ® Non-absorbable

Surgical Sutures, P.V.D.F

Monofilament

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-


Sarwar Road,

Rawalpindi. /


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Black Silk ® Non-

absorbable Surgical

Sutures, Black Braided

Silk Waxed, Ophthalmic

Sutures

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-


Sarwar Road,

Rawalpindi. /


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Cardioxyl ® Non-

absorbable Surgical

Sutures, Coated Polyester

Braid

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-


Sarwar Road,

Rawalpindi. /


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Soie/Silk ® Non-

absorbable Surgical

Sutures Waxed Silk

Braid.

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-


Sarwar Road,

Rawalpindi. /


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/-


Sarwar Road,

Rawalpindi. /

Optime-R ® Absorbable

Surgical Sutures, Coated

Polyglycolic Acid Braid

As per SRO 05

years

19-08-2013

Rs.100000/-

222


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

with Fast Resorption.

(Surgical Sutures).


Sarwar Road,

Rawalpindi. /


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Cardioflon ® Non-

absorbable Surgical

Sutures Coated Polyester

Braid.

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-


Sarwar Road,

Rawalpindi. /


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Acier ® Non-absorbable

Surgical Sutures,

Stainless Steel

Monofilament.

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-


Sarwar Road,

Rawalpindi. /


Z.I. Les Vignes 42,

rue Benoit Frachon

Bobigny Cedex,

France.

Corolene ® Non-

absorbable Surgical

Sutures, Polyproplene

Monofilament

(Surgical Sutures).

As per SRO 05

years

19-08-2013

Rs.100000/-

Maj. Gen.

Muhammad Ahmed,

(D.G. Surgery)


Rawalpindi

Prof. Dr. Imran Skindar,

Head Department

Orthopedic Surgery,

Pakistan Institute of Medical

Sciences,

Islamabad

Dr. Moeed. I. Qureshi,

Head, Department of

Surgery,

Sheikh Zayed Hospital,

Lahore.

Quality of sample sutures

provided is satisfactory and

they are recommended for

purchase.

We have done the sample

testing of all the sutures

mentioned and found to be

satisfactory as to knotting

thread strength and needle

behavior.

Awaited.

223


c. Deferred for confirmation of approval by SRA and expert opinion imported

veterinary drugs



Accordingly products were referred for views. Comments are as under. The drug is registered in

Stringent Regulatory Authorities i.e. Bulgaria, Czech Republic, Estonia, Greece, Hungary,

Malta, Poland, Romania, Slovak Republic and Spain.

S.

No.

Name of

Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

fee.

1. M/s. Marush (Pvt)

Limited, K-123,

Model Town,

Lahore. /

M/s. Laboratories

Hipra S.A, Avda,

La Selva, 135

Amer (Girona)

17170, Spain.

Gentamox Injection

Each ml contains:-

Amoxicillin

trihydrate……….150mg

Gentamicin as

Sulphate………...40mg

(Antibiotic)

Decontrolled

100ml Type II

glass vial

24

Months

08-07-2010

Dy No: 35

Rs. 15000 +

Rs. 85000/-

Prof. Dr. Muhammad

Ashraf,

Professor Emeritus,

Department of

Pharmacology and

Toxicology,

University of Veterinary and

Animal Sciences,

Lahore.

Meritorious Prof. Dr. Zafar

Iqbal, Chairman,

Department of Pharmacy,

University of Peshawar,

Peshawar.

Prof. Dr. Tanweer Khaliq,

Chairman,

Department of Physiology &

Pharmacology,

University of Agricultural,

Faisalabad.

i) It is a combination of

two antibiotics

Amoxicillin trihydrate

(150mg) and

Gentamicin sulfate

(40mg) per ml. (Ratio

about 3: 1).

Through study of the literature

shows the combination of

amoxicillin is very effective in

controlling the variety of

infections. The combination of

amoxicillin and gentamicin

acts synergistically against a

This department do not have

any legal authority to give

opinion about use of

veterinary drugs or their

registration. Regarding the

second point raised in your

letter, the department may

224

ii) A similar product

GENTA-AC (Alina)

injection have same

ingredients but

different

concentrations i.e.

Amoxicillin (50mg)

and Gentamicin

(25mg) per ml (Ratio

2:1).

iii) Combination of

Amoxicillin and

Gentamicin may have

synergistic effect.

iv) It is fixed dose

combination of two

antibiotics which are

also available

separately in the

market for veterinary

use, Amoxicillin

trihydrate injection

15% (15mg/Kg body

weight) and

Gentamicin sulfate 5%

(4mg/Kg body weight)

injection.

v) Clinical trials of the

products have been

reported with good

efficacy.

vi) Safety/Toxicity trials

at the therapeutic doses

of amoxicillin and

gentamicin have been

conducted (Side effects

like Hypersensitivity

reactions, avoid in

pregnant animals).

vii) Dosage adjustment in

renal impairment

(nephrotoxicity).

viii) Withdrawal period of

30 days for meat and 2

days for milk have

wide range of infections

caused by both Gram-positive

(e.g. Staphylococcus,

Streptococcus and

Corynebacterium spp.) and

Gram-negative (e.g E.Coli,

Pasteurella, Salmonella and

Pseudomonas spp.) bacteria in

cattle. Amoxicillin inhibits

mainly in Gram-positive

bacteria the cross-linkage

between the linear

peptidoglycan polymer chains

that make up a major

component of the cell wall.

Gentamicin binds of the 30S

subunit of the ribosome of

mainly Gram-negative

bacteria, thereby interrupting

protein synthesis.

The same combinations are

also available in other

countries like Biogenta in

Holland and Amoxigentin in

Peru. Therefore, in the light of

data provided the literature

studied the drug may be

considered for Registration.

design a research project and

after obtaining data and

analyzes the

comments/recommendation

may be made. However, the

study of literature showed that

the combination of the

gentamicin and amoxicillin is

effectively used in the

treatment of various types of

infections.

225

been recommended

and should be written

on the label of the

product to avoid tissue

residue problem.


d. Hidrasec 10mg, 30mg Sachet and Hidrasec Capsule 100mg- M/s. Abbott

Laboratories.



Accordingly products were referred for views. Comments are as under:-

S.

No.

Name of

Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

fee.

1. M/s. Abbott

Laboratories

(Pakistan) Limited,

Karachi. /

M/s. Laboratoires

SOPHARTEX 21

Rue du Pressoir

Vernouillet,

France.

Hidrasec 10mg Sachet

Each sachet contains:-

Racecadotril……10mg

(Anti-Diarrheal).

Rs.1046.30/Per

16 Sachets

24

months

29-04-2013

Rs.100,000/-

2. M/s. Abbott

Laboratories

(Pakistan) Limited,

Karachi. /

M/s. Laboratoires

SOPHARTEX 21

Rue du Pressoir

Vernouillet,

France.

Hidrasec 30mg Sachet


Racecadotril….30mg

(Anti-Diarrheal).

Rs.1046.30/Per

16 Sachets

24

months

29-04-2013

Rs.100,000/-

3. M/s. Abbott

Laboratories

(Pakistan) Limited,

Karachi. /

M/s. Laboratoires

SOPHARTEX 21

Hidrasec 100mg

Capsules

Each capsule contains:-

Racecadotril….100mg

(Anti-Diarrheal).

Rs.654/

Per 10

Capsules

24

months

29-04-2013

Rs.100,000/-

226

Rue du Pressoir

Vernouillet,

France.

Prof.Dr. Rauf Niazi,

Head of Unit-2

Pakistan Institute of Medical

Sciences,

Islamabad.

Prof.Dr. Syed Irfan Ahmed,

Professor of Medicine,

RMC & Allied Hospitals,

Benazir Bhutto Hospital,

Murree Road, Rawalpindi.

Brig.Amjad Salamat,

Military Hospital,

Rawalpindi.

I strongly recommend

registration of that Raceadotril

(acetorphan), Capsules and

Sachets, however if the price

of the drug can be brought

down, keeping in mind the

economic status of our

population these drugs would

be very useful addition, to

present drugs, available to

treat acute secretory diarrhea

and reduce morbidity of this

common condition. I highly

recommend registration of the

drug, on fast track basis.

Hidrasec is recommended for

registration for the treatment

of diarrhea in conjunction with

ORS. However it should not

be used to treat infections.

Even in Cholera, which

requires antibiotics and

intravenous saline, it should

be used with caution as severe

fluid depletion can be a “Pre-

renal” cause of renal failure.

Hidrasec has a renal mode

excretion. Also no studies

have been conducted

comparing its safety profile

with Zinc or probiotics. Hence

it can not be claimed superior

to these modes of treatment.

The capsule Essentiale has

been in use for past many

decades as hepatoprotective

agent. It is at least as good as

many similar preparations

granted approval in the last

two years. Its safety profile

has never been previously

questioned. It is recommended

that the above mentioned drug

may be added to the formulary

of drugs as per rules.

Hidrasec capsules and sachets

are recommended as anti-

diarrheal for registration but

with following comments.

The usefulness of racecadotril

in the treatment of chronic

diarrhea in HIV-positive is not

established as yet.

Caution should be mentioned

in package insert on efficacy

and safety of racecadotril in

infants and children with

persistent or chronic diarrhea,

particularly in developing

countries.

The info that it is not active

against cryptosporidium

should also be included in

package insert.

The drug is as effective as

Loperamide in Adults,

therefore the price should be

reconsidered in cases of

capsules and rationalized for

Hidrasec 10mg and 30mg

sachet which costs the same.


227

Case No. 02. Registration of imported – Inspections of manufacturing units abroad

thereof.

a. Registration of imported drugs – Comments of panel of inspectors.

i. Ali Gohar & Company (Pvt) Ltd., Karachi

Drug Registration Board in its 223rd

meeting held on 11-03-2010 approved the registration of

following drug in the name of Ali Gohar & Company (Pvt) Ltd., Karachi manufactured by M/s.

Alcon Laboratorios do Brasil Ltda., Brazil, subject to inspection of manufacturer abroad, verification

of storage facilities and price fixation / calculation etc as per policy:-

Name of drug (s)/Composition. Fee deposited. Price approved by

the Drug Pricing

Committee.

Vigadexa Sterile Ophthalmic Solution.

Each ml contains:-

Moxifloxacin Hydrochloride 5.45mg

(equivalent to 5.0mg of base).

Dexamethasone Sodium Phosphate 1.1mg

(equivalent to 1.0mg of Dexamethasone

phosphate).

Rs.50000/- Rs.468.00/5ml.

In compliance, inspection of the manufacturer abroad M/s. Alcon Laboratorios do Brasil

Ltda., Brazil (Presently M/s. Novartis Biociencias S.A. Sao Paulo, Brazil) has been carried out by

the nominated panel comprising Dr. Muhammad Tanweer Alam, DDG (E&M), Drug Regulatory

Authority of Pakistan, Karachi and Dr. Sara Awan, Assistant Drugs Controller (Pricing), Drug

Regulatory Authority of Pakistan, Islamabad.

The panel of inspectors has recommended the registration of the above said product.

Drug Pricing Committee in its 12th meeting held on 20-09-2010 approved the price of the

drug. The storage facility of the importer has also already been verified by the Area FID.

M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi have provided original CoPP of the

228

product “Vigadexa Sterile Ophthalmic Solution” duly legalized by Pakistan Embassy

and requested that the name of the manufacturer may also be changed from M/s. Alcon

Laboratorios do Brasil Ltda., Brazil to M/s. Novartis Biociencias S.A. Sao Paulo, Brazil.

The firm has also deposited the differential fee Rs.50000.

The panel of experts has suggested to the manufacturer to segregate the area by

glass partitioning or plastic partitioning to remove to the risk of mix-up of labeled &

un-labeled packs.

Changes of mix-up is a critical observation and may lead to any serious

consequences if occur as we see in some examples in recent past in PIC case. Therefore,

it is propose we may ask the firm to submit compliance report of their foreign

manufacturer for what corrective measure they have adopted after the inspection to

remove the chances of mix up.

Submitted for consideration of Drug Registration Board.

ii. M/s. Chiesi Farmaceutica Ltd

Drug Registration Board in its 236th meeting held on 20th November, 2012

approved the registration of following drugs in the name of M/s. Chiesi Pharmaceuticals

(Pvt) Ltd., Lahore, manufactured by M/s. Chiesi Farmaceutica Ltda, 151 Km 39, 2 da Estrada

dos Romeiros Santana de Parnaiba - SP Brazil, subject to inspection of manufacturer abroad,

verification of storage facilities and price fixation / calculation etc as per policy:-

S.#

Name of drug (s)/Composition. Fee deposited. Prices approved by the

Drug Pricing Committee.

1. Clenil Compositum 250mcg +

100mcg.

Each actuation contains: -

Beclomethasone Dipropionate

0.250mg.

Salbutamol Sulphate 0.120mg

(equal to Salbutamol 0.100mg).

Rs.100000 Rs.703.00/200mds

Inhaler.

229

2. Clenil Compositum 50mcg +

100mcg.

Each actuation contains: -

Beclomethasone Dipropionate

0.05mg.

Salbutamol Sulphate 0.120mg

(equal to Salbutamol 0.100mg).

Rs.100000 Rs.370.00/200mds

Inhaler.

In compliance, inspection of the manufacturer abroad M/s. Chiesi Farmaceutica Ltda, 151

Km 39, 2 da Estrada dos Romeiros Santana de Parnaiba - SP Brazil has been carried out by the

nominated panel comprising Dr. Muhammacd Tanweer Alam, DDG (E&M), Drug Regulatory

Authority of Pakistan, Karachi and Dr. Sara Awan, Assistant Drugs Controller (Pricing), Drug

Regulatory Authority of Pakistan, Islamabad.

