Minutes for 280th Meeting of Registration Board held on 15 ... Minutes for 280th thmeeting of Registration Board (15 March, 2018), DRAP 2 280th meeting of Registration Board was held

Minutes for 280th meeting of Registration Board (15

th March, 2018), DRAP 1

Minutes for 280th

Meeting of Registration Board

held on 15th

March, 2018.

*=*=*=*=*

Item No. Detail Page No.

Item No. I Confirmation of Minutes for 279th

meeting 2

Item No. II References sent by Central Licensing Board 3 – 4

Item No. III Pharmaceutical Evaluation & Registration Division

Registration-II Section

Pharmaceutical Evaluation Cell

5 – 53

5-7

8-53

Item No. IV Additional Agenda.

A. Pharmaceutical Evaluation & Registration Division

Registration-I Section


Registration-IV Section

Registration-V Section

54 – 58

54-56

57

58-59

60-61

Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4

Islamabad.



280th

meeting of Registration Board was held on 15th

March, 2018 in the Committee

Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by

Dr. Obaidullah, Director, Division of Pharmaceutical Evaluation & Registration, DRAP. The

meeting started with recitation of the verses from Holy Quran. The meeting was attended by the

following:-

1. Dr. Rafeeq Alam Khan,

Meritorious Professor, Chairman, Faculty of Pharmacy,

Univeristy of Karachi.

Member

2. Prof. Dr. Ghulam Sarwar, Dean,

Faculty of Pharmacy, Jinnah Women University, Karachi

Member

3. Dr.Qurban Ali,

Ex-Director General, NVL/ Veterinary Expert

Member

4. Dr. Amanullah Khan

Director, Drugs Testing Laboratory, Quetta

Government of Baluchistan

Member

5. Mr. Abid Hayat,

Director, Drugs Testing Laboratory, Peshawar

Government of Khyber Pakhtunkhwa.

Member

6. Syed Muzaffar Ali Jafri,

Director, Drugs Testing Laboratory, Karachi

Government of Sindh.

Member

7. Mr. Muhammad Aslam

Assistant Draftsman-II, Ministry of Law & Justice

Member

8. Mr. Zahoor Ahmad,

Assistant Controller of Patent, Representative of IPO

Member

9. Dr. Noor-us-Saba

Director, as representative of Division of Biological

Evaluation & Research, DRAP

Member

10. Dr. Hafsa Karam Elahi, Additional Director,

as representative of Division QA&LT, DRAP

Member

11. Dr.Muhammad Akram,

Assistant Animal Husbandry Commissioner, M/o NFS&R.

Co-Opted

Member

12. Mr. Abdullah, Additional Director (PE&R) Secretary

Mr. Ehsan Awan and Ch. Muhammad Yousaf (PPMA), Mr. Nadeem Alamgir (Pharma

Bureau) and Mr. Kamran Anwar (PCDA) attended the meeting as observers.

Mr. Zaheer-ud-Din M. Babar (Deputy Director R.I/R.IV), Muhammad Amin (Deputy

Director, R.II), Mr. Babar Khan (Deputy Director (R.III) / Incharge-PEC), assisted in presenting

the agenda of PE&R Division.

Item No. I: Confirmation of minutes of 279th

meeting of Registration Board.

279th

meeting of Registration Board was held on 28th

February to 2nd

March, 2018. The

Board was apprised that draft minutes of the meeting are under preparation and will be circulated

for their comments.



Item No. II: References Sent by the Central Licensing Board.

Case No.1: Drug Manufacturing Licenses cancelled by CLB.

Central Licensing Board in its various meetings cancelled Drug Manufacturing Licenses

(DMLs) of following firms as per details mentioned below:-

Sr.

No.

Name of Firms DML No. &

Type

CLB Meeting No.

1. M/s Everest Pharmaceuticals,

124, Industrial Triangle, Kahuta Road,

Islamabad

000535

(Formulation)

258th

held on

08th

March, 2018

2. M/s. Pharmawise Labs (Pvt) Ltd 25-M,

Qauid e Azam Industrial Estate, Lahore

000182

(Formulation)

256th

held on

09-10th

November,2017

3. M/s. Guyton Pharmaceuticals, 25.5 KM,

Raiwand Road, Lahore

000548

(Formulation)

252nd

held on

15th

Macrh, 2017.

4. M/s. Micko Industrial Chemicals Company

(Pvt), Ltd, 28-Km, Ferozepur Road, Lahore

000183

(Formulation)

256th

held on

09-10th

November,2017

5. M/s Vetec Laboratories, 51 Industrial

Triangle, Kahuta Road Islamabad

000320

(Formulation)

255th

held on

16-17th

August, 2017

6. M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore

Sheikhupura Road, Lahore

000366

(Formulation)

257th

held on

24–25th

January, 2018

The case is submitted for consideration of Registration Board with regard to status of

drugs registered with these firms after cancellation of their DMLs.

Decision: Keeping in view the decision of Central Licensing Board for cancellation of

Drug Manufacturing License the Registration Board deliberated and

cancelled the registration of all drug products registered in the name of

above firms.

Case No.2: Drug Manufacturing License declared invalid by CLB.

Central Licensing Board in its 250th

meetingdeclared Drug Manufacturing License

(DML) of following firm “Invalid” as per details mentioned below:-

S.

No.

Name of Firm DML No. &

Type

CLB Meeting No. Decision

1. M/s Becton Dickenson Pakistan

(Pvt) Ltd, 10-Km Muridkay-

Sheikhupura Road, Muridkay

000673

(Formulation)

250th

held on 27th

October, 2016.

Invalid


registration of drugs registered with the firms after their DML is declared Invalid.

Decision: Keeping in view the decision of Central Licensing Board for invalidity of

Drug Manufacturing License, the Registration Board deliberated and

cancelled the registration of all drug products registered in the name of

above firm.



Case No.3: Drug Manufacturing Licenses suspended by CLB.

Central Licensing Board in various meetings considered the cases and declared that DML

of different firms are suspended as per below mentioned detailed:-

S. No. Name of Firm DML No. &

Type

CLB Meeting

No.

Decision

1.

M/s Safe Pharmaceuticals (Pvt)

Ltd., Karachi

000349

(Formulation)

257th

held on

24th

– 25th

January, 2018

Rejection of

renewal.

Manufacturing shall

remain suspended.

2. M/s Kailgon Agro Industries

(Pvt) Ltd., Balochistan

000277

(Formulation)

257th

held on

24th

– 25th

January, 2018

Suspended

3. M/s Gaba Pharmaceutical

Laboratories, Karachi

000168

(Formulation)

257th

held on

24th

– 25th

January, 2018

Suspended

4. M/s Medley Pharmaceuticals,

41-A, P.S.I.E., JhangBahtar

Road, WahCantt, Rawalpindi

000237

(Formulation)

257th

held on

24th

– 25th

January, 2018

Suspended

5. M/s Qintar Pharmaceuticals, 14-

A, P.S.I.E., Lahore Road,

Sargodha

000520

(Formulation)

257th

held on

24th

– 25th

January, 2018

Suspended

6. M/s Tas Pharmaceuticals (Pvt)

Ltd., Plot No. 209, Industrial

Triangle, kahuta road Islamabad

000375

(Formulation)

257th

held on

24th

– 25th

January, 2018

Rejection of

renewal.

Manufacturing shall

remain suspended.


registration of drugs registered with the firms after their DML is declared suspended.

Decision: Keeping in view the decision of Central Licensing Board for suspension of

Drug Manufacturing License, the Registration Board deliberated and

suspended the registration of all drug products registered in the name of

above firms at serial no. 2 - 5. The Registration Board deferred the case

regarding firms at serial no. 1 and 6 till final decision by the Central

Licensing Board as their decision on Drug Manufacturing License is pending

before the Central Licensing Board.



Item No. III Pharmaceutical Evaluation & Registration Division


Case No. 1: Reply to Show-Cause Notice.

Secretary Central Licensing Board (CLB) has intimated that CLB in its 251st

meeting held on 6th

December 2017 has considered and deliberated the case of M/s Pharmatec

Pakistan (Pvt) Ltd., D-86/A, S.I.T.E, Karachi under DML No. 000024 by way of formulation and

decided to allow grant of renewal section for sterile Liquid ampoule section with the direction

that Registration Board be informed about approval of sterile Liquid ampoule section only. It is

pertinent to mention that few products of M/s OBS Pakistan, Karachi were manufactured by M/s

Pharmatec Pakistan by permission vide letter no. F.3-3/2015-Reg-II (M-249) dated 26th

August,

2015. The permission is valid for 30-06-2020.

The above stated facts of the case were presented in the 275th

meeting of Registration Board.

Wherein, it was decided to “issue a showcause notice to M/s OBS Pakistan, Karachi for their

hormonal products which were being manufactured by M/s Pharmatec Pakistan (Pvt) Ltd.,

Karachi on contract basis.”

Accordingly a show cause was issued to M/s OBS Pakistan (Pvt) Ltd., Karachi vide letter

no. F.3-12/2017-Reg-II (M-275) dated 15.02.2018. Now the firm has submitted a reply which is

summarized as below:

“The reply to the subject notice on behalf of OBS is elucidated here in below:-

1. That a contract manufacturing agreement dated 01.01.2013 was executed inter se

OBS and Pharmatec for manufacturing of the following hormonal drugs:-

S.No Drug(s) Reg.No

1. Deca-Durabolin Injection 25 mg/ml 002442



4. Sustanon 250 mg/ml 002446

2. That subsequently, vide a letter dated 26.08.2015, the Drug Regulatory Authority of

Pakistan (DRAP) granted extension in respect of the permission for contract

manufacturing till 30.06.2020.

3. That an inspection was carried out by the Federal Inspector of Drugs of the

Pharmactec’s manufacturing site, in which the following observation was given in

Paragraph No. 08 of the inspection Report:

“It was observed by the panel that the firm is manufacturing the hormonal sterile

products (androgens and anabolic steroids) in the area for the sterile Ampoules

for General products. Therefore, the firm was directed to immediately stop the

production of Hormonal products in the aforesaid area and all previous

approvals for hormone production are henceforth, stand cancelled till further

approval by the DRAP Islamabad.”



4. That the aforementioned paragraph no. 8 was challenged by OBS vide a

Constitutional petition no. 1120 of 2016 before a Division bench of the Honourable

High Court of Sindh. Through order dated 02.03.2016, CP NO. 1120 of 2016 was

disposed of in following terms:

“After arguing the matter in length, counsel says that he has taken instructions

from the petitioner who would rectify the facility in terms of Para 8 of the

Inspection report dated 21.01.2015 and will request for re-inspection afterwards,

so that in case the facility is found in accordance with the Rules of DRAP, then

the respondents should allow the petitioner to manufacture the Hormonal Sterile

Products. The Drugs Inspector present submits that the inspection was conducted

on account of certain breaches found in the premises as detailed in Para 8 of the

above report, manufacturing process was suspended in respect of Hormonal

Sterile Products being manufactured therein, and in case they comply with para 8

of above report by separating the manufacturing facility in respect of Hormonal

Sterile products, then of course permission of manufacturing of the same can be

allowed, after DRAP appoints Inspection Team to ensure that the facility is

rectified in accordance with DRAP regulations. Mr. Pirzada at the request of the

petitioner seeks disposal of this petition as the petitioner is ready to comply with

the instructions in Para 8 of the Inspection report.

…………………………………………….. The Petition along with application stands

disposed of, in above terms.”

5. That the counsel for OBS, vide a letter dated 10.03.2016 intimated to the Secretary,

CLB of DRAP and informed regarding the order passed by the Hon’ble High Court in

C.P. No. D-1120 of 2016.

6. That subsequently, vide a letter dated 13.04.2016, Pharmatec intimated to the

Secretary, CLB of DRAP that:

“Through this letter, we would like to inform you that we are preparing to convert

this existing area into a hormone-manufacturing area. The cleaning, renovation

and other preparation would be completed by third week of May-2016.”

7. That through a letter dated 04.08.2016, sent by Assistant Drug Controller Licensing,

DRAP to Pharmatec, the revised layout plan as intimated by Pharmatec to the

Secretary, CLB, was approved.

8. That subsequently, a dispute ensued between OBS and Pharmatec which culminated

in the institution of Suit No. 2523 of 2016 before Hon’ble High Court of Sindh,

Karachi. During the pendency of the aforementioned legal proceedings, Pharmatec

wrote a letter to Secretary, CLB dated 15.10.2016, wherein it was stated that:-

“We have decided to withdraw our request for the grant of approval of above

mentioned manufacturing areas and request you to kindly approve our sterile

area as per the report of inspection, conducted for the renewal Drug

manufacturing License no. 000024 dated 21.01.2015”.

9. That subsequently, vide a letter bearing reference no. F.2-48/84-Lic (IV) dated

09.08.2017 that the Secretary, Central Licensing Board communicated to the

Pharmatec that they

“decided to allow grant of renewal Section for Sterile Liquid Ampoule Section

with the direction that Drug Registration Board be informed about approval of

Sterile Liquid ampoule section only. Moreover, Federal Inspector of Drugs may



be directed to verify that no hormonal products are being manufactured in sterile

liquid ampoule section which is only meant for General Products.”

10. That surprisingly, through a letter bearing noF.2-1/2000 Lic(Vol-I) dated 10.08.2017,

sent by the Deputy Director (Licensing) of DRPA to OBS, OBS being the Petitioner in

the aforementioned CP No. D-1120 of 2016, was requested to “make a formal

request for constitution of panel for re-inspection in light of the direction of the

Hon’ble Sindh high Court, Karachi.”

11. That OBS was constrained to impugn/challenge the letter dated 09.08.2017 issued by

the Secretary, Central Licensing Board through a Suit bearing No. 2056 of 2017

before the Hon’ble Court of Sindh at Karachi. Pharmatec along with the Secretary

CLB were impleaded as Defendants in the said suit. Subsequent to the institution of

the suit under reference, an amicable settlement/compromise has been affected

between OBS and Pharmatec. In terms of the said settlement/ compromise,

Pharmatec shall apply to the DRAP and the Drug Licensing Board for obtaining

Campaign Manufacturing permission in respect of OBS’s Hormonal Drugs which

shall be granted by the DRAP in accordance with the law.

