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MINUTES OF THE 189TH MEETING OF THE REGISTRATION BOARD HELD ON 19TH
AND 20TH , APRIL, 2005 ( LOCAL MANUFACTURE NORTH & SOUTH).
The 189th meeting of the Drug Registration Board was held on 19th and 20th April, 2005 in the
Committee Room of the National Institute of Health, Islamabad under the Chairmanship of Dr. Abdul
Majid Rajput, Director General Health. It commenced with the recitation of verses from the Holy Quran
and was attended by the following members:-
i. Mam. Gen (R ) MI Burney HI (M), SI
National Institute of Health
Islamabad
ii. Maj. Gen. (R ). Nasir-ul-Islam
Rawalpindi
iii Maj. Gen Shujaat Hussain HI (M) SI (M)
Principal Army Medical College
Rawalpindi
iv. Brig. Muzammil Hassan Najmi
Prof. of Pharmacology & Therapeutics
Army Medical College,
Rawalpindi
v Prof. Shahnawaz,
Professor of Pharmacology and Head of the Department
Ayub Medical College,
Abbottabad.
vi. Dr. I.U Beg
Associate Surgeon,
Federal Government Services Hospital,
Islamabad.
vii Prof. Dr. Muhammad Jamshaid
Chairman Faculty of Pharmacy
Punjab University,
Lahore.
viii Mr. Abdul Latif Sheikh,
Director Pharmacy,
Nutrition & CSSD Services,
Agha Khan University Hospital,
Karachi.
xi Dr. Ijaz Ahmed,
Associate Professor
University of Veterinary and Animal Sciences,
Lahore.
x Mr. Attaullah Khattak
CRO
Deputy Secretary,
Ministry of Industries & Production,
Islamabad.
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xi Dr. M. Akram.
Assistant Animal Husbandary Commission
Ministry of Food , Agriculture & Livestock
Islamabad.
xii Muhammad Saad Khan
Deputy Secretary,
Ministry of Law, Justice & Human Rights,
Islamabad.
xiii Dr. Jalir-ur Rehman
Director General Health Services
Government of NWFP
Peshawar
xiv Mr. Atta –ur-Rehman
Chief Drug Inspector,
Representing
Director General Health Services
Government of Baluchistan
Quetta.
xv Dr. Farnaz Malik (Also Secretary of the Board)
Drugs Controller
Ministry of Health
Islamabad.
Mr. Abdul Sattar Sohrani Deputy Drugs Controller (Registration-II South) and Mr. Muhammad
Akhtar Abbas Khan Deputy Drugs Controller (Registration-II North), assisted the Secretary of the Board
with the agenda and working paper.
Dr. M.H Siddiqi representative of Pakistan Pharmaceutical Manufacturers Association and Mr.
M.Zafar Mooraj, representative of Pharma Bureau, Karachi also attended the meeting as observers.
ITEM NO. I CONFIRMATION OF THE MINUTES OF THE 188th MEETING HELD ON 28TH
DECEMBER, 2005
Minutes of the 188th meeting which had been circulated to all members of the Board for
comments/ views/ observations were approved unanimously by the Board.
ITEM NO. II PRESENTATION BY DR. NIAZI ON BIOTECHNOLOGY PRODUCTS.
A brief presentation was delivered by Dr. Niazi on these products which were
informative. He further added that the company is going to launch three biotech products in the start of
2006.
ITEM NO. III DISCUSSION ON POLICY ISSUES.
1. Contract Manufacturing.
After thorough deliberations and discussion the Registration & Licensing Board approved
the following policies regarding contract manufacturing based on legitimate grounds:-
i. Contract manufacturing will be allowed only between two licensed manufactures.
ii. Only Orphan and Specialized Drugs will be allowed by contract manufacturing.
iii. It will be allowed for a limited period.
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iv. On genuine reasons and as an interim arrangement like up gradation or utilization
of surplus capacity.
v. Contract manufacturing will be allowed among human to human and
vetenary to vetenary drugs licensees.
vi. The contract among the parties shall clearly fix the responsibilities regarding
purchase of raw material and packing material, quality assurance, release
of batches issuance of warranty and post marketing liabilities in addition to
record keeping.
vii. A list of Orphan Drugs / Specialized Drugs will be prepared by the Ministry
for contract manufacturing.
viii. To encourage the shifting from import to local manufacturing two years
contract will be allowed subject to undertaking that the firm will establish its
own facilities within two years.
Later on implementation of above policy was pended on the request of
observes of PPMA and Pharma Bureau till presentation by them in the next meeting.
2. PSYCHOTROPIC POLICY
The policy approved by the M/o. Health was placed before the Drug Registration
Board for consideration. The Board approved the policy as under:-
i. Segregated area for manufacturing of such drugs.
ii. Clearance of the firms for GMP compliance by a panel of inspectors
headed by the Drugs Controller.
iii. Minimum turn over of the applicant should not be less than Rs. 50
millions.
iv Track record of the company for sub-standard drugs and other
violations of the Drugs Act, 1976 and Rules framed there under would
be taken into consideration for the last 2 year. (2001and 2002).
v. Observance of clause 30 (4) of Drug (Licensing, Registering and
Advertising) Rules 1976. Firms found contravening this rule would not
be entertained.
vi. The firms shall submit income tax returns claim for manufacture of 50
million turn over.
vii The manufacturers shall be responsible for the sale of these drugs only
to distributors and chemists or hospitals. No sale to wholesale or
unauthorized agents. Records shall be provided to Federal and
provincial drug inspectors on monthly basis.
The Board also decided to request the M/o. Health to review the segregated area clause as
this is not in accordance with the scientific and legal formalities. It was also decided that increase
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of 30% quota of Psychotropic / Narcotic drugs will be allowed only to those manufacturers who
will submit proof of 50 million turn over in the form income tax returns in addition to other
requirements of rules.
The Board constituted a committee of members of the Registration Board to scrutinize
the information submitted by the pharmaceuticals firms according to approved policy for
registration of these drugs:-
1. Drugs Controller Chairperson
2. Dr. Jamshad Member
3. Brig. Najmi Member
4. Abdul Sattar Sohrani Coordinator
(DDC R-II South)
3. QUINOLONES POLICY
The Board decided that Quinolones shall be manufactured in General Antibiotic area
specified for antibiotics only. Manufacturing in General Tablets area will no be allowed to avoid
and minimize the risk of serious medical hazard due to cross contamination. The Board also
decided that this self contained facility for Quinolones and General Antibiotics shall have
independent air handling system. This self contained facility was identified by the Central
Licensing Board in the light of schedule B-5.2. of Drugs Licensing, Registering and Advertising)
rules, 1976.