The panel of inspectors has recommended the registration of the above said products. As

Beclomethasone is steroid and inspection report is silent about segregated facility. Therefore,

views of inspection panel for confirmation of segregated facility were obtained. In response,

the inspection panel has submitted that in addition to the prescribed format as submitted earlier

by the panel, they have to submit that:-

“The Clenil composition HFA containing BDP and Salbutamol is being manufactured

under very isolated area with dedicated equipments and men.

(a) The first step they have seen in the isolated dispensing under the supervision of

the Pharmacist. Dispensing was being made inside the ISSOLATER;

(b) A dedicated compounding tank was also observed with BUK valve connected to

the compounding tank.

(c) The preparation tank also separately installed for proper mixing to avoid any sort

of contamination during mixing.

(d) The dedicated filling was carried out also in dedicated area meant for the claimed

composition.

230

(e) Besides filling an IPQC arrangement was present for all in process control.

Keeping in view the segregated facility for the product containing BDP was

recommended. The panel confirmed that the manufacturing facilities were segregated.


iii. M/s. AA Pharma, Karachi

Drug Registration Board in its 236th meeting held on 20

th November, 2012 approved the

registration of following drug for import in the name of M/s. AA Pharma, Karachi manufactured by M/s.

BMI Korea Co. Ltd., 2230-4, Yeongpyeong-dong, jeju-si, Jeju-do, 690-140 Korea, subject to inspection

of manufacturer abroad:-

Name of Drug (s) & Composition. Fee deposited. Price approved by the Price

Advisory Committee.

Octstantin Injection.

Each ml contains: -

Octreotide Acetate……0.112mg

(0.1mg as Octreotide).

Rs.100,000 Rs.370/1’s.

Rs.1850/5’s.

In compliance, inspection of the manufacturer abroad M/s. BMI Korea Co. Ltd., 2230-4,

Yeongpyeong-dong, jeju-si, Jeju-do, 690-140 Korea has been carried out by the nominated panel

comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem Philip, ADC

(Licensing), Drug Regulatory Authority of Pakistan, Islamabad.

The panel of inspectors has recommended the registration of the above said product with

the remarks that registration of the drug is recommended however import should be allowed after

the desired improvement. The storage facility of the importer has already been verified by the

Area FID.

With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL,

Karachi and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of

Pakistan, Islamabad were requested to inform about type of short coming pointed out whether

231

these are critical in nature affecting the quality of the product or suggestive / advisory nature for

further processing the case.

In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that

M/s. BMI Korea Co. Ltd., 2230-4, Yeongpyeong-dong, jeju-si, Jeju-do, 690-140 Korea was

thoroughly inspected for facilities regarding the production, quality control and storage of their

products (Octstantin Injection (Octreotide Acetate) intended for registration in Pakistan. The

risk based assessment of the facilities of the firm identified a number of critical, major and

minor observations which have potential to adversely affect the quality of the concerned

product. A list of these observations along with the action plan for improvements has already

been submitted to the Directorate of Registration along with the inspection report. The

observations and their improvement schedule as submitted by the firm after the inspection is

annexed again for consideration and necessary action. It is further submitted that the firm has

also guided to submit report on the improvements directly to Directorate of Registration.

The panel informed that the certain observations are Major and very critical can affect the

quality of the product which need be rectified along with the other stated observations before

manufacturing and importing the product to Pakistan.


b. Registration of imported drug – Issuance of registration letter.

i. M/s. RG Pharmaceutica (Pvt) Ltd., Karachi

Drug Registration Board in its 236th meeting held on 20

th November, 2012 approve the

registration of following imported drug in the name of M/s. RG Pharmaceutica (Pvt) Ltd.,

Karachi manufactured by M/s. Douglas Manufacturing Ltd., Lincoln, Aukkland, New Zealand,

subject to inspection of manufacturer abroad, verification of storage facilities and price fixation /

calculation etc as per policy:-

Name of Drug & Composition. Fee deposited. Price approved by the

Drug Pricing Committee.

DP-Anastrozole 1mg Tablets. Rs.100,000 Rs.2000.00/ 10’s.

Rs.5520.00/30’s.

232

Each tablet contains:-

Anastrozole……1mg.

Drug Pricing Committee in its 7th meeting held on 21-08-2013 approved the price of the

above said drug. The storage facility of the importer has also already been verified by the Area

FID.

The applicant M/s. RG Pharmaceutica (Pvt) Ltd., Karachi have requested for issuance of

the registration letter of the aforesaid product as the product is approved by TGA. The firm has

submitted the CPP and Australian Register of Therapeutic Goods Certificate for Anastrozole 1mg

Tablets (pack of 10’s and pack of 30’s) duly attested / legalized by High Commission for

Pakistan, Canberra, Australia.

As per TGA approval (CoPP), point 3 states that certifying authority inspects manufacturing steps

carried out in Australia. For overseas manufacturers, evidence of satisfactory GMP compliance

has been supplied.


Case No. 03. Change of manufacturing site of imported registered drug.

i. Change of Manufacturer Name from M/s. DSM Pharmaceuticals Inc to M/s. Patheon

Manufacturing Services LLC for Aggrastat Injection (Reg. No.025299).

M/s. Atco Laboratories Limited, Karachi has requested to approve the change of manufacturer name of

their registered product “Aggrastat Injection (Reg. No.025299) (Tirofiban HCl equivalent to 0.25mg

Tirofiban)” from M/s. DSM Pharmaceuticals Inc., Greenville, North Carolina, 27834, USA to M/s.

Patheon Manufacturing Services LLC, Greenville, North Carolina, 27834, USA. The premises used to

manufacture the product and the physical location remains the same.

M/s. Atco Laboratories Limited, Karachi has further submitted that there will be no change in

manufacturing and primary packaging. This is site name change only. There is no change to the quality or

manufacturing of Aggrastat product due to this site name change.

233

M/s. Atco Laboratories Limited, Karachi have deposited the fee Rs.100000- and submitted

following supporting documents:-

i) Copy of registration letter.

ii) Copy of change of manufacturing site.

iii) Copy of transfer of registration letter.

iv) Copy of last renewal status.

v) Copy of CRF Clearance Certificate.

vi) Original CPP Legalized by Embassy of Pakistan.

vii) Copy of GMP Certificate.

viii) Certification of Manufacturing Site Name Letter.

ix) Certification of Establishment Registration.

x) Screenshot of the FDA website showing that the site is registered as Patheon

Manufacturing Services LLC.

As per provided CPP issued by USFDA, the product is “Not Approved”/ (Un-approved) by the

Authority. It is not on free sale in country of origin. Therefore, M/s. Atco Laboratories Limited, Karachi

was advised to explain the position.

In response, M/s. Atco Laboratories Limited, Karachi have submitted as under:-

i) The subject product is approved and registered in USA, approval

of US-FDA and updated list of US-FDA products.

ii) M/s. Correvio is supplying branch for Pakistan who does not have

the marketing rights for USA. In USA marketing rights are with

M/s. Medicure. Since M/s. Correvio has no marketing rights for

USA, therefore, US-FDA issued the CPP to M/s. Correvio

mentioning it as un-approved with the comments that M/s.

Correvio can only export the product (because they cannot market

the product in USA).

iii) It is clearly mentioned on CPP that US-FDA conducts periodic

inspection of the manufacturing facility.

Keeping in view the above submissions the firm have requested to grant the approval for change

of manufacturer name from M/s. DSM Pharmaceuticals Inc., Greenville, North Carolina, 27834, USA to

M/s. Patheon Manufacturing Services LLC, Greenville, North Carolina, 27834, USA.

The claim of the firm about registration of the product with USFDA is not correct as the approved

produt is “Aggrastat (12.5mg / 250mg) (i.e. 0.05mg/ml) and belongs to M/s. Medicure and not the

234

property of M/s. Correvio. The product of the firmj registered with DRAP Pamistan under registration

No. 025299 is “Tirofiban HCl (0.25mg/ml) which is “5 times stronger” and pack size is 50ml but the US

product is in 250ml.

Although the US Certificate verify GMP compliance but the product is different than the product

is US register under NDA#020913.

The product registered in the name of M/s. Atco Laboratories Limited, Karachi as per record

submitted is not registered / approved by US FDA as per CoPP submitted.


Case No. 04. Application for Change of Formulation of “Avi-Dex Liquid (Reg. No.063649)”.

M/s. Avicenna Laboratories (Pvt.) Ltd., Sheikhupura have requested for change of formulation of

their already registered veterinary drug “Avi-Dex Liquid (Reg. No.063649)” containing Levamisole HCl

1.5% & Trichlobendazole 5.0%. The firm has submitted that in the market product having this

combination is using Levamisole HCl 3.75% as label claim. Due to high concentration, people are using

this product having the high concentration of Levamisole HCl along with Trichlobendazole 5.0%.

Therefore, the firm has requested for change of formulation as follows. The firm has deposited required

fee Rs.20000/- for this purpose:-

Existing Formulation. New Formulation.

Avi-Dex Liquid.


Trichlobendazole ...... 0.05gm.

Levamisole HCl ...... 0.015gm.

Avi-Dex Liquid.

Containing:-

Trichlobendazole........... 5.0%.

Levamisole HCl........... 3.75%.

The firm have also submitted copy of same formulation available in the market and copy of initial

registration letter of the product.


235

Case No. 05. Grant of additional pack of registered product.

M/s. Snam Pharma, Lahore has applied for approval of additional pack of their

following registered imported veterinary drug as follows:-

S. No. Reg. No. Name of Drug/Composition. Existing

Pack.

Demanded

Additional

pack.

1 010704 KOLAMOX SP.

Contains:-

Amoxycilloin activity as the

trihydrate 12gm.

100gm. 1kg.

M/s. Snam Pharma, Lahore have deposited the required fee Rs.5000/- and submitted

following supporting documents: -

i) Copy of last renewal.

ii) Copy of transfer of registration.

iii) Copy of change of manufacturer name. iv) Copy of initial registration letter.

M/s. Snam Pharma, Lahore has submitted that the large pack is required by the big

former and it is demanded by the market.

M/s. Snam Pharma, Lahore was advised to submit approval of same pack of Kolamaox

SP (Reg. No.010704) from country of origin.

In response, M/s. Snam Pharma, Lahore has submitted Free Sale Certificate of the

product “Kolamaox SP” duly legalized by High Commission of Pakistan London.

The Export Certificate issued by the UK authorities submitted by the firm indicates that

the product mentioned above is not hold “Market Authorization” in UK. Therefore, it is an un-registered

product.


236

Case No. 06. Request for exclusion of Urdu Finished Imported Packs of Campto

(Irinotecan) and Permission for Laser Jet local Printing.

M/s. Pfizer Pakistan Limited, Karachi have requested to grant them exemption from Urdu

Text on the “International Packs” and local printing of registration number and MRP through

laser jet before releasing the “International packs” from their warehouse on the import of their

following registered imported drugs as the quantity mentioned against each. The firm has

deposited required fee Rs.10000/:-

S. No. Reg. No. Name of Drug(s). Quantity.

1. 021128 Campto 100mg Injection

(Irinotecan hydrochloride Trihydrate)

1260 units.

2. 021127 Campto 40mg Injection

(Irinotecan hydrochloride Trihydrate)

540 units.

M/s. Pfizer Pakistan Limited, Karachi have submitted that Campto (Irinotecan) is an anti-cancer

drug which is manufactured under strict conditions using high biotechnological processes and is used for

the treatment of conditions like Advanced Colorectal Cancer, Cervical Cancer and Non-small Cell lung

Carcinoma. The product is used only by specialized oncologists practicing in leading hospitals and

oncology departments. Currently Pfizer Pakistan is importing product in limited quantity due to its

restricted usage and estimated calculated 2015 sale forecast is equivalent to 1800 packs only. Therefore, it

is not possible for the principal manufacturer i.e. M/s. Pfizer Perth Pty Limited, Australia to develop

Pakistan Specific Packs in such a small quantity. To ensure availability of product for the treatment of

incapacitating cancer patients, they would request to grant them the approval for the above given

quantities to be imported in 2015 and permit them to conduct the following actions at M/s. Pfizer Pakistan

Limited, Karachi premises:-

i) Local printing of registration number and MRP through laser jet

before releasing Campto “International packs” from their

warehouse.

ii) Exemption from Urdu Text on Campto “International packs”.


237

Case No.07: Registration of Seretide Diskus 50/100mcg, 50/250mcg & 50/500mcg Powder for

Inhalation.

Registration Board in its 186th meeting held on 13th & 14th October, 2004 approved the

registration of following drugs for import in the name of M/s. GlaxoSmithKline Pakistan Limited,

Karachi manufactured by M/s. Glaxo Wellcome Operations UK Limited, Ware, UK, subject to

calculation of prices and with the brand name “Seretide 100 Accuhaler” as mentioned on CPP:-

S. # Name of Drug (s) & Composition. Fee

deposited.

Price approved by the

Price Advisory

Committee.

1. Seretide Diskus 50/100mcg Powder for

Inhalation.

Each inhalation (single dose) contains:-

Salmeterol (as xinafoate) 50mcg.

Fluticasone propionate 100mcg.

Rs.50000 Rs.950.00/60mds.


Inhalation.




Rs.50000 Rs.1040.00/60mds.


Inhalation.




Rs.50000 Rs.1170.00/60mds.

