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MINUTES OF 239th
MEETING OF DRUGS REGISTRATION BOARD HELD
ON 12th
September, 2013
239th
meeting of the Drugs Registration Board was held on 12th
September,
2013 in the Committee Room, Minitrsy of National Health Regulation Service &
Coordination Division, Local Government Building, G-5, Islamabad. The meeting was
chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division. The meeting started with the recitation of Holy Verses. The
meeting was attended by the following:-
1. Prof.Dr.Rafi-uz-Zaman Saeed-ul-Haq. Dean,
University of Lahore, Islamabad
Member
2. Lt General (R) Karamat Ahmed Karamat.
Member
3. Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean,
Basic Sciences Division, Foundation Medical
University, Rawalpindi.
awalpindi.
Member
4. Mr. A.Q. Javed Iqbal, Chief Pharmacist, PIMS,
Islamabad.
Member
5. Dr. Muhammad Arshad, President, Pakistan Veterinary
Medical Council
Member
6. Dr. Muhammad Khalid Khan
Director Drugs Testing Laboratory Government of
Khyber Pakhtoonkhwa, Peshawar.
Member
7. Muhammad Jamil Anwar
Director Drugs Testing Laboratory Government of
Punjab, Lahore.
Member
8. Dr.Amanullah Khan
Director Drugs Testing Laboratory Government of
Baluchistan, Quetta
Member
9. Sheikh Muhammad Idress
Director Drugs Testing Laboratory Government of
Sind, Karachi
Member
10. Dr.Noor Muhammad Shah
Director Medical Devices and Medicated Cosmetics,
DRAP
Member
2
11. Abdul Samad Khan representing Director, Biological
Drug, DRAP
Member
12. Dr. Obaidullah, Deputy Director General (Reg.I).
Secretary/Member
Mr.Akhter Abbas Khan (DDG R.II), Mr.Muhammad Arif (DDC R.I), Mr. Babar
Khan (DDC R.III), Dr. Tariq Siddique (DDC R.IV), Ms. Sara Mehreen (ADC R.I) and
Mr. Atiq-ul-Bari (ADC R.V) assisted Secretary of the Board with agenda.
Dr. Kaiser Waheed & Mr. Hammayun Kabir, Dr.Farid Khan and Dr.M.Qasim
Awan attended the meeting as observer on behalf of PPMA, Pharma Beauru and PVPMA
respectively.
3
Item No I: Confirmation of minutes 238th
meeting Registration Board.
238th
meeting of Registration Board was held on 5th
-6th
August, 2013 and minutes
were accordingly circulated to all members through e-mail. Only 3 members confirmed
the minutes while observations of Dr. Khalid Khan, Director, DTL, Peshawar are as
follows:
The minutes of 238th RB meeting held on 5-6 Aug. 2013 are approved subject to
partial modifications i.e.
1. In Agenda item 2. Extension in contract manufacturing cases i.e. line
extension/general products/ associated company/ sister concern cases were rejected
rather than deferred.
2. Panel inspection should be conducted by the board members to the premises and
manufacturing facilities of contract givers.
3. Agenda Item delegation of Board power to Chairman, the powers mentioned in serial
v, xii, xv, xvi, xvii, xviii,, and xix should be remained with Board rather delegated to Chairman.
v. Increase/ decrease in shelf life of finished drug.
xii. Renewal of registered drugs.
xv. Change in the packing design/packaging components/ change in label, carton/ change in
shape, colour of Capsule, Tablets and shape of blister/ aluminum foil.
xvi. Change of brand names of registered drugs.
xvii. Change of formulation of already registered drug / grant of registration for
improving Safety, efficacy & quality as per recommendations of WHO / International
Agencies.
xviii. Transfer of registration from one manufacturer/importer to another
manufacture/importer.
xix. Constitution of panel of experts for inspections
4. For medical devices specifications and testing methods. a committee should be
constituted to formulate specifications and testing method procedures according to our
country need in best interest of public at large.
Decision: The Board discussed above mentioned observations of the member
and after detailed discussion decided as follows:
Cases which were not covered in Contract Manufacturing Policy were
deferred, as said policy is under consideration by the Policy Board.
4
Panel of inspectors would inspect the manufacturing premesis for grant of
new contract manufacturing permissions, if required by the Board.
Chairman, Registration Board would continue to decide cases mentioned at
point 3. However, all cases which require evaluation of technical data will be
referred to panel of experts including atleast one member of Registration
Board. The Chairman, Registration Board will decide the case keeping in
view recommendation of experts. However, Dr.Khalid Khan maintained his
view point.
Dr.Noor Muhammad Shah, Director MD & MC apprised the Board that
draft Medical Devices Rules, 2013 have already been sent to provincial
governments and also posted / uploaded on DRAP’s website for comments.
He also requested all members of the Board to give inputs on draft
regulations at the earliest.
5
Item No II: Grant of Registration (Local manufacturing).
Applications for registration (July-September, 2010 & fast track) were forwarded to
officers of DRAP. As per review, following applications were found complete.
Registration-I.
Fast track applications for registration (Locally manufactured drugs me-too)
S. # Name of
Applicant
Name of Drug(s)/Composition Price/Pack
Size
Shelf
Life
Decision
1. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Furosebar Water Soluble Powder
Each 1000gm contains:-
Furosemide…………….20gm
Potassium Chloride……. 4gm
Calcium Carbonate…….45gm
Magnesium Sulphate…..1gm
(Diuretic, Electrolytes).
Decontrolled
100gm
250gm
500gm
1000gm
2500gm
02
years
Approved
2. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Electrobar-C Water Soluble
Powder
Each gm contains:-
Aspirin………………..200mg
Vitamin C…………….600mg
Sodium Chloride………35mg
Sodium Citrate………….7mg
(Vitamin, Electrolytes, NSAID).
Decontrolled
100gm
250gm
500gm
1000gm
2500gm
02
years
Deferred for PSI
by panel
comprising of
Area FID and
Director DTL,
Lahore.
3. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Colibar Oral Liquid
Each 1000ml contains:-
Colistine
Sulphate……..2,000,000,000 IU
(Antibiotic).
Decontrolled
100ml
500ml
1000ml
02
years
Approved
4. M/s. Elegance
Pharmaceuticals,
Chak Belli, Pandori
Road, Rawalpindi.
Flurotin Liquid
Each ml contains
Florfenicol ….200mg
(Anti-bacterial)
Decontrolled
10ml
20ml
50ml
100ml
150 ml
200ml
250ml
500ml
1Lit
02
years
Approved
6
5. M/s. Elegance
Pharmaceuticals,
Chak Belli, Pandori
Road, Rawalpindi.
Ecotin-M Powder
Each 100g contain
Enrofloxacin HCl……10 %
Colistin Sulphate……..3 %
Amantadine HCl……..4 %
(Anti-Biotic)
Decontrolled
100gm
250gm
500gm
1Kg
5Kg
10Kg
25Kg
02
years
Approved
6. M/s. Elegance
Pharmaceuticals,
Chak Belli, Pandori
Road, Rawalpindi.
Poly Quin Liquid
Each 100ml contains
Enrofloxacin………10 g
Colistin Sulphate….48 MIU
(Anti-Biotic)
Decontrolled
10ml
20ml
50ml
100ml
150 ml
200ml
250ml
500ml
1Lit
02
years
Approved
7. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
Bella Flush Powder
Each 100g contains:-
Furosemide………………2gm
Belladonna Extract……..0.2gm
(Diuretic, Anti-spasmodic).
Decontrolled
100g
250g
500g
1Kg
5Kg
10Kg
02
years
Approved
8. M/s. Nawal
Pharmaceuticals,
Small Industrial
Estate Taxila.
BELLA RAFT Powder
Each 100g contains:-
Furosemide…………….2gm
Belladonna Extract…..0.2gm
(Diuretic, Anti-spasmodic).
Decontrolled
100g
250g
500g
1Kg
5Kg
10Kg
02
years
Approved
9. M/s. Leads
Pharma (Pvt) Ltd.,
Islamabad.
Virox TD Powder
Each Kg contains:-
Doxycycline HCI………200gm
Tylosin Tartrate………..100gm
Amantadine HCI…………40gm
Colistin Sulphate……...500MIU
Bromhexine HCL…………5gm
(Antibiotic).
Decontrolled
100gm
250gm
500gm
1Kg
5Kg
25Kg
02
years
Approved
10. M/s. Leads
Pharma (Pvt) Ltd.,
Islamabad.
Amandx Powder
Each 1000gm contains:-
Doxycycline HCI…..….20%
Tylosin Tartrate ……....10%
Amantadine HCI……...4.5%
(Antibiotic).
Decontrolled
100gm
250gm
500gm
1Kg
5Kg
25Kg
02
years
Approved
11. M/s. Decent Nortrim-S Oral Liquid Decontrolled 02 Approved
7
Pharma, Rawat,
Islamabad.
Each ml contains:-
Norfloxacin ……………….10%
Sulphamethoxypyridazine...15%
Trimethoprim……………..03%
(Antibacterial).
30ml
50ml
100ml
500ml
1 Liter
2.5 Liter
5 Liter
10 Liter
years
LOCALLY MANUFACTURED VETERINARY DRUGS FOR THE MONTH OF
NOVEMBER & DECEMBER, 2010.
Registration Board thoroughly discussed the following cases and decided the cases as
mentioned against each.
S. # Name of
Applicant
Name of Drug(s)/Composition Price/Pack
Size
Shelf
Life
Decision
1. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Nilza Shell Super Suspension
Each 100ml contains:-
Oxyclozanide…………….3.0%
Levamisole Hcl…………..1.5%
Cobalt Chloride (6H20).0.075%
Sodium Selenite ……...0.035%
(Anthalmintic).
Decontrolled
100ml
150ml
250ml
450ml
500ml
1000ml
2.5 Liter
02
years
Approved
2. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Clobenda Shell Suspension
Each ml of suspension
Albendazole……….2.5%
Closantel…………..0.5%
(Anthalmintic).
Decontrolled
30ml
50ml
100ml
250ml
450ml
500ml
1000ml
2.5 Liter
02
years
Approved
3. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Oxfashell Suspension
Each 100ml contains:-
Oxfendazole………2.265%
(Anthalmintic).
Decontrolled
30ml
50ml
100ml
250ml
450ml
500ml
1000ml
2.5 Liter
02
years
Approved
8
4. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Levashell 1.5 Suspension
Each 100ml contains:-
Levamisole HCI…1.5%
(Anthalmintic).
Decontrolled
50ml
100ml
150ml
250ml
450ml
500ml
1000ml
2.5 Liter
02
years
Approved
5. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Tol Shell Liquid
Each ml contains:-
Doxycycline HCI……..200mg
Tylosin Tartrate……….100mg
Colistin Sulphate….450000 IU
Bromhexine HCI………4mg
(Antibacterial, Anti-Viral).
Decontrolled
30ml
50ml
100ml
250ml
500ml
1 Liter
5 Liter
10 Liter
25 Liter
02
years
Approved
6. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Mentho Flush Oral Liquid
Each 100ml contains:-
Sorbitol……………….140mg
1,2Propane Diol………60mg
Magnesium Sulphate
(6H20)………………..40mg
Potassium Chloride……20g
Sodium Propionate……3g
(Anti fungal, Antimicrobial).
Decontrolled
30ml
50ml
100ml
250ml
500ml
1 Liter
5 Liter
10 Liter
02
years
Approved
7. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Albashell 10 Suspension
Each 100ml contains:-
Albendazole USP………..10%
Cobalt Chloride
(6H20)………………….0.05%
Sodium Selenite………..0.07%
(Anthalmintic).
Decontrolled
30ml
50ml
100ml
250ml
450ml
500ml
1000ml
2.5 Liter
02
years
Deferred for
application on
Form 5 D
along with
revised Fee
and expert
views of
following;
a. Dr. M
Ashraf,
UVAS
b. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
8. M/s. Inshal Trizo Shell Liquid Decontrolled 02 Deferred for
9
Pharmaceutical
Industries, Rawat,
Islamabad.
Each 100ml contains:-
Trimethoprim……………..8.0g
Sulfadiazine Na Sodium….40g
(Antibacterial, Coccidial,
Bronchodilator).
50ml
100ml
200ml
250ml
500ml
1 Liter
2.5 Liter
25 Liter
years confirmation
of use as
bronchodilator
9. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Immunufur E Liquid
Each 1000ml contains:-
Sodium Selenite…….150mg
Vitamin E………..…10,000mg
Choline……………..50,000mg
Vitamin C………….35,000mg
Zinc sulphate….…..…4500mg
Biotin……………..…100mg
Sorbitol………….….50,000mg
(Immune boster, Multi Vitamin).
Decontrolled
100ml
250ml
500ml
1 Liter
5 Liter
10 Liter
25 Liter
02
years
Deferred for
application on
Form 5 D
along with
revised Fee
and expert
views of
following;
c. Dr. M
Ashraf,
UVAS
d. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
10. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Silymar 2% Liquid
Each ml contains:-
Silymarin……….20mg
Sorbitol………….50mg
(Hepatoprotective).
Decontrolled
100ml
150ml
250ml
500ml
1 Liter
2.5 Liter
02
years
Deferred for
application on
Form 5 D
along with
revised Fee
and expert
views of
following;
e. Dr. M
Ashraf,
UVAS
f. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
11. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Cyper Shell Liquid
Each 100ml contains:-
Enrofloxacin………...10g
Colistin Sulphate……50MIU
(Antibiotic).
Decontrolled
50ml
100ml
150ml
250ml
500ml
1 Liter
02
years
Approved
10
2.5 Liter
12. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Sulfadine Liquid
Each 100ml contains:-
Enrofloxacin…………...10g
Colistin Sulphate………3.5g
Amantadine HCI……….4.0g
(Antibiotic).
Decontrolled
50ml
100ml
150ml
250ml
500ml
1 Liter
2 Liter
2.5 Liter
02
years
Approved
13. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Bromo Shell Liquid
Each 100ml contains:-
Bromhexine HCI……..05g
(Bronchodilator).
Decontrolled
100ml
500ml
1 Liter
02
years
Approved
14. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Asper Shell Water Soluble Powder
Each 1000g contains:-
Vitamin C……………..…200g
Acetyl Salicylic Acid…….67g
(NSAIDS + Supplement).
Decontrolled
30g
50g
100g
250g
500g
1 Kg
5 Kg
10Kg
02
years
Deferred, for
PSI by panel
comprising of
Area FID and
A.Q.Javed
Iqbal Member
RB.
15. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Amento Water Soluble Powder
Each 100g powder contains:-
Enrofloxacin HCI……..10%
Amantadine HCI………4%
Colistin Sulphate………3%
(Antibacterial, Antiviral).
Decontrolled
100g
250g
500g
1 Kg
5 Kg
10Kg
25Kg
02
years
Approved
16. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Adekshell Water Soluble Powder
Each 1000g contains:-
Vitamin A……………..20 MIU
Vitamin D……………...2 MIU
Vitamin E……………....6g
Vitamin K3……………..5g
(Multivitamins).
Decontrolled
30g
50g
100g
250g
500g
1 Kg
5 Kg
10Kg
02
years
Deferred, for
PSI by panel
comprising of
Area FID and
A.Q.Javed
Iqbal Member
RB.
17. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Shelldox Water Soluble Powder
Each 1000gm contains:-
Doxycycline HCI…………400g
Tylosin Tartrate…………..200g
(Antibacterial, Anti-viral).
Decontrolled
100g
250g
500g
1 Kg
02
years
Approved
11
5 Kg
10Kg
18. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
OXY NEO 10/10 Water Soluble
Powder
Each 100g contains:-
Neomycin Sulphate……..10g
Oxytetracycline HCI…….10g
(Anti-infective, Antibacterial).
Decontrolled
30g
50g
100g
125g
250g
500g
1 Kg
5 Kg
03
years
Approved
19. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Levashell 15 Powder
Each 100gm contains:-
Levamisole HCI……….15%
(Anthalmintic).
Decontrolled
30g
50g
100g
250g
500g
1 Kg
5 Kg
10Kg
02
years
Approved
20. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Tifo Shell Powder
Each 100gm contains:-
Trichlorfon…………98%
(Antiparasites, Anti Helminths).
Decontrolled
30g
50g
100g
500g
1 Kg
2.5Kg
5 Kg
10Kg
25Kg
02
years
Approved
21. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Pipra Shell Water Soluble Powder
Each 1000g contains:-
Piprazine Citrate………..1000g
(Anthelmintics).
Decontrolled
100g
250g
500g
1 Kg
5 Kg
10Kg
02
years
Approved,
with brand
name change
22. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Enrodine Plus Water Soluble
Powder
Each 1000g contains:-
Enrofloxacin………..100g
Amantadine HCI……40g
Colistin Sulphate……35g
(Antibacterial, Anti-viral).
Decontrolled
100g
250g
500g
1 Kg
5 Kg
10Kg
02
years
Approved,
with brand
name change
12
23. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Sulpha Plus Water Soluble Powder
Each 100gm powder contains:-
Enrofloxacin………….10%
Amantadine HCI………4%
Colistin Sulphate………4%
(Antibacterial, Anti-Viral).
Decontrolled
100g
250g
500g
1 Kg
5 Kg
10 Kg
25 Kg
02
years
Approved
24. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Amino Flush Water Soluble
Powder
Each 100g contains:-
Ammonium Chloride………45g
Sodium Sulphate…………..25g
Magnesium Sulphate
7H2O....................................25g
(Aminoacid, Multi-Vitamin,
Expectorant).
Decontrolled
100g
250g
500g
1 Kg
5 Kg
10Kg
02
years
Approved
25. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Reno Shell Water Soluble Powder
Each 100g contains:-
Methanamine…………90g
Sorbitol………………..5g
(Aminoacid, Multi-Vitamin,
Expectorant).
Decontrolled
30g
50g
100g
250g
500g,
1 Kg
5 Kg
10Kg
02
years
Deferred for
application on
Form 5 D
along with
revised Fee
and expert
views of
following;
g. Dr. M
Ashraf,
UVAS
h. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
26. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Vita Shell Water Soluble Powder
Each 1000gm powder contains:-
Vitamin C………………200g
Acetylecylicic Acid…….67g
Potassium Chloride……..3g
Sodium Citrate………….7g
(NSAIDs + Suppliment).
Decontrolled
30g
50g
100g
250g
500g
1 Kg
5 Kg
10Kg
25Kg
02
years
Approved
27. M/s. Inshal Coxishell Water Soluble Powder Decontrolled 02 Approved
13
Pharmaceutical
Industries, Rawat,
Islamabad.
Each 1000g powder contains:-
Doxycycline HCI………..200g
Tylosin Tartrate………….100g
Bromhexine………………5g
(Antibacterial, Anti-Viral).
30g
50g
100g
250g
500g
1 Kg
5 Kg
10Kg
25Kg
years
28. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Amproshell 60% Water Soluble
Powder
Each 100gm powder contains:-
Amprolium Hcl………60gm
Coccididal).
Decontrolled
100g
500g
1 Kg
02
years
Approved
29. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Tetra Shell 20 Water Soluble
Powder
Each 1000g contains:-
Chlortetracycline HCI……..200gm
(Anti-infective, Antibacterial,
Tetracycline).
Decontrolled
30g
50g
100g
150g
200g
250g
500g
1 Kg
02
years
Approved
30. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Tilco Shell Water Soluble Powder
Each 1000g contains:-
Tilmicosin Phosphate…….10%
(Anti-infective, Antibacterial).
Decontrolled
30g
50g
100g
500g
1 Kg
2.5Kg
5Kg
10Kg
25Kg
02
years
Deferred for
application on
Form 5 D
along with
revised Fee
and expert
views of
following;
i. Dr. M
Ashraf,
UVAS
j. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
31. M/s. Inshal
Pharmaceutical
Industries, Rawat,
Islamabad.
Doxyline Water Soluble Powder
Each 1000gm powder contains:-
Doxycycline HCI………200g
Tylosin Tartrate………..100g
Colistin Sulphate…….450MIU
Decontrolled
30g
50g
100g
250g
02
years
Approved
14
Bromhexine HCI…….….4g
(Antibacterial, Anti-Viral).
500g
1 Kg
5 Kg
10 Kg
25Kg
32. M/s. Prix
Pharmaceutica
(Pvt) Ltd Lahore.
Pri-Dimidine 33.3% Injection
Each ml injection contains:-
Sulphadimidine
Sodium……………….333.3mg
(Sulphonamide).
Decontrolled
100ml
500ml
02
years
Approved
33. M/s. Prix
Pharmaceutica
(Pvt) Ltd Lahore.
Pri-Calcifort injection
Each 100 ml injectable solution
contains:-
Calcium gluconate………20g
Toldimphos sodium…….400mg
Magnesium sodium…….334mg
Baric acid………………..2.4g
Sorbitol………………….5g
(MineralsCalcium/Phosphrous/Ma
gnesium and Sugar)
Decontrolled
50ml
100ml
250ml
500ml
02
years
Deferred for
application on
Form 5 D
along with
revised Fee
and expert
views of
following;
k. Dr. M
Ashraf,
UVAS
l. Head of
Pharmacol
ogy Deptt.
UAF
Dr. M.
Arshad,
Member DRB
34. M/s. Prix
Pharmaceutica
(Pvt) Ltd Lahore.
PRI-Dolocam 7.5 Injection
Each ml contains:-
Meloxicam………7.5mg
(NSAID)
Decontrolled
5 x 10ml
25ml
50ml
100ml
02
years
Approved
35. M/s. Prix
Pharmaceutica
(Pvt) Ltd Lahore.
Pri-Deflame 5 Injection
Each ml injection
contains: -
Flunixin Meglumine…..50mg
(Nsaid)
Decontrolled
5x 10ml
20ml
50ml
100ml
02
years
Approved
15
36. M/s. Epoch
Pharmaceuticals,
Karachi.
Escour Oral Suspension
Each ml contains:-
Sulphadiazine BP……35.50mg
Sulphadimidine BP…28.40mg
Neomycin Sulphate BP1.80mg
Hysoine
Methylbromide…….0.040mg
Pectin USP…………7.1mg
Kaolin BP……………103.3mg
Vitamin B1 BP………0.150mg
Vitamin B2 BP………0.220mg
(Antibiotic, Anti-Toxins, anti-
spasmodic and Vitamins).
Decontrolled
100ml
500ml
2 years Approved
37. M/s. Epoch
Pharmaceuticals,
Karachi.
Epotizer Injection
Each 3ml contains:-
Thiamine HCI (Vitamin
B1)…………………..100mg
Pyridoxine Hydrochloride
(Vitamin
B6)…………………100mg
Cyanocobalamin (Vitamin
B12)…………………500mcg
(Vitamins).
Decontrolled
50ml
100ml
18
months
Approved
16
Registration-II.
Registration Applications of July, 2010.
S.No. Name of
firm(s)
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Decision
1. M/s Barret
Hodgson,
Karachi
DiaSet Plus Tablet
Each tablet contains:
Pioglitazone ……15 mg
Metformin
Hydrochloride…...850 mg
(Antidiabetic agent)
As per
PRC
As per
PRC
28-7-2010
Dy.No.1433
Form-5
Rs.8000/-
Rs.12,000/-
21-5-2013
Approved
2. M/s Nabi
Qasim
Karachi
Reliefal 6 Plus Suspension
Each 5ml contains:
Paracetamol BP……….250mg
(analgesic & antipyretic)
60ml
450ml
As per
PRC
01/07/2010
Dy. No. 1273
Form 5
Rs. 8000/-
Rs.12,000/1
14-5-2013
Approved
3. M/s Bosch
Pharmaceut
icals, Kar.
Bentocin 30mg Injection
Each vial contains:
Pentazocin As
lactate…………...…30 mg
(Narcotic analgesic, post
operative pain)
5’s
10’s
Rs.75/-
Rs.150/-
22-07-2010
Dy.No.1388
Form-5
Rs.8000/-
Rs.12,000/-
20-5-2013
Deferred
being
Controlled
Drug
4. M/s Barrett
Hodgson
Karachi
Ivabar 7.5mg Tablet
Each tablet contains:
Ivabradine Hydrochloride eq.
to Ivabradine……...7.5mg
(Anti anginal, anti heart
failure)
10’s
14’s
28’s
56’s
Rs.1950/-
Rs.2730/-
Rs.5460/-
Rs.10,920/-
10/07/2013
Dy. No. 691
Form 5D
Rs. 60,000/-
Fast track
application
Deferred for
i.submission of
remaining fee.
ii.
Confirmation
for approval by
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion
byBrig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
5. -do- Ivabar 5mg Tablet
Each tablet contains:
10’s
14’s
Rs.1740/-
Rs.2436/-
10/07/2013
Dy. No. 690
-Do-
17
Ivabradine Hydrochloride eq.
to Ivabradine………...5mg
(Anti anginal, anti heart
failure)
28’s
56’s
Rs.4872/-
Rs.9744/-
Form 5D
Rs. 60,000/-
Fast track
application
6. M/s
Pharmatec
Pakistan
Pvt. Ltd.
Kar.
Clogrel Plus Tablet
Each film coated tablet
contains:
Aspirin (enteric coated
pellets)………………..75 mg
Clopidogrel (as Clopidogrel
Bisulphate USP)……..75 mg
(Anticoagulant/ antiplatelet)
10x2’s As per
PRC
01/07/2013
Dy. No. 683
Form 5
Rs. 60,000/-
Fast track
application
Deferred for
product
specifi
inspection for
confirmation
of
manufacturin
g & QC
facility by
area FID &
Director
DTL, Karachi
Registration Applications of August, 2010.
S.No. Name of
firm(s)
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Comments
7. M/s Nabi
Qasim
Karachi
Letol Tablet
Each film coated tablet
contains:
Labetalol
Hydrochloride …200mg
(Beta Blockers)
10’s &
20’s
As per
PRC
11-08-2010
Dy.No.1553
Form-5
Rs.8000/-
Rs.12,000/-
14-5-2013
Deferred for
i.submission of
application on
Form5D. ii.
Confirmation
for approval by
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion by
Brig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
8. -do- Loprot Plus Capsule
Each capsule contains:-
Omeprazole ……..20mg
Sodium Bicarbonate .1100mg
7’s
10’s
14’s
As per
PRC
03-08-2010
Dy.No.1530
Form-5
Rs.8000
Referred to
review
committee
18
(Anti Ulcerant) Rs.12,000/
14-5-2013
9. -do- Letol Tablet
Each film coated tablet
contains:
Labetalol
Hydrochloride USP…300mg
(Beta Blockers)
10’s &
20’s
As per
PRC
11-08-2010
Dy.No.1554
Form-5
Rs.8000/-
Rs.12,000/1
14-5-2013
Deferred for
i.submission of
application on
Form5D. ii.
Confirmation
for approval by
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion
byBrig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
10 -do- Misotec tablet
Each tablet contains:
Misoprostol…100mcg
Mfg.Specs.NQ
(Prostaglandin Analogue)
10’s & 30 As per
PRC
17-08-2010
Dy.No.1578
Form-5
Rs.8000/-
Rs.12,000/1
14-5-2013
Approved
11 -do- Misotec tablet
Each tablet contains:
Misoprostol…200mcg
Mfg.Specs.NQ
(Prostaglandin Analogue)
3 &10’s As per
PRC
17-08-2010
Dy.No.1577
Form-5
Rs.8000/-
Rs.12,000/1
14-5-2013
Approved
12 -do- Tensel 5mg Tab.
Each tablet contains:
Nebivolol HCI equivalent to
Nebivolol…….5mg
(Anti-hypertensive)
14’s As Per
PAC
10-08-2010
1540
Form-5
Rs.8000/-
Rs.12,000/1
14-5-2013
Approved
13 -do- Letol Tablet
Each film coated tablet
contains:
Labetalol
Hydrochloride ….…100 mg
(Beta Blockers)
20’s As per
PRC
11-08-2010
Dy.No.1556
Form-5
Rs.8000/-
Rs.12,000/1
14-5-2013
Approved
Applications for Fast Track Registration
19
S.No. Name of
firm(s)
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Comments
14 M/s Indus
Pharma
Karachi
Dyclo Plus 2ml Inj.
Each 2ml contains:
Diclofenac Sodium ..75 mg
Lignocaine
Hydrochloride……..20mg
(Non Steroidal Anti-
Inflammatory)
5’s
10’s
20’s
Rs.140/-
280/-
Rs.560/-
13-05-2013
Dy.No.367
Form-5
Rs.60,000/-
Approved.
Only IM
route of
administratio
n approved
15 -do- I-Flor 250mg Schet
Each sachet contains:
Saccharomyces
Boulardii………….250 mg
(Anti diarrheal)
10’s Rs.480/- 13-05-2013
Dy.No.366
Form-5
Rs.60,000/-
Referred to
H&OTC
Division
being
probiotics
16 M/S. GSK
Pakistan
Ltd.
Karachi.
Panadol sinus Caplets
Each Caplet contains:-
Paracetamol……. 500 mg
Phenylephrine HCl. 5.00mg
(Cold Preparation)
100’s Rs.300/- 24-07-2013
Dy.No.1047
Form-5
Rs,60,000/-
Deferred for
submission of
application on
Form5D &
remaining fee.
17 M/s Sante
Pvt. Ltd,
Karachi
Cipromax 250mg Tablet
Each tablet contains:
Ciprofloxacin HCl eq. to
Ciprofloxacin……..250 mg
(Fluoroquinolone)
10’s As per
PRC
14-05-2013
Dy.No.371
Form-5
Rs.60,000/-
Approved.
The Board
advised to
change brand
name.
18 M/s
Medisure
Lab. Kar.
Sepride Tablet
Each tablet contains:
Cinitapride…….….1 mg
(Antiemetic)
10’s
50’s
As per
PRC
20-05-2013
Dy.No.498
Form-5
Rs.60,000/-
Approved
19 -do- Dexiprofen Tablet
Each tablet contains:
Dexibuprofen…….300 mg
(Analgesic agent)
10’s
30’s
As per
PRC
20-05-2013
Dy.No.496
Form-5
Rs.60,000/-
Approved
20 -do- Dexiprofen Tablet
Each tablet contains:
Dexibuprofen…..400 mg
(Analgesic agent)
10’s
30’s
As per
PRC
20-05-2013
Dy.No.497
Form-5
Rs.60,000/-
Approved
21 M/s S.J &
G, Karachi
Berica 60mg Tablet
Each film coated tablet
contains:
Etoricoxib…….…60 mg
(NSAID)
14’s Rs.600/- 29-04-2013
273
Form-5
Rs.20,000/-
Rs.40,000/-
20-05-2013
Approved
20
22 -do- Acenac 150mg Injection
Each ml contains:
Aceclofenac…….150 mg
(Non-Steroidal Anti
inflammatory drug)
5x1ml Rs.200/- 20-05-2013
273
Form-5
Rs.20,000/-
Rs.40,000/-
20-05-2013
Approved
23 M/s Sami
Pharmaceuti
cals, Kar.
D3 Injection
Each ml contains:
Cholecalciferol …...5 mg
(200,000 IU)
(Vitamin D3)
As per
PRC
As per
PRC
20-05-2013
518
Form-5
Rs.60,000/-
Approved.
The Board
advised to
change brand
name.
24 M/s Helix
Pharma kar.
Azil 40mg Tablet
Each tablet contains:
Azilsartan kamedoxomil
eq.to Azilsartan
medoxomil……..40 mg
(Anti Hypertensive)
10’s
30’s
As per
PRC
20-05-2013
515
Form-5D
Rs.60,000/-
Rs.90,000/-
24-07-2013
Deferred for i.
Confirmation
for approval by
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion
byBrig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
25 -do- Azil 80mg Tablet
Each tablet contains:
Azilsartan kamedoxomil
eq.to Azilsartan
medoxomil………80 mg
(Anti Hypertensive)
10’s
30’s
As per
PRC
20-05-2013
514
Form-5D
Rs.60,000/-
Rs.90,000/-
24-07-2013
-Do-
26 -do- Azil 20mg Tablet
Each tablet contains:
Azilsartan kamedoxomil
eq.to Azilsartan
medoxomil………20 mg
(Anti Hypertensive)
10’s
30’s
As per
PRC
20-05-2013
513
Form-5D
Rs.60,000/-
Rs.90,000/-
24-07-2013
-Do-
27 M/s
Mediate
Pharmaceuti
cals, kar
Tramorhage 250mg
Capsule
Each capsule contains:
Tranexamic acid...250 mg
20’s Rs.154/- 20-05-2013
502
Form-5
Rs.20,000/-
Rs.40,000/-
23-5-2013
Approved
28 -do- Tramorhage 500mg
Capsule
20’s Rs.310/- 20-05-2013
501
Approved
21
Each capsule contains:
Tranexamic acid…..500 mg
Form-5
Rs.20,000/-
Rs.40,000/-
23-5-2013
29 -do- Medeiron-S Injection
20mg/ml Injection
Each ml contains:
Iron sucrose…….…20 mg
5mlx5’s Rs.1250/- 20-05-2013
500
Form-5
Rs.20,000/-
Approved.
The Board
advised to
change brand
name.
30 M/s Maple
Pharma.
Kar.
Losaan 25mg Tablet
Each tablet contains:
Losartan Potassium...25 mg
(Anti hypertensive)
20’s As per
PRC
21-05-2013
526
Form-5
Rs.60,000/-
Approved
31 -do- Ciprozee 750mg Tablet
Each tablet contains:
Ciprofloxacin (as
Hydrochloride)……750 mg
(Fluoroquinolone
Antibiotic)
10’s As per
PRC
21-05-2013
525
Form-5
Rs.60,000/-
Approved
32 M/s Opal
Lab.
Karachi
Febutab 80mg Tablet
Each film coated tablet
contains:
Febusostat…………..80 mg
(Xanthine Oxidase
Inhibitor)
10’s
20’s
30’s
As per
PRC
04-06-2013
Dy.No.631
Form-5
Rs.60,000/-
Approved
33 M/s Helix
Pharma
Karachi
Lacosa 200mg Tablet
Each film coated tablet
contains:
Lacosamide……….200 mg
(Anti epileptic/ Anti-
Convulsant)
14’s
As per
PRC
17-06-2013
Dy.No.664
Form-5
Rs.60,000/-
Approved
34 -do- Lacosa 100mg Tablet
Each film coated tablet
contains:
Lacosamide……….100 mg
(Anti epileptic/ Anti-
Convulsant)
14’s
As per
PRC
17-06-2013
Dy.No.663
Form-5
Rs.60,000/-
Approved
35 -do- Lacosa 50mg Tablet
Each film coated tablet
contains:
Lacosamide……….50 mg
(Anti epileptic/ Anti-
Convulsant)
14’s
As per
PRC
17-06-2013
Dy.No.665
Form-5
Rs.60,000/-
Approved
36 -do- Rozerem Tablet
Each film coated tablet
contains:
10’s
30’s
As per
PRC
04-06-2013
Dy.No.633
Form-5D
Deferred for i.
Confirmation
for approval by
22
Ramelteon………..8 mg
(Hypnotics)
Rs.150,000/-
USFDA,
EMA,
regulatory
body of Japan
or Australia.
iii. Expert
opinion by
Brig.
M.H.Najmi,
Dr.Rizwan
Taj, PIMS
Dr.Saleem
Jehangeer, MH
Rawalpindi
37 M/s
Pharmatec
Pak.
