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The 204th meeting of the Drug Registration Board was held on 23rd

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					     MINUTES OF 205TH MEETING OFCENTRAL LICENSING & DRUGS
          REGISTRATION BOARD HELD ON 30TH – 31ST MARCH, 2007
                                            (REG-II SOUTH)


                      The 205th meeting of the Drug Registration Board was held on 30th – 31st March, ,
2007 in the Committee Room of Ministry of Health, Islamabad which was chaired by Maj. Gen
® Dr. Shahida Malik Director General Health. It commenced with the recitation of verses from
the Holy Quran. The meeting was attended by the following members:-

1.         Maj. Gen ® Nasir-ul-Islam
           Rawalpinid.

2.         Mr. Abdul Latif Sheikh,
           Director,
           Pharmacy, Nutrition & CSSD Services,
           Agha Khan University Hospital, Karachi

3.         Dr. Ijaz Ahmed, Associate Professor,
           University of Veterinary and Animal Sciences,
           Lahore.

4.         Dr. IU Baig,
           Consultant Surgeon,
           Federal Government Services Hospital,
           Islamabad.

5.         Prof. Dr. Muhammad Jamshaid,
           Principal, University College of Pharmacy,
           University of the Punjab, Lahore.

6.         Animal Husbandry Commissioner
           M/o. Food, Agriculture & Livestock,
           Islamabad

7.         Arshad M. Tabassum
           Deputy Secretary,
           M/s. Law, Justice & Human Rights,
           Islamabad

8.         Representataive of Director General Health Services,
           Government of Punjab,
           Lahore.

9.         Representative of Director General Health Services,
           Government of NWFP,
           Peshawar
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10.        Representative of Director General Health Services,
           Government of Balochistan,
           Quetta.

           Mrs. Yasmeen Abbasi
11.        Controller of Patents,
           Karachi

12.        Deputy Secretary
           M/s. Industries & Production
           Islamabad

13.        Mr. Amanullah
           Cost Accountant,
           M/o. Health, Islamabad.

14.        Dr. Farnaz Malik,                                     (Also Secretary of the Board)
           Drugs Controller, Ministry of Health,
           Islamabad.



                      Ghulam Rasool Dutani, Deputy Director General (Registration) 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.

                      Mr. Zahid Saeed representative of Pakistan Pharmaceutical Manufacturers

Association, Mr. M.Zafar Mooraj, Advisor to Pharma Bureau, Karachi, Representative of

Pakistan chemists and Druggists Association, Karachi and Mr. Ayaz Kiani, representative of the

Network for Consumer Protection also attended the meeting as observers.


Item No. I            MISCELLANEOUS CASES


Case No. 1            NEW LINCE AND NEW SECTIONS OF FOLLOWING FIRMS

1.                    The ten products of the firm were approved for registration to a newly establish
units. The 5 registrations were issued to the firm while five products were not issued due to non-
availability of prices. The firm has requested for the consideration of the pending applications
because of the huge investment on the unit could not be utilized with five products:-
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S. No.       Name of            Name of Drugs & Composition       Pack     Demanded          Decision
             firm(s)                                             Size(s)     Price
   1.          M/s.             Hemosol IV Solution              500ml     Rs. 275.48       Approved
             Marion             Each 100ml solution contains:_
              Labs,             Polygeline……3.5gm
             Karachi            Water for injection…..q.s
                                (Polygeline + Electrolytes)

   2.            -do-           Kalsol IV Solution               20ml       Rs. 8.90    Approved subject to
                                Each 20ml solution contains:_                             verification of
                                Potassium Chloride……1.49gm                               facility for 20ml
                                Water for injection…..q.s                                plastic ampoules
                                (Electrolytes)

   3.            -do-           Supersol 10 IV Solution           500ml    Rs. 30.00        Approved
                                Each 100ml solution contains:_   1000ml    Rs. 40.00
                                Dextrose………10gm
                                Water for injection…..q.s
                                (carbohydrates)

   4.            -do-           Supersol F IV Solution            500ml    Rs. 29.00        Deferred for
                                Each 100ml solution contains:_   1000ml    Rs. 34.00      clarification and
                                Fructose………5gm                                               evidence of
                                Water for injection…..q.s                                     Fructose
                                (carbohydrates).                                           availability in
                                                                                        developed countries
                                                                                        specially UK, USA.




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                                                          3
5.            -do-           Supersol IV Solution             500ml   Rs. 317.20        Deferred for
                             Each 100ml solution contains:_                            inspection of
                             L-Arginine HCl………..0.266g                                  facilities for
                             L-Histidine HCl. H20….0.135g                              verification of
                             L-Isoleucine……………0.320g                                 testing methods,
                             L-Leucine………………0.240g                                    manufacturing
                             L-Lysine HCl…………..0.250g                               facilities, stability
                             L-Methionine……….…0.300g                                   data and other
                             L-Phenylalanine……….0.400g                               allied systems by
                             L-Threonine…………..0.200g                               the following panel.
                             L-Tryptophan………….0.100g
                             L-Valine……………….0.320g                                  i.   Abdul Latif
                             Glycine………………..1.400g                                       Sheikh
                             L-Proline………….…..0.200g                                ii. Mr. Obaid Ali
                             L-Alanine…………….0.600g                                  iii. Area FID,
                             D-Sorbitol…………...10.00g
                             Riboflavin Sodium
                             Phosphate…………...0.250mg
                             Nicotinamide………..6.000mg
                             Pyridoxine HCl……...4.000mg
                             Ascorbic acid………..40.00mg
                             Inositol……………....50.00mg
                             Water for injection………..q.s
                             Electrolytes (mEq/L)
                             Sodium……………………35
                             Potassium…………………25
                             Magnesium…………………5
                             Chloride…………………...38
                             Acetate……………………35
                             Malate…………………….22
                             (Amino acids)

6.            -do-           Megamine-SG IV Solution          500ml   Rs. 359.70           -do-
                             Each 100ml solution contains:_
                             D-Sorbitol………….…...5.00g
                             L-Arginine HCl………...0.80g
                             L-Histidine HCl. H20…..0.40g
                             L-Isoleucine…………….0.55g
                             L-Leucine…………….…1.23g
                             L-Lysine HCl…………...1.86g
                             L-Methionine………..…..0.71g
                             L-Phenylalanine…………0.87g
                             L-Threonine………….…..0.54g
                             L-Tryptophan…………….0.18g
                             L-Valine………………….0.61g
                             Glycine…………………..1.00g
                             Water for injection………..q.s
                             (Parenteral nutrition)



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7.            -do-           Megamine-G IV Solution            500ml    Rs. 205.92     -do-
                             Each 100ml solution contains:_
                             D-Sorbitol………….….....5.0g
                             L-Arginine HCl………....0.27g
                             L-Histidine HCl. H20…...0.13g
                             L-Isoleucine………….….0.18g
                             L-Leucine……………..…0.41g
                             L-Lysine HCl…………....0.62g
                             L-Methionine………..…...0.24g
                             L-Phenylalanine………….0.29g
                             L-Threonine………….…..0.18g
                             L-Tryptophan…………….0.06g
                             L-Valine………………….0.2g
                             Glycine…………………..0.34g
                             Water for injection………..q.s
                             (Parenteral nutrition)

8.            -do-           Hepamine IV Solution              500ml    Rs. 457.60     -do-
                             Each 100ml solution contains:_
                             L-Arginine HCl……….....0.730g
                             L-Histidine HCl. H20…....0.320g
                             L-Isoleucine………….…..0.900g
                             L-Leucine……………...…0.100g
                             L-Lysine HCl………….....0.760g
                             L-Methionine………..…...0.100g
                             L-Phenylalanine………….0.100g
                             L-Threonine………….…..0.450g
                             L-Tryptophan…………….0.070g
                             L-Valine………………….0.840g
                             Glycine…………………..0.900g
                             L-Proline………………....0.800g
                             L-Serine………………….0.500g
                             L-Alanine………………...0.750g
                             L-Cysterine HCl. H20…...0.040g
                             Sodium Bisulfite………....0.30g
                             Chloride…………...….94mEq/L
                             Sodium…………….1.400mEq/L
                             Water for injection………..q.s
                             (Parenteral nutrition)

9.            -do-           Superlyte-M IV Solution            500ml   Rs. 35.00    Approved
                             Each 1000ml solution contains:_   1000ml   Rs. 48.00
                             Calcium Chloride……..1.5g
                             Sodium Acetate……...2.16g
                             Potassium Chloride…...1.5g
                             Dextrose……………….50g
                             Water for injection……q.s




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                                                       5
   2.         It is a newly established section. Its applications for the grant of registration were rejected
   due to in complete manufactauring and quality control methods for the Me-Too as well as new
   molecule inhaler products. Now the firm has submitted following applications only for the
   generic formulations registered in the country. Although the firm has submitted stability studies
   for the 6 months accelerated and 48 months in long terms but this needs confirmations.


S. No.     Name of              Name of Drugs & Composition         Pack      Demanded               Decision
            firm(s)                                                Size(s)      Price
   1.         M/s.              Ipra 40mcg Inhaler                  Meter     Rs. 218.50    Approved subject to
           Platinum             Each delivered dose of inhaler      dose                       inspection for
          Pharmaceut            contains:-                         aerosol                     verification of
              ical,             Ipratropium Bromide                  200                        inhaler types,
           Karachi              Monohydrate eq. to Ipratropium      doses                         standard
                                Bromide………….40mcg                                           formulations, testing
                                (Prophylactic respiratory)                                        methods,
                                                                                               manufacturing
                                                                                             facilities, stability
                                                                                            data and other allied
                                                                                               systems by the
                                                                                              following panel.

                                                                                             i.   Abdul Latif
                                                                                                  Sheikh
                                                                                             ii. Mr. Obaid Ali
                                                                                             iii. Area FID,

   2.           -do-            Socrom CFC-Free Inhaler              112      Rs. 334.86                -do-
                                Each metered dose inhalation       inhalati                       Verification of
                                contains:-                           ons                              standard
                                Sodium Cromoglycate…..1mg                                           formulation
                                (Anti-asthmatic)                                                  because sodium
                                                                                                   Cromoglycate
                                                                                                   5mg (per dose
                                                                                                   inhalers) were
                                                                                                      found in
                                                                                                     developed
                                                                                                     countries.

   3.           -do-            Salmet CFC Free Inhaler              120      Rs. 910.00               -do-
                                Each single actuation contains:_   metered
                                Salmeterol Xinafoate eq. to        actuatio
                                Salmeterol……………….25mcg                n
                                FluticasonePropionate….125mcg
                                (Anti-asthma )




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                                                           6
4.      -do-       Salbu Inhaler                        200         Rs. 84.74.00          -do-
                   Each metered inhalation delivers:_ metered
                   Salbutamol……….100mcg               inhalati
                   (oral inhalation)                    ons

5.      -do-       Airease Inhalation Solution 6mcg       100       Rs.637.00/P           -do-
                   Each metered dose contains:-         actuatio     ack of 100
                   Formoterol Fumarate                     ns        actuations
                   Dehydrate…..6mcg
                                                          120        Rs.765.00
                                                        actuatio    Pack of 120
                                                           ns        actuations

6.      -do-       Salbucort Inhaler                       200      Rs. 230.40            -do-
                   Each metered inhalation contains:-    inhalati
                   Salbutamol Micronised…100mcg            ons
                   Beclomethasone
                   Dipropionate…………….50mcg
                   (oral inhalation)

7.      -do-       Salmet CFC Free Inhaler                120       Rs. 820.40            -do-
                   Each single acuation provide:-       metered
                   Salmeterol Xinafoate eq. to          acutrati
                   Salmeterol ………………25mcg                 ons
                   Fluticasone Propionate….50mcg
                   (oral inhalation)

8.      -do-       Salmet CFC Free Inhaler                120       Rs. 1040.00           -do-
                   Each single acuation provide:-       metered
                   Salmeterol Xinafoate eq. to          acutrati
                   Salmeterol …………….…25mcg                ons
                   Fluticasone Propionate….250mcg
                   (oral inhalation)

9.      -do-       Budecort Inhaler 50mcg/dose            200       Rs. 271.13            -do-
                   Each metered inhalation delivers:-   metered
                   Budesonide……..50mcg                   doses
                   (oral inhalation)

10.     -do-       Budecort Inhaler 200mcg/dose           100       Rs. 304.30            -do-
                   Each metered inhalation delivers:-   metered
                   Budesonide……..200mcg                  doses
                   (oral inhalation)



Case No. 2     M/s NabiQasim Industries Pvt. Ltd. have informed that in the registration letter of
their product Myzogel Oral Gel, the name of the active ingredient was typed as “Miconazole
Nitrate” due to the typographic mistake instead of “Miconazole”. The use of Miconazole Nitrate
is neither recommended in the Medical text books nor in any Medical Journal or magazine. Now
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                                              7
the firm has requested for correction in the generic name or grant of new registration with correct
ingredient i.e., “Miconazole” instead of “Miconazole Nitrate”.


                        The firm has deposited Rs.8000/- for the said purpose.


Decision:               The request of the firm was acceded to.


Case No. 3              Drug Registration Board in its 176th meeting held on 31st October & 1st November
2002 had granted the permission for toll manufacturing of following products of M/s Karachi
Chemical Industries from M/s Medicaids Pakistan, Karachi for a period of three years. Now the
firm has again requested to extend the toll manufacturing permission for a further period of five
years.
                             S. No. Name of Drugs                             Reg. No.
                             1.            Kaysef (Cephradine) 250mg Inj.     024223
                             2.            Kaysef (Cephradine) 500mg Inj.     024224


           The firm has deposited Rs.8000/- for each product for the said purpose.


Decision                The request of the firm was deferred due to failure of sample of M/s. Medicaids,
                        Karachi (contract manufacturer) i.e. Ecocef 1G Injection (Batch No. 6V047 &
                        6A069) were declared substandared by CDL, Karachi vide test report No. 355-
                        A/2006 & 355-B/2006. It was decided to verify the detail from the contract
                        manufacturer to explain his position and put up the case in forthcoming meeting.

Case No. 4              M/s Excel Health Care Laboratories (Pvt.) Ltd. Karachi has informed that they are
importing the product as per detail given below:-

                S. No.       Brand Name                 Generic Name        Pack Size    Reg. No.
                  1.         Cyclogest 200mg            Progesterone        1x 15’s      033181
                                                        Pessaries

                   2.        Cyclogest 400mg            Progesterone        1x 15’s      033182
                                                        Pessaries




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           Now they want to import the above mentioned products in Bulk & get it Repack locally

from M/s Elko Organization (Pvt) Ltd. Situated at 27 & 28, sector 12/b Industrial Area, Karachi.

They have submitted a copy of agreement & deposited the requisite fee of Rs.800/- for each

product.


Decision:             The request of the firm was acceded to for a period of one year.

Case No. 5 Drug Registration Board in its 170th meeting approved the registration of Leflox
(Levofloxacin) I.V 500mg of M/s Getz Pharma by way of toll manufacturing from M/s Spencer
Pharma, Karachi. Now the firm has requested that they actually, had requested for toll
manufacturing from M/s Spencer Pharma & repacking at M/s Getz. Since on registration letter
‘Repacking At M/S Getz” has not been mentioned. Due to which they have to face difficulties
from Regulatory Authorities at Karachi. Firm want to issue the Corrigendum.

Decision:             The request of the firm for withdrawal of the request was acceded to.




Case No. 6            IMPORT OF NARCOTIC/PSYCHOTROPIC SUBSTANCES      BY
                      PHARMACEUTICAL FIRMS DURING 2005 & 2006 WITHOUT
                      OBSERVING PROCEDURE LAID DOWN IN THE DRUGS ACT 1976
                      AND STANDING INSTRUCTIONS.




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                                                       9
Name of          Name of               Irregularity                  Show Cause Notice                 Decision
 Firm           substance              committed by the
                imported               firm (in brief)
M/s Hizat     Dextropropox             The firm got clearance   I am directed to refer to Mr. Mohammad Tahir,
Pharmace       yphene HCl              of        125       kg   Assistant Drugs Controller,            Director Hizat
 uticals                               Dextropropoxyphene       Drugs                  Control        Pharmaceuticals
Peshawar                               HCl      from    ADC     Administration,       Peshawar     appeared before the
                                       Peshawar on 26-04-       letter     No.      4-13/2006-      Drugs Registration
                                       2006 but consignment     DCA(P), dated 25th July,          Board and presented
                                       was already released     2006 on the subject noted documents contending
                                       from custom on 15-04-    above and to say that M/s. that he obtained the drug
                                       2006 (10 day earlier).   Hizat          Pharmaceuticals,      import licence for
                                       The process of import    Peshawar got release the “Dextropropoxyphene”
                                       was completed without    consignment        of    125kg      on 26-04-2006. He
                                       possessing a valid       “Dextropropoxyphene HCl”         further added that the
                                       Drug Import License.     and 10kg “Pholcodine”, raw material was cleared
                                                                directly from the Custom            from customs after
                                                                Authorities without obtaining undertaking that he will
                                       Mr. Muhammad             Drugs Import Licence /               got clear from the
                                       Tahir                    clearance certificate from         concerned ADC. He
                                       Director, (P-453/C),     ADC concerned. You were stated he also obtained
                                                                hereby show caused under clearance from the ADC
                                                                Section 42 of Drugs Act,         on 26-04-2006. It was
                                                                1976 that why the following also deliberated that the
                                                                actions should not be case is incomplete and
                                                                initiated against you in         ADC is not entitled to
                                                                violation to Section 23 & 27      investigate the cases.
                                                                of Drugs Act, 1976.:-               Drugs Registration
                                                                i.                                Board afterR  thorough
                                                                      egistration of F.I.R. deliberations decided to
                                                                      under Section 30 for        proceed action as per
                                                                      violation of Section 23 expert opinion / the legal
                                                                      & 27 of Drugs Act, opinion from the Law,
                                                                      1976.                     Justice & Huamn Rights
                                                                                                         Division.
                                                                ii. Recommendation          for
                                                                      launching the case in the
                                                                      Drugs Court.

                                                                iii. Deregistration         of
                                                                     registrations of the said
                                                                     drugs.

                                                                iv. Or any actions under the
                                                                    Drugs Act, 1976.

                                                                You are hereby directed to
                                                                explain you position within 7
                                                                days. You may also appear
                                                                before       the       Drugs
                                                                Registration Board on 31-03-
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                10
                                                          2007 at 10:00 A.M to defend
                                                          your case.

          Pholcodine             The firm got clearance            As above                Mr. Tahir failed to
                                 of 10 kg Pholcodine                                     produce any document
                                 from custom with-out                                    or drug import licence
                                 obtaining        ADC                                         for the drug
                                 clearance and without                                  “Pholcodine” and it was
                                 having any valid Drug                                  also decided to proceed
                                 Import License.                                        in accordance with law
                                                                                        and opinion of the Law
                                                                                           & Justice Division.




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                                                          11
M/s PDH         Morphine              The firm got clearance    I am directed to refer to         Sheikh M.Ilyas (Joint
Pharmace        sulphate              of 01 kg Morphine         Assistant Drugs Controller,        Chairman) appeared
 uticals                              Sulphate from custom      Drugs                 Control     before the Board and
 Lahore                               on 15-12-2005 with-       Administration,      Peshawar     stated that mistakenly
                                      out obtaining clearance   letter No. 7857/2006-DCA          they have cleared the
                                      from ADC Lahore.          dated 22nd September, 2006        raw material without
                                      However the firm was      on the subject noted above       drug import licence and
                                      not possessing valid      and to say that M/s. PDH         requested for leniency.
                                      Drug Import License at    Pharmaceuticals, Lahore got      The Drugs Registration
                                      the time of import as     release the consignment of           Board decided to
                                      reported by the ADC       30kg “Pholcodine”, 10kg           proceed lenient action
                                      Lahore                    “Pethidine     HCl”       were     under the law as per
                                                                cleared without obtained          expert opinion of the
                                                                clearance from the concerned     Law, Justice & Human
                                       1. Sheikh                ADC while import licence             Rights, Division
                                         Muhammad               was valid for the both drugs.
                                         Altaf (Chairman)       However, 1kg “Morphine
                                       2. Skeikh Mamal          Sulphate”     was      cleared
                                         Altaf (MD)             without clearance from ADC
                                       3. Sheikh Aftab          and import licence was not
                                         Altaf (Deputy MD)      possessing     valid    Drugs
                                       4. Sheikh Gohar          Import Licence as required
                                         Altaf (Director)       under Drugs Act, 1976. You
                                       5. Mr. Sajjad Butt       were hereby show caused
                                         (Import Manager)       under Section 42 of Drugs
                                       6. Sheikh M.Ilyas        Act, 1976 that why the
                                         (Joint Chairman)       following actions should not
                                       7. Sheikh Mohsin         be initiated against you in
                                         Ilyas (Joint MD)       violation to Section 23 & 27
                                       8. Sheikh Ghulam         of Drugs Act, 1976.
                                         Mustaga (Director)
                                                                i.   Registration of F.I.R.
                                                                     under Section 30 for
                                                                     violation of Section 23
                                                                     & 27 of Drugs Act,
                                                                     1976.
                                                                ii. Recommendation         for
                                                                     launching the case in the
                                                                     Drugs Court.
                                                                iii. Deregistration         of
                                                                     registrations of the said
                                                                     drugs.

                                                                iv. Or any actions under the
                                                                     Drugs Act, 1976.
                                                                You are hereby directed to
                                                                explain you position within 7
                                                                days. You may also appeared
                                                                before       the       Drugs
                                                                Registration Board on 31-03-
     8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                12
                                                                2007 at 10:15 A.M to defend
                                                                your case.

              Pethidine HCl The firm got clearance                        As above                Sheikh M.Ilyas (Joint
                            of 10 kg Pethidine                                                     Chairman) appeared
                            from custom on 26-12-                                                 before the Board and
                            2005          with-out                                                stated that due to the
                            obtaining    clearance                                              confusion and change in
                            from ADC Lahore.                                                     the custom notification
                            However the firm was                                                    they got clearance
                            possessing valid Drug                                                  without ADC. The
                            Import License at the                                               Board decided to remain
                            time of import as                                                        careful in future.
                            reported by the ADC
                            Lahore

                Pholcodine             The firm got clearance             As above                       -do-
                                       of 30 kg Pholcodine
                                       from custom on 17-12-
                                       2005          with-out
                                       obtaining    clearance
                                       from ADC Lahore.
                                       However the firm was
                                       possessing valid Drug
                                       Import License at the
                                       time of import as
                                       reported by the ADC
                                       Lahore.

   M/s.    Bromazepam                  The firm got clearance   I am directed to refer to        Representatiave of the
Standphar                              of 03 kg Bromazepam      Assistant Drugs Controller,        appeared before the
    m                                  from custom with-out     Drugs                 Control     Board and stated that
 Pakistan                              obtaining    clearance   Administration,     Peshawar    due to the confusion and
(Pvt) Ltd;                             from ADC Lahore.         letter     No.    8813/2006-      change in the custom
 Lahore.                               However the firm was     DCA(L.V)          dated 3rd       notification they got
                                       possessing valid Drug    November, 2006 on the           clearance without ADC.
                                       Import License at the    subject noted above and to       The Board decided to
                                       time of import as        say that M/s. Standpharm,            remain careful
                                       reported by the ADC      Lahore got release the
                                       Lahore.                  consignment       of     3kg
                                                                “Bromazepam” directly from
                                       Dr. Farooq Ali,          the     Custom    Authorities
                                       Director (P-456/C)       without obtaining Drugs
                                                                Import Licence / clearance
                                                                certificate    from     ADC
                                                                concerned. You were hereby
                                                                show caused under Section
                                                                42 of Drugs Act, 1976 that
                                                                why the following actions
                                                                should not be initiated
                                                                against you in violation to
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                13
                                                                  Section 23 & 27 of Drugs
                                                                  Act, 1976.
                                                                  i. Recommendation          for
                                                                       launching the case in the
                                                                       Drugs Court.