Prices of the drugs have been approved by the Drugs Pricing Committee in its 8th

meeting

held on 18-11-2013.

M/s. GlaxoSmithKline Pakistan Limited, Karachi have submitted registration dossier as

per SRO 662, duly paid treasury challan as per new registration fee structure of DRA, fresh

legalized CPP and copies of earlier filed letters.

238

M/s. GlaxoSmithKline Pakistan Limited, Karachi have further clarify that the earlier filed

dossier were applied from M/s. Glaxo Wellcome Operations UK Limited, Ware, UK. Their

parent company / global manufacturing & supply team of GSK have now changed the source of

these products to M/s.Glaxo Wellcome Production, Evreux, France. Accordingly, they have also

filed fresh CPP of new source along with site master file.


meeting held on 13th

& 14th

October, 2004 approved the

registration of the above said drugs with the brand name “Seretide 100 Accuhaler” as mentioned

on CPP. The firm has now submitted new CPP withnew brand name “Seretide Diskus”.

The dossiers have been evaluated as per check list approved by the Registration Board.


239

Registration-II

Case No.08: Cancellation & Suspension of DML by Central Licensing Board.

Central Licensing Board has taken decisions in its 238th


November,

2014 as per following details:-

S. No. Name of firm(s) Case Decision of CLB


(Pvt.) Ltd, Karachi

Renewal of

Drug

Manufacturing

License

The Board decided and suspended the

renewal of DML of the firm for a period for

a period of three months accordingly to Rule

13 of Drugs (Licensing, Registering

&Advertising) Rules 1976 due to following

observation made by the panel during

inspection.

HVAC system was partially effective

due to light break ups and monitoring

was also below satisfactory.

Penicillin & Cephalosporin areas

were devoid of proper dispensing

booths.

Microbiology must be complaint as

per guidelines.

HVAC system should also be

provided in corridors of

manufacturing unit.

Sufficient persons are hired but a few

are advised to be hired as per DRAP

requirement.

To do further improvements in

documentation, calibration and

training in Q.C Laboratory.

The Board directed the firm to rectify the

above mentioned shortcomings within a

period of three months.

Case No.09: Registration of Drugs for export purpose-Not me too Drugs.

Following firms have requested for registration of following drugs for export

purpose only which are not me-too. Details are as under:-

240

S.

No.

Name of

Company

Name of product(s) Date of application,

Diary No. & Form

Export Order

1. M/s

Kaizen

Pharmace

uticals,

Karachi

Mysofo Tablet


contains:-

Sofosbuvir ….....400mg

19-11-2014

768

Rs.20,000/-

Copy of Export

Order from

Afghanistan

2. M/s The

Searle

Company

Ltd,

Karachi

Fosbuvir Tablet


contains:-


09-11-2014

773

Rs.50,000/-

Copy of Export

Order from Vietnam

3. M/s

Hilton

Pharma,

Karachi

Sofohil Tablet


contains:-

Sofosbuvir ………400mg

19-01-2015

819

Form-5

Rs.20,000/-

Copy of Export

Order from

Afghanistan

4. M/s

PharmEvo

, Karachi

Dakvir Tablet 30mg


Daclatasavir ……..30mg

28-01-2015

835

Form-5

Rs.20,000/-

Copy of Export

Order from

Colombo, Sri Lanka

5. -do- Dakvir Tablet 60mg


Daclatasavir ……..60mg

28-01-2015

833

Form-5

Rs.20,000/-

Copy of Export

Order from

Colombo, Sri Lanka

6. -do- Sofvir 400mg Tablet


contains:-


28-01-2015

836

Form-5

Rs.20,000/-

Copy of Export

Order from

Colombo, Sri Lanka

7. -do- Sofvir Plus Tablet


contains:-


Ledispasvir …… 90mg

28-01-2015

833

Form-5

Rs.20,000/-

Copy of Export

Order from

Colombo, Sri Lanka

8. -do- Simvir 150mg Capsule 28-01-2015

831

Copy of Export

241


Simeprevir ………150mg

Form-5

Rs.20,000/-

Order from

Colombo, Sri Lanka

9. -do- Ledvir 90mg Tablet


Ledispasvir ……..90mg

28-01-2015

832

Form-5

Rs.20,000/-

Copy of Export

Order from

Colombo, Sri Lanka


Case No.10: Extension in reduction of shelf life of Thyroxin Tablet, Reg. No.000374


held on 23rd

& 24th

July, 2012 had reduced shelf life of

one year (previously shelf life of two years have been assigned to the product). This permission

of one year shelf life was for six months only. The Board also directed to resolve the issue of

stability during six months under intimation to this Board.

Later on M/s GlaxoSmithKline Pakistan Ltd, Karachi have requested for extension in

permission for six (06) months to continue production of Thyroxine Tablet, Reg. No.000374

with 1 (one) year shelf life and submitted that schedule for upgradation of manufacturing facility,

project plan and stated that they anticipate completing manufacturing facility updradaton and

commencement of commercial supplies of Thyroxine Tablet, Reg. No.000374 with 18-24

months shelf life 3rd

/ 4th

quarter, 2014 subject to successful stability result.


meeting considered above request of firm and showed its

deep concern about non-availability of Thyroxine Tablet despite of reduction in shelf life as per

demand of the firm. However, the Board again acceded firm,s request for manufacturing of

Thyroxine Tablet, Reg. No.000374 with one year shelf life for further six months with strong

advise to ensure free availability of the drug across the country.

Now M/s GlaxoSmithKline, Karachi has again requested for extension for another period

of 12 months to continue production of Thyroxine Tablet with 1 year shelf life in order to

maintain uninterrupted supply of the product in the market. They have also informed that their

242

technical team has advised that ongoing technical validation and stability studies to enhance the

shelf life to 02 years are in progress and anticipated to be completed in 2015.


Case No.11: Similar brand names.

a. M/s Barrett Hodgson, Karachi.

M/s Barrett Hodgson, Karachi have requested that M/s Sante (Pvt.) Ltd, Karachi be

advised to change of brand name due to similarity. Details are as under:-

Name of

firm(s)

Brand Name(s)

& Composition

Reg.

No.

Resemble with Justification

M/s Barrett

Hodgson,

Karachi

Restasis

Ophthalmic

Emulsion 0.05%

(Cyclosporine)

Applied

drug

Ristases Eye Drops

(Cyclosporine)

Reg. No.075811

M/s Sante (Pvt.)

Ltd, Karachi

Firm has submitted that

“Restasis” brand name is

registered and marketed

by M/s Allergan, USA

worldwide and Barrett

Hodgson marketing

Allergan’s products in

Pakistan. Accordingly in

March, 2010 they have

applied Cyclosporine

Eye drops with the brand

name “Restasis” which

was approved for

registration in 231st

meeting and was

forwarded to Pricing

Section for fixation of

MRP. Now Pricing

Section has fixed MRP

but Registration letter is

not yet been issued. In

the meantime M/s Sante,

Karachi have got

registration same

formulation with slight

243

change in brand name i.e

Ristases which resemble

to their brand i.e

Restasis”

Firm has requested that

M/s Sante, Karachi be

advised to change their

brand name.


b. M/s Werrick Pharmaceuticals, Islamabad.

M/s Werrick Pharmaceutical, Islamabad have requested that M/s Getz Pharma, Karachi be

advised to change of brand name due to similarity. Details are as under:-

Name of

firm(s)

Brand Name(s)

& Composition

Reg.

No.

Resemble with Justification

M/s

Werrick

Pharma,

Karachi

Nervin Tablet

0.25mg

Nervin Tablet

0.5mg

Nervin Tablet

1mg

(Alprazolam)

015665

014374

014375

Nervon Tablet

Reg. No.039173

Nervon Injection

Reg. No.050654

(Mecobalamin)

M/s Getz Pharma,

Karachi

Brand Name of “Nervin”

is registered in favour of

M/s Werrick, Islamabad

prior to “Nervon” of M/s

Getz Pharma, Karachi.

M/s Werrick has

requested that M/s Getz

may be advised to

change their brand name.

Accordingly M/s Getz Pharma, Karachi was advised twice to change of brand name.

In response to DRAP’s letter for change of brand name due to similarity M/s Getz

Pharma, Karachi has requested that they may be allowed to retains its brand name “ NERVON”

on the following grounds:-

i) It is respectfully stated at the onset that the brand name / trademark ‘NERVON’

was adopted by Getz pharma in an honest and bonafide manner. Furthermore,

Getz Pharma is the owner of the registered trademark NERVON which was

244

registered at the Trade Marks Registry, without any opposition from M/s Werrick

Pharmaceuticals.

ii) Even otherwise, it is pertinent to highlight that the word “NERV” is used as a

prefix for grand names by a number of companies in Pakistan. As such there is or

remains no likelihood of confusion whatsoever with the use of “NERV” as a

prefix during the course of trade.

iii) Additionally, you may appreciate that NERVON tablets and injection have been

registered since 2005. A huge amount of goodwill and commercial value of the

product has been generated and Getz Pharm’s legal and equitable rights over the

brand name NERVON have been firmly established. Thus you will further

appreciate that any change in the brand name will cause a huge irreparable loss to

Getz Pharma.

It is submitted that Registration Board in its 242nd

meeting took following decisions in case

of resemblance of brand name:-

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.

Registration Board also decided that if packing material of two products resemble, then

later registration holder is bound to change packing material / design as one of condition

of registration. But in some cases, later registration holder avoids to change packing

design. Thus Board decided that in such cases DRAP will advise the manufacturer /

importer to change the pack design with 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 pack design.


245

Case No.12: Contract Manufacturing of Drugs.

a. Permission for contract manufacturing of Synthroid (Levothyroxine ) -M/s Abbott

Laboratories, Karachi


& 209th

meeting had approved following registration of

M/s Abbott Laboratories, Karachi subject to decision as mentioned in last column. Registration

letter not yet been issued.

S.

No.


Pack size

Demanded

Price

Decision

1. Synthroid 50mcg Tablets


Levothyroxine Sodium....50mcg

(Thyroid Preparation)

3x10’s Approved

(M-196)



Levothyroxin Sodium…125mcg


3x10’s Rs.37.00 (M-209)

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.





3x10’s Rs.35.00 -do-

246





3x10’s Rs.32.00 -do-





3x10’s Rs.28.00 -do-

M/s Abbott Laboratories, Karachi stated that, as they has not yet develop the facility for

manufacturing of Hormonal preparations and requested for grant of registration of above

mentioned products on contract manufacturing basis from M/s Highnoon Labs, Lahore as M/s

Highnoon are already manufacturing other hormonal product for them.

Later on Registration Board in its 245th meeting considered the request of M/s Abbott and

deferred for product specific inspection of M/s Highnoon Labs, Lahore by Director DTL,

Lahore, DDG (E&M) and area FID, DRAP Lahore with the direction that panel will also

scrutinize datas regarding product development, stability, validation of manufacturing process

and method of analysis. Accordingly panel comprising Mr. Jamil Anwar, Director DTL, Lahore,

Dr. Sheikh Akhtar Hussain, DDG (E&M) and Mr. Ajmal Sohail Asif, area FID, DRAP inspected

the premises of M/s Highnoon Laboratories, Lahore and concluded as under:-

“ Based on the areas inspected, the people met and the documents reviewed, and

considering the findings of the inspection the panel verified that M/s Highnoon Laboratories

17.5km, Multan Road, Lahore possessed manufacturing and testing facilities for product namely

Synthroid 25mcg, 50mcg, 75mcg, 100mcg and 125mcg.

Recommendation: The panel of inspectors recommends the grant above mentioned

product to be manufactured from M/s Highnoon Laboratories 17.5km, Multan Road,

Lahore subject to fulfillment of other codal formalities.


247

b. Change of contract manufacturer - M/s Novartis Pharma (Pakistan) Ltd, Karachi.

M/s Novartis Pharma (Pakistan) Ltd, Karachi has requested for change of contract

manufacturer for following registered drugs from M/s Macter International (Pvt.) Ltd., E-40,

S.I.T.E., Karachi to M/s CSH Pharmaceuticals, 32 KM, Ferozepur Road, Lahore. Firm has

deposited requisite fee @ Rs.50000/- for each product for the purpose.

S. No. Reg. No. Name of Drug(s)

1 007682 Ospamox 250mg Capsule

Amoxycillin (as Trihydrate)

2 007684 Ospamox 500mg Tablets


3 007688 Ospamox 125mg/5ml Dry Suspension


4 007689 Ospamox 250mg/5ml Dry Suspension


5 007686 Ospamox 1000mg Tablet


Above contract manufacturing permissions are valid till 30.06.2015. Provided registration

dossiers were scrutinized by In-charge, Pharmaceutical Evaluation Cell and shortcomings were

communicated to the firm which has now been rectified by the firm.

c. Registration of Drugs under Contract Manufacturing arrangements – M/s Genix

Pharma, Karachi.

M/s Genix Pharma, Karachi have applied for registration of drug under contract

manufacturing arrangement from M/s Nabiqasim Industries, Karachi. Details are as under:-

S.

No.

