192 6thAug2005 south by 87rC547

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									     MINUTES OF THE 192ND MEETING OF THE REGISTRATION BOARD HELD ON 6th August, 2005,
                              (LOCAL MANUFACTURE) SOUTH.

               The 192nd meeting of the Drug Registration Board was held on 6th August, 2005 in the
Committee Room of the Ministry of Health, Islamabad under the Chairmanship of Dr. Abdul Majid Rajput,
Director General Health. It commenced with the recitation of verses from the Holy Quran and was attended by
the following members:-

i.       Maj. Gen. (R ). Nasir-ul-Islam
         Rawalpindi

ii.      Brig. Muzammil Hassan Najmi
         Prof. of Pharmacology & Therapeutics
         Army Medical College,
         Rawalpindi

iii      Prof. Dr. Muhammad Jamshaid
         Chairman Faculty of Pharmacy
         Punjab University,
         Lahore.

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

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

vi       Animal Husbandary Commission
         Ministry of Food , Agriculture & Livestock
         Islamabad.

vii      Muhammad Saad Khan
         Deputy Secretary,
         Ministry of Law, Justice & Human Rights,
         Islamabad.

xiii     Director General Health Services
         Government of N.W.F.P,
         Peshawar

ix       Director General Health Services
         Government of Balochistan,
         Quetta
x      Deputy Secretary,
       M/o. Industries & Production,
       Islamabad

xi     Controller of Patents,
       Government of Pakistan,
       Karachi.

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

               Dr. Kausar Aamir, 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.


               Dr. M.H Siddiqi representative of Pakistan Pharmaceutical Manufacturers Association and Mr.
M.Zafar Mooraj, representative of Pharma Bureau, Karachi also attended the meeting as observers.


ITEM NO.I CONFIRMATION OF THE MINUTES OF THE 191ST MEETING HELD ON 30TH AND
          31ST MAY, 2005.

             Minutes of the 191st meeting which had been circulated to all members of the Board for
comments/ views/ observations were approved unanimously by the Board.


ITEM NO.II-A           CANCELLATION OF REGISTRATION OF METAMIZOLE CONTAINING
                       PRODUCTS.

               The Drug Registration Board in its 189th meeting had decided to review all the cases of oral
formulation containing “Metamizole” which are already registered and issue show cause notices for
cancellation of these registrations due to the reason it is associated with an increase risk of agranulocytosis and
with shock.
               Accordingly show cause notices for cancellation of already registered formulations containing
Metamizole were issued. It is mentioned here that WHO - Essential Drugs and Medicines – Quality Assurance
and Safety of Medicines, Switzerland        had published a list of countries i.e Armenia, Colobia, Morocco,
Sweden, Syria, Yemen and Zimbabwe where Metamizole has been suspended / cancelled. A list of products
containing Metamizole and reply of the firms are as under:-
S. No. Name of firm(s) Name of products                 Reg. No.   Remarks of the Company

   1.    M/s Merck       Sistalgin Compound Tablets      004157    M/s Merck Marker, Quetta has informed that due to an increase
        Marker, Quetta   Each tablet contains:-                    risk of agranulocytosis and with shock they have stopped /
                         Pramiverine …..2mg                        discontinued the production and commercialization of the
                         Metamizol ……….250mg                       products, which include Dolo-Neurobion Injection & Tablets,
                                                                   Sistalgin Compound Tablets / Ampoule and Buscopan
                                                                   Compound since beginning of October, 2004.

   2.        -do-        Sistalgin Compound Injection    004213                                -do-
                         Each 5ml ampoule contains:-
                         Pramiverine ……………2.5mg
                         Metamizol ……….2.25gm
3.     M/s Aventis   Novalgin Tablets         000235   M/s Aventis Limited, Karachi has submitted that being an
     Pharma, Karachi Each tablet contains:-            ethical company they have a stringent internal audit system of
                     Metamizole ………500mg               suspected ADR reporting which analyses ever minor side
                                                       effect occurring with their any marketed drugs. Very rare
                                                       adverse reaction of agranulocytosis have been known for
                                                       decades and communicated to healthcare professionals and
                                                       patients. However no such incidence has been reported to them
                                                       in Pakistan.

                                                       They risks associated with Metamizole have been vastly
                                                       studied and documented and the International Agranulocotosis
                                                       and Aplastic Anemia Study (IAAAS) also known as the
                                                       Boston Trials, a study conducted in 22 million patents in 1986
                                                       reported any excess risk of dipyron induced agranulocytosis as
                                                       one case in 1.1milion users per week.