                                                                  ii.  Deregistration         of
                                                                       registrations of the said
                                                                       drugs.
                                                                  iii. Or any actions under the
                                                                       Drugs Act, 1976.

                                                                  You are hereby directed to
                                                                  explain you position within 7
                                                                  days. You may also appeared
                                                                  before       the       Drugs
                                                                  Registration Board on 31-12-
                                                                  2007 at 11:00 A.M to defend
                                                                  your case.

M/s Searl    Pentazocine               The Firm was allocated     I am directed to refer to         -do-
Pakistan     Base                      120 kg Pentazocine         Assistant Drugs Controller,
Karachi                                vide    two    separate    Drugs                  Control
                                       import authorizations      Administration,      Peshawar
                                       of 60 kg each, during      letter    No.      01-01/2006-
                                       2005. The firm got         DCA(K) E&M dated 9th
                                       cleared     60        kg   October, 2006 on the subject
                                       pentazocine        from    noted above and to say that
                                       custom         with-out    M/s.       Searle     Pakistan
                                       obtaining     clearance    Limited, Karachi got release
                                       from ADC Karachi.          the consignment of 60kg
                                       However the firm was       “Pentazocine Base” directly
                                       possessing valid Drug      from the Custom Authorities
                                       Import License at that     without obtaining Drugs
                                       time as reported by the    Import Licence / clearance
                                       DDG (E&M) Karachi.         certificate     from     ADC
                                                                  concerned. You were hereby
                                       Mr. Nural Amin,            show caused under Section
                                       Sr. Purchase               42 of Drugs Act, 1976 that
                                       Manager                    why the following actions
                                       (P-437/C)                  should not be initiated
                                                                  against you in violation to
                                                                  Section 23 & 27 of Drugs
                                                                  Act, 1976.

                                                                  i.    Recommendation        for
                                                                        launching the case in the
                                                                        Drugs Court.

                                                                  ii.   Deregistration        of
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                  14
                                                                        registrations of the said
                                                                        drugs.

                                                                  iii. Or any actions under the
                                                                       Drugs Act, 1976.

                                                                  You are hereby directed to
                                                                  explain you position within 7
                                                                  days. You may also appeared
                                                                  before       the       Drugs
                                                                  Registration Board on 31-03-
                                                                  2007 at 10:30 A.M to defend
                                                                  your case.

M/s Sami     Bromazepam                The       firm      was    I am directed to refer to         -do-
Pharmace                               authorized to import 90    Assistant Drugs Controller,
 uticals,                              kg Bromazepam in           Drugs                  Control
(Pvt) Ltd                              2005.      The     Firm    Administration,      Peshawar
 Karachi                               imported 45 kg without     letter     No.    5-3/2006(l)-
                                       obtaining         ADC      DCA(K)/250        dated     2nd
                                       clearance.                 August, 2006 on the subject
                                       Part shipment was not      noted above and to say that
                                       allowed in case of         M/s. Sami Pharmaceuticals,
                                       psychotropic               Karachi got release the
                                       substances but the firm    consignment       of      45kg
                                       did not complied with      “Bromazepam” directly from
                                       the instructions of this   the     Custom     Authorities
                                       Ministry.     However,     without obtaining Drugs
                                       Drugs Import License       Import Licence / clearance
                                       was valid.                 certificate    from       ADC
                                                                  concerned. You were hereby
                                       Mr. M. Qeyam               show caused under Section
                                       Uddin,                     42 of Drugs Act, 1976 that
                                       Dy. Import Manager         why the following actions
                                       (P-438/C)                  should not be initiated
                                                                  against you in violation to
                                                                  Section 23 & 27 of Drugs
                                                                  Act, 1976.
                                                                  i. Recommendation           for
                                                                        launching the case in the
                                                                        Drugs Court.

                                                                  ii.   Deregistration         of
                                                                        registrations of the said
                                                                        drugs.

                                                                  iiii. Or any actions under the
                                                                        Drugs Act, 1976.

                                                                  You are hereby directed to
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                  15
                                                            explain you position within 7
                                                            days. You may also appeared
                                                            before       the       Drugs
                                                            Registration Board on 31-03-
                                                            2007 at 10:45 A.M to defend
                                                            your case.


Case No. 7            M/s. Ocean Pharmaceutical (Pvt) Ltd, Karachi was show caused by this Ministry
on the information forwarded by the ADC Import and Export for not manufacturing the of
following drugs & failed to import the allocated quantity of                   raw material of the subject
mentioned drugs, hence violated the conditions of the registration of the said drugs.

                            S.No.          Name of Drugs                       Reg.No.
                            1              Onax (Alprazolam)Tablets 0.25mg     018364
                            2              Onax (Alprazolam)Tablets 0.5mg      019805

                       Firm has answered that last management imported the allocated quantity of raw
material of Alprazolam and they produced all related records along with bin cards and
consolidated batch wise statement about manufacturing of Onax tablets to the Office of Drugs
Control Administration, Karachi for issuance of consumption certificate, keeping in view of the
actual position explained by us vide letter NO.OPL/C E/20/2006 dated 01-12-2006.

                      As per their request the Assistant Drugs Controller concerned has verified batch
wise statement of 02 Kgs Alprozolam consumed in manufacturing of Onax 0.25mg tablet
(R.No.18364) which was forwarded by the Deputy Director General (E&M) Drugs Control
Administration, Karachi with recommendation vide their letter No.f.1-3/2006-DCA(K) dated 08-
12-2006.

                      We already made request for allocation of quota but time to time but they have
not received any quota and without quota they are not in position to manufacture their registered
drugs i.e. Onax Tablet 0.25MG (Reg.No.018364) and Onax Tablet 0.5mg (Reg.No.019805).

                      Keeping in view of the above facts the firm has therefore, requested to kindly
withdraw the show cause notice and kindly help them regarding grant of 08 Kgs Alprazolam, so
that they may able to manufacture their registered drugs. They are also submitting an
undertaking that after grant of quota of Alprazolkam., they would follow the conditions of
manufacturing of drugs as per Drugs Act,1976


8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                            16
Decision:              Drugs Registration Board after the scrutiny of record and violations committed
                       by the firm decided to de-register the “Onax Tablet 0.25MG (Reg.No.018364)
                       and Onax Tablet 0.5mg (Reg.No.019805)” in violation to the condition of
                       registration.



Case No. 8             M/s Getz pharma have requested to register the pending products in lieu of
deregistration of some of our non-marketable products. List is attached (at Flag “C”)


              S. No. Name of Drug(s)                                              Reg No(s)
                 1.        Baxid 500mg Capsules (Lincomycin)                       022472
                 2.        Baxid 300mg/ml Injections (Lincomycin)                  022826
                 3.        Baxid Syrup (Lincomycin)                                022473
                 4.        Becom Tablets (H.P. Vit B+C)                            020628
                 5.        Becom Syrup (H.P. Vit B+C)                              020629
                 6.        EryGet 100mg Tablets (Erythromycin)                     013802
                 7.        EryGet 250mg Tablets (Erythromycin)                     014319
                 8.        EryGet 500mg Tablets (Erythromycin)                     010196
                 9.        EryGet Suspension (Erythromycin)                        014293
                 10.       EryGet Paediatric Drops (Erythromycin)                  020924
                 11.       Florex-D Capsules (Pseudoephedrine + Loratadine)        022075
                 12.       Getnizole 500mg Tablets (Secnidazole)                   020046
                 13.       Getnizole 1g Tablets (Secnidazole)                      020047
                 14.       Getnizole 500mg Suspension (Secnidazole)                020925
                 15.       Getnizole 750mg Suspension (Secnidazole)                020048
                 16.       Mevit Tablets (Vitamin + Minerals)                      020302
                 17.       Mevit Syrup (Vitamin + Minerals)                        020638
                 18.       Rofexx 25mg Tablets (Rofecoxib)                         028925
                           (Already de-registered)
                 19.       Rofexx 12.5mg Tablets (Rofecoxib)                       028926
                           (Already de-registered)
                 20.       RosiGet Dispersible Tablets (Roxithromycin)             019863
                 21.       RosiGet 150mg Tablets (Roxithromycin)                   020151
                 22.       RosiGet 300mg Tablets (Roxithromycin)                   019864
                 23.       Telefen 200mg Capsules (Telfenamic Acid)                013956

8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                       17
                 24.       Telefen Retard 300mg Tablets (Telfenamic Acid)             013957
                 25.       Theobret 90mg Tablets (Choline Theophyllinate)             009127
                 26.       Theobret 180mg Tablets (Choline Theophyllinate)            009120
                 27.       Theobret 270mg Tablets (Choline Theophyllinate)            009030
                 28.       Theobret Syrup (Choline Theophyllinate)                    011219
                 29.       Trilox Syrup (L-Argine, L-Ornithine, L-Citruline)          020639
                 30.       Trilox DS Tablets (L-Argine, L-Ornithine, L-Citruline)     020640
                 31.       Veracard 40mg Tablets (Verapamil)                          024789
                 32.       Veracard 80mg Tablets (Verapamil)                          024790
                 33.       Veracard 240mg Tablets (Verapamil)                         024791
                 34.       Vextra 10mg Tablets (Valdecoxib)                           034495
                 35.       Vextra 20mg Tablets (Valdecoxib)                           034496


Decision:              Request of the firm for de-registration of following products was acceded to and
                       as a replacement similar number of drugs were considered on fast tract basis.

Case No. 9             M/s Getz was directed by this board to change the brand name of Mibs
(Tegaserod) due to resemblance & also destroy the present stock of the product. Now the firm
has collected the stock & reported that 6215 packs have been recovered throughout the country.
Instead of destruction proposal is that the collected quantity of the drug may be donated to some
hospital under intimation to this ministry.

Decision:              The Drugs Registration Board considered options for the disposal of 6215 packs
                       of “Mibs (Tegaserod) Tablets whose name was changed to Getibs due to
                       similarity with the already registered drug. It was concluded that 6215 packs of
                       Mibs recalled by the firm according to the direction of the Board should be
                       donated to JPMC, PIMS & FPSH with the stamp not for sale instead of
                       destruction in best public interest in equal quantities.


Case No. 10 The Drug Registration Board in its 181th meeting had granted the permission of
Asacol (Mesalazine) Tablets 400 mg Registration No. 009581 & Asacol (Mesalazine) Enema
registration No. 014663 of M/s. Getz Pharma, Karachi for Bulk import & Local repack for a
period of three years that is up to 13-01-2007. Now the time period has been expired hence the
firm has requested to further extend the time period.

8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                       18
                      The firm has not mentioned the time period but has deposited the required the fee
Rs. 15000/- for each product.

Decision:             The request of the firm was acceded to for a period of one year.

Case No. 11 The Drug registration Board in its 199th meeting approved the request of M/s
W.Woodward Pakistan for approval of following new additional flavors for the Paedicare
Solution. The firm has now again requested for grant of approval of further additional flavors
against the same registration number.

                      They have submitted total of Rs.1000/- for both additional flavors.

Name of the Drugs                   Registration    Previous      Approved          New request
                                    No.             Flavor        Additional        of additional
                                                                  Flavor in 199th   flavours
                                                                  meeting
Paedicare Solution                  022597          Orange        Strawberry &      Ginger & Dill
                                                                  Lemon
           M/s Abbott Karachi has also submitted the similar request for additional flavors with the
claim that the formulation is sterile.

Decision:             The request of M/s. W. Woodward and M/s. Abbott Labs were considered by the
                      Drugs Registration Board and decided to approve those pharmacopeial flavours
                      subject to submission of international evidences and stability studies for the
                      particular flavour.

Case No. 12 The Drug Registration Board in its 199th meting deferred the registration of new
molecule Corbic (Milnacipram HCl) 25 & 50mg Capsule of M/s AGP for clarification of
availability in various countries along with list of countries. Now the firm has provided the list of
following countries where the product is available.

                      1.          Austria
                      2.          Czech Republic.
                      3.          Finland.
                      4.          France.
                      5.          Israel.
                      6.          Japan
                      7.          Lebanon
                      8.          Luxembourg.
                      9.          Poland.
                      10.         Portugal
                      11.         Russia.
8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             19
             But the firm has not submitted the evidence.

Decision:             Drugs Registration Board deferred the request of the firm and decided as a matter
                      of principal that        free sale certificates only from USA, UK and European
                      Economic Community (EEC) countries. The firm shall be asked for the same.


Case No. 13 The Drugs Registration Board in its 131st meeting had registered the drug
“Wolflam-50 (Diclofenac Sodium) Tablets in the name of M/s. Rayon Int. Karachi now the
importer has requested for bulk import and local repacking at M/s. Medisure Labs, Karachi.

                      They have deposited the Rs. 15000/- for this purpose also has submitted NOC
from M/s. Medisure Labs, Karachi

Decision:             The request of the firm was not acceded to for the product “Diclofenac Sodium”


Case No. 14 M/s. Merck Marker have applied application for the registration of “Dolo
Neurobion Tablets” for local manufacturing. The said product contains Diclofenac in
combination with Vitamin B1+Vitamin B6+Vitamin B12. The product has already been rejected
from Registration Board and also from Appellate Board. Both the Boards rejected the product on
the basis of expert evaluation by Maj. Gen. Shujaat Hussain and Brig. Muzammil Hassan Najmi,
which gave the observations as under:-
                      i.          A combination of Vitmains with Diclofenac has not been marketed in the
                                  USA or UK.

                      ii.         No justification on the basis of scientific evidence has been provided for
                                  this formulation from any source.

                      iii.        Moreover, the studies quoted also do not show any benefit of continued
                                  usage after one week.

                      iv.         Review of scientific sources of information of revealed that such
                                  combination of NSAIDs with Vitamins is not recommended in any
                                  standard textbook or other authentic medical literature.

                      v.          Further the combinations are irrational and non scientific.


Decision:             The Drugs Registration Board considered the application of the drug namely
                      “Dolo Neurobion Tablets” and rejected on the grounds that:


8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                           20
                      i.          A combination of Vitmains with Diclofenac has not been marketed in the
                                  USA or UK.

                      ii.         No justification on the basis of scientific evidence has been provided for
                                  this formulation from any source.

                      iii.        Moreover, the studies quoted also do not show any benefit of continued
                                  usage after one week.

                      iv.         Review of scientific sources of information of revealed that such
                                  combination of NSAIDs with Vitamins is not recommended in any
                                  standard textbook or other authentic medical literature.

                      v.          Further the combinations are irrational and non scientific

                      vi.         No sufficient clinical data was provided to demonstrate the efficacy and
                                  safety of the proposed drug.

                      vii.        The drug was already rejected by the registration Board and Appellate
                                  Board.

Case No. 15 The Price Recommendatory Committee in its 19th held on 26th December, 2006
has referred the case of “Asmaplus 60ml Syrup (Reg. No. 032028) of M/s. Opal Labs, Karachi to
the Drugs Registration for the de-registration of the formulation during the consideration of
price revision request of M/s Opal Labs Karachi being irrational formulation.
                                       Reg. No.     Name of Drug(s) & Composition

                                                    Asmaplus Syrup
                                           032028   Each 5ml contains:-
                                                    Theophyline……..…32.50mg
                                                    Ephedrine Hcl…..…..6.25mg
                                                    Hydroxyzine Hcl…….2.50mg

                      The has replied that the formulation is available worldwide & international search
out papers have been enclosed where in combination in syrup & tablet forms have been claimed.
The firm has also claimed that Marax Tablets of M/z Pfizer has same ingredients.



Decision:             Drugs Registration Board considered the formulation and decided to cancel the
                      registration of all the drugs in similar formulation as the said formulation was
                      withdrawn in USA due to ineffectiveness. The decision of the Court of the Law of
                      the USA was as under:-




8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                            21
                      “Department of health and human services food and drug administration [docket
                      no. 78n–0070; desi 1626] combination drugs containing theophylline, ephedrine
                      sulfate, and hydroxyzine hydrochloride; withdrawal of approval.
                      SUMMARY: The Food and Drug

                      Administration (FDA) is withdrawing approval of the new drug applications
                      (NDA’s) for Marax Tablets and Marax Syrup. FDA is also declaring all identical,
                      similar, and related drug products, not otherwise subject to an approved drug
                      application, unlawful, including Brofed Tablets and Hydroxyzine Compound
                      Syrup. Each of these products contains theophylline, ephedrine sulfate, and
                      hydroxyzine hydrochloride. The basis of the withdrawals is that there is a lack of
                      substantial evidence that these combination drugs are effective for the treatment
                      of bronchial asthma.

                      EFFECTIVE DATE: August 7, 1998. Addresses: Requests for applicability of
                      this notice to a specific product should be identified with the Docket and DESI
                      numbers found in brackets in the heading of this document and directed to the
                      Division of Prescription Drug Compliance and Surveillance (HFD–330), Center
                      for Drug Evaluation and Research, Food and Drug Administration, 7500 Standish
                      Pl., Rockville, MD 20855.

                      FOR FURTHER INFORMATION CONTACT:                       Mary E. Catchings, Center
                      for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600
                      Fishers Lane, Rockville, MD 20857, 301–594–2041.

                      SUPPLEMENTARY INFORMATION:                   As part of the agency’s drug efficacy
                      program, in a notice published in the Federal Register of September 17, 1984 (49
                      FR 36443), the Commissioner of Food and Drugs granted an evidentiary hearing
                      before an administrative law judge on the proposal to withdraw approval of NDA
                      11–768 for Marax Tablets and NDA 12–879 for Marax Syrup, each containing
                      theophylline, ephedrine sulfate, and hydroxyzine hydrochloride. The NDA’s are
                      held by J. B. Roerig, Division of Pfizer, Inc. (Pfizer), 235 East 42d St.,New York,
                      NY 10017. Other party participants were: 1. Barre-National, Inc., 4128 Haywood
                      Ave., Baltimore, MD 21215 (Barre); Hydroxyzine Compound Syrup (no NDA).2.
                      Cord Laboratories, Inc. (now Geneva Pharmaceuticals, Inc.), 2555 West Midway
                      Blvd, Broomfield, CO 80038 (Cord); Brofed Tablets (no NDA). 3. Barrows
8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                      22
                      Research Group, Inc., 99West Hawthorne Ave., Valley Stream, NY 11580
                      (Barrows). Unnamed drug product. Barrows later withdrew its hearing request.
                      Subsequently, in accordance with agreements to resolve, by other means, the issue
                      of their drug products’ effectiveness, Pfizer, Barre, and Cord withdrew their
                      hearing requests. Under those agreements, FDA has concluded that Marax Tablets
                      and Marax Syrup have not been shown to be effective, and FDA is now
                      withdrawing approval of the NDA’s for these products. This notice applies to any
                      drug product that is identical, related, or similar to these products and is not the
                      subject of an approved NDA (21 CFR 310.6). Such products include Hydroxyzine
                      Compound Syrup and Brofed Tablets, each of which contains theophylline,
                      ephedrine sulfate, and hydroxyzine hydrochloride. Any person who wishes to
                      determine whether a specific product is covered by this notice should write to the
                      Division ofPrescription Drug Compliance and Surveillance (address above). The
                      Director of the Center for Drug Evaluation and Research, under section 505 of the
                      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and under the authority
                      delegated to her (21 CFR 5.82), finds that on the basis of new information before
                      her with respect to Marax Tablets and Marax Syrup, evaluated together with the
                      evidence available to her when the applications were approved, there is a lack of
                      substantial evidence that the products will have the effect they purport or are
                      represented to have under the conditions of use prescribed, recommended, or
                      suggested in their labeling. Therefore, based on the foregoing finding, approvals
                      and all the amendments and supplements thereto of NDA 11–768 and NDA 12–
                      879 are withdrawn effective August 7, 1998. Shipment in interstate commerce of
                      the products listed above or of any identical, related, or similar product that is not
                      the subject of an approved NDA will then be unlawful.


Case No. 16 The Drugs Registration Board in its 197 –A meeting had approved the drug
“Osmolar ORS of M/s. Atco Labs, Karachi and the case was sent to Pricing Section for price
fixation. The Price Recommendatory Committee in its 19th held on 26th December, 2006 has
referred back the case to the Drugs Registration for the checking of formulations of the said
product:-




8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                       23
                          Name of Drug(s) & Composition           Pack      Demanded
                                                                   Size       Price
                          Osmolar ORS                             10gm       Rs. 5.00 /
                          Each sachet contains:-                            per sachet
                          Sodium Chloride 1..3gm eq. to
                          Sodium………..….. .37.5mmol &
                          Chloride…….….. 32.5mmol
                          Potassium Chloride.0.75gm
                           eq. to Potassium……10mmol
                          Trisodium Citrate Dihydrate
                          1.45gm eq. to Citrate…..5mmol
                          Glucose Anhydrous 6.75gm eq. to
                          Glucose…………37.5mmol
                          (Oral electrolyte replacer)



Decision:             Drugs Registration Board rejected the concern of PRC as the said formulation is
                      in accordance with the WHO formula for ORS.


Case No. 17              Drug Registration Board in its 199th meeting (23-24 August, 2006) had rejected
                      17 products. Out of which


            1.        6 (six) were cephalosporin (rejected due to not having dedicated facility &
                      HVAC).
            2.        3 (three) were irrational formulations.
            3.        8 (eight) were General Section product (rejected due to no HVAC).


S. No.         Name of                Name of Drug(s) & Composition       Pack    Demande      Decision of
                 Firm                                                     Size      d Price        Board
 1.           M/s. Zephyr             Zefradin 250mg/5ml Suspension       60ml     15% less    Rejected as
              Pharmatec,              Each 5ml contains:-                         than brand    the firm is
               Karachi                Cephradine USP….250mg                          leader    not licensed
                                      (Antibiotic)                                    price    for dedicate
                                                                                                facilites of
                                                                                                     the
                                                                                               Cephalsopor
                                                                                                  in drugs.
                                                                                                Moreover,
                                                                                                   HVAC
                                                                                                system has
                                                                                                  not been
                                                                                                 installted.



8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                         24
 2.                  -do-             Zefradin Capsules          1x10’s    15% less       -do-
                                      Each capsule contains:-             than brand
                                      Cephradine ….500mg                    leader
                                      (Antibiotic)                           price

 3.                  -do-             Fixy 100mg Suspension      30ml      15% less       -do-
                                      Each 5ml contains:-                 than brand
                                      Cefixime ….100mg                      leader
                                      (Antibiotic)                           price

 4.                  -do-             Fixy -DS Suspension        30ml      15% less       -do-
                                      Each 5ml contains:-                 than brand
                                      Cefixime ….200mg                      leader
                                      (Antibiotic)                           price

 5.                  -do-             Fixy 200mg Tablets         1x5’s     15% less       -do-
                                      Each tablet contains:-              than brand
                                      Cefixime ….200mg                      leader
                                      (Antibiotic)                           price

 6.                  -do-             Fixy 400mg Tablets         1x5’s     15% less       -do-
                                      Each tablet contains:-              than brand
                                      Cefixime ….400mg                      leader
                                      (Antibiotic)                           price

 7.                  -do-             Malgo Tablets              1x10’s   15% less     Rejected on
                                      Each tablet contains:-               than of     the grounds
                                      Artemether……..20mg                    brand         that the
                                      (Anti-malarial)                       leader      WHO has
                                                                                       recommend
                                                                                             ed
                                                                                       combination
                                                                                        therapy in
                                                                                       Malaria due
                                                                                             to
                                                                                        resistance.