4. DELEGATION OF POWERS TO DG (HEALTH).
The Drug Registration Board unanimously delegated the following powers to DG
(Health) to overcome the delays:-
i. Re-registration of drugs which were declared no more valid due to late
submission of renewal applications.
ii. Transfer of Registration from one manufacturer to other manufactures.
5. The Registration Board had taken the serious notice of the frequent incidences whereby
despite repeated visits by the panel of experts / panel of inspectors, the firms did not comply with
the instructions of panel of inspectors for improvement of shortcomings pointed out in previous
inspections. The Board decided that the panel of inspectors will only visit twice to verify the
compliance of the shortcomings / instructions pointed out in previous inspections and will give
their recommendations accordingly.
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6. Registration Board also decided to increase the number of experts to expedite the speed
and disposal of cases. In this regard Drugs Controller was authorized to increase the number
according to the requirement.
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MISCELLANEOUS CASES –189 SOUTH.
Case No. 1. The ADG (E&M) has submitted a case wherein he has informed that M/s.
Karachi Pharmaceutical Laboratories (Pvt.) Ltd; Karachi had applied for renewal of registrations
of their following drugs vide letter dated 06/11/2002:-
S. No Name of Drugs Reg.No. Date of Initial Reg. Fee Deposited
1. Pheniral Injection 020325 12/11/1997 Rs.4000/-
2. Pexopen Dry Syrup 020326 -do- Rs.4000/-
3. Dypron Injection 020327 -do- Rs.4000/-
4. Floxon Tablets 020328 -do- Rs.4000/-
5. Floxon Suspension 020329 -do- Rs.4000/-
6. Mandle’s Throat Paint 006635 22/11/2002 Rs.4000/-
The firm was asked to deposit R.4000/- as late fee for each drug but no response
was received from them. Later on they showed their reluctance to deposit late fee with the claim
that they submitted their application on 06/11/2002 before the expiry of validity period. The
Secretary Registration Board after perusal of case gave observation that the registration under
reference is no longer valid and their production will be not in accordance with the law and
advised to put up the case for consideration of the Registration Board.
Decision: The Board decided that firm shall deposit balance amount of Rs. 4000/-
(four thousands) outstanding as a late fee for each drug.
Case No. 2 The ADG (E&M) has submitted a case wherein he has informed that M/s. Ocean
Pharmaceutical (Pvt.) Ltd; Karachi had submitted the renewal applications for registrations of
their following drugs on 7th December, 2004:-
S. No
Name of Drugs Reg. No. Date of Date of Fee
Initial Reg. Validity Deposited
1. Ocezol DS Tablets 015805 20/09/1994 19/09/2004 Rs.4000/-
2. Ocezol Suspension 015806 -do- -do- Rs.4000/-
3. Oceflox Drops 015807 -do- -do- Rs.4000/-
4. Oceflox 250mg Capsules 015808 -do- -do- Rs.4000/-
5. Oceflox 500mg Capsules 015809 -do- -do- Rs.4000/-
6. Oceflox Dry Suspension 015335 22/06/1994 21/06/2004 Rs.4000/-
7. Ocepol Suspension 015082 28/02/1994 27/02/2004 Rs.4000/-
8. Cepol Tablets 015081 -do- -do- Rs.4000/-
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9. Ocelin Dry Syrup 015086 -do- -do- Rs.4000/-
10. Ammunium Chloride 015085 -do- -do- Rs.4000/-
11. Ocefen Suspension 015097 -do- -do- Rs.4000/-
12. Ocefen 200mg Tablets 015095 -do- -do- Rs.4000/-
13. Ocefen 400mg Tablets 015096 -do- -do- Rs.4000/-
14. Ocemox Dry Suspension 015089 -do- -do- Rs.4000/-
15. Ocemox 250mg Capsules 015090 -do- -do- Rs.4000/-
16. Ocemox 500mg Capsules 015091 -do- -do- Rs.4000/-
17. Ponsic Suspension 015084 -do- -do- Rs.4000/-
18. Ocetran Suspension 015092 -do- -do- Rs.4000/-
19. Ponsic 250mg Tablets 015083 -do- -do- Rs.4000/-
He has informed that all the aforesaid applications were received on 7th
December, 2004 even after the lapse of 60 days grace period. As per provision of Rule 27 of
Drugs (Licensing, Registering and Advertising) Rules 1976, these applications could not be
entertained. He has advised the firm to submit the new applications for registrations to the Drugs
Registration Board under rule 26(1) and (2) of Drugs (Licensing, Registering and Advertising)
Rules 1976 as amended vide SRO, 877(1)2000 dated 11th December, 2000. If they are interested
in manufacturing of these drugs.
The firm has submitted applications on Form-5 along with Original Treasury
Challans of Rs. 4000/- (four thousands) each renewal / re-registration of the said products.
Decision: The Board decided that firm shall deposit balance amount of Rs.
4000/- (four thousands) outstanding as a fee for each drug for re-
registration as required under Rule 26(1) of Drugs (Licensing,
Registering and Advertising) Rules, 1976.
Case No. 3 The Assistant Director General (E&M), Ministry of Health, Islamabad has
furnished a copy of letter issued by him to M/s. Woodward Pakistan (Pvt.) Ltd; Karachi wherein
he has asked them to submit complete applications for renewal / re-registration of the following
products as its renewals were received late after the expiry of gross period of 60 days as
prescribed under rules.
S. No. Name of Drug(s) Reg. No. Date of Date of
Initial Reg. Validity
i. Grovit Suspension 014435 14/10/1993 13/10/2003
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ii. Tempol 6+ Suspension 022447 09/12/1998 08/12/2003
iii. Tempol 6+ Drops 022448 -do- -do-
iv. Kaoplex Suspension 002990 11/10/1997 10/10/2002
v. Tempol Elixir 002991 -do- -do-
vi. Calwood-C Sachet 021864 20/05/1998 19/05/2003
vii. Tempol Drops 021865 -do- -do-
viii. Calwood-C Plus 022995 30/01/1999 30/01/2004
ix. Pedicare Solution 022597 28/01/1999 27/01/2004
x. Cofrest Cough Syrup 023376 30/04/1999 29/04/2004
Now the ADG(E&M) has forwarded the case wherein he has informed that the
firm has claimed that the fee submitted for renewal applications which were not entertain may be
considered for the re-registration of the aforesaid products.