Name and

address of

Applicant /

manufacturer


Pack

Proposed

MRP

Date of

application,

Diary No. &

Form

1. M/s Genix

Pharma,

Karachi

contract

manufactured by M/s

Nabiqasim

Industries,

Karahci

Xime Capsule 200mg


Cefixime USP …….200mg

5’s Rs.400.00 16-05-2009

Form-5

Rs.8000/-

Rs.42,000/-

20-05-2013

248

2. -do- Xime Capsule 400mg



5’s Rs.600.00 16-05-2009

Form-5

Rs.8000/-

Rs.42,000/-

20-05-2013

3. -do- Xime Dry Suspension 100mg / 5ml

Each 5ml contains:-


30ml Rs.400.00 16-05-2009

Form-5

Rs.8000/-

Rs.42,000/-

20-05-2013

4. -do- Xime Dry Suspension 200mg / 5ml

Each 5ml contains:-


30ml Rs.600.00 16-05-2009

Form-5

Rs.8000/-

Rs.42,000/-

20-05-2013

Registration dossiers were scrutinized by In-charge, Pharmaceutical Evaluation Cell and

shortcomings were communicated to the firm which has now been rectified.


Case No.12: Transfer of registrations from import to local manufacturing – M/s The

Searle Company, Karachi

M/s The Searle Company, Karachi applied for transfer of registration of products namely

Tramal 100 Injection, Reg. No.010172 and Tramal SR 100mg Tablet, Reg. Nos. 023317 from

import (Searle Pakistan, Shahra-e-Faisal, Karachi) to their own manufacturing. Cost & Pricing

Division was requested for opinion whether such cases be considered at same MRP or otherwise

and concerned Division directed to continue same practice (same terms & conditions). Case was

placed in 246th

meeting of Registration Board, who decided to cancel products from previous

importer and register in name of M/s The Searle Company, Karachi.

In the same 246th

meeting Registration Board, about 110 products were considered for

cancellation of registration from previous registration holder and registration in name of new

applicants. The Board principally approved these requests. However the Board decided to sent a

reference to Cost & Pricing Division for taking their opinion whether such cases may be

249

considered at same MRP or otherwise. Cost & Pricing Division decided to place the case before

Drug Pricing Committee for harmonized decision.

Case is placed before Registration Board.

Case No. 13 Deferred drugs

a. Registration of Tobacin (Tobramycin) Capsule – M/s Hiranis Pharmaceuticals,

Karachi


meeting deferred following drug of M/s Hiranis

Pharmaceuticals, Karachi for expert opinion.

Name of Drug & Composition Proposed

Pack

Demanded MRP

Tobacin Capsule


Tobramycin USP 28 mg

(Aminoglycoside)

Finished product specifications are

Manufacturer.

1’s

15’s

Rs.150.00

Rs.2250.00

Scrutinization of record showed that above formulation is already approved in 243rd

meeting of Registration Board in favour of M/s. Novartis Pharma (Pakistan) Limited, Karachi

for import basis from M/s. Novartis Pharmaceutical, USA, under brand name Tobi Podhaler

28mg Hard Capsules.


b. Registration of drugs – Colotab MR Capsule 200mg and Cyclorest ER Capsule

15mg & 30mg


meeting deferred following drugs of M/s Martin Dow

Pharmaceuticals, Karachi for reason mentioned in last column.

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

Decision

250

& Form

Colotab MR 200mg

Capsule

Each modified release

capsule contains:

Mebeverine HCl …200 mg

(Antispasmodic)

10’s

20’s

30’s

Rs.250/-

Rs.500/-

Rs.750/-

26-01-2012

Dy.No.495

Rs.15000/-

Form-5 D

Submission

of fee for

pellets,

valid GMP

certificate,

Stability

data and

COA.

Cyclorest ER 15mg

Capsule


Cyclobenzaprine

hydrochloride as extended

release pellets……..15 mg

(Muscle relaxant)

10’s

20’s

30’s

Rs.215.43/-

Rs.430.86/-

Rs.646.29/-

18-04-2012

Dy.No.744

Rs.15000/-

Form-5D

Submission

of

comparative

dissolution

profile with

originator

brand,

related

documents

and

provision of

GMP,

Stability

data, COA

and fee for

pellets

Cyclorest ER 30mg

Capsule


Cyclobenzaprine

hydrochloride as extended

release pellets……..30 mg

(Muscle relaxant)

10’s

20’s

30’s

Rs.358.43/-

Rs.716.86/-

Rs.1075.84/

-

19-04-2012

Dy.No.745

Rs.15000/-

Form-5D

Submission

of

comparative

dissolution

profile with

originator

brand,

related

documents

and

provision of

GMP,

Stability

data, COA

and fee for

pellets

251

Now firm has submitted the following information for above products:-

i) Balance fee @ Rs.85,000/- for Cyclotab Capsule and Rs.170,000/- for Cyclorest

ER 15mg & 30mg Capsule for the purpose.

ii) Comparative Dissolution Profile

iii) COA of Mebeverine HCl Pellets

iv) Stability study (Accelerated & Real Time of Mebeverine HCl Pellets.

v) GPM Certificate of M/s RA Chem Pharma Limited, Plot No.A-19/C, Road No.18,

IDA, Nacharam, Hyderabad, Andhra Pradesh duly attested by Embassy

c. M/s Opal Labs, Karachi

Registration Board in its 242nd

meeting deferred following drug of M/s Opal

Laboratories, Karachi confirmation of manufacturing facility of controlled drugs.

S. No. Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

1 Oplamanic-Cold & Flu Syrup

Each 5 ml contains

Chlorphenamine

Maleate BP …….1 mg

Pseudoephedrine

HCL USP …….15 mg

(Antihistamine Nasal

decongestant)

120ml As per PRC 27-07-10

Rs 8000/-

22-05-13

Rs. 60,000/-

2. Oplamanic-Cough Syrup

Each 5 ml contains

Dextromethorphan

Hydrobromide BP……10 mg

Pseudoephedrine

HCL USP ………….30 mg

(Antihistamine Nasal

decongestant)

120ml As per PRC 27-07-10

Rs 8000/-

22-05-13

Rs. 60,000/-

It is submitted that the requirement of segregated manufacturing facility for

controlled drugs i.e. Psychotropic and Narcotics while Pseudoephedrine is precursor.

252

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


meeting deferred following products of M/s S.J. & G Fazul

Ellahie (Pvt.) Ltd, Karachi for reason mentioned in last column.

Name of Drug & Composition Pack Demand

ed MRP

Date of

application,

Diary No. &

Form

Decision

D-Lanso Capsule 30mg


Dex-lansoprazole as enteric coated

pellets MS) ……….……..30mg

(Anti Ulcerant)

14’s

30’s

Rs.1500.00

Rs.3200.00

24-12-2009

2556

Form-5D

Rs.15000/-

17-11-2014

Rs.5000/-

Deferred for

expert opinion

D-Lanso Capsule 60mg


Dexlansoprazole as enteric coated

Pellets MS) ………….60mg

(Anti Ulcerant)

14’s

30’s

Rs.2500.00

Rs.5350.00

24-12-2009

2557

Form-5D

Rs.15000/-

17-11-2014

Rs.5000/-

29-01-2015

Rs.30,000/-

Deferred for

expert opinion

Registration Board in 245th

meeting discussed same formulation and agreed to expert

opinions and advised the firms to provide data for stability studies conducted under zone IV-A

conditions as per ICH / WHO guidelines for consideration of Registration Board.

M/s S.J. & G Fazul Ellahie (Pvt.) Ltd, Karachi has deposited remaining fee (Rs.5000/- +

30,000/) for each product and requested to consider their above formulations.

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


meeting held on 05-06 January, 2009 deferred following

products of M/s S.J. & G Fazul Ellahie (Pvt.) Ltd, Karachi for reason mentioned in last column.

Name of Drug & Composition Pack Demand

ed MRP

Date of

application,

Diary No. &

Form

Decision

253

Daricin Tablets 7.5mg

Each extended release tablet contains:-

Darifenacin Hydrobromide M.S

equivalent to

Darifenacin ………………...7.5mg

(Muscarinic receptor antagonist)

3 x10

’s

Rs.2750.00 24-10-2008

1524

Form-5-D

Rs.15,000/-

Deferred for

expert opinion

& decision will

be finalized

after expert

opinion in

North section.

Daricin Tablets 15mg

Each extended release tablet contains:-

Darifenacin Hydrobromide M.S

equivalent to

Darifenacin ……………….15mg


3x10’s Rs.5500.00 24-10-2008

1517

Form-5-D

Rs.15,000/-

-do-

M/s S.J. & G Fazul Ellahie (Pvt.) Ltd, Karachi has stated that they have also deposited

enhanced fee (Rs.35,000/-) for each product and stated that Price Advisory Committee in the

15th

meeting held on 12-04-2011 has already fixed MRP and requested to consider their above

formulations.

f. M/s Reign Pharmaceuticals PCSIR KLC, Karachi

Registration Board in 243rd

meeting had approved following registrations in favour of

M/s Reign Pharmaceuticals PCSIR KLC, Karachi. But registration letter could not be issued due

to non provision of pellets source.

S. No. Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

1 Omzol 40mg Capsule


Omeprazole……..40 mg

(Proton pump inhibitor)

As per

PRC

As per PRC 21-05-2013

Dy.No.532

Form-5

Rs.20,000/-

2 Omzol 20mg Capsule


Omeprazole……..20 mg

(Proton pump inhibitor)

As per

PRC

As per PRC 21-05-2013

Dy.No.530

Form-5

Rs.20,000/-

254

Now the firm has stated that they will purchase Omeprazole Pellets from M/s Vision

Pharmaceuticals, Islamabad.


Case No.14: Correction in Minutes.

a) M/s Bosch Pharmaceutical, Karachi


meeting approved registration in favour of M/s Bosch

Pharma, Karachi. Accordingly registration was issued. Now firm has pointed out that at the time

of submission of registration applications they have applied Dispersible Tablet but due to

typographical mistake in agenda and minutes the word “Dispersible” was not mentioned.

Existing and correct formulation are as under:-

Name of drug(s) & Composition Reg. No. Correct Composition

Zisul 20mg Tablet


Zinc Sulphate monohydrate eq. to

Elemental Zinc……….....20 mg

(Manufacturer’s Specification)

076558 Zisul 20mg Tablet

Each dispersible tablet contains:


Elemental Zinc……….....20 mg


Zisul 10mg Tablet



Elemental Zinc……..…...10 mg


076562 Zisul 10mg Tablet

Each dispersible tablet contains:


Elemental Zinc……..…...10 mg


It is submitted that Incharge, Pharmaceutical Evaluation Cell has confirmed that claim of

firm is correct as per registration application.

b) M/s High-Q Pharmaceutical, Karachi


meeting approved request for extension in toll

manufacturing permission to M/s High-Q Pharmaceuticals, Karachi for 17 drugs. Accordingly

extension letter was issued. Now firm has pointed out that contract manufacturer for following

drugs is M/s Novamed Pharmaceuticals, Lahore instead of M/s Medicaids Pakistan, Karachi as

recorded in agenda and minutes. Statement of M/s High-Q is correct as M/s Novamed, Lahore

255

was changed as contract manufacturer vide letter No.F.11-19/2006-Reg.II (N). Existing and

correct formulation are as under:-

Name of drug(s) &

Composition

Reg.

No.

Existing Contract

Manufacturer

Correct Contract

Manufacturer

Dayline 250mg I.M Injection

Each vial contains:

Ceftriaxone as Sodium...250 mg

061180 M/s Medicaids Pakistan,

Karachi M/s Novamed

Pharmaceuticals, Lahore

Dayline 500mg I.M Injection

Each vial contains:

Ceftriaxone as Sodium..500 mg

061181 -do- -do-

Dayline 1g I.V Injection

Each vial contains:

Ceftriaxone as Sodium…..1gm

061182 -do- -do-

Case No.15: Registration of Drugs – M/s Macquin’s International, Karachi.


meeting approved following registration applications

of M/s Macquin’s International, Karachi subject to inspection by Prof. Ghulam Sarwar, Dr. Ali

Akbar Sial & DDG (E&M), DRAP, Karachi.


Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Decision

Mafox Tablet


Levofloxacin ……………..250mg

(Broad spectrum antibiotic)

10’s Rs.110.00 26-12-2009

2592

Form-5

Rs.8000/-

Approved

subject to

inspection by

Prof. Ghulam

Sarwar, Dr. Ali

Akbar Sial &

DDG Karachi

Mafox Tablet


Levofloxacin ……………..500mg

(Broad spectrum antibiotic)

10’s Rs.180.00 26-12-2009

2595

Form-5

Rs.8000/-

-do-

Rosiquin Tablet


200’s Rs.150.00 26-12-2009

2594

-do-

256

Chloroquine …………….…250mg

(Anti malarial)

Form-5

Rs.8000/-

Rosiquin Syrup

Each 5ml contains:-

Chloroquine …………….…50mg

(Anti malarial)

60ml Rs.25.00 26-12-2009

2591

Form-5

Rs.8000/-

-do-

Moxidex Eye Drops


Dexamethasone ………0.1gm

Moxifloxacin ………….0.5gm

(Antibiotics)

5ml Rs.95.00 26-12-2009

2590

Form-5

Rs.8000/-

-do-

Virabin Capsule


Ribavirin ………………..400mg

(Antiviral)

10’s Rs.300.00 26-12-2009

2593

Form-5

Rs.8000/-

-do-

Antimal Plus Tablet 80/480mg

Tablet


Artemether ………………80mg

Lumifantrine ……………480mg

(Anti malarial)

8’s Rs.500.00 31-12-2009

2596

Form-5

Rs.8000/-

-do-

Now firm has furnished Inspection report dated 15th

& 24th

December, 2014 conducted for

Renewal of DML by panel comprising Dr. Muid Ahmed, Member Central Licensing Board, Mr.

Muneeza Khan, Area FID, Mr. Abdul Rasool, FID-II and Mrs. Ume-Laila, Area ADC. Firm has

requested for issuance of registration letter.