 8.                  -do-             Malgo Tablets              1x10’s   15% less        -do-
                                      Each tablet contains:-               than of
                                      Artemether……..40mg                    brand
                                      (Anti-malarial)                       leader

 9.                  -do-             Malgo Tablets              1x10’s   15% less        -do-
                                      Each tablet contains:-               than of
                                      Artemether……..80mg                    brand
                                      (Anti-malarial)                       leader




8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                            25
 10.                 -do-             Nefdin Tablets                      1x10’s   15% less   Deferred for
                                      Each tablet contains:-                        than of   confirmatio
                                      Fexofenadine                                   brand    n of HVAC
                                      Hydrochloride…….60mg                           leader      system
                                      (Anti-histamine)

 11.                 -do-             Nefdin Tablets                      1x10’s   15% less      -do-
                                      Each tablet contains:-                        than of
                                      Fexofenadine                                   brand
                                      Hydrochloride……..120mg                         leader
                                      (Anti-histamine)

 12.                 -do-             Nefdin Tablets                      1x10’s   15% less      -do-
                                      Each tablet contains:-                        than of
                                      Fexofenadine                                   brand
                                      Hydrochloride……..180mg                         leader
                                      (Anti-histamine)

 13.                 -do-             Monika 5mg Tablets                  2x10’s   15% less      -do-
                                      Each tablet contains:-                        than of
                                      Montelukast Sodium eq. to                      brand
                                      Montelukast……..5mg                             leader
                                      (Leukotriene receptor antagonist)

 14.                 -do-             Monika 10mg Tablets                 2x10’s   15% less      -do-
                                      Each tablet contains:-                        than of
                                      Montelukast Sodium eq. to                      brand
                                      Montelukast……..10mg                            leader
                                      (Leukotriene receptor antagonist)

 15.                 -do-             Levocit Tablets                     1x10’s   15% less      -do-
                                      Each tablet contains:-                        than of
                                      Levocitrazine……..5mg                           brand
                                      (Anti-allergic)                                leader

 16.                 -do-             Globin Tablets                      3x10’s   15% less      -do-
                                      Each tablet contains:-                        than of
                                      Iron Polymaltose                               brand
                                      Complex*…………..400mg                            leader
                                      Folic Acid………….0.35mg
                                      (Haematinic)

 17.                 -do-             Globin Capsules                     3x10’s   15% less      -do-
                                      Each capsule contains:-                       than of
                                      Iron Polymaltose                               brand
                                      Complex*…………..400mg                            leader
                                      Folic Acid………….0.35mg
                                      (Haematinic)



8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                           26
                      Now, the firm has informed that it had dedicated area of cephalosporin alongwith
HVAC facility at the time of decision by Drug Registration Board.
It has been found that Firm has separate area for (as indicated by this Ministry’s letter No.2-8/95-
Lic (vol-i) dated 11-12-2006).
            -      Capsule (Cephalosporins)
            -      Dry Syp (Cephalosporins)


                      But not for Cephalosporin Tablets. Further, the inspection report conducted by
FID Ahmed Din Ansari & FID Najam-us-Saqib dated 24th July, 2006, also supported the firm’s
plea since, the report mentions that HVAC facilities are almost complete in Cephalosporins &
Penicillin Sections & the remaining work will be completed within 15 days (which confirms
that separate Ceph. area was present before Registration Board decision). To confirm
HVAC in Cephalosporins following panel was constituted after the approval of Chairperson of
Drug Registration Board.
                      1.     Najam us Saquib Area FID.
                      2. Mr. Abdul Rasool Sheikh Area ADC.


                      They have confirmed that HVAC facilities are available in functional form in the
Cephalosporin & Penicillin Sections.


The firm has now requested to reconsider its products which were rejected in 199th meeting of
drug Registration Board.

Decision:             Drugs Registration Board upheld its previous decision as the relevant
                      Cephalosporin areas mentioned above wer not approved by the Central Licensing
                      Board.

Case No. 18 As per decision of Drug Registration Boards in its 179th meeting, M/.s Roche
have applied to register following solvents in their name which will be imported from M/s F.
Hoffmann-La Roche Ltd Basel, Switzerland by CENEXI SAS Fontenay-sous-Bois, France.
These solvents will be placed free of cost in the already registered Dry powder Injection.
        S. No.       Name & Composition of Drugs                       Pack Size.
           1         Water for Injection                                 5 ml
                     1 Ampoule contains
                     5 ml of sterilized water for Injections


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                                                         27
           2         Water for Injection                                        10 ml
                     1 Ampoule contains
                     10 ml of sterilized water for Injections

           3         Lidocaine 1%                                                2 ml
                     1 ml solvent contains:
                     Lidocaine hydrochloride ........10mg
                     (in form of lidocaine hydrochloride
                     monohydrate- 10.66 mg)
                     Water for injections……..a.d 1.0 ml

           4.        Lidocaine 1%                                               3.5ml
                     1 ml solvent contains:
                     Lidocaine hydrochloride ........10mg
                     (in formvfv of lidocaine hydrochloride
                     monohydrate- 10.66 mg)
                     Water for injections……..a.d 1.0 ml


Decision:             The request of the firm was acceded to.

Case No. 19 Drugs Registration Board granted registration of 20 drugs products to M/s. Aneeb
Pharmaceutical, Lahore on contract basis from M/s. Surge Labs, Lahore. Now the firm has
requested to surrender following 7 registered drugs.

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

                               1            044095      Injectazone 250mg Injection
                                                        Each vial contains:-
                                                        Cefoperazone Sodium eq. to
                                                        Cefoperazone…….250mg
                                                        BP Specification)

                               2            044096      Injectazone 500mg Injection
                                                        Each vial contains:-
                                                        Cefoperazone Sodium eq. to
                                                        Cefoperazone…….500mg
                                                        BP Specification)

                               3            044097      Injectazone 1gm Injection
                                                        Each 1gm vial contains:-
                                                        Cefoperazone Sodium eq. to
                                                        Cefoperazone…….1gm
                                                        BP Specification)

                               4            044102      Injectacef 250mg Injection
                                                        Each vial contains:-
                                                        Ceftazidime……….250mg
                                                        BP Specification)
8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             28
                       5         044103       Injectacef 1gm Injection
                                              Each vial contains:-
                                              Ceftazidime……….1gm
                                              BP Specification)

                       6         044100       Monozoline 250mg Injections
                                              Each vial contains:-
                                              Cephazoline Sodium eq. to
                                              Cephazoline………..250mg
                                              BP Specification)
                       7         044101       Monozoline 1gm Injections
                                              Each vial contains:-
                                              Cephazoline Sodium eq. to
                                              Cephazoline……….1gm
                                              BP Specification)


                 They have requested to grant contract permission of the following 7 drugs as a
replacement to the above mentioned five drugs. This will totalize the 20 products as permissible
under the contract manufacturing policy to a licence manufacturer.

        S. No.       Name of Drugs & Composition            Pack Size(s)    Demanded Price
           1.        Cefpositive 250mg Capsules                12’s            Rs. 96.00
                     Each capsule contains:-
                     Cephradine….250mg

            2.       Cefpositive 500mg Capsules                12’s           Rs. 180.00
                     Each capsule contains:-
                     Cephradine….500mg
                     (Cephalosporin)

            3.       Cefpositive 250mg Suspension              60ml            Rs. 78.00
                     Each 5ml contains::-
                     Cephradine….250mg
                     (Cephalosporin)

            4.       Primecef 500mg Injections                  1’s           Rs. 400.00
                     Each vial contains:-
                     Cefepime……500mg
                     (Cephalosporin)

            5.       Primecef 1g Injections                     1’s           Rs. 740.00
                     Each vial contains:-
                     Cefepime……1g
                     (Cephalosporin)

            6.              Injectacef 250mg Injection          1’s           Rs. 101.00
                            Each vial contains:
                            Ceftriaxone Sodium equivalent
                            to Ceftriaxone…… 250mg
8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                       29
                7.          Injectacef 1g Injection              1’s           Rs. 321.00
                            Each vial contains:
                            Ceftriaxone Sodium equivalent
                            to Ceftriaxone…………1g


Decision:             The request of the firm was acceded to



Case No. 20 U.S Food And Drug Administration Safety Alerts For Drugs Biologicals etc.
                      FDA has issued safety alerts / boxed warnings on the following drugs during the
start of 2007. Due to unsupervised use of drugs in Pakistan such alerts and warnings need special
consideration of the Registration Board for the safety of public at large. Some of the products
have been discontinued in the USA due to adverse effects. For example “Gatifloxacin” is no
more available except Eye Drops dosage form. Some of the products may be under registration
which need thorough evaluation before being registred.




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                                                      30
             Accutane (isotretinoin)
            healthcare professionals
           [Posted 03/28/2007] FDA notified consumers and healthcare professionals of a special
           webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is
           a drug approved for the treatment of severe acne that does not respond to other forms of
           treatment. If the drug is improperly used, it can cause severe side effects, including birth
           defects. Serious mental health problems have also been reported with isotretinoin use.
           The new webpage, http://www.fda.gov/buyonline/accutane/, will appear in online search
           results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis,
           and Sotret. The webpage warns that the drug should only be taken under the close
           supervision of a physician or a pharmacist, and provides links to helpful information. The
           new webpage is in addition to special safeguards put in place by FDA and manufacturers
           of isotretinoin to reduce the risks of the drug, including a risk management program
           called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not
           become pregnant, and that women who are pregnant do not use isotretinoin.


           Zyvox (linezolid)

           Audience: Infectious disease specialists, other healthcare professionals
           [Posted 03/16/2007] FDA notified healthcare professionals of new emerging safety
           concerns about Zyvox (linezolid) from a recent clinical study. This open-label,
           randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin in the
           treatment of seriously ill patients with intravascular catheter-related bloodstream
           infections including those with catheter-site infections. Patients treated with linezolid had
           a higher chance of death than did patients treated with any comparator antibiotic, and the
           chance of death was related to the type of organism causing the infection. Patients with
           Gram positive infections had no difference in mortality according to their antibiotic
           treatment. In contrast, mortality was higher in patients treated with linezolid who were
           infected with Gram negative organisms alone, with both Gram positive and Gram
           negative organisms, or who had no infection when they entered the study.

           Linezolid is not approved for the treatment of catheter-related bloodstream infections,
           catheter-site infections, or for the treatment of infections caused by Gram negative
           bacteria. If infection with Gram negative bacteria is known or suspected, appropriate
           therapy should be started immediately.

             Sedative-hypnotic drug products
           Audience: Healthcare professionals, consumers
           [Posted 03/14/2007] FDA notified healthcare professionals of its request that all
           manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or
           maintain sleep, strengthen their product labeling to include stronger language concerning
           potential risks. These risks include severe allergic reactions and complex sleep-related
           behaviors, which may include sleep-driving. Sleep driving is defined as driving while not
           fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
           FDA also requested that each product manufacturer send letters to health care providers
           to notify them about the new warnings, and that manufacturers develop Patient
           Medication Guides for the products to inform consumers about risks and advise them of
           potential precautions that can be taken.
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                                                    31
           Actimmune (Interferon Gamma 1-b)
           Audience: Pulmonologists, other healthcare professionals, consumers
           [Posted 03/09/2007] FDA notified healthcare professionals of the early termination of the
           INSPIRE clinical study of Actimmune for idiopathic pulmonary fibrosis (IPF). The study
           was stopped because an interim analysis showed that patients with IPF who received
           Actimmune did not benefit. The trial compared survival in patients getting Actimmune or
           an inactive injection (placebo). An analysis showed that 14.5% of patients treated with
           Actimmune died as compared to 12.7% of patients treated with placebo. Actimmune is
           not approved by the FDA to treat IPF.

           [March 09, 2007 - Public Health Advisory - FDA]
           [March 09, 2007 - Drug Information Page - FDA]
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         Actos (pioglitazone) Tablets
         ACTOplus met (pioglitazone and metformin hydrochloride) Tablets
           Duetact (pioglitazone and glimepiride) Tablets
          Audience: Endocrinologists, other healthcare professionals, consumers
          [Posted 03/09/2007] Takeda and FDA notified healthcare professionals of recent safety
          data concerning pioglitazone-containing products. The results of an analysis of the
          manufacturer's clinical trial database of pioglitazone showed more reports of fractures in
          female patients taking pioglitazone than those taking a comparator (either placebo or
          active). The majority of fractures observed in female patients were in the distal upper
          limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There
          were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in
          the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5
          years. Healthcare professionals should consider the risk of fracture when initiating or
          treating female patients with type 2 diabetes mellitus with pioglitazone-containing
          products.


          Gebauer Salivart Oral Moisturizer
          Audience: Dentists, pharmacists, other healthcare professionals, patients
          [Posted 03/05/2007] The Gebauer Company notified healthcare professionals and
          consumers of a nationwide recall of certain lots of Salivart Oral Moisturizer. The recall
          was initiated because some lots do not meet the Company's internal specification for
          aerobic microorganisms and mold. Use of the affected units may cause temporary and
          reversible health problems such as nausea, vomiting, and diarrhea. Customers who have
          the recalled product should stop using the product and dispose of it immediately. See the
          manufacturer's recall notice for specific lot numbers and expiration dates of the recalled
          product.

           [ March 01, 2007 - Recall Notice - Gebauer]
           Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch




8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                    32
          Baraclude (entecavir) Tablets and Oral Solution
          Audience: Infectious disease specialists and other healthcare professionals
          [Posted 02/24/2007] FDA and Bristol-Myers Squibb notified healthcare professionals of
          revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND
          USAGE/Description of Clinical Studies/Special Populations sections of the prescribing
          information for Baraclude. The revised labeling is the result of a case report in which a
          human immunodeficiency virus (HIV) variant containing the M184V resistance
          substitution was documented during Baraclude treatment for chronic hepatitis B virus
          (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously
          receiving highly active antiretroviral therapy (HAART).

           Current treatment guidelines recommend Baraclude as an option for treatment of HBV in
           the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare
           professionals are advised that when considering therapy with Baraclude in an HIV/HBV
           co-infected patient not receiving HAART, the risk of developing HIV resistance cannot
           be excluded based on current information.


         CellCept (mycophenolate mofetil)

           Audience: Cardiac transplantation healthcare professionals
           Indication: Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac
           or hepatic transplants
           [Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners
           about a clinical study (Heart Spare The Nephron) that was terminated due to an observed
           increased incidence of grade IIIA acute rejection in heart transplant patients switched
           from calcineurin inhibitor and CellCept to Rapamune (sirolimus) and CellCept at 12
           weeks post heart transplantation. The safety and efficacy of CellCept in combination with
           sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been
           established.

             Attention Deficit Hyperactivity Disorder (ADHD) drug products
           Audience: Neuropsychiatric, pediatric and other healthcare professionals
           [Posted 02/21/2007] FDA notified healthcare professionals that the manufacturers of all
           drug products approved for the treatment of Attention Deficit Hyperactivity Disorder
           (ADHD) have been directed to develop Patient Medication Guides to alert patients to
           possible cardiovascular risks and risks of adverse psychiatric symptoms associated with
           the medicines and to advise them of precautions that can be taken. Patient Medication
           Guides are handouts given to patients, families and caregivers each time a medicine is
           dispensed. The guides contain FDA-approved patient information that could help prevent
           serious adverse events.

           An FDA review of reports of serious cardiovascular adverse events in patients taking
           usual doses of ADHD products revealed reports of sudden death in patients with
           underlying serious heart problems or defects, and reports of stroke and heart attack in
           adults with certain risk factors. FDA recommends that children, adolescents, or adults
           who are being considered for treatment with ADHD drug products work with their
           physician or other health care professional to develop a treatment plan that includes a
           careful health history and evaluation of current status, particularly for cardiovascular and
           psychiatric problems (including assessment for a family history of such problems).
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                                                    33
             Xolair (omalizumab)
           Audience: Pulmonary healthcare professionals, asthmatic patients
           Indications and Usage: for treatment of adults and adolescents (12 years of age and
           above) with moderate to severe persistent asthma who have a positive skin test or in vitro
           reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled
           with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma
           exacerbations in these patients. Safety and efficacy have not been established in other
           allergic conditions.
           [Posted 02/21/2007] FDA notified asthmatic patients and healthcare professionals of new
           reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after
           treatment with Xolair (omalizumab). Usually these reactions occur within two hours of
           receiving a Xolair subcutaneous injection. However, these new reports include patients
           who had delayed anaphylaxis—with onset two to 24 hours or even longer—after
           receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including
           the first dose), even if the patient had no allergic reaction to the first dose. Health care
           professionals who administer Xolair should be prepared to manage life-threatening
           anaphylaxis and should observe their Xolair-treated patients for at least two hours after
           Xolair is given. Patients under treatment with Xolair should be fully informed about the
           signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis
           following Xolair treatment, and how to treat it when it occurs. FDA has requested
           Genentech add a boxed warning to the product label and to revise the Xolair label and
           provide a Medication Guide for patients to strengthen the existing warning for
           anaphylaxis.

           [February 21, 2007 - Drug Information Page - FDA]
           [February 21, 2007 - News Release - FDA]


          Avandia (rosiglitazone maleate)
          Avandamet (rosiglitazone maleate and metformin hydrochloride)
          Avandaryl (rosiglitazone maleate and glimepiride)
          Audience: Endocrinologists, other healthcare professionals, consumers
          Indication: Treatment of type 2 diabetes mellitus
          [Posted 02/20/2007] Glaxo SmithKline (GSK) notified healthcare professionals of the
          results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients
          with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare
          glycemic control with rosiglitazone relative to metformin and glyburide monotherapies.
          Significantly more female patients who received rosiglitazone experienced fractures of
          the upper arm, hand, or foot, than did female patients who received either metformin or
          glyburide. At GSK's request, an independent safety committee reviewed an interim
          analysis of fractures in another large; ongoing; controlled clinical trial and preliminary
          analysis was reported as being consistent with the observations from ADOPT. Healthcare
          professionals should consider the risk of fracture when initiating or treating female
          patients with type 2 diabetes mellitus with rosiglitazone.

           [February 2007 - Letter - GSK]
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8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                    34
            Erythropoiesis Stimulating Agents:
           Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa)
           Audience: Oncologists, nephrologists, other healthcare professionals
           [UPDATE 03/09/2007] FDA notified healthcare professionals of new safety information
           for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin
           alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher
           chance of serious and life-threatening side effects or death with the use of ESAs. These
           research studies were evaluating an unapproved dosing regimen, a patient population for
           which ESAs are not approved, or a new unapproved ESA. FDA believes these new
           concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA
           and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full
           prescribing information for these drugs to include a new boxed warning, updated
           warnings, and a change to the dosage and administration sections for all ESAs.

           [Posted 02/16/2007] FDA notified healthcare professionals of the results from a large
           clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia
           in cancer patients not receiving chemotherapy. In this study, patients received either
           Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated
           with Aranesp had a higher death rate and no reduction in the need for transfusions
           compared to those treated with placebo. The findings in the Aranesp study may apply to
           other ESAs. Additionally, the findings show that treating anemic cancer patients not
           currently on chemotherapy with an ESA may offer no benefit and may cause serious
           harm.

           [March 09, 2007 - Public Health Advisory - FDA]
           [March 09, 2007 - News Release - FDA]
           [March 09, 2007 - Questions and Answers - FDA]
           [February 16, 2007 - Drug Information Page - FDA]
           [March 2007 - Label for Epogen/Procrit - Amgen]
           [March 2007 - Label for Aranesp - Amgen]

           Previous MedWatch Alerts:

           [January 27, 2007]
           [November 17, 2006]
           Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch




          Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq)
          Audience: Pediatric healthcare professionals, consumers
          [Posted 02/13/2007] FDA issued a Public Health Notification to inform health care
          providers and consumers about 28 post-marketing reports of intussusception following
          administration of Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq). Intussusception
          is a serious and potentially life-threatening condition that occurs when the intestine gets
          blocked or twisted.

           Because vaccine adverse events are not always reported to FDA, there may be additional
           cases of intussusception following vaccination of which we are unaware. This
           information is important in helping FDA and CDC assess whether RotaTeq may be
           associated with an increased risk of intussusception and, if so, to what degree. Healthcare
8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                    35
       professionals and others are encouraged to report any cases of intussusception or other
       serious events that may be associated with the use of RotaTeq to the Vaccine Adverse
       Event Reporting System (VAERS). Parents should contact their child’s doctor
       immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or
       change in their bowel movements, as these may be signs of intussusception.

       [February 13, 2007 – Public Health Notification – FDA]
       [January 2007 – Label – Merck]
       [January 2007 – Patient Product Information – Merck]
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        Ketek (telithromycin)
       Audience: Infectious disease and pulmonary specialists, other healthcare professionals,
       consumers
       [UPDATE 03/26/2007] Sanofi-Aventis issued a "Dear Healthcare Professional" letter.

       [Posted 02/12/2007] FDA and Sanofi-Aventis notified healthcare professionals of
       revisions to the prescribing information, including a BOXED WARNING and a new
       Patient Medication Guide, for the antibiotic Ketek. Two of the three previously approved
       indications, acute bacterial sinusitis and acute bacterial exacerbations of chronic
       bronchitis, were removed from the prescribing information because the balance of
       benefits and risks no longer support approval of the drug for these indications. Ketek will
       remain on the market for the treatment of community acquired pneumonia of mild to
       moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver
       injury), loss of consciousness, and visual disturbances. The BOXED WARNING states
       that Ketek is contraindicated in patients with myasthenia gravis. The Patient Medication
       Guide, which must be distributed to all patients, informs them about the risks of the drug
       and how to use it safely.

       [March 2007 – Letter – Sanofi-Aventis]
       [February 12, 2007 – Press Release – FDA]
       [February 12, 2007 – Label –Sanofi-Aventis]
       [February 12, 2007 – Medication Guide – Sanofi-Aventis]
       [February 12, 2007 – Drug Information Page – FDA]

       Previous MedWatch Alerts

       [June 29, 2006]
       [January 20, 2006]
       Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch




          Custom Ultrasonics System 83 Plus Washer/Disinfector
           System 83 Plus Mini-flex Washer/Disinfector
           Audience: Hospital risk managers, nursing supervisory staff
           [UPDATE 02/27/2007] FDA issued a Public Health Notification to further inform
           hospitals and other user facilities about FDA’s action, and to provide recommendations
           for facilities currently using the affected products.
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                                                      36
           [Posted 02/07/2007] FDA informed healthcare professionals that Custom Ultrasonics
           agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and
           the System 83 Plus Mini-flex Washer/Disinfector, used to wash and disinfect flexible
           endoscopes, until it brings its manufacturing methods and controls into compliance with
           FDA requirements. Endoscopes that are not properly cleaned and disinfected can be a
           source of transmission of pathogens between patients, causing life threatening infections.
           FDA advised health care providers to discontinue using these products, using an
           alternative device or following appropriate protocols to manually wash and disinfect the
           device.