Decision: The Board recommended the registration of aforementioned drugs on
same prices, terms and conditions.
Case No. 4 The ADG (E&M) M/o Health, Islamabad has forwarded the case of renewal / re-
registrations of the following drugs of M/s. Nabiqasim Industries (Pvt.) Ltd; Karachi:
S. No. Name of Drug(s) Reg. No. Date of Date of
Initial Reg. Validity
i. Otosol Ear Drops 003681 13/03/1978 12/03/2003
ii. Optisol Eye Drops 003683 -do- -do-
The registrations of aforesaid drugs were declared no more valid on account of
delayed submission of renewal applications even after the expiry of grass period of 60 days. The
ADG (E&M) has received the applications along with Original Treasury Challans of Rs. 8000/-
(eight thousands) each of the aforesaid products and furnished photocopies to this Section with
the request to place the case on agenda of forthcoming meeting of the Registration Board.
Decision: The Board recommended the re-registration of aforementioned drugs on
same prices, terms and conditions.
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Case No. 5 M/s. Pharmatec Pharmaceuticals, Karachi have informed that in reference to their
registration applications for manufacturing of drugs {Innoflex(Glucosamine) and Innoflex Plus
Glucosamine+Chondroitin)} for M/s. Innopharm, Karachi dated 21/01/2004, wherein they have
informed that they have not received any response so far.
They have also clarified that Glucosamine is marketed in USA & UK as a
nutritional supplement for regeneration of Cartilage and is available over the counter. In Pakistan
a few importers have also marketed it on the same basis without registration. However, the
imported drugs are very expensive. M/o. Health, gave registration to M/s. Hilton Pharma,
Karachi for local manufacture of products containing Glucosamine under the brand name
“Gevolox” and they have manufactured and launched both Glucosamine and Glucosamine +
Chondroitin combinations.
They have already applied for registration on the same basis but the matter has
been laying pending for almost a year now.
They have therefore, requested for early registration of the said products or
alternatively, confirmed to them that being nutritional supplement, the related registrations are
not required.
Decision:- The request of the firm was acceded to.
Case No. 6 The Registration Board in its 169th meeting held on 18th-19th & 20th February,
2002 had granted the registration of following drugs to M/s. Pharmatec Pakistan (Pvt.) Ltd;
Karachi, for toll manufacturing by M/s. Brookes Pharma, Karachi for a period three years:-
S. No. Name of Drug(s) Reg. No.
1. Fozidim 250mg IM/IV Injection 024323
(Ceftazidime)
2. Fozidim 500mg IM/IV Injection 024324
(Ceftazidime)
3. Fozidim 1gm IM/IV Injection 024325
(Ceftazidime)
4. Eftriax 250mg IM Injection 024317
(Ceftriaxone Sodium)
5. Eftriax 500mg IM Injection 024318
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(Ceftriaxone Sodium)
6. Eftriax 1gm IM Injection 024319
(Ceftriaxone Sodium)
7. Eftriax 250mg IV Injection 024320
(Ceftriaxone Sodium)
8. Eftriax 500mg IV Injection 024321
(Ceftriaxone Sodium)
9. Eftriax 1gm IV Injection 024322
(Ceftriaxone Sodium)
Now the firm has informed that they are in advance stage of construction of their
own “Cephalosporins” block the civil work phase will be completed by April, 2005 after which
they will commence the installation of equipments followed by the qualifications work. These
various phases are likely to be completed in 3 to 4 months, and then they will be in a position to
carry their trail production of each product. During this whole period they will need to ensure
that they continuously have adequate stock in their hands of the above products to meet the
market demand.
They have therefore, requested for extension in the said toll manufacturing
permission for a further period of one year. They have furnished the Original Treasury Challan
of Rs. 8000/- each for this purpose.
Decision: The request of the firm was acceded to with the extension in contract
manufacturing permission for six months only.
Case No.7 M/s Bayer Pakistan (Pvt.) Ltd., Karachi. has informed that M/s Bosch
Pharmaceuticals, Karachi has accepted the Intellectual Property Rights / patent right for
“Moxifloxacin” and had withdrawn their product’s registration and undertaken that they shall
not import, produce, formulate, market, sell or offer for sale of any “Moxifloxacin’ containing
products in Pakistan in any manner without permission / license from M/s Bayer Pakistan (Pvt.)
Ltd., Karachi.
Now M/s Bayer have requested to Ministry of Health to cancel all such
registration as soon as possible and do not issue any new registration letter to other companies to
protect Bayer Intellectual Rights.
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It is submitted that a number of firms were granted registration of “Moxifloxacin”
containing products and registration of “Moxifloxcin” has already been cancelled on request of
M/s. Bosch Pharmaceuticals, Karachi.
Decision: The Board decided that all the cases will be taken up in the light of rules
applicable.
Case No. 8 M/s. Bayer have requested for bulk import and local repacking of 6.5 million
capsules over a 3 years period (to be imported on a quarterly basis).
The firm had given a presentation on 7th March, 2005 to MOH about “Adalat
Capsules availability”. Wherein they informed that the results of “Adalat 10mg Capsules”
manufactured at M/s. Catts Pharmaceutical, Karachi did not comply with the required standards
(Toll manufacturing was allowed in Registration Board’s 165th meeting held on 3rd September,
2001). The firm also assured that all efforts are being made for developing a local solution which
required a total period of 24 to 30 month. For this interim period, they have requested for bulk
import and local repacking.
Decision: The request of firm was not acceded to and firm shall be directed for local
manufacturing.
Case No. 9 The Registration Board in its 187th meeting held on 25th –26th November, 2004
had approved the registration of “Laraim Tablets {Mefloquine (base)} 250mg”of M/s. Roche
Pakistan Limited, Karachi for complete local manufacturing. During issuance of registration
letter the representative of firm has informed that they had applied for registration of the said
drug for bulk import and local repacking.
2. Now the firm has submitted a copy of registration application of the said product
wherein it is mentioned that the product “will be imported in bulk in strips and repacked locally”.
They have also enclosed a photocopy of Treasury Challan of Rs. 15,000/- (Fifteen Thousands)
for this purpose. If approved we may issue the registration letter for bulk import and local
repacking.
Decision: The firm was allowed for a period of one year import from “F. Hoffmann-
La Roche Ltd; 4070-Basle, Switzerland” in bulk and local repacking and
then complete local manufacturing.
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Case No. 10 Tamiflu (Oseltramivir) 75mg Capsules was put for bulk import and local
th th th
repacking in the agenda of Registration Board’s 175 meeting held on 13 –14 September,
2002. Wherein the case was deferred for local clinical trails and provision of further supporting
data.