Case No.16: De-Registration of registered drugs.

a) Tabros Pharma, Karachi

M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs.

Details are as under:-

S.

No.

Name of

applicant(s)

Reg. No. Name of drug(s) Reason /

Justification

1. M/s Tabros Phrma,

Karachi

014347 Rumolon Dispersible Tablet 10mg


Piroxicam ………10mg

Due to some

unavoidable

circumstances

257

and

unfeasibility

in the market

2. -do- 014781 Rumolon Dispersible Tablet 20mg


Piroxicam ………120mg

-do-

b) M/s Johnson & Johnson Pakistan (Pvt.) Ltd, Karachi

M/s Johnson & Johnson Pakistan (Pvt.) Ltd, Karachi has requested for

de-registration of Ethicon Sutures i.e Catgut and Slik, Reg. No.001678 due beyond control of a

manufacturer, of a drug which may lead to reduction in the production.

Licensing Division has also informed that application of M/s Johnson & Johnson

Pakistan (Pvt.) Ltd, Karachi for discontinuation of Ethicon Sutures of local production is under

process and firm has also applied for de-registration of suture produced locally.

Case No.17 Extension in permission for import in finished form for a further period of

two years.

The Registration Board in its 193rd

meeting M/s Otsuka Pakistan Ltd, Baluchistan was

granted registration of following drugs for bulk import from M/s Otsuka Pharmaceutical Co.,

Ltd, Kandu Tsukasa-cho, Chiyoda-ku, Tokyo, 1018535, Japan and then local repacking at M/s

Efroze Chemical Industries, Karachi for a period of 02 years w.e.f 26th

October, 2005. Further

extensions were granted in said permission in different meetings and last permission was granted

on 16th

February, 2010 in 222nd

meeting of Registration Board with the condition that no further

extension will be granted and firm should develop facility for local manufacturing of these drugs

during this period.

S. No. Reg. No. Name of drug(s)

1 029294 Pletaal 50mg Tablet

(Cilostazol)

2 029295 Pletaal 100mg Tablet

(Cilostazol)

258

Later on M/s Otsuka Pakistan Ltd, Baluchistan has submitted that they have initiated the

arrangements for local manufacturing at M/s Efroze Chemical, Karachi and for this Otsuka,

Japan made Technical transfer to Efroze Chemical. The training of the Technical staff from QC

& Production was imparted at Otsuka Japan. This was followed by Technical transfer of

manufacturing and validation batches were prepared. But due to unfortunate incident at Efroze,

all these work has been halted and wasted and it would required all to be re-done that will take at

least 18 months after all issue are resolved and after M/s Efroze facility is re-approved by Otsuka

Japan.

The Registration Board in its 236th

meeting was considered above situation and firm was

granted permission for import in finished form of above mentioned drugs from M/s Otsuka

Pharmaceutical Co., Ltd, Kandu Tsukasa-cho, Chiyoda-ku, Tokyo, 1018535, Japan for period of

18 months.

Now M/s Otsuka Pakistan has informed that their Principal Company M/s Otsuka

Pharmaceuticals Co. Ltd, Japan is not agreed yet for local contract manufacturing in M/s Efroze

or elsewhere due to proper resolution of quality assurance matters. Thus the subsequent technical

transfer to the new proposed local manufacturing site is yet to be followed as they have planned

for local manufacturing at Otsuka Pakistan site. The matter is under study with Otsuka Japan as

the feasibility of this project is very weak. They are trying to convince them for approving this

investment for local manufacturing at their site.

Due to above situation M/s Otsuka Pakistan has requested that permission for import in

finished form of above mentioned drugs may be extended for a further period of two years. To

support their request they have furnished following documents:-

1. Copy of last permission

2. Fee @ Rs.100,000/- for each product for the purpose

3. Form 5-B for each product

4. Copy of initial registration letter

5. Copy of last renewal (extension in import in bulk & local repacking)

259

Case No.18: Change in manufacturing process.

M/s Sami Pharmaceuticals, Karachi has submitted that their following registered drugs

are being produced through filling from imported lyophilized powder into vials under aseptic

conditions:-

S. No. Reg. No. Name of drug(s) & Composition

1 057830 TEpH Infusion

Each vial contains:-

Omeprazole as Sodium ……...40 mg

(Manufacturer’s Specifications)

2 057831 NovoTEpH Infusion


Esomeprazole as Sodium …….40 mg


3 057832 Neege 40mg Injection


Pantoprazole as Sodium

Sesqui hydrate ……………….40 mg


Now firm has stated that they have developed in-house unit lyophilization facility which

has been approved by the Central Licensing Board. Firm has requested for change of

manufacturing process of above mentioned products in their approved freeze dried products

(General). Firm has also deposited fee @ Rs.5000/- for each product for the purpose.

Firm submitted revised Form-5 which was scrutinized by In-charge, Pharmaceutical

Evaluation Cell and shortcomings have been rectified by the firm.

Case No.19: Manufacturing of drug at own premesis.

M/s Getz Pharma, Karachi has requested for transfer of following drug from contract

manufacturing to in-house manufacturing at their own facility i. M/s Getz Pharma (Pvt.) Ltd, 29-

30, Sector -27, Korangi Industrial Area Karachi instead of contract manufacturing from M/s

Spencer Pharma, Karachi.

260

Reg. No. Name of product(s)

023366 Pantra 100mg Ampoule

Each 2ml contains:-

Tramadol HCl ……….100mg

Firm has submitted following documents to support their request.

Copy of registration letter

Copy of contract manufacturing permission letter

Renewal Status

Fee Rs.20,000/- for the purpose

Firm submitted Form-5 which was scrutinized by In-charge, Pharmaceutical Evaluation

Cell and shortcomings have been rectified by the firm.

Case No.20: Combo pack – Osmolar ORS (Reg. No.0454416) with Zincat-OD Syrup (Reg.

No.053094) – M/s Atco Laboratories, Karachi

M/s Atco Laboratories Ltd, Karachi has stated that they intend to pack two already

registered drugs in one Combo pack as per following details:-

S.

No.

Reg. No. Name of drug(s) & Composition Quantity in

Combo Pack

1. 045416

Osmolar ORS


Sodium Chloride BP ……….1.3g

Potassium Chloride BP …….0.75g

Sodium Citrate BP …………1.45g

Glucose Anhydrous ………. 6.75g

Two sachets

2. 053094 Zincat – OD Syrup

Each 5ml contains:-

Elemental Zinc (as Zinc Sulphate

Monohydrate USP) ……………….20mg

One pack of 60ml

Firm has submitted following justifications to support their request:-

261

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. copy of registration letter with last renewals

ii. two copies of proposed art work of combo pack duly singed by QC & Production

inchange

iii. Packaging specifications of combo pack

iv. Reference, indicting that the prescribing information is in line with information

approved by the international regulatory authority.

v. copy of valid DML, NOC for CRF

vi. Undertaking

vii. Variation fee of Rs.5000/- for the purpose.

Case No.21: Change of Flavour – Flagyl Suspension, Reg. No.001214 – M/s Sanofi Aventis

Pakistan Ltd, Karachi.

M/s Sanofi Aventis Pakistan Ltd, Karachi have requested for change of flavour from

Lemon to Strawberry in their already registered drug i.e Flagyl Suspension, Reg. No.001214 in

order to improve patient’s palatability which would ultimately enhance patient compliance. They

have further stated that change in flavour will not affect the quality, safety and efficacy of the

product. Firm has provided following documents in support of their application:

06 months accelerated stability data

Undertaking

Specification & control method

Registration letter valid DML & NOC for CRF

Fee @ Rs.5000/-

262

Case No.22: Change in formulation – Progrel AP 75mg Tablet, Reg. No.057936 – M/s

Tabros Pharma, Karachi.

M/s Tabros Pharma, Karachi have requested for change in formulation of their already

registered drug Progrel AP 75mg Tablet, Reg. No.057936 as per following details:-

Existing formulation Proposed formulation

Each film coated tablet contains:-

Clopidogrel as Bisulphate …….75mg

Aspirin Enteric Coated Granules

eq. to Aspirin …………………75mg

Each covered tablet contains:-

Inner Enteric Coated Tablet contains:-

Aspirin ……………….……75mg

Outer (Cover) Tablet Contains:-

Clopidogrel Bisulphate eq. to

Clopidogrel………………..…….75mg

Aspirin Enteric Coated Granules

eq. to Aspirin …………………75mg

Firm has provided following documents in support of their application:

Registration letter

Validation in process report of 03 trial batches

Validation of equipment & Manufacturing process

Finished good specification

Testing Method

Fee @Rs.5000/-

Case No.23: Investigation of M/S Meezab International, Karachi

Following products of M/s Meezab International, Karachi were initially registered

for import and then permitted for local contract manufacturing. Registration Board in 238th

meeting considered case for extension in contract manufacturing of these products (import to

local contract) and deferred for submission of data about grant of registration, transfer to contract

manufacturing, subsequent renewal and copy of DSL. Later on, the firm provided documents and

the Board in 241st meeting extended contract manufacturing permission of following products till

30.06.2015 and contract manufactured by M/s Farmaceutics International, Karachi. As per DSL

No.450 dated 24.12.2013, address of M/s Meezab International is F1-A/3-A, SITE, Karachi and

proprietor is Muhammad Anees S/O Muhammad Usman.

263

S. No. Reg. No. Name of drug(s) & Composition

1. 021906 Diclovat 75mg Injection

Each 3ml contains:

Diclofenac Sodium…………….75mg

2. 015730 Labentrol 250mg Tablet


Ciprofloxacin HCl eq. to Ciprofloxacin…250 mg

3. 021907 Diclovat 50mg Tablet


Diclofenac sodium …………..50 mg

4. 014638 Lomadryl 150mg Tablet


Ranitidine HCl eq. to Ranitidine…….150 mg

5. 021905 Alenstran 10mg Tablet


Cetirizine dihydrochloride…………..10mg

6. 021908 Tradolint 100mg Injection


Tramadol HCl………………..100 mg

7. 021904 Lomadryl 50mg Injection


Ranitidine HCl eq. to Ranitidine…………50 mg



Ciprofloxacin HCl eq. to Ciprofloxacin…..500 mg

9. 014675 Molelant 1gm Injection

Each vial contains:

Cefotaxime Sodium eq. to Cefotaxime………1 gm

10. 021903 Molelant 250mg Injection

Each vial contains:

Cefotaxime Sodium eq. to Cefotaxime………250mg



Ciprofloxacin HCl eq. to Ciprofloxacin……750mg

12. 014639 Alenbit 400mg Tablet


Norfloxacin ……………………….….400 mg

13. 023694 Katinol 250mg Capsule


Cefaclor………………………………250 mg

14. 014677 Molelant 500mg Injection

Each vial contains:

Cefotaxime Sodium eq. to Cefotaxime………500mg

15. 021909 Tradolint 50mg Capsule


264

Tramadol HCl…………………….…50 mg

16. 014637 Lamadryl 300mg Tablet


Ranitidine HCl……………………...300mg

17. 021902 Suprin Suspension

Each 5ml contains:

Cefixime…………………………….100 mg

18. 021901 Bifin 10mg Injection

Each vial contains:

Nalbuphine HCl……………………..…10 mg

Later on, Mr. Mukhtiar Ahmad, Assistant General Manager of M/s Meezab International,

Karachi has sent a reference along with a set of documents (advertisement in news papers,

memorandum of agreement of business acquisition, copy of Drug sale License) stating and

claiming that Mr. Rajesh is owner of the business. As per Drug sale License No.650 dated

17.03.2014; Mr. Rajesh is proprietor of the firm and address is Office No.8, 5th

floor, Namco

centre, Campbel Street, near city court, Karachi.


meeting considered request of Mr. Mukhtiar Ahmad and

after detail consideration / discussion constituted a committee comprising of DDG (E&M),

DRAP, Karachi and Chief Drugs Inspector, Sindh to investigate the matter in detail (for

determining proprietor of the M/s Meezab International and address). The committee has been

advised twicely to investigate the matter and submit report in 30 days but still no report is

received.

Submitted for further directions of Registration Board.

265

Registration-III

Case No. 24:


meeting deferred the drugs of M/s.Wenovo Pharmaceuticals,

Taxil due to following reasons:

1. M/s

Wenovo

Pharma

ceuticals

Taxila.

Tablet

Genera

Capsule

Gen.

Lansodex 30mg Capsules


Dexlansoprazole…30mg

Source: Dexlansoprazole

delayed-release pellets

17% w/w of Vision

Pharmaceuticals

Islamabad

(Proton Pump Inhibitor)

Manufacturer specs

As per

SRO/Pack

of 2x7’s

Form 5

New

License

Dy No 233

dated 13-02-

2014

13-02-2014

20,000/-

DEXILA

NT

(dexlans

oprazole

)

capsule,

delayed

release

(Takeda

Pharmac

euticals

America,

Inc)

Not

provided.

Deferred

till expert

opinion

and Form

5D, fee

2. -do- Lansodex 60mg Capsules


Dexlansoprazole

….60mgSource:

Dexlansoprazole delayed-

release pellets 17% w/w

of Vision Pharmaceuticals

Islamabad

PPI, Manufacturer’s specs

As per

SRO/Pack

of 2x7’s

Form 5

New

License

Dy No 234

dated 13-02-

2014

13-02-2014

20,000/-

Dexilant

(dexlans

oprazole

)

capsule,

delayed

release

(Takeda

Pharmac

euticals

America,

Inc)

Not

provided

Deferred

till expert

opinion

and Form

5D, fee


meeting approved the same molecule and strength for various

firms. Now the firm has requested for registration of above mentioned drugs.