12. That through an order dated 07.11.2017; the said suit was decreed in the

aforementioned terms of settlement/compromise. It has been expressly mentioned in

the said order that permission in respect of Campaign Manufacturing of the

Hormonal Drugs shall be granted by the DRAP and the Secretary, CLB in

accordance with Law.

13. It may be noted that Pharmatec will shortly be writing to DRAP and CLB of the

DRAP for seeking permission for the Campaign Manufacturing of OBS Hormonal

Drugs which shall be granted in accordance with law. Furthermore, DRAP being a

party to the aforementioned proceeding before the Hon’ble High Court of Sindh at

Karachi.

PRAYER

In view of the above legal facts and circumstances, it is very humbly prayed that the show cause

notice bearing No. F.3-12/2017-Reg-II (M-275) dated 15.08.2018 addressed to OBS be vacated

and discharged.

Decision: The Board considered and deferred the case till decision of Central Licensing

Board on application of the firm for campaign manufacturing.



Pharmaceutical Evaluation Cell

S.No. Details

Case No. 01 Registration applications for local manufacturing of (Human) drugs

a) New cases

b) Deferred cases

Case No. 02 Registration applications of import (Human) cases

Case No. 03 Registration applications of newly granted DML or New section (Human)

a. New/Additional section(s)

b. Deferred cases

Case No. 04 Deferred cases of previous meetings (Human)

Case No. 05 Deferred cases of previous meetings (Veterinary)

Case No. 06 Verification of stability study data

Case No.1: Registration Applications for Local Manufacturing of (Human) Drugs.

a) New cases 1. Name and address of manufacturer /

Applicant

M/s. Caliph Pharmaceuticals, Plot No. 17, Special

Industrial Zone, Risalpur, Pakistan.

Brand Name +Dosage Form + Strength Moxcin 400mg tablet

Composition Each film coated tablet contains:

Moxifloxacin (as hydrochloride)………400mg

Diary No. Date of R& I & fee Dy. No.1978; 20-02-2017; Rs.20,000/- (20-02-2017)

Pharmacological Group Quinolone

Type of Form Form-5

Finished product Specifications USP

Pack size & Demanded Price 1x5’s; As per SRO

Approval status of product in

Reference Regulatory Authorities

Avelox 400 mg film-coated tablets by M/s Bayer

(MHRA approved)

Me-too status (with strength and

dosage form)

Metoxim 400mg Tablet by M/s Foray Pharmaceutical

GMP status GMP inspection conducted on 07-03-2017 concluded that

firm is working at satisfactory level of GMP compliance.

Remarks of the Evaluator Applicant has claimed USP specifications but applied

formulation is not present in available USP & BP.

Decision: Approved with innovator’s specifications.

2. Name and address of manufacturer /

Applicant



Brand Name +Dosage Form + Strength Tizid 2mg tablet


Tizanidine (as hydrochloride)………2mg


Pharmacological Group Skeletal muscle relaxant

Type of Form Form-5





Approved in US-FDA (but discontinued) however it is

written that product was not withdrawn or discontinued

because of safety and efficacy reasons.




dosage form)

Muslex Tablet 2 mg of Danas Pharmaceutical



Remarks of the Evaluator

Decision: Approved.


Applicant








Type of Form Form-5





Approved in US-FDA


dosage form)

Tandolax 4mg Tablet of High-Q Pharmaceuticals




Decision: Approved.


Applicant








Type of Form Form-5





Could not be confirmed


dosage form)

Could not be confirmed



Remarks of the Evaluator E Evidence of approval of applied formulation in reference

agencies is required.

E Evidence of Me too of applied formulation is required.

Decision: Deferred for the following reasons:

Evidence of applied formulation/drug for generic / me-too status.

Evidence of approval of applied formulation in reference regulatory authorities/

agencies which were declared approved registration Board in its 275th

meeting.


Applicant



Brand Name +Dosage Form + Strength CP-Lium 10mg tablet


Domperidone (as maleate)………10mg




Pharmacological Group Anti-dopaminergic

Type of Form Form-5

Finished product Specifications Manufacturer’s specifications




Approved in MHRA


dosage form)

Omeprin Tablets 10 mg of Bio Labs (Pvt) Ltd



Remarks of the Evaluator Applicant has claimed Manufacturer’s specifications but

applied formulation is not present in available BP.

Decision: Approved with B.P specifications.


Applicant

M/s. Nawan Laboratories (Pvt.) Ltd., 136, Sector 15,

Korangi Industrial Area, Karachi.

Brand Name +Dosage Form + Strength Itowan tablet 50mg


Itopride hydrochloride……….…………50mg


Pharmacological Group Gastroprokinetic

Type of Form Form-5


Pack size & Demanded Price 10’s; As per DPC



PMDA approved


dosage form)

Ganaton 50mg tablet of Abbott

GMP status GMP inspection conducted on 26-09-2017 shows that

firm is operating at satisfactory level of GMP compliance.


Decision: Approved with Innovator’s Specifications.


Applicant



Brand Name +Dosage Form + Strength Coxim tablet 30mg


Etoricoxib……….…………30mg


Pharmacological Group NSAID

Type of Form Form-5





MHRA approved


dosage form)

Not provided



Remarks of the Evaluator Applicant has claimed Manufacturer’s specifications but

applied formulation is not present in available USP & BP.

Decision: Deferred for submission of evidence of applied formulation/drug for generic / me-too

status.




Applicant



Brand Name +Dosage Form + Strength Coxim tablet 60mg


Etoricoxib……….…………60mg



Type of Form Form-5





MHRA approved


dosage form)

Oraxib 60mg tablet of M/s Atco Labs.



Remarks of the Evaluator ● Applicant has claimed Manufacturer’s

specifications but applied formulation is not

present in available USP & BP.



Applicant

M/s. Aspin Pharma (Pvt.) Ltd., Plot # 10 & 25, Sector 20,


Brand Name +Dosage Form + Strength Benicort-F cream

Composition Each gram contains:

Betamethasone (as valerate)………1mg

Fusidic acid.………………………20mg


Pharmacological Group Corticosteroids/ Antibacterial

Type of Form Form-5


Pack size & Demanded Price 5gm; As per DPC



Fucibet cream (MHRA approved)


dosage form)

Fucicort Leo cream of M/s Leonine Pharma

GMP status GMP Compliant; dated 18-8-2017

Remarks of the Evaluator ● Applicant has claimed manufacturer’s specifications

and applied formulation is not present in available USP

and BP.

● Firm has proposed following alternate brand names:

➢ Bactovate-F

➢ Betni-F



Applicant



Brand Name +Dosage Form + Strength Benicort-N ointment



Neomycin sulphate………………..5mg



Type of Form Form-5







MHRA approved


dosage form)

Betnovate-N ointment of M/s GSK




and BP.


➢ Bactovate-N

➢ Betni-N



Applicant



Brand Name +Dosage Form + Strength Benicort-N cream



Neomycin sulphate………………..5mg



Type of Form Form-5





MHRA approved


dosage form)

Betnovate-N cream of M/s GSK




and BP.


➢ Bactovate-N

➢ Betni-N



Applicant

M/s. Alza Pharmaceuticals, Al-Shifa Trust Eye Hospital,

Jehlum Road, Rawalpindi.

Brand Name +Dosage Form + Strength Vagicin 2% cream


Clindamycin (as phosphate)………20mg


Pharmacological Group Antibacterial

Type of Form Form-5


Pack size & Demanded Price 15gram; As per PRC



Cleocin (USFDA approved)


dosage form)

Clindanor 2% cream of M/S Nortech pharmaceuticals



Decision: Approved.




Applicant

M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super

Highway Industrial Area, North Karachi.

Brand Name +Dosage Form + Strength Ephastine-10mg tablet


Ebastine ………….10mg


Pharmacological Group Antihistamine

Type of Form Form-5


Pack size & Demanded Price 1x10’s and 2x10’s; As per SRO



Kestin 10mg film coated tablets (ANSM approved)


dosage form)

Histabid 10mg film coated tablets of M/s Platinum

Pharmaceuticals

GMP status Last GMP inspection conducted on 27-04-2017 and the

panel recommended the grant of GMP certificate.

Remarks of the Evaluator ● On clarification regarding submission of

accelerated stability studies data before production

firm submitted the following response:

“Submitted accelerated stability study is for small scale

trial batches however we will provide 06 months

accelerated and real time stability after production starts as

per submitted undertaking to conduct & submit stability

studies along with data as per guidelines/requirements

approved by the Registration Board.”

● Applicant has claimed manufacturer’s

specifications and applied formulation is not

present in available USP and BP.



Applicant



Brand Name +Dosage Form + Strength Roxin150mg tablet


Roxithromycin ………….150mg


Pharmacological Group Macrolide antibiotic

Type of Form Form-5





Roximycin 150mg film coated tablet(TGA approved)


dosage form)

Roxibiotic 150mg film coated tablet of M/s Alpine Pharma



















Applicant



Brand Name +Dosage Form + Strength Des-Loratlax 5mg tablet


Desloratadine ………….5mg


Pharmacological Group Antihistamine

Type of Form Form-5





Clarinex 5mg film coated tablet (USFDA approved)


dosage form)

Desdine 5mg film coated tablet of M/s Hygeia

Pharmaceuticals

















Applicant



Brand Name +Dosage Form + Strength Iropharm-F tablet

Composition Each chewable tablet contains:

Elemental iron (as iron (III) hydroxide polymaltose

complex………...….100mg

Folic acid ………….0.35mg


Pharmacological Group Haematinic

Type of Form Form-5


Pack size & Demanded Price 1x10’s, 2x10’s and 3x10’s; As per SRO



Could not be confirmed.


dosage form)

RBC-F chewable tablet of M/s Genix Pharma














Decision: Approved.


Applicant



Brand Name +Dosage Form + Strength Ephacard 5mg tablet

Composition Each tablet contains:

Amlodipine (as besylate) ………….5mg


Pharmacological Group Calcium antagonist

Type of Form Form-5





Norvasc 5mg tablet (TGA, USFDA approved)


dosage form)

Ampress tablets of M/s Barrett Hodgson Pakistan












Decision: Approved.


Applicant



Brand Name +Dosage Form + Strength Clofen 100mg tablet


Aceclofenac ………….100mg



Type of Form Form-5


Pack size & Demanded Price 1x10’s, 2x10’s and 3x10’s; As per SRO



Preservex tablets (MHRA approved)


dosage form)

Airtal of M/s Highnoon laboratories



















Applicant

M/s. Welwrd Pharmaceuticals ,Plot No. 3, Block A,

Phase I-II, Industrial Estate, Hattar,

Brand Name+Dosage Form + Strength W-PentopTablet 40mg

Composition Each enteric coated tablet contains:

Pantoprazole as Sodium Sesquihydrate…..40mg

Diary No. Date of R& I & fee Dy. No. 593, 1-11-2016 , Rs.20,000/- (1-11-2016)

Pharmacological Group PPIs

Type of Form Form-5

Finished product Specification USP

Pack size & Demanded Price 7’s, As per SRO


Reference Regulatory Authorities.

Pantoprazole tablets by Rakeda

(MHRA Approved)

Me-too status APTIZOLE by Global Pharma

GMP status 14 June, 2017, GMP compliant.

Remarks of the Evaluator. ● Rs.20,000/- (15-02-2018) for change of formulation

from film coated to enteric coated tablet.

Decision: Approved.


Applicant

M/s. Wnsfield Pharmaceuticals ,Plot No. 122, Block

A, Phase V, Industrial Estate, Hattar,

Brand Name+Dosage Form + Strength Terbilet Cream 1 %

Composition Each tube contains

Terbinafine Hydrochloride….1%


Pharmacological Group Antifungal

Type of Form Form-5

Finished product Specification JP

Pack size & Demanded Price 5gm, 10gm, As per SRO



MHRA Approved

Me-too status Terbiderm Cream 1.0% by M/s Atco Laboratories

Limited (Reg#032004)

GMP status Date of inspection: 18-1-18

Purpose of inspection: renewal of DML

Conclusion: Recommended

Remarks of the Evaluator. ● Shelf life after opening: 1 month.

Decision: Approved.


Applicant

M/s. Welmark Pharmaceuticals ,Plot No.122, Block B,

Phase V, Industrial Estate, Hattar,

Brand Name+Dosage Form + Strength Muctein Sachet 100mg

Composition Each sachet contains :

Acetylcystein….100mg


Pharmacological Group Expectorant



Type of Form Form-5

Finished product Specification Manufacturer Specs.

Pack size & Demanded Price 30’s As per SRO



Switzerland Approved

Me-too status Registration Number: 021175

Brand Name: Fluimucil 100mg/ 1gm Sachet

Manufacturer Name: Zambon Group SPA

Importer Name: Sanital Pharmaceutical

GMP status Date of inspection: 16-09-2017.

Purpose of inspection: Routine GMP

Conclusion: GMP complaint

Remarks of the Evaluator. .



Applicant

M/s. Welmark Pharmaceuticals ,Plot No.122, Block B,

Phase V, Industrial Estate, Hattar,

Brand Name+Dosage Form + Strength Markcol Sachet

Composition Each 13.8g sachet contains:

Polyethylene glycol…13.125 mg

Sodium Chloride…350.7 mg

Potassium Chloride…46.6mg

Sodium Bicarbonate…178.5mg


Pharmacological Group Laxative

Type of Form Form-5


Pack size & Demanded Price As per SRO



MHRA Approved

Me-too status Brand Name: Wivocol Sachet

Registration Number: 080543

Manufacturer Name: Winthrox Pharmaceuticals,

GMP status Date of inspection: 16-09-2017.