M/s. Roche have furnished information about “Oseltramivir and its potential use
with event of an influenza pandemic” from the Journal of Anti-Microbial Chemotherapy
wherein it is stated that drug has been approved for the treatment and chemoprophylaxis of
influenza in adults and children in 80 countries worldwide.
They have further stated that clinical trials can not be conducted locally. Since
there is presently no case or patient available for the trial. Hence, they have requested to grant
the registration and waive off the condition of local clinical trial.
It is also noted that one time import of 500 packs of “Oseltramivir” have been
approved for emergency situation. (dated 14th April, 2005).
Decision: The request of the firm was not acceded to as the firm has been already
permitted for import of 500 packs of said drug to meet the emergency
requirements.
Case No. 11 M/s. Roche have applied for “Xenical (Orlistat) 120mg Capsules” for bulk import
and local repacking which was deferred by Registration Board in its 175th meeting held on 13th –
14th September, 2002. Registration Board deferred the case for local clinical trials and provision
of further supporting data.
In response, the firm had furnished the required report / clinical trials conducted
by two eminent doctors i.e. Dr. Prof. Javed Akram, King Edward Medical Collage, Lahore and
Dr. Haroon Nabi of Lahore Medical and Dental Collage. The case was again put up in to the
188th meeting of Registration Board held on 13th – 14th October, 2004, wherein Board deferred
the case for evaluation / expert opinion by Brig. M. H. Najmi and Prof. Dr. Shah Nawaz,
comments of the evaluations have now been received which are as follows:-
Brig. M.H. Najmi
i. The action of drug is restricted to lumen of G.I.T. so
systemic concentrations are minimal.
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ii. In contract to other Anti-Obesity drugs, it does not act
on brain and so no dependence.
iii. Approved by FDA.
Hence is recommended for registration.
Prof. Dr. Shah Nawaz.
i. It inhibits absorption of fats from G.I.T. so, it is better
to avoid fats in diet.
ii. BNF states that drug should not be used beyond one
year and in no case for more than two years. While
obesity is a chronic disease.
iii. Not cost effective.
Therefore, Not Recommended for registration.
Decision: The Drugs Registration Board approved the registration of drug as bulk
import and local repacking for two years made under license from F.
Hoffmann La Roche Ltd; Basel, Switzerland by Roche S.p.A. Milan,
Segrate, Italy.
Case No. 12 The Committee of Registration Board in its 182nd (B) Meeting held on 16th April,
2004 had deferred the decision on registration of “Aloha Plus Injection” of M/s. Bosch
Pharmaceuticals, (Pvt.) Ltd; Karachi for submission of complete formulation.
Now the firm has furnished complete formulation the registration of which has
already been granted to M/s. Barrett Hodgson, Karachi under the brand name of “Jectofer Plus
Injection”
Un Complete Formulation Complete / Demanded Formulation
Each ampoule contains:_ Each ampoule contains:-
Iron sorbitol citric acid complex Iron Sorbitol Citric Acid Complex B.P.
eq. to Elemental Iron ………75mg eq. to Elemental Iron……………………..75mg
Folic Acid ………………750mcg Hydroxycobalmin Acetate as Vit. B12…..75mcg
Folic Acid B.P…………………………..750mcg
Decision: The request of the firm was not acceded to and it was also decided to
review the already registered formulations.
Case No. 13 The Registration Board in its 182nd(D) meeting held on 29th April, 2004 had
deferred the decision on registration of “Mobikare Spray Gel” of M/s. Barrett Hodgson Pakistan
(Private) Ltd; Karachi for confirmation of local production facility.
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Now the firm has informed that they had applied for registration of “Mobikare
Spray Gel” on 24th February, 2003, which can not be manufactured locally, though they have
latest state-of- the-art manufacturing facilities to produce Tablets, Syrups, Ointments etc. They
have informed the reasons for not manufacturing “MobiKare Spray Gel” as under:-
The specific galenic form of MobiKare (Diclofenac) Spray Gel is
patented in the European countries with valid patent protection. Barrett
Hodgson Pakistan has entered into licensing agreement with M/s. MIKA
Pharma GmbH, Germany for exclusive rights to market this product in
Pakistan. Mika Pharma would export this “Diclofenac Spray Gel 4%” in
bulk which is manufactured by M/s. Pharbil Waltrop GmbH, Germany.
This spray Gel would then be packed locally (Carton & Labels). The new
patented technology offers unsurpassed topical and targeted delivery of
“Diclofenac” from the “Micellar Formulation” into the affected tissue.
The obtained concentration of the drug in the traumatized tissue is much
higher as obtained after oral treatment with comparable amounts of
“Diclofenac”. This also saves the patients from the systemic side effects
of “Diclofenac”.
The manufacturing and filling requires special conditions. Taking into
account the initial low volumes of products for sales in Pakistan, it is not
practicable and economically feasible to built additional manufacturing
area for this product. Year-I requirement is as under:-
Year-I
MobiKare Spray Gel 4% 15ml 5,000 units
3,000 units
Keeping in view the above fact they have requested to kindly grant registration of
“MobiKara Spray Gel” at the earliest in the interest of patients and as it is not possible for them
to manufacture “MobiKare Spray Gel 4%” in their local production facilities.
Decision: The request of firm was not acceded to.
Case No. 14 The Registration Board in its 177th meeting held on 30th –31st January, 2003 had
deferred the decision on registration of “Amino Plus Tablets” of M/s. Platinum Pharmaceuticals,
Karachi for clarification of formulation.
The firm has informed that the same formulation has already been registered for
import from M/s. Recip AB Astra, Sweden By M/s. Multicare Distribution Services (Pvt.) Ltd;
Karachi under the brand name of “Aminess N” (Reg. No. 021147).
Decision: The request of firm was not acceded to and already registered drugs in this
combination may be reviewed.
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Case No. 15 M/s. Helix Pharma (Pvt.) Ltd; Karachi have requested for change of registration
of their following product from their previous name of firm M/s. Hakeem Sons Chemical
Industry, to their new name i.e. M/s. Helix Pharma:-
S. No. Name of Drug(s) Reg. No.
1. Cerelium 2mg Tablets 002668
2. Cerelium 5mg Tablets 002669
3. Vitacimin Sweetlets Tablets 008174
4. Hitac 150mg Tablets 010919
5. Hifen 400mg Tablets 006973
6. Fradex Eye / Ear Drops 011193
7. Tobracin 0.3% Eye Drops 015830
8. Segate Eye Drops 026647
9. Oflocin 0.3% Ear Drops 024440
10. Oflocin 0.6% Ear Drops 024441
11. Zavir 400mg Tablets 024644
12. Zavir 600mg Tablets 024645
13. Altoron Eye Drops 027019
14. Helipred Eye Drops 025826
15. Fenoptic Eye Drops 026648
16. Hiflone Eye Drops 025825
17. Hipro Eye 0.3% Drops 022542
18. Framycin Eye / Ear Drops 011192
19. Timoptic Eye 0.5% Drops 019749
They have furnished Original Treasury Challan of Rs. 8000/- each for this
purpose.