                                                        Moreover may other analgesics including Acetaminophen,
                                                       antibiotics including Penicillin and cephalosporins, diuretics
                                                       including Acetazolamide and antimalarials including
                                                       Amodiaquine and Hydroxchloroquine have been reported to
                                                       have rare risk of angranulocytosis.

                                                       The firm has requested that on the basis of information the use
                                                       of Metamizole should be continued in Pakistan and also
                                                       requested for personal hearing.

4.        -do-      Novalgin Syrup            000234                                -do-
                    Each ml contains:-
                    Metamizole ………50mg

5.        -do-      Novalgin Injection        000232                                -do-
                    Each 2ml contains:-
                    Metamizole ………50mg
6.      M/s Elite     Elpyron Injection              024865   M/s Elite, Lahore has submitted that as far as side effects of this
     Pharma, Lahore   Each 2ml contains:-                     drug are concerned, many drugs currently being manufactured
                      Metamizole Sodium DAB..500mg            have side effects of one type or another, so the case of side effects
                                                              is not limited to Metamizole only. Whereas the use of
                                                              Metamizole is justified in serious or life threatening situation
                                                              where no antipyretic is available or sutable and that too under the
                                                              supervision of medical practioner. Prolonged or habitual use of
                                                              this drug is certainly going to produce side effects and again this
                                                              logic holds good for number of drugs rather majority of drugs
                                                              currently being manufactured.

                                                              In October, 2000 the Russian Ministry of Health that the
                                                              Metamizole officially is not recommended for OTC (with out
                                                              prescription) pharmacy sale to customers under 18 years old.

                                                              They suggested that a study carrying out at University level
                                                              before a decion is taken in this regard, since it iinvolves lot of
                                                              controversy. Nevertheless, whatever is the decision of
                                                              honourable Board, they shall abide by that decision.

7.        -do-        Hyoscine Compound Injection    022240                                   -do-


8.    M/s Dosaco      Dipyron Injection                       M/s Dosaco Labs., Lahore have informed that they are
      Labs, Lahore                                            producing these formulations since 1977 and meet the
                                                              requirement of the market. Since than they have not received
                                                              any complaint about its adverse effect from any physician nor
                                                              from any customer. In their opinion it is one of the safest and
                                                              the most potent medicines. They have also added that they
                                                              have 3 Tons of “Metamizole” in their godown and about 10
                                                              Tons are on the way for which they have already paid the
                                                              amount in foreign exchange.

                                                              They have also requested for giving them a chance of personal
                                                              hearing.
9.         -do-        Hyoscine Compound Tablets            002697                                 -do-
                       Each tablet contains:-
                       Hyoscine – N- Butylbromide …..10mg
                       Metamizole ………250mg

10.      M/s Ideal     Dipyron Tablets                               M/s Ideal Pharma, Lahore have furnished that in 1988 this
      Pharmaceuticals,                                               matter of Metamizole containing drugs side effect like severe
          Lahore                                                     agranulocytosis came in the notice of Ministry of Health and
                                                                     that time firstly it was decided to replace “ Metamizole” with “
                                                                     Paracetamol” but after collection of further information from
                                                                     the origin country Germany and on pressing demand of
                                                                     doctors it was decided to allow to continue this product. They
                                                                     have further added that technical side of this drug then like all
                                                                     the other drugs, Metamizole has its side effects. Major side
                                                                     effects of any drug appear after its overdose or after prolonged
                                                                     use and in that case that particular drug is replaced by another
                                                                     drug by the doctors. In combination with other anti-
                                                                     spasmodics like Hyoscine-N-Butylbromide it is a wonderful
                                                                     drug in the treatment of biliary and renal colic pains. In these
                                                                     conditions such type of combination is given to patients only
                                                                     for 2-3 days or whenever the pain appears again. There is no
                                                                     prolonged use of drug is given in such condition. Side effect
                                                                     like agranucytoris appear only when this drug is given in large
                                                                     dose or during prolonged therapy.

                                                                     In the last the firm have accepted the decision what so ever
                                                                     decided by the Board but they added here that before any final
                                                                     decision please do collect more and more technical
                                                                     information from the country of origin.