266

Case No.25:


& 246th

meeting deferred the following drugs of M/s. Caraway

Pharmaceuticals, Rawat due to following reasons:

1. -do- ONDENLES

Tablet 8mg


contains:

Ondansetron hydrochloride

dihydrate

≡ Ondansetron…8mg

5HT-3 Antagonist

USP

Form-5

Dy. No:

9774

dated

18th

October

2010

20,000/-

As per

SRO

Zofran of

GSK

Zofran of

GSK,

Karachi

Latest

inspectio

n

report is

required.

Deferred

for

latest

GMP

status of

the firm.

M-246

2. M/s

Caraway

Pharmace

uticals,

Plot No

12,Street

No

3,National

Industrial

Zone,

Rawat,

Islamabad

1.AVIMER 800mg Tablets

2.Oral

3.Each film coated tablet

contains Sevelamer

Carbonate (anhydrous)

800mg

4.Phosphate binder

1.Form 5

2.Fast

Track

3.As per

SRO Pack

of 30’s

4.5802

dated

10/09/13

5.10/09/2

013

Rs.60,000

/-

1.Manufactu

rer’s 2.Me

too (Renavel

of Genome)

3. Firm was

inspected on

24-09-2012

by the area

FID and

considered

to be GMP

compliant

Deferred

for

confirmat

ion of me

too status

regarding

salt form

of API,

Me-too

status

M-242

& M-244

3. –

d

o

-

-do-

1.Steril Tablets

2.Oral

3.Each tablet contains Alpha

keto Methionine analogue to

(calcium salt)59mg,

Alpha keto analogue to

Phenylalanine

(calcium salt) 68mg,

Alphaketo analogue to

Isoleucine

(calciumsalt)67mg,


Leucine(calcium salt)101mg,


valine (calcium salt)86 mg,

1.Form 5

2.Fast

Track

3.As per

SRO

Blister of

10’s

4.5801dat

ed

10/09/13

5.10/09/2

013

Rs.60,000

/-

1.Manufactu

rer’s 2.Me

too (

Ketosteril of

Medipak) 3.

Inspection

report of 24-

09-2012 is

submitted.

Firm was

inspected on

24-09-2012

by the area

FID and

considered

Deferred

for

product

specific

inspectio

n for

confirmat

ion of

manufact

uring and

testing

facility

by

Director

DTL

267

L-lycine aceate 105 mg,

L-threinone 53mg,

L-tryptophan 23mg,

L-histidine 38mg,

L-tyrosine 30mg,

Total nitrogen content per tab

36mg,calcium per tablet

0.05gm 4.Amino acids

to be GMP

compliant

Peshawar

, DDG

DRAP

and FID.

Item at S.No.I was deferred due to non-availability of GMP report. Item No.2Sevelamer

Carbonate (anhydrous) 800 mg had been registered under the name of Sevela 800 mg of M/s.

Hilton Pharma, and Plasev 800 mg Tablets of M/s. Platinium Pharma, Karachi. The item at

S.No.3 was deferred in 242nd


& 25th

February, 2014 for product specific

inspection by the panel constituted by Drug Registration Board i.e Director DTL Peshawar,

DDG DRAP and FID. Meanwhile, the panel of CLB comprising Prof. Dr. Gul Majeed Khan,

Ch. Zeeshan Nazir, FID and Mr. Muhammad Ansar, ADC, Islamabad inspected the Unit M/s.

Caraway Pharmaceutical, Rawat on 26.12.2014 and recommended renewal of Drug

Manufacturing License in view of GMP compliance and good rating (Ref: Central Licensing

Board meeting No.239).

Submitted for consideration of the Registration Board.

Case No.26:


meeting approved the following drugs of M/s. Herbion

Pakistan Ltd, Islamabad:-

1 Evoflox 250mg Tablets


contains:-

Levofloxacin hemihydrate USP

eq. to Levofloxacin… 250 mg

(quinolone/ antibiotics)

Rs.230.00/10’s Approved

2 Evoflox 500mg Tablets Rs.230.00/10’s Approved

268


contains:-

Levofloxacin hemihydrate USP

eq. to Levofloxacin … 500 mg

(quinolone/ antibiotics)

The firm informed that they applied for the price of Rs.400.00/10’s for Tablet of 500mg

Levofloxacin (as hemihydrate) but it was inadvertently mentioned as Rs.230/10’s in agenda and

minute-243 of DRB meeting. The case was referred to Evaluation Cell for confirmation of

price from the original dossier. The incharge Evaluation Cell has confirmed that the firm

correctly applied for price as Rs.400/10’sof Tablet of 500mg Levofloxacin (as hemihydrate).


Case No.27:

Instant case relates to the similarity of brand name and efficacy of Beflam Tablet Reg.

No.031123 manufactured by M/s. Batala Pharmaceuticals, Gujranwala. In this regard letters

were issued to M/s. Batala Pharmaceuticals for providing alternate names to rectify the

complaint of Dr. Syed Muhammad Ali Shah which was addressed to the Honourable Minister for

Health. Reply of Batala Pharmaceuticals dated 15-12-2014 reference nil was received on 19-1-

2015. Meanwhile, M/s. Batala Pharmaceuticals registered a case in the Honourable Court of Mr.

Muhammad Inamullah Civil Judge 1st Class Magistrate Section-30, Islamabad (West) and the

summons were received on 20-1-2015 at about 11.30 to 12.00 PM. I attended the Court on

behalf of respondents of DRAP on 20-1-2015 and 27-1-2015. The Honourable Judge granted

extension up to 23-02-2015 for submission of parawise comments.


269

Case No.28:


committee meeting deferred the following drugs reason

mentioned against each:-

1. M/s Wel

Wink

Pharmaceuti

cals

Gujranwala

Winkmycin 500 mg Injection


Azithromycin Dihydrate

≡ Azithromycin…. 500mg

(Macrolide Antibiotics)

1’s As

Per

SRO

25-02-2013

Dy.No.1200

Fee.

Rs.20,000

Deferred for

clarification

whether

Lyophilizati

on

procedure is

mandatory

required for

such

formulation

or not.

2. -do- Clari-Wink 500 mg Injection


Clarithromycin … 500mg

(Treat Chest Infections)

1’s As

Per

SRO

25-02-2013

Dy.No.1199

Fee.

Rs.20,000

-do-

3. -do- Lansokk 30 mg Injection


Lansoprazole ………30mg

(Proton Pump Inhibitor)

1’s As

Per

SRO

25-02-2013

Dy.No.1193

Fee.

Rs.20,000

-do-

It is the general practice for the similar products that firms import lyophilized dried powder

(active pharmaceutical ingredient) and refills the vials in Pakistan in similar manner and are not

liable to claim the terms of Lyophilization for such products.


270

Registration-IV

Case No.29:



& 16th

June, 2010 deferred the following

dossiers of registration of M/s Saaaf Pharmaceuticals, Risalpur for manufacturing on basis of toll

till the finalization of contract policy:-

1. Saafbactum Injection 1gm


Cefoperazone Sodium

≡ Cefoperazone.... 500 mg

Sulbactam Sodium

≡ Sulbactam……. 500 mg

(Cephalosporin)

Per

vial

As Per

SRO

Deferred till the

finalization of

contract policy

2. Saafbactum Injection 2gm


Cefoperazone Sodium

≡ Cefoperazone…… 1 g

Sulbactam Sodium

≡ Sulbactam………… 1 g

(Cephalosporin)

Per

vial

As Per

SRO

-do-

Now the toll manufacturing policy has been finalized and the management of the firm has

deposited the fee of Rs.50,000/each and requested to change the manufacturer from

M/s.Medicraft Pharmaceuticals Peshawar to M/s.Astellas Pharmaceuticals, Peshawar and also to

change the brand name of products. The dossiers have been evaluated with the collaboration of

Incharge Evaluation Cell as per check list.


Case No.30

The Drug Registration Board in its 239th

meeting held on 12-09-2013 deferred the following

products of M/s. Saaaf Pharmaceuticals, Risalpur for product specific inspection by Director

DTL, DDG (E&M) and ADC, Peshawar.

S.N

o

Name of

manufacturer Name of drugs (s)

Pack

size

Demande

d MRP

Decision

271

1. M/s. Saaaf

Pharmaceuticals

, Risalpur

Varisaf Tablets


Mebeverine HCl… 200 mg

(Antispasmodic)

3x10’s As Per

SRO

Deferred for Product

Specification

Inspection. & GMP

229th

Meeting

22.1.2011. Fee paid,

confirmation of

formulation. 237th

26.02.2013

2. -do- XL Tablets


contains:-

Linezolid……. 600 mg

(Antibiotic)

10’s As Per

SRO

Deferred for P.S.I &

GMP 229th

Meeting

22.1.2011.

Fee paid, confirmation

of formulation. 237th

26.02.2013

3. -do-

XL Dry Powder Suspension

Each 5 ml contains:-

Linezolid ……. 100 mg

(Antibiotic)

60 ml As Per

SRO

Deferred for P.S.I &

GMP 229th

Meeting

22.1.2011.

Fee paid, confirmation

of formulation. 237th

26.02.2013

Now the panel comprising Dr. Khalid Khan Director DTL Peshawar and FID Peshawar

inspected the unit on 29.11.2014 and recommended the registration of above mentioned

products.


Case No.31

M/s. Cirin Pharmaceuticals, Hattar has requested for registration of Sovir Tablets 400mg for the

purpose of export only:-

The firm submitted all the relevant documents alongwith the fee of Rs.20000/- and requested for

registration of drug for export purpose only.


1.

Sovir Tablets 400mg

Each film coated

tablet contains:-

Sofosbuvir…..400mg

Original Export

Order annexed.

272

Case No.32

M/s. Genome Pharmaceuticals, Hattar has requested for registration of Dapox Tablets 60mg

for the purpose of export only:-

The firm submitted all the relevant documents alongwith the fee of Rs.20000/- and requested

for registration of drug for export purpose only.


Case No.33


meeting deferred the following drugs of M/s. Medicraft

Pharmaceuticals, Peshawar due to reasons mentioned below:

1. Epimed 75 mg Capsules


Pregabalin……75 mg

(Gaba Analogue)

10’s As Per

SRO

1-6-2010 Deferred till

decision of

committee

constituted for the

purpose

2. Epimed 100 mg

Capsules


Pregabalin.… 100 mg

(Gaba Analogue)

10’s As Per

SRO

-do- Deferred till

decision of

committee

constituted for the

purpose

Now the policy of Pregabalin preparation has been finalized and the firm’s request is placed

before the Registration Board for consideration. Dossiers have been evaluated accordingly.


1. Dapox 60 mg Tablets


contains:-

Dapoxetine HCl

≡ Dapoxetine………….60 mg

Original Export

Order annexed.

273

Case No.34


meeting deferred the drug of M/s. Genome Pharmaceuticals,

Hattar for the following reasons:

1. M/s. Genome

Pharmaceuticals

, Hattar

Venlor-SR Capsules

Each SR capsule

contains:-

Venlafaxine HCl SR

pellets

≡ Venlafaxine… 75 mg

(5HT/Nor-adrenaline

reuptake inhibitor)

Source of SR pellets 32%

w/w Vision

Pharmaceuticals

Islamabad.

14’s As

Per

SRO

Deferred for

remaining fee,

submission of

documents for

Source, Certificate of

Analysis, GMP, and

Stability Data.

Now the firm deposited the remaining fee and submitted source along with Certificate of

Analysis, GMP and Stability Data and requested for registration of drugs. It will be better to

substitute “SR (Sustained Release)” with “XR (Extended Release)” to conform the terminology

of official compendia.


Case No.35


meeting deferred the following drugs of M/s. Aries

Pharmaceuticals, Peshawar:-

1. M/s. Aries

Pharmaceuticals,

Peshawar

1.Tab General

2. Capsule Gen

3.Tab

Psychotropics

Pranax 1 mg

Tablets

Each tablet

contains:-

Alprazolam… 1 mg

(Antidepressant)

3x10’s Rs.369.00 Deferred

being

controlled

drug.

274

2. -do- Pranax 2 mg

Tablets

Each tablet

contains:-

Alprazolam… 2

mg

3x10’s Rs.738.00 Deferred

being

controlled

drug.

Now the firm again stated that Pranax 0.5mg (Alprazolam0.5 mg) is already registered with

the firm where as Pranax 1 mg & 2 mg are the additional strengths of Alprazolam which are

requested to be registered. In the last meeting-246 the Board granted registrations of

psychotropic drugs for local manufacturing to M/s Navegal Hattar.


Case No.36


meeting approved the registration of drug of M/s. Wnsfeild

Pharmaceuticals, Hattar:-

S.No Formulation to be

corrected

Per vial Corrected Formulation

1. Winomax 500 mg

injection


Azithromycin

monohydrate

≡ Azithromycin .… 40

mg

(Anti-infective)

Pervial Winomax 500 mg injection


Azithromycin monohydrate

≡ Azithromycin .… 500 mg

(Anti-infective)

It is submitted that the strength of Azithromycin Monohydrate was inadvertently typed as 40

mg instead of 500mg. The firm has requested for correction of composition of above mentioned

drug.


Case No.37


meeting approved the registration of drug of M/s.Ferozsons

Laboratories, Nowshera for the purpose of export only-

275

It is submitted that Phenylephrine HCl 50mg was inadvertently included instead of Vitamin

C 50mg. The firm has requested for correction of composition of above mentioned drug.