Decision: The request of the firm was acceded to for the transfer of registration of
aforementioned drugs in the name of M/s. Helix Pharma, Karachi.
Case No. 16 Registration Board in its 182nd meeting held on 23rd April, 2004 had deferred the
decision on registration of Anti-T.B. drugs of M/s. Helix Pharma, Karachi for confirmation of
WHO recommended formulations as under:-
S. No. Name of Drug(s)
i. Ezid Tablets
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Each film coated tablet contains:-
Ethambutol HCl……. 400mg
Isoniazid………….... 150mg
(Chemotherapeutic Agent for the
Treatment of Tuberculosis)
ii. Rizid 150mg Tablets
Each film coated tablet contains:-
Rifampicin………….150mg
Isoniazid…….. …….100mg
(Chemotherapeutic Agent for the
Treatment of Tuberculosis)
It has been found that formulation of “Ezid Tablets” is in accordance with WHO
recommended FDC. While “Rizid 150mg Tablets” is different. The WHO, FDC for “Rizid
150mg Tablets” is (Rifampicin 150mg + Isoniazid 150mg).
The firm has now submitted the formulation of the “Rizid 150mg Tablets” in
accordance with WHO, FDC.
Decision: The request of the firm was acceded to subject to submission of Form-5 in
accordance with WHO recommended formulations for “Rizid 150mg
Tablets”.
Case No. 17 The Registration Board in its 186th meeting held on held on 13th –14th October,
2004 had deferred the decision on registration of “Spasmogin Tablets” of M/s. Epla Laboratories
(Pvt.) Ltd; Karachi for clarification regarding registration of the same brand name under different
formulation.
Now the firm has informed that they had applied for registration of “Spasmogin
Tablets” with the following formulation:
Each tablet contains:-
Acetaminophen BP………300mg
L-Hyoscyamine BPC……0.15mg
The M/o. Health had already been granted the registration of “Spasmogin Plus
Tablets” (Reg. No. 002804) with the following formulation:
Each tablet contains:_
Paracetamol BP…………...300mg
Papaverine Hcl BP…………60mg
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L-Hyoscyamine BPC…….0.15mg
They have therefore, requested for registration of the said product at the earliest as
the said explanation will clarified the whole situation.
Decision: Rejected on the grounds that both the formulation are irrational.
Case No. 18 M/s. Searle Pakistan Limited; Karachi have requested for de-registration of their
registered drugs i.e. “Solicam 10mg & 20mg Capsules” (Reg. No. 024090 & 024091)due to the
reason that:
They had submitted the registration applications of the said
products for import of pre-filled capsules, manufactured and filled
by a special technology of the parent company S.M.B.
Laboratories-Belgium. However, M/o. Health granted approval for
local manufacture to which the principal company did not agree.
Decision: The request of the firm was not acceded to.
Case No. 19 The Registration Board in its 169th meeting held on 18th-19th & 20th February,
2002 had granted the registration of “Fenogal (Fenofibrate) 200mg Capsules” to M/s. Searle
Pakistan Limited, Karachi.
Now the firm has informed that:-
Their initial registration dated 11th June, 2001 was for the import of prefilled
capsules for local repackaging.
As a matter of fact the Lidose (Gelatin Capsules containing a paste) can be
considered as a raw material as the capsules and its content constitute a
hormogeneous entity.
They have requested to allow them to import prefilled capsules for local repacking according to
their original request.
Decision: The request of the firm was not acceded to.
Case No. 20 M/s. Getz Pharma, Karachi have informed that the source for bulk import of
“Uniferon (Inteferon Alfa-2b) 3MIU & 5MIU Injection” is changed from M/s. Sicor Biotech
UAB, Lithuania to Lemery S.A. de C.V., Mexico due to the consolidation of manufacturing
premises form Lithuania to Mexico for the manufacture of biological products. Lemery has also
been their supplier for their already registered drug “Risek Infusion” (Reg. No. 024170). They
have also received approval for the bulk import of their recently registered oncology drugs from
the same company. Both their companies are having good mutual understanding for the past 3
years now.
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They have requested for approval of change of source as the product composition,
manufacturing process, finished product specifications and release specifications remains
unchanged. They have furnished 2 Original Treasury Challan of Rs. 15000/- (fifteen thousands)
each and relevant documents for this purpose.
Decision: The request of the firm was not acceded to.
Case No. 21 The Registration Board in its 151st, 154th and 155th meeting held on 16-
17/02/2000, 24-25/05/2000 and 21-23/08/2000 had granted the permission for toll manufacturing
of the following drugs of M/s. Wyeth Pakistan Ltd; Karachi from M/s. Macter International,
Karachi:-
S. No. Reg. No Name of Drug(s) Permission Approved
Granted Up To Extension Up To
1. 000093 Omnipen 250mg Capsules 02-03-2002 01-03-2005
(Ampicillin)
2. 000091 Omnipen 500mg Capsules -do- -do-
(Ampicillin)
3. 000092 Omnipen 125mg -do- -do-
Suspension (Ampicillin)
4. 000092 Omnipen 250mg -do- -do-
Suspension (Ampicillin)
5. 010015 Wymox 250mg Capsules -do- -do-
(Amoxicillin)
6. 010016 Wymox 500mg Capsules -do- -do-
(Amoxicillin)
7. 010017 Wymox 125mg Suspension -do- -do-
(Amoxicillin)
8. 012816 Wymox 250mg Suspension -do- -do-
(Amoxicillin)
9. 006128 Omnipen-N 250mg 12-09-2002 11-09-2005
Injection (Ampicillin)
10. 006127 Omnipen –N 500mg -do- -do-
Injection (Ampicillin)
11. 013747 Wymox 250mg Injection -do- -do-
(Amoxicillin)
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12. 013748 Wymox 500mg Injection -do- -do-
(Amoxicillin)
13. 000199 Penidure LA 1.2mu 21-06-2002 20-06-2005
Injection (Benzathine
Pencillin)
14. 000200 Penidure LA 0.6mu -do- -do-
Injection (Benzathine
Pencillin)
15. 011582 Penidure LA 2.4mu -do- -do-
Injection (Benzathine
Pencillin)
The said permissions were extended by the Registration Board in its 170th
meeting held 19/03/2002 for a period of 3 years.