11.        -do-        Hyoscine Compoud Tablets             010158                                 -do-
12.   M/s L.C.P.W.,   Dipyron Tablets                               M/s L.C.P.W., Lahore have informed as under:-
         Lahore                                                        i)     withdrawal of registration containing Metamizole
                                                                              was take up by the Ministry of Health earlier in
                                                                              1987 and after thorough consideration the Ministry
                                                                              of Health in 1988 withdrew the withdrawal of
                                                                              Metamizole preparation. No once again the matter
                                                                              has been probed up.
                                                                       ii)    The drug „ Metamizole‟ is being used
                                                                              internationally throughout the world.
                                                                       iii)   Dipyron / Metamizole is included in BP 2002 an is
                                                                              also included in the 4th Edition of European
                                                                              Pharmacopeia..
                                                                       iv)    There is no such compelling circumstance that all
                                                                              of a sudden to withdraw the Metamizole
                                                                              preparation just on the initiation of a company
                                                                              having vested interests to withdraw the medicine
                                                                              and to market another preperation with higher price
                                                                              for particular gains and the object is to increase to
                                                                              overburdened the ailing humanity.

                                                                       In the last the firm has requested for personal hearing so
                                                                       that the matter is thoroughly demonstrated that the
                                                                       withdrawal is neither legal nor justifiable.

13.       -do-        Hyospan Injection                    003084                                -do-
                      Each 5ml ampoule contains:-
                      Hyoscine – N- Butylbromide …..20mg
                      Metamizole ………2.5gm

14.       -do-        Hyospan Compound Tablets             001750                                -do-
                      Each 5ml ampoule contains:-
                      Hyoscine – N- Butylbromide …..10mg
                      Metamizole ………250mg
15.    M/s AGP,      Magnopyrol Injection                 002365   M/s AGP, Karachi have referred the discussion of Maj. Gen.
        Karachi      Each 2ml contains:-                           Shujjat Hussain and submitted that he was very clear in his
                     Phenyl Dimethyl-Pyrazolone Methyl-            views that Metamizole Magnesium is therapeutically active
                     Aminomethane magnesium sulphonate             and has great clinical value and strongly recommended to
                     0.8gm                                         maintain this drug in the list of registered drugs. They have
                                                                   requested that on the basis of above recommendation they
                                                                   were allowed to continue the manufacturing of these drugs.

16.      -do-        Magnopyrol Syrup                     016914                               -do-
                     Each 5ml contains:-
                     Phenyl Dimethyl-Pyrazolone Methyl-
                     Aminomethane magnesium sulphonate
                     250mg

17.      -do-        Magnopyrol Tablets                   002364                               -do-
                     Each tablet contains:-
                     Phenyl Dimethyl-Pyrazolone Methyl-
                     Aminomethane magnesium sulphonate
                     0.5gm

18.      -do-        Spaslar Capsules                     013366                               -do-
                     Each capsule contains:-
                     Hyoscine – N- Butylbromide …..10mg
                     Metamizole ……..250mg

19. M/s Medicaids,   Hyoscine Compound Tablets            003216   M/s Medicaids, Karachi have informed that they have already
       Karachi                                                     suspended the production and started working on a revised
                                                                   formulation deleting Metamizole.
20.    M/s Wilshire    Hyoscine Compound Tablets              010563   M/s Wilshire Labs, Lahore have full regard for opinion of
       Labs., Lahore                                                   Honourable Registration Board regarding side effects of
                                                                       Metamizole i.e Agranulaocytosis and submit the proposals
                                                                       (i)    This Drug may be deregistered and registration fee
                                                                       adjusted against a new registration (ii) This formulation may
                                                                       be amended as Hyoscine-N-Butyl Bromide 10mg and
                                                                       Paracetamol 500mg

21.        -do-        Lospasm Tablets                        010563                                 -do-
                       Each tablet contains:-
                       Hyoscine-N-Butyl bromide........10mg
                       Metamizole Sodium..250mg

22.        -do-        Dipyron Tablets                        008212                                 -do-

23.      M/s Indus    Nosgin Injection                        011416   M/s Indus Pharma, Karachi have submitted that they are
      Pharma, Karachi Each 2ml contains:-                              exporting these formulations to Central Asian States is there is
                      Fenpiverinium Bromide ..0.02mg                   big market for these drugs earned foreign exchange for the
                      Pitofenone HCl …2mg                              country. They have added that Metamizole sodium its use is
                      Metamizole Sodium………500mg                        justified as antipyretic in serious or life threatening situations
                                                                       where no alternative is available or suitable. They have
                                                                       requested to continue the registration of drugs containing
                                                                       Metamizole as active ingredient.