Karachi
Alptec 0.5mg Tablet
Each tablet contains:
Alprazolam ………..0.5 mg
(Anxiolytic)
3x10’s As per
PRC
03-06-2013
Dy.No.616
Form-5
Rs.60,000/-
Deferred
being
controlled
Drug
38 -do- Reltus Forte Cough
Expectorant
Each 5ml contains:
Ammonium
chloride……….100mg
Ephedrine
Hydrochloride……7 mg
Chlorpheniramine
maleate…………..2 mg
(Cpigj ex[ectprant)
120ml As per
PRC
07-06-2013
Dy.No.640
Form-5
Rs.60,000/-
Deferred
being
controlled
Drug
39 M/s Sanofi
Aventis,
Karachi
Aprovasc 300/10mg Tablet
Each tablet contains:
Irbesartan……….300 mg
Amlodipine besylate.14 mg
eq. to amlodipine…10 mg
(Alntihypertensive,
angiotensin II receptor
antagonist)
28’s Rs.2212/- 04-06-2013
Dy.No.630
Form-5D
Rs.150,000/-
Deferred for i.
Confirmation
for approval by
USFDA,
EMA,
regulatory
body of Japan
or Australia. ii.
Expert opinion
by Brig.
M.H.Najmi,
Dr.Shahid
Nawaz, PIMS
Dr.Ghulam
Haider, Shifa
International
40 -do- Aprovasc 150/10mg Tablet
Each tablet contains:
Irbesartan……….150 mg
Amlodipine besylate.14 mg
eq. to amlodipine…10 mg
28’s Rs.2620.8/- 04-06-2013
Dy.No.624
Form-5D
Rs.150,000/-
-Do-
23
(Alntihypertensive,
angiotensin II receptor
antagonist)
41 -do- Aprovasc 150/5mg Tablet
Each tablet contains:
Irbesartan……….150 mg
Amlodipine besylate.7 mg
eq. to amlodipine……5 mg
(Alntihypertensive,
angiotensin II receptor
antagonist)
28’s Rs.1456/- 04-06-2013
Dy.No.631
Form-5D
Rs.150,000/-
-Do-
42 -do- Aprovasc 300/5mg Tablet
Each tablet contains:
Irbesartan……….300 mg
Amlodipine besylate.7 mg
eq. to amlodipine……5 mg
(Alntihypertensive,
angiotensin II receptor
antagonist)
28’s Rs.2114/- 04-06-2013
Dy.No.628
Form-5D
Rs.150,000/-
-Do-
43 M/s Abbott
Laboratorie
s, kar.
Rondec E Syrup
Each 5ml contains:
Salbutamol………….2 mg
Guaifenesin ……..200 mg
Bromhexine HCl…….4mg
(Expectorant with
bronchodilator cough
syrup)
60ml
120ml
Rs.60/-
Rs.120/-
07-06-2013
Dy.No.639
Form-5D
Rs.150,000/-
Deferred for i.
Confirmation
for approval by
USFDA,
EMA,
regulatory
body of Japan
or Australia. ii.
Expert opinion
by Brig. Aslam
Khan,
Dr.Rehana
Kausar, PIMS
Head, Dept of
Chest
Diseases,
Shaikh Zayed
Hospital,
Lahore
44 M/s Barrett
Hodgson
Pak. Kar.
Megaklar DS Suspension
250mg/ml
Each 5ml contains:
Clarithromycin*…250mg
(Antibacterial and
Antibiotic)
60ml Rs.450/- 27-06-2013
Dy.No.675
Form-5
Rs.60,000/-
Deferred for
confirmation
whether
powder or
granules
24
Item No.III Miscellaneous Cases:
Registration-I
Case No:01 Transfer of Registration of Drugs from M/s. Pakistan Business
International, Karachi to M/s. Zenith International, Karachi.
M/s. Zenith International, Karachi have requested for transfer of registration of
the following registered Surgical Sutures from the name of previous agent M/s. Pakistan
Business International, Karachi to their name for import and approved the change of
manufacturer’s name of the products from M/s. Shandong Shanxian Medical Suture
Materials Co. Ltd. China to M/s. Shandong Sinorgmed Co. Ltd., China:-
S. No. Reg. No. Name of Products.
1. 031371 PLAIN CATGUT (Plain Catgut Surgical Sutures).
2. 031372 CHROMIC CATGUT (Chromic Catgut Surgical
Sutures).
3. 031373 POLYGLYCOLIC ACID (Synthetic Absorbable
Sutures).
4. 031374 SILK BRAIDED (Silk Braided Surgical Sutures).
5. 043055 Black Monofilament Nylon Surgical Suture.
6. 043056 Blue Polypropylene Surgical Suture.
7. 043057 Green Braided Polyester Surgical Suture.
The firm has deposited the fee Rs.15000 x 7 = Rs.105000/- and submitted
following supporting documents:-
i. No objection certificate to transfer the registration in the name of M/s.
Zenith International, Karachi from the manufacturer abroad M/s.
Shandong Sinorgmed Co. Ltd., China.
ii. Manufacturer declaration regarding termination of their previous agency.
iii. Manufacturer declaration of change in company name.
iv. Certificate from Heze Food and Drug Administration of Peoples Republic
of China certifying the change in company name.
No Objection Certificate of the former agent M/s. Pakistan Business International,
Karachi was not provided. M/s. Pakistan Business International, Karachi was asked either
to submit their NOC in this regard or provide their fresh agency agreement (if any) with
the manufacturer abroad. They have informed that they do have strong objection in
transferring the said drugs to other applicant/company without their consent and shall be
25
furnishing fresh Agency Agreement and relevant documents as soon as they receive.
However the principals abroad M/s. Shandong Sinorgmed Co. Ltd., China have
meanwhile confirmed that they have appointed M/s. Zenith International, Karachi as their
sole agent for all their products and have terminated their agency with M/s. Pakistan
Business International, Karachi.
Show Cause Notices were issued to M/s. Pakistan Business International, Karachi
two times for cancellation of registration of said drugs from their name. In response they
have requested to grant them an appointment to appear in person to explain the details.
They have also informed that they already pursue the matter with Wafaqi
Mohtasib (Ombudsman’s) Secretariat Regional Office Karachi to counter the challenges
and forward copies of proceedings as and when required by this office.
M/s Zenith International, Karachi have submitted relevant documents from
manufacturer abroad that are not endorsed by Pakistan embassy in China.
Accordingly, M/s. Pakistan Business International, Karachi was called for
personal hearing before the Drug Registration Board in its 237th
meeting held on 26-02-
2013.
In response, M/s. Pakistan Business International, Karachi have submitted that the
letter for personal hearing received too late leaving no time, not even a single day to
move / attend the scheduled hearing before Drug Registration Board on 26th
February,
2013.
The Drug Registration Board in its 237th
meeting held on 26-02-2013 and also
placed in 238th
meeting held on August 5-6, 2013 the board considered and deferred the
case and decided to issue final show cause notice to call the firm for personal hearing in
next board’s meeting.
Decision:
The representative of the firm Mian Abdul Jabbar CEO appeared before the
Board and informed that his firm i.e. M/s. Pakistan Business International, Karachi
is still authorized agent of M/s. Shandong Sinorgmed Co. Ltd., China for above
referred products and requested for two week time for submission of legalized New
Sole agency agreement from M/s. Shandong Sinorgmed Co. Ltd., China. The Board
26
after detailed deliberations allowed him to submit the same within 15 days for
further actions on the request of M/s. Zenith International, Karachi.
Case No:02. Re-registration of BONEFOS Capsules (REG. NO.013031).
On the request of M/s. Medipharm (Private) Limited, Karachi the Drug
Registration Board in its 236th
meeting held on 20th
November, 2012 de-registered their
drug “Bonefos Capsules (Disodium Clodronate 400mg) (Reg. No. 013466)” due to non-
available business with immediate effect.
Now M/s. Medipharm (Private) Limited, Karachi have informed that they have
two presentations of Bonefos Capsules, registered with DRAP Bonefos Capsules, 1x
100’s pack and Bonefos Capsules, 1x30’s pack. They have pointed out that they applied
for withdrawal / discontinue one of the above mentioned presentations i.e., Bonefos
Capsules, 1x100’s pack, with the intention to continue with the sale of Bonefos Capsules
1x30’s. Unintentionally wrong registration number was mentioned which was corrected
in subsequent clarification letter.
Now surprisingly, they have received the letter with the subject, “de-registration
of drug” in which there are two main confusions:-
i) The registration number (013466) mentioned is not of Bonefos capsules,
but of another unrelated product.
ii) The letter does mention Bonefos Capsule but confusingly does not
mention the de-registration presentation, i.e., Bonefos Capsules, 1x100’s
pack. While they had clearly mentioned the desired pack size in their
request letter.
They have stopped further sales of Bonefos Capsules. To avoid any further
confusion, they have requested:-
i) Please confirm withdrawal / discontinuation of Bonefos Capsules 1x100’s
presentation.
ii) Please confirm continued registration of Bonefos Capsules 1x30’s pack
size having Registration No.013031 so that it can continue to be marketed.
27
The firm has submitted that Bonefos is used on long term basis, in life threatening
cancers, so to avoid any inconvenience to the patients already on Bonefos Capsules
requested to treats this matter at the earliest.
Decision:
The Board after detailed discussion accepted the request of the firm for re-
registration of Bonefos Capsules (Registration No. 013031) in pack size of 30’s on
same terms and conditions.
Case No:03. APPEAL FILED BY M/S. FINE TRADERS INTERNATIONAL
AGAINST THE DECISION OF REGISTRATION BOARD REGARDING
REJECTION OF REGISTRATION APPLICATION OF NEOCLOXIN
POWDER.
The Drug Registration Board in its 210th
meeting held on 26th
– 27th
October,
2007 considered and rejected the application of “Neocloxin Powder” applied by M/s.
Fine Traders International Faisalabad for import from M/s. Agrar Holland BV Holland
due to irrational formulation.
Against the decision of Drug Registration Board M/s. Fine Traders International
Faisalabad filed an appeal before the Drugs Appellate Board. The Drugs Appellate Board
in its 138th
meeting held on 13-01-2010 considered and passed orders on the appeal
preferred by the firm against the decision of the Drug Registration Board regarding
rejection of their application for grant of registration due to the reason as follows: -
Name of Drug (s) & Composition. Orders Passed by the Drugs Appellate Board.
Neocloxin Powder
Each gm contains: -
Oxytetracycline HCl 100mg.
Neomycin Sulphate 50mg.
Chloramphenicol 100mg.
After hearing to arguments of the appellant and
the basis of decision by the respondent i.e. the
Registration Board as stated by its secretary and
taking into consideration all the relevant pros and
cons of the matter, the Board decided to remand
the case back to the Registration Board for
getting expert evaluation of this formulation from
University of Veterinary and Health Sciences,
Lahore and also to verify its formulation in other
countries and to decide the matter on merit
accordingly.
28
The Drug Registration Board in its 226th
meeting held on 20th
& 21st July 2010
considered and decided that the instructions of the Drugs Appellate Board be processed
accordingly.
As per decision of the Drug Registration Board in its 226th
meeting held on 20th
&
21st July 2010 case was referred to Prof. Dr. Muhammad Nawaz, Vice Chancellor,
University of Veterinary and Health Sciences, Lahore for their detailed views/expert
opinion and recommendations on the matter. The views/expert opinion of Prof. Dr.
Muhammad Nawaz is not received so far.
Decision:
The Board discussed the matter in detail. Dr. Arshad, Member DRB also
recommended that chloramphenicol containing formulation should be banned in
veterinary drugs. Thus the Board rejected the request of the firm. The Board
further decided to issue cuase notices to all manufactures / importers of veterinary
drugs for de-registration of all chloramphenicol containing products.
Case No:04. Correction in Composition of Solvasole Forte Injection.
M/s. Mylab (Private) Limited, Bahawalpur have requested for correction of
composition of their registered veterinary drug “Solvasol Forte Injection (Reg.
No.075602)” that one of the ingredient “Etilefrine 10mg/ml” is written by mistake in the
registration application instead of “Etilefrine 0.2mg/ml”. They have therefore requested
for correction of composition of the product as follows. M/s. Mylab (Private) Limited,
Bahawalpur have deposited required fee Rs.20000/-:-
Incorrect composition Correct composition
Solvasol Forte Injection.
Each ml contains:-
Novaminsulfon …………….. .40mg.
Etilefrin…………………….10mg.
Calcium Gluconate …………100mg.
Magnesium Gluconate ……… 10mg.
Sodium Salicylate …………… 7mg.
Nicotinamide ………………… 0.3mg.
Caffeine………………………. 10mg.
Solvasol Forte Injection.
Each ml contains:-
Novaminsulfon …………….. .40mg.
Etilefrin……………………0.2mg.
Calcium Gluconate …………100mg.
Magnesium Gluconate ……… 10mg.
Sodium Salicylate …………… 7mg.
Nicotinamide ………………… 0.3mg.
Caffeine………………………. 10mg.
29
Boric acid………………………10mg. Boric acid………………………10mg.
The firm have further requested that the above composition is already registered
and is a Mee-Too product. They have given the following references of already registered
products:-
S. No. Name of Manufacturer. Name of Product. Reg. No.
1. M/s. Nawan Laboratories, Karachi Nevit Forte Injection 058987
2. M/s. Selmore Pharmaceuticals, Lahore Aminox Injection 029663
3. M/s. Star Laboratories, Lahore Novastar Injection 035134
4. M/s. Zakfas Pharma, Multan Novafon 052325
Keeping in view of above submitted documents request of the firm for correction
of composition of the drug “Solvasol Forte Injection (Reg. No.075602)” may be
considered for approval please.
Decision:
Request of the firm was approved by the Board
.
Case No:05. Change of Manufacturing Site of Tarceva Tablets.
M/s. Roche Pakistan Limited, Karachi have requested to approve the change of
manufacturing site of their following registered imported drugs from M/s. F. Hoffmann-
La Roche Ltd., Basel, Switzerland to M/s. Roche S.p.A., Segrate (Milano), Italy:-
S. No. Reg. No. Name of Drug (s).
1. 043002 Tarceva 100mg Tablets.
Each film-coated tablet contains:-
Erlotinib hydrochloride corresponding to
100mg of Erlotinib.
2. 043003 Tarceva 150mg Tablets.
Each film-coated tablet contains:-
Erlotinib hydrochloride corresponding to
150mg of Erlotinib.
30
M/s. Roche Pakistan Limited, Karachi has deposited required fee submitted
following supporting documents:-
i) Copy of initial registration letter.
ii) Copy of change of manufacturing site.
iii) Copy of last renewal of drugs.
iv) Original COPP of drugs issued by EMA.
M/s. Roche Pakistan Limited, Karachi was advised to confirm about status of
Tarceva 25mg Tablets (Reg. No.043001) whether it will be supplied from previous
manufacturing site. In response, M/s. Roche Pakistan Limited, Karachi have submitted
that “Tarceva 25mg Tablets” strength is not prescribed by specialist doctors, which
leaves it with no place in the market; therefore they do not intend to continue marketing
this strength.
Keeping in view the submitted documents request of the firm for change of
manufacturing site from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s.
Roche S.p.A., Segrate (Milano), Italy is submitted for consideration of the Drug
Registration Board.
Decision:
The Board after discussion approved the change in manufacturing site of
Tarceva tablets from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s.
Roche S.p.A., Segrate (Milano), Italy. However the Board advised to provide site
master file of new manufacturing site and authorized its Chairman to accord
approval for issuance of letter.
Case No:06. Change of Manufacturing Site of Integrilin Injections.
M/s. Schering-Plough Pakistan (Pvt) Limited, Karachi have requested to approve
the change of manufacturing site of their following registered imported drugs from M/s.
Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia SPA, Ferentino, Italy, while
the Labeling, Secondary Packaging and Batch release site of the finished products remain
the same i.e. M/s. Schering-Plough Labo N.V., Belgium:-
S. No. Reg. No. Name of Drugs.
1. 033145 Integrilin 0.75mg/ml Injection.
31
2. 033146 Integrilin 2.0mg/ml Injection.
They have deposited required fee and submitted following documents in support
of their request:-
i) Original declaration letter from their parent company M/s. Schering-
Plough Corporation, USA affecting this change requirement.
ii) Patheon’s GMP and Manufacturing Certificates duly notarized and
legalized in original by Pakistan embassy, Rome, Italy.
iii) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from
Italy for Integrilin 0.75mg/ml Injection.
iv) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from
Italy for Integrilin 2.0mg/ml Injection.
v) FDA approval of Integrilin 0.75mg/ml &2.0mg/ml in US.
vi) Notarized Merck letter confirming availability of Integrilin in US from the
manufacturing site Patheon Italia S.p.A. Ferentino, Italy.
vii) Legalized and Notarized FDA approval of Integrilin with the source of
supply Patheon Italia S.p.A in US.
The Registration of the drug is valid till 16th
December 2013 as change in the
name of manufacturing site was approved on 17th
December 2008.
Keeping in view the submitted documents request of the firm for change
of manufacturing site from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon
Italia SPA, Ferentino, Italy is submitted for consideration of the Drug Registration Board.
Decision:
The Board approved the change in manufacturing site of Integrilin
Injection from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia
SPA, Ferentino, Italy, while the labeling, secondary packaging and batch release site
of the finished products remain the same i.e. M/s. Schering-Plough Labo N.V.,
Belgium. However the Board advised to provide site master file of new
manufacturing site and authorized its Chairman to accord approval for issuance of
letter.
32
Case No: 07. Transfer of Registration of Imported Drugs and Change of
manufacturing site.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer
of registration of the under-mentioned registered imported drugs from the name of
previous importer M/s. Highnoon Laboratories Ltd., Lahore to their name as due to an
International Acquisition of the Pharmaceutical Section of Solvay with all associated
companies has been acquired by the Abbott group since February 15, 2010: -
S# Reg.
No.
Name of Drugs. Existing Name of
Manufacturer.
New Name of
Manufacturer.
1. 018552 Physiotens 0.2mg
Tablets.
M/s. Eli Lilly S.A.,
Spain.
Manufactured by: M/s.
Rottendrof Pharma GmbH,
Germany.
Packed by: -
M/s. Abbott Healthcare
SAS, France.
2. 018551 Physiotens 0.3mg
Tablets.
-do- -do-
3. 018550 Physiotens 0.4mg
Tablets.
-do- -do-
They have deposited required fee and submitted following supporting documents:
-
i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd.,
Lahore.
ii) Copy of the acknowledgement of last renewal of registration of the
products applied by the previous importer M/s. Highnoon Laboratories
Ltd., Lahore.
iii) Copies of acknowledgement of receipt issued by the German National
authority BfArM & a notification submitted by the Solvay to the Germany
authority for the change in manufacturer name to M/s. Rottendrof Pharma
GmbH, Germany.
iv) Copy of NOC for CRF.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi was advised to provide the
33
proof of approval of the “Physiotens tablets” from EMA, US FDA, Japan & WHO form
the same source, the product is not approved from any of these regulatory bodies and as
per Import Policy the inspection of the source is required before transfer.
The case is submitted for consideration of the Drug Registration Board.
Decision:
The Board approved transfer of registration of Physiotens Tablet from M/s.
Highnoon to M/s. Abbott Laboratories (Pakistan) Ltd. Karachi alongwith the
change in manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof
Pharma GmbH, Germany, while the packaging site of the finished products will be
M/s. Abbott Healthcare SAS, France. The Board advised to provide site master file
of both sites and panel will inspect the manufacturing sites as well to comply the
provisions of import policy. The Board authorized its chairman to accord approval
for issuance of letter after compliance of aforementioned provisions.
Case No:08. Change of Manufacturing Site of Clozaril Tablets.
M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the
change of manufacturing site of their following registered imported drugs from M/s.
Novartis Pharmaceuticals, Horsham, Great Britain to M/s. Norartis Urunleri, Kurtkoy,
Istanbul, Turkey:-
S. No. Reg. No. Name of Drug (s).
1. 016329 Clozaril Tablets 25mg.
2. 016330 Clozaril Tablets 100mg.
They have deposited required fee and submitted following supporting documents:-
i) Copy of registration letter.
ii) Original legalized GMP Certificate of new manufacturing site.
iii) Copy of evidence of approval of Clozaril Tablets by FDA.
iv) Copy of evidence of approval of Clozaril Tablets by EMEA.
v) Copy of GMP Certificate of new site issued by MHRA.
vi) Copy of NOC for CRF.
34
vii) Original legalized GMP Certificate issued by Medicines and Healthcare
Products Regulatory Agency (MHRA), United Kingdom.
viii) Original legalized CPP issued by Ministry of Health, Republic of Turkey
as an evidence of approval in the country of origin.
ix) Copies of the acknowledgement of last renewal of registration of the
products.
x) Copy of transfer of registration from M/s. Sandoz (Pakistan) Limited,
Karachi to M/s. Novartis Pharma (Pakistan) Limited, Karachi.
M/s. Novartis Pharma (Pakistan) Limited, Karachi have further submitted that
they will be importing these products from M/s. Novartis Pharma Stein AG, Switzerland
till they receive products from new manufacturing site.
M/s. Novartis Pharma (Pakistan) Limited, Karachi was advised to provide
legalized / notarized documents for approval of the “Clozaril tablets” from EMA, US
FDA, Japan & WHO form the same source. In reply the firm has provided legalized
Certificate of Pharmaceutical Product (CPP) of Australia from Australian Government,
Department of Health and Ageing, Therapeutic Goods Administration (TGA) as the proof
of approval of the “Clozaril tablets” manufactured by to M/s. Norartis Urunleri, Kurtkoy,
Istanbul, Turkey.
Decision:
Registration Board approved change in manufacturing site of Clozaril
Tablets from M/s. Novartis Pharmaceuticals, Horsham, Great Britain to M/s.
Norartis Urunleri, Kurtkoy, Istanbul, Turkey. However, the Board advised to
deposit remaining fee and provide site master file of manufacturing site. The Board
authorized its chairman to accord approval for issuance of letter after compliance of
aforementioned provisions.
Case No:09. Change of Manufacturing Site of Eloxatin Injetcion.
M/s. Sanofi-Aventis Pakistan Limited, Karachi have requested to approve the
change of manufacturing site of their following registered imported drugs from M/s.
Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to M/s. Sanofi-
Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany
:-
S. No. Reg. No. Name of Products.
1. 044890 Eloxatin 50mg/10ml Concentrate for
Solution for Infusion.
35
Each ml contains:-
Oxaliplatin …………… 5mg.
2. 044891 Eloxatin 100mg/20ml Concentrate for
Solution for Infusion.
Each ml contains:-
Oxaliplatin …………… 5mg.
They have deposited required fee and submitted following supporting
documents:-
i) Copies of Registration Documents.
ii) Original Legalized Certificate of Pharmaceutical Products.
iii) Original Legalized GMP Certificate.
iv) Original Legalized Manufacturing Authorization.
M/s. Sanofi-Aventis Pakistan Limited, Karachi was advised to provide legalized /
notarized documents for approval of the “Eloxatin Injection” from EMA, US FDA, Japan
& WHO form the same source. In response the firm has submitted a letter addressed to
Director Registration, Drug Regulatory Authority of Pakistan, Islamabad regarding
confirmation of registration and approval “Eloxatin Injection” from M/s. Sanofi-Aventis
Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany.
Keeping in view the submitted documents request of the firm for change of
manufacturing site of the products from M/s. Aventis Pharma, Rainham Road South,
Dagenham, United Kingdom to M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse
50, D-65926 Frankfurt am Main, Germany is submitted for consideration of the Drug
Registration Board.
Decision:
The Board approved the change in manufacturing site of above products
from M/s. Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to
M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am
Main, Germany. However, the Board advised to provide site master file of new
manufacturing site and authorized its chairman to accord approval for issuance of
letter after compliance of aforementioned provision.
36
Registration-II
Case No.10 Permission for bulk import and local repacking – Telfast D tablets
(Reg. No: 023617).
Registration Board in its 215th
meeting deferred request of M/s Aventis, Karachi
for extension in bulk import and local repacking of Telfast- D Tablet (Reg. No.023617)
for five years, for clarification from the firm for plan of local manufacturing of Telfast- D
Tablet. Last permission for extension for bulk import and local repacking of subject item
was granted by the Chairman, Registration Board for two years which is up to 29th
August, 2009. Firm submitted an undertaking to establish their own facilities for
manufacturing of Telfast-D Tablets within this period. Permission was subject to no
further extension in future. Later on firm submitted that Telfast-D Tablet is manufactured
at Sanofi-aventis Pharmaceuticals Inc. USA and involves sophisticated unique
technology that enables slow release of pseudoephedrine using a tan-wax matric in these
bi-layered tablets. This also follows strict analytical procedures and quality tests to
maintain specification standards and safety precautions to be taken during its
manufacturing and analysis. Due to these facts, this site is responsible for supply bulk
tablet to all sanofi-aventis subsidiaries across the world to be imported in bulk followed
by local repacking at local units.
The Registration Board in its 223rd
meeting discussed the case and advised firm to
transfer technology as committed previously and must develop facility for manufacturing
of Telfast-D Tablet. If firm is still interested for import, then they should brief the
Registration Board.
In the Registration Board’s 224th
meeting dated 21st & 22
nd April, 2010
Mr.Muhammad Amjad, Director Technical, Sanofi Aventis appeared before the board
and presented that Telfast-D Tablet cannot be manufactured in Pakistan due to low sale
volume and safety concern in manufacturing of fexofenadine and pseudoephedrine
combination. The board considered firm’s view about safety concern in manufacturing of
fexofenadine and discussed that firm is presently manufacturing fexofenadine tablets and
firm has already taken safety measures in its manufacturing. However in order to avoid
scarcity of product in market, it was decided to extended bulk import and local repacking
permission of Telfast- D Tablet (Reg. No.023617). Permission was valid till August
37
2011. The board also advised firm to transfer technology as committed previously and
must develop facility for manufacturing of Telfast-D Tablet. No further extension will be
granted after this permission. The Board after detailed discussion deferred the case for
personal hearing in next Registration Board.
Now firm has requested for further extension in the permission for bulk import
and local repacking of Telfast-D Tablets and have deposited fee amounting to
Rs.100,000/- for the purpose.
Decision:
Mr.Muhammad Idress incharge QA and Mr.Jaffar Zaida, Regulatory Officer, SITE
appeared before the Board and presented that initially M/s Sanofi Aventis, Karachi
was granted registration for finished import from M/s Sanofi Aventis, Kansas, USA
and later on permitted for bulk import and local repacking at their manufacturing
site. As per directions of Registration Board they have tried to make arrangements
for local manufacturing of the product but their principal did not agree to the
proposal as M/s Sanofi Aventis, Arkansas, USA is the only site of M/s Sanofi Aventis
for providing Telfast-D tablets across the globe.
Registration Board discussed and decided to permit M/s Sanofi Aventis, Karachi for
import of Telfast-D tablet from M/s Sanofi Aventis, Kansas, USA in tablet form and
then further processing to finished form in M/s Sanofi-Aventis, Karachi for 02 years
time. However, the Board advised firm to provide legalized COPP of the source and
authorized its chairman to accord approval for issuance of regsirtation letter.The
Board further advised the firm to apprise them about future strategy for transfer of
technology to Pakistan in 02 months time.
Case No:11: Use of packaging materials with old address.
M/s Novartis Pharma (Pakistan) Ltd, West Wharf, Karachi was granted
permission for bulk import and local repacking of their Amoxi-Clav range of products at
M/s CSH Pharmaceuticals, Lahore. They have now informed that they have imported
bulk stocks with repackaging address of 15, West Wharf Road, Karachi instead of CSH
Pharmaceuticals, Lahore due to error which was caused to due to some misunderstanding.
S. Reg. No. Name of drug(s) Quantity Value in
38
No. rupees
1. 031354 Amoxi-Clav Injection 1.2gm 980,273 116,652,463
2. 031355 Amoxi-Clav 375mg Tablet 743,492 52,044,426
3. 031356 Amoxi-Clav 625mg Tablet 2,554,843 196,722,880
4. 031357 Amoxi-Clav 1gm Tablet 417,131 43,798,734
5. 031353 Amoxi-Clav Injection 600mg 72,000 6,847,920
6. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension
60ml
732,132 51,351,738
7. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension
100ml
69,048 6,503,631
8. 031359 Amoxi-Clav 312.5mg/5ml Dry Suspension
60ml
921,024 83,500,036
9. 031359 Amoxi-Clav 312.5mg/5ml Dry
Suspension100ml
90,000 12,136,500
Total 6,579,942 569,558,329
Firm has requested that they may be allowed to repack the above mentioned
quantities at M/s CSH Pharmaceuticals; Lahore mentioning the address of M/s Novartis
Pharma (Pakistan) Ltd, 15, West Wharf Road, Karachi and bulk manufacturer address
will remain same i.e Sandoz Kundl, Austria.
Decision: Dr.Farid Khan, representative Pharma Beauru presented samples of
Amoxi-Clav 375mg Tablet onwhich old address has been blocked but new address
was yet to print. The Board discussed the matter in detail and advised the firm to
present samples of all drugs with blocked old address and printed new address for
its consideration.
Case No.12 Deferred Drugs.
a. M/s Healthtek Pharma, Karachi – 2SUM 500mg Injection
Registration Board in 237th
meeting deferred following application of M/s
Healthtek Pharma, Karachi
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Decision
2SUM 500mg Injection
Each vial contains:
Cefoperazone as sodium
……………...250 mg
As per
PRC
As per PRC 07-09-2012
1551
Form-5
Rs.8000/-
Deferred for
submission of
application on
form5D with
39
Sulbactam as sodium
……………..250 mg
Rs.52,000/-
27-1-2013
balance fee
Later on scrutiny of record reveals that this formulation is already registered in favour of
M/s Global Pharma, Islamabad under brand name of Toxibid Injection, Reg. No.049233.
Decision: The Board approved above product for registration for M/s Healthtek
Pharma, Karachi
b. Pharmatec Pakistan (Pvt.) Ltd, Karachi
Following product of M/s Pharmatec Pakistan, Karachi was deferred in 237th
meeting
for review the case after submission of balance fee, GMP of source, COA and stability
data by the Expert Committee of Registration Board.
Name of Drug & Composition Pack size Demanded
MRP
Prazol 40mg Capsule
Each capsule contains:
Omeprazole……………..40 mg
(Anti peptic ulcerants)
14’s As per PRC
Now the firm has requisite information as under:-
i) Omeprazole Pellets will be purchased from M/s Vision Pharma, Islamabad
ii) GMP Certificate of M/s Vision Pharma, Islamabad
iii) Certificate of Analysis
iv) Stability data (for Zone IV. Both accelerated i.e 400C / 75% RH and long
term studies i.e 300C / 65% RH)
Decision: The Board approved above product for registration for M/s
Pharmatec Pakistan, Karachi.
c. M/s OBS Pakistan, Karachi
The Registration Board in 237th
meeting deferred following application of M/s
OBS Pakistan, Karachi
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Decision
C-Yalta 20mg Capsules 10’s Rs. 400.00 14-12-2010 The Sub Committee
40
Each capsule contains:-
Duloxetine HCL……….20
mg
(Antidepressants)
Dy.No.2168
Form-5
Rs.8000/-
Rs.52,000/-
06-2-2013
decided to review the
cases after
submission of
balance fee, GMP of
source of pellets,
COA and stability
data
C-Yalta 60mg Capsules
Each capsule contains:-
Duloxetine HCL……….60
mg
(Antidepressants)
10’s Rs. 1200.00 14-12-2010
Dy.No.2170
Form-5
Rs.8000/-
Rs.52,000/-
06-2-2013
-do-
C-Yalta 30mg Capsules
Each capsule contains:-
Duloxetine
HCL………..30 mg
(Antidepressants)
10’s Rs. 600.00 14-12-2010
Dy.No.2173
Form-5
Rs.8000/-
Rs.52,000/-
06-2-2013
-do-
M/s OBS Pakistan, Karachi has now furnished the following documents:-
i) GMP Certificate of API source M/s Spansules Formulation, India
ii) Certificate of Analysis
iii) Stability study data on accelerated and real time study of API
iv) Remaining fee Rs.240,000/- for each product for the purpose.
Decision: The Board approved above product for registration for M/s OBS
Pakistan, Karachi.
d. Correction cases:
i. M/s Sami Pharmaceuticals (Pvt.) Ltd, Karachi
M/s Sami Pharma, Karachi has requested for change of drug profile from plain to
extended release formulation for their already registered drug i.e ITP 150mg Tablet, Reg.
No.075852 containing Itopride HCl ….150mg. Firm has submitted that as the innovator
M/s Abbott Lab’s product Ganaton OD is available as extended release tablet, hence they
would like to market their product as extended release tablet. Firm has furnished
following document / information to support their request:-
i) Form-5
ii) Comparative study of Dissolution profile with innovator
41
iii) Method of analysis
iv) Stability summary
v) Fee Rs.20,000/- for the purpose.
Decision: The Board discussed firms’s request and reviewed documents
submitted by the firm and then approved their request for change of drug profile
from plain to extended release formulation for their already registered drug i.e ITP
150mg Tablet, Reg. No.075852 containing Itopride HCl 150mg.
ii. Pharmatec Pharmaceuticals, Karachi.
The Registration Board in 236th
meeting approved the following registration of
M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi and accordingly registration letter was
issued. Now the firm has pointed out some typographical mistakes in the said registration
letter. Details are as under:-
S.
No.
Existing Name & Composition Reg. No. Correct name & Composition
1 Fenzitec Depot Injection
Each ml contains:-
Fluphenazine Decanoate …25mg
(Manufacturer’s Specification)
Pack Size : 5’s x1ml
MRP : Rs.215.00
073773 Fenzitec Depot Injection
Each ml contains:-
Fluphenazine Decanoate …25mg
(Manufacturer’s Specification)
Pack Size : 1mlx1’s
MRP : Rs.100.00
Pack Size : 1mlx10’s
MRP : Rs.1000.00
Firm has stated that they have applied aforementioned product with demanded
pack and MRP as mentioned in last column, as evidence firm has furnished Form-5. Firm
has requested for issuance of correction letter.
Decision: The Board agreed to the firm’s request and referred matter to Drug
Pricing Committee for fixation of MRP of Fluphenazine Decanoate …25mg/ml in
pack sizes of 1’s and 10’s.
42
Registration-III
Case No.13 M/s Saibins Pharmaceuticals, Islamabad
The Registration Board in its 237th
meeting referred the following product of M/s
Saibins Pharmaceuticals, Islamabad to a Committee comprising of following members.
The Board further decided that the recommendations of committee will be submitted to
the Chairman, Registration Board for decision & Ten (10) products per section policy
will be followed for new License / Section in accordance with the priority as given by the
firm:-
1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of
the Committee).
2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam
University, Islamabad (Member Registration Board)
3. DDG (Reg-II)
The recommendations of the above committee which were approved by the Chairman
Registration Board are reproduced in the last column as below:-
S.
No.
Brand Name / Label
Claim
Demande
d Pack
Size
Demanded Price
Date of Submission
Previous
Decision
M-237
1. Muscide 4mg Capsules
Each capsule contains:-
Thicolchicoside ……4mg
(Anti-rheumatics (anti-
inflammatory agents).