Case No.38

M/s. Lawari International, Swat has requested to transfer the manufacturing site fromM/s.

Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contractbasis:-

The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated.


Formulation to be corrected Corrected Formulation

Lemcare Cold & Flu Dry

Powder for Oral Suspension in

Sachet


Paracetamol……. 650 mg

Phenylephrine HCl….50 mg

Lemcare Cold & Flu Dry

Powder for Oral Suspension in

Sachet


Paracetamol………….. 650

mg

Ascorbic Acid (Vit C)...50 mg

1. From

Fassgen

Hattar

To

Mediate

Karachi

056685 Spiro Injection 250mg IV


Ceftriaxone Sodium

≡ Ceftriaxone……..250mg

(Cephalosporin)

2. From

Fassgen

Hattar

To

Mediate

Karachi

056686 Spiro Injection 500mg IV


Ceftriaxone Sodium

≡ Ceftriaxone……..500mg

(Cephalosporin)

3. From

Fassgen

Hattar

To

Mediate

Karachi

056687 Spiro Injection 1 gm IV


Ceftriaxone Sodium

≡ Ceftriaxone……..1 gm

(Cephalosporin)

276

Case No.39

Registration Board granted the registration of Permethrin Lotion 5% strength to the various

firms. During scrutiny it is revealed that the Permethrin Lotion dosage form is internationally

available in 1% strength. The drug is manufactured by Reedco Inc, HCO4 Box 4013, Humacao,

Puerto Rico, Product license holder: Stafford Miller Limited, Brentford Middlesex TW89GS.

The case is submitted to the Registration Board for information and reconsideration.

277

Registration-V

Case No. 40. Case deferred for expert opinion. M/s CCL Pharma, Lahore

The Registration Board in its 245th meeting has deferred the following products of M/s. CCL

Pharmaceuticals, Lahore for expert opinion of Prof. Dr. Muzamil Hassan Najmi, Member

Registration Board. The product was also deferred in 241st meeting of Registration Board for

experts opinion:-

S.No. Name of Drug(s) with

formulation

Pack size Demanded

pricie

Fee & form

1.

OAB Tablets 4mg


FesoterodineFumarate …. 4mg


28‘s As per

brand leader

03.02.2011

Fee 15000

20.05.2013

Fee.135,000

Form 5-D

2.

OAB Tablets 8mg

Each ER tablet contains:

FesoterodineFumarate …… 8mg


28‘s As per brand

leader

03.02.2011

Fee 15000

20.05.2013

Fee.135000

Form 5-D

Following two expert opinions was presented before the Registration Board in its 245th

meeting:-

Dr. Khalid Mehmood

Assistant Prof. Hazara University

Havelian Campus

In view of the studies, the product seems beneficial for a considerable segment of the

society. However, DRAP may decide the matter considering above comments on dossiers in the

light of summary review of FDA on Toviaz product of original manufacturer that provides

necessary information on safety & efficacy of the product. DRAP should also ensure no conflict

of interest or violation of patent rights‖.

Prof. Dr. Muhammad Naeem

Head of the Department of Urology

PIMS, Islamabad.

Keeping in view the various studies conducted, it is concluded that “Fesoterodine” is a newer

antimuscarinic agent with good efficacy and safety profile. Hence it is recommended for

registration. However, the name of the brand should be reconsidered.‖ Fesoterodine‖ is a new

once daily antimuscarinic, hence will be economical OAB treatment relative to first OAB

therapy.

278

Comments of the 3rd

Expert has received as under:-

Prof. Dr. Syed Muzamil Hassan Najmi

Associate Dean, Basic Sciences Divison

Foundation Medical University, Rawalpindi

Member Registration Board.

The active drug in OAB tablet is Fesoterodine which is an anti-muscarinic drug. It has been

shown effective in various countries; The drug may cause all the adverse effects of atropine-like

drugs e.g dry mouth, constipation, blurred vision and tachycardia. It should not b used in patients

suffering from urinary retention or glaucoma. Fesoterodine is approved by EMA and USFDA for

symptomatic management of overactive bladder syndrome. The drug is recommended for

registration in Pakistan for treatment of overactive bladder syndrome, with proper precautions

and warnings as mentioned above.


Case No. 41 Expert opinion for registration of Nepadya Ophthalmic Suspension.

Registration Board in its 242nd

meeting deferred the following product of M/s.

Remington Pharmaceuticals, Lahore for expert opinion by Gen. Mazhar, Head Al-Shifa Eye

Trust and Head of PIMS, Islamabad:-

S.

No.

Name of Drug(s) Form & Fee Available brands Decision of Board

1. 1.Nepaday

2.Ophthalmic

Suspension 3. Each ml

contains: Nepafenac

… 3.0mg 4. analgesic

1. Form 5-D 2. Fast

Track 3. Rs.900/- plastic

vial fitted with dropping

nozzle and hard PVC

Pilfer Proof cap

containing solution in

two pack sizes 5ml,

10ml,

4. Dy. No.Nil dated Nil

5. 18-09-2013

Rs.60,000/- Differential

fee of 90,000/- on 20th

January 2014

(1,50,000/-)

1. Manufacturer

2. New molecule

3. Inspection of

the firm was

carried out on

19/12/2013 by

area FID and as

per report the firm

was considered to

be operating at

good level of

compliance with

GMP guidelines.

Deferred for

expert opinion by

Gen Mazhar,

Head Al-Shifa

Eye Trust and

Head PIMS

279

Both the experts have provided their opinion as under:-

i. Prof. Dr. Wajid Ali Khan

(Chief Consultant/Dean)

Shifa Eye Trust, Rawalpindi.

“With regard to the registration of Nepafenac 0.3%, kindly note that there is

enough evidence provided by the company which answers question raised earlier

by us. The registration process may be proceeded”.

Prof. Farooq Afzal

Head of Ophthalmology Department,

PIMS, Islamabad

“Having gone through the dossier provided on the Nepaday 0.3%, I am of the

opinion that this would be a “usefull” addition in ophthalmic medication and

recommend its registration”.


Case No. 42: De-registration of drug(s).

i. M/s. Friends Pharma (Pvt.) Ltd; Lahore has requested for de-registration of following

product. The management of the firm has informed that the product is not manufactured by them

and they want to reduce the burden of registration on the part of their company as well as

DRAP:-

S. No. Name of Drug(s) Reg. No.

1. Piloxin Tablet 400mg


Pefloxacin (as Mesylate) ………..

400mg

038998


ii. M/s. Allmed Pharmaceutical, Lahore has requested to de-register their following

products:-

S.No. Reg.No. Name of Drug(s) with formulation

280

1. 045011 Endime 500mg Injection

(Ceftazidime)

2. 045012 Endime 1gm Injection

(Ceftazidime)

They have requested to register Ivoryzone (Ceftriaxone) IV Injection 250mg & 500mg

against same registration number as mentioned above.


iii. M/s. BF Bio Sciences, Lahore was served a show cause notice dated 01-12-2014 for

cancellation of registration of drug Omega (Omeprazole) Injection (Reg.No.067967) on the

decision of Central Licensing Board in its 235th

meeting. In response the firm has informed that

after getting the registration letter of injection Omera, they have not manufacture the injection till

to date and have no intension to manufacture it in future as well. They have requested to de-

register the said product.


Case No. 43: CORRECTION OF STRENGTH OF ATROPINE SULPHATE AS 25MG


meeting deferred the following product of M/s. Irza

Pharma (Pvt.) Ltd; Lahore for confirmation of strength of Atropine Sulphate:-

S. No. Name of Drug(s) Form & fee Available brand

-do- 1.Omotil

2.Tablet

3.Each tablet contains:

Diphenoxylate

hydrochloride………….2.5mg

Atropine Sulphate…25mg

4.Opiate/ Anticholinergic

1.Form5

2.Routine

3.As per PRC

4.19-07-2010

Rs.8000/-

Rs.12,000/-

17-05-2013

It is me too

(Global)

FDA : Colonaid

(But arophine is

0.025mg per

tablet)

Deferred for

confirmation of

strength of

Atropine Sulphate

The firm has informed that they had applied strength of Atropine sulphate as 25mcg instead of

25mg but while typing the agenda it was typed as Atropine sulphate as 25mg inadvertently. They

have requested to grant them registration with correct brand name.

281

It is submitted that the case was referred to Pharmaceutical Evaluation Cell for confirmation of

applied strength and Evaluator-II has verified that the firm had applied Atropine sulphate as

25mcg & is available in US-FDA approved with brand name “Colon aid” manufactured by

“Medpoint Pharma HLC”.


Case No. 44 Reply to show cause notices for suspension of registration.

a. Registration Board in its meeting No. 245th

decided to served a show cause notice to M/s.

British Pharma, Lahore as production activities were suspended by Central Licensing Board on

directions in its 235th

meeting(CLB). In response to show cause notice the firm has submitted

that the CLB again discussed this case in its 237th

meeting held on 01-10-2014 and has decided

as under:-

i. On considering the inspection report of the panel of experts allowed resumption

of production of M/s. British Pharma, Lahore.

ii. The firm would be re-inspected within 03 months panel at the time of active

production.

The firm has requested to issue the registration letter as approved.


b. M/s. Farmigea Pakistan (Pvt.) Ltd

M/s. Farmigea Pakistan (Pvt.) Ltd; Lahore was issued a show cause notice for suspension

of registrations registered in steroidal section in respect of Registration Board’s decision in 245th

meeting. Initially the firm was directed for stop production by Central Licensing Board in its

235th

meeting while discussing the case of renewal of Drug Manufacturing License of the firm.

Now the firm informed that panel of experts allowed the resumption of production in all

section except steroidal products and advised the firm to develop the dedicated facility within

282

one year for the manufacturing of steroidal product. They have requested that their layout plan is

approved for Eye Drop (steroidal Section) from DRAP. The firm has already got registration of

steroidal preparations (eye drops).


Case No. 45 REGISTRATION OF DRUG(S) FOR EXPORT PURPOSE ONLY.

M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of

following products for export purpose only (Me-too status is not confirmed):-

S. No Name of Products

1. Peropil Tablet 5mg


Perindopril arginine equivalent to

Perindopril …………………………………….. 5mg

2. Peropil Tablet 10mg


Perindopril arginine equivalent to

Perindopril …………………………………….. 10mg

3. PeropIN Tablet


Perindopril Arginine …………………………… 2.5mg

Indapamide …………………………………… 0.625mg

4. PeropIN Tablet


Perindopril Arginine ……………………………… 5mg

Indapamide ……………………………………… 1.25mg

The firm has submitted the following documents:-

a. Fee of Rs. 20000/- for this purpose.

b. Form-5.

c. Under taking stamp paper.

d. Copy of GMP inspection.

e. CRF clearance certificate.

f. Export orders.


283

Case No. 46 Submission of incomplete information to different laboratories.

Chief, National Institute of Health, Islamabad has forwarded a letter wherein she

has informed that M/s. Ameer Pharma, (Pvt.) Ltd; Lahore provided them incomplete

specification/method of testing of their products which do not have important test like sterility,

bacterial endotoxin. Similarly limits for active ingredients are also not mentioned. This is routine

practice of M/s Ameer Pharma, Lahore they always provided incomplete specification of their

proprietary as well as generics products (whose method of testing are not available in any

pharmacopeia). Therefore, it is requested to direct the above said manufacturer to provide

method of testing of their proprietary as well as generic products complete in all respects.

It is submitted that it is one of the condition of registration letter that all manufacturer

will provide one of the complete method of testing of finished drug(s) (containing full details of

minor and major steps and protocols along with specifications, lower and upper limits) shall be

submitted to all Federal and provincial laboratories. But some of firm has not provided complete

method of testing as mentioned above. Registration Board is requested to provide guidelines in

this regard.


Case No. 47 Extension of Contract Manufacturing Permission.


meeting deferred the following products of M/s.

Surge Laboratories through contract manufacturing by M/s. Nabiqasim Industries (Pvt.) Ltd;

Sheikhupura for confirmation of source of pellets manufacturer and requisite fee :-

Name of the

applicant firm

Name of

contract

manufacturer

Reg. No. Name of Drug(s) Form and fee Remarks

M/s.Surge

Laboratories

(Pvt) Ltd.

Sheikhupura

M/s.

Nabiqasim

Industries

(Pvt) Ltd.

Karachi

041893

27-10-2005

Esprol Capsule 40mg


Esomeprazole

magnesium Trihydrate

eq. to Esomeprazole (in

enteric coated pellet

15-04-2013

Rs.42000/-

20-12-2010

Rs.7500.00

Form-5

28-09-2010

Sister Concern

284

forms)………...40mg Rs. 15000

M/s.Surge

Laboratories

(Pvt) Ltd.

Sheikhupura

M/s.

Nabiqasim

Industries

(Pvt) Ltd.

Karachi

041894

27-10-2005

Esprol Capsules 20mg


Esomeprazole

Magnesium Trihydrate

eq. to Esomeprazole

enteric coated pellet

forms) …………20mg

15-04-2013

Rs.42000/-

20-12-2010

Rs.7500.00

Form-5

28-09-2010

Rs. 8000

Sister Concern

M/s. Surge Laboratories (Pvt.) Ltd; Sheikhupura has informed that they were importing

Esomeprazole pellets from M/s. Glenmark Generics Ltd; India now they want to use their own

source i.e M/s. Nabiqasim Industries, Karachi. They have also deposited more fee of Rs. 20,000/-

for this purpose.


Case No. 48 AVAILABILITY OF DRUG(S) FOR DEFERRED PRODUCT(S).