Now the firm has requested for further extension of the said toll manufacturing
permission (period not mentioned). They have submitted 15 Original Treasury Challan of Rs.
8000/-(eight thousands) each for this purpose.
Decision: The request of the firm was acceded for the drugs at Sl. No. 13 to 15, up to
31st December, 2005, while decision regarding the remaining drugs was
deferred for personal hearing in the next meeting.
Case No. 22 The application for registration of “Lxyzol Tablets” in the name of M/s. Eli Lilly,
Gohar toll manufactured by M/s. AGP, Karachi was recommended for registration by the
Registration Board, in 183rd meeting held on 29th & 30th June, 2004. But in the 188th meeting of
Registration Board held on 28th December, 2004 the Board after thorough discussion decided to
grant 6 months toll manufacturing permission to those firms which were in process of
establishment of their own manufacturing facility and shown improvement in development of
their own facility.
Now the expansion of layout-plan of M/s. Eli Lilly Gohar has been approved by
this Ministry’s letter No.F. 2-49/84-Lic (Vol. II) dated 29th March, 2005. The case may be
considered for the approval of toll for one year by M/s. AGP in the name of M/s. Eli Lilly
Ghohar.
Decision: The request of the firm was accede to up to 31st December, 2005.
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AVIALBILITY OF DRUGS.
Case No. 23 The ADG (E&M) M/o. Health, Islamabad has forwarded a case wherein it is
informed that regular complaints regarding the availability of monopoly drugs manufactured by
multinational companies.
Under the Drugs Act, 1976 it is the main responsibility of the manufacturer /
importer / indenter to manufacture and ensure the smooth and frequently supply of all registered
drugs under rules 30 (40 of Drugs (Licensing, Registering & Advertising) Rules, 1976.
It is also responsibility of the Provincial Governments under Sub-Section 12 of
Section (7) of Drugs Act, 1976 to take all such steps as may be necessary to ensure compliance
with the conditions of registration and as availability of drugs is a condition of registration. So it
is proposed that the Provincial Governments may be directed to implement the said clause of
Drugs Act, 1976 for regular supply of the registered drugs specially the life saving / essential
drugs which remain commonly short in the local market or are partially available.
Decision: The Drug Registration Board decided that registration section shall submit
list of drugs and manufactures who are not manufacturing their registered
drugs or fail to manufacture and make available in the market within 6
months of the registration. The discontinuation of any registered drug
without prior permission from the Registration Board shall not be allowed
and action shall be initiated under rules against the defaulters. The Board
also requested the observers of PPMA and Pharma Bureau to do needful in
this regard and direct their members for availability of the registered
drugs. In this regard the Registration Board also decided to direct the FIDs
for inspections of pharmaceuticals units in their respective jurisdictions
and furnish reports to the Drugs Section for submission in the next
meeting.
Case No. 24 The Registration Board in its 175th meeting held on 13th –14th September, 2002,
had granted the registration of drug “Antus-P Syrup” (Reg. No. 029214) to M/s. PharmEvo (Pvt.)
Ltd; Karachi. The firm has been requested for correction in formulation of the said product as
under:-
Existing Formulation Demanded Formulation
Antus-P Syrup Antus-P Syrup
Each 5ml contains:- Each 5ml contains:-
Triprolidine……….1.5mg Triprolidine…….1.25mg
Pseudophedrine……36mg Pseudophedrine..…30mg
Paracetamol………300mg Paracetamol………80mg
The firm has deposited the requisite fee of Rs. 8000/- (eight thousands) for this purpose.
Decision: The request of the firm was acceded.
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Case No. 25 M/s. Merck Marker (Pvt.) Ltd; Quetta have informed that “Evion 600mg
Capsules” (Reg. No. 016099) is their product which was registered in the name of M/s. Catts
Pharmaceuticals (Pvt.) Ltd; Karachi. They have therefore, requested for transfer of registration of
the said product to their name. However, the same product would continue to be manufactured
by M/s. Catts Pharmaceuticals, Karachi.
They have furnished N.O.C. from M/s.Catts and an Original Treasury Challan of
Rs. 8000/- (eight thousands) for further processing the case.
Decision: The request of the firm was acceded to.
Case No. 26 M/s. Merck Marker, Quetta have informed that atomic absorption
Spectrophotomerter has been installed and become operative in their manufacture site at M/s.
Catts Pharmaceuticals, S.I.T.E, Karachi which is the subsidiary of M/s. Merck Marker.
Decision: The request of the firm was acceded to.
Case No. 27 The firm has further informed that the production and commercialization of the
products containing “Metamizole” i.e. “Dolo-Neurobion Injection & Tablets, Sistalgin Comp,
Ampoule/ Tablets have been stopped since October, 2004. The decision to discontinue
“Metamizole is based on the fact that it is associated with an increase risk of agranulocytosis and
with shock.
Decision: The Board decided to review all the cases of oral formulation containing
“Metamizole” which are already registered and issue show cause notices
for cancellation of these registrations. The Board also directed to submit
the list in the forthcoming meeting of Registration Board.
Case No. 28 M/s. Adamjee Pharmaceuticals (Pvt.) Ltd; Karachi have requested for de-
registration of their following registered products for various reasons:-
S. No. Name of Drug(s) Reg. No(s)
1. Ampicillin Capsules 007612
2. Aspirin Tablets 006839
3. Aspirin Compound Tablets 007102
4. Chloropheneramine Maleate Injection 008180
5. Chloropheneramine Maleate Tablets 006842
6. Chloroquine Phosphate Injection 007614
7. Cisallium Suspension (Cisapride) 022434
8. Cisallium Tablets(Cisapride) 019166
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9. Depre Injection (Trazodone) 015189
10. Dexazone Injection (Dexamethasone) 011853
11. Enzyme Syrup 008990
12. Ethambutol-INH Tablets 006800
13. Ferrous Sulphate Folic Acid Capsules 007606
14. Histalong Injection (Phenerimine Maleate) 011302
15. Isopropamid Compound Tablets 006802
16. Lignocaine + Adrenaline Injection 009258
17. Nikethamide Injection 008954
18. Phenylbutazone Injection 009491
19. Phenylbutazone Tablets 017760
20. Samcol Syrup (Cough Syrup) 007395
21. Samohex Powder (Comp. Effervasent) 007608
22. Samoplex Injection (B-Complex) 007617
23. Samoplex Tablets(B-Complex) 007610
24. Spasmol Injection (Hyocine Compound) 011852
25. Spasmol Plain Injection (Hyocine) 013931
26. Sulphadiazine Tablets 007105
27. Water of Injection 007615
Reasons:
They have informed that the products at Sl. No. 1 to 6 were registered previous
owner of the company and 7 to Eleven were registered by them. At present they are unable to
continue with production of their injectable range due to intense price competition within this
field. In almost all cases their cost is higher than the selling prices of a number of company. It
may be noted that all products except “Deprel Injection” are of general nature and are being
manufactured by many companies. Hence there is not question of shortage of these items.