10’s As Per
SRO
21-01-2013
Dy.No.996
Fee
Rs.20,000
Deferred
for
confirmation
of registration
status in
international
and national
market.
Now, the firm has submitted information that the above formulation is registered in
Grece, France, Italy, Poland, Portugal, Turkey & India. The applicant has also provided
the evidence of registration of above formulation in Pakistan of M/s Searle with brand
name Muscoril 4mg Cap & Inj. Other locally registered brands are Myoron (M/s
Angelini) & Thiolax (M/s SJ & G Fazul Ellahi). They have therefore requested to register
above formulation in their name.
Decision: The Registration Board after thorough deliberation decided to refer the
case to the review committee for review of formulation.
43
Case No.14: M/s Winilton Pharmaceuticals (Pvt) Ltd, Rawat
The Registration Board in its 237th
meeting referred the following products of M/s
Winilton Pharmaceuticals (Pvt) Ltd, Rawat to a Committee comprising of following
members. The Board further decided that the recommendations of committee will be
submitted to the Chairman, Registration Board for decision & Ten (10) products per
section policy will be followed for new License / Section in accordance with the priority
as given by the firm:-
1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of
the Committee).
2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam
University, Islamabad (Member Registration Board)
3. DDG (Reg-II)
The recommendations of the above committee which were approved by the Chairman
Registration Board are reproduced in the last column as below:-
S.
No.
Brand Name / Label
Claim
Demande
d Pack
Size
Demanded Price
Previous Decision
M-237
2. Kastwin 10mg Dispersible
Tabs.
Each Dispersible tablet
contains:-
Montelukast ………… 10mg
(Respiratory System)
14’s As Per SRO
Fee
Rs.60,000
Deferred
for confirmation of
me-too status.
3. Fenacwin 75mg Dispersible
Tabs.
Each Dispersible tablet
contains:-
Diclofenac
Potassium…..75mg
(Anti-Rheumatics, Systemic)
2x10’s As Per SRO
Fee
Rs.60,000
Deferred
for confirmation of
me-too status.
Now the firm has clarified that due to typographical mistake the products at Sl.No.2 & 3
have been applied as dispersible while in actual fact the dosage form of product at
Sl.No.2 is chewable tablets and for product at sl.No.3 is plain tablets instead of
dispersible tablet. The firm has therefore, requested for issuance of registration of above
product in chewable dosage form for Sl.No.2 and in Plain Tablets for Sl.No.3.
44
Decision: The Registration Board deferred the above applications for
submission of complete registration dossier on Form-5 with clarification of dosage
forms of drugs.
Case No.15. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
The Registration Board in its 237th
meeting referred the following product of M/s
Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi to a Committee comprising of following
members. The Board further decided that the recommendations of committee will be
submitted to the Chairman, Registration Board for decision & Ten (10) products per
section policy will be followed for new License / Section in accordance with the priority
as given by the firm:-
1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of
the Committee).
2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam
University, Islamabad (Member Registration Board)
3. DDG (Reg-II)
The recommendations of the above committee which were approved by the Chairman
Registration Board are reproduced in the last column as below:-
S.
No.
Brand Name / Label
Claim
Demande
d Pack
Size
Demande
d Price Date of
Submission Previous
Decision
M-237
4. Mark Injection
Each ampoule (5ml)
contains:-
Zoledronic Acid as
Monohydrate………..4mg
(Bisphosphonic Acid)
1’s As Per
SRO
19-12-2011
Fee
Rs.60,000
Deferred
for confirmation
of formulation
whether it is Dry
Powder or
Liquid
Ampoule.
The firm actually applied in Liquid Ampoule. Due to this reason the committee
recommended to defer the request of firm for confirmation of dosage form. Now the firm
has clarified that due to typographic error they applied in ampoule dosage form. But
actually dosage form / presentation of the formulation is Vial. The firm has therefore
requested to issue the registration of above product in Vial.
45
Decision: The Registration Board deferred the above registration application for
product specific inspection for verification of manufacturing and quality control
facility and the data / information submitted in the registration dossier by A.Q.
Javed Iqbal (Member, Registration Board) and Director DTL, Peshawar and area
FID.
Case No.16. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha
The Registration Board in its 223rd
meeting deferred the following products firm M/s
Trison Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column
as below:-
S.
No.
Brand Name / Label Claim Demande
d Pack
Size
Demanded
Price
Previous Decision
M-223
1 Triphenamol Tablets
Each tablet contains:-
Orphenadrine Citrate………35mg
Paracetamol………..450mg
(Manufacturer Specifications)
100’s Rs.350.00
Fee Rs.20,000
Deferred
2 Tricidol Tablets 0.5mcg
Each film coated tablet contains:-
Alfacalcidol BP…………0.5mcg
(USP Specifications)
10’s Rs.145.00
Fee Rs.20,000
Deferred
3 Trivelox 400mg Tablets
Each film coated tablet contains:-
Moxifloxacin (as HCl)……400mg
5’s Rs.460.00
Fee Rs.20,000
Deferred
4 Trigesic 550mg Tablets
Each film coated tablet contains:-
Naproxen Sodium……….550mg
(Manufacturer Specifications)
20’s Rs.180.00
Fee Rs.20,000
Deferred
5 Trinolol Tablets 50mg
Each film coated tablet contains:-
Atenolol USP……….50mg
(USP Specifications)
20’s Rs.110.00
Fee Rs.20,000
Deferred
6 Tribastin Tablets 10mg
Each film coated tablet contains:-
Esbastine BP………….10mg
10’s Rs.100.00
Fee Rs.20,000
Deferred
7 Trizadine Tablets 2mg
Each film coated tablet contains:-
Tizanidine (as HCl) …………2mg
(USP Specifications)
10’s Rs.102.00
Fee Rs.20,000
Deferred
Now the firm has submitted that in 2010 the Registration Board in its 223rd
meeting
granted five products per section to the new licensees and deferred the remaining product
46
as per policy. Now three years have passed it is therefore requested to grant the
registration above remaining product in their name. The firm has submitted an inspection
report dated 11-01-2011 which verifies the GMP status bearing the words “Firm was
GMP compliant at the time of inspection”.
Decision: The Registration Board deferred the above registration applications for
the evaluation of the registration dossiers. For Alfacalcidol tablet, product specific
inspection will be carried out by Director DTL, Lahore and area FID for
confirmation of manufacturing and quality control facilities.
Case No.17. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha
The Registration Board in its 226th
meeting deferred the following products of M/s Trison
Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column as
below:-
S.
No.
Brand Name / Label Claim Demanded
Pack Size
Demanded
Price Previous Decision
M-226
1 Gerdnil 40mg Capsule
Each capsule contains:-
Esomeprazole as Magnesium
enteric coated (Pellets) Eq. to
Esomeprazole……..40mg
(Product Complies to
Manufacturer Specifications)
14’s Rs.300.00
Fee
Rs.20,000
Deferred for toll
Policy
2 Prelin 75mg Capsules
Each capsule contains:-
Pregabalin……..75mg
14’s Rs.800.00
Fee
Rs.20,000
Deferred for toll
Policy
3 Prelin 150mg Capsules
Each capsule contains:-
Pregabalin………….150mg
(Manufacturer Specifications)
14’s Rs.1200.00
Fee
Rs.20,000
Deferred for toll
Policy
4 Azotri Capsule
Each capsule contains:-
Azithromycin (as
diyhydrate)…..250mg
(Manufacturer Specifications)
6’s Rs.500.00
Fee
Rs.20,000
Deferred for toll
Policy
5 Omegab 20mg Capsule
Each capsule contains:-
Omeprazole as enteric
coated Pellets.……20mg
(Manufacturer Specifications)
14’s Rs.475.00
Fee
Rs.20,000
Deferred for toll
Policy
47
6 Trigab 100mg Capsules
Each capsule contains:-
Gabapentin USP…….100mg
(Manufacturer Specifications)
10’s Rs.85.00
Fee
Rs.20,000
Deferred for toll
Policy
7 Trigab 300mg Capsules
Each capsule contains:-
Gabapentin USP…….300mg
(Manufacturer Specifications)
10’s Rs.220.00
Fee
Rs.20,000
Deferred for toll
Policy
8 Hematose –F Syrup
Each 5ml contains:-
Iron (III) Hydroxide
Polymaltose Complex Eq. to
Elemental
Iron………………….50mg
Folic Acid BP….….0.43mg
60ml Rs.80.00
Fee
Rs.20,000
Deferred for toll
Policy
Now, the firm has informed that they have developed their own facility of Capsule
(General) and Dry Powder Suspension (General) sections. The firm has therefore
requested that the above mentioned products which were initially applied on contract
manufacturing may please be registered in their own name. For product at S.No19 (Iron
Polymaltose Syrup) the firm has clarified that the dosage form is Dry Powder
Suspension. In support of this, the firm has stated that they have already been granted
Registration of Iron Polymaltose formulation plain in Dry Powder Suspension
Reg.No.063300 (Brand name Trifer). The firm also provided the reference of already
registered same formulations in Dry Suspension of following firms:
1. M/s Pharmedic (Brand Biofer Suspension).
2. M/s Trison Labs. (Brand Trifer Suspension)
Decision: The Registration Board deferred the above registration applications for
the evaluation of the registration dossiers.
Case No.18. M/s Medley Pharmaceuticals Wah Cantt
The Registration Board in its 234th
meeting approved the following products of M/s
Medley Pharmaceuticals Wah Cantt in the same strength i.e. 20mg.
S.No
.
Name and Composition of
Product
Pack
size
Demanded
Price
Previous
Decision
M-234
48
1 Esowel Capsules 20mg
Each Capsule Contains:
Esomeprazole (Pellets)….20mg
(Antipeptic Ulcerant)
2x7’s As Per SRO Approved
2 Esowel Capsules 20mg
Each Capsule Contains:
Esomeprazole (Pellets)….20mg
(Antipeptic Ulcerant)
2x7’s As Per SRO Approved
At the time of issuing registration letter, the firm pointed out that, they actually applied
the above products with two different strengths as under:-
S.No
.
Name and Composition of
Product
Pack
size
Demanded
Price
Decision
1 Esowel Capsules 20mg
Each Capsule Contains:
Esomeprazole (Pellets)….20mg
(Antipeptic Ulcerant)
2x7’s As Per SRO Approved
2 Esowel Capsules 40mg
Each Capsule Contains:
Esomeprazole (Pellets)….40mg
(Antipeptic Ulcerant)
2x7’s As Per SRO Approved
The firm has deposited the fee of Rs.20,000/= for each product. The request of firm has
been verified from the dossiers. Actually due to typographic mistake the same strength
has been return in the agenda of Registration Board meeting. The firm has therefore
requested to please issue the registration of above formulation in 40mg. The registration
of above formulation in 20mg has been already issued to firm.
Decision: The Registration Board has approved request of firm.
Case No. 19. M/s Kanel Pharma, Gujranwala.
Registration Board in its 236th
meeting approved the following product of M/s Kanel
Pharma, Gujranwala. The decision of the Registration Board is mentioned in last column
as under:-
S.No Name and Composition of Pack Demanded Previous
49
. Product size Price Decision
M-236
1 Paroxin 12.5mg Capsules
Each capsule contains:-
Paroxetine as HCl …………
12.5mg
(Antidepressant)
30’s As Per SRO
Fee
Rs.20,000/=
Approved subject to compliance of
following:-
1. GMP
Certificate of
Source.
2. COA
Certificate of
Analysis.
3. Stability
studies.
At the time of issuance of Registration letter, the firm informed that Paroxetine is not
available in Pellets or / Capsules dosage form & they actually, applied erroneously for
capsule dosage form. The firm has now requested to please change/correct the dosage
form as tablet. The firm has deposited Rs.5000/= in support of their request previously
the applicant had deposited Rs.15000/= for above product in capsule dosage form, at the
time of application before meeting of Registration Board. The firm has also requested to
adjust their already deposited fee of Rs.15,000/= for the instant request.
Decision: Registration Board has approved request of firm.
Case No.20. M/s Miracle Pharmaceuticals (Pvt) Ltd, Rawat
Registration Board in its 235th
meeting deferred the following products of M/s Miracle
Pharmaceuticals (Pvt) Ltd, Rawat, with the conditions as mentioned in the second last
column against each product as under:-
S.N
o.
Name and Composition of
Product
Previous
Decision
M-235
Information
submitted by the
firm.
1 Clomin Tablets
Each film coated tablet contains:-
Clomiphene Citrate …… 50mg
(Antioestrogen)
Deferred for
rectification of
following
observation in the
dossier in the
dossier:-
1. Methyline
Chloride should be
replaced with some
other suitable film
coating material
The firm has submitted
that:
1. They will use methanol
as coating material instead
of Methylene chloride.
50
2 Dimet DS Tablets
Each film coated tablet contains:-
Diloxanide Furoate
(USP)..500mg
Metronidazole (USP)……
400mg
(Nitroimidazole, Amoebicide)
Deferred for
rectification of
following
observation in the
dossier in the
dossier:-
1. Methyline
Chloride should be
replaced with some
other suitable film
coating material
2. Dissolution test
is absent in finished
product
specification.
The firm has submitted
that:
1. They will use methanol
as coating material instead
o Methylene chloride.
2. Dissolution test has
been submitted by the
firm alongwith finished
specifications of products.
3 Marither Forte
Each tablet contains:-
Artemether ……… 80mg
Lumefantrin ……. 480mg
(Synthetic Anti-Malarial derived
from Artemisinin synthetic
Recemic Flourene Mixture)
Deferred for
rectification of
following
observation in the
dossier:-
1. Dissolution test
is absent in finished
product
specification.
The firm has submitted
that:-
1. Dissolution test has
been submitted by the
firm alongwith finished
specifications of product.
4 Irovit Capsules
Each capsule contains:-
Iron III hydroxide polymaltose
complex eq. to Elemental
Iron……………. 100mg
Folic Acid ……. 0.35mg
(Haematinic)
Deferred for
rectification of
following
observation in the
dossier:-
1. Dissolution test
is absent in finished
product
specification.
-do-
Now the firm has fulfilled all the formalities as per decision of Registration Board. The
firm therefore requested to grant the registration of above in their name.
Decision: Registration Board after thorough deliberation approved products at Sl.
No.2 (Diloxanide Furoate + Metronidazole) & 3 (Artemether + Lumefantrin). While
the products at Sl.No.1 & 4 have been deferred by the Registration Board for
product specific inspection for confirmation of manufacturing and quality control
facilities by A.Q. Javed Iqbal (Member, Registration Board) and Director, DTL,
Peshawar and area FID. Brand name of product at S.No.1 will be changed.
51
Case No.21. M/s Global Pharmaceutical, Islamabad
Registration Board in its 229th
meeting approved the following product of M/s Global
Pharmaceutical, Islamabad. The decision of the Registration Board is mentioned in last
column as under:-
S.No. Name and Composition of
Product
Pack size Demanded
Price
Previous
Decision
M-229
5. Tamsol-D Tablets
Each film coated tablet
contains:-
Tamsulosin Hydrochloride
…0.4mg
(as modified – release tablets)
Dutasteride………………0.5mg
10’s As Per SRO
Fee
Rs.8,000/=
Approved
Accordingly the Registration was granted to the firm on 11th
September, 2012. Later on,
it was identified that the above formulation does not exist in tablet dosage form
internationally or locally. However, it is available in capsule dosage form. The case is
submitted for reconsideration of formulation by the Registration Board.
Decision: Registration Board after considering the technical opinion by its members
decided to ask the manufacturer to appear before Registration Board for
presentation of his opinion regarding efficacy of the above drug formulation. The
Board further ordered that till final decision, the registration of above product
would remain suspended under section 7(11) (ad) of Drug Act, 1976.
Case No.22. M/s Warafana Pharmaceutical, Islamabad.
Registration Board in its 235th
& 237 meeting deferred the following products of M/s
Warafana Pharmaceutical, Islamabad. The decision of the Registration Board is
mentioned in last column as under:-
S.No. Name and Composition of
Product
Pack
size
Demande
d Price
Previous Decision
M-235th
& 237th
1 Clari-250 Tablets
Each tablet contains:-
Clarithromycin ……250mg
1x10’s As Per
SRO
Deferred for
rectification of
following observation
52
(Macrolide Antibiotic)
Fee
Rs.8000
Balance
fee
Rs.12000/
=
in the dossier:-
1. Methylene
Choloride should be
replaced with some
other suitable film
coating materal.
2 Fusifit-B Cream
Each gm contains:-
Fusidic Acid ……..2.0% w/w
Betamethasone as Valerate
(BP)……………. 0.1% w/w
(Anti-Inflammatory & Anti-
Pruritic Effects).
1’s As Per
SRO
Fee
Rs.60,000
Deferred
for confirmation of
steroidal section
and me-too status.
3 Fusifit-H Cream
Each gm contains:-
Fusidic Acid ……..…..20mg
Hydrocortisone Acetate
BP..10mg
(Anti-Inflammatory & Anti-
Pruritic Effects).
1’s As Per SRO
Fee
Rs.60,000
-do-
Now the firm has submitted that they have replaced Methylene Choloride with water base
film coated material FC 4-H for the product at Sl.No.30 (Clarithromycin 250mg Tablet).
For the products at Sl.No.31&32 the firm has submitted the proof / approval of steroidal
section for cream. The firm has requested for issuance of registration of above products.
Decision: The Registration Board has approved request of firm.
53
Registration-IV
Case No. 23. M/s. Saaaf Pharmaceuticals, Risalpur
The Drugs Registration Board in its 237th
meeting held on 26-02-2013 had deferred the
following products of M/s. Saaaf Pharmaceuticals, Risalpur for rectification of
shortcoming of the following products.-
S.N
o
Name of
manufactu
rer
Name of drugs (s) Pack
size
Demande
d MRP Decision
1.
M/s. Saaaf
Pharmaceutica
ls, Risalpur
Varisaf Tablets
Each tablet contains:-
Mebeverine
HCl……200 mg
(Antispasmodic)
3x10’s As Per
SRO
Deferred for
P.S.I & GMP
229th
Meeting
22.1.2011.
Fee paid,
confirmation of
formulation.
237th
26.02.2013
2.
-do-
XL Tablets
Each film coated tablet
contains:-
Linezolid……..600
mg
(Antibiotic)
10’s As Per
SRO
Deferred for
P.S.I & GMP
229th
Meeting
22.1.2011.
Fee paid,
confirmation of
formulation.
237th
26.02.2013
3.
-do-
XL Dry Powder
Suspension
Each 5 ml contains:-
Linezolid ……..100
mg
(Antibiotic)
60 ml As Per
SRO
Deferred for
P.S.I & GMP
229th
Meeting
22.1.2011.
Fee paid,
confirmation of
formulation.
237th
26.02.2013
The firm paid the differential fee. The management could not rectify the relevant
shortcomings in comparison of the brand leader (Mebeverine HCl 200mg/ Colofac Cap of
Abbott Lab); Linezolid Film coated tablet: Incorrect M.O.T. and dissolution profile not
submitted; Linezolid Dry Powder Suspension M.O.T. incorrect, Master formulation is
54
ambiguous. The management requested to grant the registration of above mentioned
products.
Decsion: Registration Board decided to conduct product specific inspection by
Director DTL, DDG (E&M) and ADC, Peshawar, Peshawar for above products.
Moreover, firm will be advised to complete registration applications.
Case No. 24. Deferred Drug
The Drugs Registration Board in its 237th
meeting held on 26th
February, 2013 had been
deferred the following application due to shortcomings in application dossiers:-
S.No. Name of Firms Name of Drugs /label
Claim
AU Price Date Remarks
1. M/s. Novae
Pharmaceuticals,
Hattar
General Tablets
General
Capsules
Dry Powder
Suspension
General
Xiben 200 mg Capsule
Each capsule contains:-
Celecoxib…….200 mg
(NSAID)
10’s
20’s
As
Per
SRO
25-
1-
2013
SDS > FDA limit
To be deferred
2. -do- Macrozith 250 mg
Capsule
Each capsule contains:-
Azithromycin dihydrate
≡ Azithromycin ……250
mg
(Macrolide)
6’s
10’s
As
Per
SRO
-do- Principally Film Coated
Tablet
Master Formulation does
not conform with film
coated tablet
Uniform decision is
required about existing
dosage form of Capsule
Azithromycin
3. -do- Voxipro 250 mg Dry
Powder Suspension
Each 5 ml contains:-
Ciprofloxacin
Hydrochloride
≡ Ciprofloxacin …..250
mg
(Quinolone) (Mfg Spec)
60 ml As
Per
SRO
-do- Master formulation
MOP
Inconformity
MOT
To be deferred.
55
4. -do Arthen Dry Powder
Suspension
Each 5 ml contains:-
Artemether……..15 mg
Lumefantrine…..90 mg
(Antimalarial)
30 ml
60 ml
As
Per
SRO
-do- SDS > FDA limit
To be deferred
5. -do- Leoflox 125 mg Dry
Powder Suspension
Each 5 ml contains:-
Levofloxacin
hemihydrates
≡ Levofloxacin
………..125 mg
(Quinolone)
60 ml As
Per
SRO
-do- Label claim
MOT’
Incorrect
To deferred.
6. -do- Zason 10 mg Dry Powder
Suspension
Each 5 ml contains:-
Zinc Sulphate
monohydrate
≡ Zinc (element)………10
mg
(Antidiarrhoeal & Zinc
Supplement)
60 ml As
Per
SRO
-do- Master formulation
ambiguous /incorrect.
Deferred for
7. -do- Bevexin 20 mg Tablets
Each tablet contains:-
Piroxicam β-Cyclodextrin.
≡ Piroxicam………….20
mg
(NSAID)
2x10’s As
Per
SRO
-do- Master formulation
MOT +Specification
Deferred.
8. -do- Leoflox Tablets 250 mg
Each film coated tablet
contains:-
Levofloxacin Hemihydrate
≡ Levofloxacin ……..250
mg
(Quinolone)
1x10’s As
Per
SRO
-do- Film coated
Wrong label claim
Wrong specification.
Incorrect DIT
Chromatographic
condition not mentioned
Deferred for 9. -do- Leoflox Tablets 500 mg
Each film coated tablet
contains:-
Levofloxacin Hemihydrate
≡
Levofloxacin…………500
mg
(Quinolone)
1x10’s As
Per
SRO
-do- Incorrect Specification
Incorrect MOP/MOT
Signature of QCM/PM
Deferred.
56
10. -do- Voxipro 250 mg Tablets
Each film coated tablet
contains:-
Ciprofloxacin
Hydrochloride
≡ Ciprofloxacin …….250
mg
10’s As
Per
SRO
-do- Specification
MOP
MOT
Master formulation
To be deferred
11. -do- Voxipro 500 mg Tablets
Each film coated tablet
contains:-
Ciprofloxacin
Hydrochloride
≡ Ciprofloxacin………
.500 mg
(Quinolone) (B.P.)
10’s As
Per
SRO
-do- Incorrect
Specification/MOP/MOT
Finished
Signature of QCM/PM
deferred
12. -do- Moxigrat 400 mg Tablets
Each film coated tablet
contains:-
Moxifloxacin HCl
Moxifloxacin ……….400
mg
(Quinolone)
1x5’s
1x10’s
As
Per
SRO
-do- SDS is more than FDA
limits
MOT/MOP
Specification incorrect
Deferred.
13. -do- Arthen DS Tablets
Each tablet contains:-
Artemether……..40 mg
Lumefantrine…..240 mg
(Antimalarial)
1x8’s As
Per
SRO
-do- Master formulation
Subject to correction
for.
14. -do- Montigrat Tablets 10 mg
Each film coated tablet
contains:-
Montelukast Sodium
≡Montelukast …..….10
mg
(Leukotriene Receptor
Antagonist)
14’s
2x10’s
As
Per
SRO
-do- MOP coating procedure
is mentioned
Coating material has not
been mentioned
MOT is not correct.
To be deferred.
15. -do- Novaefen 100 mg Tablets
Each film coated tablet
contains:-
Flurbiprofen....100 mg
(NSAID)
3X10’S As
Per
SRO
-do- Product Specification
MOP/MOT do not
conform
To be deferred.
57
16. -do- Painclay 75 mg Tablets
Each enteric coated tablet
contains:-
Diclofenac Potassium…75
mg
(NSAID)
1x10’s
2x10’s
3x10’s
As
Per
SRO
-do- Spec/MOT/MOP are
contradicting
To be deferred.
17. -do- Painclay 100 mg Tablets
Each enteric coated tablet
contains:-
Diclofenac Potassium..100
mg
(NSAID)
1x10’s
2x10’s
3x10’s
As
Per
SRO
-do- Spec/MOT/MOP are
contradicting
To be deferred.
Now the firm has rectified shortcomings upto S.No.16. But the master formulations
(S.No. 17) of tablet Diclofenac potassium does100mg not conform with the
internationally available dosage forms.
Decision: Registration Board approved products at S.No.1-16 while product at
S.No.17 deferred for confirmation of international availability.
Case No. 25. M/s. Hizat Pharmaceuticals, Peshawar
The Drugs Registration Board in its 237th
meeting held on 26-02-2013 had deferred the
following products for rectification of shortcoming:-
M/s. Hizat
Pharmaceuticals,
Peshawar
Esoprazol capsule
Each delayed release
capsule contains:-
Esomeprazole enteric
coated pellets
≡Esomeprazole……...40
mg
(Proton Pump Inhibitor)
10’s Rs.159.00
Submission
of differential
fee
and
confirmation
of
formulation.
Pellet’s fee
unpaid
-do-
Lanzprazole Capsule
Each Delayed Release
Capsule contains:-
Lansoprazole enteric coated
pellets
≡ Lansoprazole……30 mg
(Proton Pump Inhibitor)
10’s Rs.160.00
Submission
of differential
fee and
confirmation
of
formulation.
Pellet’s fee
unpaid
58
The firm had rectified relevant shortcoming and paid differential fee mentioning Vision
Pharmaceutical as the source of pellets of Esomeprazole (22.5% w/w) and Lansoprazole
(8.5% w/w) .The firm requested to grant the registration of above mentioned products.
Decision: Request of firm was approved by the Board.
Case No.26 Navegal Labs, Hattar
The Drugs Registration Board in its 237th
meeting held on 26-02-2013 had deferred the
following products of M/s. Navegal Labs Hattar for submission of complete method of
manufacturing and studies regarding dissolution/release of the following drug:-
S.
No.
Manufacturer Name of the Drug Pack
size
Demanded
Price
Decision
Navegal Labs
Hattar
Movez SR Capsule
100 mg.
Each Capsule
Contains:-
Diclofenac Sodium
Sustained Release/
Coated Pellets
≡ Diclofenac
sodium…100 mg.
1x10 Rs.8.5/capsule. Deferred in
view of
strength and
uniform
policy. Fee
paid
It is pointed out that sustained release coated pellets of Diclofenac Sodium 100mg are
manufactured by M/s. Vision Pharmaceuticals, Islamabad which can be approved subject
to submission of Specification of product, GMP, Certificate of Analysis and Stability data
for zone IV. Fee is paid according to local manufacturer.
Decision: Request of firm was approved with source of pellets will be M/s.
Vision Pharmaceuticals, Islamabad.
Case No. 27. M/s Alen Pharmaceutical (Pvt) Ltd, Risalpur.
Drug Registration Board in its 237th
meeting had deferred the following products of M/s.
Alen Pharmaceuticals (Pvt.) Ltd; Risalpur subject to the confirmation of formulation.
S.No Manufacturer Name of Drugs A/Unit Price Remarks
59
1. M/s Alen
Pharmaceutical
(Pvt) Ltd,
Risalpur
Mitex Tablets.
Each film coated tablet
contains:-
Ivermectin BP………6
mg.
1’s Rs.
100.00
Confirmation
of
formulation.
Total fee
paid
The firm had rectified relevant shortcoming and paid differential fee. The firm had
requested to grant the registration of above mentioned products
Decision: Request of firm was approved by the Registration Board.
Case No.28 M/s. Aries Pharmaceuticals, Peshawar.
M/s. Aries Pharmaceuticals, Peshawar has requested for registration of the
following drugs:-
1. M/s. Aries
Pharmaceuticals,
Peshawar
1.Tab General
2. Capsule Gen
3.Tab Psycho
Levocap Capsules 250
mg
Each capsule contains:-
Levofloxacin
Hemihydrate
≡ Levofloxacin ….250
mg
(Quinolone)
10’s Rs.260.00 -
do-
Fee paid,
deferred for
uniform
decision.
2. -do- Levocap Capsules 500
mg
Each capsule contains:-
Levofloxacin
Hemihydrate
≡ Levofloxacin ….500
mg
(Quinolone)
10’s Rs.520.00 -
do-
Fee paid,
deferred for
uniform
decision.
3. -do- Pranax 1 mg Tablets
Each tablet contains:-
Alprazolam…….1 mg
(Antidepressant)
3x10’s Rs.369.00 -
do-
As per policy
on
psychotropic/
narcotics.
Fee paid.
Deferred.
4. -do- Pranax 2 mg Tablets
Each tablet contains:-
Alprazolam…….2 mg
3x10’s Rs.738.00 -
do-
As per policy on
psychotropic/
narcotics. Fee
60
paid.
Deferred
These drugs were considered in 237th
meeting of Registration Board decision mentioned
against each. Now the firm has stated that Pranax 0.5mg (Alprazolam0.5 mg) is already
registered with the firm where as Pranax 1 mg & 2 mg are the additional strengths of
Alprazolam which are requested to be registered.
Levofloxacin 250 mg/500 mg Capsules have been registered with many manufacturer
therefore the firm requested to approve registration of the Levofloxacin 250 mg/500 mg in
the form of Capsules. Levofloxacin in the form of Capsule (dosage form) has to be decided
uniformly.
Decision: The Board referred products at S.No.1 & 2 to review committee for
evaluation and recommendation. Products at S.No. 3 & 4 were deferred being
controlled drug.
Case No.29. M/s. Libra Pharma (Pvt.) Ltd; Peshawar
The Drug Registration Board in its 195th
meeting had approved the following products of
M/s. Libra Pharma (Pvt.) Ltd; Peshawar subject to installation & verification of HVAC
system and segregated section. It is submitted that the ingredients and strength of some
products were typed incorrectly which were approved accordingly.
S.No Name of drug with
incorrect formulation
Name of drug with
correct
formulation/strength
Pack
size
Demande
d MRP
Decision
1 Cryptosad Tablets
Each tablet contains:-
Cyproterone acetate
…...2mg
Ethinyloestroadioe….35
mg
Cryptosad Tablets
Each sugar coated
tablet contains:-
Cyproterone acetate
…… 2 mg
Ethinyloestradiol .
…..35 mcg
21’s Rs.240.0
0
Approved
subject to
installatio
n and
verificati
on of
HVAC
System
and
Segregate
d section.
2 U-Dine 100 mg Tablets
Each tablet contains:-
U-Dine 100 mg
Tablets
14’s Rs.1600.
00
-do-
61
Lamivudine……..100
mg
(Anti-retroviral)
Each film coated
tablet contains:-
Lamivudine……..10
0 mg
(Anti-retroviral)
3 Osteocol Oinetment
Each tablet contains:-
Tacalcitol……….2mcg
(Antipsoriasis / Vitamin
Osteocol Ointment
Each gm contains:-
Tacalcitol
monohydrate
≡ Tacalcitol.…. 2
mcg
1x10’
s
Rs.275.0
0
Approved
4 Diploprate Cream
Each gam contains:-
Diflucortolone
valeate...0.001gm
Chlorquinalolol..….0.01
0gm
Diploprate Cream
Each gm contains:-
Diflucortolone
valerate.…1 mg
Chlorquinaldol……
…. 10 mg
5gm Rs.21.20 Approved
subject to
installatio
n and
verificati
on of
HVAC
System
and
Segregate
d section
The firm has furnished copy of inspection report wherein FID, Peshawar has reported that
the firm has installed HVAC and has requested to grant the registration of above
mentioned product. The Licensing Section confirmed that the firm got approval of
Hormonal Tablets Section as segregated with HVAC but Hormonal Ointment/Cream
Section is not present in record of licensing unit.
The firm has deposited remaining fee amounting Rs. 12000/- for each formulation and
furnished copy of inspection report and has requested to grant the registration of above
mentioned products. It is worthwhile to mention that Tacalcitol monohydrate equivalent
to Tacalcitol is available in the form of Ointment/Lotion (Curatoderm Ointment/Lotion)
but the strength is 4 mcg/gm in both dosage form instead of 2 mcg/gm as mentioned in
the application dossier. .
Decision: Registration Board approved products at S.No.1 &2 and advised to
review the registration dossiers before issuance of registration letter and authorized
its Chairman to grant approval for issuance of registration letter. Products at S.No3
& 4 were deferred for confirmation of steroidal section for cream and ointment. As
62
Tacalcitol is available only in 4 mcg/gm thus referred to review committee for
review.
Case No.30 Extension in contract manufacturing permissions.
The following drugs of M/s. Navegal Laboratories, Hattar for toll manufacturing
extension were left over due to oversight. The firm had deposited the Rs.8000/- each on
29th
September, 2010 and remaining fee of Rs. 42000/- each on 9th
April, 2013.
1. 045442 M/s.
Navegal
Pharmaceuti
cals, Hattar
Toll
manufactured by
M/s. Welmark
Pharma, Hattar
Uneek 250mg
Injection
Each vial contains:-
Ceftriaxone (as
Sodium)……..250mg
(USP Specification)
Dy.
No.2873
Form-not
Rs.42000/-
Rs.8000/-
dated 29-
09-2010
Cephalospori
n
2. 053219 -do- -do- Uneek 500mg
Injection
Each vial contains:-
Ceftriaxone (as
Sodium)……..500mg
(USP Specification)
Dy.
No.2873
Form-not
Rs.42000/-
Rs.8000/-
dated 29-
09-2010
Cephalospori
n
3. 045441 -do- -do- Uneek 1gm Injection
Each vial contains:-
Ceftriaxone (as
Sodium)……..1gm
(USP Specification)
Dy.
No.2873
Form-not
Rs.42000/-
Rs.8000/-
dated 29-
09-2010
Cephalospori
n
4. 045443 -do- -do- Sobeta 2gm Injection
Each vial contains:-
Cefoperazone (as
Sodium) ….....1gm
Sulbactam (as
Sodium)…1gm
(USP Specification)
Dy.
No.2873
Form-not
Rs.42000/-
Rs.8000/-
dated 29-
09-2010
Cephalospori
n
5. 045444 -do- -do- Sobeta 1gm Injection
Each vial contains:-
Cefoperazone (as
Sodium) ….....0.5 gm
Sulbactam (as
Sodium)……..0.5 gm
(USP Specification)
Dy.
No.2873
Form-not
Rs.42000/-
Rs.8000/-
dated 29-
09-2010
Cephalospori
n
63
6. 045438 -do- -do- Effo 500mg Injection
Each vial contains:-
Cefepime HCl with
L-arginine
≡Cefepime
…….500mg
(USP Specification)
Dy.
No.2873
Form-not
Rs.42000/-
Rs.8000/-
dated 29-
09-2010
Cephalospori
n
Decision: Request for extension in contract manufacturing acceded till
30.06.2015.