           [February 27, 2007 – Public Health Notification – FDA]
           [February 07, 2007 – News Release – FDA]
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          Lucentis (ranibizumab injection)
          Audience: Ophthalmological healthcare professionals
          Indication: Treatment of patients with neovascular (wet) age-related macular
          degeneration
          [Posted 02/01/2007] Genentech informed healthcare professionals of preliminary safety
          information from a planned interim analysis in an ongoing study (SAILOR) which
          confirmed the higher incidence of stroke in the 0.5 mg dose group compared to the 0.3
          mg dose group (1.2% versus 0.3%, respectively; P=0.02) of patients with neovascular
          (wet) age-related macular degeneration who received intravitreal Lucentis. The rates of
          stroke for both dose groups are lower than the rates seen in the controlled clinical trials
          and included in the approved labeling. The planned frequency of dosing was not the same
          as that described in the approved labeling. This comparison was one of many made
          during this interim analysis.

           [January 24, 2007 – Letter – Genentech]
           [June 30, 2006 - Label - Genentech]
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          Aranesp (darbepoetin alfa)
          Audience: Oncological healthcare professionals
          [Posted 01/27/2007] Amgen notified the oncology medical community of the results of a
          large, multicenter, randomized, placebo-controlled study showing that Aranesp was
          ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who
          have anemia that is not due to concurrent chemotherapy. The study also showed higher
          mortality in patients receiving Aranesp. Aranesp is approved for the treatment of patients
          with anemia caused by the chemotherapy treatment of the malignant disease and should
          only be used in accordance with its approved product labeling.

           [January 26, 2007 – Letter – Amgen]
           Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch




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                                                                    37
          Cough and Cold Medications in Children Less Than Two Years of Age
          Audience: Pediatric and primary care healthcare professionals and patients
          [Posted 01/12/2007] The Centers for Disease Control and Prevention (CDC) issued a
          Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S.
          infants aged less than 12 months associated with cough and cold medications. These
          medications were determined by medical examiners or coroners to be the underlying
          cause of death. The cases described in this report underscore the need for clinicians to use
          caution when prescribing and caregivers to use caution when administering cough and
          cold medications to children aged less than 2 years.

           [January 12, 2007- MMWR Weekly - CDC]
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           Tamiflu (oseltamivir phosphate)
           Audience: Pediatric and primary care healthcare professionals and patients
           Indication: Treatment of uncomplicated acute illness due to influenza infection in
           patients 1 year and older who have been symptomatic for no more than 2 days.
           [Posted 01/04/2007] Roche notified healthcare professionals of a correction to a Dear
           Healthcare professional letter issued on November 13, 2006. The original letter
           referenced changes to the PRECAUTIONS Section of prescribing information for
           Tamiflu about post marketing reports of self-injury and delirium with the use of Tamiflu
           in patients with influenza. The prescribing information that accompanied the letter
           contained an incorrect dosing chart for the Standard Dosage of Tamiflu Oral Suspension
           for prophylaxis of influenza in pediatric patients. The chart incorrectly specified twice
           daily instead of once daily dosing under "Recommended Dose" for 10 days. Healthcare
           professionals should discard the incorrect version of the package insert included in the
           November 13, 2006 mailing and refer to the new dosing chart included in the December
           26, 2006 letter.

           [December 26, 2006 - Letter - Roche]
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Decision:             1.           The Board decided to withdraw the formulations of “Gatifloxacin” except
                                  Eye Drops. Due to “Dysglicemic” effects of the “Gatifloxacin”. It was
                                  therefore decided that show cause notices should be issued to the relevant
                                  firm.


                      2.          It was also decied that all the firms should include above mentioned
                                  warnings and alerts into the labeling of their registered drugs with
                                  immediate effects and Provincial Governments should implement this into
                                  the labels.



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                                                                    38
Case No. 21 M/s. AGP, Karachi was granted registration as imported products which were
transferred to local manufacturing since 13th October, 2003 and Kefadim 250mg (Reg. No.
036178) was registered for local manufacturing since 10th January, 2005. The firm has requested
for contract manufacturing permission from M/s. PharmEvo, Karachi for a period of 3 years to
build new and most morden facility for these products.


                                     S. No.    Reg. No(s)   Name of Drug(s)
                                           1    003756      Kefzol 1gm Injection
                                                            (Cephazolin)
                                           2    003755      Kefzol 500mg Injection
                                                            (Cephazolin)
                                           3    036178      Kefadim 250mg
                                                            Injection (Ceftazidime)
                                           4    018069      Kefadim 500mg
                                                            Injection (Ceftazidime)
                                           5    018070      Kefadim 1gm Injection
                                                            (Ceftazidime)


Decision:             The request of the firm was deferred due to the substandard report of Bestrix
                      250mg Injection (Batch No. 6C133 & 535005) vie test report No. 363-A/2006 &
                      363-B/2006 of M/s. PharmEvo (contract manufacturer). It was decided that
                      explanation of the firm may be obtained befor any decision.


Case No. 22 M/s. Organon has requested for deregistration of their registered drug “Orabolin
(Ethylestrenol) 2mg Tablets ” (Reg. No. 001795) on the grounds that the same will no longer
produce nor distributed as decied by our parent company N.V. Organon, Os, Netherland due to
strategic reasons.


                      The product has been also discontuned in USA but it is available for illegal use by
the private firm through internet.


Decision:             The request of the firm was acceded to


Case No. 23 M/s. Barrett Hodgson applied for the grant of registration of the following drugs
which was regjected by in 181-B Me-Too Committee meeting constituted by Drugs Registration


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                                                            39
Board on the grounds that no therapeutic efficacy established in children. It is not recommended
for use in children:-


                              Name of Drug                     Pack     Demanded
                                                               Size       Price
                              Bambec Oral Solution             60ml     Rs.170.00
                              Each ml contains:-
                              Bambuterol Hydrochloride 1mg
                              (Long acting Beta-2 Stimulant)



                      But the same formulation was approved in 195-A Committee meeting for M/s.
Platinum Pharmaceuticals as under:-


                                     Reg. No.
                                                Name of drug(s) & Composition
                                      042478    Pulmitac Oral Solution
                                                Each 5ml contains:-
                                                Bambuterol HCl..……5mg
                                                (BP Specification)

                      It is important to mention that “Bambuterol” is a Pro-Drug of “Terbutaline”
but it is not approved by the UK and USA Regulatory Authorities for Pediatric use and it is
specifically mention in the BNF that the drug is not recommended in children. On the other
hand firm has contended that drug is registered in a number of countries like Dinmark, Germany,
Portugal, Sweden, Hong Kong, South Korea, Vietnam, Bahrain, Cambodia, Kuwait, Myanmar,
Oman, Peru, Sri Lanka, Thailand, Trinida & Tobage, Brazil, New Zealand, Philippines,
Singapore and etc.


Decision:             The Drugs Registration Board after going through the detail of the matter decided
                      to reject the application because Syrup formulation of “Bambutrol” is not
                      evaluated in children. It is not approved in UK & USA. It was also decided that
                      already registered formulation “Pulmitac Oral Solution” (Reg. No. 042478) of
                      M/s. Platinum shall be show caused for cancellation of registration.




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                                                       40
Case No. 24 M/s. Barrett Hodgson applied for the registration of following drug which was
considered in 193-A Committee meeting and following recommendations were approved by the
Committee:-




     Name of Drug & Compostion                          Pack   Demanded     Recommendations of Me-
                                                        Size     Price           Too Committee
     Ciprodex Topical Sterile Eye Drops                 5ml    Rs. 225.00   Deferred for verification of
     Each 1ml contains:-                                                     separate hormonal drops
     Ciprofloxacin USP (as Ciprofloxacin                                              section
     HCl)….…..3.0mg
     Dexamethasone USP…….1.0mg
     (Anti-infective/ steroid
     combinations)

                      But the firm had submitted that they are already manufacturing same formfulation
approved as Ear Drops and there is no need separate section. The important matter to be
considered is that “Ciprofloxacin” in combination with Steroid i.e. Dexamethasone is neither
approved by the FDA nor UK MHRA.But a number of similar preparations have been approved
by the Drugs Registation Board and are avialble being manufactured by various concerns. This
needs special consideration of the Registration Board because safety and efficacy of any
formulation either alone or in combination could only be achieved if such formulation is
thoroughly evaluated demonstrating pharmacological, pharmaceutical and clinical datas in
support of formulation, dosage form, dose, efficacy, indications, side effects, precautions, for use
in special groups like preganency, oldage, children, neonates and etc. The only antiobotics
approved with steroid are Gentamycin, Neomycin, Tobramycin and Polymixin as Eye and Ear
preparations.
Decision:             The request of the firm was not acceded to on the grounds that the said
                      formulation is approved by UK & USA and safety and efficacy of the drug are not
                      established. It was also decided to withdraw the already registered formulation
                      and issue show cause notices in this respect.


Case No. 25 M/s. Bristrol-Myers Squibb has requested for extension in bulk import and local
repacking of the following for a period of one year. They have undertaken that after completing
stability studies and validation they will start its local manufacturing within this period. The drug
is being imported from M/s. Bristol Myers Squibb Spa,Latina, Ital:-
                                  S. No.   Reg. No(s)    Name of Drug(s)

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                                                          41
                                  1        025548    Maxipime 500mg Injections
                                                     (Cefepime)
                                  2        025549    Maxipime 1gm Injections
                                                     (Cefepime)


Decision:             The request of the firm was acceded to for a period of one year.
Case No. 26 The deregistration application of M/s. BMS for the drug “Corgard (Nadolol)
80mg Tablets (Reg. No. 005328) was considered by the Drugs Registration Board in its 199
meeting and it was decided that the availability of the raw material may be verified now M/s.
Brisol Myers Squibb Company Director Supply Chain has stated that technical operations has
been ceased to manufacture “Nadolol” API in 2006 due to declining global requirements and
manufacturing costs.


Decision:             The request of the firm was acceded to


Case No. 27 M/s. Pfizer Laboratories, Karachi has requested for approval for the import of
60,000 units of “Diflucan (Fluconazole) I.V Injection (Reg. No. 011830) in finished form as the
already granted permission is going to be expired on 15th Decmber, 2007. They have further
submitted that the drug is a life saving only “Antifungal” available in injection form and its
utilization is very low.


                      They will import this quantity within 3 years with 20,000 vials on yearly basis.
For this purpose they have deposited a fee of Rs. 1000/- which in sufficient as the fee of Rs.
15000/- for this purpose.


Decision:             The request of the firm was acceded to


Case No. 28 Drugs Registration Board considered the registration application of M/s. Sami
Pharmaceuticals, Karachi for the drug “Coxim (Nimesulide) Mouth Dissolving Tablets” for want
of personal hearing in the justification of said dosage form. Now the firm has submitted that Our
application for registration of said drug dated 25th April, 2000 and subsequent queries and our
clarifications to the same, we now find limited interests in the products and request you to
consider our application as withdrawn.


Decision:             The request of the firm was acceded to
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                                                      42
Case No. 29 M/s. Platinum Pharmaceuticals, Karachi has applied for the re-registration of their
registered products due to failure in submission of applications within the prescribed period of 60
days. The last date for the submission of renewal application was 22nd November, 2006. The
products are as under:-
              S. No. Reg. No. Name of Drugs & Composition               Pack      MRP
                                                                       Size(s)
                  1.         023887 Apofer 100mg Chewable Tablets      1x10’s    Rs. 90.00
                                    Each tablet contains:-
                                    Iron (III)-Hydroxide Polymaltose
                                    Complex eq. to Elemental
                                    Iron……………..100mg


                  2.         023888 Apofer –F 100mg Chewable           1x10’s    Rs. 90.00
                                    Tablets
                                    Each tablet contains:-
                                    Iron (III)-Hydroxide Polymaltose
                                    Complex eq. to Elemental
                                    Iron……………....100mg
                                    Folic Acid……...0.750mg



Decision:              The request of the firm was acceded to




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                                                      43
   Item No. II APPLICATION(S) FOR ADDITIONAL SECTION OF M/S. EPOCH
   PHARAMCEUTICAL, KARACHI.

                         a).         Human Liquid Injection (General Antibiotic)
                         b).         Ophthalmic Drops (General Antibiotic)


S. No.     Name of              Name of Drugs &                     Pack      Demande       Decision
            firm(s)             Composition                        Size(s)     d Price
  1.      M/s. Epoch            Relaxon Injection                    1’s      Rs. 35.00 Approved subject to
          Pharmaceut            Each 5ml ampoule contains:-                             submission of fee of
              ical,             Suxamethonium                                               Rs. 8000/-
           Karachi              Chloride…100mg
                                (Muscle relaxdant)

  2.            -do-            Buphine 10 Injections                1’s      Rs. 49.00       Rejected on the
                                Each ampoule contains:-                                     grounds that it does
                                Nalbuphine HCl……10mg                                           not fulfil the
                                (BP Specification)                                          requirements of the
                                (Analgesic)                                                   Psychotropic /
                                                                                              Narcotic policy.

  3.            -do-            Buphine 20 Injections                1’s      Rs. 63.00             -do-
                                Each ampoule contains:-
                                Nalbuphine HCl……20mg
                                (BP Specification)
                                (Analgesic)

  4.            -do-            Water for injections                 5ml           As per   Approved subject to
                                Each ampoule contains:-             10ml           SRO      submission of fee of
                                Water for injection                                             Rs. 8000/-

  5.            -do-            Quin 200 Injections                 Vial      Rs. 760.00       Rerjected on the
                                Each 100ml vial contains:-                                     grounds that the
                                Ofloxacin as Ofloxacin                                       infusion section of
                                HCl…..….200mg                                                   the firm is not
                                (Quinolone)                                                 approved. Moreover,
                                                                                               the firm has not
                                                                                            elaborated procedure
                                                                                                  to make the
                                                                                            formulation isotonic
                                                                                            as per pharmacopeial
                                                                                                 requirement.

  6.            -do-            Licain 1% Injections              2mlx100’s   Rs. 200.00 Approved subject to
                                Each ml ampoule contains:-        10mlx50’s   Rs. 500.00 submission of fee of
                                Lignocaine HCl……10mg                                         Rs. 8000/-




   8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             44
7.            -do-            Levocin Injections                  Vial      Rs. 800.00      Rerjected on the
                              Each 100ml vial contains:-                                    grounds that the
                              Levofloxacin                                                infusion section of
                              Hemihydrate…..500mg                                            the firm is not
                              (Fluoroquinolone antibiotic)                               approved. Moreover,
                                                                                            the firm has not
                                                                                         elaborated procedure
                                                                                               to make the
                                                                                         formulation isotonic
                                                                                         as per pharmacopeial
                                                                                              requirement.

8.            -do-            Epogen Injections                   25’s      Rs. 20.80    Approved subject to
                              Each ampoule contains:-           ampoule        Per       submission of fee of
                              Gentamycin……..80mg                            ampoule          Rs. 8000/-
                              (Aminoglycoside)

9.            -do-            Epozole Injections                Per vial    Rs. 57.00       Rerjected on the
                              Each 100ml vial contains:-                                    grounds that the
                              Metronidazole…….500mg                                       infusion section of
                              (PIA, Amoebicide)                                              the firm is not
                                                                                         approved. Moreover,
                                                                                            the firm has not
                                                                                         elaborated procedure
                                                                                              to make the
                                                                                         formulation isotonic
                                                                                         as per pharmacopeial
                                                                                              requirement

10.           -do-            Lomin Injections                    vial      Rs. 35.00    Approved subject to
                              Each 2ml vial contains:-          Ampoule     Rs. 37.50    submission of fee of
                              Lincomycin (as HCl)….600mg                                     Rs. 8000/-

11.           -do-            Epophenicol Eye Drops             10’s vial   Rs. 40.00            -do-
                              Each vial contains:-
                              Chloramphenicol……0.5%w/v
                              (BP Specification)
                              (Anti-infective)

12.           -do-            Epophenicol Eye Drops               vial      Rs. 35.00            -do-
                              Each vial contains:-
                              Chloramphenicol……1.0%w/v
                              (BP Specification)
                              (Anti-infective)

13.           -do-            Tilol Eye Drops                     Vial      Rs. 128.00           -do-
                              Each vial contains:-
                              Timolol Maleatel……0.5%w/v
                              (S1E, Miotics)


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                                                           45
14.           -do-            Ciflox Eye Drops                 Vial   Rs. 110.00   -do-
                              Each vial contains:-
                              Ciprofloxacin……0.3%w/v
                              (S1E, Anti-infective)

15.           -do-            Dexadron-T Eye Drops             Vial   Rs. 123.50   -do-
                              Each vial contains:-
                              Dexamethasone (as Sodium)
                              Phosphate.……..…0.1%
                              Tobramycin ….0.3%w/v
                              (BP Specification)
                              (S1C, corticosteroid, anti-
                              infective)

16.           -do-            Epox Eye Drops                   Vial   Rs. 87.00    -do-
                              Each vial contains:-
                              Ofloxacin….0.3%w/v
                              (BP Specification)
                              (S1A, eye anti-injective)

17.           -do-            Rolone Eye Drops                 Vial   Rs. 62.00    -do-
                              Each vial contains:-
                              Prednisolone Acetate..1.0%w/v
                              (BP Specification)
                              (S1B, costicosteriods)

18.           -do-            Sidic Eye Drops                  Vial   Rs. 160.00   -do-
                              Each vial contains:-
                              Fusidic Acid……..1.0%w/v
                              (BP Specification)
                              (S1A, eye anti-injective)

19.           -do-            Epogen Eye / Ear Drops           Vial   Rs. 20.00    -do-
                              Each vial contains:-
                              Gentamycin……....0.3%w/v
                              (BP Specification)
                              (anti-injective)

20.           -do-            Ramycin Eye Drops                Vial   Rs. 118.00   -do-
                              Each vial contains:-
                              Tobramycin……....0.3%w/v
                              (BP Specification)
                              (anti-injective)




 8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                          46
         Item No. III NEW APPLICATIONS FOR REGISTRATIONS

                                  a.       HVAC SYSTEM IS CONFIRMED OF FOLLOWING FIRMS

S. No.     Name of               Name of Drugs & Composition         Pack     Demanded            Decision
            firm(s)                                                 Size(s)     Price
  1.       M/s. Zafa             Arteza 80mg/ml Injection             5’s     Rs. 120.00          Approved
          Pharmaceuti            Each ml contains:-
          cal, Karachi           Artemether….80mg
                                 (Anti-malarial)

  2.             -do-            Arteluma Tablets                    16’s     Rs. 320.00            -do-
                                 Each tablet contains:-
                                 Artemether……..20mg
                                 Lumefantrine….120mg
                                 (Anti-malarial)

  3.        M/s. Helix           Bonamin Plus Capsules               20’s        Rs.       Rejected on the grounds
             Pharma,             Each capsule contains:-                      14.00/per     that the formulation is
             Karachi             Glucosamine Sulphate                            cap          irrational and not
                                 USAN………………….500mg                                          approved any where in
                                 Chondroitin Sulphate                                      the World. Moreover, it
                                 INN…………………200mg                                             was also decided that
                                 Calcium Carbonate BP…75mg                                    already rejectered
                                 Vitamin-C BP………….25mg                                      formulation should be
                                 (Anti-arthritic)                                              show caused for
                                                                                              cancellation of its
                                                                                                  registration.

  4.           M/s.              GenCart Plus Caplet                 10’s     Rs. 165.00            -do-
              Barrettt           Each caplet contains:-
             Hodgson,            Glucosamine Sulphate…500mg
             Karachi             Chondroitin Sulphate….200mg
                                 Calcium Carbonate….75.0mg
                                 Ascorbic Acid……….25.0mg
                                 (Anti-rheumatic drug)

  5.        M/s. Epla            Aspirel Tablets                     10’s     Rs. 21.00/          Approved
             Labs,               Each tablet contains:-                        per tab
            Karachi              Clopidogrel (as Clopidogrel
                                 Bisulphate)…….75mg
                                 Aspirin………75mg
                                 (Anti-Platelet)




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                                                               47
6.            -do-            Cardio Guard Tablets                 20’s   Rs. 14.00/             -do-
                              Each film coated tablet contains:-           per tab
                              Clopidogrel (as Clopidogrel
                              Bisulphate)…….75mg
                              (Anti-Platelet)

7.            -do-            Ezestim 10/10 Tablets                10’s   Rs. 30.00/             -do-
                              Each tablet contains:-                      per tablet
                              Ezetimibe……….10mg
                              Simvastatin……..10mg

8.            -do-            Ezestim 10/20 Tablets                10’s   Rs. 305.00             -do-
                              Each tablet contains:-
                              Ezetimibe……….10mg
                              Simvastatin……..20mg

9.     M/s. Bosch Somezol Injection                                1’s    Rs. 250.00             -do-
       Pharmaceuti Each vial contains:
       cal, Karachi Esomeprazole (as Sodium)…20mg
                    (Proton Pump Inhibitor)

10.           -do-            Somezol Injection                    1’s    Rs. 422.00             -do-
                              Each vial contains:
                              Esomeprazole (as Sodium)…40mg
                              (Proton Pump Inhibitor)

11.           -do-            Opram 10mg Tablets                   14’s   Rs. 630.00             -do-
                              Each tablet contains:-
                              Escitalopram Oxalate eq. to
                              Escitalopram…….10mg
                              (5th reuptake inhibitor)

12.           -do-            Zecef 500mg Tablets                  14’s   Rs. 980.00             -do-
                              Each film coated tablet contains:-
                              Cefuroxime (as Axetil)….500mg
                              (Anti-infective)

13.           -do-            Calamox 0.3g Injection               1’s    Rs. 45.00     Rejected on the grounds
                              Each vial contains:-                                     that this strength was not
                              Amoxycillin Sodium eq. to                                approved in UK & USA.
                              Amoxycillin………250mg
                              Potassium Clavulanate eq. to
                              Clavulanic Acid……50mg
                              (Anti-biotic)

14.     M/s. Merck            Gababion 100mg capsules              10’s   Rs. 8.90/           Approved
         Marker,              Each capsule contains:-                      per cap
         Karachi              Gabapentin…..100mg
                              (Anti-convulsant)


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                                                             48
15.           -do-            Gababion 300mg capsules            10’s    Rs. 18.90/              -do-
                              Each capsule contains:-                     per cap
                              Gabapentin…..300mg
                              (Anti-convulsant)

16.           -do-            Gababion 400mg capsules            10’s    Rs. 23.90/              -do-
                              Each capsule contains:-                     per cap
                              Gabapentin…..400mg
                              (Anti-convulsant)

17.      M/s. Elko            Becmin 500mcg Injection            10x1m   Rs. 500.00              -do-
           Org.               Each ml contains:-                   l
         Karachi              Mecobalamin……..500mcg
                              (Vitamin B12-co-enzyme)

18.           -do-            Pirom 500mg Injection               1’s    Rs. 300.00              -do-
                              Each vial contains:-
                              Cefpirome (as Cefpirome
                              Sulphate)……..500mg
                              (Cephalosporin)

19.           -do-            Pirom 1g Injection                  1’s    Rs. 500.00              -do-
                              Each vial contains:-
                              Cefpirome (as Cefpirome
                              Sulphate)……..1g
                              (Cephalosporin)

20.         M/s.              Cechew 500mg Tablets               40’s    Rs. 67.00    Drugs Registration Board
         Nabiqasim            Each chewable tablet contains:-                         deferred the applications
         Industries,          Ascorbic Acid …..500mg                                   for inspection to verify
          Karachi             (Vitamin)                                                following informations.

                                                                                      a.    Toal number       of
                                                                                           registered drugs

                                                                                      b.   Total number       of
                                                                                           marketed drugs

                                                                                      c.      stability record of
                                                                                           the applied drugs
                                                                                           along with drug
                                                                                           development       data
                                                                                           verification

                                                                                      d. Capacity of the firm.