“Deprel Injection” is an Antidepressant which has not really been accepted by doctors and they
have to stop marketing this product also. However, “Deprel Tablets” is being marketed by them
quite successfully for the past ten years.
In the past they had operated their injectable department almost solely on the
basis of exports to Yemen. However, unfortunately due to severe competition from India their
sales to Yemen have completely finished. Considering the above, they would like to close their
injection department. This area which is next to their liquid department will be utilized as part of
the Liquid Area which is growing quite rapidly, and for which they require additional space.
They would also like to request to allow them registration of eleven products in Tablets, Liquid,
Capsule or Ointments forms in lieu of giving up the above mentioned eleven injections.
Decision: The request of the firm was acceded to.
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Case No. 29 The Registration Board in its 186th meeting held on 13th –14th October, 2004 had
rejected the registration of “Spinalcain-3H 7.5mg (Bupivacaine) Injection of M/s. Geofman
Pharmaceuticals, Karachi due to safety reason as this strength is not available in UK and USA.
Now the firm has informed that the same strength / formulation has already been
registered under the brand name “Abocain Spinal” (Reg. No. 018143) in the name of M/s.
Abbott Laboratories, Karachi and is being prescribed and sold in Pakistan.
Decision: The request of the firm was acceded to.
Case No. 30 The Registration Board in its 180th meeting of the Registration Board held on 19th
September, 2003 had deferred the decision on registration of “Dinemic (Trimetazidine
Dihydrochloride) SR 25mg Tablets” of M/s. Efroze Chemical Industries, Karachi which to be
referred to the review committee.
Now the firm has informed that the said formulation has already been registered
under the brand name of “Vastarel (Trimetazidine Dihydrochloride) MR 35mg Tablets” in the
name of M/s. Servier Research & Pharmaceuticals Pakistan Ltd; Lahore and is already available
in the market. They have also informed that they are manufacturing and marketing the same
formulation in 20mg strength.
They have therefore, requested to grant registration of the said product as soon as
possible to provide quality product to the cardiovascular patients. As its registration is pending
for more than 20 months with the M/o. Health.
Decision: The firm shall be directed to submit clinical trials as well as stability data
for the drug.
Case No. 31 The DDC(R.R.R.) M/o. Health has forwarded the case wherein it is informed that:
Renewal of registration of drug is granted under Rule 26(amended vide SRO
691(1)91 dated 29th July, 1991, SRO 959(1)/91 dated 26th September, 1991 and SRO
877(1)/2000 dated 9th December, 2000 and Rule 27 of Drugs (Licensing, Registering &
Advertising) Rules, 1976, according to which if the application for renewal of registration is
made after the expiry of the period of the validity of the certificate / registration it shall treated as
a fresh application for the registration of drugs, provided that if the application for renewal is
made with in 60 days after the expiry of period of validity of certificate then late fee is required
as per schedule F of the said rules. The firms when apply for renewal of registrations, their last
8bf8db69-b12c-4cc4-b1cc-181b0548f6ac.doc
renewal submitted is also checked in addition to the required documents. Upon scrutiny of
documents, it is revealed that many firms have submitted their last renewal applications after the
expiry of registration certificates but with in the 60 days grace period, however the late full fees
have not been paid.
The firms however are reluctant to pay late fees for their last renewals on the
ground that when they applied for renewals, five years back, the Ministry did not object or asked
them to pay the required late fees at that time and the registrations remain valid. Moreover, as
there is no proper system or data base available in order to check if all the firms are submitting
their renewal applications, therefore only those firms have been asked to submit the late fees of
the last renewals (which is five years back) which are applying for the renewals of registration of
their drugs, and there is no monitoring of the firms which are no applying for renewals.
The said action i.e. asking firms to submit late fees for their last renewals should
be taken five years back. Moreover, to trace such old record in this Ministry is also an up hill
task and in the current scenario is not possible as almost 40,000 drugs are registered, the officer
is without any computer and most of the old record is not traceable. Due to this reason many
cases of the firms are pending some of which are detailed below, and similar type of cases are
unidentified yet.
Therefore, in order to streamline the system and for the renewal of registration
letter to the firms a policy decision should be taken by the Drug Registration Board. It is
proposed that when firms apply for the renewal of registrations, their last renewals should be
accepted on the ground that there was no objection from this Ministry and their applications were
accepted at the time and the registrations of the drugs remains valid for five years.
Decision: It is observed that many firms have submitted their last renewal
applications after the expiry of registration certificates but with in the 60
days grace period, however the late full fees have not been paid, therefore,
the Drug Registration Board have decided that the drugs for which due /
pending renewal fees i.e. last renewal fees, late renewal fees (if application
is submitted after expiry of validity of registration certificate but with in
grace period of 60 days) and current renewal fees etc, have not been paid
by the firms, the registrations for those drugs shall be considered as not
valid. The firms may however apply for the fresh registrations with full
registration fees, if they desire.
2. With regards to the exact date of validity of a registration certificate, the
Board clarified that the validity shall stand expired on the date printed on
the certificate (after validity period of five years or any other period
specified), therefore, the renewal applications due for the registrations of a
drug shall be considered one day late if submitted on the exact date of
issuance of registration letter after including five years or any other period
specified.
Case No. 32 The Registration Board in its 186th meeting held on 13th – 14th October, 2004
deferred the request of M/s. Pharmacia Pakistan (Pvt.) Ltd; Karachi for change of source of
“Cytosar” (Cytarabine) 100mg & 500mg Injections” (Reg. Nos. 005771 & 022545) from Purrs
Belgium to Nerviano Plant, Italy for confirmation regarding availability of the said drugs in the
country of origin.