24.        -do-        Nosgin Tablets                         015397                                 -do-
                       Each tablet contains:-
                       Fenpiverinium Bromide ..0.01mg
                       Pitofenone HCl …5mg
                       Metamizole Sodium………500mg

25.      M/s Helix    Spalin Injection                        011637   M/s Helix Pharma, Karachi have agree with the decision and
      Pharma, Karachi Each 5ml ampoule contains:-                      requested for cancellation of their registrations.
                      Hyoscine-N-Butyl bromide........20mg
                      Metamizol ……….2.5gm
26.         -do-        Spalin Compound Tablets                    002458                               -do-
                        Each tablet contains:-
                        Hyoscine-N-Butyl bromide....10mg
                        Metamizol ……….250mg

27.     M/s Bloom      Surfen Tablets                              022362   M/s Bloom Pharma, Hattar has informed that as per instruction
      Pharmaceuticals, Each tablet contains:-                               they have ceased manufacturing of this product. However they
          Hattar       Hyoscine-N-Butyl bromide....10mg                     have requested for replacement of Metamizole with
                       Metamizol ……….250mg                                  Paracetamol.

28.    M/s Munawar      Hyoscine Compound Injection                022933                        Reply not received.
      Pharma, Lahore    Each 5ml contains:-
                        Hyoscine N Butylbromide..20mg
                        (Metamizole.....250mg

29.     M/s Mass        Hyopen Injection                           022463                        Reply not received.
      Pharma, Lahore    Each 5ml contains:-
                        Hyoscine N-Butyl BromideBP.....20mg
                        Metamizole BP..1000mg

30.     M/s K.P.L,      Dypron Injection                           020327                        Reply not received.
         Karachi        Each ml contains:-
                        Metamizole.........500mg

31.         -do-        Hyoscine Compound Tablets                  007858                        Reply not received.

32.     M/s Epoch      Epospan Tablets                             020612                        Reply not received.
      Pharmaceuticals, Each tablet contains:-
          Karachi      Hyoscine-N-Butyl bromide.............10mg
                       Metamizole Sodium..250mg

33.         -do-        Dipyrol Tablets                            020577                        Reply not received.
                        Each tablet contains:-
                        Metamizole ……500mg
34.    M/s Humayun      Humapan Injection                          020743   Reply not received.
       International,   Each 5ml contains:-
        Faisalabad      Hyoscine -N-Butyl
                        Bromide................20mg
                        Metamizole.........1000mg

35.        -do-         Dipyrex Injection                          020744   Reply not received.
                        Each ml contains:-
                        Metamizole...........500mg

36.     M/s Global      Surfen Tablets                             022362   Reply not received.
         Pharma,        Each tablet contains:-
        Islamabad       Hyoscine -N Butylbromide............10mg
                        Metamizole.............250mg

37.     M/s Macter      Mizolin Injection (I.M/I.V)                021731   Reply not received.
       International,   Each ml contains:-
          Karachi       Metamizole Sodium..500mg

38.        -do-         Mizolin M Injection (I.M/I.V)              021732   Reply not received.
                        Each ml contains:-
                        Metamizole Magnesium.400mg

39. M/s PDH Labs,       Pyrexil Injection                          002466   Reply not received.
        Lahore          Each ml contains:-
                        Metamizole Sodium....500mg


40.      M/s Alen      Hyoscine Compound Tablets                   004012   Reply not received.
      Pharmaceuticals, Each tablet contains:-
          Risalpur     Hyoscine Butylbromide......10mg
                       Metamizole.............250mg
41. M/s Swiss Pharma, Dipyron 500mg Tablets            027942   Reply not received.
         Karachi      Each tablet contains:-
                      Metamizole ……..500mg

42.    M/s Regent      Dipyron Tablets                 030157   Reply not received.
      Labs., Karachi   Each tablet contains:-
                       Metamizole………..500mg

43.    M/s Chas A.     Anapyrol Injection              031266   Reply not received.
        Mendoza,       Each 2ml contains:-
        Karachi        Metamizole Magnesium…80mg

44.        -do-        Anapyrol Syrup                  031267   Reply not received.
                       Each 5ml contains:-
                       Metamizole Magnesium…..50mg

45.        -do-        Anapyrol Tablets                031268   Reply not received.
                       Each tablet contains:-
                       Metamizole Mangesium……80mg

46. M/s Macquin‟s ,    Mauscopan Ampoules              039186   Reply not received.
        Karachi        Each 5ml contains:-
                       Hyoscine-N-Butylbromide..20mg
                       Dipyron (Metamizole)….250mg

47.   M/s Opal Labs,   Analgin Tablets                 000880   Reply not received.
         Karachi       Each tablet contains:-
                       Metamizole ……..500mg

48.        -do-        Analgin Drops                   010576   Reply not received.
                       Each ml contains:-
                       Metamizole ……..500mg
49.      M/s Bliss    Blisspyron Syrup                                Reply not received.
      Pharma, Karachi Each ml contains:-
                      Dipyron …..50mg

50.     M/s Amros     Dipyron Injection                      019369   Reply not received.
      Pharma, Karachi

51.        -do-         Hyoscine Compound Injection          019381   Reply not received.