Purpose of inspection: Routine GMP

Conclusion: GMP complaint

Remarks of the Evaluator. .

Decision: Approved.


Applicant

M/s. Wellborne Pharmachem & Biological, Hattar.

Brand Name+Dosage Form+Strength Dulox 60 mg Capsule

Composition Each Capsule Contains:-

Enteric coated pellets of Duloxetine hydrochloride 17.65%

w/w…... eq. to Duloxetine ….…. 60 mg

Source of pellets: M/s Spansules Formulations, Telangana

state, India.

Diary No. Date of R& I & fee Dy.No. (R&I) 251, 20-7-2016; Rs.20,000/- (20-07-2016)

Rs. 80,000/- (08-02-2018)

Pharmacological Group Antidepressant

Type of Form Form-5


Pack size & Demanded Price As per policy



Approved by USFDA



Me-too status Dulan capsules of M/s Hilton Pharma (Pvt.) Limited

Karachi (Reg.# 055448)

GMP status Last inspection conducted on 27-02-2017“Strictly

following the GMP compliance.”

Remarks of the Evaluator.

Decision: Registration Board referred the case to QA & LT Division to conduct GMP

inspection of Firm on priority. The Board also directed the firm to change the brand name.


Applicant


Brand Name+Dosage Form+ Strength Dulox 20 mg Capsule





state, India.

Diary No. Date of R& I & fee Dy. No. (R&I) 250, 20-7-2016; Rs.20,000/- (20-07-2016)

Rs. 80,000/- (08-02-2018)


Type of Form Form-5





Approved by USFDA



GMP status Last inspection conducted on 27-02-2017 “Strictly






Applicant


Brand Name+Dosage Form+ Strength Dulox 30 mg Capsule





state, India.

Diary No. Date of R& I & fee Dy. No. (R&I) 249, 20-7-2016; Rs.20,000/- (20-07-2016)

Rs. 80,000/- (08-02-2018)


Type of Form Form-5





Approved by USFDA



GMP status Last inspection conducted on 27-02-2017 “Strictly







S

#

#

.

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

Remarks of

the Evaluator

Decision

26. Ray Pharma

(Pvt) Ltd., S-58.

SITE Extension,

Hawksbay Road,

Karachi

SHELET Tablet

Each film coated

tablet contains:

Letrozole….2.5mg

(Non-Steroidal

aromatase inhibitor)

USP Specs

Form 5

Dy No. 1314

22-10-2012

PKR 8,000/-

(22-10-2012)

+

PKR 12,000/-

(22-10-2012)

30’s:

Rs.8500/-

Femara Tablets by

Novartis

(MHRA Approved)

Femara tablets by

Novartis

Last inspection report

dated 8-8-2017

confirms satisfactory

compliance to GMP

Approved.

27. Ray Pharma

(Pvt) Ltd., S-58.

SITE Extension,

Hawksbay Road,

Karachi

IVFer Injection

Each 5ml ampoule

contains:

Iron (as iron

sucrose)….100mg

(Anti anaemics)

BP Specs

Form 5

Dy No. 1313

22-10-2012

PKR 8,000/-

(22-10-2012)

+

PKR 12,000/-

(22-10-2012)

5ml x 5’s:

Rs.1400/-

Venofer Injection by

Vifor

(MHRA Approved)

Venofer injection by

Gastrocare


dated 8-8-2017

confirms satisfactory

compliance to GMP

Approved

28. CSH

Pharmaceuticals,

North (Pvt) Ltd.,

38-A, Industrial

Estate,

Hayatabad,

Pshawar

PROLIFE 7.5mg

Tablet

Each film coated

tablet contains:

Ivabradine (as

hydrochloride)

….7.5mg

(Anti-anginal)

Form 5

Dy No. 1017

10-12-2012

PKR 20,000/-

(10-12-2012)

1 x 14’s:

Rs. 1150/-

Ivabradine 7.5mg

tablet by Teva UK

(MHRA Approved)

Sivab 7.5mg tablet

by Getz


28-2-2017: No

observations by the

FID as per data

provided by QA

division

Registration

Board

referred the

case to QA &

LT Division

to conduct

GMP

inspection of

Firm on

priority

29. Al Fazal Pharma

Industries (Pvt)

Ltd., Plot No.

20-22, 16.5 Km,

Sheikhupura

Road Lahore

CECO CAPSULE

200mg

Each capsule

contains:

Celecoxib….200mg

(Cox-II inhibitor)

Form 5

23-5-2014

PKR 20,000/-

(23-05-2014)

(Duplicate)

15g: As per

SRO

Bioxcel 200mg

Genthon

(MHRA

Approved)

Nuzib capsule by

Bosch

Last GMP

inspection report

dated 25-10-2017

concludes “The

Approved

with

innovator’s

specification.



firm need further

improvement

regarding

documentation,

SOP’s, validation

processes of

manufacturing/

QC. However

overall

upgradation

condition of firm

was satisfactory

30. Al Fazal Pharma

Industries (Pvt)

Ltd., Plot No.

20-22, 16.5 Km,

Sheikhupura

Road Lahore

E-THIN cream

Each grm cream

contains:

Eflornithine

hydrochloride……13

.9%

(Antiprotozoal)

Form 5

23-5-2014

PKR 20,000/-

(23-05-2014)

(Duplicate)

15g: As per

SRO

Vaniqa cream by

Skinmedica

(USFDA Approved)

Depilus cream by

Atco

Last GMP inspection

report dated

25-10-2017

concludes “The firm

need further

improvement

regarding

documentation,

SOP’s, validation

processes of

manufacturing/ QC.

However overall

upgradation

condition of firm was

satisfactory

Approved with

innovator’s

specification.

31. Al Fazal Pharma

Industries (Pvt)

Ltd., Plot No.

20-22, 16.5 Km,

Sheikhupura

Road Lahore

LORAMIDE

Capsule 2mg

Each capsule

contains:

Loperamide

hydrochloride….2mg

(Antipropulsive)

USP Specs

Form 5

23-5-2014

PKR 20,000/-

(23-05-2014)

(Duplicate)

30’s: As per

SRO

Diafix 2mg capsule

by Galpharm

(MHRA Approved)

Imodium capsule by

Johnson & Johnson

Last GMP inspection

report dated

25-10-2017

concludes “ The firm

need further

improvement

regarding

documentation,

SOP’s, validation

processes of

manufacturing/ QC.

However overall

upgradation


satisfactory.

Approved.



32. Al Fazal Pharma

Industries (Pvt)

Ltd., Plot No.

20-22, 16.5 Km,

Sheikhupura

Road Lahore

PROZINE SYRUP

Each 5ml contains:

Promethazine

hydrochloride

…..5mg

(antihistamine)

USP Specs

Form 5

23-5-2014

PKR 20,000/-

(23-05-2014)

(Duplicate)

60ml, 120ml:

As per SRO

Phenergan Elixir by

Sanofi

(MHRA Approved)

Phenergan elixir by

Sanofi

Last GMP inspection

report dated

25-10-2017

concludes “The firm

need further

improvement

regarding

documentation,

SOP’s, validation

processes of

manufacturing/ QC.

However overall

upgradation


satisfactory

Approved.

33. Al Fazal

Pharma

Industries (Pvt)

Ltd., Plot No.

20-22, 16.5

Km,

Sheikhupura

Road Lahore

TRETIN

CREAM

Each gram

contains:

Tretinoin….0.05%

(Anti acne)

USP Specs

Form 5

23-5-2014

PKR 20,000/-

(23-05-2014)

(Duplicate)

15g: As per

SRO

(USFDA Approved)

0.05% cream

Tretinex cream by

Mass Pharma

Last GMP inspection

report dated

25-10-2017

concludes “ The firm

need further

improvement

regarding

documentation,

SOP’s, validation

processes of

manufacturing/ QC.

However overall

upgradation


satisfactory

Approved.

34. Barrett Hodgson

Pakistan (Pvt)

Ltd., F/423,

SITE, Karachi

MalEra Sachet

40/240 mg

Each sachet contains:

Artemether….40mg

Lumefantrine….240

mg

(Antimalarial)

Form 5

Dy No. 270

21-3-2011

PKR 8,000/-

(21-3-2011)

8’s: Rs. 450/-

Could not be

confirmed

Could not be

confirmed

Last inspection

report dated 8-8-

2017 confirms

satisfactory

compliance to

GMP

Evidence of

approval in

reference

regulatory

authorities

could not be

confirmed.

Evidence of

me-too could

not be

confirmed.

Evidence of

12,000 fee

Registration

Board rejected

the application

as applied

formulation is

not approved

by any

reference

regulatory

authority and

firm has not

submitted

safety and

efficacy data.



chalan dated

05‐09‐2013

could not be

confirmed.

80/480

sachet is

already

rejected in

258th

meeting of

Registration

Board

Case No. 02: Registration applications of import (Human) cases

35. Name and address of Applicant M/s M&M Pharma, 1

st Floor, opposite gate No. 2, Pepsi

Factory, Guru-mangat Road, Gulberg-II, Lahore Pakistan

Detail of Drug Sale License Address: 1st Floor Javaid Plaza Opposite Gate No. 2, Pepsi

Road Guru-mangat Road, Gulberg-II, Lahore

Validity: 22/07/2018

Status: License to sell drugs as a “Distributor”

Name and address of manufacturer M/s T.P. Drug Laboratories (1969) Co. Ltd., (Rama 2

Branch) 22 Bangkradee 30, Rama II Road Samaedam, Bang

KhunThian, Bangkok 10150, Thailand

Name and address of marketing

authorization holder

Same as above

Name of exporting country Thailand

Type of Form Form 5-A

Diary No. & Date of R& I Dy No. 2065: 9-5-2017

Fee including differential fee PKR 100,000/-: 3-5-2017

Brand Name +Dosage Form +

Strength

DEPTONE Solution for Injection 150mg

Composition Each ml contains:

Medroxyprogesterone acetate…….150mg

Finished Product Specification USP

Pharmacological Group Progestogens

Shelf life 3 Years along with real-time stability data

Demanded Price 7.50 USD

Pack size 1 x 25 ml vials

International availability Depo-Provera 150 mg/ml by Pfizer Limited (MHRA

Approved)

Me-too status Medroxy Depo Injection by Global Pharma

Detail of certificates attached CoPP:

Original, legalized CoPP (Certificate No. 2-2-10-3-16-00297)

issued by Thailand Food and Drug Administration dated 13th

July 2016 is provided by the firm which confirms free sale as

well as GMP status of the manufacturer.

● Firm has also submitted original legalized free sale

certificate valid till 12 July 2018

● Firm has also submitted original, legalized GMP certificate


Decision: Approved as per Policy for inspection of Manufacturer abroad.



Case No. 03: Registration applications of newly granted DML or New section (Human)

a. New/Additional section(s)

M/s. Akhai Pharmaceuticals Plot #A-248 & A-256 to A-259 H.I.T.E Lasbela, Balochistan, Pakistan

Previously considered molecules: 03

Tablet section( Psychotropic): Products:01, Molecules:01


Applicant

M/s. Akhai Pharmaceuticals Plot #A-248 & A-256 to A-

259 H.I.T.E Lasbela, Balochistan, Pakistan

Brand Name +Dosage Form + Strength Alpram 0.5mg tablet

Other suggested names:

Azpram 0.5mg tablet

Bupram 0.5mg tablet


Alprazolam………0.5mg


Pharmacological Group Anti-depressant/Anxiolytic

Type of Form Form-5

Finished product Specifications USP specifications

Pack size & Demanded Price 10’s; As per SRO

Approval status of product in Reference

Regulatory Authorities

Approved in US-FDA

Me-too status (with strength and dosage

form)

Jibrone 0.5mg tablet of Martin Dow


firm is operating at satisfactory level of GMP

compliance.


Decision: Approved.



b. Deferred Cases

M/s Pharmasol (Pvt) Ltd.

Diluents and water for Injection (Human)

07 Products / 05 Molecules

Decision in 278th

meeting of Registration board held on 29-31st January, 2017 against above mentioned

section was ‘Deferred for confirmation whether manufacturing facility of “Diluents and water for Injection

(Human)” is approved for “Ampoules” or “Vials”.

Evaluation by PEC:

● Firm has responded via letter dated 13/02/2018 that it has facility for filling both ampoule and vials

which is mentioned in panel inspection report.

● Panel inspection report was checked and it was verified that section under consideration has facility to fill

both vials and ampoules.


Applicant

M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial

Estate, Raiwind Road, Lahore.

Brand Name +Dosage Form + Strength PSOL Sterile water for injection 5ml

Diary No. Date of R& I & fee Diary No: 24154, 13-12-2017, Rs: 20,000/-

Composition Each Ampoule Contain

Sterile water for injection (as diluent)

Pharmacological Group Diluent/Solvent for Reconstitution

Type of Form Form-5


Pack size & Demanded Price 5ml ampoule/ As per SRO


Regulatory Authorities.

Water for Injections by M/s Macarthys Laboratories Limited

(MHRA approved )

Me-too status Sterile water for injection 5ml by M/s Getz Pharma (Reg. No.

053041)

GMP status 13-07-2017/ Grant of new DML,

Panel recommends grant of new DML.


Decision: Approved.


Applicant



Brand Name +Dosage Form + Strength PSOL Sterile water for injection 20ml

Diary No. Date of R& I & fee Diary No: 24155 ,13-12-2017 , Rs: 20,000/-

Composition Each Vial Contains:

Sterile water for injection….20ml


Type of Form Form-5


Pack size & Demanded Price 1’s vial x 20ml / As per SRO



Water for Injections BP by M/s Hameln Pharmaceuticals

Limited (MHRA Approved)

Me-too status Sterile water for injection by Mendoza Pharma

(Reg.No.058646) 20ml

GMP status 13-07-2017/Grant of new DML,



Decision: Approved.