                                                                                      e. number of technical
                                                                                         personnel

                                                                                      f.    Capacity of quality
                                                                                           control and stability
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                            49
                                                                                            chambers to conduct
                                                                                            new              drug
                                                                                            development by the
                                                                                            following panel.

                                                                                        i. Abdul Latif Sheikh.
                                                                                        ii. Zahid Saeed (PPMA)
                                                                                        iii. Obaid Ali.

                                                                                        This panel will submit its
                                                                                              report for the
                                                                                           consideration of the
                                                                                                  Board.
                                                                                        The firm has submitted
                                                                                        36 applications which are
                                                                                        included in this meeting
                                                                                        and the qualified staff
                                                                                        was found in sufficient as
                                                                                        required in SRO. 662 OF
                                                                                        2005.

21.           -do-            Ciflox 500mg Tablets                 10’s   Rs. 499.00              -do-
                              Each film coated tablet contains:-
                              Ciprofloxacin Hydrochloride eq. to
                              Ciprofloxacin …..500mg
                              (Anti-bacterial)

22.           -do-            GoodLife Energy-Vit Tablets          30’s    Rs. 30.00              -do-
                              Each tablet contains:-
                              Ferrous Fumarate …….150mg
                              Folic Acid……………..0.5mg
                              (Iron supplement)

23.           -do-            Glanorm 5mg Tablets                  60’s    Rs. 89.00              -do-
                              Each core tablet contains:-
                              Glibenclamide……..5mg
                              (Anti-diabetic agent)

24.           -do-            Azitin 5mg Tablets                   10’s   Rs. 999.00              -do-
                              Each film coated tablet contains:-   14’s   Rs. 1399.00
                              Memantine Hydrochloride….5mg
                              (receptor antagonist)

25.           -do-            Azitin 10mg Tablets                  10’s   Rs. 1670.00             -do-
                              Each film coated tablet contains:-   14’s   Rs. 2338.00
                              Memantine Hydrochloride…10mg
                              (receptor antagonist)




      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             50
26.         -do-        Azitin 10mg /g Oral Drops Solution         20g’g   Rs. 3340.00   -do-
                        1g solution (20 drops) contains:-          50g’s   Rs. 8350.00
                        Memantine Hydrochloride…10mg
                        (receptor antagonist)

27.         -do-        Ferrin Tablets                             20’s    Rs. 199.00    -do-
                        Each film coated tablet contains:-
                        Iron Polymaltose Complex eq. to
                        Elemental Iron…..…100mg
                        (Haematinic)

28.         -do-        Ferrin Syrup                               120ml   Rs. 199.00    -do-
                        Each teaspoonful (5ml) contains:-
                        Iron Polymaltose Complex eq. to
                        Elemental Iron…..…50mg
                        (Haematinic)

29.         -do-        Ferrin Oral 30ml Drop                      30ml    Rs. 139.00    -do-
                        Each 1ml (20 drops) contains:-
                        Iron Polymaltose Complex eq. to
                        Elemental Iron…..…50mg
                        (Haematinic)

30.         -do-        Rosit 2mg Tablets                          10’s    Rs. 450.00    -do-
                        Each film coated tablet contains:-
                        Rosiglitazone Maleate eq. to
                        Rosiglitazone.…..…2mg
                        (Anti-diabetic)

31.         -do-        Rosit 4mg Tablets                          10’s    Rs. 890.00    -do-
                        Each film coated tablet contains:-
                        Rosiglitazone Maleate eq. to
                        Rosiglitazone.…..…4mg
                        (Anti-diabetic)

32.         -do-        Azro 250mg Tablets                          6’s    Rs. 228.00    -do-
                        Each film coated tablet contains:-
                        Azithromycin (As
                        Trihydrate).…..…250mg
                        (Macrolide antibiotic)

33.         -do-        Azro 500mg Tablets                          6’s    Rs. 449.00    -do-
                        Each film coated tablet contains:-
                        Azithromycin (As
                        Trihydrate).…..…500mg
                        (Macrolide antibiotic)

34.         -do-              Diamet 250mg Tablets                 30’s     Rs. 29.90    -do-
                              Each film coated tablet contains:-   60’s     Rs. 59.90
                              Metformin Hydrochloride..250mg
                              (antibiotic)
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                                                             51
35.           -do-            Diamet 500mg Tablets                    30’s    Rs. 59.00    -do-
                              Each film coated tablet contains:-      60’s    Rs. 119.00
                              Metformin Hydrochloride..500mg
                              (antibiotic)

36.           -do-            Multical-D Sachet                       10’s    Rs. 112.00   -do-
                              Each sachet cotains:-
                              Calcium Lactate
                              Gluconate....................1000mg
                              Calcium Carbonate…....327mg
                              Vitamin D3 100 iu/mg…..4mg
                              Ascorbic Acid………....500mg
                              Vitamin B6 ………….…10mg
                              (calcium and vitamin)

37.           -do-            Fersul 200mg Tablets                   1000’s   Rs. 300.00   -do-
                              Each sugar coated tablet contains:-
                              Ferrous Sulphate….200mg
                              (Haematinic)

38.          -do-.            Lotel Tablet 20mg                       Per     Rs.32.5/-    -do-.
                              Each tablet contains:-                 Tablet
                              Temisartan……………20mg
                              (ACE Inhibitor)

39.           -do-            Lotel Tablet 40mg                       Per      Rs.60/-     -do-
                              Each tablet contains:-                 Tablet
                              Temisartan……………40mg
                              (ACE Inhibitor)

40.           -do-            Perrin-FA Tablet                        30’s    Rs.229.00    -do-
                              Each film coated chewable Tablet
                              contains:
                              Iron Polymaltose complex
                              equivalent to elemental
                              iron…………………..100mg
                              Folic acid B.P…………0.35mg
                              (Haematinic)

41.           -do-            Zudic Sluspension 90ml                 90ml     Rs.699.00    -do-
                              Each 5ml contains:
                              Fusidic acid Ph.Eur……….250mg
                              (Antibiotic).

42.           -do-            Ferrin-FA Syrup 120ml                  120ml    Rs.199.00    -do-
                              Each teaspoonful (5ml) contains:
                              Iron polymaltose complex eq. to
                              elemental iron…..50mg
                              Folic Acid B.P……..0.35mg
                              (Haematinic)

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                                                                52
43.           -do-            Zudic 250mg Tablet                    10,s    Rs.560.00                -do-
                              Each Tablet contains:
                              Sodium fusidate Ph. Eur…250mg
                              (Antibiotic)

44.          -d o-            Lotel 80mg Tablet                     10’s    Rs..1100.00             -d o-
                              Each film coated tablet contains:     30,s    Rs.3300.00
                              Telmisartan…………….80mg
                              ACE inhibitors (Anti-hypertensive)

45.           -do-            Biolysine Tablet                      100,s   Rs.150.00                -do-
                              Each chewable tablet contains:
                              Ascorbic Acid B.P.(Vitamin
                              C)…100mg
                              Lysine Monohydrochloride
                              U.S.P…50mg
                              (Vitamin & Amino Acid).

46.           -do-            Zetor tablet                          10’s    Rs.450.00                -do-
                              Each film coated tablet contains:
                              Atorvastatin Calcium Dihydrate Eq.
                              to Atorvastatin……..10mg
                              Ezetimibe……………….10mg
                              (HMG-CoA reductase inhibitor)

47.           -do-            Zetor Forte tablet                    10’s    Rs.550.00                -do-
                              Each film coated tablet contains:
                              Atorvastatin Calcium Dihydrate Eq.
                              to Atorvastatin……..20mg
                              Ezetimibe……………….10mg
                              (HMG-CoA reductase inhibitor)

48.      M/s. AGP,            Lucast 4mg Sachet                     14’s    Rs. 475.00    Rejected on the grounds
          Karachi             Each sachet contains:-                                      that:-
                              Montelukast Sodium…4mg
                              (Leukotriene receptor antagonist)                           The firm has not
                                                                                          completed the application
49.           -do-            Zolium 20mg Capsules                  14’s    Rs. 170.00    files with respect to
                              Each capsule contains:-                                     following     documents.
                              Esomeprazole (as Enteric Coated                             The           resubmitted
                              Pellets of Esomeprazole                                     documents lack again the
                              Magnesium Trihydrate)…20mg                                  following        required
                              (Anti-peptic Ulcerants)                                     informations:

50.           -do-            Zolium 40mg Capsules                  14’s    Rs. 323.00    1. Stability Studies.
                              Each capsule contains:-
                              Esomeprazole (as Enteric Coated                             2. Manufacturing
                              Pellets of Esomeprazole                                     methods
                              Magnesium Trihydrate)…40mg
                              (Anti-peptic Ulcerants)                                     3. Specifications with
                                                                                          validations
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                               53
51.           -do-            Osnate Neo Tablets                  30’s   Rs. 247.00
                              Each tablet contains:-                                   4. HVAC System
                              Vitamin D………….…400iu
                              Ossein Mineral Complex…830mg                             5. Water facility.
                              Corresponding to:
                              Calcium……………..177.6mg*                                   6. Type of Container.
                              Phosphorus……….…82.2mg*
                              Residul Mineral Salt…24.9mg                              Hence proposed to be
                              Collagen…………….224.0mg                                    rejected.
                              Other Proteins………66.4mg
                              Trace Elemental…..Fl, Mg, Fe, Zn,
                              Cu, Ni
                              Corresponding to Approx 440mg
                              Hydroxapatite

52.           -do-            Osnate Plus Sachet                  30’s   Rs. 247.00
                              Each sachet contains:-
                              Ossein Mineral Complex…830mg
                              Vitamin D3 …………….400iu
                              Vitamin C (Ascorbic
                              Acid)………………….500mg
                              Vitamin B6 ……………10mg
                              (Calcium & Vitamins)

53.           -do-            Dexicam 10mg Tablets                14’s   Rs. 655.50
                              Each tablet contains:-
                              Escitalopram Oxalate eq. to
                              Escitalopram…..10mg
                              (Anti-depressant)

54.           -do-            Dexicam 20mg Tablets                14’s   Rs. 664.60
                              Each tablet contains:-
                              Escitalopram Oxalate eq. to
                              Escitalopram…..20mg
                              (Anti-depressant)

55.           -do-            Cardeon 25mg Tablets                30’s   Rs. 741.00
                              Each tablet contains:-
                              Quetiapine Fumarate eq. to
                              Quetiapine…….25mg
                              (Anti-Psychotic)

56.           -do-            Cardeon 100mg Tablets               30’s   Rs. 2913.00
                              Each tablet contains:-
                              Quetiapine Fumarate eq. to
                              Quetiapine…….100mg
                              (Anti-Psychotic)




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                                                            54
57.           -do-            Cardeon 200mg Tablets             30’s   Rs. 4958.00
                              Each tablet contains:-
                              Quetiapine Fumarate eq. to
                              Quetiapine…….200mg
                              (Anti-Psychotic)


58.     M/s. Searle           Trimit 10mg Capsules              10’s   Rs. 1000.00           Approved
           Pak,               Each capsule contains:-
         Karachi              Sibutramine Hydrochloride
                              Monohydrate…..10mg
                              (Anti-Obesity)

59.           -do-            Trimit 15mg Capsules              10’s   Rs. 1300.00              -do-
                              Each capsule contains:-
                              Sibutramine Hydrochloride
                              Monohydrate…..15mg
                              (Anti-Obesity)

60.           -do-            Lencor 10mg Tablets               10’s   Rs. 591.20               -do-
                              Each tablet contains:-
                              Alendronate Sodium eq. to
                              Alendronate….…..10mg
                              (Bone calcium regulators)

61.           -do-            Lencor 70mg Tablets               4’s    Rs. 1520.00              -do-
                              Each tablet contains:-
                              Alendronate Sodium eq. to
                              Alendronate….…..70mg
                              (Bone calcium regulators)

62.           -do-            Olesta 5mg Tablets                10’s   Rs. 250.00        Deferred for expert
                              Each tablet contains:-                                      evaluation of the
                              Olmesartan..…..5mg                                           pharmaceutical,
                              (Hypertension)                                            pharmacological and
                                                                                      clinical data to establish
                                                                                     safety and efficacy of the
                                                                                                drug.

63.           -do-            Olesta 20mg Tablets               10’s   Rs. 900.00               -do-
                              Each tablet contains:-
                              Olmesartan..…..20mg
                              (Hypertension)

64.           -do-            Olesta 40mg Tablets               10’s     Rs. 175                -do-
                              Each tablet contains:-                      0.00
                              Olmesartan..…..40mg
                              (Hypertension)



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                                                           55
65.        M/s.     Gramex Gel                                      5g    Rs. 80.00      Rejected on the grounds
        Platinum    Contains:_                                     10g    Rs. 150.00    that standard formulation
       Pharmaceuti Metronidazole….1%w/w                            15g    Rs. 220.00    is 0.7% of Metronidazole
       cal, Karachi

66.           -do-            Osteomin Plus Tablets                20’s   Rs. 320.00    Rejected on the grounds
                              Each film coated tablet contains:-                         that the formulation is
                              Glucosamine Sulphate…500mg                                   irrational and not
                              Chondroitin Sulphate….200mg                                approved any where in
                              Calcium Carbonate…….75mg                                  the World. Moreover, it
                              Vitamin C……………….25mg                                        was also decided that
                              (Antirheumatics)                                             already rejectered
                                                                                         formulation should be
                                                                                            show caused for
                                                                                           cancellation of its
                                                                                               registration.

67.           -do-            Levotam 250mg Tablets                20’s   Rs. 1000.00   Drugs Registration Board
                              Each film coated tablet contains:-   30’s   Rs. 1500.00   deferred the applications
                              Levetiracetam……250mg                                      for inspection to verify
                              (Anti-epileptic)                                          following informations.

                                                                                        a. Toal number of
                                                                                           registered drugs

                                                                                        b. Total number of
                                                                                           marketed drugs

                                                                                        c. Stability record of the
                                                                                           applied drugs along
                                                                                           with              drug
                                                                                           development        data
                                                                                           verification

                                                                                        d. Capacity of the firm.

                                                                                        e. number of technical
                                                                                           personnel

                                                                                        f. Capacity of quality
                                                                                           control and stability
                                                                                           chambers to conduct
                                                                                           new              drug
                                                                                           development by the
                                                                                           following panel.

                                                                                        i. Abdul Latif Sheikh.
                                                                                        ii. Zahid Saeed (PPMA)
                                                                                        iii. Obaid Ali.

                                                                                        This panel will submit its
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             56
                                                                                               report for the
                                                                                            consideration of the
                                                                                                   Board.
                                                                                         The firm has submitted
                                                                                         40 applications which are
                                                                                         included in this meeting

68.           -do-            Levotam 500mg Tablets                20’s    Rs. 2000.00             -do-
                              Each film coated tablet contains:-   30’s    Rs. 3000.00
                              Levetiracetam……500mg
                              (Anti-epileptic)

69.           -do-            Levotam 750mg Tablets                20’s    Rs. 3000.00             -do-
                              Each film coated tablet contains:-   30’s    Rs. 4500.00
                              Levetiracetam……750mg
                              (Anti-epileptic)

70.           -do-            Levotam 1g Tablets                   10’s    Rs. 2000.00             -do-
                              Each film coated tablet contains:-   20’s    Rs. 4000.00
                              Levetiracetam……1g                    30’s    Rs. 6000.00
                              (Anti-epileptic)

71.           -do-            Erdos 150mg Capsules                 20’s    Rs. 160.00              -do-
                              Each capsule contains:-
                              Erdosteine…..150mg
                              (Fluidifying agent)

72.           -do-            Erdos 175mg Suspension               100ml   Rs. 160.00              -do-
                              Each 5ml contains:-
                              Erdosteine……….175mg
                              (Fluidifying agent)

73.           -do-            Quepin 25mg Tablets                  30’s    Rs. 889.50              -do-
                              Each film coated tablet contains:-
                              Quetiapine Fumarate eq.to
                              Quetiapinde………25mg
                              (Dibenzothiazepine)

74.           -do-            Quepin 100mg Tablets                 30’s    Rs. 2985.00             -do-
                              Each film coated tablet contains:-
                              Quetiapine Fumarate eq.to
                              Quetiapinde………100mg
                              (Dibenzothiazepine)

75.           -do-            Zipra 20mg Capsule                   10’s    Rs. 429.00             -do-
                              Each capsule contains:-              14’s    Rs. 600.00         New mocecule
                              Ziprasidone Hydrochloride            20’s    Rs. 857.00
                              Monohydrate eq. to                   30’s    Rs. 1286.00
                              Ziprasodine…..20mg
                              (Dopamine antagonist)

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                                                             57
76.           -do-            Zipra 40mg Capsule                   10’s    Rs. 857.00        -do-
                              Each capsule contains:-              14’s    Rs. 1200.00   New mocecule
                              Ziprasidone Hydrochloride            20’s    Rs. 1714.00
                              Monohydrate eq. to                   30’s    Rs. 2572.00
                              Ziprasodine…..40mg
                              (Dopamine antagonist)

77.           -do-            Glit 15mg Tablets                    10’s    Rs. 70.00         -do-
                              Each tablet contains:-               20’s    Rs. 140.00
                              Pioglitazone Hydrochloride eq. to    30’s    Rs. 210.00
                              Pioglitazone……15mg
                              (Non-Insullin-dependent)

78.           -do-            Glit 30mg Tablets                    10’s    Rs. 120.00        -do-
                              Each tablet contains:-               20’s    Rs. 240.00
                              Pioglitazone Hydrochloride eq. to    30’s    Rs. 360.00
                              Pioglitazone……30mg
                              (Non-Insullin-dependent)

79.           -do-            Glit 45mg Tablets                    10’s    Rs. 160.00        -do-
                              Each tablet contains:-               20’s    Rs. 320.00
                              Pioglitazone Hydrochloride eq. to    30’s    Rs. 480.00
                              Pioglitazone……45mg
                              (Non-Insullin-dependent)

80.           -do-            Glit-M 15mg/500mg Tablets            10’s    Rs. 83.16         -do-
                              Each film coated tablet contains:-   20’s    Rs. 166.32
                              Pioglitazone Hydrochloride eq. to    30’s    Rs. 249.00
                              Pioglitazone……15mg
                              Metformin Hydrochloride eq. to
                              Metformin……..500mg
                              (Non-Insullin-dependent)

81.           -do-            Glit-M 15mg/850mg Tablets            10’s    Rs. 89.16         -do-
                              Each film coated tablet contains:-   20’s    Rs. 178.32
                              Pioglitazone Hydrochloride eq. to    30’s    Rs. 267.00
                              Pioglitazone……15mg
                              Metformin Hydrochloride eq. to
                              Metformin……..850mg
                              (Non-Insullin-dependent)

82.           -do-            Chlorbenz Solution                   120ml    Rs. 97.50        -do-
                              Contains:-
                              Benzydamine
                              Hydrochloride…….0.15%w/v
                              Chlorhexidine
                              Gluconate……….0.12%w/v
                              (Pharangeal preps/ analgesic)



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                                                              58
83.           -do-            Succiron Tablet                     20,s   Rs.226.00             -do-
                              Each Tablet contains:               30,s   Rs.340.00
                              Iron Protein succinylate) .400mg
                              (Equivalent to Iron (Fe+3)…20mg)
                              Folic Acid (USP)……….2.5MG
                              (Haematinic or Anti anemia).

84.           -do-            Meloxi 7.5mg Tablet                10,s     Rs.70.00             -do-
                              Each tablet contains:
                              Meloxicam BP……..7.5mg
                              (Anti-
                              (inflammatory/NSAIDS)Oxicam



85.           -do-            Esom 20mg Capsule                  14,s    Rs.200.00             -do-
                              Each Capsule contains:
                              Enteric coated Pellets of
                              Esomeprazole Magnesium
                              Trihydrate eq. to Esomeprazole
                              20mg
                              (Magnesium trihydrate)

86.           -do-            Levetam Oral solution 100mg/ml     60ml    Rs.1200.00            -do-
                              Each ml contains:                  120ml   Rs.2400.00
                              Levetiracetam………..100mg
                              (Antiepileptic (AEDs).

87.           -do-            Meloxi 15mg Tablet                 10,s     Rs.120.00            -do-
                              Each tablet contains:              20,s     Rs.240.00
                              Meloxicam BP........15.00mg        30,s    \Rs.360.00
                              (Anti-Inflammatory/
                              NSAIDS/Oxicam)

88.           -do-            Esom 40mg Capsule                  14,s    Rs.360.00             -do-
                              Each Capsule contains:
                              Enteric coated Pellets of
                              Esomeprazole Magnesium
                              Trihydrate eq. to Esomeprazole
                              40mg
                              (Proton Pump Inhibitor (PPI)

89.      M/s. Chas.           Hydrolate Solution                 500ml   Rs. 44.40    Rejected on the grounds
            A.                Each 500ml contains:-                                   that the application was
         Mendoza,             Sodium Chloride…….1.755gm                                incomplete in stability
          Karachi             Sodium Citrate………...1.45gm                                 data and validation
                              Potassium Chloride……0.75gm                                    specification.
                              Glucose Anhydrous…...10.0gm
                              In orange/lemon/ice cream soda &
                              strawberry flavors
                              (Oral Electrolyte)
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                            59
90.      M/s. Getz            Edical D Chewable Tablets            30’s     Rs. 70.08    Deferred due to Vitamin
         Pharma,              Each chewable tablet contains:-                                    policy.
         Karachi              Calcium (as Calcium Carbonate
                              1000mg)…….400mg
                              Vitamin D3 (as Cholecalciferol
                              100iu)……..2.5mcg
                              (Calcium supplement)

91.           -do-            Ezitor Tablets                       14’s    Rs. 611.55    Rejected on the grounds
                              Each film coated tablet contains:-                          that no approved by the
                              Ezetimibe…………………10mg                                       FDA and MHRA. Hence
                              Atorvastatin (as Calcium)...10mg                           efficacy and safety of the
                              (Cardiovascular agents)                                          product is not
                                                                                                established.