52.    M/s Geofman     Dipyron Injection                     004966   Reply not received.
      Pharmaceuticals,
          Karachi

53.        -do-         Dipyron Tablets                      002507   Reply not received.

54.        -do-         Geospasmocin Injection               002494   Reply not received.
                        Each 5ml ampoule contains:-
                        Hyoscine – N- Butylbromide …..20mg
                        Metamizole ………250mg

55.        -do-         Geospasmocin Tablets                 002495   Reply not received.
                        Each tablet contains:-
                        Hyoscine – N- Butylbromide …..10mg
                        Metamizole ………250mg

56.     M/s Saydon     Dipyron Tablets                       020004   Reply not received.
      Pharmaceuticals,
         Peshawar

57.     M/s Semos     Dipyron Tablets                        014383   Reply not received.
      Pharma, Karachi

58.      M/s Siza       Dipyron Tablets                               Reply not received.
       International,
          Lahore
59.   M/s Star Labs.,   Dipyron Tablets                        Reply not received.
         Lahore
60.        M/s          Dipyron Tablets               001776   Reply not received.
       UnexoLabs.,
         Lahore

61.        -do-         Hyoscine Compound Tablets     007577   Reply not received.

62.    M/s Elko         Elkopyron Injection           012020   Reply not received.
      Organization,     Each ml contains:-
        Karachi         Dipyron ……….500mg

63.        -do-         Elkopyron Syrup               011575   Reply not received.
                        Each ml contains:-
                        Dipyron ……….50mg

64. M/s Pharmacare      Fibrex Tablets                012372   Reply not received.
     Labs., Lahore      Each tablet contains:-
                        Metamizole …….500mg

65. M/s Irza Phama,     Javalgin Injection            012696   Reply not received.
        Lahore          Each 2ml contains:-
                        Dipyron ……….1000mg

66.        -do-         Javalgin Tablets              007808   Reply not received.
                        Each tablet contains:-
                        Dipyron ……….500mg

67.        -do-         Hyoscine Compoud Tablets      008189   Reply not received.

68.                     Hyoscine Compound Injection   012692   Reply not received.
69.     M/s Lisko      Liskogin Tablets                     010971   Reply not received.
        Pakistan,      Each tablet contains:-
         Karachi       Metamizole ……500mg

70.        -do-        Liskogin Syrup                       003958   Reply not received.
                       Each ml contains:-
                       Metamizole ……50mg
71.    M/s Krka-Pak,   Metavine Tablets                     012048   Reply not received.
         Karachi       Each tablet contains:-
                       Metamizole ………500mg

72.        -do-        Metavine Syrup                       004021   Reply not received.
                       Each 5ml contains:-
                       Metamizole ………50mg


73.    M/s Harman      Hyoscine Compound Injection          017770   Reply not received.
      Pharma, Lahore

74.     M/s Mediate    Hyoscine Compound Tablets            011517   Reply not received.
      Pharmaceuticals, Each tablet contains:-
          Karachi      Hyoscine – N- Butylbromide …..10mg
                       Metamizole ……………..…250mg
Decision:          The Drug Registration Board examined the replies of the show cause notices submitted by
pharmaceutical manufacturers.    The representative of M/s. AGP. Syed Abid Mumtaz, Deputy Managing
Director and Mr. Hamayun Regional Sale Manger appeared before the Board and extended their arguments in
favour of non-withdrawal of Metamizole registrations. They were of the view that Metamizole adverse effects
are limited to combinations forms and M/s. AGP (Pvt.) Ltd; has already been withdrawn its drugs which were in
combination form i.e. “Spaslar Capsule & Syrup. They also submitted different reports indicating that
“Agranulocytosis Attributable to Dipyrone was having geographical attitude with very minute appearance as
indicated through different studies and are limited to 1% of the using population. On the query of Member
Registration Board it was stated that the drug is not available in USA & UK. Similarly Dr. Aman Ullah Khan
and Dr. Musharaf of M/s. Sanofi Aventis presented arguments in favour of non-withdrawal of the “Metamizole”
preparation. They were also of the view that reported estimate of the risk of Agranulocytosis associated with
“Metamizole” have widely varied. They stated that the risk was high only in Sweden. They also requested non-
withdrawal of the registrations of “Metamizole” drugs. The Drug Registration Board after consideration and
analysis replies to the show cause notice by the firms and presentations of M/s. AGP, Karachi and M/s. Sanofi
Aventis, Karachi decided:-
              i. To cancel all the drug registrations with immediate effect in oral dosage
                 forms containing “Metamizole” either alone or in combination form.