Case No.31. M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar
M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar has applied for registration
of following drugs for the purpose on export only:-
S. No. Name of Drug(s) Remarks
1. Phenomed 30 mg Tablet
Each tablet contains:-
Phenobarbiton ……..……. 30 mg
The relevant documents and
total fee received,
Approved subject to the concurrence of
Narcotic Control Department /Board.
2. Dipam 5 mg Tablet
Each tablet contains:-
Diazepam …………….. 5 mg
-do-
The firm has submitted following documents:-
i. Application on Form-5.
ii. Fee of Rs. 20000/- for each formulation.
The firm possesses the relevant facility to manufacture the above mentioned
products. This case was discussed in the 237th
meeting or Registration Board. The
decision of the Board is mentioned against each.
Decision: Committee on allocation of controlled Drug has already conveyed that
Registration Board may take decision according to its rules. Thus Board approved
firm’s request. Matter regarding allocation of quota will be dealt by Committee on
allocation of controlled Drug accordingly.
Case No.32. M/s. Shaheen Pharmaceuticals, Swat
64
The Drug Registration Board in its 235th
meeting had deferred the following products of
M/s. Shaheen Pharmaceuticals, Swat subject for deletion of Methylene Chloride from the
formulation.
1. M/s. Shaheen
Pharmaceutical
s, Swat
1. Tab General
2.Tab Antibiotic
3.Cap General
4.Dry Powder
Susp (Ceph)
Finas-M 1mg
Tablets
Each tablet
contains:-
Finasteride
………..1mg
(5-alpha reductase
inhibitor)
3x10’
s
As
Per
SRO
-do- Deferred due to
Methylene
Chloride.
2. -do- Paroxet 10mg
Tablets
Each tablet
contains:-
Paroxetin (as
HCl).10mg
(Antidepressant)
3x10’
s
As
Per
SRO
-do- Deferred due to
Methylene
Chloride.
3. -do- Paroxet Plus 20mg
Tablets
Each tablet
contains:-
Paroxetin (as
HCl).20mg
(Antidepressant)
3x10’
s
As
Per
SRO
-do- Deferred due to
Methylene
Chloride.
4. -do- Nomide 20mg
Tablets
Each tablet
contains:-
Leflunomide……2
0mg
(Anti-rheumatic
systemic)
3x10’
s
As
Per
SRO
-do- Deferred due to
Methylene
Chloride.
Now the firm has rectified the shortcoming of the formulation. The firm had
requested to grant them the registration of above mentioned products
Decision: Registration Board approved firm’s request.
Registration-V
65
Case No. 33. Transfer of Registration of contract manufacturer from Contract
Donor.
M/s Allmed (Private) Ltd. Lahore (Formerly M/s Ever Green Pharmaceuticals (Pvt.) Ltd.
Lahore) have requested for transfer of registration of following product manufactured by
them on contract basis for M/s. Ontech Corporation, B-154 Block-13-D/2 Gulshan-e-
Iqbal, Karachi to their name.
S. No. Reg. No. Name of Drug with
Composition
1. 041199 Norepine Injectable
Each 4ml contains:-
Noradrenaline tartarate…8mg
It is submitted that the product was initially registered for import in the name of M/s.
Ontech Corporation, Karachi for finished import. Later on the product was transferred
from import to local toll manufacturing by M/s Allmed (Private) Ltd. Lahore (formerly
M/s. Evergreen Lahore).
Registration Board in 237th
meeting has already delegated the power of transfer of
registration from one manufacturer/importer to another manufacturer/importer to its
Chairman. However in this case the contract manufacturer is applying for transfer of
registration from contract giver. The firm has also applied for extension of contract
manufacturing for the said product and has submitted the following for transfer of
registration:-
1. Fee challan of Rs.20,000/-
2. Form-5
3. N.O.C on transfer from M/s Ontech Corporation, Karachi.
4. Import Registration letter in the name of M/s. Ontech Corporation, Karachi.
5. Copy of earlier toll permission letter.
Decision: Registration Board deferred the request of the firm for following:
Confirmation whether transfer of registration is permissible under
contract manufacturing policy or otherwise.
Verification of testing facility by Director DTL, Lahore and area FID.
Case No.34. M/s. Paradise Pharmaceuticals, Lahore
66
M/s. Paradise Pharmaceuticals, Lahore was granted the registration of following
product:-
S. No. Name of Drug(s) Reg. No.
1. Ampride Syrup
Each 5ml contains:-
Ammonium Chloride ……………… 100mg
071546
The firm has requested that this product in not according to products being
marketed locally. They have therefore, requested to change the formulation as under:-
Ampride Syrup
Each 5ml contains:-
Chlorpeniramine Maleate ………..… 2mg
Ammonium Chloride ……………… 100mg
They have deposited fee of Rs. 20000/- for this purpose and furnished application
dossier on Form-5.
It is submitted that the firm has attached the outer packing of British Pharma
which contains Sodium Citrate also in addition of Chlorpeniramine Maleate 2mg &
Ammonium Chloride 100mg. However, according to the firm Sodium Citrate is not an
active ingredient and has been included in in-active ingredients. US FDA also mentioned
Sodium Citrate as inactive ingredient in syrup dosage form
Decision: The request of the firm was acceded to.
Case No. 35 M/s. Medipak Ltd; Lahore
The Drugs Registration Board in its 222nd
meeting had deferred the following
product of M/s. Medipak Ltd; Lahore for review committee. Initially the case was
discussed in 141st meeting of the Drug Registration Board and was deferred for price
comparison and subsequently again deferred in 213th
meeting of DRB for getting
clarification from the firm regarding the use of the formulation:-
Medisol Solution
Each liter contains:-
Citric acid (Anhydrous)............7.30gm
Sodium Citrate (Dihydrate)…22.00gm
Dextrose (Monohydrate).24.50gm
Water for Injection....Q.S
(Anticoagulant Solution)
67
The firm has informed that the pricing section has approved the price of the subject
product in 19th
meeting of Price Recommendatory Committee held on 26-12-2006 and
has requested for grant of registration of above mentioned product. The firm has
deposited fee of Rs. 15000/- in addition to Rs.5000/- and has not submitted new form-5.
Decision: The Registration Board deferred the case for submission of new dossier,
applicable fee for the product and expert opinion by Brig. Qaiser, AFIC.
Case No. 36 M/s. CCL Pharma Lahore.
Following application of M/s. CCL Pharma Lahore was deferred in sub/expert committee
meeting 237th
of Drug Registration Board due to inadequate fee for fast track and
different formulation from originator. The originator formulation is as following
(Duodart / Jalyn capsule by GSK):-
Each Capsule contains the following:
• One dutasteride oblong, opaque, dull-yellow soft gelatin capsule, containing 0.5 mg of
dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-di-glycerides of
caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric
oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium
dioxide.
• Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin
hydrochloride and the inactive ingredients: methacrylic acid copolymer dispersion,
microcrystalline cellulose, talc, and triethyl citrate.
S.No Name of the drugs with
composition
Pack
Size
Proposed
Price
Date of
Submission
Recomme
ndations of
Committe.
1. BPH Capsules
Each capsule contains:-
Dutasteride….0.5mg
Tamsulosin….0.4mg
10’s As per
brand
leader
15-6-2011
Fee.8000
Fast track
fee
submission
Fee.52000
21-2-2013
Deferred.
The firm has submitted fee of Rs. 300,000/- and has submitted that competitor
formulation is immediate release dutasteride pellets in soft gel capsule filled in hard
gelatin capsule along with sustained release tamsulosin pellets, which has no technical
68
advantage but a novelty. But in their formulation they are using a blend of immediate
release dutasteride pellets along with sustained release tamsulosin pellets filled in hard
gelating capsule. They have submitted 2 reference products of india Tamlocept D
Capsule by Lupin Ltd. (Pinnacle Pharmaceuticals, India) and Tamdura Capsule by Sun
Pharmaceutical industries Ltd. India. Containing Dutasteride IR + Tamsulosin SR pellets.
They have submitted comparative dissolution profile with Duodart capsules.
Decision: The Registration Board deferred the case for evaluation by the review
committee.
Case No. 37. Cases of 237th
meeting Registration Board
Following applications (Fast track) were considered in 237th
meeting and subsequently in
me-too committee on 08-03-2013 subject to differential fee. Now differential fee have
been paid for following applications.
S.No Name of Firm Name of the drugs with composition Pack
Size
Proposed
Price
Previous
Decision
Remarks
1. M/s Saffron
Pharmaceutica
ls Faisalabad
Noctis Capsule
Each capsule contains:-
Omeprazole…40mg
14’s Rs 300/- Approved
subject to
Source
GMP
certificate,
COA and
stability
study of
pellets.
Rs.2,40,000/-
+ Fee
deposited
Rs.60,000/-
GMP
certificate of
M/s
Metrochem
API Pvt. Ltd.,
India.,CoA,
2. M/s. English
Pharmacutical
s Industries,
Lahore
Terol 4mg SR Capsules
Each capsule contains:-
Tolterodine HCl equiv. to
Tolterodine SR…4mg
3×10’s Rs.2300/- Deferred for
confirmatio
n of
me-too
status and
comparative
dissolution
profile with
originator
Detrusitol
Capsule SR 4
mg (Pfizer)
Comparative
Dissolution
profile with
originator.
3. M/s. English
Pharmacutical
s Industries,
Urimax 0.4 mg Capsule
Each capsule contains:-
Tamsulosin HCl equiv to
3×10’s Rs.1100/- Approved
subject to
remaining
Rs.240, 000/
has been
deposited,
69
Lahore Tamsulosin…0.4mg
(Alpha-1-adrenergic blocker)
fee of
Rs.240,
000/ (in
case of
import of
pellets),GM
P certificate
of source,
COA and
stability
studies of
pellets.
GMP
certificate of
source, COA
and stability
studies of
pellets.
4. M/s. English
Pharmacutical
s Industries,
Lahore
K-Cit Tablets
Each tablet contains:-
Potassium Citrate…10 mEq
3×10’s Rs.650/- Deferred for
confirmatio
n of me-too
status.
Urocit K of
Universal
(Allmed
Pharma)
5. M/s. English
Pharmacutical
s Industries,
Lahore
Dutride-T Capsules
Each capsule contains:-
Dutasteride …….0.5mg
Tamsulosin
Hydrochloride….0.4mg
30’s Rs.
2700/-
Deferred Fee submitted.
Firm wants to
fill in pellets.
6. M/s. English
Pharmacutical
s Industries,
Lahore
Ucholin 10mg Tablet
Each tablet contains:-
Bethanechol Chloride equiv. to
Bethanechol …..10mg
60’s Rs.1500/- 06-02-2013 Deferred for
confirmation of
me-too status.
Decision: Registration Board decided as follows:
Approved products at S.No.1 and 3.
Product at S.No.2 deferred for verification of complete formulation with
originator (Detrusitol Capsule SR 4 mg by Pfizer) and Comparative
Dissolution profile with originator.
Product at S.No.4 deferred for Product Specific Inspection by Director DTL
Lahore, Director DTL, Quetta and Area FID.
Product at S.No.5. The firm has submitted a separate application for tablet
dosage form. The DRB deferred the case for evaluation by review committee.
Product at S.No.6 deferred for expert opinion by Gen.Dr. Tassawar Husain,
Dr. Falak Sher Bhatti, Nescom., Prof. Shoaib Shafi, RMC.
70
Case No. 38. M/s. Medipak Ltd; Lahore
The Drugs Registration Board in its 201st meeting had rejected the following
product of M/s. Medipak Ltd; Lahore as the cGMP condition of the section was not
good:-
Medisol ½+5% Infusion.
Each 1000ml contains:-
Dextrose
Monohyrate……….55gm.
Sodium Chloride….4.5gm.
(BP)
500ml As per
Policy
Rejected as the
CGMP condition
of the section is
not good.
The firm submitted application in Drug Appellate Board and the Drug Appellate Board in
its 135th
sitting held on 123-11-2008 decided and accepted the appeal to grant them the
registration of above mentioned product.
Decision: The Registration Board deferred case for product specific and GMP
inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore;
DDG E&M, Lahore and Area FID.
Case No: 39 M/s. Medipak Ltd; Lahore
M/s Medipak Limited, Lahore has requested that their product “Moxidex Eye
Drops” was included in Agenda of 229th
DRB meeting, but they said product was written
under the name of M/s Vega Pharma Lahore by mistake and the product was deferred for
GMP & Product specific Inspection.
They have submitted that their Eye Drop section is already approved and GMP inspection
report dated 11-02-10 submitted. They have submitted copy of registration dossier.
Decision: The Registration Board deferred case for product specific and GMP
inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore;
DDG E&M, Lahore and Area FID..
Case No.40. M/s. Medisave Pharmaceuticals, Lahore.
M/s. Medisave Pharmaceuticals, Lahore has requested for registration of
following drugs for export purpose only:-
71
S.No Name of the products with composition
1. Flusave Tablets
Each Tablet contains:-
Triprolidine HCl B.P……… 2.5mg
Pseudoephedrine HCl B.P …...60mg
2. Sorefix-P Tablets
Each Tablet contains:
Pseudoephedrine ……36mg
Triprolidine….1.5mg
Paracetamol……..300mg
3. Sorefix-DX Tablets
Each Tablet contains:
Pseudoephedrine ……..90mg
Triprolidine……2.5mg
Clemastine as hydrogen fumarate…..1mg
4. Sorefix Tablets
Pseudoephedrine ……….60mg
Triprolidine …………2.5mg
The firm submitted the following documents.
i. Fee i.e. Rs.20000/-for the each products.
ii. Copy of form 5
iii. Copy of export order from Hong Kong.
Registration Board in its 237th
meeting referred the case to committee on
controlled drugs, Narcotic Control Division for its recommendation and authorized
Chairman Registration Board to take decision for the grant of export registration or
otherwise in light of recommendation of the committee and submission of differential
fee.
Committee of the allocation of controlled drugs in its 11th
meeting held on 6th
May, 2013 decided that Registration Board may consider the registration of Controlled
Drugs for export and local manufacturing in the light of relevant Act and rules and the
Committee on the allocation of controlled drugs will consider matter for allocation of
Controlled Drugs in the light of relevant laws and rules after registration.
Decision: Committee on allocation of controlled Drug has already conveyed that
Registration Board may take decision according to its rules. Thus Board approved
firm’s request. Matter regarding allocation of quota will be dealt by Committee on
allocation of controlled Drug accordingly.
72
Case No. 41. M/s. Highnoon Laboratories Ltd Lahore.
Following products of M/s. Highnoon Laboratories Ltd Lahore were deferred for expert
opinion. Two experts gave their recommendations while the opinion of 3rd
expert was
awaited. The Drug Registration Board in its 237th
meeting referred these products for expert
opinion to Brig. (R).Prof. Dr. Muzammil Hasan Najmi after submission of differential fee.
Now opinion of all experts has received as under:-
Name of Products MRP/
Pack
Size.
Name of Expert Comments by the
expert
Brig. (R).Prof. Dr.
Muzammil Hasan
Najmi
Pidogrel-CAP 75
Each capsule contains:-
Clopidogrel (as
bisulphate) ……75mg
Aspirin (as enteric
coated pellets) 75mg
Rs.215.0
0/10’s
Prof.Dr.
Mahmood Ahmad
Faculty of
pharmacy and
alternative
medicine,
The Islamia
University of
Bahawalpur
As this product is
already manufactured by
the same company under
Re. No. 038902 in tablet
form and according to
the available literature
and stability data
provided both the
strengths of pidogrel are
stable and retain its
efficacy in combination
in capsule form.
Therefore, the pidogrel-
Cap 75mg & pidogrel-
Cap 150mg may be
registered.
This is a combination of
clopidogrel with enteric
coated aspirin pallets in
capsule form. A
combination of
clopidogrel with aspirin
without enteric coating
is already being
marketed by the same
manufacturer and some
other companies. The
two drugs in
combination are platelet
inhibitors acting by
independent different
mechanisms. These are
used in treatment and
prophylaxis of
thromboembolic
disorders. However their
use in the form of a
fixed dose combination
is not approved by FDA
of USA.
In the formulation under
review, aspirin has been
replaced with enteric
coated aspirin and the
dosage form has been
changed from tablet to
capsule. Dissolution
profile of the new
73
dosage form has been
submitted by the
manufacturer which
shows satisfactory
pattern of dissolution.
In view of the
registration and
availability of
combinations of
clopidogrel and aspirin
in Pakistan, Pidogrel-
CAP 75 is
recommended for
registration.
Pidogrel-CAP 150
Each capsule contains:-
Clopidogrel (as
bisulphate) ……75mg
Aspirin (as enteric
coated pallets) 150mg
Rs.225.0
0/10’s
Brig Syed M.
Imran Majeed
Preparations are
considered suitable for
registrations.
Dr. Iqbal
Saifullah Head of
Cardiology PIMS
Islamabad
The products are
recommended for
registration.
Loprin-AT Capsules
Each capsule contains:-
Atorvastatin (as
calcium trihydrat)
………….10mg
Aspirin (as enteric
coated pallets)
…………… 75mg
Rs.300.0
0/10’s
Prof.Dr.Muhamm
ad Ishaq Karachi
Institute of Heart
Diseases Karachi
This combination of
Atorvastatin and Asprin
can be used for CAD
patients and potential
patients. Both drugs as
individual molecules are
established sherapeutic
agents as lipid lowering
and antiplatlets. The
advantages of
combination include
beeter compliance at
reduced cost. However
being fixed combination
the side effects can be
difficuit to as ses. The
only major country
having this combination
is India as such there are
no reasons against this
formulation to be made
It is a combination of
Atorvastatin with enteric
coated aspirin.
Atorvastatin is an
inhibitor of HMG Co A
Reductase enzyme and
helps to lower
cholesterol level in
patients of dyslipidemia
while aspirin is an
Antiplatelet drug used to
treat and prevent
thromboembolism.
While the two drugs
may be required to be
used together in several
patients, their
availability in a fixed
dose combination is not
supported by the
scientific literature.
74
available in Pakistan. Such combination is not
approved by FDA of
USA and European
Medicines Agency.
Loprin-AT is therefore
NOT
RECOMMENDED for
registration.
Dr. Iqbal
Saifullah
Head of
Cardiology PIMS
Islamabad
Additive effect of
antiplatelet therapy and
cholesterol lowering
agent has been proved in
reducing cardiovascular
events. Combination of
these two agents reduces
the risk of
cardiovascular mortality
in non-diabetic patients
with known IHD as well
as coronary artery
disease diabetics.
Combination of asprin
and Atorvastatin is
widely used in Pakistan.
Fixed dose combination
will also provide better
patient compliance.
Loprin AT is
recommended for
registration.
Syed Khalid
Saeed Bukhari
WHO Country
advisor/NPO
Essential
medicines
Pakistan
Aspirin has been used as
very effective
antiplatelet therapy in
cardiovascular diseases,
while Atorvastatin is
antihyperlipidemic and
used to lower
cholesterol levels.
Combination of these
two agents reduces the
risks of cardiovascular
mortality in non diabetic
patients with known
IHD as well coronary
artery disease diabetics.
75
Fixed dose combination
of these tow agents is
available in other
countries. Loprin-At
Capsule which is a
combination of
atorvastatin and enteric
coated aspirin pallets
will offer the benefit of
combined aspirin with
statin therapy.
Aspirin is present as
enteric coated pellets
therefore it will avoid
aspirin related GI side
effects leading to cost
effective therapy.
Aspirin is present as
enteric coated pallets
therefore it will avoid
aspirin related GI side
effects leading to
costeffectiveness; it will
definitely increase better
patient compliance. So
product may be
recommended for
registration with
positive opinion.
Nebizide 10 Tablet
Each tablet contains:-
Nebivolol (as
HCl)…..10mg
Hydrochlorthiazide….1
2.5mg
Rs.735.0
0/14’s
Prof.Dr.Muhamm
ad Ishaq Karachi
Institute of Heart
Diseases Karachi
Nebivolol is a novel
cardioselective beta
blocker being used as an
effective
Antihypertensive. It’s
unse in Heart failure is
not recommended so far.
The molecule is FDA
approved bot separately
and in combination.
Recommend the
availability of this
product for our
hypertensive patints.
Fised dose combination
of these two products
76
are already available in
other ountries.
Nebizide 5 Tablet
Each tablet contains:-
Nebivolol (as
HCl)…..5mg
Hydrochlorthiazide….1
2.5mg
Rs.385.0
0/14’s
-do- Both strength are
recommended
This is a combination of
Nebivolol with
Hydrochlorothiazide.
Nebivolol is a beta
blocker with high degree
of selectivity for beta 1
receptors and additional
vasodilator property.
Like other beta blockers,
it is used for treatment
of hypertension and
other cardiovascular
diseases.
Hydrochlorothiazide is a
diuretic which is also
useful in hypertension.
Studies have been
reported in scientific
literature showing a
synergistic action of the
two drugs in
hypertension. Many
other beta blockers are
also available in
combination with
thiazide diuretics.
Nebizide 5 mg and 10
mg is therefore,
recommended for
registration.
Syed Khalid
Saeed Bukhari
WHO Country
advisor/NPO
Essential
medicines
Pakistan
Nebivolol is a beta
blocking drug used for
hypertension while
hydrochlorothiazide is
antidiuretic which is
also used as
antihypertensive.
Combination of
Nebivolol and
Hydrochlorothiazide has
been evaluated in large
scale clinical trials.
Nebivolol and HCTZ is
and effective and well
77
Decision: The Board decided following:
Pidogrel-CAP 75: Deferred for the confirmation of approval of formulation
by USFDA, EMA, TGA, and Japan.
Pidogrel-CAP 150: Deferred for the confirmation of approval of formulation
by USFDA, EMA, TGA, and Japan.
Loprin-AT Capsules: Deferred, as the formulation is not approved by US-
FDA, EMA, TGA, Japan.
Nebizide 10 Tablet: Deferred for the confirmation of approval of formulation
by FDA, EMA, TGA, and Japan
Nebizide 5 Tablet: Deferred for the confirmation of approval of formulation
by FDA, EMA, TGA, and Japan
Case No. 42. M/s. Shrooq Pharma Lahore.
tolerated therapeutic
strategy for management
of hypertension
including diabetic and
elderly patients.
Combination of these
two products called
Nebizide is fixed dose
which is bioequivalent
to the two agents
administered
concomitantly.
This combination is
useful as monotherapy
nonresponders and for
those who required rapid
BP control to prevent
end organ damage.
Post marketing
surveillance studies
published so far has
shown that drug is
effective and well
tolerated therapeutic
strategy in clinical trials.
SO product may be
recommended for
registration with
positive opinion.
78
M/s. Shrooq Pharma Lahore applied for following applications. These were
considered in 235th
meeting of Drug Registration Board Held On 18th
September 2012
and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman, member
Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC after
completion of files. The meeting of the subcommittee was held on 08-11-2012 but
complete dossiers were not received at that time. Now the firm has submitted differential
fee and duplicate dossiers (photocopies) of these products and has requested for the
registration of these products.
S
.No
Name of
Firm
Name of the
drugs with
composition
Pack Size Proposed
Price
Decision in the
235th
meeting.
Remarks
1. M/s.
Shrooq
Pharma
Lahore
March,
2010
Isono Tablets
10mg
Each tablet
contains:-
Isotretinon…..1
0mg
(Dermatologica
l)
10’s As Per
SRO
Approved subject
to the submission
of duplicate files
and completion of
registration
dossier and
recommendations
of the committee
comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.
Me-too status of
10mg tablets not
confirmed. S.No
14 of form 5 not
correct.
Dissolution test
method not
provided.
2. -do- Isono Tablets
20mg
Each tablet
contains:-
Isotretinon…..2
0mg
(Dermatologica
10’s As Per
SRO
-do- S.No 14 of form 5
not correct.
Dissolution test
method not
provided.
79
l)
3. -do- Micin-T Lotion
Each ml
contains:-
Clindamycin
(phosphate)….
10mg
(antifungal)
30ml -do -do- The firm has no
external liquid
preparation
section; however
oral liquid and
semi solid sections
are present.
4. -do- Lumart-Forte
Dispersible
Tablets
Each tablet
contains:-
Artemether
….80mg
Lumefantrin….
480mg
(anti Malarial)
6’s -do- -do- No comments
5. -do- Benz-C Lotion
Each ml
contains:-
Clindamycin
(phosphate)…
….10mg
Benzyl
peroxide….50
mg
(Antifungal
and
dermatological)
30ml As Per
SRO
Approved subject
to the submission
of duplicate files
and completion of
registration
dossier and
recommendations
of the committee
comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.
Confirmation of
me-too status?
S.No 13 of Form 5
not correct (Clycin
Plus Lotion not
found). The firm
has no external
liquid preparation
section; however
oral liquid and
semi solid sections
are present.
80
6. -do- Duaba Sachet
Each sachet
contains:-
Strontium
ranelate….2.00
g
10’s -do- -do- Saccharin sodium
3.5g per sachet=
50%.
7. -do- Clerox Liquid
Each 5ml
contains;-
Ciclopirox
Olamine….1.5
%
(Anti-fungal)
60ml As per
SRO
-do- The firm has no
external liquid
preparation
section; however
oral liquid and
semi solid sections
are present. Me-
too status not
confirmed.
Stieprox by stiefel
not found in
Pharmaguide,
however pricing
minutes mention it
with Salycilic acid
which is not
present in this
formulation.
8. -do- Medison
Cream
Each gram
contains:-
Mometasone
Furoate………
0.1%
(Corticosteroid
s)
5g As per
SRO
Approved subject
to the submission
of duplicate files
and completion of
registration
dossier and
recommendations
of the committee
comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
The firm has no
semi solid
steroidal section.
Raw material
specifications not
provided.
81
firm.
9. -do- Sugrel Tablets
Each tablet
contains:-
Prasugrel
Hydrochloride
…………….5
mg
(Platelet
aggregation
inhibitor)
10’s
20’s
Rs.1275.0
0
Rs.2550.0
0
Approved subject
to the submission
of duplicate files
and completion of
registration
dossier and
recommendations
of the committee
comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.
S.No 13 of Form 5
not filled.
10. -do- Sugrel Tablets
Each tablet
contains:-
Prasugrel
Hydrochloride
…………….2.
5mg
(Platelet
aggregation
inhibitor)
10’s
20’s
Rs.640.00
Rs.1280.0
0
Deferred for
confirmation of
formulation,
submission of
duplicate file and
completion of
registration
dossier.
S.No 13 of Form 5
not filled.
Me-too status not
confirmed in 2.5
mg strength.
11. -do- Scabease
Tablets
Each tablet
contains:-
Ivermectin……
……….6mg
(Anti-parasitic
and Anti-
scabietic)
10’s As per
SRO
Approved subject
to the submission
of duplicate files
and completion of
registration
dossier and
recommendations
of the committee
comprising of
Prof. Rafi-Uz-
Zaman, member
82
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.
12. -do- Lite Orange
Sachet
Each sachet
contains:-
Sodium
citrate………
…..2.9
Sodium
Chloride……
……..2.6g
Potassium
chloride………
.1.5g
Dextrose
monohydrate…
……….13.50g
(Electrolyte)
10’s Rs.196.00 -do-/ and also
subject to WHO
formulation.
Formulation is
according to
WHO.
Saccharin sodium
3.5g per
sachet=14.28%
13. -do- Lumart
Dispersible
Tablets
Each tablet
contains:-
Artemether…
………20mg
Lumefantrine
…………..120
mg
(Anti-Malarial)
16’s As per
SRO
Approved subject
to the submission
of duplicate files
and completion of
registration
dossier and
recommendations
of the committee
comprising of
Prof. Rafi-Uz-
Zaman, member
Registration
Board, Secretary
Registration
Board, DDG
(Reg) and
Confirmation of
me-too status in
Dispersible form.
83
concerned DDC.
Five products per
section will be
granted on the
priority list of the
firm.
Decision: The Board decided following:
Isono Tablets 10mg: Deferred for confirmation of Me-too status of 10mg
tablets, submission of new complete signed form 5 and dissolution test
method.
Isono Tablets 20mg: Approved. However the Board advised to submit new
complete signed Form 5 and dissolution test method.
Micin-T Lotion: Rejected as the firm has no external liquid preparation
section.
Lumart-Forte Dispersible Tablets: Approved.
Benz-C Lotion: Rejected as the firm has no external liquid preparation
section.
Duaba Sachet: Deferred for clarification of master formula and change of
inactive ingredients according to FDA limits.
Clerox Liquid: Rejected as the firm has no external liquid preparation
section.
Medison Cream: Deferred till decision of semi solid steroidal products in
semi solid general section by licensing section and submission of raw material
specifications.
Sugrel Tablets 5mg: Approved. However the Board advised to submit new
complete and signed form 5.
Sugrel Tablets 2.5 mg: Deferred for confirmation of me-too status in 2.5 mg
strength and submission of new complete and signed form 5.
Scabease Tablets: Approved. The firm shall propose other brand names
which do not resemble with already registered brands.
Lite Orange Sachet: Deferred for clarification of master formula and change
of inactive ingredients according to FDA limits.
Lumart Dispersible Tablets: Deferred for confirmation of Me-too status in
dispersible form.
Case No. 43. M/s Pacific Pharma, Lahore.
Following application of M/s Pacific Pharma, Lahore was rejected in 189th
Meeting of the Registration Board because the experts did not recommend the product for
registration.
84
The firm got registration of the product for export purpose and applied for transfer of
registration from export to local manufacturing on 02-07-2010 on form-5D.
Now the firm has submitted the differential fee and requested for the registration of the
product because according to them the product is registered in countries like Germany,
Italy, Belgium, Spain, Greece, and Portugal.
Name of
Firm
Name of the drugs with
composition
Pack Size Proposed Price Date of
Submission
Remarks
M/s Pacific
Pharma,
Lahore.
Exituss Syrup
Each 5 ml contains:-
Levodropropizine…30mg
(Anti-tussive)
60ml
120ml
Rs. 195/-
Rs.390/-
02-07-2010
(Rs. 8000/-
+Rs.15000/-
+Rs.27000/-)
Form-5 D ,
New
application.
Decision: Registration Board deferred the case for confirmation of availability of
formulation in USFDA, EMA, Australia or Japan.
Case No.44. M/s Rasco Pharma, Lahore.
Director (Quality Control) has informed that M/s Rasco Pharma, Lahore has
manufactured Nil-Gesic Tablets which is counterfeit of Wilgesic Tablets manufactured
by M/s Wislon Pharmaceuticals, Islamabad.
He has directed the DDG (E&M) Lahore to inspect the premises and to rectify the
counterfeit packing and has requested the Drug Registration Board for cancellation of
registration of counterfeit Nilgesic manufactured by M/s Rasco Pharma, Lahore.
In this regard the FID Lahore-II has inspected the premises of the firm and he has
observed that no stock of packing of counterfeit “Nil-Gesic Tablet” was found in the
premises.
Meanwhile M/s. Rasco Pharma, Lahore has requested for change of packing
design of counterfeit “Nil-Gesic Tablet” and has submitted following documents:-
i. Undertaking that all of their current and future production will be packed
in new design of carton & Aluminum foil.
ii. Undertaking that their product “Nilgesic Tablet” with existing packing
material/design is not available in the market and has been withdrawn
from the market and there is no case pending/under process in any Court
of Pakistan and the firm has also undertake that their proposed packing
design does not resemble with already available drugs.
iii. Prescribed fee of Rs. 5000/- for the purpose.
85
Later on the firm was asked to why they have change the packing design without
prior approval of the Drug Regulatory Authority of Pakistan. As per reply of the firm and
FID report the firm was manufacturing the said drug in its original approved packing, but
on the demand of marketing department they manufactured only three batches of the
product without approval from DRAP. According to the firm as soon as they came to
know about the resemblance, they stopped manufacturing and have requested to change
the design again to its original approved packing and have tender apology for this act.
Decision: The Drug Registration Board decided to approve the packing design and
directed to change the name of the product immediately. The Board also decided to
issue warning to the firm and advised to be careful in future.
Case No.45. M/s. Mediways International, Lahore.
The Drug Registration Board in its following meetings had deferred the following
products of M/s. Mediways International, Lahore as mentioned in relevant column for
each product. The firm has deposited remaining fee of Rs. 12000/- for each product and
provided copy of inspection report dated 19-06-2013 in which the panel has verified that
the firm has installed HVAC in the manufacturing area of the premises. They have
requested to grant them the registration of these products.
Brand Name/Label claim Demande
d Pack
size
Demand
ed Price
Decision of
Board
Remarks
Coftus Syrup
Each 5ml contains:-
Dextromethorphan HBr
BP…..10mg
Pseudoephedrine HCl
BP…….30mg
Chloropheniramine Maleate
BP.......2mg
5ml Rs.2.25 Deferred
(M-223)
Formulation
contains
Pseudoephe
drine
Flucof Syrup
Each 5ml contains:-
Paracetamol B.P
…………....325mg
Dextromethorphan HBr
5ml
60ml
120ml
Rs.2.50.0
0
Rs.30.00
Rs.60.00
Deferred
(M-223)
Formulation
contains
Pseudoephe
drine
86
B.P….10mg
Pseudoephedrine HCl
B.P……30mg
Chloropheniramine as
maleate…..1mg
(analgesic)
Vomax Suspension.
Each 5ml Contains:-
Domperidone B.P………5mg.
60ml Rs.2.50/
5ml.
Deferred till
the
installation
of HVAC.
(M-201)
the firm has
installed
HVAC
Certex Syrup.
Each 5ml Contains:-
Cetirizine HCl B.P eq. to
Cetirizine base……….5mg.
60ml. Rs.3.08/
5ml.
-do-
(M-201)
the firm has
installed
HVAC
Neurotone Syrup
Each 5ml contains:-
Piracetam ………………1.0gm
5ml
120ml
Rs.15.42
Rs.370.0
0
Deferred for
Licensing
section’s
comments
on
requirement
of HVAC in
Syrup
section.
(M-225)
The firm has
installed
HVAC. The
molecule is
under
review.
Nu-Fer Syrup
Each 5ml contains:-
Iron (III) Hydroxide Polymaltose
Complex Eq. to elemental
Iron…………..…..50mg
Folic Acid………...0.35mg
60ml
120ml
Rs.6.60
per 5ml
-do- The firm has
installed
HVAC.
Decision: Registration Board decided as follows:
Coftus Syrup: Deferred till decision on controlled drugs.
Flucof Syrup: Deferred till decision on controlled drugs.
Vomax Suspension: Approved.
Certex Syrup: Approved.
Neurotone Syrup: Deferred for review committee as the formulation is under
review.
87
Nu-Fer Syrup: Deferred for product specific inspection by Director DTL,
Lahore, DDG E&M, Lahore and Area FID
Case No. 46. M/s. English Pharmaceutical Industries Lahore.
M/s. English Pharmaceutical Industries Lahore applied for following applications.
These were considered in 235th
meeting of Drug Registration Board Held On 18th
September 2012 and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman,
member Registration Board, Secretary Registration Board, DDG (Reg) and concerned
DDC after completion of files. The meeting of the subcommittee was held on 08-11-2012
but complete dossiers were not received at that time. Now the firm has submitted
differential fee and new dossiers of these products and has requested for the registration
of these products.