Applicant



Brand Name +Dosage Form + Strength NSOL 0.9% W/V Solution for Injection

Diary No. Date of R& I & fee Diary No: 24156 , 13-12-2017 , Rs: 20,000/-




Sodium chloride…9mg


Type of Form Form-5


Pack size & Demanded Price 5ml ampoule/ As per SRO



Sodium Chloride Injection BP 0.9% w/v by M/s Hameln

pharmaceuticals limited (MHRA Approved)

Me-too status Sacro Injection (0.9%w/v) 5ml by M/s Macter (Reg#079756)

GMP status 13-07-2017

Grant of new DML,



Decision: Approved.


Applicant



Brand Name +Dosage Form + Strength Bensol(Bacteriostatic Water) for injection


Composition Each ml of sterile water contains:

Benzyl alcohol …….9mg

Pharmacological Group Diluent/Solvent for Reconstitution for methyl prednisolone

dry injection

Type of Form Form-5


Pack size & Demanded Price 1’s ampoule x 7.8ml/ As per SRO



Bacteriostatic Water for Injection by M/s Pfizer Limited

(MHRA Approved) (1 ml pre-filled syringe)

Me-too status Bacteriostatic water 7.8ml by M/s Upjohn (Reg#031265)



Remarks of the Evaluator. ● Applied pack size of 7.8ml ampoule not confirmed from


Decision: Approved.


Applicant



Brand Name +Dosage Form + Strength SBSOL Diluent (Bacteriostatic saline)



Sodium chloride…9mg

Benzyl alcohol…9mg

Pharmacological Group Diluent

Type of Form Form-5


Pack size & Demanded Price 1ampoule x 5ml/ As per SRO



Bacteriostatic sodium chloride solution

Hospira (USA/EU)

Me-too status Bacteriostatic Sodium chloride Injection by M/s Spencer

Pharma (Reg#042113) (pack size not confirmed)


Grant of new DML,


Remarks of the Evaluator. ● Applied pack size of 5ml ampoule not confirmed from

Reference Regulatory Authorities and me-too database.



● Firm has not specified for which formulation/ product the

diluent will be used

Decision: Deferred for confirmation of drug product for which instant formulation/ product will

be used as diluent.


Applicant



Brand Name +Dosage Form + Strength Diluent For Dotaxol 20mg


Composition Each vial contains:

Ethanol 95%.…………..13%(V/V)

Water for Injection………..87%(V/V)

Pharmacological Group Diluent for docetaxel injection

Type of Form Form-5

Finished Product Specification Innovator's specifications

Pack size & Demanded Price 1’sx1.5ml / As per SRO



Taxotere solvent by Sanofi-Aventis (Canada Approved)

Me-too status Diluent for Meberexel 20mg by M/s CCL Pharmaceuticals

1.5ml (Reg#045609)

GMP status 13-07-2017 / Grant of new DML,



Decision: Deferredfor consideration along with applied drug products by the firm.


Applicant



Brand Name +Dosage Form + Strength Diluent For Dotaxol 80mg


Composition Each vial contains:

Ethanol 95%.BP…………..13%(V/V)

Water for Injection………..87%(V/V)

Pharmacological Group Diluent for docetaxel injection

Type of Form Form-5

Finished Product Specification Innovator's specifications

Pack size & Demanded Price 1’sx6ml / As per SRO



Taxotere solvent by Sanofi-Aventis (Canada Approved)

Me-too status Diluent for Meberexel 80mg by M/s CCL Pharmaceuticals

6ml (Reg#045607)




Decision: Deferred for consideration along with applied drug products by the firm.

Liquid Injection (General) (Human)

14 Products / 10 molecules

Decision in 278th

meeting of Registration board held on 29-31st January, 2017 against above mentioned

section was ‘Deferred for confirmation whether manufacturing facility of Liquid Injection (General)

(Human) is approved for “Small Volume Parenteral” or “Large Volume Parenteral”

Evaluation by PEC:

● Firm has responded via letter dated 13/02/2018 that it has 2 vial washing machines (one for large volume

vials and one for small volume vials) and one vial filling machine. The vial filling machine has ability to

fill both large volume vials and small volume vials.

● Firm has submitted broacher and import documents.

● Submitted import documents do not mention the model of machine used for filling.



● According to import documents the ability of filling machine ranges from 2ml to 10ml and 100ml to

250ml.

● Panel inspection report was checked and it could not be verified that section under consideration has

facility to fill vials as both SVP and LVP.


Applicant



Brand Name +Dosage Form + Strength Typhoxcin Injection 200mg/100ml

Diary No. Date of R& I & fee Diary No: 24068, 13-12-2017 , Rs: 20,000/-

Composition Each 100ml vial contains:

Ofloxacin (as hydrochloride)...200mg

Pharmacological Group Quinolone Antibacterial

Type of Form Form-5

Finished Product Specification Innovator’s specifications

Pack size & Demanded Price 1'sx100ml/As per SRO



Tarivid IV Infusion Solution 2mg/ml by M/s Sanofi, MHRA

approved

Me-too status Tariflox Infusion 200mg/100ml by M/s Bosch (Reg#021506)




Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by

area FID.


Applicant



Brand Name +Dosage Form + Strength Ciproxol Infusion 200mg/100ml



Ciprofloxacin (as lactate)…200mg


Type of Form Form-5





Ciprofloxacin 2 mg/ml solution for infusion by M/s

HikmaFarmacêutica (Portugal), S.A.(MHRA Approved)

Me-too status Qilox 200mg/100ml Infusion by M/s Bosch (Reg#073417)





area FID.


Applicant



Brand Name +Dosage Form + Strength Ciproxol Infusion 400mg/100ml



Ciprofloxacin (as lactate)…400mg


Type of Form Form-5





Cipro IV 400mg Bayer healthcare Pharmaceuticals Inc. New

Jersey, USA (not confirmed)

Me-too status Novidat DS Injection 400mg/100ml by M/s Sami Phama

(Reg#042270)





Remarks of the Evaluator. ● Approval status of product in Reference Regulatory

Authorities not confirmed.


area FID.


Applicant



Brand Name +Dosage Form + Strength Levoxol Infusion 500mg/100ml



Levofloxacin (as hemihydrate)…500mg


Type of Form Form-5





Evoxil 5 mg/ml solution for infusion by M/s Beacon

Pharmaceuticals, (MHRA approved )

Me-too status Lorex Infusion 500mg/100ml by M/s Regal Pharmaceuticals

(Reg#081996)





area FID.


Applicant



Brand Name +Dosage Form + Strength Levoxol Infusion 750mg/150ml


Composition Each 150ml of solution for infusion contains:

Levofloxacin (as hemihydrate)…750mg


Type of Form Form-5


Pack size & Demanded Price 1'sx150ml /As per SRO



Cravit IV by M/s Daiichi Sankyo, Japan (Pack size of 150ml

not confirmed from approved website of PMDA)

Me-too status Leflox 750mg/150ml Infusion By Getz Pharma (Reg.No.

058590),



Remarks of the Evaluator. ● Pack size of 150ml and packaging of applied formulation

in vials not confirmed from RRA.


area FID.


Applicant



Brand Name +Dosage Form + Strength M-Flox Infusion 400mg/250ml


Composition Each 250ml contains:

Moxifloxacin (as hydrochloride)…400mg


Type of Form Form-5




Pack size & Demanded Price 1'sx250ml /As per SRO



Avelox 400 mg/250 ml solution for infusion by M/s Bayer

plc, (MHRA approved)

Me-too status Mofest Infusion 400mg/250ml by M/s Sami (Reg#053227)



Remarks of the Evaluator. ● Confirmed as glass vial from MHRA


area FID.


Applicant



Brand Name +Dosage Form + Strength Linzol Infusion 200mg/100ml


Composition Each 100ml solution for infusion contains:

Linezolid…200mg

Pharmacological Group Oxazolidone Antibiotic

Type of Form Form-5


Pack size & Demanded Price 1’sx100ml /As per SRO



ZYVOX linezolid 200mg/100mL injection infusion bag by

M/s Pfizer Australia Pty Ltd, (TGA approved.)

Me-too status Ecasil Infusion 200mg/100ml by M/s Sami (Reg#067516)





area FID.


Applicant






Linezolid…600mg


Type of Form Form-5





Linezolid 2 mg/ml solution for infusion by M/s Pfizer

Limited , MHRA approved

Me-too status Zolrest Infusion 600mg/300ml by M/s Bosch (Reg#055916)





area FID.


Applicant






Linezolid…400mg




Type of Form Form-5





ZYVOX linezolid 400mg/200mL injection infusion bag by

M/s Pfizer Australia Pty Ltd, TGA approved.

Me-too status Linolid Infusion 400mg/200ml by M/s Bio-Labs

(Reg#073088)





area FID.


Applicant



Brand Name +Dosage Form + Strength Parasol Infusion 1g/100ml



Paracetamol…1000mg

Pharmacological Group Antipyretic/Analgesic

Type of Form Form-5


Pack size & Demanded Price 1's /As per SRO



PERFALGAN 10 mg/ml, solution for infusion by M/s

Bristol-Myers Squibb Pharmaceutical Limited, (MHRA

approved )

Me-too status Falgan Infusion 1000mg/100ml by M/s Bosch (Reg#055540)


Grant of new DML,




area FID.


Applicant



Brand Name +Dosage Form + Strength Konacane Infusion 200mg/100ml



Fluconazole…2mg

Pharmacological Group Anti-Fungal

Type of Form Form-5





Diflucan 2 mg/ml solution for infusion by M/s Pfizer Limited

(MHRA Approved)

Me-too status Diflucan 2mg/ml IV infusion 50ml by M/s Pfizer (Reg.

No.011830), (pack size not same as of applied formulation.)


Grant of new DML,


Remarks of the Evaluator. ● Confirmed as glass vial from MHRA

● Pack size of 100ml not confirmed from available me-too

database.

● Firm initially applied for 100ml pack size. When



communicated with shortcoming, firm replied that they

mistakenly wrote pack size 100ml instead of 50ml. Firm

has submitted revised form-5 and master formulation.


area FID.


Applicant



Brand Name +Dosage Form + Strength Diazole Injection 500mg/100ml



Metronidazole…500mg

Pharmacological Group Imidazole derivatives/ Antibacterial

Type of Form Form-5





Metronidazole Braun 5 mg / ml solution for infusion b M/s

B. Braun Melsungen AG (Medical Products Agency, Sweden

Approved)

Me-too status Metrosol I.V Infusion 100ml by M/s Atlantic (Reg.No.

055042)


Grant of new DML,




area FID.


Applicant



Brand Name +Dosage Form + Strength Combifer Infusion 500mg/10ml


Composition Each 10ml vial contain:

Iron carboxymaltose complex eq.to Elemental Iron …500mg

Pharmacological Group Haematinic

Type of Form Form-5





Ferinject 50 mg iron/mL solution for injection/infusion. By

M/s Vifor France (MHRA approved)

Me-too status Ferinject 500mg/10ml by M/s RG. Pharmaceuticals

(Reg#072548)



Remarks of the Evaluator. ● Confirmed as 2ml, 10 ml and 20ml vial in MHRA, UK.


area FID.


Applicant



Brand Name +Dosage Form + Strength Tirosol Injection 12. 5mg/50ml


Composition Each ml contains

Tirofiban (as hydrochloride monohydrate)…0.25mg

Pharmacological Group Antithrombotic agents (Platelet aggregation inhibitors excl.

heparin)



Type of Form Form-5





AGGRASTAT (250 micrograms/ml) concentrate for solution

for infusion 50ml vial by M/s Correvio (UK) Ltd (MHRA

Approved)

Me-too status Aggrastat Injection 0.25mg/ml 50ml vial by M/s Atco Labs

(Reg#025299),





area FID


Applicant

M/s Genetics Pharmaceuticals Pvt Ltd. Plot#539-A, Sunder

Industrial Estate, Lahore.

Brand Name +Dosage Form + Strength Dobalta 20mg Capsule

Diary No. Date of R& I & fee Each capsule contains:

Duloxetine as hydrochloride (enteric coated pellets

20%)…20mg

Composition Diary No: 416, 17/11/2016, Rs. 20,000/-

Pharmacological Group SSRI

Type of Form Form 5


Pack size & Demanded Price 10’s,14’s,20’s,28’s / As per SRO



Cymbalta (Duloxetine Delayed-Release Capsules) 20mg by

M/s Eli Lilly, (USFDA Approved)

Me-too status D-Lex DR 20 mg Capsule by M/s Ciba Pharmaceuticals,

Karachi. (Reg#081577)

GMP status New DML granted 25/8/16

Previous Remarks of the Evaluator.

● Source of pellets RA Chem Pharma Ltd, India., (Plot#

A-19/C, Road No. 18, Nacharam, Hyderabad – 500076,

Telangana, INDIA)

● GMP certificate of pellet source valid till 23-03-18

● Proof of approval of pellets from Relevant Regulatory

Authority is provided.

Decision in previous meeting 274th Meeting Registration Board held on 21-23

rd

September, 2017.

Deferred for submission of differential fee for imported

pellets.

Evaluation by PEC

● Firm has submitted evidence of submission differential fee for imported pellets of by providing

yellow copy of fee challan of Rs. 80,000/-

(Challan no. 0580838

Ref: TT163570RD8K)

Verified from Statistical Department.

● Furthermore, when firm was asked to furnish latest inspection report conducted within 1 year, the

firm replied:

‘Dobalta 20mg Capsule is submitted in DRAP on 9th November, 2016 and was deferred in 274

th DRB

meeting dated 21-22nd

September, 2017 for verification of challan of pellets and PEC has further raised

a query regarding latest GMP inspection report of our manufacturing facility i.e. Genetics

Pharmaceuticals Pvt Ltd. Located at Plot#539-A, Sunder Industrial Estate, Lahore.

We would like to submit as under;

DRAP has conducted inspection of our new manufacturing facility on 15th June, 2016 and issued us

DML on 25th August, 2016 which is valid for 05 years till 24-08-2021. So far we have not yet started

manufacturing at our plant as we are in process of receiving registrations of products i.e. 10 molecules



per section. Also we are procuring their raw materials and products are under trial for product

development and stability studies and we will soon start commercial manufacturing.