92.           -do-            Tamivir 75mg Capsules                10’s    Rs. 1500.00         Deferred for
                              Each capsule cotains:-                                      bioequivalence studies.
                              Oseltamivir Phosphate….75mg
                              (Antiviral)

93.           -do-            Zalas Tablets                        100’s   Rs. 405.33           Approved
                              Each tablet contains:-
                              Sulfasalazine…..500mg
                              (Salicylate-sulphonamide)

94.           -do-            Effecta Syrup                        120ml    Rs. 50.05    Deferred due to Vitamin
                              Each 5ml contains:-                                                policy.
                              Calcium Glubionate…..1.4375g
                              Calcium Lactobionate….0.295g
                              (Calcium supplement)

95.           -do-            Ciproget 250mg Tablets               10’s    Rs. 256.38           Approved
                              Each film coated tablet contains:-
                              Ciprofloxacin (as
                              Hydrochlorde)……250mg
                              (Anti-infective)

96.           -do-            Ciproget 500mg Tablets               10’s    Rs. 491.00              -do-
                              Each film coated tablet contains:-
                              Ciprofloxacin (as
                              Hydrochlorde)……500mg
                              (Anti-infective)

97.           -do-            Feromine Chewable Tablets            14’s    Rs. 200.33    Deferred due to Vitamin
                              Each tablet contains:-                                             policy
                              Iron Protein Succinylate…400mg
                              {eq. to Iron (Fe+3 ) 20mg}
                              Folic Acid………………..2.5mg
                              (Iron supplement)


      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             60
 98.           -do-            Feromine 800mg Syrup                 120ml   Rs. 190.13      -do-
                               Each 15ml contains:-                  20ml   Rs. 370.20
                               Iron Protein Succinylate…800mg
                               {eq. to Iron (Fe+3 ) 40mg}
                               (Iron supplement)

 99.           -do-            Genrin 100mg / 5ml Suspension        60ml     Rs. 60.00    Approved
                               Each 5ml contains:-
                               Silymarin…….100mg
                               (Hepatoprotective drug)

100.           -do-            Genrin 200mg Tablets                 20’s    Rs. 121.78      -do-
                               Each film coated tablet contains:-   30’s    Rs. 177.46
                               Silymarin…….200mg
                               (Hepatoprotective drug)

101.           -do-            Zeget Suspension                     15ml    Rs. 115.12      -do-
                               Each 5ml contains (on
                               reconstition):-
                               Azithromycin (as
                               Dihydrate)……..100mg
                               (Anti-biotic)

102.           -do-            Zeget 250mg Capsules                 12’s    Rs. 398.42      -do-
                               Each capsule contains:-
                               Azithromycin (as
                               Dihydrate)……..250mg
                               (Anti-biotic)

103.           -do-            Zeget 500mg Tablets                   3’s     Rs. 99.39      -do-
                               Each tablet contains:-
                               Azithromycin (as
                               Dihydrate)……..500mg
                               (Anti-biotic)

104.           -do-            Rava Tablets                         30’s    Rs. 600.00      -do-
                               Each film coated tablet contains:-
                               Leflunomide…..10mg
                               (Anti-rheumatic)

105.           -do-            Rava Tablets                         30’s    Rs. 1154.52     -do-
                               Each film coated tablet contains:-
                               Leflunomide…..20mg
                               (Anti-rheumatic)

106.           -do-            Rava Tablets                         10’s    Rs. 1871.62     -do-
                               Each film coated tablet contains:-
                               Leflunomide…..100mg
                               (Anti-rheumatic)


       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                              61
107.           -do-            Fenoget 67mg Capsules               10’s   Rs. 415.00     Rejected on the grounds
                               Each capsule contains:-                                  that the content of active
                               Fenofibrate………..67mg                                      ingredient Finofibrate is
                               (Hpolipidemic)                                               67mg while it is not
                                                                                            mentioned that it is
                                                                                        micronized form because
                                                                                            67mg of micronized
                                                                                            Finofibrate is eq. to
                                                                                        100mg Finofibrate of non
                                                                                             micronized active.
                                                                                         Hence this will result in
                                                                                        subpotent formulation. It
                                                                                            was also decided to
                                                                                             verify the already
                                                                                          registered formulations
                                                                                          of this salt to verify the
                                                                                              quality of active
                                                                                                 ingredient.

108.           -do-            Fenoget 134mg Capsules              10’s   Rs. 810.50               -do-
                               Each capsule contains:-
                               Fenofibrate………..134mg
                               (Hpolipidemic)

109.           -do-            Fenoget 200mg Capsules              10’s   Rs. 1200.00              -do-
                               Each capsule contains:-
                               Fenofibrate………..200mg
                               (Hpolipidemic)


110.           -do-            Doss 0.25mcg Capsules               10’s   Rs. 120.00      Approved subject to
                               Each capsule contains:-                                  abroad inspection of the
                               Alfacalcidol……….0.25mcg                                  principal manufacturer.
                               (Vitamin-D analogue)
                               (bulk import and local repacking)
                               R.P Scherer GmbH & Co. KG,
                               Gammelsbacher Strabe2,69412
                               Eberbach, Germany)

111.           -do-            Doss 0.5mcg Capsules                10’s   Rs. 180.00               -do-
                               Each capsule contains:-
                               Alfacalcidol……….0.5mcg
                               (Vitamin-D analogue)
                               (bulk import and local repacking)
                               R.P Scherer GmbH & Co. KG,
                               Gammelsbacher Strabe2,69412
                               Eberbach, Germany)




       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                           62
112.           -do-            Doss 1mcg Capsules                  10’s    Rs. 330.00              -do-
                               Each capsule contains:-
                               Alfacalcidol……….1mcg
                               (Vitamin-D analogue)
                               (bulk import and local repacking)
                               R.P Scherer GmbH & Co. KG,
                               Gammelsbacher Strabe2,69412
                               Eberbach, Germany)

113.           -do-            Oric Capsules                       20’s    Rs. 350.46    Rejected on the grounds
                               Each spansule capsule contains:-                         that there is antagonistic
                               Blended Pellets of Elemental Iron                          action in absorption of
                               (as Carbonyl Iron)…..….50mg                               Zinc and elemental iron
                               Elemental Zinc (as Zinc                                     with each other and
                               Sulphate 61.8)….22.5mg                                    similar formulation was
                               Folic Acid ……..0.5mg                                     already rejected. It is not
                               (Haematinic)                                             approved in USA & UK.

114.    M/s. Epoch Epoclor Drops                                   15ml    Rs. 114.00           Approved
        Pharmaceuti Each ml contains:-
        cal, Karachi Cefaclor…….50mg
                     (cephalosporin)

115.           -do-            Gyala Suspension                    60ml    Rs. 250.00              -do-
                               Each 5ml contains:-
                               Cefixime (As
                               Trikydrate)……100mg
                               (Cephalosporin)

116.     M/s. S.J. &           Sinmos Injections                    6’s    Rs. 350.00   Drugs Registration Board
          G Fazul              Each ml contains:-                  ampou                deferred the applications
          Ellahie,             Artemether……….80mg                    le                  for inspection to verify
          Karachi                                                                        following informations.

                                                                                        a.    Toal number        of
                                                                                             registered drugs

                                                                                        b.   Total number        of
                                                                                             marketed drugs

                                                                                        c. Stability record of the
                                                                                           applied drugs along
                                                                                           with              drug
                                                                                           development       data
                                                                                           verification

                                                                                        d. Capacity of the firm.

                                                                                        e. Number of technical
                                                                                           personnel

       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             63
                                                                                        f.    Capacity of quality
                                                                                             control and stability
                                                                                             chambers to conduct
                                                                                             new              drug
                                                                                             development by the
                                                                                             following panel.

                                                                                        i. Abdul Latif Sheikh.
                                                                                        ii. Zahid Saeed (PPMA)
                                                                                        iii. Obaid Ali.

                                                                                        This panel will submit its
                                                                                              report for the
                                                                                          consideration of the
                                                                                                 Board.

                                                                                          The firm has submitted
                                                                                        45 applications which are
                                                                                         included in this meeting
                                                                                         agenda. Whereas 2 new
                                                                                        sections of the firm along
                                                                                          with registrations were
                                                                                           granted in the earlier
                                                                                        meeting and the qualified
                                                                                            staff was found in
                                                                                         sufficient as required in
                                                                                           SRO. 662 OF 2005.

117.           -do-            Sinmos Suspension                  60ml    Rs. 325.00               -do-
                               Each 5ml contains:-
                               Artemether……….40mg

118.           -do-            Spazoff Injection                  30’s    Rs. 150.00               -do-
                               Each 4ml ampoule contains:-
                               Hydrated Phloroglucinal….40mg
                               Trimethyl
                               Phloroglucinal……0.040mg
                               (Musculotropic)

119.           -do-            Bonafide 2mcg/ml Injections         10’s   Rs. 600.00               -do-
                               Each ml contains:-                 0.5ml
                               Alfacalcidol……2mcg
                               (Vitamin D analogue)

120.         M/s.              Bupron 150mg Tablets               30’s    Rs. 2400.00           Approved
          Pharmatec            Each tablet contains:-
           Pakistan,           Bupropion (as
           Karachi             Hydrochloride)…….150mg
                               (Anti-depressasnt agents)


       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                             64
121.           -do-            Oxzapin 600mg Tablets                 50’s    Rs. 1250.00             -do-
                               Each tablet contains:-
                               Oxcarbazepine……..600mg
                               (Anti-eplieptics agents)


122.           -do-            Zaplon 5mg Capsules                   20’s    Rs. 700.00    Deferred due to product
                               Each capsule contains:-                                       is sedative in comes
                               Zaleplon…..5mg                                               under the Psychtropic
                               (Short acting hypnotic agents)                                       policy.

123.     M/s. Hilton           Arco 125/50 Tablets                    8’s    Rs. 186.00     Rejected on the grounds
          Pharma,              Each tablet contains:-                                      that the said combination
          Karachi              Artemisini………125mg                                            is not evaluated by the
                               Naphthoquine Phosphate eq. to                                    FDA and MHRA.
                               Naphthoquine……..50mg                                            Moreover, it is not
                               (Anti-malarial)                                                recommended by the
                                                                                                      WHO.


124.           -do-            Arco 250/100 Tablets                   4’s    Rs. 186.00              -do-
                               Each tablet contains:-
                               Artemisini………250mg
                               Naphthoquine Phosphate eq. to
                               Naphthoquine……..100mg
                               (Anti-malarial)

125.           -do-            Piozer Plus 15/1000 Tablets           14’s    Rs. 490.00     Rejected on the grounds
                               Each tablet contains:-                28’s    Rs. 980.00     that said combination is
                               Pioglitazone Hydrochloride.15mg                             not evaluated by the FDA
                               Metformin Hydrochloride.1000mg                                      and MHRA

126.     M/s. Sami Avrin 600mg Tablets                               10’s    Rs. 80.00/           Approved
        Pharmaceuti Each tablet contains:-                                    per tab
        cal, Karachi Ribavirin…….600mg
                     (Anti-viral)

127.           -do-            Sarcon 80mg Tablets                   20’s     Rs. 5.50/              -do-
                               Each tablet contains:-                         per tabl
                               Gliclazide…..80mg
                               (oral hypoglycemic)

128.           -do-            Tulose 66.70g/100ml Syrup             120ml   Rs. 110.00       Approved subect to
                               Each 100ml contains:-                                       submission of source of
                               Lactulose………66.70g                                           lactulose concentrate,
                               (Osmotic laxative)                                            GMP certificate and
                                                                                           balance fee of Rs. 7000/-




       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                                65
129.           -do-            Sopan 250mg/5ml Suspension           60ml     Rs. 100.00   Deferred due to Vitamin
                               Each 5ml contains:-                                                policy.
                               Ossein Mineral Complex….250mg
                               (Mineral complex)

130.           -do-            Onocin 200mg Tablets                 10’s     Rs. 11.50/          Approved
                               Each film coated tablet contains:-             per tab
                               Ofloxacin….200mg                              New name
                               (quinolone)                                     Perari

131.           -do-            Actim 2.5mg Tablets                  14’s     Rs. 21.14/             -do-
                               Each film coated tablet contains:-             per tab
                               Bisoprolol Fumarate…….2.5mg
                               (cardioselective beta-blcoker)

132.           -do-            NovoTEpH 20mg Capsules               14’s     Rs. 12.14/           Approved
                               Each capsule contains:-                        per tab     Subjec to submission of
                               Enteric coated pellets of                                   source of pellets, GMP
                               Esomeprazole Magnesium                                     certification and balance
                               Trihydrate eq. to                                              fee of Rs. 7000/-
                               Esomeprazole…….20mg
                               (Antipeptic)

133.           -do-            Mepiril Tablet 1.25mg                 Per     Rs.7.14/-           Approved
                               Each Tablet contains:-               Tablet
                               Ramipril USP………1.25mg
                               (ACE Inhibitor)

134.           -do-            Mepiril Tablet 5mg                    Per     Rs.14.28/-             -do-
                               Each Tablet contains:-               Tablet
                               Ramipril USP………5mg
                               (ACE Inhibitor)

135.           -do-            Winurina Capsules 100mg               Per       Rs.5/-               -do-
                               Each Capsule contains:-              capsul
                               Gabapentin……..100mg                    e
                               (Anti-epileptics )

136.           -do-            Co-Valso Tablet 160mg+12.5mg          Per     Rs.30.5/-              -do-
                               Each film coated tablet contains:-   Tablet
                               Valsartan USP……160mg
                               Hydrochlorothiazide USP..12.5mg

137.        M/s                Azomax Tablets                        3’s      Rs.199/-       Approved subject to
           Novartis            Each film coated tablet contains:-                           evidene of approval of
           Pharma              Azithromycin……..500mg                 6’s      Rs.398/-    tablet dosage form in UK
           Karachi.            (Antibiotic)                                                         / USA.




       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                              66
138.        M/s                Cutivate Ointment 0.005%               5g        Rs.65/-           Approved
         GlaxoSmith            Each Gram contains:-
            Kline              Fluticasone Propionate (micronised)    15g      Rs.195/-
          Karachi.             HSE……….50µg

139.     M/s Sultan            Cotton Pearl White B P C              1000g/    Rs.190/-     Already approved in 202
          Cotton &             Absorbant Cotton Wool (Carded)          roll                         meeting
         Bandages                                                     500g/    Rs.110/-
         Mirpurkhas                                                    roll
                                                                      400g/     Rs.95/-
                                                                       roll
                                                                      250g/     Rs.70/-
                                                                       roll
                                                                      200g/     Rs.60/-
                                                                       roll
                                                                      100g/    Rs.37.50
                                                                       roll
                                                                     50g/ro     Rs.25/-
                                                                        ll      Rs.15/-
                                                                     25g/ro
                                                                        ll

140.      M/s. Indus           Exone 15mg Tablet                     14x2     Rs.7.00 Per         Approved
           Pharma              Pioglitazone (As Pioglitazone                    Tablet
          (Pvt) Ltd,           Hydrochloride)
           Karachi.            (Antidiabetic)

141.           -do-            Exone 30mg Tablet                     14x2      Rs.12.00              -do-
                               Pioglitazone (As Pioglitazone                  Per Tablet
                               Hydrochloride)
                               (Antidiabetic)

142.           -do-            Exone 45mg Tablet                     14x2      Rs.16.00              -do-
                               Pioglitazone (As Pioglitazone                  Per Tablet
                               Hydrochloride)
                               (Antidiabetic)

143.     M/s. Barrett          Adgam Eye Drops                       2.5ml    Rs. 1000.00            -do-
          Hodgson,             Each ml contains:_
          Karachi              Latanoprost…0.05mg
                               (Prostaglandin Analogue)

144.           -do-            Adgam-T Eye Drops                     2.5ml    Rs. 1050.00            -do-
                               Each ml contains:_
                               Latanoprost…0.05mg
                               Timolol (as Timolol
                               Maleate)…….5.0mg
                               (Prostaglandin Analogue)



       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                               67
145.      M/s. Atco            Eputin Injjections                   5ml                 Approved subject to
           Labs,               Each ml contains:-                  ampou                   completion of
          Karachi              Phenytoin Sodium….50mg                le                 deficiebcues as the
                               (Anticonvulsant)                                          product is Orphan

146.      M/s. BSN             Cuticell ® Classic                  5cmx5   Rs. 11.00           -do-
          Medical,             Paraffin Gauze Dressing B.P.          cm    Rs. 25.00
          Karachi                                                  10cmx
                                                                    10cm   Rs. 55.00
                                                                   10cmx
                                                                    40cm   Rs. 47.00
                                                                   15cmx
                                                                    20cm   Rs. 77.00
                                                                   10cmx   Rs.342.00
                                                                     1m
                                                                   10cmx
                                                                     7m


147.           -do-            Cuticell ® C                        5cmx5   Rs. 11.00           -do-
                               Chlorhexidine Acetate Tulle Gras      cm    Rs. 23.00
                               Dressing B.P                        10cmx
                                                                    10cm   Rs. 47.00
                                                                   15cmx
                                                                    20cm   Rs. 77.00
                                                                   15cmx   Rs. 115.00
                                                                     1m
                                                                   15cmx
                                                                     2m

148.       M/s.                Eczemus 0.1% Ointment               10gm                        -do-
          Brookes              Each gm contains:-
        Pharmaceuti            Tacrolimus (as
           cals,               Monohydrate)….1mg
          Karachi              (Manufacturer’s Specification)
                               (Macrolide, Immunomodulating
                               agent)

149.           -do-            Eczemus 0.03% Ointment              10gm                        -do-
                               Each gm contains:-
                               Tacrolimus (as
                               Monohydrate)….0.3mg
                               (Manufacturer’s Specification)
                               (Macrolide, Immunomodulating
                               agent)

150.      M/s. Indus           Nadix 250mg/5ml Suspension          60ml    Rs. 32.00           -do-
           Pharma,             Each 5ml contains:-
           Karachi             Nalidixic Acid…..250mg
                               (Antibiotic)

       8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                              68
                      b.         HVAC SYSTEM IS NOT CONFIRMED OF FOLLOWING FIRMS.

S. No.   Name of              Name of Drugs & Composition          Pack     Demanded              Decision
          firm(s)                                                 Size(s)     Price
   151.     M/s.              Rabucer Tablets                      10’s     Rs. 200.00       Deferred due to non
          Karachi             Each tablet contains:-                                        confirmation of HVAC
         Chemical             Rabeprazole Sodium…20mg                                              System
        Industries,           (proton pump inhibitor)
          Karachi

   152.        -do-           Sofiron Tablets                      20’s      Rs. 140.00             -do-
                              Each tablet contains:-
                              Iron (III) Hydroxide Poly Maltose
                              Complex eq. to Elemental
                              Iron…………….…100mg
                              (Anti-Anaemic, preparation)

   153.        -do-           Sofiron –F Tablets                   20’s      Rs. 150.00             -do-
                              Each tablet contains:-
                              Iron (III) Hydroxide Poly Maltose
                              Complex eq. to Elemental
                              Iron……………..100mg
                              Folic Acid……..350mcg
                              (Anti-Anaemic, preparation)

   154.        -do-           Sofiron Syrup                        60ml      Rs. 95.oo              -do-
                              Each 5ml contains:-                 120ml      Rs. 172.00
                              Iron (III) Hydroxide Poly Maltose
                              Complex eq. to Elemental
                              Iron……50mg
                              (Anti-Anaemic, preparation)

   155. M/s. Atco             Vastor 40mg Tablets                  10’s      Rs. 400.00             -do-
         Labs,                Each tablet contains:-
        Karachi               Atorvastatin (Calcium
                              Trihydrate)…..40mg
                              (Hypolipidaemic agents)

   156.        -do-           Hydrocort Tablets                    30’s     As per leader    Deferred due to non
                              Each tablet contains:-                                        confirmation of HVAC
                              Hydrocortisone…..20mg                                                 System
                              (Corticosteroids)                                                   Section for
                                                                                             steroids/hormones is
                                                                                                 not available
   157.        -do-           Lostress 100mg Tablets               20’s      Rs. 320.00               -do-
                              Each tablet contains:-
                              Losartan Potassium…..100mg
                              (Angiotensin receptor antagonist)



     8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                           69
158.        -do-           Neophrine Injection                5’sx1ml As per leader    -do-
                           Each ml contains:-
                           Phenylephrine HCl…..10mg
                           (Sympathomimetics)

159.        -do-           Norsaline-P Drops                   15ml    As per leader   -do-
                           Each ml contains:-                              price
                           Sodium Chloride….9mg
                           (Electrolyte)

160.        -do-           Mist Norsaline-P                    15ml    As per leader   -do-
                           Each ml contains:-                              price
                           Sodium Chloride….9mg
                           (Electrolyte)




161.        -do-           Pestelin Lotin                      60ml     Rs. 80.00      -do-
                           Each 100ml contains:-
                           Permethrin……..5gm
                           (scabicidal)

162.        -do-           Pestelin Cream                      30gm     Rs. 45.00      -do-
                           Each 100gm contains:-
                           Permethrin……..5gm
                           (scabicidal)

163. M/s. Elko             Monti 5mg Tablets                   10’s     Rs. 300.00     -do-
       Org.                Each tablet contains:-
     Karachi               Montelukast (as Montelukast
                           Sodium)……..5mg
                           (Anti-Asthma)

164.        -do-           Monti 10mg Tablets                  10’s     Rs. 500.00     -do-
                           Each tablet contains:-
                           Montelukast (as Montelukast
                           Sodium)……..10mg
                           (Anti-Asthma)

165.        -do-           Ronate 10mg Tablets                 10’s     Rs. 200.00     -do-
                           Each tablet contains:-
                           Alendronate (as Alendronate
                           Sodium)……..10mg
                           (Anti-osteoporosis)

166.        -do-           Ronate –OW Tablets                   4’s     Rs. 400.00     -do-
                           Each tablet contains:-
                           Alendronate (as Alendronate
                           Sodium)……..70mg
                           (Anti-osteoporosis)
  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                         70
167.        -do-           Becmin 500mcg Tablets               20’s     Rs. 180.00   -do-
                           Each tablet contains:-
                           Mecobalamin……..500mcg
                           (Vitamin B12-co-enzyme)

168.     M/s.              LevoZal 5mg Tablets                 10’s     Rs. 75.00    -do-
       Novins Int.         Each tablet contains:-
        Karachi            Levocetirizine Dihydrochloride
                           eq. to Levocetirizine……5mg
                           (Anti-Allergic)

169.        -do-           RosiNorm 2mg Tablets                14’s     Rs. 150.00   -do-
                           Each tablet contains:-
                           Rosiglitazone Maleate eq. to
                           Rosiglitazone…..2mg
                           (Anti-Diabetic)

170.        -do-           RosiNorm 4mg Tablets                14’s     Rs. 300.00   -do-
                           Each tablet contains:-
                           Rosiglitazone Maleate eq. to
                           Rosiglitazone…..4mg
                           (Anti-Diabetic)

171.        -do-           RosiNormet Tablets                  14’s     Rs. 250.00   -do-
                           Each tablet contains:-
                           Rosiglitazone Maleate eq. to
                           Rosiglitazone…………2mg
                           Metformin HCl……500mg
                           (Anti-Diabetic)

172.        -do-           RosiNormet-D Tablets                14’s     Rs. 250.00   -do-
                           Each tablet contains:-
                           Rosiglitazone Maleate eq. to
                           Rosiglitazone…………4mg
                           Metformin HCl……500mg
                           (Anti-Diabetic)

173. M/s. Wood             IRO-3 Chewable Tablets              10’s     Rs. 75.00    -do-
       Ward                Each tablet contains:-
     Pakistan,             Iron Polymaltose Complex eq. to
      Karachi              Elemental Iron…..100mg
                           Folic Acid……….350mcg
                           (Haematinic)

174.    M/s W.             Klod Tablets 75mg                    Per      Rs.14/-     -do-
       Woodward            Each tablet contains:-              Tablet
        Karachi.           Clopidogrel
                           (as bisulphaqte)……75mg
                           (Anti-Platelet)


  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                          71
175.      M/s.             Usic 2% Cream                       5gm     15% less              -do-
        Zephyr             Each one gm contains:-             15gm     than the
       Pharmatec,          Fusidic Acid…..20mg                       brand leader
        Karachi            (Antibiotic)

176.        -do-           Spasmo 80mg Tablets                10’s     15% less              -do-
                           Each tablet contains:-                      than the
                           Phloroglucinol Hydrate…..80mg             brand leader
                           Trimethyl
                           Pholoroglucinol………..80mg
                           (Musculotropic antispasmodic)

177.        -do-           Loxy 250mg Tablets                          15% less              -do-
                           Each tablet contains:-                      than the
                           Levofloxacin…..250mg                      brand leader
                           (Antibiotic)

178.        -do-           Loxy 500mg Tablets                          15% less              -do-
                           Each tablet contains:-                      than the
                           Levofloxacin…..500mg                      brand leader
                           (Antibiotic)

179.        -do-           Geflox 200mg Tablets               70’s     15% less              -do-
                           Each tablet contains:-                      than the
                           Gatifloxacin…..200mg                      brand leader
                           (Antibiotic)

180.        -do-           Geflox 400mg Tablets               70’s     15% less              -do-
                           Each tablet contains:-                      than the
                           Gatifloxacin…..400mg                      brand leader
                           (Antibiotic)

181. M/s. S.J. &           Durance 20mg Capsules              14’s   Rs. 175.00     Drugs      Registration
      G Fazul              Each capsule contains:-                                  Board deferred the
      Ellahie,             Omeprazole …..20mg                                       applications        for
      Karachi              (as enter coated microgranules)                          inspection to verify
                           (Anti-ulcerant)                                          following
                                                                                    informations.