S
.No
Name of
Firm
Name of the drugs
with composition
Pack
Size
Proposed
Price
Decision in the 235th
meeting.
1 M/s.
English
Pharma
Lahore.
Zital 20mg Tablet
Each tablet
contains:-
Escitalopram (as
oxalate)….20mg
10’s As per
S.R.O
Approved subject to the
submission of duplicate
files and completion of
registration dossier and
recommendations of the
committee comprising
of Prof. Rafi-Uz-Zaman,
member Registration
Board, Secretary
Registration Board,
DDG (Reg) and
concerned DDC. Five
products per section will
be granted on the
priority list of the firm.
2 -do- X-Ron 15mg Tablets
Each tablet
contains:-
Mirtazapin….15mg
10’s -do- Approved subject to the
submission of duplicate
files and completion of
registration dossier and
recommendations of the
committee comprising
of Prof. Rafi-Uz-Zaman,
member Registration
Board, Secretary
88
Registration Board,
DDG (Reg) and
concerned DDC. Five
products per section will
be granted on the
priority list of the firm.
3 -do- X-Ron 30mg Tablets
Each tablet
contains:-
Mirtazapin….30mg
10’s -do- -do-
Decision: Registration Board approved above products for registration. Brand
name of Zital tablets will be changed.
Case No.47. Extension in Contract Manufacturing
S.No Applicant Contract
manufacturer
Reg. No.
Name of Drug (s) &
Composition
Date of
application,
and Form.
Category
1. M/s. Feroza
International
Pharma
Lahore
M/s.
Medisave
Pharma
Lahore
024050 Ferophin injection IM
Each vial contains:-
Ceftriaxone sodium
eq.to
Ceftriaxone…..250mg
(anti-Biotic)
26-08-
2013
Rs.50000/-
Form 5
Dedicated
section
2. -do- -do- 024051 Ferophin injection IM
Each vial contains:-
Ceftriaxone sodium
eq.to
Ceftriaxone…..500mg
(anti-Biotic)
26-08-
2013
Rs.50000/-
Form 5
Dedicated
section
3. -do- -do- 024055 Ferophin injection IV
Each vial contains:-
Ceftriaxone sodium
eq.to
Ceftriaxone…..1gm
(anti-Biotic)
26-08-
2013
Rs.50000/-
Form 5
Dedicated
section
4. -do- -do- 024054 Ferophin injection IV
Each vial contains:-
Ceftriaxone sodium
eq.to
Ceftriaxone…..500mg
(anti-Biotic)
26-08-
2013
Rs.50000/-
Form 5
Dedicated
section
5. M/s. Allmed
(Pvt) Ltd,
(formall
M/s.
Medisave
Pharma
045001 Ivoryzone 1gm
Injection
Each vial contains:-
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
89
M/s.
Evergreen
Pharma
Lahore
Lahore Ceftriaxone (as
sodium)….1gm
6. -do- -do- 045014 Rutex 400mg Caspule
Each capsule
contains:-
Cefixime……400mg
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
7. -do- -do- 045013 Rutex 100mg Dry
Suspension
Each 5ml contains:-
Cefixime……100mg
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
8. -do- -do- 044491 Greenec 2gm Injection
Each vial contains:-
Cefoperazone (as
sodium)…..1.0gm
Sulbactam (as
sodium)….1.0gm
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
9. -do- -do- 045002 Ivoryzone 500mg
Injection
Each vial contains:-
Ceftriaxone (as
sodium)….500mg
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
10. -do- -do- 044493 Puna 1.0gm Injection
Each vial contains:-
Cefepime (as
HCl)…..1.0gm
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
11. -do- -do- 044490 Greenec 1gm Injection
Each vial contains:-
Cefoperazone (as
sodium)…..500mg
Sulbactam (as
sodium)….500mg
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
12. -do- -do- 044493 Puna 500mg Injection
Each vial contains:-
Cefepime (as
HCl)…..500mg
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
13. -do- -do- 045003 Ivoryzone 250mg
Injection
Each vial contains:-
Ceftriaxone (as
sodium)….250mg
12-8-2013
Rs.50000/-
Form 5
Dedicated
section
Decision: Registration Board extended above products till 30.06.2015. The
Board advised the firms to select either IM or IV for products at S.No. 5, 9 and 13.
90
Item No.IV New Section-New License-Anomly cases:
Registration-II
a. M/S, City Pharmaceuticals, Karachi
Capsule (General)
231st RB meeting: 05
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Decision
1 Orex-500mg Capsule
Each capsule contains:
Cefadroxil………500 mg
(Anti bacterial/Antibiotic)
As per
PRC
As per PRC 27-03-2013
Dy.No.191
Form-5
Rs.20,000/-
Approved
However the
Registration
Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
Suspension (Cephalosporin)
231st RB meeting: 04
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Remarks
1 Orex-250mg Dry Suspension
Each 5ml contains:
Cefadroxil………250 mg
(Anti bacterial/Antibiotic)
As per
PRC
As per PRC 27-03-2013
Dy.No.190
Form-5
Rs.20,000/-
Approved
However the
Registration
Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
91
letters
2 Orex-125mg Dry Suspension
Each 5ml contains:
Cefadroxil……125 mg
(Anti bacterial/Antibiotic)
As per
PRC
As per PRC 27-03-2013
Dy.No.189
Form-5
Rs.20,000/-
-Do-
b. M/S, Kaizen Pharmaceuticals, Karachi.
Dry Powder Suspension Section.
235th
RB meeting: 05
236th
RB meeting: 04
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Remarks
1 Proart Dry Suspension
Each 5ml contains:
Dihydroartemisinin..15mg
Piperaquine
phosphate……..…120 mg
(Anti malarial)
30ml
40ml
60ml
80ml
As per PRC 08-11-2012
Dy.No.1766
-A
Form-5
Rs.20,000/-
Deferred for
me too staus
&
confirmatio
n of WHO
approved
formulation
c. M/s, Reign Pharmaceuticals PCSIR-KLC (Pvt.) Ltd, Karachi
Tablet (General).
235th
RB meeting: 05
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Remarks
1 Montikol 10mg Tablet
Each tablet contains:
Montelukast
Sodium………….10 mg
(Is oral leukotriene
receptor antagonist)
As per
PRC
As per PRC 21-05-2013
Dy.No.528
Form-5
Rs.20,000/-
Approved
However the
Registration
Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
2 Spastol Tablet
Each tablet contains:
As per
PRC
As per PRC 21-05-2013
Dy.No.529
Deferred for
review
92
Phloroglucinol ……80 mg
Trimethylphloroglucinol…
…………………..80 mg
(Antispasmodic)
Form-5
Rs.20,000/-
committee
consideration
Capsule (General)
235th
RB meeting: 05
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Remarks
1 Fluben 100mg Capsule
Each capsule contains:
Flurbiprofen……100 mg
(NSAID)
As per
PRC
As per PRC 21-05-2013
Dy.No.531
Form-5
Rs.20,000/-
Approved
However the
Registration
Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
2 Omzol 40mg Capsule
Each capsule contains:
Omeprazole……..40 mg
(Proton pump inhibitor)
As per
PRC
As per PRC 21-05-2013
Dy.No.532
Form-5
Rs.20,000/-
-Do-
3 Omzol 20mg Capsule
Each capsule contains:
Omeprazole……..20 mg
(Proton pump inhibitor)
As per
PRC
As per PRC 21-05-2013
Dy.No.530
Form-5
Rs.20,000/-
-Do-
Dry Powder (Suspension)
235th
RB meeting: 05
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Remarks
1 Fosfon 250mg/5ml oral
Suspension
As per
PRC
As per PRC 21-05-2013
Dy.No.533
Approved
However the
93
Each 5ml contains:
Fosfomycin
Sodium………….250 mg
(Broad Spectrum
Antibiotic of macrolide
group)
Form-5
Rs.20,000/-
Registration
Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
2 Renflox 250mg/5ml Dry
Powder Suspension
Each 5ml contains:
Ciprofloxacin ….250 mg
(Antibiotic)
As per
PRC
As per PRC 21-05-2013
Dy.No.535
Form-5
Rs.20,000/-
-Do-
3 Zinkid 20mg/5ml Susp.
Each 5ml contains:
Zinc Sulphate ……20 mg
(Astringent (for zinc
deficiency)
As per
PRC
As per PRC 21-05-2013
Dy.No.534
Form-5
Rs.20,000/-
-Do-
Sachet Section.
235th
RB meeting: 03
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Remarks
1 Lotrol Low Osmolarity
Sachet
Each sachet contains:
Sodium chloride….1.3g
Potassium Chloride..0.75g
Trisodium Citrate
Dihydrate…….1.45 g
Glucose anhydrous…6.75g
Eq. to sodium 37.5mmol,
Potassium10.00mmol,
chloride 32.5mmol, citrate
5.00mmol, Glucose
37.5mmol.
(Low-Osmolarity
As per
PRC
As per PRC 21-05-2013
Dy.No.540
Form-5
Rs.20,000/-
Deferred for
confirmatio
n of WHO
approved
formula
94
electrolytes/ORS)
2 Fem-C Plus Sachet
Each sachet contains:
Calcium Gluconate..587mg
Calcium carbonate..327mg
Calcium lactate…422 mg
Asc orbic acid….500 mg
Cyanocobalamin..250 mcg
Folic acid…………1 mg
As per
PRC
As per PRC 21-05-2013
Dy.No.539
Form-5
Rs.20,000/-
Referred to
review
committee
for
evaluation
Liquid Syrup.
235th
RB meeting: 02
S.No. Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Remarks
1 Anafe-F Syrup
Each 15ml contains:
Iron Protein Succinylate
800mg eq. to elemental
Iron ………….40 mg
Folic acid………..2.5 mg
(Anaemia, Haematinic)
As per
PRC
As per PRC 21-05-2013
Dy.No.527
Form-5
Rs.20,000/-
Deferred for
confirmation
of me too
status
2 DuMol Syrup
Each 5ml contains:
Paracetamol…….120 mg
(Analgesic and antipyretic)
As per
PRC
As per PRC 21-05-2013
Dy.No.536
Form-5
Rs.20,000/-
Approved.
The Board
advised to
change brand
name.
The
Registration
Board also
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
3 Irofer-F Syrup
Each 5ml contains:
Iron (III) Hydroxide
polymaltose complex eq.t o
As per
PRC
As per PRC 21-05-2013
Dy.No.541
Form-5
Rs.20,000/-
Deferred for
PSI by
Director
DTL,
Karachi and
95
elemental iron …..50mg
Folic acid………0.35 mg
(For iron deficiency
anemia, haematinic)
area FID
4 Irol-F Syrup
Each 5ml contains:
Iron Polysacharide
complex eq.t o elemental
Iron ………..100 mg
Folic Acid………..0.35 mg
(For iron deficiency
anemia, haematinic)
As per
PRC
As per PRC 21-05-2013
Dy.No.538
Form-5
Rs.20,000/-
Deferred for
confirmation
of me too
status and
PSI by
Director
DTL,
Karachi and
area FID
5 Nuprin 100mg Suspension
Each 5ml contains:
Ibuprofen………100 mg
(Analgesic and antipyretic
NSAID)
As per
PRC
As per PRC 21-05-2013
Dy.No.537
Form-5
Rs.20,000/-
Approved
Registration-V
S. No Name of
Firm
Name of the drugs with composition Pack
Size
Proposed
Price
Date of
Submission
Decsion
1. M/s. Simz
Pharma
Lahore
Diclosim-75mg Tablets
Each tablet contains:-
Diclofenac Potassium ….75mg
(analgesic)
10’s As Per
SRO
18-7-2013
20000/-
Deferred
for
submission
of Raw
material
specificatio
ns and latest
GMP
Inspection
report.
2. -do- Simfexo 60mg Tablets
Each tablet contins:-
Fexofenadine HCl….60mg
(anti allergic)
10’s -do- 18-7-2013
20000/-
-Do-
3. -do- Simfexo 120mg Tablets
Each tablet contins:-
Fexofenadine HCl….120mg
(anti allergic)
10’s -do- 18-7-2013
20000/-
-Do-
4. -do- Simfexo 180mg Tablets
Each tablet contins:-
10’s -do- 18-7-2013
20000/-
-Do-
96
Fexofenadine HCl….180mg
(anti allergic)
5. -do- Zithosim 500mg Tablets
Each tablet contains:-
Azithromycin as
dihydrate…500mg
(macrolide antibacterial)
6’s -do- 18-7-2013
20000/-
-Do-
6. -do- Diclosim 100mg SR Tablets
Each tablet contains:-
Diclofenac potassium….100mg
(analgesic)
10’s -do- 18-7-2013
20000/-
-Do-
7. -do- Simclar 250mg Tablets
Each tablet contains:-
Clarithromycin….250mg
(antibiotic)
10’s -do- 18-7-2013
20000/-
-Do-
8. -do- Simclar 500mg Tablets
Each tablet contains:-
Clarithromycin…..500mg
(antibiotic)
10’s -do- 18-7-2013
20000/-
-Do-
9. -do- Omepza 40mg Capsule
Each capsule contains:-
Omeprazole enteric coated
Pellets…..40mg
(proton pump inhibitor)
14’s -do- 18-7-2013
20000/-
-Do-
10. -do- Fansimz 80-480mg Tablets
Each tablet contains:-
Artemether….80mg
Lumefentrine….480mg
(anti malarial)
7’s -do- 18-7-2013
20000/-
-Do-
11. -do- Fansimz 15/90mg Dry
Suspension
Each 5ml contains:-
Artemether…15mg
Lumefentrine…90mg
(anti malarial)
60ml -do- 18-7-2013
20000/-
-Do-
12. M/s.
Novartana
Amrosal Syrup
Each 5ml contains:-
60ml As Per
SRO
22-5-2013
Rs.20000/-
Deferred
for
confirmati
97
Pharma
Lahore
Ambroxol as HCl……15mg
Salbutmol…..1gm
Guaphenesin…..50mg
Menthol….1mg
on of me
too status,
Submissio
n of
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
ons.
13. -do- Acnov 20mg Capsule
Each capsule contains:-
Isotretinoin…..20mg
10’s -do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
ons.
14. -do- Acnov 10mg Capsule
Each capsule contains:-
Isotretinoin…..10mg
10’s -do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
98
ons.
15. -do- Vantrin Suspension
Each 5ml contains:-
Artemether……15mg
Lumefantrine….90mg
60ml -do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
correct
signed
application
on form 5,
verificatio
n of
product for
dry
suspension
as
formulatio
n contains
water and
raw
materials
and
finished
product
specificati
ons.
16. -do- Irofer Syrup
Each 15ml contains:-
Iron protein succinylate
complex 800mg equivalent to
40mg elemental iron
120ml
-do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
correct
signed
application
on form 5
and raw
materials
and
finished
product
specificati
ons.
99
17. -do- Prebalin 75mg Capsule
Each capsule contains:-
Pregabalin….75mg
10’s -do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
correct
signed
application
on form 5,
raw
materials
and
finished
product
specificati
ons and
decision of
review
committee.
18. -do- Prebalin 150mg Capsule
Each capsule contains:-
Pregabalin….150mg
10’s -do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
correct
signed
application
on form 5,
raw
materials
and
finished
product
specificati
ons and
decision of
review
committee.
19. -do- Orthin 50mg Capsule
Each capule contains:-
Diacerein….50mg
10’s -do- 22-5-2013
Rs.20000/-
Deferred
for
Submissio
n of
100
correct
signed
application
on form 5,
raw
materials
and
finished
product
specificati
ons and
decision of
review
committee.
20. -do- Amrosal Syrup
Each 5ml contains:-
Ambroxol as HCl……15mg
Salbutamol….1mg
Guaphenesin….50mg
Menthol….1mg
60ml -do- 22-5-2013
Rs.20000/-
Duplicate
entry
21. -do- Olit Capsule
Each capsule contains:-
Orlistat…..120mg
30’s As Per
SRO
1-8-2013
Rs.20000/-
Deferred
for
Submissio
n of
GMP
Certificate
of pellets
manufactu
rer,
Certificate
of
Analysis
and
stability
studies of
pellets.
22. -do- Irofol Syrup
Each 5ml contains:-
Iron (III) Hydroxide
polymaltose complex….50mg
120ml -do- 1-8-2013
Rs.20000/-
-Do-
101
Folic Acid…..0.35mg
23. -do- Tamo Capsule
Each capsule contains:-
Tamsulosin HCl…….0.4mg
20’s -do- 1-8-2013
Rs.20000/-
Deferred
for
Submissio
n of
GMP
Certificate
of pellets
manufactu
rer,
Certificate
of
Analysis
and
stability
studies of
pellets.
24. -do- Amrosal Syrup
Each 5ml contains:-
Ambroxol as HCl……15mg
Salbutamol BP……1mg
Guaphenesin BP…..50mg
Menthol BP….1mg
120ml -do- 21-7-2013
Rs.20000/-
Duplicate
entry
102
Item No. V. Quality Control cases
Case No.01: Deferred Cases
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
1. Pamectin Drench
Batch NO.
V026/PMC/H/23
(Levermectin)
(F. No. 3-16/2013-
QC)
M/s. Nawan
Laboratories
(Pvt) Ltd.,
Animal
Health
Division
Karachi.
Substandard in
respect of Assay
for Ivermectin:
Percentage: 44.8%
Limits: 90.0 % to
110.0% Does not
comply with
manufacturer’s
specifications.
Not challenged Samples drawn from manufacturer’s premises on
25-02-2013 by FID Karachi-III. The firm could not
provide any valid justification for non conformance
of the product, in question, with the specifications.
Show Cause Notice, for cancellation / suspension
of registration / prosecution, was issued on 04-05-
2013. Accused Licensee namely Naseer Ahmed
Awan, Muhammad Akram Rana, Mohammad
Younus and the Firm / their Representative were
called for personal hearing before 238th
DRB
meeting held on 06-08-2013,
Since no one appeared on behalf of the
accused/firm before the 238th
meeting of the Board
so the Board deferred the case to give final
opportunity of the personal hearing to the
firm/accused. The Board, in the same meeting,
further decided to stop production of Pamectin
Drench till final decision by the Board.
During proceeding of the 239th
meeting, the Board
was informed that the orders for stoppage of the
production of Pamactin Drench, taken in its 238th
103
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
meeting, could not be conveyed as the approval of
minutes was not received in time from members.
Mr. Ahsan Naseer Awan, Director, Nawan
Laboratories, appeared on behalf of the firm and
stated that, as per their investigation, mal
functioning of mixer lead to improper mixing
resulting in low percentage of active drug in certain
portions of the mixture. He further informed that
problem has been rectified and the sub-standard
product has been recalled.
Decision:-
The Board in view of the personal hearing and
available record of the case decided as under:-
Production of Pamectian Drench be
stopped till further orders
Inspection of the firm by the following panel
in order to indentify the problems and
confirm the actions taken by the firm:-
Director, DTL Quetta,
DDG, (E&M) Karachi.
Area FID.
104
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
2. Hydrogen Peroxide
Solution Batch No.
840
(F. No. 3-21/2012-
Q.C)
M/s.
Karachi
Pharmaceuti
cal
Laboratories
, Karachi
Substandard in
respect of Acidity
& Assay for
Hydrogen
Peroxide:
Assay
Determined:
3.402%w/v
Limits: 5.0%w/v to
7.0%w/v.
Does not comply
with BP 2011
Not challenged Samples drawn from JPMC, Karachi on 09-
07-2012 by FID Karachi-III. The firm could not
provide any valid justification for non conformance
of the product in question with the specifications.
Show Cause Notices, for cancellation / suspension
of registration / prosecution, were issued on 07-05-
2013. Accused Licensee namely Muhammad Saleh
Memon, Mrs. Amina Mehboob Ali, Mrs. Farida
Qureshi and the Firm / their representative, were
called for personal hearing before 238th
DRB
meeting held on 06-08-2013.
The case was deferred by the Board in its 238th
meeting on request of Mr. M. Shaban, Regional
Manager, KPL. The Board, in the same meeting,
further decided to stop production of Hydrogen
Peroxide till final decision by the Board.
During proceeding of 239th
DRB meeting, The
Board was informed that the orders for stoppage of
the production of Hydrogen Peroxide, taken in its
238th
meeting, could not be conveyed as the
approval of minutes was not received in time from
members.
Mr. Muhammad Shaban, Manager Quality
Assurance, appeared on behalf of the firm and
105
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
submitted a written reply. As per the reply the firm
claimed to have recalled and replaced the sub-
standard stocks from the JPMC. The firm further
pointed out that a sample of the same batch, drawn
by FID from distributor of the firm, has been
declared of standard Quality by CDL. The firm’s
representative also referred to their request for
appellate testing made vide letter dated 10-09-
2012, which, as per photocopy submitted by the
firm, was received at DRAP Karachi office on 11-
09-2012.
With regards to the standard report of the same
batch issue by the CDL, the Board noted that, the
Federal Government Analyst, in this report, has
stated that quality of the bottle and sharpness,
visibility and colour of the labels text of the
sample was different from the one declared sub-
standard vide its earlier report. The Board
However, observed that appellate testing request of
the firm appears to be with in time as per
documents / evidence of the receipt submitted by
the firm.
Decision:-
The Board, in view of the personal hearing and
106
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
available record of the case, decided as under:-
Production of Hydrogen Peroxide be
stopped till further orders
The Board’s portion of the sample
(Hydrogen peroxide Batch No 840) already
drawn from JPMC, Karachi will be sent for
appellate testing.
3. Carded Absorbent
Cotton Wool,
Batch No. 4555-C,
F.No.3-20/2012-QC
M/s
National
Absorbent
Cotton Mills
Co, Karachi
Sub-Standard:- in
respect of
description:-
Not well carded
cotton, not
bleached to a good
white, it is free
from leaf shells &
foreign mater, it
does not offer any
appreciable
resistance when
pulled and it does
not shed any
appreciable
Sub-Standard:- in
respect of
description
White cotton, free
from pieces of
thread, leaf, shell
and foreign matter.
It do not offer
appreciable
résistance when
pulled and shed
heavy dust when
gently shaken. The
staple length of fiber
is less than 08mm.
Samples drawn from M/s Pharmex Fair Price Drug
Store, JPMC, Karachi on 16-08-2012 by FID-III
Karachi. The Appellate Lab, to which Sample was
sent on firm’s request, also declared the sample sub-
standard. Show Cause Notice, issued on 05-07-2013
to the accused namely Mr.Kashif Iftikahr C.E.O,
Mr. Zahid Hussain I/C Q.C, Mr. Ilyas Khan, I/C
Production and the Firm. The Accused Licensee /
Representative were called for personal hearing
before 238th
DRB meeting held on 06-08-2013.
Since no one appeared on behalf of the
accused/firm before the 238th
meeting of the Board,
so the Board deferred the case to give final
opportunity of the personal hearing to the
firm/accused. The Board, in the same meeting,
107
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
quantity of fiber
matter when gently
shaken.
Does not comply
with the
description
PC.1973
(Does not comply
with revised
specification which
states that the cotton
wool should be well
carded, should have
a staple length of not
less than 08mm,
should be bleached
to a good white and
be odorless, should
be free from pieces
of thread and
reasonable free from
leaf, shell and
foreign matter
should offer
appreciable
resistance when
pulled and should
not shed any
appreciable quantity
of dust when gently
shaken.
further decided to stop production of Carded
Absorbent Cotton Wool till final decision by the
Board.
During proceeding of the 239th
meeting, the Board
was informed that the orders for stoppage of the
production of Carded Absorbent Cotton Wool,
taken in its 238th
meeting, could not be conveyed as
the approval of minutes was not received in time
from members.
Mr. Raziuddin Ahmed, Manager and Mr. Ilyas
Khan, represented, National Absorbent Cotton
Mills/accused, and stated that the report of CDL
and Appellate Lab’s are contradictory.
The Board observed that the report of Appellate
Lab is conclusive evidence of the facts stated
therein under Section 22(5) of Drugs Act 1976.
Decision:-
The Board in view of the personal hearing and
available record of the case decided as under:-
Suspension of Registration of Carded
Absorbent Cotton Wool for three months
Inspection of the firm by the following panel
108
Sr.
#
Name of Drugs Firm CDL Report Appellate Testing Details/Decision
for reporting on GMP Compliance:-
Director, DTL Quetta,
DDG, (E&M) Karachi.
Area FID.
Case No.02. NEW CASES
Sr.
No
Name of Drugs Firm CDL Report Appellate Testing Detail / Decision
1. (i). Normal Saline
Injection (0.9%
Sodium Chloride)
Batch No. 0105235
F. No. 3-15/2012-
DDC-QC-II
M/s Marion
Laboratories
, Karachi
Sub- Standard:-
Assay for sodium
Chloride:
Determined
amount/100ml:
1.023gm
Sated amount
/100ml: 0.9gm
Percentage:
113.67%
Limits: 95.0% to
105.0% Does not
Not Challenged Samples drawn from manufacturer’s premises
on 19-03-2012 by ADC Karachi from
consignment meant for export.
The firm could not provide any valid
justification for non conformance of the
products in question, with the specifications.
Show Cause Notice were issued on 07-08-
2013 to the accused namely Mr. Saboor,
Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
C.E.O.
Accused Licensee and accused were called
for personal hearing
109
comply Mr. Imran Saboor represented M/s Marion
Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
authorities later allowed resumption of
production after confirming that the firm has
made required improvements.
The Board noted that the firm failed to give
any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd
meeting held on 29-30th
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.
110
Decision:-
The Board in view of the personal
hearing and available record of the case
decided to cancel registration of
Normal Saline Injection.
(ii). Normal Saline
Injection (0.9%
Sodium Chloride)
Batch No. 0105238
F. No. 3-15/2012-
DDC-QC-II
M/s Marrion
Laboratories
, Karachi
Sub- Standard:-
Assay for sodium
Chloride:
Determined
amount/100ml:
1.006gm
Sated amount
/100ml: 0.9gm
Percentage:
111.77%
Limits: 95.0% to
105.0% Does not
comply
Not Challenge Samples drawn from manufacturer’s premises
on 19-03-2012 by ADC Karachi from
consignment meant for export.
The firm could not provide any valid
justification for non conformance of the
products, in question, with the specifications.
Show Cause Notice were issued on 07-08-
2013 to the accused namely Mr. Saboor,
Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
C.E.O.
Accused Licensee and accused were called for
personal hearing
Mr. Imran Saboor represented M/s Marion
Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
111
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
authorities later allowed resumption of
production after confirming that the firm has
made required improvements.
The Board noted that the firm failed to give
any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd
meeting held on 29-30th
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.
Decision:-
The Board in view of the personal
hearing and available record of the case
decided to cancel registration of
112
Normal Saline Injection.
(iii). Marivell-5
Injection Batch
No.0205852
(Dextrose)
F. No. 3-15/2012-
DDC-QC-II
M/s Marrion
Laboratories
, Karachi
Sub-Standard:-
In respect of
Endotoxins Test
Does not comply
Not Challenge Samples drawn from manufacturer’s premises
on 19-03-2012 by ADC Karachi from
consignment meant for export.
The firm could not provide any valid
justification for non conformance of the
products, in question, with the specifications.
Show Cause Notice, were issued on 07-08-
2013 to the accused namely Mr. Saboor,
Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
C.E.O.
Accused Licensee and accused were called for
personal hearing
Mr. Imran Saboor represented M/s Marion
Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
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authorities later allowed resumption of
production after confirming that the firm has
made required improvements.
The Board noted that the firm failed to give
any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd
meeting held on 29-30th
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.
Decision:-
The Board in view of the personal
hearing and available record of the case
decided to cancel registration of
Marivell-5 Injection.
(iv). Marivell-5
Injection Batch
No.0205854
(Dextrose)
F. No. 3-15/2012-
M/s Marrion
Laboratories
, Karachi
Sub-Standard:-
In respect of
Endotoxins Test
Does not comply
Not Challenge Samples drawn from manufacturer’s premises
on 19-03-2012 by ADC Karachi from
consignment meant for export.
The firm could not provide any valid
justification for non conformance of the
products, in question, with the specifications.
114
DDC-QC-II
Show Cause Notice, were issued on 07-08-
2013 to the accused namely Mr. Saboor,
Director, Syed Asghar Afaque, Assistant
Production manger and the Firm / through its
C.E.O.
Accused Licensee and accused were called for
personal hearing
Mr. Imran Saboor represented M/s Marion
Laboratories and informed that his father S.M
Saboor, the Director of the firm, is seriously
ill. He stated that the samples were drawn
from the 16 batches of various drugs but only
04 samples were declared sub-standard.
However, on instructions of the DRAP
authorities, they recalled all the batches,
including the one declared standard, from the
market. He further claimed that their
production was suspended due to sub-standard
manufacturing. However, The DRAP
authorities later allowed resumption of
production after confirming that the firm has
made required improvements.
The Board noted that the firm failed to give
any valid justification for sub-standard
manufacturing. The Board also considered the
recommendations of the Central Licensing
Board given its 232nd
meeting held on 29-30th
115
July, 2013 regarding Cancellation/ suspension
of registration of Marivel-5 Injections for sub-
standard export to Rawanda. (Case 03 (b) of
Miscellaneous Cases of the Agenda). It was
also noted that the Drug Manufacturing
License of the firm has been suspended for six
months by the Central Licensing Board.
Decision:-
The Board in view of the personal
hearing and available record of the case
decided to cancel registration of
Marivell-5 injection.
2. Aerolin Syrup
Batch No. 404
(Salbutamol)
F.No.03-16/2012-
DDC QC
M/s Ankaz
Pharmex,
Karachi
Sub-Standard:
Assay for
Salbutamol:
Determined
amount/5ml:
1.4778 mg
Stated amount/5ml:
2.0mg
Percentage:
73.89%
Limits:- 90.0% to
105.0 % Does not
Adulterated
Remarks:-
During the analysis of
salbutamol Sulphate
Syrup unidentifiable
peaks eluted alongwith
active ingredient at the
retention time of 2.48and
4.803 minutes. The area
of these unidentifiable
peaks found two times
greater than the area of
active ingredient
Samples drawn from manufacturer’s premises
on 19-07-2012 by FID Karachi-III
The firm requested for appellate testing
In response to Show Cause Notice the firm did
not agree with the appellate Lab’s report.
Show Cause Notices, were issued on 07-08-
2013 to the accused namely Mr. Zafar Shah
Production Incharge, Mr. Jubair Ali, Quality
Control Manager and the Firm / through its
C.E.O.
Accused Licensee and accused were called for
personal hearing
116
comply with BP
2011
Mr. Nazurl Islam, Quality Assurance Manager
of Ankaz Pharmex represented the firm and
stated that the drug is of standard quality as
per test/analysis of the keeping samples by
their Q.C Department and no adulteration was
found. He further claimed that the NIH report
wrongly interpreted the eluted extra peaks as
unidentifiable which, in fact, were of
excipient.
The Boar however was of the view that the
issue needs to be thoroughly
examined/investigated
Decision:-
The Board in view of the personal hearing
and available record of the case decided as
under:-
Production of Aeroline Syrup be
stopped till further orders
Inspection of the firm by the following
panel to thoroughly investigate the
matter
Director, DTL Lahore,
DDG, (E&M) Karachi.
Area FID.
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3. Pracmol
Suspension Batch
No. PM-28
(Paracetamol)
F.No. 03-22/2013-
QC
M/s Glitz
Pharma
Islamabad
Sub-Standard
Assay for
Paracetamol:-
Determined
amount/5ml:
99.264 mg
Stated amount:
120.0 mg
Percentage:
82.72%
Limits:- 95.0% to
105.0% Does not
comply BP 2011
Sub-Standard:-
Assay for Paracetamol:-
Stated:- 120mg/5ml
Found:- 96.03mg/5ml
Limit: 95-105%
Percentage: 80.02%
Samples drawn from manufacturer’s premises
on 18-03-2013 by FID Islamabad
The firm requested for appellate testing.
Show Cause Notice, were issued on 07-08-
2013 to the accused namely Chaudhry
Munawar Hussain, Chief Executive Officer,
Mr. Sheikh Imran Aslam, Production
Manager, Mr. Kiramat ullah, Quality Control
Manger and the Firm / through its C.E.O.
Accused Licensee and accused were called for
personal hearing
Mr. Ch. Munawar Hussain, C.E, Shaikh Imran
Aslam, Prod. Manager, Kiramat ullah, Q.C
Manager, appeared before the Board and
stated that the drug is of standard quality as
per repeated test/analysis of the keeping
samples by their Q.C Department and they are
trying to find out the cause of the problem..
The Boar however was of the view that the
consistent CDL and Appellate Lab’s results
clearly indicate that the product is not up to
the specified standards.
Decision:-
The Board in view of the personal hearing
118
and available record of the case decided as
under:-
Suspend registration of Paracmol
suspension for six months.
Inspection of the firm by the following
panel to thoroughly investigate the
matter
Prof. Dr. Rafi-uz-Zaman
DDG, (E&M) Islamabad.
Area FID.
119
Case No.03: MISCELLANEOUS CASES.
Case No a. MANUFACTURE AND SALE OF SPURIOUS, SUBSTANDARD AND
ADULTERATED ISOTAB TABLETS BY M/S. EFROZE CHEMICAL
INDUSTRIES KARACHI.
In January, 2012 on receipt of reports of number of deaths / serious reaction in large
number of patients, receiving medicines from the Punjab Institute of Cardiology, the than Drug
Control Administration and Government of Punjab initiated investigation to find out facts the
case. Subsequently a foreign laboratory reported contamination of antimalarial drug
“Pyrimethamine” in samples of Isotab tablets of M/s Efroze Chemical Industries, sent by the
Punjab Government. Since at that time the subject of “Drugs and Medicines” was devolved to
the provinces under 18th
Amendment, therefore, the Drug Control Administration at Federal
level could not process the matter further.
The Punjab Government, however, initiated its own independent investigation during this
period. An FIR, against M/s Efroze Pharmaceuticals, Karachi, was lodged by Punjab
Government and a Judicial Commission, headed by Judge of High Court, had also been set up by
them for carrying out detail investigation of the case.
The Provincial Quality Control Board, Punjab later, vide its order dated 01-02-2012,
reported that the samples of Tablet Isotab-20 Batch No. J-093, manufactured by M/s Efroze
Chemical industries (Pvt) Ltd., Karachi, drawn by Drug Inspector, Data Ganj Bakhsh Town
Lahore, (from stocks of the medicines retrieved from the patients (who received free medicines
from PIC Lahore), were declared to be adulterated with “Pyrimethamine”, by the Government
Analyst, Drug Testing Laboratory, Punjab. The quantity of “Pyrimethamine” determined, was
46.21 mg per tab and percentage of Isosorbide-5-mononitrate (API) was declared to be 122.8%,
whereas the official limit of active ingredient was 95-105%. The Provincial Quality Control
Board Punjab, after considering the matter recommended cancellation of Registration of Isotab
Tablet and Drug Manufacturing License of M/s Efroze Chemical Industries, Karachi vides its
ordered dated 01-02-2012.
The recommendations regarding cancellation of Drug Manufacturing License was taken
up by Central Licensing Board in its 231st meeting held on 30-01-2013, wherein the Board,
suspended Tablet Section of Efroze Pharma and ordered to launch prosecution against the
120
responsible persons of the firm. The Board further recommended to the Registration Board for
the cancellation of registration of Isotab Tablet.