8bf8db69-b12c-4cc4-b1cc-181b0548f6ac.doc
The firm has provided the free sale certificates from the country of origin (Italy)
wherein the name of the product is ARACYTIN. They had already submitted the Original
Treasury Challans of Rs. 15000/- (fifteen thousands) each.
Decision: The request of the firm was acceded to.
Case. No. 34 The Me Too Committee in its 181st held on 4th March, 2003 had deferred the
decision for the registration of “Pladex-5 Extra Safe I/V Infusion” and “Ringolact Extra Safe
Injection 500ml & 1000ml” in plabottle of M/s. Otsuka Pakistan Limited, Karachi for
submission of justification / clarification for registration of said drugs with “Special Plifer Proof
Flif-Off Caps” instead of having already registration of same formulation in their name.
Now M/s. Otsuka Pakistan Limited Karachi have informed that “Pladex-D Extra
Safe” Intravenous I/V infusion and “Ringolact Extra Safe Injection 500ml & 1000ml” and
plabottle with “Special Plifer Proof Flif Cap” are special designed by Japan Otsuka for safer use
on intravenous infusion and asptic drug dilution with infusion bottle to avoid contamination
specially for critically ill patients where even a minor reaction could not be affordable. This extra
safe packing make the product much safer and reliable as compared to similar drugs available in
the market.
Decision: The request of the firm was not acceded to due to cost effectiveness.
Case No. 35 The ADC (I&E) had forwarded a case stating that the following firms had
requested first time for the allocation of quota of Narcotic/Psychotropic substances, after 13
years (M/s. Mediate Pharma) and 5 years (M/s. Tagma Pharma) of their initial registration. The
firms had contravened one of the conditions of registration, which states that the drug will be
marketed within 6 months of its registration. The firms were not granted quota and the matter
was placed for the consideration of Drug Registration Board’s as per DC’s instruction:-
S.No. Name of Name of Drug/Reg Active Number and Renewal
Firm No. Ingredient Date of Reg Status
Letter.
i. M/s Mediate Bromazepam 3mg Bromazepam No.F.6-7/90.R-II Up-to-date
Pharma, Tablets(Reg No. (M-81)
Karachi 011257) dated 30/06/1990
ii. M/s Tagma Tide Tablets Midazolam No.F.3-2/99.R-II Up-to-date
Pharma, (Reg No. 023380) (M-140)
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(Pvt.) Ltd, dated 30/04/1999
Lahore.
The said case was put up to the Registration Board in its 183rd meeting held on
29-30/06/2004 as such. The Board had observed that both the firms had not imported the active
ingredient for the manufacturing of the said drugs for the last 5 to 15 years which was the
violation of the condition of registration under the Drugs Act, 1976 i.e to market the dugs within
the six month after the registration. The Board therefore decided to issue Show Cause Notices to
both the firms for cancellation of registrations of the drugs in question. Accordingly Show
Cause Notices were issued to them.
Now they have replied to the said show cause notices as under:-
i) M/s. Tagma Pharma (Pvt.) Ltd., Lahore have informed that
when they get the registration for “Tide 7.5mg Tablets” (Reg.
No. 023380) its raw-material was not available in the
International market and only the parent company i.e M/s.
Roche were manufacturing the product using its own raw-
material. After two years of that its raw-martial became
available in the International market with a price of 15,000 US
$ /KG. With this price it was not feasible to manufacture the
products with the price given by the M/o Health at the time
of registration. They kept an eye on the price of the raw-
material & now it is available in the International market with a
price of 3000 US $ /Kg, and it is possible for them to
manufacture the product with its given price. So they are
interested to manufacture & market the said product for healthy
competition. They have therefore, requested to kindly grant
them the permission to import “Midazolam Maleate 20kg” for
manufacturing of Tide 7.5mg Tablets (Reg. No. 023380).
In future they will not do such mistake and will market the registered product well
in time.
ii) M/s. Mediate Pharmaceuticals (Pvt.) Ltd., Karachi have
informed that in 2003 their new management i.e M/s. Mediate
Pharmaceuticals (Pvt.) Ltd., Karachi had taken over the
possession from the farmer management of M/s. Prema
products (Pvt.) Ltd., Karachi. The question regarding
import/manufacture of Bromazepam was the responsibility of
former management, when they taken over the possession of
unit, then they had immediately applied for quota of
Bromazepam and the same has not been granted so far.
They are ready to manufacture their registered product “Lexatec 3mg Tablets
(Bromazepam) (Reg. No. 011257) but since last year no response has been given to their request
regarding allotment of quota of Bromazepam and they are waiting for the same.
8bf8db69-b12c-4cc4-b1cc-181b0548f6ac.doc
In view of the above position they have requested that the Show Cause Notice may
kindly be withdrawn and necessary quota of Bromazepam for the year 2003 and 2004 may
please be issued.
They will be highly grateful if due consideration is given to their request.
Decision: The representative of M/s. Tagma Pharma, Lahore appeared before the
Board while M/s. Mediate Pharma, Karachi failed to appear:-
i) The Board has decided to de-register the “Tide (Midazolam)
Tablets” (Reg. No. 023380) of M/s. Tagma Pharma, Lahore.
ii) The Board has decided to de-register the formulation of
“Bromazepam (Bromazepam) 3mg Tablets” (Reg No. 011257) of
M/s. Mediate Pharma, Karachi.
Case No. 36 The Appellate Board remanded back the following appeals:-
S. No. Appeal No. Company Purpose of Appeal
i. 711 M/s. Pfizer Registration of Drug
Laboratories, “Viagra (Sildenafil
Karachi. Citrate) 25mg, 50mg &
100mg Tablets” for
import.
The Board in its 120th sitting had decided that “All drug manufacturers of same
category may be called collectively in next sitting of the Board so that the Board could take
appropriate decision after taking into consideration all aspects of the case. The representative of
the firms manufacturing the said salt are called for personal hearing as under:-
S. No. Name of Firm(s)
i. M/s. Wilson Pharmaceuticals, Islamabad.
ii. M/s. Werrick Pharmaceuticals, Islamabad.
iii. M/s. Helicon Pharmaceutiek, Faisalabad.
iv. M/s. Alina Combine, Karachi
v. M/s. Spencer Pharma, Karachi
vi. M/s. Highnoon Labs, Lahore
vii. M/s. Atco Labs, Karachi
viii. M/s. Hilton Pharma, Karachi.
ix. M/s. Farmaceutics, Karachi
x. M/s. Medisure Labs, Karachi.
Decision: To follow the decision for brand leader i.e. “Viagra” which is being dealt
by Registration-I Section.
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