As we are applying for new registrations, the evaluation cell of DRAP has raised a query regarding

GMP inspection report plus we are unable to get registration letters of our products approved in DRB

meetings.

We assure you that we will have GMP inspection of our manufacturing plant as soon as we will start

manufacturing of products.

Therefore in view of the above we request you to please consider DML till GMP inspection can be

done, so that we can get registration of products to be manufactured at our newly manufactured

facility.’

● However, it was confirmed from R-V section that M/s Genetics Pharmaceuticals Pvt Ltd. Located

at Plot#539-A, Sunder Industrial Estate, Lahore was issued products registration letter in March,

2017.

Decision in previous meeting 277th Meeting of Registration Board held on 27-29

th

December, 2017.

Registration Board referred the case to QA & LT Division

to conduct GMP inspection of Firm on priority.

Evaluation by PEC:

● A letter was forwarded by Area FID, Lahore with letter No.2090/2018-DRAP(L-I) dated 12-2-2018

with subject ‘Inspection of M/s Genetics Pharmaceuticals (Pvt) Ltd. Lahore’. The letter read.

‘Inspection of M/s Genetics Pharmaceuticals (Pvt) Ltd. Lahore was conducted on 05-01-2018

to verify GMP compliance status of the firm for grant of registration of products. The firm has

developed following sections to manufacture drugs by way of formulation:

I.) Tablet Section (General)

II.) Capsule Section (General)

The firm was granted DML on 25-08-2016. The firm has not started manufacturing at their

plant till date. No production activity was being carried out in production area at the time of inspection.

However, the trial batches of Monilor 4mg Tablet and Trampol Tablet were being manufactured in

R&D section of the firm.

The GMP compliance status of the firm could not be verified because the firm was not

operational at the time of production. However, the premise was found well maintained and at a

satisfactory level of sanitation SOPs were also available.’

Decision: Approved.

59. Name and address of Manufacturer /

Applicant

M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek

Industrial Park, Karachi.

Brand Name+DosageForm+Strength Palsonate Injection 30mg IV

Composition Each vial contains:-

Artesunate…. 30mg

Diary No. Date of R&I & fee Dy No.22346; 28-11-2017; Rs.20,000/-

Pharmacological Group Antimalarial

Type of Form Form-5

Finished Product Specification International Pharmacopoeia Specifications

Pack Size & Demanded Price As per SRO



WHO recommended formulation

Me-too status Gen-M by Genix Pharma

GMP status New License (Inspection Date: 14th April 2017)

Remarks of Evaluator Applicant was asked to provide justification of submitted

stability studies that how you have performed stability

studies of applied formulation before issuance of DML. The

applicant instead of providing justification has provided

stability studies of applied formulation after issuance of

DML.



Previous Decision Registration Board in its 277th meeting deferred the case for

clarification/justification of following observation:

● How & where the firm has performed stability studies of

applied formulation before issuance of DML?

The firm may submit its response either in writing or may

appear before the Board to clarify its position.

Evaluation by PEC Firm has submitted that we had attached stability study data

by mistake in the registration dossier of trial batches which

were only prepared for training purpose of staff. Sorry for

including in dossier of registration.

We can further explain in person.

Decision: Registration Board deliberated the matter in detail and considering the fact that since

applied formulation is Me-too/Generic for which manufacturer will conduct stability study

before sale of drug product, thus Board Approved the case.


Applicant



Brand Name+DosageForm+Strength Palsonate Injection 60mg IV


Artesunate…. 60mg



Type of Form Form-5













DML.
















Applicant



Brand Name+Dosage Form+Strength Palsonate Injection 120mg IV


Artesunate…. 120mg





Type of Form Form-5













DML.



How & where the firm has performed stability studies of













Applicant



Brand Name+Dosage Form+Strength Palzidime Injection 250 mg IV/IM

Composition Each vial contains

Ceftazidime (as pentahydrate)...…250 mg

Diary No. Date of R&I & fee Dy. No.12302; 28-11-2017; Rs.20,000/-

Pharmacological Group cephalosporin, Antibiotics

Type of Form Form-5

Finished Product Specification USP specifications




Fortum 250 mg of GSK Ltd. UK (MHRA,USFDA)

Me-too status Vegazid 250mg Injection of Vega Pharmaceuticals


Remarks of evaluator Applicant was asked to provide justification of submitted





DML.


















Applicant



Brand Name+Dosage Form+Strength Palzidime Injection 500 mg IV/IM

Composition Ceftazidime (as pentahydrate)...…500 mg


Pharmacological Group Cephalosporins, Antibiotics

Type of Form Form-5





Fortum 500 mg of GSK Ltd. UK (MHRA)

Me-too status Vegazid 500mg Injection of Vega Pharmaceuticals







DML.
















Applicant



Brand Name+Dosage Form+Strength Palzidime Injection 1gm IV/IM

Composition Ceftazidime (as pentahydrate)...…1gm


Pharmacological Group Cephalosporin, Antibiotics

Type of Form Form-5





Fortum 1 g of GSK Ltd. UK (MHRA)

Me-too status Vegazid 1g Injection of Vega Pharmaceuticals









DML.
















Applicant



Brand Name +Dosage Form + Strength Bactopal 2g injection.

Diary No. Date of R& I & fee Dy No. 22344, 25-11-2017, Rs.20,000/-


Cefoperazone as sodium ….1000mg

Sulbactum as sodium… 1000mg

Pharmacological Group Antibiotics ( Cephalosporin)

Type of Form Form-5

Finished Product Specification Manufacturer’s Specs.




Approved in Europe (Poland, Slovakia, Czech Republic)

by EMA

Me-too status SUFZONE by Global Pharmaceuticals.


Remarks of the Evaluator. Applied formulation is present in JP

Previous Decision Registration Board in its 277th meeting deferred the case

for clarification/justification of following observation:

● How & where the firm has performed stability

studies of applied formulation before issuance of DML?



Evaluation by PEC Firm has submitted that we had attached stability study

data by mistake in the registration dossier of trial batches

which were only prepared for training purpose of staff.

Sorry for including in dossier of registration.



applied formulation is Me-too/Generic for which manufacturer will conduct stability study before sale

of drug product, thus Board Approved the case.


Applicant



Brand Name+Dosage Form + Strength Bactopal 1g injection

Diary No. Date of R& I & fee Dy No. 3224, 13-04-2017, Rs.20,000/-


Cefoperazone as sodium ….500mg

Sulbactum as sodium… 500mg



Pharmacological Group Antibiotics ( Cephalosporin)

Type of Form Form-5

Finished Product Specification Manufacturer’s Specs.




Approved in PMDA

Me-too status SUFZONE by Global Pharmaceuticals.


Remarks of the Evaluator. Applied formulation is present in JP

Previous Decision Registration Board in its 277th meeting deferred the case

for clarification/justification of following observation:

● How & where the firm has performed stability

studies of applied formulation before issuance of DML?



Evaluation by PEC Firm has submitted that we had attached stability study

data by mistake in the registration dossier of trial batches

which were only prepared for training purpose of staff.

Sorry for including in dossier of registration.



applied formulation is Me-too/Generic for which manufacturer will conduct stability study before sale

of drug product, thus Board Approved the case.

Case No. 04: Deferred cases of previous meetings (Human)


Applicant

M/s Medisynth Pharmaceuticals, Plot No. 55, Street No. S-

5, National Industrial Zone, Rawat, Islamabad.

Brand Name +Dosage Form + Strength Tirasynth 500mg tablets


Levetiracetam……….500mg

Diary No. Date of R& I & fee Dy.No.1028;(13-02-2017);Rs.20,000/-(13-02-2017)

Pharmacological Group Antiepileptic

Type of Form Form-5


Pack size & Demanded Price 3x10’s; As fixed by MoH



Keppra (USFDA approved)

Me-too status Eppra of M/s Global Pharma


report concludes that the firm is operating at fair level of

GMP compliance.

Previous remarks of the Evaluator. Original fee challan for Tirasynth 500mg capsules is

attached instead of Tirasynth 500mg tablets.

Previous decision(s) Deferred in 278th meeting for evidence of fee submitted for

applied formulation

Evaluation by PEC The submission of firm has been verified from original fee

challan (Deposit slip No.0555214) dated 13-02-2017.

Decision: Approved




Applicant

Medisynth Pharmaceuticals, Plot # 55, Street No. S-5,

National Industrial Zone, Rawat, Islamabad.

Brand Name +Dosage Form + Strength Synmol Tablet

Composition Each sustained release tablet contains:

Tramadol…….37.5mg

Paracetamol……325 mg


Pharmacological Group Opiate analogue + Analgesic.

Type of Form Form-5





Ultra Cet by Janssen pharma (USFDA)

Me-too status Acetra by Amarant

GMP status Last inspection report conducted on 19-09-2017 &

concluded satisfactory GMP compliance status.

Previous remarks of the Evaluator.

Previous decision(s) Deferred in 278th meeting for clarification of applied

dosage form as reference product is not approved as

sustained release tablet.

Evaluation by PEC The composition of immediate release film coated tablet

has been verified from master formulation of applied

product. The correct formulation is as under:

Each Film Coated tablet contains:

Tramadol…….37.5mg

Paracetamol……325 mg

Decision: Approved.


Applicant

M/s Medizan laboratories (pvt) Ltd. Plot 313, industrial

triangle Kahuta road, Islamabad

Brand Name +Dosage Form + Strength Tamsulim 0.4 mg Tablets

Composition Each capsule contains:-

TamsulosinHCl…………..0.4mg

Diary No. Date of R& I & fee Dy.No. 984, 10-1-2017, Rs.20,000/=

Pharmacological Group alpha-blocker

Type of Form Form-5


Pack size & Demanded Price 20’s; As Per SRO



Flomax of BoehringerIngelheim

Me-too status Alfamax of Platinum Pharmaceuticals

GMP status Last GMP Inspection conducted on 20-11-17 with

conclusive remarks of acceptable level of cGMP.


Previous decision(s) Deferred in 277th meeting for source of pellets, along with

stability studies data, GMP certificate of supplier and

differential fee in case of import of pellets.

Evaluation by PEC Source of pellets (TamsulosinHCl SR pellets 0.2%):

Vision Pharma

The firm has submitted GMP of manufacturer (valid till

21-02-2018), COA of pellets, Stability studies of three

batches.

Decision: Approved.

70. DELETED Due to repetition.




Applicant

M/s. Sharex Labs, Sadiqabad

Brand Name +Dosage Form + Strength Cetirex Tablet


Cetirizine Dihydrochloride (B.P) ..…. 10mg

Diary No. Date of R& I & fee Dairy No. 103 dated 08.01.2013 Rs:20,000/-

Pharmacological Group Antihistaminic & Anti Allergic)

Type of Form Form-5


Pack size & Demanded Price Rs. 42/ 10 Tabs



Approved by MHRA of UK

Me-too status Serzine of M/s Qintar Pharmaceuticals. (Reg.# 030644)

GMP status

Previous remarks of the Evaluator. Deferred in 258th meeting for following:

Commitment as per 251st meeting of RB is required. Shelf

life is 3 years mentioned by the firm whereas 2 years are

allowed by the Board. Availability is SRA is not provided

Previous decision(s) Deferred in 261th meeting for rectification of

shortcomings

Evaluation by PEC ● Following reference for applied formulation has been

verified:

“Cetec 10 mg film-coated tablets of M/s Bristol

Laboratories Ltd, approved by MHRA of UK”

● USP monograph is available for applied formulation.

● Commitments as per 251st meeting have been

declared as conditions of registration letter by

Registration Board.

Decision: Approved with USP specifications.


Applicant


Brand Name +Dosage Form + Strength Pedisal Liquid


Sodium Chloride….1.750g

Sodium citrate….1.450g

Potassium Chloride…..0.750g

Glucose……10g

Diary No. Date of R& I & fee Dy. No: 2695 Dated 11.10.2011, Rs. 8,000/-

29.05.2014, Rs. 12,000/-

Pharmacological Group Electrolyte Replenisher

Type of Form Form-5

Finished product Specification Manufacturer

Pack size & Demanded Price Rs. 80/500ml



WHO recommended Standard ORS formulation

Me-too status Pedia Fresh Liquid of M/s Fozan Pharmaceuticals

Industries (Pvt.) Ltd. (Reg.# 064266)

GMP status GMP inspection dated 29-03-2017 concluding satisfactory

GMP compliant status

Previous remarks of the Evaluator. Deferred in 261st meeting for the submission of following

i. Inspection report

ii. Commitment as per decision of board

iii. Finished product specification is incomplete.

iv. Fee Rs. 8000/- and 12000/- is Photocopy

v. Approval status in reference country and Pakistan

https://www.medicines.org.uk/emc/product/1755#companyDetails

https://www.medicines.org.uk/emc/product/1755#companyDetails



Previous decision(s) Deferred in 261th meeting for rectification of

shortcomings

Evaluation by PEC Following reference The applied formulation is WHO

recommended standard ORS formulation and me-too

status has also been verified.

Decision: Registration Board deferred the case for confirmation whether applied formulation is

preservative free or not. Moreover evidence of sterilization facility for applied formulation shall

also be submitted.