The Drug Registration Board in its 237th
meeting held on 26-02-2013 considered the
matter and took following decisions.
i) Registration of Isotab Tablet is suspended for one year.
ii) Show Cause Notice to be issued to the Firm( for cancellation of Drug
Registration)
iii) The case be evaluated/investigated by an Expert Committee to be constituted
by the Chairman, Policy Board
As per above decisions of the Board, the following actions have been taken.
a. Firm has been issued Show Cause Notices dated 09-04-2013
b. Registration of Isotab Tablets has been suspended vide letter dated 22nd
March,
2013
c. A seven member committee headed by Prof. Dr. Tahir S. Shamsi of National
Institute of Blood Disease and Bone Marrow Transplant, has been constituted
vide letter dated 08-03-2013 to evaluate the case in detail and give its
comprehensive report and recommendations with in seven days. The CLB in its
232nd
meeting directed that the Committee may be asked to finalize its report on
top priority basis preferably with in week’s time.
The report of the Committee has been received recently. The Committee, as per its TOR,
has evaluated report of Defective Drugs Inquiry Tribunal, recommendation of PQCB Punjab,
investigation of area of FID Karachi and Inspection/investigation reports of National and
International Agencies. The Committee also inspected the firm for assessing the GMP
compliance status. The report of the Committee discussed the actions taken by Federal and
Provincial Authorities against M/s Efroze Chemical Industry and its finding related to GMP
status of the firm. The excerpts of the report and remarks of the Committee is Annexed
It is further Informed that M/s Efroze Chemical Industries, also file in appeal before
appellate Board against suspension of their Tablet Section by CLB. The Appellate Board
allowed manufacturing in Tablet Section on limited scale under strict monitoring.
M/s Efroze Chemical Industry has been called for personal hearing with reference to the
Show Cause Notice issued for cancellation of registration of Isotab Tablet.
Decision:-
The Board decided to defer the case till next meeting in order to provide final opportunity
of personal hearing to M/s Efroze Chemical Industry, Karachi, failing which an ex-parte
121
decision shall be taken. In the mean time, the members may also study the report of the
Committee and come up with their recommendations/views in next meeting.
Case No b. Manufacture and Export of Sub-Standard Marivell-5 Injections by M/s
Marion Laboratories (Pvt) Karachi
The Secretary Central Licensing Board has forwarded have the following decision of the
Central Licensing Board taken in its 232 meeting held on 29-30 July,2013 for consideration of
Drug Registration Board:-
“The Board also decided to send recommendation to the Registration Board for
cancellation/suspension of registration of Injection Marivell-5 (Dextrose 5%)
500ml under Section 42 of Drugs Act, 1976 and rules framed there under for
manufacturing and supply of Sub-Standard drug in the importing country”.
M/s Marion laboratories manufactured and exported two consignments of Marivell-
5 Injection (246240 Bottles) to Rawanda via Darussalam Tanzania through M/s Royal
Groups Karachi in early 2012. The Consignments were reported to be declared sub-
Standard by Rawanda Bio Medical Center of the importing country which also
recommended for rejection of whole consignments. A dispute between M/s Marion Labs
and M/s Royal Group arose on the issues of the destructions of stocks at Darussalam and
Rawanda and compensation. Falling to settle the matters with M/s Marion, the Royal
Group approached the DRAP Authorities for support claiming that manufacture of sub-
standard drug for export by M/s Marion Lab’s has put Pakistan reputation at stake and
could seriously effects export of drugs of Pakistani origin if the dispute is not appropriately
settled. The DRAP Authorities and Central Licensing Board asked M/s Marion
Laboratories number of times to settle the matter amicably with M/s Royal particularly
regarding destruction of the Sub-Standard exported consignments lying at the port of
Darussalam and at Rawanda, in order to avoid bringing bad name to Pakistan export. M/s
Marion, however, failed to cooperate and appeared to have resorted to delaying tactics.
With regards to substandard exports, a GMP inspection of the firm was carried out
and the production of the firm remain suspended till September, 2012. Thereafter the firm
was found closed by an inspection panel which visited the firm on 11th
, June 2013. The
panel formally closed production of the firm vides its inspection report dated 11-06-2013.
122
The matter was subsequently considered by the Central Licensing Board in its 232nd
meeting wherein Board took number of decision including suspension of Drug
Manufacturing License of M/s Marion Lab’s Karachi for six months.
Decision:-
The Board considered the case along with sub-standard cases of M/s Marion Laboratories
Karachi, included in the New Cases {Case No.2(1)}of the Q.C Agenda, wherein the Board
already decide to cancel the registration of Marivell-5 Injection for sub-standard
manufacturing.
Case No c: MANUFACTURE / SALE OF SUBSTANDARD MACRONIDE
INFUSIONS BY M/S MAC & RAIN PHARMACEUTICALS, LAHORE.
The Federal Inspector of Drugs on 31st May, 2011 and 4th June, 2011 drew samples of
five different batches of Macronid 100ml Infusion from the Main Medical Store, MCH and Store
of Children Hospital at PIMS. On 4th June, 2011 different batches of Macronid Infusions at Burn
Center, Store of Children Hospital and Main Store at PIMS were also ordered Not to Dispose off
for three months by the FID. The FID, Islamabad later reported that the reports of the
aforementioned samples were not received until May, 2012. On 17th May, 2012 photocopies of
two substandard test reports, number 489/2011 & 490/ 2011 dated 28-05-2011, issued in respect
of Macronid Infusion batch No. 105209 and 105208 were received. The other three batches of
Macronid Infusions i-e 104262, 105123 and 010271 were declared standard Quality as per
photocopies of reports of CD L provided by FID.
Immediately, on receipt, the two substandard reports were sent to PIMS and stocks of
substandard batches were again ordered Not to Dispose off 18(1)(i) of Drugs Act, 1976 by FID
on 21-05-2012 at Burn Center, Main Medical Store and MCH at PIMS and requested for
extension of not to dispose off period under Section 18 of the Act. The FID’s request for
extending not to dispose off orders was put up in June 2012, but file returned in April 2013,
without any action. The Federal Inspector of Drug in the mean time also called explanation of
the manufacturer M/s Mac & Rains Pharmaceuticals Lahore. The firm in response did not agree
with the repots and stated that one of batch of Macronid Infusion (No 105208) was already
declared standard by DTL, Punjab and further stated that the direct temperature shock applied on
123
the bottle during sealing (remarks of Federal Government Analyst) has compromised the sterility
of the product.
The Federal Inspector of Drugs is of the view that the same method of seal was applied to
all the other sample of Mecronid Infusion sent to Central Drug Laboratory and the reports of
other three batches of the product, wherein the thermal shock was also reported by the Federal
Government Analysis, were of standard quality and the firm’s contention therefore is not valid.
The Federal Inspector of Drugs, therefore, concluded that the firms has violated the section (23)
(1) (a) (V), of Drug Act 1976.
Decision:-
The Board, in view of the available record and facts of the case, decided as under:-
Show Cause Notice be issued to the firm and responsible persons.
FID may be advised to pass not to dispose off orders/make seizure, which ever is
applicable, for the sub-standard stocks at PIMS.
Initiate recall proceedings for sub-standard stocks if supplied in the market
124
Item No.V Any Other Item with permission of chair
Registraion-I
Case No: 01. Aplications for registration (locally manufactured Veterinary drugs (me-
too/new drugs) for fast track.
S. # Name of
Applicant
Name of Drug(s)/Composition Price/Pack
Size
Shelf
Life
Decision
1. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Nemasol Plus Drench
Each ml contains:-
Levamizole …………..15mg
Oxyclozanide………..30 mg
Cobalt Sulphate ...…1.67 mg
Sodium Selenite ..….0.50mg
Decontrolled
150ml
500ml
1000ml
5 Litre
10 Litre
02
years
Approved
2. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Hepanol Oral Solution
Each 100ml contains:-
Sorbitol …………...….35gm
Acetyl Metionine …….10gm
Choline HCL ……….7.5 gm
Betain …………….6.0 gm
Lysine Hydrochloride .2.0gm
Decontrolled
100ml
250ml
500ml
1000ml
02
years
Deferred for
application on
Form 5 D along
with revised Fee
and comments of
following experts;
1. Dr. M
Ashraf,
UVAS
2. Head of
Pharmacolog
y Deptt.
UAF
3. Dr. M.
Arshad,
Member
DRB.
3. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Imnate Injection
Each ml contains:-
Imidocarb
Dipropionate………120mg
Decontrolled
10ml
20ml
50ml
100ml
02
years
Approved
4. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Melodyl Injection
Each 100ml contains:-
Cyanocobalamine …0.05mg
Sodium Selinite ……100 mg
Adenosine Triphosphate
Tetrasodium
Trihydrate……………0.1gm
Potassium Aspartate Semihydrate
…………1.0gm
Magnesium Aspartate
Decontrolled
10ml
20ml
50ml
100ml
02
years
Deferred for
application on
Form 5 D along
with revised Fee
and comments of
following experts;
a. Dr. M Ashraf,
UVAS
b. Head of
Pharmacology
125
Tetrahydrate ……….1.5gm Deptt. UAF
c. Dr. M.
Arshad,
Member DRB
5. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Rivaflor 300 Injection
Each ml contains:-
Florfenicol ………...300mg
Decontrolled
10ml
20ml
50ml
100ml
02
years
Approved
6. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Terralon 50 Injection
Each ml contains:-
Oxytetracycline ……50mg
Decontrolled
10ml
20ml
02
years
Approved
7. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Tetrasol Injection
Each ml contains:-
Chlortetracycline.2.45% w/w
(Antibiotic)
Decontrolled
100ml
02
years
Deferred for
application on
Form 5 D along
with revised Fee
and comments of
following experts;
a. Dr. M Ashraf,
UVAS
b. Head of
Pharmacology
Deptt. UAF
c. Dr. M.
Arshad,
Member DRB
8. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Xylax Injection.
Each ml contains:-
Xylazine HCl 23.32mg.
(Analgesic, Sedative).
Decontrolled
5ml
10ml
20ml
25ml
30ml
50ml
100ml
2 years Approved
9. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Duretic Injection.
Each ml contains:-
Furosemide………50mg.
(Diuretic).
Decontrolled
5ml
10ml
20ml
30ml
50ml
100ml
2 years Approved
10. M/s. Mylab (Pvt)
Ltd. Khanqah
Sharif,
Bahawalpur.
Vantix Solution
Each 100ml contains:-
Fipronil……….0.25gm
(Disinfectant).
Decontrolled
100ml
250ml
500ml
1000ml
03
years
Deferred for
application on Form
5 D along with
revised Fee and
comments of
following experts;
a. Dr. M Ashraf,
UVAS
126
b. Head of
Pharmacology
Deptt. UAF
c. Dr. M. Arshad,
Member DRB
11. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Zoleriq 10% Oral Drench
Each ml oral drench contains:-
Albendazole……100mg
(Benzimidazole).
Decontrolled
100ml
250ml
500ml
1000ml
02
years
Approved
12. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Oxfendaox Plus Oral Drench
Each ml contains:-
Oxyclozanide ……..62.50mg
Oxfendazole …………22.65
Cobalt Sulphate……1.67mg
Sodium Selenite…….0.50mg
(Salicylanilide, Benzimodazole,
Trace Elements).
Decontrolled
100ml
500ml
1000ml
2500ml
02
years
Approved
13. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Zolesel-CS Oral Drench
Each ml contains:-
Albendazole……….50mg
Cobalt Sulphate……3.82mg
Sodium Selenite……0.35mg
(Benzimodazole, Trace Elements).
Decontrolled
100ml
500ml
1000ml
2500ml
02
years
Approved
14. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Levoxbar-Plus Drench
Each ml contains:-
Levamisole HCL..15mg
Cobalt Sulphate…1.67mg
Oxyclozanide…………30mg
Sodium Selenite……0.50mg
(Salicylanilide, Trace Elements).
Decontrolled
100ml
150ml
500ml
1000ml
2500ml
03
years
Approved
15. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Levacob-SS Oral Drench
Each ml contains:-
Levamisole HCL……15mg
Cobalt Sulphate……3.82mg
Sodium Selenite…….0.50mg
(Salicylanilide, Trace Elements).
Decontrolled
100ml
500ml
1000ml
2500ml
03
years
Approved
16. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Amantadox-T Water Soluble
Powder
Each 1000 gm powder contains:-
Tylosin Tartrate
…….100gm
Doxycyline HCL……200gm
Amantadine HCl…….45gm
(Antibiotic)
Decontrolled
100gm
250gm
500gm
1000gm
2500gm
5000gm
02
years
Approved
17. M/s. Baariq
Pharmaceuticals,
Raiwind Road,
Lahore.
Colibect Water Soluble Powder
Each 100gm powder contains:-
Colistin Sulphate…500,000,000 IU
(Antibiotic, Antibacterial).
Decontrolled
100gm
250gm
500gm
1Kg
02
years
Approved
127
2.5Kg
5Kg
10Kg
25Kg
18. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
LEVANIDE-CS Suspension
Each 100ml contains:-
Oxyclozanide…….3.0g
Levamisole HCl …1.5g
Cobalt Sulphate ….0.382%
Decontrolled
100ml
150ml
250ml
400ml
500ml
1Litre
2.5Litre
25 Litre
02
years
Approved, with
Brand Name
change
19. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
ALBENMARS Suspension
Each 100ml contains:-
Albendazole…….2.5g
Sodium selenite ...0.035%
Cobalt chloride …0.075%
Decontrolled
100ml
150ml
250ml
400ml
500ml
1Litre
2.5Litre
25 Litre
02
years
Approved
20. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
LEVAMARS Suspension
Each 100ml contains:-
Levamisole HCl …1.5%
Decontrolled
100ml
150ml
250ml
400ml
500ml
1Litre
2.5Litre
25 Litre
02
years
Approved
21. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
TOLTRA MARS Liquid
Each 1000ml contains:-
Toltrazuril …..25g
Vitamin K3 …3g
Decontrolled
100ml
250ml
500ml
1Litre
2.5Litre
02
years
Approved, with
Brand Name
change
22. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
FENMARS Suspension
Each ml contains:-
Oxfendazole … 22.65mg
Decontrolled
100ml
150ml
250ml
400ml
500ml
1Litre
2.5Litre
25 Litre
02
years
Approved
23. M/s. Medi-Vet
(Pvt) Limited,
Floxivet-Col + Oral Solution
Each 100ml contains:-
Decontrolled
100ml
02
years
Deferred as
production of firm
128
Lahore.
Enrofloxacin HCI
CP………………..10.0gm
Amantadine HCI
BP………………..04.0gm
Colistin Sulphate
BP…......................3.5gm
(Antibiotic/Antibacterial/Antiviral).
250ml
500ml
1000ml
has been stopped
by CLB
24. M/s. Medi-Vet
(Pvt) Limited,
Lahore.
Floxivet-C Injection
Each ml contains:-
Enrofloxacin B.P Vet…100mg/ml
Colistin Sulphate BP..250000 iu/ml
(Antibiotic/Antibacterial).
Decontrolled
100ml
250ml
500ml
1000ml
02
years
-Do-
25. M/s. Medi-Vet
(Pvt) Limited,
Lahore.
Amcol-Vet Oral Suspension
Each 100ml contains:-
Amoxicillin base (as
Trihydrate……..B.P…15gm
Colistin Sulphate B.P…..50 MIU
(Antibiotic/Antibacterial).
Decontrolled
100ml
250ml
500ml
1000ml
03
years
Rejected as firm
does not have the
separate Penicillin
Section.
26. M/s. Medi-Vet
(Pvt) Limited,
Lahore.
Medi-Voc Injection
Each ml contains:-
Ivermectin B.P………..10mg
(Dewormer/ Anthelmintic).
Decontrolled
100ml
250ml
500ml
1000ml
02
years
Deferred as
production of firm
has been stopped
by CLB
27. M/s. Medi-Vet
(Pvt) Limited,
Lahore.
Medi-Dox Plus Solution
Each 100ml contains:-
Tylosine Tartrate B.P
Vet………………..10gm
Doxycycline HCI
B.P……………….20gm
Colistin SulphateB.P…….500,000
IU
Bromhexine HCI
B.P…………………500mg
(Antibiotic/Antibacterial).
Decontrolled
100ml
500 ml
1000ml
02
years
-Do-
129
Case No.2: Change of formulation of already approved veterinary drugs.
M/s. D-Maarson Pharmaceuticals, Islamabad have requested for change of formulation of
their already approved veterinary drugs by the Drug Registration Board in its 237th
meeting held
on 26-02-2013. The registration letters of the drugs have not been issued so far due to new
formulation. Now the firm has requested for change of formulation as per already approved
drugs:-
S.No. Existing Formulation. New Formulation.
1. Col-Plus Oral Liquid
Each 100 ml contains:-
Florfenicol……15gm.
Colistin Sulphate … 50 MIU
Col-Plus Oral Liquid
Each 100 ml contains:-
Florfenicol…… 20gm
2. Coli En Liquid.
Each 100ml contains:-
Enrofloxacin ……10gm.
Colistin sulphate…. 55 MIU
Coli En Liquid.
Each 100ml contains:-
Enrofloxacin ……..20gm
Colistin sulphate …50 MIU
Decision: Request of the firm was acceded by the Board.
Case No.3: Change of manufacturing site of registered imported drug
M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the change
of manufacturing site of their registered imported drug namely “Galvus Tablets 50mg (Reg.
No.059038)” from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis
Farmaceutica S.A., Spain.
M/s. Novartis Pharma (Pakistan) Limited, Karachi have deposited required fee
Rs.50000/= (Pages 44-45/Corr) and submitted following supporting documents:-
i) Copy of registration letter.
ii) Original legalized EMA CPP of new manufacturing site.
iii) Copy of NOC for CRF.
iv) Registration of the drug is valid.
Decision:
The board after detailed discussion approved the change in manufacturing site of
Galvus Tablets from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis
130
Farmaceutica S.A., Spain. The Board advised to deposit balance fee as per revised fee
schedule and site master file of new manufacturing site.
Registration-II
Case No.4 Deferred cases.
a. Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi
Following product of M/s Adamjee Pharmaceuticals, Karachi was deferred for review the
case after submission of balance fee, GMP of source, COA and stability data by the Expert
Committee of Registration Board in its 237th
meeting.
Name of Drug & Composition Pack size Demanded
MRP
Papazole Capsule
Each capsule contains:-
Pantoprazole sodium sesquihydrate
equivalent to Pantoprazole…………….40mg
(Selective inhibitor of Cyclic Guanosine
Monophosphate)
2x7’s As Per SRO
Now the firm has requisite information as under:-
i) Pantoprazole Pellets will be import from M/s Glukem Pharmaceuticals (Pvt.) Ltd,
Plot No. 205/2A, First Floor, IDA, Phase-II, Cherlapally, Hyderabad, Andhra
Pradesh, India
ii) GMP Certificate of bulk import source issued on 23-07-2012 valid for one year.
iii) Certificate of Analysis
iv) Stability data (Accelerated i.e 400C / 75% RH and long term studies i.e 25
0C /
65% RH)
v) Balance fee Rs.240,000/-
Decsion: Regsitartion Board approved firm’s request. However, the Borad advised to
provide valid GMP certicate or identify another manufacturer and submit its relevant
documents and authorized its Chairman to accord approval for issuance of regiatration
letter.
131
b) M/s Abbott Laboratories, Karachi
The Registration Board in 237th
meeting deferred registration of following drug of M/s
Abbott Laboratories, Karachi reason mentioned in last column.
S.
No
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Decision
1 Klaricid-DS Granules
Each 5ml contains:
Clarithromycin 250 mg
(Antibiotics)
60ml Rs.630/- 16-06-2011
Dy.No.1601
Form-5
Rs.8000/-
Rs.12000/-
12-10-2012
Rs.40,000/-
29-1-2013
Sub-Committee
decided to review
the case after
submission of
balance fee, GMP
of source, COA and
stability data
M/s Abbott Labs, Karachi has now furnished the following documents:-
i) GMP Certificate of API source M/s Ranbaxy Laboratories Ltd, Industrial Area
No.3 A.B. Road, Dewas 455 001 (MP), India issued on 15-02-2013 valid till 15-
01-2015.
ii) Certificate of Analysis
iii) Stability data (only long term studies for 36 months at 250C / 60% RH)
iv) Remaining fee Rs.240,000/- for each product for the purpose.
Decsion: Regsitartion Board approved Klaricid-DS Granules for registration
with source of pellets mentioned above.
c) M/s PharmEvo (Pvt.) Ltd, Karachi
The Registration Board in 227th
meeting deferred following product of M/s PharmEvo
Pakistan, Karachi
132
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Decision
Acrova Tablet
Each tablet contains:-
Rivaroxaban ……..10mg
(Anti thrombotic agent)
7’s
14’s
Rs.1200.00
Rs.2400.00
Deferred for
confirmation of
formulation
Later on scrutiny of registration data reveals that the above formulation is already
approved in 238th
meeting of Registration Board for M/s Getz Pharma, Karachi under the brand
name “Xalto Tablets 10mg”.
Decsion: Regsitartion Board approved Acrova Tablet for registration.
d) Pharmatec Pakistan (Pvt.) Ltd, Karachi.
Following product of M/s Pharmatec Pakistan, Karachi was deferred, for submission of
application of Form-5D with balance fee, by the Expert Committee of Registration Board in its
237th
meeting.
Name of Drug & Composition Pack size Demanded
MRP
Maltofer Fol Syrup
Each 5ml contains:
Iron as iron (III) hydro oxide
ploymaltose………..….100 mg
Folic acid…………….400 mcg
(Supplementation and treatment of ID and
IDA)
150ml As per PRC
Now the firm has furnished registration application on Form-5D along with remaining fee
Rs.90,000/-. The firm has also submitted the justification for the proposed syrup dosage form
that it has better compliance and tolerability.
133
Decision: Registration Board deferred request for PSI by Director DTL, Karachi and
area FID. Moreover, case will be referred to Head, dept of Gynacology, FGSH, PIMS and
RGH.
e) M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi
The firm M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi had applied for the
registration of the below mentioned formulation, which was considered in the 237th
meeting of
the Registration Board and deferred for reason recorded in the last column:
S.
No.
Name of
applicant(s)
Name of drug(s) Decision
1. M/s Amarant
Pharmaceuticals ,
Karachi
Cycline 250mg Capsule
Each capsule contains:
Cycloserine……250mg
(A broad spectrum
antibiotic)
Deferred for
confirmation of
manufacturing
facility.
Now the firm has submitted that they have the facility for manufacture of the said
formulation i.e., Capsule (General) section and that a number of firms are manufacturing the
same product in Capsule (General) section.
Decision: Registration Board approved Cycline 250mg Capsule for registration.
f) M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, Karachi
The Registration Board in its 229th
meeting deferred following products of
M/s Pakistan Pharmaceutical Products, Karachi for the reasons mentioned in last column.
S.
No.
Name of drug(s) & Formulation Pack
size
MRP Reason
1. Pilot Suspension 125mg/5ml Rs.11.25 / Deferred for panel
inspection to
134
Each 5ml contains:-
Cefadroxil ………….….125mg
(Antibiotics)
5ml evaluate GMP
compliance & track
record
2. Pilot Suspension 250mg/5ml
Each 5ml contains:-
Cefadroxil …………….250mg
(Antibiotics)
Rs.20.83 /
5ml
-do-
3. Pilot Capsule 500mg
Each capsule contains:-
Cefadroxil …………...500mg
(Antibiotics)
Rs.25.75
(Per
capsule)
-do-
Now, the firm has submitted product specific inspection report dated 28-02-2011 of panel
constituted by the Registration Board in its 227th
meeting and routine GMP inspection dated 13-
02-2013 conducted by the area FID. Where the FID has mentioned in inspection report that firm
has concerned Cephalosporin Oral Dry Syrup and Capsule Sections and concluded as follows:-
“ based on the areas inspected, the people met and the documents
reviewed , and considering the findings of the inspection of M/s Pakistan
Pharmaceutical Products, site was considered to be operating at good
level of compliance with GMP guidelines as per Drugs Act, 1976 and
rules framed there under”
Decision: Registration Board deferred request for PSI by Director DTL, Karachi and
area FID.
g) M/s Aventis Pharma, Karachi – Claforan 2.0gm Injection
The Registration Board in 237th
meeting deferred following application of M/s Aventis
Pharma, Karachi for reason recorded in last column.
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
Decision
135
& Form
Claforan 2.0g Injection
Each vial contains:-
Cefotaxime as
Sodium ….2gm
(Antibiotics)
Per vial Rs.550.43 19-05-2011
1257
Form-5
Rs.8000/-
Rs.72,000/-
29-1-2013
Deferred for
approval by
USFDA, EMA,
regulatory body of
Japan & Australia.
Now the firm has submitted that the above formulation is already registered for several firms
including M/s Alina Combine, Karachi under the brand name “ Hexime Injection 2gm” Reg.
No.012814 and M/s P.D.H Pharmaceuticals, Karachi under the brand name of “Cephronate
Injection” Reg. No.019699. The said formulation has also been approved by USFDA, MHRA &
Regulatory Body of Australia.
Decision: Registration Board approved Claforan 2.0g Injection for regsitration.
h) M/s Macter International, Karachi
The Registration Board in 237th
meeting deferred registration of following drug of M/s
Macter International, Karachi reason mentioned in last column.
S.
No
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No.
& Form
Decision
1 Itoguard OD 150mg
Capsule
Each capsule contains:
Itopride hydrochloride
(as sustained release
pellets)……….150 mg
(Gastro kinetic)
10’s
14’s
20’s
30’s
Rs.33/-
Per Cap.
06-09-2012
1515
Form-5
Rs.8000/-
Rs.52,000/-
23-1-2013
The Sub-
Committee decided
to review the case
after submission of
balance fee, GMP
of source, COA and
stability data
M/s Macter International, Karachi have now furnished the following documents:-
i) Certificate of Analysis
136
ii) Comparative Dissolution Method
iii) GMP Certificate of source M/s Spansules Formulation, India
iv) Stability study data
v) Fee Rs. 300,000/- for the purpose.
Decision: Registration Board approved Itoguard OD 150mg Capsule for regsitration.
i) M/s Amarant Pharmaceuticals, Karachi
The Registration Board in 228th
meeting deferred for expert opinion the registration of
following drug of M/s Amarant Pharmaceuticals, Karachi
S.
No
Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
1 Amprexa-F Capsules 6/25mg
Each capsule contains:-
Olanzapine …………..…6mg
Fluoxetine HCl ……….25mg
As per
SRO
As per SRO
Later on scrutiny of registration data reveals that the above formulation is already registered for
M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg.
No.073778.
Decision: Registration Board approved Amprexa-F Capsules 6/25mg for regsitration.
j) M/s Nabiqasim Industries, Karachi
The Registration Board in 237th
meeting deferred for confirmation of Me-Too status the
registration of following drug of M/s Nabiqasim Industries, Karachi
S.
No
Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
1 Co-Dep 6/25 Capsule 10’s As per PRC
137
Each capsule contains:
Olanzapine ……………6 mg
Fluoxetine HCl………..25 mg
(Anti psychotropic)
14’s
20’s
30’s
2 Co-Dep 3/25 Capsule
Each capsule contains:
Olanzapine ……………3 mg
Fluoxetine HCl………..25 mg
(Anti psychotropic)
10’s
14’s
20’s
30’s
As per PRC
Later on scrutiny of registration data reveals that the above formulation is already registered for
M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg.
No.073778 & Lanzif 3/25mg Capsule, Reg. No.073777
Decision: Registration Board approved above products for regsitration.
Case No.3 BULK IMPORT AND LOCAL REPACKING – M/S
GLAXOSMITHKLINE PAKISTAN LTD, KARACHI
M/s GlaxoSmithKline Pakistan Ltd, Karachi has requested for grant of permission for
bulk import from parent UK source and local repacking in limited quantity i.e 04 million tablets
in divided shipments of Zinacef 250mg, Reg. No.011340 containing Cefuroxime to avoid any
shortages in local market due to extension and renovation of their Cephalosporin facility at
Korangi Factory (DML No.000248).
Firm has also deposited fee Rs.100,000/- for the purpose.
Decision:
Registration Board deferred firm’s request and advised to provide following
documents for decision:
a. Renovation plan with time lines duly approved by manitenace department of the
firm and confirmation by licensing section, DRAP.
b. Manufacturing status of other products in same section.
138
c. Legalized COPP for proposed manufacturer.
d. Form 5.
Case No.4 Change of Formulation
a) M/s Noa Hemis Pharmaceuticals, Karachi
M/s Noa Hemis Pharmaceuticals, Karachi has requested for change of formulation of
following registered drug. Existing and proposed formulations are as under.
S.
No
Reg.
No.
Previous formulation Proposed formulation
01 032179 Mucof Syrup
Each 100ml contains:-
Ephedrine HCl …………...100mg
Chlorpheniramine Maleate.100mg
Terpinhydrate…………….200mg
Pot. Bicarbonate …………...2mg
Ammonium Chloride…….500mg
Tr. Senega ………………..1.0ml
Menthol …………………..20mg
Bromhexine HCl ………….20mg
Pot. Guaicol Sulph ……….100mg
Pot. Citras ………………..…2mg
Tr. Ipecac …………………0.5ml
Ext. Glycyrrhiza Liq. ……….2ml
Mucof Syrup
Each 5ml contains:-
Chlorpheniramine Maleate…5mg
Terpinhydrate…………….10mg
Pot. Bicarbonate ………...0.1mg
Ammonium Chloride…….25mg
Menthol …………………..1mg
Aminophylline Ph Eur …….32mg
Pot. Guaicol Sulph ……….5mg
Pot. Citrate ………………..0.1mg
Flavour & Base ……………q.s
Firm has submitted that proposed formulation is already registered in fvaour of M/s CCL
Pharmaceuticals, Lahore i.e Pulmonol Syrup, Reg. No.000874. Firm has also furnished new
form-5 along with requisite fee Rs.20,000/- for the purpose.
139
Decsion: Registration Board deferred firm’s request for PSI by Director DTL,
Karachi and DDG (E&M), Karachi.
Case No.5 Registration for export purpose containing controlled drugs
M/s Amarant Pharmaceuticals, Karachi and M/s Pharmatec Pakistan, Karachi has
requested for registration of following drugs for export purpose only:-
S. No. Name of
Manufacturer(s)
Name of drug(s) & Composition
1 M/s Amarant
Pharma, Karachi
Amalor-D Tablet
Each tablet contains:-
Loratadine ……………..5mg
Pseudoephedrine HCl ….60mg
2 M/s Pharmatec
Pakistan, Karachi
Flu-Gone Day and Night Capsule (Combi Pack)
Each combi pack contains:-
Each day-time capsule contains:- (Strip-1)
Paracetamol ……………….400mg
Psedoephedrine HCl …….. 30mg
Caffeine Anhydrous ………30mg
Each night-time capsule contains:- (Strip-2)
Paracetamol ……………….400mg
Psedoephedrine HCl …….. 30mg
Cetirizine (as Dihydrochloride)..10mg
Dextramethorphan HBr ……..10mg
140
Decision: Committee on allocation of controlled Drug has already conveyed that
Registration Board may take decision according to its rules. Thus Board approved firm’s
request. Matter regarding allocation of quota will be dealt by Committee on allocation of
controlled Drug accordingly.
Case No. 6 De-Registration of registered drugs.
Following manufacturers have requested for de-registration of their registered drugs.
Details are as under:-
S.
No.
Name of
applicant(s)
Reg. No. Name of drug(s) Reason /
Justification
1. M/s Bosch Pharma,
Karachi
050507 Telocin 400mg Tablet
Each film coated tablet
contains:
Telithromycin……400mg
Not interested
in
manufacturing
and marketing
2. -do- 030606 Arbel 50 tablets
Each tablet contains:-
Losartan Potassium
…50mg
-do-
3. M/s Tabros
Pharma, Karachi
004088 Paracetamol Compound
Tablets
(Paracetamol + Aspirin)
Not mentioned
4. -do- 004175 Sulphadiazine Tablets
(Sulphadiazine)
-do-
5 -do- 004173 Sulphadimidine Tablets
(Sulphadiamidine)
-do-
Decsion: Registration Board de-registered above products. However, the Board
advised firm to provide undertaking for not pending any case at any forum.
141
Case No.7 Request for withdrawal of registration application – M/s AsianContinental
(Pvt.) Ltd, Karachi
M/s AsianContinental (Pvt.) Ltd, Karachi has requested for withdrawal of their
registration application i.e Extrac Plus Tablets, containing Clopidogrel …75mg +
Aspirin…..75mg submitted on August, 2010.
Decsion: Registration Board approved firm’s request for withdrawl of above
regsitartion application (Extrac Plus Tablets).
Case No.8 Correction in minutes
a) M/s High-Q, Karachi
Following product of M/s High-Q, Karachi was considered in the 236th
meeting of the
Registration Board.
Pirokeu 20mg tablet
Each tablet contains:
Piroxicam Betacyclodextrin eq. to Piroxicam ….. 20mg
(NSAID)
The aforementioned registration application was referred to the committee comprising
Prof. Dr. Rafi-uz-Zaman Saeed-ul-Haq, Member Registration Board, DDC (Reg-II), and DDG
Reg. However, in the minutes of the said subcommittee meeting, the above mentioned product
was erroneously approved as “Piroxicam 20 mg tablet” instead of “Piroxicam Betacyclodextrin
20mg tablet” and the registration letter has not been issued. The firm has now requested that the
registration may be granted with the correct formulation.
Decsion: Request of firm for correction as Piroxicam Betacyclodextrin 20mg
tablet approved by the Board.
b) M/s Getz Pharma, Karachi
The Registration Board in its 238th
meeting had considered registration application file in
Month of May & June, 2010. However, the following registration application of M/s Getz
Pharma, Karachi was erroneously not included in Agenda of 238th
meeting. Details of the case
are as under:-
142
S. No.
Name of drug(s) &
Composition
Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Remarks
1. Trizid MR Tablets 35mg
Each film coated tablet
contains:-
Trimetazidine
Dihydrochloride……35mg
(Anti-anginal)
20’s
30’s
Rs.300.00
Rs.450.00
19/05/2010
Dy. No. 1013
Form 5
Rs. 8000/-
Rs.12,000
20-2--2013
Comparative
dissolution
profile with
originator
brand and
related
documents
Decsion: Registration Board deferred firm’s request for submission of comparative
dissolution profile with brand leader.
Case No.9 Transfer of registration from import to local toll manufacturing
M/s High-Q International, Karachi has informed that following drugs are registered for
import in finished form. Now they have intend to transfer the registration from import to local
manufacturing under contract manufacturing arrangements as mentioned against each. Details
are as under:-
S.
No.
Reg.
No.