Following products of M/s. Searle IV Solutions (Pvt.) Ltd; Lahore was deferred for

confirmation of me-too status in 243rd

meeting of Registration Board:-

S. No. Name of Drug(s) Pack size Form & fee Availability

provided by the

firm.

1. Esteine Dry Suspension

Each 5ml (when reconstituted) contains:-

Erdosteine ………………… 175mg

(Mucolytic)

(Manufacturer’s spec.s)

Rs.

160/100ml

From-5

09-01-2014(318)

09-01-2014

(Rs. 20,000/-)

Dostin

175mg/5ml Dry

Suspension (Reg.

No. 032330) of

M/s. Brookes

Pharma, Karachi.

Sertin 175mg/5ml

Dry Suspension

M/s.

GlaxoSmithKline

Philippines, Inc.

2. Melose Eye Drop

Each ml contains:-

Hypromellose …. 3mg

Rs.

165.00/10ml

10ml bottel

From-5

18-12-2013(1198)

18-12-2013

Gentel Eye Drops

(Reg.No.045693)

of M/s. Novartis

285

(Lubricant)

(USP Spec.s)

(Rs. 20,000/-) Karachi.

Genteal Eye

Drops of M/s.

Novartis,

Australia.

The management of the firm has informed that the products are available nationally and

internationally as mentioned above in last column. They have requested to grant them

registration of above mentioned products.


Case No.49:


meeting deferred the following product of M/s Allmed

(Pvt.) Ltd; Lahore which was presented before Registration Board due to the reasons mentioned

below:-

Confirmation whether transfer of registration is permissible under contract

manufacturing policy or otherwise.

Verification of testing facility by Director DTL, Lahore and area FID.

S. No. Reg. No. Name of Drug with Composition

1. 041199 Norepine Injectable

Each 4ml contains:-

Noradrenaline tartarate…8mg

The product was transferred from import to local toll manufacturing by M/s. Allmed

Pharma, Lahore (Formerly M/s Ever Green Pharmaceuticals (Pvt.) Ltd. Lahore) and initially

registered in the name of M/s. Ontech Corporation, B-154 Block-13-D/2 Gulshan-e- Iqbal,

Karachi manufactured by M/s. Sterop Laboratories, Belgium.

Firm has provided following documents for this purpose.

1. Form-5/

286

2. Fee challan of Rs.20,000/-

3. Form-5

4. N.O.C on transfer from M/s Ontech Corporation, Karachi.

5. Import Registration letter in the name of M/s. Ontech Corporation, Karachi.

The panel of inspector comprising Jamil Anwar, Director DTL, Lahore and Asim Rauf,

FID area, Lahore, has reported that HVAC, Quality Control and Quality Assurance operations

was satisfied with their testing capabilities at the time of inspection.


287

Item No. VI Registration of Biological Drugs – Biological Evaluation & Research Division

Case No.01: EXEMPTION OF MANUFACTURING DATE ON INNER LABEL OF

HUMULIN 70/30 100IU/ML VIAL – 10ML (REG NO. 011146) AND

HUMULIN N 100IUI/ML VIAL – 10ML (REG NO. 08300)

M/s Eli Lilly Pakistan (Pvt) Ltd, Karachi has requested for exemption of manufacturing

date on inner label for their following already approved products. The firm has deposited an

amount of Rs. 5000/- for each of following registered products: -

Sl.

No.

Products Batch No. Manufacturing date Expiry Date Quantity

(Packs)

1 Humulin 70/30 100

IU/ml vial

C367371C 03rd

September,

2014

2nd

September,

2017 218,482.

C367386A 11th

September,

2014

10th

September,

2017 235000.

2. Humulin N

100IU/ml Vial

C370902A 17th

September,

2014

16th

September,

2017 65,000.

The firm has submitted as under: -

i) The firm has received first shipment of new stocks from their manufacturing site

of Indianapolis, USA after source change from Egypt and noticed that

manufacturing date is not mentioned on inner labels and cartons of the drugs.

ii) The firm has coordinating with their US manufacturing site to make special

arrangements for them to print Manufacturing dates on labels and cartons for

future shipments. However, this process is expected to take a few months.

Humulin (Human Insulin):

Life saving product for patients with diabetes in Pakistan to control their blood level.

Contributes more than 75% of the requirements of patients using human insulin

Manufactured by Indianapolis, USA on high tech equipment.

Impact of Humulin, if out of stock:

Every Humulin patient needs his/her insulin dose on daily basis with meals as

mandatory to control diabetes and monthly consumption of each patient is 1 to 1.5

vials.

Unavailability of an economical life saving high quality human insulin from FDA

approved site can create a serious health issue on 75% of Pakistan’s diabetic patients

who use Humulin (human insulin).

288

There are around 290,000 patients of Humulin 70/30 and 26,000 patient of Humulin

N Vial across the Pakistan will not get Humulin dose from 1st week of February 2015

for one month.

2. The firm has requested for exemption of Manufacturing Date on Inner Label on the

shipment which they had received and quantity of imported shipment is shown in the colum

above. As the product is an insulin and biological product which is very sensitive to temperature

variations and therefore the quality of Humulin (insulin) can be compromised if they open the

pack in order to manually print manufacturing date on the inner label.

3. The file was processed internally. The Director Legal Affairs has remarked on the file as

under:

under clause (i) of rule 3 of the Drugs (Labeling and Packing) Rules, 1986 provide for

printing of date of manufacture on the label of the inner most container of a drug and also on

the covering in which such container is packed. However, Registration Board is competent to

allow relaxation.Chairman DRB has remarked on the file, to place it as agenda item in this

meeting.

On the direction of Chairman DRB, the case is placed before the Drug Registration Board for a

decision.

Case No. 02

M/s Novo Nordisk, Karachi had requested for grant of registration of Histidine

solvent in Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for

solution for Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated) 1mg and

NovoSeven 100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) along with

Hisitidine 2ml each vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an

amount of Rs. 50,000/- for each product. The composition detail is as under: -

Name of Drugs Composition

Novo Seven 50KIU(1mg) Powder for Solution for

Injection.

Each vial contains: -Eptacog alfa (activated) 1mg

Composition of solvent L – Histidine

1.55mg/ml

Water for injection…….q.s. to make

1ml.

Novo Seven 100KIU(2mg) Powder for Solution for Composition of solvent L – Histidine

289

Injection.

Each vial contains: -

Eptacog alfa (activated) 2mg

1.55mg/ml

Water for injection…….q.s. to make

2ml.

The Drug Registration Board in 246th

meeting deferred the case subject to confirmation of status

of solvent in CoPP.

In response to the decision of 246th

meeting of Drug Registration Board, the firm has provided

legalized CoPP indicating the presence of solvent with composition.

The case is placed before the Registration Board for a decision.

Case No. 03 CHANGE OF MANUFACTURING SITE AND CHANGE OF BRAND

NAME FOR ALREADY REGISTERED DRUGS BY M/S. HOSPITAL

SERVICES & SALES, KARACHI.

M/s Hospital Services & Sales, Karachi has submitted the application for change of manufacture

site and change of brand name of their already registered vaccine for below mentioned products.

Sl.No. Reg.

No.

Previous Brand

Name and

composition.

Proposed Brand

Name

Existing

Manufacturing

Site

New proposed

manufacturing

site

1. 053813 EASYFIVE –

Pentavalent

Vaccine

Each dose 0.5ml

contains: -

Diphtheria

Toxoid: 20Lf

(30IU)

Tetanus Toxoid:

7.5Lf(40IU in

guinea pig and

60 IU in mice)

Pertussis

Vaccine: 12OU

(4IU)

r-Hepatitis B

surface antigen

(HBsAg):

10mcg

Haemophilus

type b conjugate

vaccine: 10mcg.

EASYFIVE – TT

Pentavalent Vaccine

Each dose 0.5ml

contains: -

Diphtheria Toxoid:

20Lf (30IU)

Tetanus Toxoid:

7.5Lf(40IU in guinea

pig and 60 IU in

mice)

Pertussis Vaccine:

12OU (4IU)

r-Hepatitis B surface

antigen (HBsAg):

10mcg

Haemophilus type b

conjugate vaccine:

10mcg.

M/s. Panacea

Biotech Ltd.,

New Delhi,

India.

M/s. Panacea

Biotech Limited,

Malpur, Baddi,

Distt. Solan

(H.P.) 173 205,

India.

290

In support M/s Hospital Services & Sales, Karachi has provided following documents to support

their claim:-

1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per

product).

2. Copy of registration letter and last renewal status.

3. NOC for CRF clearance (Not required for Importer)

4. Original CoPP provided for new manufacturing site.

5. Site Master file

6. The firm has also provided evidence of WHO prequalification of EASYFIVE –

TT vaccine.

The case was placed before the Registration Board 246th

meeting for a decision. The Board has

approved the registration of solvent exclusively to be used with EASYFIVE – Pentavelent

Vaccine, Reg No. 053813. DRB has given registration of solvent exclusively to be used with

EASYFIVE, which was a typographic mistake. The case was processed for change of brand

name by excluding the word Vaccine and change of manufacturing site, which got omitted.

The new site (Biotech Limited, Malpur, Baddi, Distt. Solan (H.P.) 173 205, India) is a WHO

pre-qualified site, and India is a non SRA country.

The case is again placed before the Registration Board for a decision on the request for change of

brand name by deleting the word Vaccine & change of manufacturing site from M/s. Panacea

Biotech Ltd., New Delhi, India to M/s. Panacea Biotech Limited, Malpur, Baddi, District. Solan

(H.P.) 173 205, India.

Case No. 04. CHANGE OF MANUFACTURING SITE FOR ALREADY REGISTERED

DRUGS OF M/S PFIZER PAKISTAN, KARACHI.

The case of change of manufacturing site of M/s Pfizer Pakistan, Karachi was placed

before the Drug Registration Board for approval of following registered product: -

S.# Product &

Registration No.

Existing

Manufacturing site

New Manufacturing

Site

1. Prevenar 13

Suspension for

injection

(Reg # 066110)

Baxter Pharmaceutical

Solutions LLC 927

South City Curry Pike,

Bloomington IN, USA

Pfizer Ireland

Pharmaceuticals

Grange Castle

Business Park,

Clondalkin, Dublin 22

Ireland.

291

The case was approved in 246th

Meeting of Drug Registration Board, the name of company was

wrongly written as Pfizer Pakistan, Karachi instead of Wyeth Pakistan, Karachi. Wyeth and

Pfizer both have merged internationally.

The case is placed before the Drug Registration Board for information of correction of

typographic mistake.

Case No 05. COURT CASE OF M/S FORWARD SOLUTION V/S DRAP.

The case of M/s Forward Solution was discussed in 243rd

and 246th

Meeting of the Drug

Registration Board. The board decided that as the case is under the consideration of the

Honourable Court. The firm M/s. Well Pharma, Lahore shall be asked to substantiate their claim

of sole agent of the manufacturer in order to satisfy the legal procedure.

The decision of the board was communicated to both of the companies. M//s Well Pharma,

Lahore has not provided any sole agent agreement.

2. The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High

Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan

is not granting the Registration due to inaction of the functionary of the Drug Regulatory

Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).

Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization

and submission to Honourable Court. Meanwhile Federal Investigation Agency (FIA) has also

directed to appear before them to provide the details of the case. DRAP officers had appeared

before FIA in the subject case.

3. In the subsequent development, FIDLahore-I has stated that the counsel for the petitioner

has again filed an application in the court of Senior Judge (Mr. Naeem Shahbaz, new judge)

Civil Court, Lahore on 24.01.2015) to reopen the case. The FID has informed that the case was

adjourned and fixed for 03.02.2015. The petitioner has now increased the number of

respondent(s) including CEO of DRAP.

The matter is submitted for information of the Drug Registration Board and necessary

instruction/order if any.

292

Case No. 06

The appeal to Federal Ombudsmen (Wafaqi Mohtasib) by local manufacturer M/s. Macter

International Karachi and case of others (M/s. Getz Pharma Karachi, M/ Nextar Pharma,

Karachi and M/s. Hilton Pharma, Karachi).

The decision of Drug Registration Board has been communicated to Ministry for onward

submission to Wafaqi Mohtasib. The latest information about the case shall be provided on the

date of meeting as correspondences are going on between Wafqi Mohtasib, Ministry of National

Health Services Regulation & Coordination and DRAP, to handle the situation in the pursuit of

Law.

The case is placed before the DRB for updated information.

Case No. 07 CHANGE OF MANUFACTURING SITE FOR ALREADY REGISTERED

DRUGS BY M/s. ROCHE PAKISTAN, LTD, KARACHI.

M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing

site.

The details are as under:-

Product /

Registration No.

Previous Name of

Manufacturing

Site

New Name of

Manufacturing site

Referon – A Injection

3 MIO IU


Lyophilized

Interferon

Alfa-2a…3.3x106

IU

Sodium Chloride

9.6 mg

Human Serum

Albumin 5.0 mg

M/s F . Hoffmann-

La

Roache Ltd., Basel,

Switzerland

M/sF . Hoffmann La-Roche

Ltd.,

Wurmisweg 4303,

Kaiseraugst,

Switzerland.

M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:-

293

1. Application on form 5-A with required fee as per SRO (Rs.50, 000/-).

2. Copy of registration letter and last renewal status.

3. NOC for CRF clearance (Not required for Importer)

4. Original CoPP provided for new manufacturing site.

5. Site Master file

The case is placed before the Registration Board for decision.

Agenda for 247 Meeting, Registration Board to be held on 04 ...

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