Applicant


Brand Name +Dosage Form + Strength Cynoplex Injection

Composition Each 2ml contains:-

Vitamin B1 BP ….. 10mg



Nicotinamide BP …. 75mg

Dexpanthanol BP ….. 5mg

Diary No. Date of R& I & fee Dy# 3271 (08-3-2011); Rs.8,000/- Form-5 Dy #1087

(29.05.2014) Rs. 12,000/- (14-03-2013)

Pharmacological Group Vitamin

Type of Form Form-5

Finished product Specification --

Pack size & Demanded Price Pack size / 2ml x 25s Rs. 90/-



--

Me-too status Amroplex injection of M/s Amros, Karachi

(Reg.#042164)



Previous remarks of the Evaluator. Deferred in 261st meeting for the submission of following

i. Inspection report

ii. Commitment as per decision of board

iii. Finished product specification are incomplete.

iv. Fee Rs. 8000/- and 12000/- is Photocopy

v.Approval status in reference country and Pakistan

Previous decision(s) Deferred in 264th meeting for review of formulation and

evidence of submission of Fee of Rs.12,000/-

Evaluation by PEC ● The applied formulation is approved in Austria with

slight different composition. (MultiVit B-Forte

injection) as under:

“Each 2ml ampoule contains

Vitamin B1 … 11mg

Vitamin B2 … 3.8mg

Vitamin B6 … 5mg

Nicotinamide 110mg

Dexpanthenol … 6 mg

Decision: Deferred for evidence of approval of applied formulation in reference regulatory

authorities/agencies as approved by the Registration Board in its 275th

meeting as submitted

reference is of different composition.


Applicant


Brand Name +Dosage Form + Strength RT-FAST Plus Suspension

Composition Each 5ml suspension (when reconstituted) contains:

Artemether…..15mg

Lumifantrine….90mg



Diary No. Date of R& I & fee Dy. No: 7853 dated 23-08-10 Rs.8,000/- dated 23-08-10

Rs.12,000/- dated 28-08-13


Type of Form Form-5

Finished product Specification IP

Pack size & Demanded Price Rs. 200/ pack of 60ml




Me-too status Artem of Hilton Pharma Karachi




Previous decision(s) Rejected in 258th meeting as the firm does not possess

oral dry powder section.

Evaluation by PEC Firm has referred to inspection report of DML renewal

dated 11-05-2016 in which it is mentioned that the firm

do possess Sachet/powder/Dry powder suspension

Section.

Also the recommendation from panel also mentions

renewal of License for manufacturing by way of

formulation for following sections which include

Sachet/powder/Dry powder Section.

The case is placed before the Board for review of

previous decision.

Decision: Registration Boar referred the case to Licensing Division for confirmation of approved

manufacturing facility of “Dry powder suspension Section (general)”.


Applicant


Brand Name +Dosage Form + Strength Pyodex Solution 10%

Composition Each 100ml contains:-

Iodinated povidone 10gm eq to iodine 1gm

Diary No. Date of R& I & fee Dy# 3539 16-03-2011 Rs. 8,000/- Form 5

Dy #1084 29-05-2014

Pharmacological Group Antiseptic

Type of Form Form-5





MHRA approved Betadine

Me-too status Septinil 10% Antiseptic Solution of M/s Valor

Pharmaceuticals (Reg.# 031107)




Previous decision(s) Deferred in 264th meeting for confirmation of required

manufacturing facility/section

Evaluation by PEC Firm has referred to inspection report dated 08-05-2008 in

which it is mentioned that the firm do possess Topical

preparation section.

Moreover firm has referred to their two already registered

products:

Curittoothace drops (Reg.# 007871)

Sharexol Solution (Reg.# 025122)

Decision: Approved with change of brand name.




Applicant


Brand Name +Dosage Form + Strength Pyrofen Plus Tablet

Composition Each tablet contains:-

Codeine Phosphate ……. 20mg

Ibuprofen …………… 200mg

Diary No. Date of R& I & fee Dairy No. 104 dated 08.01.2013 Rs:20,000/-

Pharmacological Group Analgesic

Type of Form Form-5

Finished product Specification Manufacturer

Pack size & Demanded Price Rs. 108/ 36 Tabs



--

Me-too status Brucodin Tablets of M/s Abbott Labs, Karachi (Reg.#

044415)




Previous decision(s) Deferred in 261st meeting for the confirmation of approval

status by reference regulatory authorities and

manufacturing section of the firm.

Evaluation by PEC Firm has referred already registered product of M/s Abbot

Labs. Of similar composition.

Moreover the applied combination is available in Sweden

with following strength:

Each tablet contains:-

Codeine Phosphate ……. 30mg

Ibuprofen …………… 200mg

Firm has approved tablet General section.

Decision: Deferred for following:

i. Evidence of approval of required manufacturing facility of “Tablet Section (psychotropic)

ii. Evidence of approval of applied formulation in reference regulatory authorities/agencies as

approved by the Registration Board in its 275th

meeting.



Sr.

No

Name and

address of

manufactur

er /

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

Approval

status in

Reference

regulatory

agencies /

authorities

Me-too status/

GMP status

Previous

Decisions

Evaluation by

PEC

77. M/s

PharmEvo

(Pvt)Ltd,

Plot#A-

29,North

Western

Industrial

Zone, Port

Qasim,

Karachi-

75020

Cinap 1mg Tablet

Film coated Tablet

Each film coated

tablet contains:

Cinitapride….1mg

Antiulcer agent.

(Manufacturers

Specs)

Form5

14-5-2014

Dy.No.738

Routine

Rs.20,000/-

Rs. 500/10’s

Rs.1500/30’s

Rs.2500/50’s

Approved in

Spanish

Agency of

Medicines

and Health

Products

Cinic tablet

of Fynk

Pharma

(Reg #

074446)

GMP

inspection

conducted on

23-02-2018

and the report

concludes

that the firm

was

considered to

be operating

at an

acceptable

level of

compliance

with GMP

standards.

Deferred as

formulation is

under review as

per decision of

250th DRB

meeting(M-262)

Deferred in

277th meeting

for the

following

submission:

Change in

formulation to

uncoated tablet

as per the

reference

product in

Spain.

Fee for change

of formulation

Clarification of

salt form of API

of the product

since the

reference

product contains

Cinitapride as

acid tartarate.

The firm has

submitted

formulation

to uncoated

tablet as per

the reference

product in

Spain.

Fee challan

of

Rs.20,000/-

(Deposit slip

No.0702679)

dated

16-2-2018

for change of

formulation

The firm has

clarified salt

form of API

“Cinitapride

as acid

tartrate”.

Decision: Approved with innovator’s specifications

78. M/s

PharmEvo

(Pvt)Ltd,

Plot#A-

29,North

Western

Industrial

Zone, Port

Qasim,

Karachi-

75020

Cinap Syrup

Each 5ml contains:

Cinitapride….1mg

Antiulcer agnet.

(Manufacturer’s

Specifications)

Form5

14-5-2014

Dy.No.429

Routine 733

Rs.20,000/-

Rs.600/120ml

Approved in

Spanish

Agency of

Medicines

and Health

Products

Gutt oral

solution of

Global

pharma (Reg.

#075278)

GMP

inspection

conducted on

23-02-2018

and the report

concludes

Deferred as

formulation is

under review as

per 250th DRB

meeting(M-262)

Deferred in

277th meeting

for the

following

submission:

Change in

formulation to

oral solution as

per the reference

product in

Spain.

The firm has

submitted

revised

formulation

to oral

solution as

per the

reference

product in

Spain.

Fee challan

of Rs.

20,000/-

(Deposit slip

No.0702680)

dated



that the firm

was

considered to

be operating

at an

acceptable

level of

compliance

with GMP

standards.

Fee for change

of formulation.

Clarification of

salt form of API

of the product

since the

reference

product contains

Cinitapride as

acid tartarate

16.2.2018 for

change of

formulation

The firm has

clarified salt

form of API

“Cinitapride

as acid

tartrate”.


79. M/s GT

Pharma

(Pvt) Ltd,

Lahore

GT-CIP 250mg Dry

Powder Suspension

Each 5ml

reconstituted

suspension

Contains

Ciprofloxacin taste

masked granules

35% eq to

Ciprofloxacin

……..250mg

Quinolones

(Manufacturer’s

Specification)

Source of pellets

M/s Vision

Pharmaceuticals,

Kahuta Road

Islamabad

Form 5

Rs. 20,000/-

vide

Dy. No. 2691

dated 11-12-

2015

Pack size of

1 x 30ml as

per

price fixed by

Government

Ciproxin

250mg/5ml

Granules

and solvent

for oral

suspension

(MHRA

approved)

Quash

suspension

250mg of

Wilshire

Pharma (Reg

# 071192)

Inspection

conducted

on 8-8-2017,

the firm was

granted

GMP

certificate.

Registration Board

deferred in 256th

meeting the

application and

advised to follow

master formulation

of innovator brand

which consist of

granules of

ciprofloxacin base

and a diluent as per

innovator’s

composition.

Registration Board

in 269th

approved the

formulation

and solvent

for oral

suspension as

per reference

product

approved by

USFDA and

MHRA.


80. M/s GT

Pharma

(Pvt) Ltd,

Lahore

GT-CIP 500mg

Dry

Powder Suspension

Each 5ml Contains

Ciprofloxacin taste

masked granules

35% eq to

Ciprofloxacin

…….500mg

Quinolones

(Manufacture

Specification)

Source of pellets–

M/s Vision

Pharmaceuticals,

Kahuta Road,

Islamabad

Quinolones

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide

Dy. No. 2688

dated 11-12-

2015

Pack size of

1 x 60ml as

per

price fixed by

Government

Ciproxin

(USFDA)

Quash

suspension

500mg of

Wilshire

Pharma (Reg

# 071193)

Inspection

conducted

on 8-8-2017,

the firm was

granted

GMP

certificate.

Registration Board

deferred in 256th

meeting the

application and

advised to follow

master formulation

of innovator brand

which consist of

granules of

ciprofloxacin base

and a diluent as per

innovator’s

composition.

Registration

Board in 269th

approved the

formulation

and solvent for

oral

suspension as

per reference

product

approved by

USFDA and

MHRA.




Case No. 05: Deferred Cases of Previous Meetings (Veterinary).

i. Cases of M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM, Ferozpur

Road, Lahore.

The CLB in its 248th

meeting held on 13th

July, 2016 has considered and approved the grant

of two additional sections of firm M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., Lahore

(Drug Manufacturing License No. 000478-formulation) as under:

● Veterinary Dry powder (General)

● Veterinary Dry powder (General Antibiotic)

Now, the firm has applied for registration of 10 molecules in Veterinary Dry Powder

(General) and 10 molecules in Veterinary Dry powder (General Antibiotic).

Veterinary Dry powder (General)


Applicant

M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM,

Ferozpur Road, Lahore.

Brand Name +Dosage Form + Strength FrusaMore Oral Powder

Diary No. Date of R& I & fee 2012, 20-02-2017, 20,000/-, 20-02-2017

Composition Each 100gm contains:-

Frusemide……………….…..…2%

Belladonna Extract…………....0.2%

Pharmacological Group Flusher

Type of Form Form-5

Finished Product Specification In-house

Pack size & Demanded Price 10gm, 30gm,50gm,100gm,500gm,1000gm,5000gm;

Decontrolled



N/A

Me-too status Not provided by the firm.

GMP status Inspection Report dated 06-07-2016 showed good intention

to improve further.

Remarks of the Evaluator. ● The firm did not submit me-too reference.

● Information regarding dosage of applied product for

different animal species is not clearly mentioned.

● The firm did not mention reference of finished product

specifications whether Pharmacopoeial or non-

pharmacopoeial.

Previous decision Deferred in 272nd

meeting for following reasons:

1. Evidence of me-too reference,

3. Evidence of reference of finished product specifications,

4. Submission of GMP inspection report conducted within a

period of 1 year.

5. Formulation is required to be reviewed.

Evaluation by PEC The submitted me-too reference “Lexi-Fursikon Powder

of Lexicon Pharma (Reg # 041275)” has been verified.

● GMP inspection on 12-12-2017 concluded that at the

time of visit, the different areas of the premises found

clean and maintained. HVAC was also installed in the

sections and functional. No production activity was

observed at the time of visit.

● The firm has corrected enclosures of Form-5.

Decision: Deferred for following;

Clarification of source of Belladonna extract

Rationale of hydroalcoholic extract in veterinary practice.




Applicant

M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM,


Brand Name +Dosage Form + Strength Morenovan Water Soluble Powder


Composition Each 100g contains:-

Trichlorfon………...……..98gm

Pharmacological Group Ectoparasidal

Type of Form Form-5


Pack size & Demanded Price 100g, 500g, 1Kg, Box of 4 ×250g; Decontrolled



N/A

Me-too status Tagafon Powder of Star laboratories


to improve further.

Remarks of the Evaluator. ● The submitted me-too reference is of different

strengths/compositions.





pharmacopoeial.




2. Clarification of dosage of applied product for different

animal species,



period of 1 year.

Evaluation by PEC The submitted me-too reference “Trichlor WSP of Alina

Combine Pharma (Reg # 052334)” has been verified.









Applicant

M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,21-KM,


Brand Name +Dosage Form + Strength Ampromore-60 Water Soluble Powder


Amprolium hydrochloride…………..60gm

Diary No. Date of R& I & fee 3816, 19-04-2017, 20,000/-

Pharmacological Group Anti-coccidial

Type of Form Form-5

Finished Product Specification In-house specifications

Pack size & Demanded Price 100g, 500g, 1000g, Sachet/ Jar; Decontrolled



N/A

Me-too status Amprolirex powder of Kaaz International;

Amproval of Symoms pharmaceuticals;

Medi AM of Medi Vet;

SB Amprol of SB Pharma




to improve further.

Remarks of the Evaluator. ● The submitted me-too references are of different

strengths.





Pharmacopoeial.

● GMP inspection report is not within the period of 1 year.





animal species,



period of 1 year.

Evaluation by PEC ● GMP inspection on 12-12-2017 concluded that at the





● The submitted me-too reference “Ampro-60 WSP of

M/s. Decent Pharma (Reg # 079825)” has been verified.

● Target animal species are poultry, turkey and rabbits.


Veterinary Dry powder (General Antibiotic)


Applicant

M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,

21-KM, Ferozpur Road, Lahore.