Name of Drug(s)
Existing Import
Manufacturer(s)
Proposed Contract
Manufacturer (s)
1 045616 Ruling Injection 40mg
Each vial contains:-
Omeprazole
(as Sodium) ….40mg
M/s Hainan
Lingkang
Pharmaceutical Co.,
Ltd., China
(Bulk Import and
Local repacking)
M/s Nabiqasim
Industries, Karachi
2 018501 Remethan Injection
75mg
Each 3ml contains:-
Diclofenac
Sodium………….75mg
M/s Shin Poong
Pharmaceutical Co
Ltd, Seoul Korea
M/s Surge Labs,
Sheikhupura
3 019467 Cycin 100mg / 50ml
Injection I.V/ I.M
Each vial contains:-
Ciprofloxacin ..100mg
M/s Shin Poong
Pharmaceutical Co
Ltd, Seoul Korea
M/s Surge Labs,
Sheikhupura
4 019468 Cycin 200mg/100ml M/s Shin Poong M/s Surge Labs,
143
Injection I.V/ I.M
Each vial contains:-
Ciprofloxacin ..200mg
Pharmaceutical Co
Ltd, Seoul Korea
Sheikhupura
5 022645 Hizone Injection
250mg IM
Each vial contains:-
Ceftriaxone as
Sodium………250mg
M/s Shin Poong
Pharmaceutical Co
Ltd, Seoul Korea
(Bulk import and
local repacking)
M/s Surge Labs,
Sheikhupura
6 018300 Hizone Injection 1gm
IV
Each vial contains:-
Ceftriaxone as
Sodium………1gm
M/s Shin Poong
Pharmaceutical Co
Ltd, Seoul Korea
(Bulk import and
local repacking)
M/s Surge Labs,
Sheikhupura
7 014947 Cefapezone Injection
1gm
Each vial contains:-
Cefoperazone
Sodium………..1gm
M/s Shin Poong
Pharmaceutical Co
Ltd, Seoul Korea
(Bulk import and
local repacking)
M/s Surge Labs,
Sheikhupura
8 015589 Fugacin Tablets
Each film coated tablet
contains:-
Ofloxacin ……..200mg
M/s Shin Poong
Pharmaceutical Co
Ltd, Seoul Korea
M/s High-Q
Pharmaceuticals,
Karachi
9 019522 Cycin 500mg Tablets
Each tablet contains:-
Ciprofloxacin
HCl………… 500mg
M/s IL Dong
Pharmaceutical Co.
Ltd, Korea
M/s High-Q
Pharmaceuticals,
Karachi
10 019523 Cycin 250mg Tablets
Each tablet contains:-
Ciprofloxacin
HCl………… 250mg
M/s IL Dong
Pharmaceutical Co.
Ltd, Korea
M/s High-Q
Pharmaceuticals,
Karachi
Firm has furnished following information to support their request.
Registration dossier on Form -5.
Original consent of M/s Nabiqasim Industries (Pvt.) Ltd, Karachi (page12/Corr) and M/s
Surge Laboratories, Sheikhupura & M/s High-Q Pharmaceuticals, Karachi
144
Contract manufacturing agreement with M/s Nabiqasim Industries (Pvt.) Ltd, Karachi
and M/s Surge Laboratories, Sheikhupura (page 26/Corr) & M/s High-Q
Pharmaceuticals, Karachi
Copy of Registration letters & Renewal
Fee of Rs.50,000/- for each product for the purpose.
Decision: Registration Board deferred firm’s request till next meeting for detailed
delibrations in light of contract manufacturing policy.
Case No.10 Extension in contract manufacturing permission.
The Registration Board in its 238th
meeting had considered case for extension in contract
manufacturing permissions. However, the following case of M/s Sami Pharmaceuticals, Karachi
was erroneously not included in Agenda of 238th
meeting. Details of the case are as under:-
S.
No.
Applicant Contract
manufactur
er
Reg. No. Name of drug(s) &
Composition
Date of
applicatio
n, Diary
No. &
Form
Category
1. M/s Sami
Pharma,
Karachi
M/s
Healthek
Pvt. Karachi
037541 Oroxim 100mg Film
Coated Tablets
Each film coated
tablet contains:
Cefpodoxime proxetil
eq. to
cefpodoxime..100 mg
15-04-
2013
Dy.No.13
5
Form-05
Rs.50,000/
-
Dedicated
facility
Cephalosp
orin
Decsion: Registration Board extended above product till 30.06.2015.
145
Case No.11: Fast track registration scrutinized by evaluators.
S.N
o
Name of manufacturer
Name of drug with
composition
Pack size
Demanded price
Date Remarks
1. M/s. Ferozsons Labs, Nowshera
Valiant-M Tablets’
Each film coated tablet
contains:-
Vildagliptin………….50
mg
Metformin HCl…..850
mg
(Ant-diabetic)
10’s 30’s
As Per SRO
24-4-
2013 Recommended
2. -do- Valiant-M Tablets’
Each film coated tablet
contains:-
Vildagliptin……………
…….50 mg
Metformin
HCl………...1000 mg
(Ant-diabetic)
10’s 30’s
As Per SRO
-do- Recommended
3. M/s. Winbrain Research
Laboratories, Hattar
Toll manufactured
by M/s. Weather Fold
Pharmaceutical, Hattar
Cefwell 250mg Injection
IM
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone………..250
mg
(Anti-infective)
Per Vial
As Per SRO
22-5-
2013 The products are
recommended if manufacturer is
already producing
the same drugs as
it is an
application of toll
manufacturing
and not
manufacturing by
M/s. Winbrain.
Note:- Weather
Fold is already
having approved
section for
production of
Cephalosporin
Injection and
registered
product as well.
4. -do- Cefwell 500mg Injection
IM
Each vial contains:-
Ceftriaxone Sodium
Per Vial
As Per SRO
-do- -do-
146
≡ Ceftriaxone………..500
mg
(Anti-infective)
5. -do- Cefwell 1gm Injection
IM
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone………..1gm
(Anti-infective)
Per Vial
As Per SRO
-do- -do-
6. M/s. Shazeb
Pharmaceutical
s, Distt
Haripur
Zeesol-5% I.V Infusion
Each 100ml contains:-
Dextrose Anhyrous……..5
gm
(Caloric solution)
100ml As Per
SRO
13-5-2013 No Batch Size
description
Batch cycle
Sterilization
Cycle
Source of Raw
Materials
Testing of Raw
Materials
Price Paper /
Comparison of
Dextrose 5%
Not
recommended.
Shortcoming
rectified 7. -do- Zeesol-NS O.V Solution
Each 100ml contains:-
Sodium
chloride……….0.9 gm
(Electrolyte)
100ml As Per
SRO
-do- No Batch Size
description
Batch cycle
Sterilization
Cycle
Source of Raw
Materials
Testing of Raw
Materials
Price Paper /
Comparison of
Dextrose 5%
Not
recommended.
Shortcoming
rectified 8. -do- Zee Hesta 3%
Each 1000ml contains:-
500ml As Per
SRO
-do- Check
Hydroxyethyl
147
Hydroxyethyl
Starch………30 gm
Sodium
Chloride…….……9 gm
(Plasma Substitute)
Standards
Not
recommended.
Shortcoming
rectified 9. -do- Zee Haemagel I.V
Infusion
Each 1000ml contains:-
Degraded gelatin
Polygeline) of average
molecular weight…….35
g
Sodium
Chloride….….…..8.50 g
Potassium
Chloride….……0.7 g
Calcium
chloride…….....0.38 g
(Plasma Substitute)
500ml As Per
SRO
-do- Not
recommended.
The firm has
informed that they
can’t rectify
immediately
therefore thye
requested to
postpone till next
DRB meeting.
10. M/s. Bloom Pharmaceuticals
, Hattar
Darcin-250mg Capsules
Each capsule contains:-
Azithromycin dihydrate)
≡ Azithromycin……..….250
mg
(Macrolide)
1x6’s As Per
SR
16-5-
2013 Method of
Manufacturing
Detail required for
>45% humidity
and >30 C
temperature.
Method of
Analysis
Method (Limits) are
for Doxycycline
Hyclate.
Method 2
Is
spectrophotometer
method but in detail
is given
Chromatograph
Specification.
Clinical
Indication Vogue.
03 years shelf
life
Stability Studies
not given
Type of Mixer
(Bottle Mixer)
148
not clear.
Not
recommended.
Shortcoming
rectified
11. M/s. Genome Pharmaceutical
s, Hattar
Ibufam Tablets
Each film coated tablet
contains:-
Ibuprofen………..800
mg
Famotidine……..26.6 mg
(NSAID/H2-receptor)
10’s As Per SRO
2-5-
2013 Dual core tablet
machine
unavailable. To
be deferred.
Outline of
method of
manufacture
does not
contains the
coating process.
However, in
detailed
procedure it has
been given in
general.
IPA is
inflammable
substance.
Safety measures
for tray drawing
of materials
containing IPA
has not been
provided.
Specification of
sodium starch
glycolaed have
been provided in
dossier but the
material is not
reflecting in the
composition of
drug.
Recommended
with above
corrections.
149
12. M/s. Onyx Pharmaceutical
s, Mansehra
Sulpride 50mg Tablets
Each tablet contains:-
Levosulpiride………..50
mg
(Antidpressant/Anti-
gastroprokinetics)
1`0’s As Per SRO
20-5-
2013 Minor
shortcoming
rectified.
Decsion: Registration Board decided as follows:
Products at S.No. 1, 2, 6, 7, 10 and 12 approved for registration, as firms have
rectified shortcomings in registration dossiers.
Products at S.No. 3, 4 and 5 deferred for discussion in forthcoming meeting in light
of contract manufacturing policy.
Products at S.No. 8 and 9 deferred for PSI by Director DTL, Peshawar and area
FID. For product at S.No.9, firm will rectify shortcomings as mentioned above.
Products at S.No.11 for correction of shortcomings.
150
Case No.12: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.
Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th
meeting as under:-
Name of the drugs with
composition Pack Size
Proposed Price
Decision
Epipro CR Tablets
Each tablet contains:-
Divalproex Sodium USP……..500mg
(Anti-Epileptics)
5x10’s As per SRO Deferred for submission of comparative
dissolution profile with originator and relative documents.
The firm has submitted comparative dissolution profile of their product EPIPRO CR Tablet with
originator reference product Tablet EPIVAL CR of M/s Abbott Laboratories Pakistan Ltd.
Decision: The Drug Registration Board deferred the case till expert evaluation of
comparative dissolution profile documents by Director DTL Peshawar.
Case No.13: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.
Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th
meeting for confirmation of formulation in developed countries.
Name of the drugs with composition
Pack Size
Proposed Price
Decision
CIP Suspension 10%
Each 5ml contains:-
Ciprofloxacin HCl USP……..500mg
(Anti-Biotic)
60ml
100ml
As per SRO Deferred for confirmation of formulation in
developed countries.
The firm has submitted that the drug is approved by US-FDA with the name of CIPRO for M/s
Bayer Pharmaceuticals Corporation, USA and provided copies of references (approvals / study).
The firm also submitted that the same formulation has been approved in 227th
meeting of DRB
held on 26-27 Aug 2010 for M/s Wilshire Lab. Lahore and Drug Pricing Committee fixed its
price in its 14th
meeting held on 11th
January 2011. It is submitted that ciprofloxacin
microcapsules in base form is used in FDA approved Bayer’s Cipro formulation. Price has also
151
been approved for base form as Microencapsulated Ciprofloxacin eq.to Ciprofloxacin ….500mg,
while in this formulation Ciprofloxacin HCl has been applied.
Decision: The Drug Registration Board deferred the case for confirmation of USFDA
approval of formulation and confirmation of formulation with originator.
Case No.14: Grant of registration-New formulation & fast track.
Following firms have applied following products on Form 5-D as new applications and fast track
fee. Decision is recorded in last column.
S.N
o
Name of
Firm
Name of the drugs with
composition
Pack
Size
Proposed
Price
Date of
Submission
Decision
1. M/s Saffron
Pharmaceut
icals (Pvt)
Ltd,
Faisalabad.
Provate GM Topical Ointment
Each gram contains:-
Betamethasone…0.05% w/w
Gentamicin….0.1% w/w
Miconazole….2% w/w
(cortisteriod/antibiotic/antifungal)
20gm
10gm
Rs.300.00
Rs.150.00
10-7-2013
Rs.60,000/-
05-09-2013
Rs. 90,000/-
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
2. -do- Provate GM Topical Cream
Each gram contains:-
Betamethasone…0.05% w/w
Gentamicin….0.1% w/w
Miconazole….2% w/w
(cortisteriod/antibiotic/antifungal)
20gm
10gm
Rs.300.00
Rs.150.00
10-7-2013
Rs.60,000/-
05-09-2013
Rs. 90,000/-
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
3. M/s
Highnoon
Lab. Ltd.
Lahore
Tagipmet XR 100/1000Tablet
Each bilayered tablet contains:-
Sitagliptin (as
phosphate)…100mg
Metformin HCl (as sustained
release)…1000mg
(Anti-diabetic)
N.A N.A 10-04-13
Rs. 150,000/-
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
152
4. -do- Tagipmet XR 50/500Tablet
Each bilayered tablet contains:-
Sitagliptin (as phosphate)…50mg
Metformin HCl (as sustained
release)…500mg
(Anti-diabetic)
N.A N.A 10-04-13
Rs. 150,000/-
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
5. -do- Tagipmet XR 50/1000Tablet
Each bilayered tablet contains:-
Sitagliptin (as phosphate)…50mg
Metformin HCl (as sustained
release)…1000mg
(Anti-diabetic)
10-04-13
Rs. 150,000/-
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
6. -do- Axesom 10 Sachet
Each Sachet contains:-
Esomeprazole (as Magnesium
trihydrate) …10mg as Gastro-
resistant granules
22-04-13
Rs. 150,000/-
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
7. -do- Ebernet 1% Cream
Each gram contains:-
Eberconazole (as nitrate)….10mg
(anti fungal)
10gm Rs.320.00 21-06-2011
Rs. 8000/-
27-06-2011
Rs. 7000/-
10-7-2013
135000/-
(Total: Rs.
150000/-)
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
8. M/s Servier
Research
and
Pharmaceut
icals (pvt).
Ltd.
Lahore.
Daflon 1g Tablet
Each tablet contains:-
Diosmin… 900mg
Hesperidine …100mg
(Vascular protector and
Venotonic)
20’s Rs.
32.50/table
t
30-04-13
Fee Rs.
150,000/-
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
153
Japan.
9. -do- Natrilam 10mg Tablets
Each tablet contains:-
Indapamide SR…..1.5mg
Amlodapine Besilate…..10mg
(Antihypertensive diuretic +
Calcium antagonist)
30’s Rs.72.52/T
ablet
20-6-2012
Rs.8000/-
30-04-13
Rs. 130,000/-
Total Fee Rs.
150,000/-
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
10. -do- Natrilam 5 mg Tablets
Each tablet contains:-
Indapamide SR…..1.5mg
Amlodapine Besilate…..5mg
(Antihypertensive diuretic +
Calcium antagonist)
30’s Rs.36.26/t
ablet
05-04-2011
Rs.8000/-
30-04-13
Rs. 130,000/-
Total Fee Rs.
150,000/-
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
11. -do- Natrilam 2.5 mg Tablets
Each tablet contains:-
Indapamide SR…..1.5mg
Amlodapine Besilate…..2.5mg
(Antihypertensive diuretic +
Calcium antagonist)
30’s Rs.26.26/t
ablet
05-04-2011
Rs.8000/-
30-04-13
Rs. 130,000/-
Total Fee Rs.
150,000/-
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
12. M/s. CCL
Pharmaceut
icals,
Lahore
OAB Tablets 4mg
Each tablet contains:
Fesoterodine Fumarate …. 4mg
(Muscarinic receptor antagonist)
28’s As per
brand
leader
03.02.2011
Fee 15000
20.05.2013
Fee.135,000
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
154
13. -do- OAB Tablets 8mg
Each ER tablet contains:
Fesoterodine Fumarate …… 8mg
(Muscarinic receptor antagonist)
28’s As per
brand
leader
03.02.2011
Fee 15000
20.05.2013
Fee.135000
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
14. -do- Virata Tablets 90mg
Each tablet contains:
Ticagrelor ………. 90mg
(Platelet inhibitor)
20’s As per
brand
leader
12.01.2012
Fee 15000
20.05.2013
Fee.135000
Form 5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
15. -do- Lina-Met 2.5/500 Tablet
Each tablet contains:
Linagliptin....................2.5mg
Metformin HCI………500mg
14’s As per
brand
leader
08.04.2013
Fee 50000
Fee.100000
20.05.2013
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
16. -do- Lina-Met 2.5/850 Tablet
Each tablet contains:
Linagliptin…....................2.5mg
Metformin HCI…………850mg
14’s As per
brand
leader
08.04.2013
Fee 50000
Fee.100000
20.05.2013
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
17. -do- Lina-Met 2.5/1000 Tablet
Each tablet contains:
Linagliptin ......................2.5mg
Metformin HCI……….1000mg
14’s As per
brand
leader
08.04.2013
Fee 50000
Fee.100000
20.05.2013
Form-5D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
155
18. M/s Neutro
, Lahore
Nupreced Injection
Each 2ml contains:-
Dexmedetomidine
Hydrochloride…200mcg
(Sedative)
2ml Rs. 5500/-
per
ampoule
17-05-13
Fee Rs.
60,000/-+ Rs.
90,000(28-
05-13)
Form5-D
Deferred for
confirmation
of availability
of
formulation
in FDA,
EMA,
Australia and
Japan.
156
Case No.15. Extension in Contract Manufacturing Permissions:
Following cases were considered and decided by the Registration Board in 238th
meeting but erroneously missed in minutes. The
decision of Board is recroded in last column.
157
S.# Name of
Applicant
Name of
Manufacturer
Reg.
No.
Name of Drug with
composition
Date & diary #
& Fee
Category Decision
1. M/s Noble
Pharmaceutical,
Islamabad
M/s EG
Pharmaceutical
Islamabad earlier
approved
manufacturer
was Biorex
Pharmaceutical
Islamabad
023134 Cefodime Injection
Each vial contain:
Ceftazidime……..1gm
15-04-13
Dy.
No.2248R&I
Dy. No. 1356.
DDC(R-III)
Rs.50000/
Rs.8000/-(23-
06-2010)
import to local
contract
manufacturing
Extended till
30.06.2015
2. -do-
-do- 023135 Cefodime Injection
Each vial contain:
Ceftazidime…..250gm
-do- -do-
-do-
3. M/s Focus &
Rulz
Pharmaceutical,
Islamabad
M/s Bio Labs.
(Pvt) Ltd,
Islamabad earlier
approved
manufacturer
was M/s Spadix
Pharmaceutical,
Islamabad
054652 Ruzone Injection 250mg
Each Vial Contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxon…250mg
(USP Specification)
15-04-13
Dy.
No.1251R&I
Rs.20,000/
Dedicated
facility
Cephalosporin
Extended till
30.06.2015. The
firm will deposit
remaining fee &
select IM/IV
4. -do- -do- 054653
`
Ruzone Injection 500mg
Each Vial Contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…500mg
(USP Specification)
-do- -do-
-do-
5. -DO- -do- 054654 Ruzone Injection 500mg
Each Vial Contains:-
Ceftriaxone Sodium
equivalent to
-do -do-
-do-
158
Ceftriaxone…500mg
(USP Specification)
6. -do- -do- 054655 Trag Injection 250mg
Each Vial contains:-
Cefotaxime sodium
equivalent to
Ceftotaxime…250mg
-do- -do-
Extended till
30.06.2015. The
firm will deposit
remaining fee
7. -do- -do- 054656 Trag Injection 500mg
Each Vial contains:-
Cefotaxime sodium
equivalent to
Ceftotaxime…500mg
-do- -do-
-do-
8. -do- -do- 054657 Trag Injection 500mg
Each Vial contains:-
Cefotaxime sodium
equivalent to
Ceftotaxime…500mg
-do- -do-
-do-
9. M/s Medley
Pharmaceutical,
Plot 41-A, P.S.I.
E. Jhang Bahtar
Road Wah Cantt.
Rawalpindi
M/s Fassgen
Pharmaceutical
Hatter. Earlier
approved
contract
manufacturer
was M/s Neutro
Pharma Hattar
030245 Qsef Injection 250mg
Each vial contain:-
Cefotaxime Sodium eq.
to Cefotxime
…….250mg
15-04-13
Dy. No.2319
R&I
Dy. No.
1358D.D.C(R-
III)
Rs.50000/-
Dedicated
facility
Cephalosporin
Extended till
30.06.2015
10. -do- -do- 030246 Qsef Injection 500mg
Each vial contain:-
Cefotaxime Sodium eq.
to Cefotxime
…….500mg
-do- -do-
-do-
11. -do- -do- 030247 Qsef Injection 1gm -do -do- -do-
159
Each vial contain:-
Cefotaxime Sodium eq.
to Cefotxime
…….1gmmg
12. -do- -do- 030243 Kintrex 500mg Injection
I.V
Each vial contains:-
Ceftriaxone Sodium eq.
to. Cefriaxone….500mg
-do- -do-
Extended till
30.06.2015. the firm
will select either
IM/IV
13. -do- -do- 030244 Kintrex 1gm Injection
I.V
Each vial contains:-
Ceftriaxone Sodium eq.
to. Cefriaxone….1gm
-do- -do-
-do-
14. -do- -do- 030241 Kintrex 500mg Injection
I.M
Each vial contains:-
Ceftriaxone Sodium eq.
to. Cefriaxone….500mg
-do- -do-
-do-
15. M/s Goodman
Laboratories,
Islamabad
M/s Spadix
Pharmaceutical
Islamabad.
Earlier approved
contract
manufacturer
was M/s Global
Pharmaceutical
Islamabad
056677 Martazone 250mg IM
Injection
Each vial contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…250mg
(USP Specification)
11-02-13
Dy. No.1497
R&I
Dy. No.
41D.D.C(R-
III)
Rs.20000/-
Extended till
30.06.2015
& Rs.8000/-
(29-09-2010)
Dedicated
facility
Cephalosporin
Extended till
30.06.2015. the firm
will deposit
remaining fee &
slect IM/IV
16. 056678 Martazone 500mg IV
Injection
-do- -do-
-do-
160
Each vial contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…500mg
(USP Specification)
17. 056679 Martazone 1gm IV
Injection
Each vial contains:-
Ceftriaxone Sodium
equivalent to
Ceftriaxone…1gm
(USP Specification)
-do- -do-
-do-
18. M/s Fassgen
Pharmaceutical,
Hattar
M/s Medley
Pharmaceutical,
Wah Cantt.
Earlier approved
contract
manufacturer
was M/s
WelMark
Pharmaceuticals
Hattar
056452 Stigen 0.5mg Injection
Each ml contains:-
Neostigmine
Methylsuphate….0.5mg
(USP specification)
Fee not
deposited
Dy. No. 1378
Dated:09-05-
2013
General
products
Deferred since the
request of firm does
not fall under
present contract
policy & applicant
has to deposit fee.
19. -do- -do- 056453 Traxic 250mg Injection
Each 5ml contains:-
Tranexamic
Acid…..250mg
(B.P Specification)
-do- -do-
-do-
20. -do- -do- 056454 Traxic 500mg Injection
Each 5ml contains:-
Tranexamic
Acid…..500mg
(B.P Specification)
-do- -do-
-do-
21. -do- -do- 056456 Dyronex 500 Infusion -do- -do- -do-
161
Each 100ml contains:-
Metronidazole USP
(USP Specification)
22. -do- -do- 056457 Cebect Infusion 200mg
Each 100ml contains:-
Ciprofloxacin Lactate
eq. to Ciprofloxcin
USP…..200mg
(USP Specification)
-do- -do-
-do-
23. -do- -do- 056458 Vectra 75mg Injection
Each 3ml contains:-
Diclofenac Sodium
…….75mg
(Medley Specification)
-do- -do-
-do-
24. -do- -do- 056459 Pepgen 20mg Injection
Each 2ml contains:-
Famotidine………20mg
(Medley Specification)
-do- -do-
-do-
25. -do- -do- 056461 Suxagen 100mg
Injection
Each 2ml contains:-
Suxamethonium
Chloride BP…..100mg
(Medley Specification)
-do- -do-
-do-
26. -do- -do- 056462 Artegen 80mg Injection
Each 1ml coantains:-
Arthemether………..80
mg
(Medley Specification)
-do- -do-
-do-
27. -do- -do- 056463 Vibra 40mg Injecgion
Each 1ml contain:-
Triamcinolone
acetonide
-do- -do-
-do-
162
BP………40mg
(B.P Specification)
28. -do- -do- 056464 Mecobon 500mg
Injection
Each 1ml Contain:-
Mecobalamine
………500mcg
(Medley Specification)
-do- -do-
-do-
29. -do- -do- 056466 Fasdic Injection
Each 2ml ampoule
contains:-
Diclofenac sodium
75mg
Lidocain HCl…..20mg
(Medley Specification
-do- -do-
-do-
30. -do- -do- 056825 Levotar Infusion 500mg
Each vial contain:-
Levofloxacin (as
hemihydrates)…..500m
g
(Medley specification)
-do- -do-
-do-
31. -do- -do- 056826 Fasicam 20mg Injection
Each 1ml apoule
contains:
Piroxicam USP….20mg
(Medley Specification)
-do- -do-
-do-
32. M/s Danas
Pharmaceutical,
Islamabad
M/s Global
Pharmaceutical,
Islamabad.
Earlier approved
contract
manufacturer
was M/s Florence
045077 Burgundy Igm Injection
Each Vial contain:
Ceftriaxone
(as Sodium)…...1gm
(USP Specification)
15-04-13
Dy. No.2218
R&I
Dy. No.
115D.D.C
(R-III)
Rs.42000/-
Dedicated
facility
Cephalosporin
Extended till
30.06.2015. The
firm will select
IM/IV
163
Islamabad
Rs.8000/-(30-
09-2010)
33. -do- -do 045078 Burgundy 250mg
Injection
Each Vial contain:
Ceftriaxone (as Sodium)
……..250mg
(USP Specification)
-do- -do-
-do-
34. -do- -do- 045079 Burgundy 500mg
Injection
Each Vial contain:
Ceftriaxone (as Sodium)
……..500mg
(USP Specification)
-do- -do-
-do-
35. -do- -do- 045080 Milkish 1gm Injection
Each Vial contain:
Cefepime (as HCl with
L-Arginine)
……..1gm
(USP Specification)
-do- -do-
Extended till
30.06.2015
36. -do- -do- 045081 Milkish 500mg
Injection
Each Vial contain:
Cefepime ( as HCl with
L-Arginine)
……..500mg
(USP Specification)
-do- -do-
-do-
37. -do- -do- 045093 Joop 1gm Injection
Each Vial contains:
Cefoperazone (as
Sodium)……….0.5gm
Sulbactam (as
Sodium)………0.5gm
-do- -do-
-do-
164
(USP Specification)
38. -do- -do- 045094 Joop 2gm Injection
Each Vial contains:
Cefoperazone (as
Sodium)…….1gm
Sulbactam (as
Sodium)……1gm
(USP Specification)
-do- -do-
-do-
39. M/s Benson
Pharmaceuticals
M/s Shawan
Pharmaceuticals,
Islamabad.
Earlier approved
contract
manufacturer
was
M/s Fassgen
Pharmaceuticals,
Lahore
060423 Triben 1gm Injection
I/V
Each vial contains:-
Ceftriaxone Sodium eq.
to Ceftriaxone …..1gm
(USP Specs.)
Dy. No. 2274
R&I 15-04-13
Dy. No.1168
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
Dedicated
facility
Cephalosporin
Extended till
30.06.2015. The
firm will select
either IM/ IV
40. 060424 Triben 500mg Injection
I/V
Each vial contains:-
Ceftriaxone Sodium eq.
to
Ceftriaxone………..500
mg
(USP Specs.)
Dy. No. 2275
R&I 15-04-13
Dy. No.1176
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
-do-
-do-
41. 060425 Triben 250mg Injection
I/V
Each vial contains:-
Ceftriaxone Sodium eq.
to Ceftriaxone...250mg
Dy. No. 2283
R&I 15-04-13
Dy. No.1167
DDC(R-III)
(22-2-2013)
-do-
-do-
165
(USP Specs.) Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
45. 060426
Benzone 1gm Injection
Each vial contains:-
Cefoperazone (as
Sodium)……..500mg
Sulbactam (as
Sodium)…………500m
g
(USP Specs.)
Dy. No. 559
R&I 22-02-13
Dy. No.1169
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
-do-
Extended till
30.06.2015.
46. 060427 Benzone 2gm Injection
Each vial contains:-
Cefoperazone (as
Sodium)……..1gm
Sulbactam (as
Sodium)…………1gm
(USP Specs.)
Dy. No. 2280
R&I 15-04-13
Dy. No.1170
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
-do-
-do-
47. 060428 Benpime 1gm Injection
Each vial contains:-
Cefepime (as HCl)
…….1gm
(USP Specs.)
Dy. No. 2281
R&I 15-04-13
Dy. No.1171
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
-do-
-do-
166
(15-4-2013)
48. 060429 Benpime 500mg
Injection
Each vial contains:-
Cefepime (as HCl)
…….500mg
(USP Specs.)
Dy. No. 2276
R&I 15-04-13
Dy. No.1174
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
-do-
-do-
49 053607 Taxiben 250mg
Injection
Each vial contains:-
Cefotaxime (as
Sodium)………250mg
(USP Specs.)
Dy. No. 2282
R&I 15-04-13
Dy. No.1173
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
-do-
-do-
50. 053608 Taxiben 500mg
Injection
Each vial contains:-
Cefotaxime (as
Sodium)………500mg
(USP Specs.)
Dy. No. 2277
R&I 15-04-13
Dy. No.1172
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
-do-
-do-
51. 053609 Taxiben 1gm Injection Dy. No. 2278 -do- -do-
167
Each vial contains:-
Cefotaxime (as
Sodium)………1gm
(USP Specs.)
R&I 15-04-13
Dy. No.1175
DDC(R-III)
(22-2-2013)
Rs.20,000/-
(22-4-2013)&
Rs. 30,000
(15-4-2013)
52. M/s Drugs Inn
Pharmaceutical
Islamabad
M/s EG
Pharmaceutical,
Islamabad.
Earlier approved
contract
manufacturer
was M/s Biorex
Pharmaceutical
Islamabad
022619 Prezone 250mg IM/IV
Injection
Each vial contains:-
Ceftriaxone Sodium eq.
to 250mg Ceftriaxone
Sodium base.
12-04-13
Dr.
No.1060R&I
Dy. No.
1212D.D.C(R-
III)
Rs.42000/-
Rs.8000/-
(23-06-2010)
import to local
contract
manufacturing
Extended till
30.06.2015. The
firm will select
either IM/ IV
53. -do- -do- 023168 Prezone 500mg
Injection
Each vial contains:-
Ceftriaxone Sodium eq.
to 500mg
Ceftriaxone Sodium
base.
-do- -do-
-do-
54. -do- -do- 022654 Prezone 1GM Injection
Each vial contains:-
Ceftriaxone Sodium eq.
to 1gm Ceftriaxone
Sodium base.
-do- -do-
-do-
55. -do- -do- 022694 Kefcef 250mg Injection
Each vial contains:-
Ceftriaxone Sodium eq.
-do- -do-
-do-
168
to 250mg Ceftriaxone
Sodium base.
56. -do- -do- 022695 Kefcef 500mg Injection
Each vial contains:-
Ceftriaxone Sodium eq.
to 500mg Ceftriaxone
Sodium base.
-do- -do-
-do-
57. -do- -do- 022696 Kefcef 1gm Injection
Each vial contains:-
Ceftriaxone Sodium eq.
to 1gm Ceftriaxone
Sodium base.
-do- -do-
-do-
58. -do- -do- 022653 Gencef 1gm Injection
Each Vial contains:-
Ceftotaxim Sodium eq.
to 1gm Cefotaxime
Sodium base.
-do- -do-
Extended till
30.06.2015.
59. M/s Well Care
Pharmaceutical,
A/7 P.S.I.E
Sargodha
M/s Fassgen
Pharmaceutical
Hatter.Earlier
approved
contract
manufacturer
was M/s Neutro
Pharmaceutical
Lahore.
060808 Carewel 250mg
Injection
Each injection contains:
Ceftriaxone sodium eq
to Ceftriaxone
U.S.P……50mg.
15-04-13
Dr. No.2314
R&I
Dy. No.
1363D.D.C(R-
III)
Rs.50,000/-
Dedicated
facility
Cephalosporin
Extended till
30.06.2015. The
firm will select
either IM/ IV
.
60. -do -do- 060809 Carewel 500mg
Injection
Each injection contains:
Ceftriaxone sodium eq
to Ceftriaxone U.S.P…
500mg
15-04-13
Dr. No.2314
R&I
Dy. No.
1356D.D.C(R-
III)
Rs.50,000/-
-do-
-do-
169
61. -do -do- 060810 Carewel 1gm Injection
Each injection contains:
Ceftriaxone sodium eq
to Ceftriaxone
U.S.P…….1gm
-do- -do-
-do-
62. M/s Salus
Pharmaceutical
Rawalpindi
M/s Warafana
Pharmaceutical
Islamabad
021057 Salxone 0.25gm
Injection
Each Vial Contains:
Ceftriaxone Sodium
Eq. to Ceftriaxone
….0.25gm
19-12-11
Dy. No.993
R&I
Dy. No.
1415D.D.C(R-
III)
Rs.50,000
import to local
contract
manufacturing
Extended till
30.06.2015. The
firm will select
either IM/ IV.
.
63. -do- 021058 Salxone 1gm Injection
Each Vial Contains:
Ceftriaxone Sodium
Eq. to Ceftriaxone
….1gm
19-12-11
Dy. No.993
R&I
Dy. No.
1416D.D.C(R-
III)
Rs.50000
-do- -do-
64. -do- 021059 Salxone 0.5gm Injection
Each Vial Contains:
Ceftriaxone Sodium
Eq. to Ceftriaxone
….0.5gm
19-12-11
Dy. No.993
R&I
Dy. No.
1417D.D.C(R-
III)
Rs.50000
-do- -do-
170
Case No.16. Correction in minutes of 238th
meeting.
a. Grant of registration-Vetrenary Drugs:
S. # Name of
Applicant
Name of Drug(s)/Composition Price/Pack
Size
Shelf
Life
Decision
recoded in
238th
meeting
Correct
Decision
1. M/s. Noble
Pharma, Mir Pur
Azad Kashmir.
Nobiaminox Injection
Each ml contains:-
Novaminsulfon……..40.00mg
Etilefrin……………...0.20mg
Calcium Gluconate……..100.00mg
Magnesium Gluconate…..10.00mg
Nicotinamide……..….0.03mg
Caffeine………….…10.00mg
Sodium Salicylate………...7.00mg
Boric Acid………….10.00mg
(Electrolytes)
Decontrolled
100ml
200ml
450ml
500ml
1000ml
02
years
Deferred for
application
on Form 5 D
along with
revised Fee.
Approved
However the
Registration
Board
advised the
registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters.
2. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Adeka Injection
Each 1ml contains:-
Vitamin A………..100000 IU
Vitamin D3………40000 IU
Vitamin E………..40mg
(Nutritional Supplement).
Decontrolled
50ml
100ml
02
years
-Do- -Do-
3. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Genin Injection
Each 1ml contains:-
Tylosin Tartrate………..100mg
Gentamycin Sulphate….50mg
(Antibiotic).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
4. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Genak-10 Injection
Each 1ml contains:-
Gentamycin Sulphate…100mg
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
171
(Antibiotic).
5. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Ectin Injection
Each 1ml contains:-
Ivermectin…………10mg
(Anthelemtic).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
6. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Fenak Injection
Each 1ml contains:-
Ketoprofen…………100mg
(NSAID).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
7. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Folak Injection
Each 1ml contains:-
Florfenicol…………300mg
(Antibiotic).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
8. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Tine-20 Injection
Each 1ml contains:-
Tylosin Tartrate……..200mg
(Antibiotic).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
9. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
Rofox-10 Injection
Each 1ml contains:-
Enrofloxacin……….100mg
(Antibiotic).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
10. M/s. A & K
Pharmaceutical,
Sargodha Road,
Faisalabad.
FMO Injection
Each 1ml contains:-
Oxytetracycline BP………..300mg
Flunixine Meglomine USP..20mg
(Antibiotic).
Decontrolled
10ml
20ml
50ml
100ml
02
years
-Do- -Do-
172
b. Grant of registration-Human drugs:
S. # Name of
Applicant
Name of Drug(s)/Composition Price/Pack
Size
MRP Decision
recoded in
238th
meeting
Correct
Decision
1 M/s. Saaaf
Pharmaceuticals,
Risalpur.
Heap Syrup
Each 5ml contains:-
Iron (III) polymaltose complex eq. to
elemental iron ………50mg
Folic Acid……………0.35mg
(Heamatinic)
120ml As Per
SRO
Deferred for
fee
Approved
The
Registration
Board
advised the
Registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
Domprid Suspension
Each 5ml contans:-
Domperidone……….5mg
(Antidopaminergic)
60ml
120ml As Per
SRO
-Do- -Do-
Zinc Saf Suspension
Each 5ml contains:-
Zinc Sulphate ……….20mg
(Antidiarroeals)
60ml
120ml As Per
SRO
-Do- -Do-
Diasaf Plus Suspension
Each 5ml contains:-
Metronidazole……………75mg
Furazolidone……………..25mg
(Amobecide)
60ml
120ml As Per
SRO
-Do- Deferred for
review of
formulation by
review
committee
Losaf Suspension
Each 5ml contains:-
Loratadine…………5mg
(Antihistamine)
60ml
120ml As Per
SRO
-Do- Approved
The
Registration
Board
advised the
Registration
sections to
again review
the
Registration
Dossiers
before
issuance of
Registration
letters
173
c. Registration Board in 238th
meeting extended following contract manufacturing permissions for Khos Pharma, Hyderabad. But
scrutiny of record revealed that these products are registered for M/s Treat Pharma, Bannu. Correct details are as follows:
M/s Treat
Pharma, Bannu
M/s Mediate
Pharmaceuticals,
Karachi
073248 K-Xime Suspension
Each 5ml contains:
Cefixime……….200 mg
15-04-2013
DyNo.229
Form-05
Rs.42,000/-
Rs.8000/-
18.08.2011
Dedicated
facility
Cephalosporin
Extended till 30.06.2015.
-do- -do- 073247 K-Xime Suspension
Each 5ml contains:
Cefixime……….100 mg
15-04-2013
DyNo.229
Form-05
Rs.42,000/-
Rs.8000/-
18.08.2011
Dedicated
facility
Cephalosporin
Extended till 30.06.2015.
-do- -do- 073246 K-Xime Capsule
Each capsule contains:
Cefixime……….400 mg
15-04-2013
DyNo.229
Form-05
Rs.42,000/-
Rs.8000/-
18.08.2011
Dedicated
facility
Cephalosporin
Extended till 30.06.2015.
d. Registration Board in 238
th meeting extended following contract manufacturing permissions for contract manufactured by M/s
AGP Health Care Pvt. (Formerly, Eli Lilly Gohar, Karachi). Later on scrutiny of record revealed that contract manufacturer is M/s
PharmEvo, Karachi. Submitted for correction and issuance of corrigendum as per following correct details.
M/s AGP, Kar. M/s PharmEvo,
Karachi
003755 Kefzol 500mg Injection
Each vial contains:
12-04-2013
DyNo.308
Dedicated
facility
Extended till 30.06.2015
174
Cefazolin sodium……….…500mg Form-05
Rs.42,000/-
Rs.8000/-
02-6-2011
Cephalosporin
-do- -do- 003756 Kefzol 1g Injection
Each vial contains:
Cefazolin sodium……….…1gm
29-04-2013
DyNo.309
Form-05
Rs.42,000/-
Rs.8000/-
02-6-2011
-Do- Extended till 30.06.2015
Case No.17. Extension in contract manufacturing permissions.
M/s Sapient
Pharma, Lhr
M/s Mediate
Pharmaceuticals,
Kar.
060472 COA Dry Suspension
Each 5ml contains:
Cefixime……….200 mg
15-04-2013
Form-05
Rs.42,000/-
Rs.8000/-
07.09.2010
Dedicated
facility
Cephalosporin
Extended till 30.06.2015.
-do- -do- 060473 COA Capsule
Each capsule contains:
Cefixime……….400 mg
15-04-2013
Form-05
Rs.42,000/-
Rs.8000/-
07.09.2010
Dedicated
facility
Cephalosporin
Extended till 30.06.2015.
175
(Medical Devices)
Case No.18. Applications for registration of Medical Devices for Import.
The Registration Board considered the following applications of medical
devices and decided as mentioned against each. These applicationshave already been
recommended by Expert Committee on Medical Devices. Approved applications are subject to
inspection of manufacturer abroad, verification of storage facilities etc as per policy.
A: CATHETERS:
S.No. Name of Importer and
Manufacturer/Exporter.
Name of Medical
Device.
Demanded
price &
Pack size
Shelf life Decision
1. M/s.Cor-Med,
2nd
Floor, 36/62, Rehman
Plaza, Bank Road, Saddar,
Rawalpindi
Manufactured by
M/s. IHT, Iberhospitex
S.A, Barcelona, Spain
Fairway
Rapid Exchange
dilatation catheter for
PTCA
Length (mm):
10,15,20, 25,30, 35,40.
Dia (mm):
1.5, 2.0, 2.5, 3.0, 3.5,
4.0, 4.5.
Decontrolled
(Different
product codes
available)
24
months Approved.
B: STENTS:
S.No. Name of Importer and
Manufacturer/Exporter.
Name of Medical
Device
Demanded
price &
Pack size
Shelf life Decision
1. M/s.Cor-Med,
2nd
Floor, 36/62, Rehman
Plaza, Bank Road, Saddar,
Rawalpindi
Manufactured by
M/s. IHT, Iberhospitex S.A,
Barcelona, Spain.
Bionert Inert Coronary
Stent
(Bare Metal Stent)
Bionert :
Stent Length (mm):
9, 14, 18, 23, 28, 36.
Stent Dia (mm):
3.0, 3.50, 4.00, 4.50.
Bionert Small:
Stent Length (mm):
9, 14, 19, 23, 28.
Decontrolled
(Different
product
codes
available)
24
months Approved.
176
Stent Dia (mm):
2.0. 2.25, 2.50, 2.75.
2. M/s.Cor-Med,
2nd
Floor, 36/62, Rehman
Plaza, Bank Road, Saddar,
Rawalpindi
Manufactured by
M/s. IHT, Iberhospitex S.A,
Barcelona, Spain.
Active Paclitaxel
Eluting Coronary
Stent.
Active :
Stent Length (mm):
9, 14, 18, 23, 28, 36.
Stent Dia (mm):
3.0, 3.50, 4.00, 4.50.
Active Small:
Stent Length (mm):
9, 14, 19, 23, 28, 36.
Stent Dia (mm):
2.0. 2.25, 2.50, 2.75.
Decontrolled
(Different
product
codes
available)
18
months Approved.
C: SYRINGES:
S.No. Name of Importer and
Manufacturer/Exporter.
Name of Medical Device. Demanded
price &
Pack size
Shelf
life
Decision
1. M/s. Excel Corporation,
435 BYJ Society,
Bahadurabad, Karachi
Manufactured by
M/s. Changzhou Jinliyuan
Medical Devices, Co., Ltd.,
No.6 West Xihe Road,
Sanhekou, Zhenglu Town,
Wujin District, Changzhou
City, China.
A-Star Disposable syringe Decontrolled
1ml
3ml
5ml
10ml
20ml
5years Approved.
2. M/s. Excel Corporation,
435 BYJ Society,
Bahadurabad,Karachi
Manufactured by
M/s. Changzhou Jinliyuan
Medical Devices, Co., Ltd.,
No.6 West Xihe Road,
Sanhekou, Zhenglu Town,
Wujin District, Changzhou
City, China.
A-Star Disposable syringe Decontrolled
30ml
50ml
5years Approved.
3. M/s Becton Dickinson
Pakistan (Pvt) Ltd,
BD Emerald TM
Pro (Reuse
Prevention) Luer Slip
Decontrolled
5 years Approved.
177
19-D/1, Gulberg-III,
Lahore.
Manufactured by:
M/s Becton Dickinson, S.A.
Ctra. Mequinenza, s/n
22520 Fraga (Huesca),
Spain.
Syringe. 2ml
5ml
10ml
Case No.19. Registration of Medical Devices of M/s Otsuka Pakistan Limited, Lasbela
Distt. Balochistan.
Registration Board in its 230th
meeting considered and approved the following
medical devices of M/s. Otsuka Pakistan Limited, Lasbela Distt. Balochistan subject to
inspection of manufacturer abroad, local storage facility etc:-
S.No. Name of Importer and
Manufacturer / Exporter.
Name of Drug (s)
Composition &
Therapeutic Group.
Demanded
Price &
Pack Size.
Shelf Life
1. M/s. Otsuka Pakistan Limited,
Lasbela Distt. Balochistan. /
M/s. Mircroport Medical
(Shanghai) Co. Ltd.,
Shanghai. P.R. China.
Jive PTCA Balloon
Catheter
(Medical Device).
Decontrolled
02 years
2. M/s. Otsuka Pakistan Limited,
Lasbela Distt. Balochistan. /
M/s. Mircroport Medical
(Shanghai) Co. Ltd.,
Shanghai. P.R. China.
Mustang Stent
Stainless Steel
Coronary Stent
System
(Medical Device).
Decontrolled
02 years
3. M/s. Otsuka Pakistan Limited,
Lasbela Distt. Balochistan. /
M/s. Mircroport Medical
(Shanghai) Co. Ltd.,
Shanghai. P.R. China.
Firebird Rapamycin
Eluting Stainless
Steel Coronary Stent
System
(Medical Device).
Decontrolled
12 months
4. M/s. Otsuka Pakistan Limited,
Lasbela Distt. Balochistan. /
M/s. Mircroport Medical
(Shanghai) Co. Ltd.,
Shanghai. P.R. China.
Firebird 2
Rapamycin Eluting
Cobalt Chromium
Coronary Stent
System
(Medical Device).
Decontrolled
09 months
178
Accordingly inspection of M/s. Microport Medical (Shanghai) Co. Ltd., Shanghai.
P.R. China was conducted by the nominated panel. During the inspection, the panel of
inspectors observed certain shortcomings related to GMP and therefore did not recommend the
products for registration.
M/s Microport Medical (Shanghai) Co. Ltd., Shanghai. P.R. China submitted an
Action Plan for taking corrective actions on the deficiencies mentioned in the inspection report.
After that M/s Otsuka Pakistan Ltd., Karachi submitted the Corrective Action Report dated 12th
October, 2012, forwarded by their principal manufacturer in which the manufacturer submitted
that they have taken Corrective Action on the non-conformities mentioned in the inspection
report and are ready for re-inspection of their premises.
Accordingly a panel of inspectors was nominated for re-inspection. The panel
conducted the inspection of all key manufacturing areas which were involved in manufacturing
and quality control of applied products. The points observed by the previous panel were also
checked. The panel has given the following recommendations:-
(i) Mustang Stent Stainless Steel Coronary Stent System is recommended for
grant of registration with shelf life of 24 months alongwith following sizes:-
Stent Dia (mm): 2.0, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00,
4.50, 5.00.
Stent Length (mm): 5 to 40.
(ii) Firebird 2 Rapamycin Eluting Cobalt Chromium Coronary Stent System is
recommended for grant of registration with shelf life of 12 months alongwith
following sizes:-
Stent Dia (mm): 2.5, 2.75, 3.0, 3.5, 4.0.
Stent Length (mm): 13, 18, 23, 29, 33.
Quantity of Rapamycin
Coated on stent (µg): 120, 160, 210, 268, 305.
(iii) Jive PTCA Balloon Dilatation Catheter is not recommended for grant of
registration because the product is neither registered by SFDA China nor
available in China. However, the firm manufactures it for export purpose only.
(iv) Firebird Rapamycin Eluting Stainless Steel Coronary Stent System is not
recommended for grant of registration because the registration status of the
product by SFDA China is valid till April, 2013 and firm has already
179
discontinued its domestic sale hence it’s not on free sale in China. Moreover,
management of M/s Microport also informed that they don’t intend to apply for
extension of its registration beyond April, 2013 for local sale. However, they
will continue to export the product, if ordered.
Decision: The Board approved Mustang Stent Stainless Steel Coronary Stent System with
shelf life 24 months and Firebird 2 Rapamycin Eluting Cobalt Chromium
Coronary Stent System with increased shelf life of 12 months as recommended by
the panel of inspectors while the Board rejected Jive PTCA Balloon Dilatation
Catheter and Firebird Rapamycin Eluting Stainless Steel Coronary Stent
System as recommended by the panel of inspectors.
180
Biological Evaluation & Registration
Case No.20: Import in GE pack and Local Printing of Reg. No., MRP and Urdu
labelling at own licensed site: F-268, SITE, Karachi having DML No. 000233
M/s GlaxoSmithKline, Karachi has requested import of Fluarix in GE packing and local
printing of Registration number, MRP, and Urdu version at their licensed site at F-268, SITE,
Karachi DML No. 000233.
The reason is because of centralized manufacturing at one Global manufacturing site at
GlaxoSmithKline, Belgium where the GE packs are now manufactured and due to production
time constraints the seasonal flu vaccine has one year shelf life and 6 month window period in
which it is to be used. Pakistan specific packing is not possible in this short time hence
availability in Pakistan is a major issue. Therefore Reg. No., MRP and Urdu instructions can
be printed at the company’s own licensed site at Karachi for a period of two years.
Fee Rs 5000/- has been paid by the firm.
Board is requested to allow the permission for import of Fluarix vaccine in GE packing and
local printing of Reg. No., MRP., and Urdu printing with inject printing at GlaxoSmithKline,
Karachi licensed site F-268, SITE, Karachi having DML No. 000233.
Decision: Board permitted the import of Fluarix vaccine in GE packing and local
printing of Reg. No., MRP., and Urdu version with inject printing at GlaxoSmithKline,
F-268, SITE, Karachi having DML No. 000233 for a period of two years.
Case No.21: Registration letter correction- Fluarix vaccine reg no. 022612.
M/s GlaxoSmithKline, Karachi’s Fluarix vaccine is an inactivated influenza vaccine (split
virion) containing antigens of at least three strains of the seasonal influenza viruses that are
notified by WHO for each year. Thus 15 mcg of haemagglutinin of each of the recommended
strain has to be added in the vaccine; therefore the wording on the Reg. letter needs to be
corrected to reflect the same as following:
Exiting wording on the Reg letter Correct wording as per CPP and Form 5
original application
“Each 0.5 ml vaccine dose contains: 15 mcg
of haemagglutinin (inactivated and purified
split influenza vaccine)”
“Each 0.5 ml vaccine dose contains: 15 mcg
of haemagglutinin of each of the
recommended strain”.
The case was submitted on 19.09.2012.
181
The Board is requested to please allow the correction to meet international requirements
subject to submission of fee by the firm.
Decision: The Board allowed the correction to meet international requirements subject
to submission of fee by the firm.
Case No. 22: Engerix B vaccines in prefilled syringes: 10 mcg Reg No. 012370; 20 mcg
Reg No. 009823
M/s GlaxoSmithKline, Karachi has requested import in GE packing and local printing of
Registration number, MRP, and Urdu version on their registered product at their licensed site
Karachi F-268, SITE, Karachi DML No. 000233. The reason is because of centralized
manufacturing at one Global manufacturing site at GSK Belgium where the GE packs are
now manufactured and due to production constraints Pakistan specific packing is not possible
hence availability is a major issue. Whereas the GE pack is readily available and can be
imported at the time of need and locally the Reg. No. MRP and Urdu instructions can be
printed at the company’s own site.
Fee Rs 5,000/- has been paid by the firm.
Board is requested to allow the permission for import of Engerix B vaccines in prefilled
syringes and in GE packing and local printing of Reg. No., MRP., and Urdu printing with
inject printing at GlaxoSmithKline, Karachi licensed site F-268, SITE, Karachi having DML
No. 000233.
Decision: Board allowed the permission to import Engerix B vaccines in prefilled
syringes in GE packing and local printing of Reg. No., MRP., and Urdu version with
inject printing at GlaxoSmithKline, F-268, SITE, Karachi having DML No. 000233 for a
period of two years.
Case No. 23: Registration of “Sterile water for injection-0.5ml vial” for reconstitution of
Vaxapox vaccine Reg No. 074628.
M/s Sind Medical Store, Karachi has requested that their varicella vaccine Vaxapox is
already registered vide reg no. 074628 to be imported from M/s Changchun BCHT
Biotechnology Co., Changchun China but the case of registration of its diluent was not
submitted at that time, hence the company is not able to market it in combo pack.
Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost.
Complete application on Form 5-A, product dossier, Embassy certified Free sale certificate,
182
CPP, copies of the cGMP certificate, and DML, are in file; the production and quality control
procedures are in order.
The Board is requested to grant registration of “Sterile water for injection-0.5ml” for
reconstitution of Vaxapox (Varicella) vaccine Reg No. 074628 to be supplied free of cost along
with the vaccine manufactured by the same company i.e., M/s Changchun BCHT Biotechnology
Co., Ltd., China.
Decision: The case was deferred due to payment of full fee and other codal formalities. The
Board advised to present detailed case in next meeting.
Case No. 24: Registration of “Sodium Chloride Injection BP-0.1 ml ampoule for
reconstitution of BCG vaccine reg no. 053816.
M/s Hospital Services and Sales, Karachi has requested that their product BCG vaccine is
already registered but the case of registration of diluent to be supplied with the BCG vaccine for
its reconstitution was not submitted at that time to be imported together with the vaccine from
M/s Serum Institute of India Ltd., India in combo pack.
Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost. Complete
application on Form 5-A, product dossier, Embassy certified Free sale certificate, CPP, copies of
the cGMP certificate, and DML, are in file; the production and quality control procedures are in
order.
The Board is requested to grant registration of diluent to be supplied free of cost with the BCG
vaccine to be imported with vaccine from the same supplier in combo pack.
Decision: The case was deferred due to payment of full fee and other codal formalities. The
Board advised to present detailed case in next meeting.
Case No. 25: Registration of “Diluent for Indirab injection-1.0 ml for reconstitution of
Indirab 1ml injection.
M/s Sind Medical Store, Karachi has requested their rabies vaccine Indirab injection which
was approved in the 227th
meeting of DRB held on 26-27th
, 2010 requires a diluent for the
reconstitution. The vaccine cannot be imported without the diluent which is to be supplied
free of cost. The vaccine registration letter has not been issued due to pending inspection.
Hence both the cases may be treated together for registration. Both the products are
manufactured by M/s Bharat Biotech International Limited, Andhra Pradesh, India. Fee Rs
183
50,000 thousand has been paid by the firm. The Board is requested to allow combining the
vaccine and its diluent case together for registration.
Decision: The case was deferred due to payment of full fee and other codal formalities. The
Board advised to present detailed case in next meeting.
Case No. 26: Approved cases whose foreign inspections have been successfully
conducted:
a) M/s Hitech Pharmaceuticals, Lahore had applied for new site inspection of their three already
registered products with change of brand names and one diluent for vaccine. The site inspection
has been conducted by the panel comprising of Dr Noor Muhammad Shah and Prof Dr. Ijaz
Ahmad, the report was submitted on 22.05.2013. The panel has recommended their products and
the site at Fort Dodge Saude Animal Ltda, Brazil for cGMP compliance. The products are as
follows:
S.No. Registration
Number
Existing Brand name New requested
Brand Name
Inspection
Report
Remarks
1 009677 EDS Vaccine EDS Vac. Good
2 003787 Poulvac Marek
(CVI+HVT)
Poulvac Ovoline
(CVI+HVT)
Good
3 010719 Egg Drop Syndrome-
Newcastle Disease
Infectious Bronchitis
Vaccine
EDS New Bronz
Vac.
Good
The firm had also applied for inspection of their foreign site for the manufacture of diluent for
their already registered vaccine Poulvac Ovoline CVI+HVT Reg No. 003787 under the new
DRAP policy to register the diluent as a separate entity; the same panel also visited the diluent
manufacturing site at M/s Baxter Hospitalar Ltda, Brazil and recommended the product and the
plant for cGMP compliance.
S.No. Registration
Number
Brand Name Inspection Report
Remarks
1 New to be supplied
with vaccine
Pro-Cell sterile diluent for
Marek Vaccine reg no.
003787
Good
Decision: The Board approved change of manufacturing site and brand name for above
products. The Board also approved registration of diluent for Poulvac Ovoline vaccine.
184
b) M/s Martin Dow had applied for the registration of six biological products which were
approved in the 237th
DRB meeting and for which panel inspection was conduct by a
panel consisting of Dr Uzar ul Ghani, Dr Najmus Saqib of the firm M/s Nanogen
Biopharmaceuticals, Tang NhonPhua ward, Vietnam. The panel has submitted the report
on 09.04.2013 and have recommended following products for registration:
S. No. Product Brand
Name
Generic name Inspection Report
Remarks
1. PEGNANO, PFS Peg Interferon alfa-2a 180
mcg
Good
2. FERONSURE,
PFS
Interferon alfa-2a 3MIU Good
3. FERONSURE,
VIAL
Interferon alfa-2a 3 MIU Good
4. NANOKINE,
PFS
Erythropoietin alfa, 4000
IU
Good
5. FICOCYTE, PFS Filgrastim, 30 mcg Good
6. PEGCYTE, PFS Peg Filgrastim, 6 mg Good
Decision: Registration Board deferred above cases for confirmation of evaluation by
ECBD.
c) M/s Aster had applied for the registration of their five biological products which were
approved in 237th
DRB. Panel inspections have been conducted for the inspection of their
three biological products to be imported from M/s LG Korea. The inspection has been
conducted by Mr. Ghulam Rasool Dutani and Mr. Arif Choudary. They have
recommended these products and manufacturer for cGMP compliance. The same panel
has also recommended two biological products to be imported by the same company
from M/s Beijing Shuanglu Pharmaceutical Co. Ltd., China.
S. No. Product Brand
Name
Generic name Inspection Report
Remarks
1. Consensus-
Asteron alpha 9
mcg injection
Each Vial containing
Recombinant Consensus
Interferon alpha 9 mcg,
Good
M/s Beijing Shuanglu
Pharmaceutical Co.
Ltd., China
2. Consensus-
Asteron alpha 15
mcg Injection
Each Vial containing
Recombinant Consensus
Interferon alpha 15 mcg
Good
M/s Beijing Shuanglu
Pharmaceutical Co.
185
Ltd., China
3. Epotiv
2,000IU/0.5ml Pre-
filled syringe.
Recombinant human
erythropoietin 2,000
IU/0.5ml
Good
M/s LG Lifge
Sciences. Ltd., Korea
4. Epotiv
4,000IU/0.4ml Pre-
filled syringe
Recombinant human
erythropoietin, 4,000
IU/0.4ml
Good
M/s LG Lifge
Sciences. Ltd., Korea
5. Epotiv 10,000I
U/ml Injection
10000 IU/ml Pre-
filled syringe
Recombinant human
erythropoietin 10,000
IU/ml
Good
M/s LG Lifge
Sciences. Ltd., Korea
Decision: Registration Board deferred above cases for confirmation of evaluation by
ECBD.
Case No.27: FDA/EMA/TGA/WHO approved new cases of important Biologicals for
registration as per import policy.
S.No. Product Name Drug Category/
Major Indication
Applicati
on/Dossie
r Filing
Date
Registration Status
EMA
US-FDA
Australia (TGA)
Japan
Revised
Fee/
Fee
Differential
Paid
1. PROLIA Injection
(Denosumab 60mg)
Importer M/s
GlaxoSmithKline,
Karachi
From Manufacturer:
M/s Amgen
Manufacturing
Limited, Juncos,
Puerto Rico, USA
NCE/Post
Menopausal
Osteoporosis
and bone loss in
patients
undergoing
hormone ablation
for prostate or
breast cancer.
Each prefilled
syringe contains
60mg of
denosumab in 1ml
solution
(60mg/1ml)
14.11.201
1
EMA -
Approved
US FDA -
Approved
Complete dossier
present
EMA CPP verified
by Embassy of
Pakistan present
Yes
2. XGEVA Injection
(Denosumab 120mg)
Importer M/s
NCE/Cancer
Therapy –
prevention of
skeletal related
15.05.201
2
EMA -
Approved
US FDA -
Approved
Yes
186
GlaxoSmithKline,
Karachi
From Manufacturer:
M/s Amgen
Manufacturing
Limited, Juncos,
Puerto Rico, USA
events with bone
metastates from
solid tumors.
Each vial contains
120mg of
denosumab in 1.7
ml solution
(70mg/1ml)
Shelf life 36
months
Complete dossier
present
FDA CPP verified
by Embassy of
Pakistan present
3. BENLYSTA Injection
(Belimumab 120mg)
Importer M/s
GlaxoSmithKline,
Karachi.
Manufacturer: M/s
Hospira Inc, Kansas,
USA. Supplying site:
GlaxoSmithKline
Manufacturing S.p.a.,
Pharma, Itlay.
autoantibody
positive Systemic
lupus
erythematosus
(SLE)
Each vial contains
120 mg
belimumab
(80mg/ml after
reconstitution)
Shelf life 36
months
16.05.201
2
EMA -
Approved
US FDA -
Approved
Complete dossier
present
CPP verified by
Embassy of Pakistan
present
Yes
4. BENLYSTA Injection
(Belimumab 400mg)
Importer M/s
GlaxoSmithKline,
Karachi.
Manufacturer: M/s
Hospira Inc, Kansas,
USA. Supplying site:
GlaxoSmithKline
Manufacturing S.p.a.,
Pharma, Itlay.
autoantibody
positive Systemic
lupus
erythematosus
(SLE)
Each vial contains
400 mg
belimumab
(80mg/ml after
reconstitution)
Shelf life 36
months
16.05.201
2
EMA -
Approved
US FDA -
Approved
Complete dossier
present
CPP verified by
Embassy of Pakistan
present
Yes
5. Qlaira, (eastradiol
valerate) Hormone
combination
Importer M/s Bayer
Pakistan (Pvt) Ltd.,
Karachi from
Hormone
replacement
therapy
Film coated tablet
contains: 3.0 mg
estradiol valerate
24.08.201
1
TGA approved
CPP verified by
Embassy of Pakistan
present
Complete dossier
present
Yes
187
M/s Bayer Weimer
GmbH und Co. KG
Doebereinerstrasse 20
99427 Weimer,
Germany.
as active
ingredients
6. Eylea (Aflibercept)
40mcg/ml
Importer M/s Bayer
Pakistan (Pvt) Ltd.,
Karachi from
M/s Bayer Pharma AG
Mullerstrabe 178
13353 Berlin
Germany.
Ophthalmogicals/
neurovascular
degeneration
Each vial contains
Aflibercept 40
mg/ml
Shelf life 2 years
29.03.201
3
EMA/FDA approved
EMA CPP verified
by Embassy of
Pakistan present
Complete dossier
present
Yes
7. Yellow fever vaccine
(live Freezedried) 2
doses ampoules/1.0 ml
Importer M/s Hospital
Services & Sales,
Karachi from
Federal State Unitary
Enterprise on
Manufacture of
Bacterial and Viral
Preparations of
Chumakov Institute of
Poliomyelitis & Viral
Encephalitis, Russian
Academy of Medical
Sciences, Russia.
Yellow fever
vaccine
Each single 0.5ml
dose of vaccine
contains:
Yellow fever virus
no less than 1,000
LD50 or 1,600 PFU
Supplied with
diluent water for
injection 1.25 ml
in ampoules
11.09.201
3
WHO prequalified
vaccine,
The other yellow
fever vaccine
available from M/s
Sanofi Aventis,
France has
developed some
technical problems
as notifed by the
company on
11.09.2013 so
supply of another
vaccine is necessary
to cover any
shortage, hence this
application is
presented
CPP, FSC, GMP
certificate, and other
relevant documents
verified by the
Pakistan Embassy
present
Yes
8. Yellow fever vaccine
(live Freezedried) 5
doses ampoules/2.5 ml
Importer M/s Hospital
Services & Sales,
Karachi from
Yellow fever
vaccine
Each single 0.5ml
dose of vaccine
contains:
11.09.201
3
-do- Yes
188
Federal State Unitary
Enterprise on
Manufacture of
Bacterial and Viral
Preparations of
Chumakov Institute of
Poliomyelitis & Viral
Encephalitis, Russian
Academy of Medical
Sciences, Russia.
Yellow fever virus
no less than 1,000
LD50 or 1,600 PFU
Supplied with
diluent water for
injection 3.0 ml in
ampoules
Decision: Registration Board referred above case for consideration of ECBD, as
these cases have not been yet evaluated by the aforementioned committee.
Case No. 28: Change of source of an approved vaccine for local manufacture:
The case relates to “Bulk import local repacking” of the then WHO prequalified vaccine
i.e., Pentavalent vaccine that was approved in 213 DRB meeting with the following
composition and source:
From: Amsovax-5: Diptheria, Tetanus, whole cell Pertussis, Hepatitis-B and
Haemophilus influenza type B conjugate vaccine as per WHO formula, from M/s
Shanta Biotech India, India.
At the time of application this source was WHO prequalified but latter on it
was derecognised by WHO, hence the local company applied for change of
source to a new WHO prequalified source;
To: Amsovax-5: New WHO prequalified product from M/s Biological E, Ltd., India
with the same composition of vaccine. The application was submitted on 16.09.2011
and the dossier of the new product was submitted on 28.10.2011. The vaccine is
Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and Haemophilus
Type B Conjugate Vaccine (Adsorbed)-(Hib vaccine lyophilised in separate vial
which is to be reconstituted with DTwP-rHepB vaccine filled in a separate vial).
Shelf life is 24 months. The packing applied for is 10 doses per vial. As per Schedule
I of DRAP Act, 2012 the naked vials without labels will be imported in bulk
quantities that will be locally labelled and Vaccine Vials Monitor (VVM) will be
applied before packing in cartons).
The firm was communicated the approval on 11.03.2013 and was asked to submit the
WHO approval and technical information on the CTD format; the firm submitted the
required information on 01.04.2013. The WHO approval status has been verified
from the WHO Web site as well.
189
The local facility is a licensed to manufacture vaccine by way of formulation since
1995 for HepB, TT, and antivenom serum; recommended for approval subject to
local panel inspection for facility suitability for handling such product.
Decision: Registration Board deferred firm’s request for evaluation by ECBD.
Case No. 29: Registration of WHO prequalified liquid Pentavalent vaccine to be
imported in finished form for EPI in single vial.
M/s Amson Vaccine & Pharma (Pvt) Ltd., Islamabad submitted a case for import of a
Pentavalent vaccine in finished form for EPI from M/s Biological E. Ltd., India. Rs
100,000 fee has been paid. The vaccine is WHO prequalified and has following
composition:
Source: Composition Presentation
M/s Biological E Ltd.,
Shameerpet Mandal,
Andhra Pradesh, India
Diphtheria Toxoid 25Lf(≥30IU)
Tetanus Toxoid 5.5Lf(≥60IU)
B.pertissis (Whole cell)
16IOU(≥4IU)
r-HBsAg 12.5 mcg
Purified capsular polysaccharide 11
mcg
Tetanus Toxoid (Carrier protein)
30.36.7mcg
Al+++
(as AlPO4) ≤1.25 mg
Thiomersal BP 0.01%w/v
10 dose vials
Decision: Registration Board deferred firm’s request for evaluation by ECBD.
190
Case No. 30: Registration of safe drugs.
Registration Board discussed letter written by Dr.Obaid Ali, Deputy Drug
Controller dated 22.08.2013 on matter of registration of drugs. The Board discuused points
mentioned in letter as follows:
a. Registration of Drugs without Assessment, Review and evaluation of Application
Dossier.
The Board showed their satisfaction on present system of scrutinization / evaluation of
registration applications. The Board was informed that DRAP has agreed in principal to creat a
cell for evaluation of registration applications. The cell will be operative soon and will be
entrusted with the duty of scrutinization / evaluation of registration applications as required
under Drug Act, 1976.
b. Registration of Drugs without Assessment of site master file etc and GMP inspection.
As per procedure in vogue, licensing section is responsible for the grant of licenses / sections
to pharmaceutical units after completion of all requirements as required under Drugs (Licensing,
Registering & Advertising) Rules, 1976. Registration Board considers registration application on
the basis of approvals granted by licensing section. Similarly Quality Assurance section conducts
inspections of licensed units for compliance towards GMP. Registration Board considers these
inspection reports while considering registration applications. Moreover, the Board also
constitutes its own panel for product specific inspections, where it considers necessary. Members
of the Board were satisfied with the procedure adopted for inspection of pharmaceutical units.
However, for better compliance of GMP, the Board advised QA section to strictly monitor the
GMP of the licensed units for manufacturing of quality products for ailing masses.
c. Registration of Drugs without summary of approvals and transparency.
As mentioned in point a, the evaluation cell will evaluate the registration applications and
forward its recommendation including summary of approval for consideration of the Board.
Registration applictions are included in agenda of the meeting on FIFO basis.
d. Registration of Drugs without Post Marketting Requirements & Commitments.
After promulgation of DRAP Act, 2012; Pharmacovigilance section has been established
under Pharmacy Services Division. This section will perform all the activities of
Pharmacovigilance including post marketing survelliance etc of the marketed products. The
pharmaceutical companies will coordinate with this section for matters related to
191
pharmacovigilance. Members showed their desire that Registration Board be informed about the
pharmacovigilance activities per formed by the Pharmacy Services Division.
e. Registration of drugs/ Blanket approval on its Label Claim and Promotion.
Regsitartion Board grant registration of drug based on label claim approved by the regulatory
body of country of origin / USFDA / EMA / TGA / Japan / developed countries. However,
evaluation cell for the scrutinization / evaluation of registration application will also review all
label claims of the applicant.
f. Ignorance of International Norms and implementation of Harmonized Documents.
Presently registration applications are submitted on prescribed Forms (5, 5A, 5D, 5E) as
required under Drugs (Licensing, Registering & Advertising) Rules, 1976. The matter of
submission of the application on CTD format is already under discuusion in DRAP and will be
implemented after ammendement in aforementioned rules.
g. Barricade of working of DDC (Biological Drugs) and authorization of illegitimate
working.
It is an administrative matter and not related to Registration Board.
XDr. Obaid Ullah
Secretary, Drug Registration Board
XMr. Ghulam Rasool Dutani
Chairman, Drug Registration Board
Recommended