              ii. All the manufacturers shall withdraw the stocks of these drugs within 14 days
                  from the market through their market forces and authorized agents, as
                  prescribed in Rule 30 (10) (a) of Drugs (Licensing, Registering &
                  Advertising) Rule 1976. .

              iii. Advertisements shall be published by all the concerned manufacturers in the
                   national newspapers regarding the withdrawal of “Metamizole” drugs within a
                   week and compliance report shall be submitted to this Ministry within
                   fortnight period.

              iv. Provincial Governments shall supervise the withdrawal during the stipulated
                  period and after the withdrawal period of 14 days start legal proceedings
                  against those manufacturers, distributors and retailers involved in the
                  manufacturing and selling of these drugs as provided under clause b of Sub-
                  Section 12 of Section 7 of Drug Act, 1976, which states that Provincial
                  Government shall take all such steps as may be necessary to prevent the
                  manufacture or sale of a drug, the registration of which has been cancelled or
                  stand suspended.

              The decision of cancellation of drug registration is based on the following grounds:-
               As stated in clause b & d of Sub-Subsection 11 of Section 7 of Drug Act,
                1976, the circumstances in which drugs were registered no longer exist and
   sufficient evidence is available about the toxicity / adverse effects of these
   drugs either alone or in combination to cancel these drug registrations.

 M/s. Merck Marker Pakistan, Karachi has voluntarily withdrawn all their
  registered drugs containing “Metamizole”.

 The drug “Metamizole” was not available at the market of USA and UK either
  alone are combination form.

 According to World Health Organization pharmaceutical restrictions in ued
  and availability report prepared within the context of United Nation
  Publication in the up date of 6th issue March, 2001 report “Metamizole” was
  placed in the consolidated list of products whose consumption and / or sale
  have been banned, withdrawn, severely restricted or not approved by the
  governments:- “Metamizole was withdrawn from the market of the following
  countries as stated below:-

            S. No. Name of Country(s)        Date of Withdrawal
              1.     Armenia                 February, 2000
              2.     Colombia                June, 200
              3.     Maracoo                 May, 2000
              4.     Sweden                  1999
              5.     Syria                   1998
              6.     Yuman                   1998
              7.     Zimbabwe                1998
              8.     Saudia Arabia           1999
ITEM NO.II-B PERSONAL HEARINGS


               UNETHICAL MARKETING PROMOTION


               M/s Bosch Pharmaceuticals, Karachi have complained that M/s Sanofi Aventis, Karachi is
playing unethical marketing promotional activities. As in the product promotional material the firm is
propagating that local companies are generally producing sub-standard drugs which often take longer time
disintegration, dissolution, thus making no therapeutic effect and importing cheap raw material from India,
Bangladesh and China to decrease the cost. This practice is the violation of Rule 31 (6) of Drugs (Licensing,
Registering and Advertising) Rules, 1976 which clearly states that “no advertisement under this rule shall
contain direct or indirect compare in any way with and other drugs or substances or remedy for any diseases for
the purpose of attracting customers or with a view to discredit other such products. This is also violation of
Schedule 4 of these rules.

               The representative of M/s Sanofi Aventis, Karachi have been called for personal hearing to
explain their position before the Drugs Registration Board.

Decision:-     Dr. Musharaf    and Dr. Aman Ullah of M/s. Sanofi Avenits, Karachi appeared before the
Registration Board and defended their way off advertisement through “Portraying” The Daily Dawn news repot
on the promotion material for the information of prescribers. The Daily Dawn newspaper report pasted on
promotion material contained that:-
               i. Local Pharmaceutical companies are generally proceedings substandard drugs,
                  which often take longer time in disintergradations, dissolution and thus
                  making no therapeutic efficacy.

               ii. Generally local companies imported cheap raw materials from India,
                   Bangladesh and China to lessen the cost.

               iii. Products are below standards and hence not effective for therapeutic use. The
                    most probable cause of poor quality of drug is absence of adequate quality
                    assurance during manufactures.

               iv. Substandard drugs source in pharmacy of less developed countries could
                   contribute to global  microbial resistance and the therapeutic failure of
                   infections diseases.
               The Chairman and the members of the Board took serious notice of this unethical way promotion
and malpractice and decided:-
               1. Marketing manager of M/s. Sanofi Aventis Pakistan, Karachi ho is responsible
                  for the violation of Rule 31 (6) of Drugs (Licensing, Registering &
                  Advertising) Rules, 1976, shall submit unconditional apology to the M/o.
                  Health with the undertaking to refrain the same in future.