Brand Name +Dosage Form + Strength CT More Water Soluble Powder



Chlortetracycline hydrochloride….……………20gm


Type of Form Form-5


Pack size & Demanded Price 100g, 500g, 1000gm jar containers of HDPE; Decontrolled



N/A

Me-too status CTC Mont WSP of Westmont Pharmaceuticals


to improve further.

Remarks of the Evaluator. ● The firm has not revised the Form-5 as different active

ingredients were mentioned under enclosure of chemical

name of Form-5.

● Undertaking of Form-5 is not signed.

● The outline of method of manufacture contains active

ingredients other than applied composition.


different animal species is not mentioned.



pharmacopoeial.






1. Revision of Form-5 as different active ingredients were

mentioned under enclosure of chemical name of Form-5.

2. Signature of applicant on Form-5,

3. The outline of method of manufacture contains active

ingredients other than applied composition,


animal species,



period of 1 year.

Evaluation by PEC ● The me-too reference “Chlore-20 Powder of Nawan

Laboratories (Reg # 026416)” for applied formulation

has been verified.









Applicant



Brand Name +Dosage Form + Strength Lincomix 4.4 Feed Premix



Lincomycin hydrochloride……..……..4.4gm

Pharmacological Group Antibiotic/Antibacterial

Type of Form Form-5

Finished Product Specification In-house specifications

Pack size & Demanded Price 10gm, 30gm,50gm,100gm,500gm,1000gm,5000gm;

Decontrolled



N/A

Me-too status Licocen 44 of Mustfa Bros;

Lincovet Premix of Medi-Vet (pvt), Ltd;

Linco GP of Jfrin pharmaceuticals


to improve further.

Remarks of the Evaluator. ● The submitted me-too references are of different

strengths /compositions.





pharmacopoeial.


Previous Decision Deferred in 272nd




animal species,



period of 1 year.



Evaluation ● The firm has submitted me-too reference “Lincos-P

Powder of A & K Pharma (Reg # 049667)” has been

verified.









Applicant



Brand Name +Dosage Form + Strength Neomore-72 Water Soluble Powder



Neomycin Sulphate…………..….72gm


Type of Form Form-5

Finished Product Specification The firm has claimed manufacturer’s specifications.

Pack size & Demanded Price 100g, 500g, 1Kg, Box of 4 ×250g; Decontrolled



Not provided by the firm.

Me-too status Neomix WSP of Ghazi Brothers


to improve further.

Remarks of the Evaluator. ● The name of applied product is different in different

parts of Form-5. The firm did not revise Form-5.

● Form-5 undertaking is not signed.

● The submitted me-too reference could not be found in

available database of DRAP.





pharmacopoeial.




1. Revision of Form-5 as the name of applied product is

different in different parts/enclosures of Form-5,

2. Signature of applicant on Form-5,



animal species,



period of 1 year.

Evaluation by PEC ● The firm has submitted signed Form-5.

● The submitted me-too reference “72% Neomycin

Powder of M/s. Mallard Pharma (Reg # 069635)” has

been verified.










Case No. 06: Verification of Stability Study Data.

Verification of Authenticity of Stability Data (Dexia 30mg, 60mg capsules-Dexlansoprazole)

M/s Ferozesons Laboratories Ltd, Amangarh, Nowshera Khyber Pakhtunkhwa – 02 Products

Background:

Registration Board in its 277th Meeting decided to constitute the following panel for onsite investigation to

confirm genuineness/ authenticity of stability data and associated documents, import of API, quality,

specification, test analysis, facilities etc. of above 02 Products of M/s Ferozesons Laboratories Ltd,

Amangarh, Nowshera Khyber Pakhtunkhwa.

● Mr. Abid Hayat Director DTL, Peshawar

● Mr. FarhadUllah Assistant Director DRAP Peshawar

● Syed Adnan Ali Shah Assistant Director PE & R, Islamabad

Details of Investigation:

Sr.# Description Observation by panel

1.

Do you have documents confirming the

import of Dexlansoprazole API?

Firm has documents confirming the import of

Dexlansoprazole modified release pellets 22.5%

(Batch No. DEXPDA-0050-006) from M/s. RA Chem

Pharma Limited India along with approval by DRAP

for import.

2.

What was the rationale behind selecting the

particular manufacturer of API?

The firm has informed that they have selected the

manufacturer (i.e M/s RA Chem Pharma Limited

India) on the basis of its GMP compliance and

provision of stability studies of Dexlansoprazole

modified release pellets 22.5%.

3.

Do you have documents confirming the

import of Dexlansoprazole reference

standard and impurity standards?

Firm has documents confirming the import of

Dexlansoprazole reference standard from M/s. RA

Chem Pharma Limited India whereas impurities

standard import from M/s. Chromachemie Laboratory

Pvt. Ltd India.

4. Do you have certificate of Analysis of the

API, reference standards and impurity

standards?

Firm has certificate of analysis of API and reference

standard.

5. Do you have any approval of API or GMP

certificate of API manufacturer issued by

regulatory authority of country of origin?

Firm has provided copy of GMP certificate issued by

Drugs Control Administration (Telangana), India

6. Do you use API manufacturer method of

testing?

The firm has used API manufacturer’s method of

testing for carrying out tests of API.

7. Do you have stability studies reports on

API?

The firm has real time and accelerated stability study

data sheets provided by the API manufacturer.

8. If yes, whether the stability testing has been

performed as per SIM method and

degradation products have been quantified?

The stability studies have been performed as per SIM

method and the degradation products have been

quantified.

9. Do you have method for quantifying the

impurities in the API?

The firm has used the method provided by API

manufacturer for quantification of impurities.

10. Do you have some remaining quantities of

the API, its reference standard and

impurities standards?

The firm don’t have remaining quantities of the API &

reference standard. However, some quantities of

impurity standards were available.



11. Have you used pharmaceutical grade

excipients?

Not applicable.

Since firm has imported pellets which were filled in

the capsules without using any excipients.

12. Do you have documents confirming the

import of the used excipients?

Not applicable.

Since firm has imported pellets which were filled in

the capsules without using any excipients.

13. Do you have test reports and other records

on the excipients used?

Not applicable.

14. Do you have written and authorized

protocols for the development of

Dexlansoprazole capsules?

The firm has written and authorized protocols for the

development of Dexia 30mg and 60mg capsules.

15. Have you performed Drug-excipient

compatibility studies? Not applicable.

16. Whether firm has performed comparative

dissolution studies?

Firm has performed comparative dissolution profile

against Dexilant Capsule of M/s. Takeda.

17.

Do you have product development (R&D)

section

The firm has product development (R&D) section with

requisite manufacturing facilities. However,

development of trial batches of Dexia capsules was

performed in production area as R&D section is

established recently.

18. Do you have necessary equipments

available in product development section

for development of Dexlansoprazole

capsules?

The firm has all the necessary equipment in product

development section. However, development of Dexia

capsule was performed in production area.

19. Are the equipments in product

development section qualified?

The equipments used in the product development

section were qualified.

20. Do you have proper maintenance /

calibration / re-qualification program for

the equipment used in PD section?

The firm has proper maintenance and calibration for

the equipments used in product development.

21. Do you have qualified staff in product

development section with proper

knowledge and training in product

development?

Firm has qualified staff with proper knowledge in

product development.

22. Have you manufactured three stability

batches for the stability studies of

Dexlansoprazole capsules as required?

The firm has manufactured three stability batches for

the stability studies of Dexia 30mg & 60mg capsules.

23. What was the criteria for fixing the batch

size of stability batches?

Firm has informed that criteria approved in 251st

meeting of DRB were followed for fixation of batch

size of the stability batches.

24. Do you have complete record of production

of stability batches?

The firm has complete batch manufacturing record of

all the batches of Dexia 30mg & 60mg capsules.

25. Do you have protocols for stability testing

of stability batches?

Firm has protocols for stability testing of the stability

batches.

26. Do you have developed and validated the

method for testing of stability batches?

The firm has developed and validated the method for

the testing of Dexia 30mg & 60mg capsules.

27. Do you have method transfer studies in

case when the method of testing being used

by your firm is given by any other lab?

The firm has not conducted method transfer studies;

however, they have validated their method.



28. Do you have documents confirming the

qualification of equipments / instruments

being used in the test and analysis of

Dexlansoprazole API and the finished

drug?

Firm has complete record of qualification of

equipment / instruments used in the test and analysis of

API and Dexia 30mg & 60mg capsules.

29. Do your method of analysis stability

indicating? The method of analysis is stability indicating.

30. Do your HPLC software is 21CFR

compliant? The HPLC software of the firm is 21CFR compliant.

31. Can you show Audit Trail reports on

Dexlansoprazole testing?

Firm has demonstrated audit trail reports of testing.

32. Do you have some remaining quantities of

degradation products and stability batches?

The firm has some remaining quantities of stability

batches

33. Do you have commitment batches kept on

stability testing?

The firm has remaining quantities of stability batches.

34. Do you have valid calibration status for the

equipments used in Dexlansoprazole

capsules production in analysis?

The firm has valid calibration status of all equipment

used in production and analysis of Dexia 30mg &

60mg capsules.

35.

Do proper and continuous monitoring and

control are available for stability chamber?

The firm has stability chambers for carrying out

accelerated and real time stability studies provided

with uninterrupted power supply and data loggers,

which are set for recording temperature and humidity.

36. Do related manufacturing area, equipment,

personnel and utilities be rated as GMP

compliant?

Related manufacturing area, equipment, personnel and

utilities are as per GMP compliance.

Conclusion:

On risk-based approach the genuineness / authenticity of stability data submitted by the firm for registration

of Dexia (Dexlansoprazle) 30mg and 60 mg Capsules is verifiable to satisfactory level.

Decision: Registration Board decided to approve registration of “Dexia (Dexlansoprazle) 30mg and

60mg Capsuleby M/s Ferozesons Laboratories Ltd, Amangarh, Nowshera Khyber Pakhtunkhwa.

Manufacturer will place first three production batches of both products on long term stability studies

throughout proposed shelf life and on accelerated studies for six months.



Item No. IV Additional Agenda

Registration-I Section.

Human Imported Cases

Case No. 01: Request of M/s. Webros Pharmaceuticals Plot No.1 Street No. 10 National

Industrial Zone, Rawat, Islamabad for Registration of Detamol Injection

2ml” (Reg. No. 016138).

M/s.Webros Pharmaceuticals Plot No.1 Street No. 10 National Industrial Zone, Rawat,

Islamabad has submitted an application for registration of “Detamol Injection 2ml” (Reg. No.

016138) manufactured by M/s Thai P.D. Chemicals Co. Ltd Thailand from the name of existing

agent M/s. The Healers, Rawalpindi to M/s.Webros Pharmaceuticals Plot No.1 Street No. 10

National Industrial Zone, Rawat. The firm deposited requisite fee of Rs.100,000/- for approval.

Details are as under:

Sr.# Name / detail of

documents

Documents / information provided by firm

1. Product Name /

Composition

Detamol Injection 2ml

As per record:

Each 2ml contains:

Paracetamol…......300mg

Lidocaine HCL….20mg

Benzyl alcohol .....30mg

As per COPP (issued by Thailand authority’s):

Each ml contains.

Paracetamol ..........................150.0mg.

Lignocaine Hydrochloride ....10.0mg

2. Name and address of

Applicant (transferee)

M/s.Webros Pharmaceuticals Plot No.1 Street No. 10 National

Industrial Zone, Rawat.

3. Name of Transferor M/s. The Healers, D/206-2. Satellite Town, Rawalpindi

4. Detail of Drug Sale

License

Flat No. 1-B, First Floor sharif Plaza, IJP Road Near

PindoraChungi Rawalpindi.


manufacturer

M/s. Thai P.D. Chemicals Co. Ltd, 2, SoiVibhavadiRangsit 16/41,

VibhavadiRangsit Road, Dindaeng, Dindaeng, Bangkok 10400,

Thailand.


product license holder

M/s. Thai P.D. Chemicals Co. Ltd, 2, SoiVibhavadiRangsit 16/41,

VibhavadiRangsit Road, Dindaeng, Dindaeng, Bangkok 10400,

Thailand.

7. Name of exporting country Thailand

8. Diary No. & Date of R& I Dy. No. 709 Dated 25/05/2016

9. Finished Product

Specification

Not provided

10. Shelf life 36 months (as per Form-5A)

a) Copy of valid Drug Sale License.

b) Fresh & original NOC dated 08-02-2018 from existing registration holder as

the already submitted NOC was issued on 15-03-2016.

c) Clarification in respect of difference in composition in provided documents

(i.e. Initial registration letter & COPP).

d) Site master file.

e) Initial Registration letter with renewal status.

Decision: Registration Board deferred the case and advised firm for provision of

evidence of approval of the said formulation in stringent regulatory

authorities (as specified by Registration Board in its 275th

meeting) for

further consideration of Board.



Veterinary Cases

Case No.02: Inspection of Manufacturer Abroad/Issuance of Registration Letter.

The Registration Board in its 275th

meeting approved various products of M/s. Hassan

Brothers, Faisalabad manufactured by M/s. Samyang Anipharm Co. Ltd. Seoul, Korea with

various corrections. In One of the approved product Peperoxin Solution the pack size was

mentioned in Kg inadvertently by the applicant and the same was mentioned in the agenda and

minutes of the Registration Board’s meeting as per following details:-

S.No. Name of Manufacturer/

Importer

Name of drug(s) &

Composition

Decontrolled/

Packs Size

Shelf

Life

1. M/s. Hassan Brothers,

Faisalabad. / manufactured

by M/s. Samyang

Anipharm Co. Ltd. Seoul,

Korea.

Peperoxin Solution

Each Litre contains:-

Pefloxacin………100g

(as Pefloxacinemethanesulfonate

……139.6g)

Excipients (Purified water etc)

………………………Q.S

500gm

1 Kg

2.5 Kg

5 Kg

3 years

The firm subsequently submitted revised Form-5A and deposited fee of Rs.5000/- for

making the correction in pack size as 500ml, 1 Litre, 2.5 Litre & 5 Litre.