                                                                                    a. Toal number of
                                                                                       registered drugs

                                                                                    b. Total number of
                                                                                       marketed drugs

                                                                                    c. Stability record of
                                                                                       the applied drugs
                                                                                       along with drug
                                                                                       development data
                                                                                       verification

  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                         72
                                                                                  d.     Capacity of the
                                                                                       firm.

                                                                                  e. Number of
                                                                                     technical
                                                                                     personnel

                                                                                  f. Capacity of quality
                                                                                     control        and
                                                                                     stability chambers
                                                                                     to conduct new
                                                                                     drug development
                                                                                     by the following
                                                                                     panel.

                                                                                  i. Abdul Latif
                                                                                       Sheikh.
                                                                                  ii. Zahid Saeed
                                                                                       (PPMA)
                                                                                  iii. Obaid Ali.

                                                                                  This panel will submit
                                                                                      its report for the
                                                                                    consideration of the
                                                                                            Board.
                                                                                  The firm has submitted
                                                                                  45 applications which
                                                                                    are included in this
                                                                                      meeting agenda.
                                                                                       Whereas 2 new
                                                                                    sections of the firm
                                                                                          along with
                                                                                     registrations were
                                                                                   granted in the earlier
                                                                                      meeting and the
                                                                                     qualified staff was
                                                                                   found in sufficient as
                                                                                   required in SRO. 662
                                                                                           OF 2005.

182.        -do-           Serod 6mg Tablets                  10’s   Rs. 400.00            -do-
                           Each tablet contains:-
                           Tegaserod Maleate eq. to
                           Tegaserod……..6mg
                           (as enter coated microgranules)
                           (Anti-ulcerant)




  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                         73
183.        -do-           Drate Plus D Tablets            10’s   Rs. 2000.00      Rejected on the
                           Each tablet contains:-                                grounds that the said
                           Alendrante Sodium eq. to                               formulation is not
                           Alendronic Acid……70mg                                 approved in UK and
                           Cholecalciferol…….70mcg                                      USA
                           (Bisphosphonate)

184.        -do-           Desora Syrup                    60ml   Rs. 150.00    Drugs      Registration
                           Each ml contains:-                                   Board deferred the
                           Desloratadine…..0.5mg                                applications        for
                           (Antihistamine)                                      inspection to verify
                                                                                following
                                                                                informations.

                                                                                a. Toal number of
                                                                                   registered drugs

                                                                                b. Total number of
                                                                                   marketed drugs

                                                                                c. Stability record of
                                                                                   the applied drugs
                                                                                   along with drug
                                                                                   development data
                                                                                   verification

                                                                                d.     Capacity of the
                                                                                     firm.

                                                                                e. Number of
                                                                                   technical
                                                                                   personnel

                                                                                f. Capacity of quality
                                                                                   control        and
                                                                                   stability chambers
                                                                                   to conduct new
                                                                                   drug development
                                                                                   by the following
                                                                                   panel.

                                                                                i. Abdul Latif
                                                                                     Sheikh.
                                                                                ii. Zahid Saeed
                                                                                     (PPMA)
                                                                                iii. Obaid Ali.

                                                                                This panel will submit
                                                                                   its report for the
                                                                                 consideration of the
                                                                                         Board.
  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                      74
                                                                               The firm has submitted
                                                                               45 applications which
                                                                                 are included in this
                                                                                   meeting agenda.
                                                                                   Whereas 2 new
                                                                                 sections of the firm
                                                                                      along with
                                                                                  registrations were
                                                                                granted in the earlier
                                                                                   meeting and the
                                                                                  qualified staff was
                                                                                found in sufficient as
                                                                                required in SRO. 662
                                                                                       OF 2005.


185.        -do-           Spazoff Tablets                 30’s   Rs. 150.00            -do-
                           Each coated tablet contains:-
                           Hydrated Phloroglucinal….80mg
                           Trimethyl Phloroglucinal…80mg
                           (Musculotropic)

186.        -do-           Ordain 10mg Tablets             10’s   Rs. 65.00             -do-
                           Each tablet contains:-
                           Bambuterol HCl…..10mg
                           (long acting beta-2)

187.        -do-           Ordain 20mg Tablets             10’s   Rs. 130.00            -do-
                           Each tablet contains:-
                           Bambuterol HCl…..20mg
                           (long acting beta-2)

188.        -do-           Ordain Syrup                    60ml   Rs. 45.00        Rejected on the
                           Each ml contains:-                                   grounds that it is not
                           Bambuterol HCl………1mg                                   recommended in
                           (long acting beta-2)                                       children

189.        -do-           Bonafide 0.25mcg Tablets        10’s   Rs. 100.00   Drugs      Registration
                           Each tablet contains:-                              Board deferred the
                           Alfacalcidol……0.25mcg                               applications        for
                           (Vitamin D analogue)                                inspection to verify
                                                                               following
                                                                               informations.

                                                                               a. Toal number of
                                                                                  registered drugs

                                                                               b. Total number of
                                                                                  marketed drugs

                                                                               c. Stability record of
  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                      75
                                                                                   the applied drugs
                                                                                   along with drug
                                                                                   development data
                                                                                   verification

                                                                              d.     Capacity of the
                                                                                   firm.

                                                                              e. Number of
                                                                                 technical
                                                                                 personnel

                                                                              f. Capacity of quality
                                                                                 control        and
                                                                                 stability chambers
                                                                                 to conduct new
                                                                                 drug development
                                                                                 by the following
                                                                                 panel.

                                                                              i. Abdul Latif
                                                                                   Sheikh.
                                                                              ii. Zahid Saeed
                                                                                   (PPMA)
                                                                              iii. Obaid Ali.

                                                                              This panel will submit
                                                                                  its report for the
                                                                                consideration of the
                                                                                        Board.
                                                                              The firm has submitted
                                                                              45 applications which
                                                                                are included in this
                                                                                  meeting agenda.
                                                                                   Whereas 2 new
                                                                                sections of the firm
                                                                                      along with
                                                                                 registrations were
                                                                               granted in the earlier
                                                                                  meeting and the
                                                                                 qualified staff was
                                                                               found in sufficient as
                                                                               required in SRO. 662
                                                                                       OF 2005.

190.        -do-           Bonafide 0.5mcg Tablets        10’s   Rs. 160.00            -do-
                           Each tablet contains:-
                           Alfacalcidol……0.5mcg
                           (Vitamin D analogue)


  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                     76
191.        -do-           Bonafide 1mcg Tablets                10’s   Rs. 225.00   -do-
                           Each tablet contains:-
                           Alfacalcidol……1mcg
                           (Vitamin D analogue)

192.        -do-           Cherish 250mg Tablets                10’s   Rs. 25.00/   -do-
                           Each film coated tablet contains:_           per tab
                           Cefprozil Monohydrate eq. to
                           Anhydrous Cefprozil…..250mg
                           (Anti-bacterial)

193.        -do-           Cherish 500mg Tablets                10’s   Rs. 50.00/   -do-
                           Each film coated tablet contains:_           per tab
                           Cefprozil Monohydrate eq. to
                           Anhydrous Cefprozil…..500mg
                           (Anti-bacterial)

194.        -do-           Cherish 125mg / 5ml Suspension       50ml   Rs. 135.00   -do-
                           Each 5ml constituted contains:_
                           Cefprozil Monohydrate eq. to
                           Anhydrous Cefprozil…..125mg
                           (Anti-bacterial)

195.        -do-           Cherish 250mg / 5ml Suspension       50ml   Rs. 250.00   -do-
                           Each 5ml constituted contains:_
                           Cefprozil Monohydrate eq. to
                           Anhydrous Cefprozil…..250mg
                           (Anti-bacterial)

196.        -do-           Fenla XR Capsules                    14’s   Rs. 650.00   -do-
                           Each capsule contains:-
                           Venlafaxine HCl eq. to
                           Venlafaxine……..75mg
                           (as coated microgranules)
                           (anti-depressant)

197.        -do-           Acenac SR Tablets                    10’s   Rs. 400.00   -do-
                           Each film coated tablet contains:-
                           Aceclofenac………200mg
                           (Anti-Flammatory)

198.        -do-           Acenac Plus Tablets                  10’s   Rs. 200.00   -do-
                           Each film coated tablet contains:-
                           Aceclofenac………100mg
                           Paracetamol………500mg
                           (Anti-Flammatory)




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                                                         77
199.        -do-           Acenac MR Tablets                    10’s    Rs. 350.00              -do-
                           Each film coated tablet contains:-
                           Aceclofenac………100mg
                           Paracetamol………500mg
                           Chlorzoxazone……500mg
                           (muscle relaxant)

200.        -do-           Acenac Gel                           20gm    Rs. 150.00              -do-
                           Each film coated tablet contains:-
                           Aceclofenac………1.5%w/w
                           (muscle relaxant)

201. M/s. Genix            Genart Suspension                     60ml   Rs. 215.00   Drugs      Registration
      Pharma,              Each 5ml conatains:-                  90ml   Rs. 232.00   Board deferred the
      Karachi              Artemether……30mg                     120ml   Rs. 430.00   applications        for
                           (anti- malarial)                                          inspection to verify
                                                                                     following
                                                                                     informations.

                                                                                     a. Toal number of
                                                                                        registered drugs

                                                                                     b. Total number of
                                                                                        marketed drugs

                                                                                     c. Stability record of
                                                                                         the applied drugs
                                                                                         along with drug
                                                                                         development data
                                                                                         verification
                                                                                     d. Capacity of the firm.

                                                                                     e. Number of technical
                                                                                         personnel

                                                                                     f.    Capacity of quality
                                                                                          control         and
                                                                                          stability chambers
                                                                                          to conduct new
                                                                                          drug development
                                                                                          by the following
                                                                                          panel.

                                                                                     i. Abdul Latif Sheikh.
                                                                                     ii. Zahid Saeed
                                                                                           (PPMA)
                                                                                     iii. Obaid Ali.
                                                                                      This panel will submit
                                                                                          its report for the
                                                                                        consideration of the
                                                                                                Board.
  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                         78
202.        -do-           Levobac 750mg Tablets                10’s   Rs. 300.00              -do-
                           Each tablet contains:-
                           Levofloxacin Hemihydrate eq. to
                           Levofloxacin……750mg
                           (Quinolone)

203.        -do-           Efecip 750mg Tablets                 10’s   Rs. 340.00              -do-
                           Each tablet contains:-
                           Ciprofloxacin HCl eq. to
                           Ciprofloxacin……750mg
                           (Quinolone)

204.        -do-           Gen-M 80/48mg Tablets                4’s    Rs. 400.00   Rejected on the grouns
                           Each tablet contains:-                                   that said formulation is
                           Artemether..………80mg                                         not approved any
                           Lumefantrine……480mg                                        where in the World
                           (Anti-malarial)

205.        -do-           Sero-N 100/15mg Tablets              20’s   Rs. 300.00   Rejected on the gounds
                           Each tablet contains:-               40’s   Rw. 600.00        that Irratinal
                           Nimesulide………….100mg                 50’s   Rs. 750.00        formulation
                           Serratiopeptidase….…15mg
                           (eq. to Enzyme activity 30,000
                           units, as enteric coated granules)

206.        -do-           Acef 100mg Tablets                   30’s   Rs. 90.00    Drugs      Registration
                           Each tablet contains:-                                   Board deferred the
                           Aceclofenac……100mg                                       applications        for
                           (NSAID)                                                  inspection to verify
                                                                                    following
                                                                                    informations.

                                                                                    a. Toal number of
                                                                                       registered drugs

                                                                                    b.    Total number of
                                                                                         marketed drugs

                                                                                    c.     stability record of
                                                                                         the applied drugs
                                                                                         along with drug
                                                                                         development data
                                                                                         verification

                                                                                    d. Capacity of the firm.
                                                                                    e. Number of technical
                                                                                        personnel
                                                                                    f. Capacity of quality
                                                                                        control          and
                                                                                        stability chambers
                                                                                        to conduct new
  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                          79
                                                                                         drug development
                                                                                         by the following
                                                                                         panel.

                                                                                      i. Abdul Latif Sheikh.
                                                                                      ii. Zahid Saeed
                                                                                           (PPMA)
                                                                                      iii. Obaid Ali.

                                                                                      This panel will submit
                                                                                         its report for the
                                                                                       consideration of the
                                                                                               Board.
207.        -do-           Freal 35mg Tablets                    4’s    Rs. 1120.00             -do-
                           Each film coating tablet contains:-
                           Risedronate Sodium….35mg
                           (Pyridinyl Bisphosphonate)

208.        -do-           Halofan 250mg Tablets                  6’s   Rs. 188.24        Rejected on the
                           Each film coating tablet contains:-   12’s   Rs. 376.48     grounds that the drug
                           Halofantrine eq. to                                            cardiotoxicity
                           Halofantrine HCl……..….250mg
                           (Anti-malarial)

209.        -do-           Panfre 5mg Tablets                    20’s   Rs. 100.00        Rejected on the
                           Each tablet contains:-                40’s   Rs. 200.00       grounds that the
                           Serrationpeptidase eq. to             50’s   Rs. 250.00       formulatin is not
                           Serrationpeptidase                                          approved by UK &
                           (10,000IU)……………5mg                                         USA and therapeutic
                                                                                      efficacy not establish
                                                                                      in the said indication.
                                                                                      Decided to withdraw
                                                                                      the already registered
                                                                                           formulation

210.        -do-           Panfre 10mg Tablets                   20’s   Rs. 150.00             -do-
                           Each tablet contains:-                40’s   Rs. 300.00
                           Serrationpeptidase eq. to             50’s   Rs. 350.00
                           Serrationpeptidase
                           (10,000IU)……………10mg

211.        -do-           Panfre 20mg Tablets                   20’s   Rs. 200.00             -do-
                           Each tablet contains:-                40’s   Rs. 400.00
                           Serrationpeptidase eq. to             50’s   Rs. 450.00
                           Serrationpeptidase
                           (10,000IU)……………20mg




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                                                         80
212.        -do-           Rosvin 5mg Tablets                  7’s   Rs. 550.50    Drugs      Registration
                           Each tablet contains:_             14’s   Rs. 1081.80   Board deferred the
                           Rosuvastatin Calcium eq. to        28’s   Rs. 2163.36   applications        for
                           Rosuvastatin Calcium….5mg                               inspection to verify
                           (Lipid lowering agent)                                  following
                                                                                   informations.

                                                                                   a. Toal number of
                                                                                      registered drugs

                                                                                   b.    Total number of
                                                                                        marketed drugs

                                                                                   c.     stability record of
                                                                                        the applied drugs
                                                                                        along with drug
                                                                                        development data
                                                                                        verification

                                                                                   d. Capacity of the firm.
                                                                                   e. Number of technical
                                                                                       personnel
                                                                                   f. Capacity of quality
                                                                                       control          and
                                                                                       stability chambers
                                                                                       to conduct new
                                                                                       drug development
                                                                                       by the following
                                                                                       panel.

                                                                                   i. Abdul Latif Sheikh.
                                                                                   ii. Zahid Saeed
                                                                                        (PPMA)
                                                                                   iii. Obaid Ali.

                                                                                   This panel will submit
                                                                                      its report for the
                                                                                        consideration

213.        -do-           Rosvin 10mg Tablets                 7’s   Rs. 550.50               -do-
                           Each tablet contains:_             14’s   Rs. 1081.80
                           Rosuvastatin Calcium eq. to        28’s   Rs. 2163.36
                           Rosuvastatin Calcium….10mg
                           (Lipid lowering agent)

214.        -do-           Rosvin 20mg Tablets                 7’s   Rs. 900.00               -do-
                           Each tablet contains:_             14’s   Rs. 1781.40
                           Rosuvastatin Calcium eq. to        28’s   Rs. 3562.50
                           Rosuvastatin Calcium….20mg
                           (Lipid lowering agent)

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                                                         81
215.        -do-           Rosvin 40mg Tablets              7’s    Rs. 900.00    Rejected on the grounds
                           Each tablet contains:_          14’s    Rs. 1781.40    that maximum for the
                           Rosuvastatin Calcium eq. to     28’s    Rs. 3562.50   persons of Asian origin
                           Rosuvastatin Calcium….40mg                             is 20mg as referred in
                           (Lipid lowering agent)                                     BNF 49 & 50

216.      M/s.             Skel-Fen 100mg Tablers          30’s     Rs. 182.00    Deferred due to non
        Pakistan           Each tablet contains:-                                confirmation of HVAC
       Pharmaceut          Flurbiprofen…..100mg                                         System
          ical             (Anti-rhematics)
        Product,
        Karachi

217.        -do-           Atopazole 40mg Tablets          14’s     Rs. 430.00            do-
                           Each tablet contains:-
                           Pantaprazole Sodium
                           Sesquihydrate…….40mg
                           (Antipeptic)

218.       M/s             K-Cid Tablets                  1x30’s     Rs.185/-             do-
         Alkemy            Each tablet contains:-
       Pharmaceut          Flurbiprofen………100mg
        icals Lab.         (Propionic Acid)
         Karachi


219.        -do-           Laret Tablets                  1x10’s     Rs.125/-             do-
                           Each tablet contains:-
                           Loratadine………..100mg
                           (Anti-Histamine)

220.        -do-           Amlosine Tablets               2x10’s     Rs.400/-             do-
                           Each tablet contains:-
                           Amlodinpine
                           Besylate………….10mg

221.        -do-           Rendix Tablets                 1x10’s     Rs.120/-             do-
                           Each tablet contains:-
                           Ranatadine
                           (as hydrochloride)……...150mg
                           (H2 Blocker)

222.        -do-           Byrin                          1x10’s   Rs.350.00              do-
                           Each tablet contains:
                           Elhambutol HCl……….300mg
                           Rifampicin…………….150mg
                           Isouazide……………….. 75mg
                           (Antituberculasis)



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                                                     82
223. M/s Amros             Antimal Capsules               1x10’s    Rs.280/-       Rejected on the
     Pharmaceut            Each Capsule contains:-                             grounds that WHO has
        icals              Artemether…………40mg                                       recommended
      Karachi.             (Anti-Malarial)                                          withdrawal of
                                                                               individual Artemisinin
                                                                                   products due to
                                                                                      resistance

224.        -do-           Antimal Injection              6 x 1ml   Rs.390/-    Deferred due to non
                           Each ml contains:-                                  confirmation of HVAC
                           Artemether…………80mg                                         System
                           (Anti-Malarial)




  8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                     83
         Item No. IV NEW APPLICATIONS FOR REGISTRATIONS.



S. No.    Name of              Name of Drugs & Composition       Pack     Demanded              Decision
           firm(s)                                              Size(s)     Price
   1.     M/s. Eros            Eroplex Syrup                     60ml         ?        Rejected on the grounds
         Pharmaceut            Each 15ml contains:-             120ml                  that:
             ical,             Vitamin B1…….3mg                 450ml                  .
          Karachi              Vitamin B2…….3mg                                        i. No Indication has been
                               Vitamin B6….…2mg                                              mentioned
                               Nicotinamide….23mg                                      ii. No. Stability data.
                               (Vitamins)                                              iii. No master formula and
                                                                                             inprocess.
                                                                                       iv. No HVAC description
                                                                                       v. No pharmacopoeial or
                                                                                             other specs of finished
                                                                                             products.
                                                                                       vi. Undertaking or
                                                                                             validation given.

   2.          -do-            Lotin Tablets                     10’s                              -do-
                               Each tablet contains:-
                               Loratadine…10mg
                               (Antihistamine)

   3.          -do-            Erogyl 200 Tablets                10’s                              -do-
                               Each tablet contains:-
                               Metronidazole..…200mg
                               (Amoebicide)

   4.    M/s. Amros            Amoxycillin 250mg Dry Powder               Rs. 51.00    Rejected on the grounds
         Pharmaceut            Syrup                                                   that:
            icals,             Each 5ml contains:-
          Karachi              Amoxycillin….250mg                                      i.   No list of signature
                               (Antibiotic)                                                 undertaking.
                                                                                       ii. Each pasge of original
                                                                                            file still unsigned.
                                                                                       iii. Manufacturing method
                                                                                            not complete
                                                                                       iv. No HVAC detail
                                                                                       v. No prrof of facility
                                                                                            approval.

   5.    M/s. Genix            Sero D 50/10mg Tablets            20’s     Rs. 15.00/   Rejected on the grounds
          Pharma,              Each tablet contains:-            40’s      per tab.    that:
          Karachi              Diclofenac Potassium…50mg         50’s
                               Serratiopeptidase………10mg                                i. No HVAC description
                               (Anti-inflammatory)                                     ii. Irrational formulation.
                                                                                       Iii. No evidence for
                                                                                       international approval
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                                                           84
6.       M/s.               Esotec 20mg Capsules                2x7’s    Rs. 160.00   Rejected on the grounds
       Pakistan             Each capsule contains:_                                   that:
      Pharmaceut            Esomeprazole Magnesium
         ical               Pellets eq. to                                            i. No HVAC
       Product,             Esomeprazole….…20mg                                       ii. No. finished drugs
       Karachi              (Anti-peptic ulcerants)                                        specifications and
                                                                                           validations
                                                                                      iii. Incomplete Stability
                                                                                           studies and supporting
                                                                                           data.
                                                                                      iv. Source of Pellets and
                                                                                           GMP certificate

7.          -do-            Esotec 40mg Capsules                2x7’s    Rs. 272.00               -do-
                            Each capsule contains:_
                            Esomeprazole Magnesium
                            Pellets eq. to
                            Esomeprazole….…40mg
                            (Anti-peptic ulcerants)

8.          -do-            Febtec Tablets                      5x10’s   Rs. 210.00               -do-
                            Each tablet contains:_
                            Ibuprofen……………200mg
                            Pseudophedrine HCl….30mg
                            (cold and cough preparation)


9.          -do-            Febtec Forte Tablets                5x10’s   Rs. 380.00               -do-
                            Each tablet contains:_
                            Ibuprofen……………400mg
                            Pseudophedrine HCl….60mg
                            (cold and cough preparation)

10.         -do-            Febtec Suspension                   60ml     Rs. 20.00                -do-
                            Each 5ml contains:_
                            Ibuprofen……………100mg
                            Pseudophedrine HCl….15mg
                            (cold and cough preparation)

11.         -do-            Arcofen Suspension                  60ml     Rs. 21.00                -do-
                            Each 5ml contains:_
                            Ibuprofen……………100mg
                            (Anti-rhematics, systemic)




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                                                           85
12. M/s. Ocean              Roxet 20mg Tablets                       10’s   Rs. 400.00   Rejected on the grounds
    Pharmaceut              Each film coated tablet contains:                            that:
       ical,                Paroxetine (as Paroxetine
     Karachi                Hydrochlordie                                                i. No HVAC
                            Hemihydrate)……20mg                                           ii. No. finished drugs
                            (Anti-depressant)                                                specification
                                                                                         iii. Name of the firm
                                                                                             change to M/s. Safe
                                                                                             Pharmaceuticals,

13.         -do-            Xide Tablets                             20’s   Rs. 780.00                -do-
                            Each film coated tablet contains:-
                            Losartan Potassium….50mg
                            Hydrochlorthizide….12.5mg
                            (Angiotensin-II Receptor)

14.         -do-            Oxiron 10mg Tablets                      10’s   Rs. 555.00                -do-
                            Each film coated tablet contains:-
                            Alendronate Sodium….10mg
                            (Bone Metabolism)

15.         -do-            Silymarin Tablets                        15’s   Rs. 90.00                 -do-
                            Each tablet contains:-
                            Silymarin INN..….200mg
                            (Cholagogues & Hepatic
                            Preparation)

16.         -do-            Silymarin Suspension                     60ml   Rs. 55.00                 -do-
                            Each 5ml contains:-
                            Silymarin INN..….100mg
                            (Cholagogues & Hepatic
                            Preparation)



17.    M/s. GSK,            Cetrimax Tablets                         10’s   Rs. 42.51    Rejected on the grounds
        Karachi             Each tablet contains:-                                       that:
                            Cetirizine
                            Dihydrochloride…...10mg                                      i. incomplete
                            (Antihistamine)                                                   manufacturing method
                                                                                         ii. No HVAC description
                                                                                         iii. No Pharmacopeial
                                                                                              reference specifications .