               2.    Marketing Manager of M/s. Sanofi Avenits, Karachi who is responsible for
                    the violation of Rule 31 (6) of Drugs (Licensing, Registering & Advertising)
                    Rules, 1976, shall publish unconditional apology in one English and one Urdu
                    newspaper having country wise circulation with the denial that all the above
                    mentioned four allegations made part of promotional material of M/s. Sanofi
                    Aventis, Karachi are based less and this will not be repeated in future.

               3. Compliance to this decision shall be submitted by the firm within 15 days
                  along with the copies of press clippings published. In case of failure to comply
                  with the decision the matter will be placed in the next meeting of the Board
                  for reconsideration.

ITEM NO. III. MISCELLANEOUS CASES

                 AVAILABILITY OF ORAL PILLS AS OVER THE COUNTER PRODUCT.

                 M/s. Greenstar Social Marketing has raised the issue regarding sale of oral pills and submit
their observation as under:-

               Oral pill is classified as a medicine and officially it is available from a licensed
               chemist with prescription. This restricts its availability, though efforts to
               encourage voluntary practice of birth spacing warrant its easy access at
               convenient locations, which includes the general stores. The convenient
               availability is particularly problematic in small towns and far flung rural, where
               majority of our population reside. The effect of all fertility moderation efforts
               largely depends on increase level of acceptance and continued practice by this
               major group of the target population.

               The Social marketing organizations are only allowed to train doctors, LHVs and
               chemists. They are not allowed to train shopkeepers or even paramedics, who may
               be selling the pills, or whose customers may want them to dispense the product.
               Similarly, manufacturers of pill such as M/s. Zafa are not allowed to visit these
               shops for training and promotional activities. These barriers to access need to be
               considered and addressed to meet the unmet need of family planning in particular.

               Greenstar has taken up the matter with M/s. Health and reiterated the point of
               marking pill available as over the counter product. The rationale was explained
               and practices being followed in the neighboring countries cited. In India, pill was
               reclassified and included in Schedule H, as an over the counter product.
               Bangladesh has piloted a scheme with 500 successful and helping to promote was
               availability of pill. Similar initiatives have been taken in countries such as
               Indonesia, the Philippines and Sri Lanka.

               Pakistan needs to consider moving in this direction as well, particularly when they
               are striving for raising the CPR in the pursuit of population stabilization goal. The
               issue apparently requires a review of the Drug Act and the Rules in order to
               accommodate the desired provision. The Drug Contoller may kindly undertake
               the review for initiating appropriate action.


               It is submitted that as per SRO 497 (I)/2001 dated 26th June, 2001 the oral contraceptives are sale
on the following conditions:-

               i. The contraceptive is stored, and distributed by a Lady Health Visitor or a
                  Health Care Personnel under the authority of an organization duly registered
                  with the M/o. of Population Welfare and not for any commercial purpose.

               ii. The contraceptive is stored, and distributed for a Population Welfare
                   Programme duly approved, by the M/o. Population Welfare and not for any
                   commercial purpose.

               iii. The price charged for the contraceptive, by the Lady Health Visitor or Health
                    Care Personnel shall not be more than the approved maximum retail price.

Decision:-     The request of M/s. Social Marketing was deferred for expert opinion from the gynecologists
about the side effects / misuses of contraceptives if allowed.