Registration Board in its 276th

meeting decided to defer the case for clarification

regarding the demanded pack sizes i.e. 500ml, 1 liter, 2.5 liter and 5 liters as the demanded pack

sizes are not mentioned on the free sale certificate issued by Korean Authority provided by the

firm. The firm has now provided certificate of product registration from Ministry for Agriculture

Food and Rural Affairs of Republic of Korea mentioning pack sizes of 100ml, 500ml, 1 Litre&

20 Litre.

The representative of M/o. Food Security pointed out that there is need to review use of

this molecule in veterinary practices especially with reference to development of resistance in

human.

Decision: Registration Board deferred the case for further clarification from the firm

regarding the submitted certificate of product registration.

The Board further decided to place the molecule “Pefloxacin” before

Working Group on Veterinary Drugs for its review.

Case No.03. Request of M/s. Medi-Vet (Pvt) Ltd., Lahore Sheikhupura Road,

Sheikhupura for additional packs of already Registered Veterinary Drugs.

M/s. Medi-Vet (Pvt) Ltd., Lahore has applied for approval of additional packs of their

registered veterinary drugs as per details mentioned against each:-

S. No. Regn.

No.

Name of Drug(s)/

Composition

Already Granted

Pack Size(s)

Demanded

Additional

Pack(s)

Justification

1. 025396 Albavet Powder

Each Kg contains:-

Albendazole………..200gm

Cobalt Sulphate……7.64gm

100gm

500gm

5gm Due to market

demand.



2. 025398 Albavet Drench Plus Liquid

Each 100ml contains:-

Albendazole…………10gm

Cobalt Sulphate……0.382gm

100ml

500ml

1 Litre Due to market

demand.

M/s. Medi-Vet (Pvt) Ltd., Lahore has deposited the required fee of Rs.5,000 x 2 =

Rs.10,000/- and submitted following supporting documents:-

(i) Copies of registration letters.

(ii) Copies to renewal status.

(iii) Copy of Drug Manufacturing License.

(v) Copy of CRF.

The demanded packs are not given to other firms.

Decision:- Registration Board approved M/s. Medi-Vet (Pvt) Ltd, Lahore request for

grant of additional pack size of “5 gm” and “1 litre” for registered drugs

Albavet Powder (Reg.No.025396) and Albavet Drench Plus Liquid

(Reg.No.025398), respectively, on same terms and conditions.

Case No.04. Request of M/s. Intervac (Pvt) Ltd., Lahore Sheikhupura Road, Sheikhupura

for additional packs of already Registered Veterinary Drugs.

M/s. Intervac (Pvt) Ltd., Lahore Sheikhupura Road, Sheikhupura has applied for approval

of additional packs of their registered veterinary drug as mentioned below:-

S.No. Regn.

No.

Name of

Drug(s)/Composition

Already

Granted Pack

Size(s)

Demanded

Additional

Pack(s)

Justification

1. 069651 Nega-97% Water Soluble

Powder

Each 100gm contains:-

Trichlorphon ……97%.

10gm

20gm

50gm

100gm

250gm

500gm

1Kg

5Kg

25 Kg

50 Kg

The

commercial

clients wide

scale of

business

required the

large packing.

The packs of 25Kg & 50Kg not given to other firms so far. M/s. Intervac (Pvt) Ltd.,

Lahore Sheikhupura Road, Sheikhupura has deposited the required fee of

Rs.5,000x2=Rs.10,000/- and submitted following supporting documents:-

(i) Copy registration letter.

(ii) Copy to renewal status.

(iii) Copy of CRF.

The demanded packs are not given to other firms.

Decision:- Registration Board approved M/s. Intervac (Pvt) Ltd., Lahore Sheikhupura

Road, Sheikhupura request for grant of additional pack sizes of “25 Kg” and

“50 Kg” for registered drug Nega-97% Water Soluble Powder (Reg.No.

069651) on same terms and conditions.

The Board further decided to refer the case to working group on veterinary

drugs for review of already granted small pack sizes of Trichlorphon for

possible misuse.




Case No. 05: Rejection of Renewal Application of Drug Manufacturing License No. 000554

(Formulation) of M/s Farmaceutics International, F-1, A-3, S.I.T.E, Karachi.

Secretary, Central Licensing Board vide a letter No. F.2-9/2003-Lic (Vol-I) has informed

that Central Licensing Board in 256th

meeting decided as follows:

“ Proceedings and Decision of Central Licensing Board in 256th

meeting.

Mr. Jamel Hussain Qureshi, Legal Counsel for the firm appeared before the

Board and handed over documents before the Board and contended that if there was any

shortcoming he would submit within 24 hours. He also contended that documents

regarding CRF have been submitted with relevant Division. He further contended that all

formalities are complete and showcause may be withdrawn. The Board after hearing

representative of the firm and perusal of the documents observed that firm has been

manufacturing and selling medicines without approval of qualified approved staff since

more than three years. Moreover, Secretariat of Central Licensing Board accepts

certificate regarding CRF issued from the Division of Budget and Accounts which was

not available at the time of proceedings. The Board, therefore, decided to reject the

application of renewal of the Drug manufacturing License No. 000554 by way of

formulation of M/s Farmacuetics International, F-1, A-3, S.I.T.E., Karachi with

immediate effect under Section 41 of the Drugs Act, 1976 read with Rule 12 of The Drugs

(LR&A) Rules, 1976 for not complying the provisions of Rule 16 and Rule 5 (2A) of

Drugs (LR&A) Rules, 1976”.

He has further informed that the said manufacturing License stands cancelled with

immediate effect under the Drugs Act, 1976 and rules framed thereunder. Manufacturing of

Drugs in the name of said license and at said premises is prohibited and punishable offence under

section 23 and section 27 of Drugs Act, 1976 and rules framed thereunder.

Registration Board deliberated the matter in its 277th

meeting and decided to cancel the

registration of all drug products held by M/s. Farmaceutics International, Karachi, keeping in

view the decision of Central Licensing Board (CLB) taken in its 256th

meeting for cancellation

of their DML.

The firm filed an appeal before Appellate Board in its 148th

meeting and the appellate Board

decided as under:-

“The Board, after hearing arguments and perusing prevailing record and updated

status decided to convert the cancellation into suspension for six (06) months, as

provided by the Central Licensing Board in other similar cases. The firm was

directed to submit documents related to appointment, qualification and experience of

qualified persons to the Licensing Division which shall evaluate and decide the

matter for compliance within thirty (30) days after giving personal hearing to the

appellant and accordingly report to this Board for allowing resumption of the

suspension, compliance of the manufacture and bases on the recommendations of the

Licensing Board”.

Decision: Registration Board deferred the case till Central Licensing Board decides the

matter in light of decision given by the Appellate Board in its 148th

meeting.

Board also directed to solicit opinion from Legal Affairs Division in this

regard.



Registration-IV Section

Case No.6: Approved Products of M/s. Cherwel Pharmaceuticals, Hattar.

Registration Board in its 227th

meeting approved the following products of M/s.

Cherwel Pharmaceuticals, Hattar subject to Panel GMP Inspection, as per following details:-

S.No

.

Name of

Firm

Name of Drugs /label

Claim

Demand

ed Pack

size

Demande

d Price

Date Decision Remarks

1. M/s.

Cherwel

Pharmaceu

ticals,

Hattar

Nimswel 100mg

Tablets


Nimesulide

.....100mg

(NSAID)

Per

tablet

Rs.6.00 6-10-

2009

Approved

subject to Panel

GMP Inspection.

EMA approved.

Registration Board’s

Decision in 269TH

meeting:

Registration Board

approved the

formulation of

Nimesulide Tablets

100mg with a pack

size of 15 tablets as

per

recommendations of

EMA only for the

following

indications:

Treatment of

acute pain

Primary

Dysmenorrhea

2. -do- Salmocin 400mg

Tablets


Ofloxacin …..400mg

(Quinolone)

Per

tablet

Rs.20.0

0

-do- -do- USFDA Approved

formulation is film

coated.

3. -do- Flexy 100mg Tablets


Flurbiprofen

…..100mg

(NSAID)

Per

tablet

Rs.6.20 -do- -do- USFDA approved

formulation is film

coated.

4. -do- Natwel 100mg

Tablets


Diclofenac

Sodium…100mg

(NSAID)

Per

tablet

Rs.9.80 -do- -do- Standard

formulation

approved by

Reference

Regulatory

Authorities is

Sustained Release

Tablet.

5. -do- Odicam 7.5mg

Tablets


Meloxicam…..7.5mg

(Oxicam)

Per

tablet

Rs.7.00 -do- -do- USFDA approved

6. -do- Odicam 15mg

Tablets

Each tablet contains:

Meloxicam....15mg

(Oxicam)

Per

tablet

Rs.12.0

0

-do- -do- USFDA approved



7. -do- Azicap 500mg

Capsules

Each capsule contains:

Azithromycin

………500mg

(Macrolides)

Per

capsule

Rs.41.6

0

-do- -do- Decision of 250th

Meeting:

Applicants shall

either revise their

formulation to

tablet dosage form,

if not registered

previously and if

manufacturing

facility is approved

by CLB (new

registration

application with

complete fee)

8. -do- Klariwel 250mg

Tablets

Each tablet contains:

Clarithromycin

…..250mg

(Macroldie)

Per

tablet

Rs.34.0

0

-do- -do- Standard

formulation is film

coated tablet.

9. -do- Klariwel 500mg

Tablets


Clarithromycin

……..500mg

(Macroldie)

Per

tablet

Rs.64.0

0

-do- -do- Standard

formulation is film

coated tablet.

The firm has submitted copy of Panel Inspection Report conducted for renewal of DML

dated 27-09-2014 and GMP Inspection Report dated 17-03-2017 (Status: Satisfactory).

The Board was also informed regarding items at S.No.2,3,8 and 9 that the standard

formulations approved by Reference Regulatory Authorities are film coated tablets and the firm

has subsequently submitted revised formulations, accordingly.

Decision: Registration Board decided as under:

i. Approved for the grant of registration for product at S.No. 1 with

“Innovator’s Specifications” in accordance with the decision taken by the

Board in its 269th

meeting.

ii. Approved for the grant of registration for products at S.No.2, 3, 8 and 9 with

film coated tablets and USP Specifications.

iii. Approved for the grant of registration for products at S.No.5 and 6 with

“USP Specifications”.

iv. Deferred the product at S.No. 4 for correction of formulation in accordance

with the standard formulation approved by Reference Regulatory

Authorities along with fresh fee of Rs.20,000/-.

v. Deferred the product at S.No.7 and directed the firm to proceed in

accordance with the decision taken by the Registration Board vide its 250th

meeting for revision of formulation.

vi. The Board further decided that the above mentioned cases shall be processed

in the light of the procedure outlined by the Registration Board vide its 264th

meeting regarding verification of challan/deposit slips which are not

traceable.



Registration-V Section

Case No.7: Products of M/s. Xenon Pharma, Lahore.

Registration Board in its various meetings has considered the following products of

M/s. Xenon Pharma, Lahore as per details mentioned below:-

Sr.

No.

Name of

Firm

Name of Drugs

/label Claim

Date of

Application /

Demanded

Pack size/

Price

Decision of

previous meeting

of Registration

Board

Remarks

1. Xenon

Pharma,

Lahore

Noplat Tablets

75mg

Each film coated

tablet contains:-

Clopidogrel as

Clopidogrel

bisulphate

…….75mg

(Anti-coagulants/

Platelet

aggregation)

30-06-2010

10’s

Rs.125.00

M-238

Deferred till

decision of DRAP

on show cause

notice/ stop

production to the

firm dated 23rd

April, 2013 and

provision of Latest

GMP Inspection

Report.

Panel inspection for renewal

of DML conducted on

16.02.2017.

Firm has submitted letter

N0.F.16-1/2013 (Reg-V)

dated 07-03-2013 as

evidence of paid fee.

Rs.20,000/-

2. Xenon

Pharma,

Lahore

Zepred Syrup

Each 5ml

contains:

Prednisolone…5

mg

60ml

Rs.4.50 per

5ml

M-226

Approved subject to

separate section

UK MHRA approved.

Section verified from Panel

inspection for renewal of

DML conducted on

16.02.2017.

Photocopy of DRAP’s

receiving of Rs.8,000/-

dated 16-01-2006 and fresh

fee of Rs. 12000/- have been

submitted.

Furthermore, the firm has

also submitted clarification

regarding the formulation

i.e.

Each 5ml contains:

Prednisolone as sodium

phosphate…5mg.

Request for change of brand

name to Preloid.

Decision: Registration Board approved above mentioned products.



Case No.8: Products of M/s. Sharex Laboratories, Sadiqabad.

Registration Board in its various meetings has considered the following products of

Sharex Laboratories, Sadiqabad as per details mentioned below:-

S.

No.

Name of Firm Name of Drugs /

label Claim

Demanded

Pack size /

Price

Decision of previous

meeting of

Registration Board

Remarks

1. Sharex

Laboratories,

Sadiqabad

R.T-Fast Injection

Each vial contains:-

ArtemetherInt.P….

80mg

(Anti malarial)

5x75

Rs.75.00/

Amp

M-236

Approved

Photocopy challan of

Rs.12000/-along with

drap’s receiving

Panel Inspection

Report dated

29-3-2017

Status: Satisfactory

2. -do- N-Cid Tablet

Each tablet

contains:

Flurbiprofen

…100mg

(Anti Inflammatory)

30’s

Rs.186.00

M-238

Approved. The Board

advised to provide

Coating specification

Firm has now

submitted evidence

of film coating

specification.

Photocopy challan of

Rs.12000/-along with

DRAP’s receiving.

Decision: Registration Board approved above mentioned products. Reference will be

sent to Budget & Accounts Division, DRAP for verification of challan of

Rs.12,000/- and the Board also authorized the Chairman, Registration Board

for issuance of registration letter.

Meeting ended with a vote of thanks to and from the chair.

End of Document

******************************************************************************