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                                                                86
18. M/s. S. J &             Lanzit Injection                   Vial   Rs. 400.00   Rejected on the grounds
     G. Fazul               Each vial contains:-                                   that:
     Ellahie,               Lansoprazole….30mg
     Karachi                (Antiulcerant)                                         The lyophilization unit is
                                                                                   not approved which is a
                                                                                   special    technique    in
                                                                                   manufacturing.

                                                                                   The firm has submitted 45
                                                                                   applications    which are
                                                                                   included in this meeting
                                                                                   agenda. Whereas 2 new
                                                                                   sections of the firm along
                                                                                   with registrations were
                                                                                   granted in the earlier
                                                                                   meeting and the qualified
                                                                                   staff was found in sufficient
                                                                                   as required in SRO. 662 OF
                                                                                   2005.

19.         -do-            Durance Injection                  Vial   Rs. 300.00               -do-
                            Each vial contains:-
                            Omeprazole Sodium eq. to
                            Omeprazole…..40mg
                            (Antiulcerant)

20.         -do-            Contour Injection                  Vial   Rs. 400.00               -do-
                            Each vial contains:-
                            Esomeprazole Sodium eq. to
                            Esomeprazole…..40mg
                            (Antiulcerant)

21.         -do-            Glit 250mg Injection               50ml   Rs. 175.00   Rejected on the grounds
                            Each 50ml contains:-                                   that:
                            Levofloxacin Hemihydrate eq. to
                            Levofloxacin……..250mg                                  Incomplete master formula.
                            (Antibacterial)                                        No effort displayed in the
                                                                                   formulation      to    ensure
                                                                                   isotonacity as required for
                                                                                   large    volume       parental
                                                                                   preparations.     In process
                                                                                   control and manufacturing
                                                                                   data is not sufficient to
                                                                                   manufacture       a    quality
                                                                                   product. The firm has
                                                                                   conducted stability studies
                                                                                   at 280 C with 60% humidity
                                                                                   and stated that the product is
                                                                                   stable but no chromatogram
                                                                                   are spectra has been
                                                                                   enclosed to verifiy the
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                          87
                                                                                     results. Even stability data is
                                                                                     not given instead of stating
                                                                                     percentage of the drug.

22.         -do-            Glit 500mg Injection               100ml   Rs. 275.00                 -do-
                            Each 100ml contains:-
                            Levofloxacin Hemihydrate eq. to
                            Levofloxacin……..500mg
                            (Antibacterial)

23.         -do-            Cinoflox 100 Injection             50ml    Rs. 100.00                 -do-
                            Each 50ml contains:-
                            Ciprofloxacin ……..100mg
                            (Antibacterial)

24.         -do-            Meritrol 10mg Tablets              10’s    Rs. 135.00    Rejected on the grounds
                            Each tablet contains:-                                   that:
                            Ezetimibe …….10mg
                            (Lipid lowering agent)                                   The firm has submitted 45
                                                                                     applications    which are
                                                                                     included in this meeting
                                                                                     agenda. Whereas 2 new
                                                                                     sections of the firm along
                                                                                     with registrations were
                                                                                     granted in the earlier
                                                                                     meeting and the qualified
                                                                                     staff was found in sufficient
                                                                                     as required in SRO. 662 OF
                                                                                     2005.

25.         -do-            Arizo 5mg Tablets                  10’s    Rs. 200.00                 -do-
                            Each tablet contains:-
                            Aripiprazole …….5mg
                            (Antipsychotic)

26.         -do-            Telecin 400mg Tablets              10’s    Rs. 5000.00              -do-
                            Each film coated tablet                                    Severe adverse effects.
                            contains:-                                                Reported two indications
                            Telithromycin …….400mg                                        deleted by FDA

27.         -do-            Serod 2mg Tablets                  10’s    Rs. 140.00                 -do-
                            Each tablet contains:-
                            Tegaserod Maleate eq. to
                            Tegaserod …….2mg
                            (Antibacterial)

28.         -do-            Zolidem 10mg Tablets               20’s    Rs. 175.00               -do-
                            Each film coated tablet                                     Sedative control drug
                            contains:-
                            Zolpidem Tartrate …….10mg
                            (Hypnotic)
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                                                          88
29.         -do-            Olmeta 10mg Tablets                 10’s   Rs. 350.00           -do-
                            Each film coated tablet                                     New molecule
                            contains:-
                            Olmesartan Medoxomil….10mg
                            (Antigotensin II receptor)

30.         -do-            Olmeta 20mg Tablets                 10’s   Rs. 600.00            -do-
                            Each film coated tablet
                            contains:-
                            Olmesartan Medoxomil….20mg
                            (Antigotensin II receptor)


31.         -do-            Olmeta 40mg Tablets                 10’s   Rs. 1000.00          -do-
                            Each film coated tablet                                     New molecule
                            contains:-
                            Olmesartan Medoxomil….40mg
                            (Antigotensin II receptor)

32.         -do-            Direx 250mg Tablets                 10’s   Rs. 1100.00          -do-
                            Each enteric coated tablet                                  New molecule
                            contains:-
                            Dirithromycin..….250mg
                            (Antibacterial)

33.         -do-            Direx 500mg Tablets                 10’s   Rs. 2000.00          -do-
                            Each enteric coated tablet                                  New molecule
                            contains:-
                            Dirithromycin..….500mg
                            (Antibacterial)

34.         -do-            Vomitan 2.5mg Tablets               3’s    Rs. 150.00            -do-
                            Each film coated tablet
                            contains:-
                            Zolmitriptan..….2.5mg
                            (Selective-5 Hydroxytryptamine)

35.         -do-            Vomitan 5mg Tablets                 3’s    Rs. 285.00            -do-
                            Each film coated tablet
                            contains:-
                            Zolmitriptan..….5mg
                            (Selective-5 Hydroxytryptamine)

36.         -do-            Ferose Tablets                      20’s   Rs. 200.00             -do-
                            Each film coated tablet                                  Irrational formulation
                            contains:-                                                 New formulations.
                            Ferrous Bis-Glycinate.…150mg
                            Folic Acid………………0.5mg
                            Vitamin B12………….7.5mcg
                            Zinc Picolinate…………52mg
                            (Haematinic)
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                                                           89
37.         -do-            Ferose Syrup                          60ml   Rs. 120.00               -do-
                            Each 5ml contains:-                  120ml   Rs. 200.00      Irrational formulation
                            Ferrous Bis-Glycinate.…75mg                                    New formulations.
                            Folic Acid…………….0.25mg
                            Vitamin B12………….3.75mcg
                            Zinc Picolinate…………..26mg
                            (Haematinic)

38.         -do-            Viophos-B Plus Sachet                120ml   Rs. 65.00              -do-
                            Each 15ml contains:-                                           New formulation
                            Thiamine Mononitrate…...6mg
                            Riboflavine……………....3mg
                            Pyridoxine HCl……….....6mg
                            Panthenol……………….1.8mg
                            Nicotinamide…………...45mg
                            Vitamin C……………..375mg
                            Calcium
                            Glycerophosphate…..….69mg
                            Sodium
                            Glycerophosphate…….81.9mg
                            Potassium
                            Glycerophosphate……..8.5mg
                            Manganese
                            Glycerophosphate……….5mg
                            (vitamins / Glycerophosphate)


39.     M/s.                Airmax 10mg Tablets                  10’s    Rs. 139.00   Rejected on the grounds
      Nabiqasim,            Each tablet contains:-               30’s    Rs. 399.00   that:
       Karachi              Bambuterol
                            Hydrochlordie…..10mg                                      The      applications     are
                            (Bronchodilator)                                          incomplete in various aspect
                                                                                      including finished drugs
                                                                                      specification master formula
                                                                                      and critical steps stability
                                                                                      studies etc. The spectra and
                                                                                      chromatograms            not
                                                                                      enclosed.

                                                                                      The firm has submitted 36
                                                                                      applications   which are
                                                                                      included in this meeting
                                                                                      and the qualified staff was
                                                                                      found in sufficient as
                                                                                      required in SRO. 662 OF
                                                                                      2005.




      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                            90
40.         -do-            Airmax 20mg Tablets                10’s    Rs. 260.00                -do-
                            Each tablet contains:-             30’s    Rs. 750.00
                            Bambuterol
                            Hydrochlordie……20mg
                            (Bronchodilator)

41.         -do-            Cytotex 100mcg Tablets             10’s    Rs. 350.00                -do-
                            Each tablet contains:-             30’s    Rs. 999.00
                            Misoprostol….…..100mcg
                            (Antiulcer)

42.         -do-            Cytotex 200mcg Tablets             10’s    Rs. 650.00                -do-
                            Each tablet contains:-             30’s    Rs. 1899.00
                            Misoprostol….…..200mcg
                            (Antiulcer)

43.         -do-            Deslor 2.5mg Tablets               10’s    Rs. 230.00                -do-
                            Each tablet contains:-
                            Desloratadine….…..2.5mg
                            (Antihistamine)

44.         -do-            Deslor 5mg Tablets                 10’s    Rs. 250.00                -do-
                            Each tablet contains:-
                            Desloratadine….…..5mg
                            (Antihistamine)

45.         -do-            Deslor 60ml Syrup                 60ml     Rs. 276.00                -do-
                            Each ml contains:-
                            Desloratadine….…..0.5mg
                            (Antihistamine)

46.         -do-            Colospas Fibro Sachet              10’s    Rs. 220.00                 -do-
                            Each sachet contains:-             30’s    Rs. 655.00    This is new combination not
                            Mebeverine                                               registered in any developed
                            Hydrochloride….….….135mg                                 country neither the firm has
                            Ispaghula Husk………..3.5mg                                 provided such evidence
                            (Antispasmodic)

47.     M/s. Getz           EPL Capsules                      5x10’s   Rs. 17.53/    Rejected on the grounds
        Pharma,             Each capsule contains:-                     per cap.     that:
        Karachi             EPL (Essential
                            Phospholipids)……..….175mg                                The firm has submitted 40
                            Vitamin B1……………..3.0mg                                   applications   which are
                            Vitamin B2……………..3.0mg                                   included in this meeting
                            Vitamin B6……………..3.0mg                                   agenda     and    all     the
                            Vitamin B12………..….3.0mg                                  applications lack complete
                            Nicotinamide…………15.0mg                                   manufacturing        formula
                            Vitamin E-Acetate….….3.3mg                               which should ensure that the
                            (Phospholipids)                                          product      would         be
                                                                                     manufactured resulting in
                                                                                     quality    products.     The
      8775cc35-d454-4c3c-ae8e-5f38518f04fe.doc
                                                         91
                                                                                        supporting      data      and
                                                                                        chromatograms / spectra are
                                                                                        missing        in       these
                                                                                        applications.        Stability
                                                                                        studies    are    also    not
                                                                                        supported with these.

48.         -do-            Flexil 5mg Tablets                    1x10’s   Rs. 255.48                -do-
                            Each film coated tablet contains:-    2x10’s   Rs. 500.43   New        molecule        no
                            Cyclobenzaprine HCl…..5mg                                   supportive evidence a data
                            (Muscle Relaxants)                                          given in this application to
                                                                                        verify indications dosage
                                                                                        form,     precautions    side
                                                                                        effects and other prescribing
                                                                                        informations.

49.         -do-            Reventa-Plus Tablets                  1x10’s   Rs. 255.48   Rejected on the grounds
                            Each reventa plus tablet              2x10’s   Rs. 500.43   that:
                            contains:-
                            Alendronate (as Alendroante                                 The firm has submitted 40
                            Sodium)………..70mg                                            applications    which are
                            Cholecalciferol…..2800iu                                    included in this meeting
                            (eq. to 70mcg Vitamin D3)                                   agenda     and     all     the
                            (Antisorptives)                                             applications lack complete
                                                                                        manufacturing        formula
                                                                                        which should ensure that the
                                                                                        product        would        be
                                                                                        manufactured resulting in
                                                                                        quality    products.     The
                                                                                        supporting      data      and
                                                                                        chromatograms / spectra are
                                                                                        missing        in       these
                                                                                        applications.        Stability
                                                                                        studies    are    also    not
                                                                                        supported with these.

50.         -do-            Zetas 10/10 Tablets                   1x14’s   Rs. 559.55               -do-
                            Each tablet contains:_
                            Ezetimibe…….10mg
                            Simvastatin…..10mg
                            (Cardiovascular agents)

51.         -do-            Zetas 10/20 Tablets                   1x14’s   Rs. 573.73               -do-
                            Each tablet contains:_
                            Ezetimibe…….10mg
                            Simvastatin…..20mg
                            (Cardiovascular agents)




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                                                             92
52.         -do-            Zetas 10/40 Tablets                   1x14’s   Rs. 601.75                -do-
                            Each tablet contains:_
                            Ezetimibe…….10mg
                            Simvastatin…..40mg
                            (Cardiovascular agents)

53.         -do-            Zetas 10/80 Tablets                   1x14’s   Rs. 657.66                -do-
                            Each tablet contains:_
                            Ezetimibe…….10mg
                            Simvastatin…..80mg
                            (Cardiovascular agents)

54.         -do-            Leflox 750mg Tablets                  1x5’s    Rs. 978.22                -do-
                            Each film coated tablet contains:-    2x5’s    Rs. 502.27
                            Levofloxacin……750mg
                            (Anti-infective)

55.      M/s.               Nidol Gel                             20gm     Rs. 75.00    Rejected on the grounds
        Medisure            Each gm contains:-                                          that:
         Labs,              Nimesulide…..2%w/w
        Karachi             (Musculo-skeletal)                                          It is new dosage form which
                                                                                        has already been rejected by
                                                                                        the Board. The application
                                                                                        is incomplete

56.         -do-            Bronal Syrup                          60ml     Rs. 75.00+   Rejected on the grounds
                            Each ml contains:_                                          that:
                            Levodropropizine…..6mg
                            (Antitussive)                                               The        application       is
                                                                                        incomplete        and      the
                                                                                        manufacturing and testing
                                                                                        validations are missing. No
                                                                                        data for stability studies has
                                                                                        been produced in the
                                                                                        application            dossier.
                                                                                        Moreover, the drug seem to
                                                                                        be new molecule. No
                                                                                        evidence for approval of
                                                                                        any Regulatory Authroity
                                                                                        has been provided except a
                                                                                        list of certain countries and
                                                                                        reference of Martendale.




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                                                             93
57.         -do-            Kold Tablets                    10x10’s   Rs. 221.90   Rejected on the grounds
                            Each tablet contains:-                                 that:
                            Ibuprofen….200mg
                            Pseudoephedrine HCl…30mg                               The       application      is
                            (Flu, fever & cold)                                    incomplete and in process
                                                                                   control is given for the
                                                                                   syrup      dosage       form.
                                                                                   Moreover,         deficencies
                                                                                   reported in the application
                                                                                   dossier were not completed
                                                                                   by the firm. The supporting
                                                                                   data and chromatograms /
                                                                                   spectra are missing in these
                                                                                   applications

58.         -do-            Kold Frothe Tablets             10x10’s   Rs. 388.40               -do-
                            Each tablet contains:-
                            Ibuprofen….400mg
                            Pseudoephedrine HCl…60mg
                            (Flu, fever & cold)

59.         -do-            A-SPA 40mg Tablets               20’s     Rs. 45.24                -do-
                            Each tablet contains:-
                            Drotaverine HCl…..40mg
                            (Antispasmodic)

60.         -do-            A-SPA Forte Tablets              20’s     Rs. 74.69                -do-
                            Each tablet contains:-
                            Drotaverine HCl…..80mg
                            (Antispasmodic)




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                                                       94
      Item No. V            CASES OF REGISTRATION OF NEW MOLECULES REFERRED TO
                            EXPERTS FOR THEIR EVALUATION.

1.   M/s Getz                                    Prof. Mumtaz Hassan                 Dr. Rafeeq Alam Khan,
                                                 Principal, King Edward Medical Chairman, Biochemical
     Gamotin 2.5 & 5mg Tablet                    College & Al;lied Hospital, Lahore. Pharmacology & Toxicology

                                                                                     University of Karachi
     (2.5mg)                                     1. Cost effective.                  Karachi.
     Rs. 187.76/30’s                             2. RECOMMENDED.
     Rs. 297.64/50’s
                                                                                      Efficacy:
     (5mg)                                       Tassawar Hussain
                                                                                      It enhances upper G.I.T motility
     Rs. 313.56/30’s                             Major General
                                                                                      & gastric emptying.
     Rs. 507.32/50’s                             Director General Medicine
                                                 Rawalpindi..
                                                                                      Safety:
                                                                                      Has to be evaluated locally.
                                                 NOT RECOMMENDED.
                                                                                      Contraindicated in patients with
                                                                                      GIT hemorrhage & mechanical
                                                                                      obstruction. It increases liver
                                                                                      enzymes & decrease fasting blood
                                                                                      glucose, there it should be
                                                                                      cautiously given.

                                                                                      Quality:
                                                                                      The documents are not signed by
                                                                                      any company official.
                                                                                       Stability data is for 18 months
                                                                                              while shelf life is 3 years.
                                                                                       Moreover,           manufacturing
                                                                                          protocol indicates the quantity
                                                                                          of active ingredient for 2.5mg
                                                                                          & 5mg tablets to be exactly
                                                                                          2.64 mg & 5.29 mg which is
                                                                                          very difficult.
                                                                                       Normal procedure is to give
                                                                                          the range of active ingredient
                                                                                          which is usually + 10% of the
                                                                                          actual quantity.
                                                                                      Cost Effectiveness:Retail cost of
                                                                                      the product may be reduced
                                                                                      proportionally after considering
                                                                                      the price of mosapride in
                                                                                      International market, since a
                                                                                      drug of different pharmacological
                                                                                      for similar indication is available
                                                                                      at quite lower rate.

      Decisio:              Rejected on the grounds that the experts not recommended due to incomplete
                            information in the dossier.

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                                                                  95
2.   M/s S. J & G Fazul                DR. JAMAL ZAFAR                 DR. NAJMA
                                       Assoc. Professor                SULTANA                     DR. ABDULLAH DAYO
     Ellahi (Pvt), Ltd.
                                       Department of General           Dean, Faculty of            Faculty of Pharmacy
     Karachi.                          Medicine                        Pharmacy                    Univaersity of Sindh
                                       PIMS                            KARACHI.                    JAMSHORO
                                       ISLAMABAD
     Pitarol Tablets 1                                                 1.    Pitavastatin     is   In the light of the
     mg                                1.HMG Co A INHIBITOR            SAFE                  &     information available in the
     Each Tablet contains:             is the class of drug for        EFFICACIOUS           in    dossier provided, the product
     Pitavastatin……1mg                 reducing lipid level with       reducing LDL cholesterol    Pitavastatin 1mg & 2mg Are
                                       the intention to reduce a       levels as compared with     Effective & its indications
                                       therosclerotic    vascular      Atorvastatin 10mg           are as an adjunct to diet to
     Pitarol Tablets 2                 disease.                        2.    Further randomized    reduce       elevated      total
     mg                                                                comparative studies are     cholesterol LDL-cholestrol,
                                       2. After the review it seems
     Each Tablet contains:                                             needed to clarify the       apo-protein-b & triglyceride
                                       that Pitavastatin is an other
     Pitavastatin……1mg                 addition to the Statins class   effect of a low dose of     levels & to increase HDL-
                                                                       Pitavastatin.               cholestrol levels in patients
                                       with no added benefits
     Pack size:10’s                    over the other drugs of this    3.    Cost of product is    with                   familial
     Price:Rs.225/-                                                    high compared to other      hypercholesterolemia.
                                       class.
                                                                       statins    marketed   in    3. The comparison with
                                       3. RECOMMENDED for
     Pack size:10’s                    Registration        at      a   Pakistan.                   already available products in
     Price:Rs.365/-                    comparable price.                                           local market have some
                                                                                                   difference.
                                                                                                   4. There is no any
                                                                                                   information of this drug price
                                                                                                   in different countries where
                                                                                                   drug is available /registered
                                                                                                   which is very essential to be
                                                                                                   required for drug
                                                                                                   registration. The firm has
                                                                                                   been informed accordingly.

        Decision:             Rejected on the grounds that the drug is not approved by FDA and there are
                              effective medicines already available.




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                                                                  96
3.   M/s PharmEvo                           Prof. Mumtaz Hassan         Dr. Mehmood               Col. Akbar Waheed
     Karachi.                               Professor of Medicines,     Chairman,                 Assistant Professor
                                            King Edward Medical         Department of Pharmacy,   Of Pharmacology
     Amlosar Tablet                         College,                    Islamia University,       Army Medical College
     Each Tablet Contains:-                 Lahore.                     Bahawalpur.               Rawalpindi.
     Amlodipine ---0.0625mg
     Losartan---------0.625mg               1. The combination of the 1. No similar drug is 1.RECOMMENDED
                                            two anti hypertensive drugs      available      in     the for registration
                                            is not recommended. The          country but available
     Rs. 300.0                              literature of the drug           in
                                            provided does not show any       Canada & India with
                                            study in which these two         name       Amlopres-Z,
                                            drugs have been tried in         Covalmo & Tozam
                                            combination .                    whose price after
                                            2. The suggested price of the    conversion             in
                                            drug is too high for use in      Pakistani rupees are
                                            this country. NOT                663.60,      874.0     &
                                            RECOMMEND                        712.0. So price is
                                            registration.                    acceptable.
                                                                          2. It appears to be safe.
                                                                             3. RECOMMENDED
                                                                                     for registration.




          Decision:             Rejected on the grounds that the formulation is not evaluated and approved by
          FDA. Hence efficacy and safety of drug not established.

          Item No. VI Any other item with the permission of chair.

                                On the request of observer from PPMA Mr. Zahid Saeed, it was unanimously
          recommedned that availability of registered drug after the grant of marketing authorization shall
          be mandatory within one year instead of 6 months. However it was verified that registrations of
          the drugs shall be liable to cancellation in case of failure to manufacture within this period.




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                                                                  97

				
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