                INSPECTION COMMITTEE

               The Central Licensing & Registration Board formulated a committee of following members for
the finalization of format of check list / Inspection Performa regarding the visits / inspections of pharmaceutical
units-
               1.   Abdul Latif Shiekh                Chairman (Member CL &RB)
               2.   ZafarMooraj                       Representative, Pharma Bureau
               3.   Dr. M.H Siddiqi                   Representative, PPMA
               4.   Mr. Fakhurddin Aamir              Secretary (FID, Karachi)

               This committee will finalize their recommendations within 20 days to the Secretary Central
Licensing & Registration Board which will be circulated to all the members of Board for their comments and
finally submitted for approval by the Registration Board.
               AMENDMENT COMMITTEE

               A committee of following members was constituted:-
               1. Dr. Jamshad                     Chairman (Member CL&RB)
               2. Mr. Atta-ur-Rehman              Member, (Chief Drug Inspector, Balochistan)
               3. Mr. Abdul Sattar Sohrani        Secretary (Deputy Drugs Controller (Reg-II), Islamabad
               4. Dr. Sheikh Akhtar Hussain       FID, Lahore
               This committee will finalize recommendations for amendments in the rules in accordance with
the needs in the current scenario / policies approved by the Central Licensing & Registration Board. Main focus
of this committee will be import policy.


               RATIONALIZATION OF PRICES.

Decision:-     During the discussion of shortage of drugs Mr. Zafar Mooraj Observer on the Board complained
about the low prices of certain drugs. The Chairman Registration Board after through discussion again reiterated
that the M/o. Health is in favour of rationalization of prices. The prices of drugs which are very low should be
increased and the prices of those drugs which are very high should be decreased. It was also decided that
disparity of prices of multinational and local pharmaceutical firms shall be minimized Dr. Haroon Saddiqi
observer of PPMA supported the decision. The Chairman Registration Board requested the PPMA and Pharma
Bureau to come up with the proposals and mechanism to rationalize the prices of drugs which shall be made
available to this Ministry within 20 days for discussion in the next Board meeting.
               0




               SHORTAGE OF ORPHAN DRUGS / NON-AVAILABILITY OF REGISTERED DRUGS
Decision:-     The matter of shortage of registered drugs was again taken up in the Registration Board and it
was decided to produce data base about the manufacturing of registered drugs and their availability following
measures shall be adopted:-
               i. As prescribed in Rule 30 (6) of Drugs (Licensing, Registering & Advertising)
                  Rule, 1976 a record of quarterly production and disposal of drug shall be
                  maintained and supplied to the Chairman Registration Board in Form-7 in
                  months of January, April, July and October each year.

               ii. The FID / field officer of Drug Control Administration shall prepare the list of
                   registered drugs during the inspection of each manufacturer indicating those
                   being manufactured and those not being manufactured during the last 6
                   months. This report shall be included with the inspections and enclosed with
                   the inspection reports to the Secretary Drug Registration Board.
               ESTABLISHMENT OF QUALITY CONTROL REFERENCE LABORATORY / BIO
               EQUILANCE CENTER

Decision:-     Chairman Registration Board reiterated during the discussion that a state of the art quality
control laboratory may be established equipped with all the requisite facilities and equipments along with a bio
equilance center in private public partnership with autonomous status. He requested the Pharma Bureau and
PPMA representatives to put feasibility and plan as soon as possible because it is need of the hour. He also
added a bio equilance center shall also be included in the project to facilitate the local pharmaceuticals industry
as well as M/o. Health to ascertain certain the level of quality efficacy different pharmaceutical groups.


               PATIENT INFORMATION SHEET FOR CELECOXIB


Decision:-     The matter of Celecoxib‟s increase risk of serious cardiovascular events such as heart attack or
stroke was considered in the meeting of Drug Registration Board. The Drug Registration Board approved the
recommendations of FDA regarding the “Celecoxib”. It was decided that package insert of the drug shall be
revised to include a serious warning to highlight the potential increased risk of cardiovascular events and well
none risk of potentially life threatening stamen diseases. The approved and revised text of “Celecoxib” patient
information sheet by the FDA was duly approved by the Drug Registration Board and it was decided that all the
manufacturing firms already having market authorization of this drug shall add this information in the leaflets /
package insert for the information of prescribers as well as patients. The compliance shall be submitted within a
week time. U.S. FDA “Celecoxib” patient information is enclosed at (annex-A).


               ANALYSIS OF VARIOUS BRANDS OF OFLOXACIN                                 BY THE CONSUMER
               PROTECTION NETWORK.

Decision:      Consumer protection network conducted a study about the analysis of various brands of
“Ofloxacin” and concluded that most of the brands are of substandard quality including Tarivid Infusion of
M/s. Aventis. This study came under the discussion of Central Licensing & Registration Board and it was
concluded that the procedures for test / analysis of “Ofloxacin” adopted by the consumer protection network are
defective and incredible. The effort made by the consumer protection network although may be with good intent
but it is beyond the mandate and jurisdiction. It was decided that displeasure shall be conveyed to the consumer
protection network.

								
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