MINUTES OF 203RD MEETING OF THE REGISTRATION BOARD HELD ONWord下载.docx
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DirectorPharmacy,Nutrition&
CSSDServices,
AgaKhanUniversityHospital,
Karachi.
5.
Dr.IjazAhmed,
AssociateProfessor,
UniversityofVeterinaryandAnimalSciences,
6.
Dr.I.U.Beg,
ConsultantSurgeon,
FederalGovernmentServicesHospital,
Islamabad.
7.
Dr.R.H.Usmani,
AnimalHusbandryCommissioner,
MinistryofFood,Agricultural&
Livestock,
GovernmentofPakistan,Islamabad.
8.
Dr.Jalil-Ur-Rehman,
DirectorGeneralHealthServices,
GovernmentofNWFP,
Peshawar,
9.
AssistantChief,
MinistryofIndustries&
Production,
GovernmentofPakistan,
10.
Mr.MuhammadSaadQureshi,
DeputySecretary,
MinistryofLaw,Justice&
HumanRights,
11.
Mr.Amanullah,
CostAccountant,
MinistryofHealth,
GovernmentofPakistan,
12.
Dr.FarnazMalik,
DrugsController,
Secretary
Mr.ZafarMooraj,representativeofPharmaBureau,Karachi,Mr.ZahidSeed,representativeofPakistanPharmaceuticalManufacturersAssociation,KarachiandMr.M.NaeemShami,representativeofPakistanChemists&
DruggistsAssociation,Karachialsoattendedthemeetingasobservers.
Mr.GhulamRasoolDutani,DeputyDirectorGeneral(Registration)wasalsopresenttoassisttheSecretaryRegistrationBoardwiththeagendaandissuesrelatedtoimportedhuman/veterinarydrugs.
ITEMNO.I.DRUGSDEFERREDFORINSPECTIONOFMANUFACTURERABROAD.
i)TheDrugRegistrationBoardconsideredandapprovedthefollowingdrugssubjecttopricecalculation:
S.#
NameofImporter/
Manufacturer.
NameofDrug(s)/
Composition.
Demanded
Price&
PackSize.
M/s.BoschPharmaceuticals,Karachi/
TobeimportedinnakedvialfromM/s.ShanghaiWanxingBio-PharmaceuticalCo.Ltd.,Shanghai,ChinaandLabeling&
Packingwillbelocally.
Alferon-3Injection.
Eachvialcontains:
RecombinantHumanInterferonAlfa-2bequivalentto3MIUofInterferonalfa-2b
Rs.890.00/Pervial.
Alferon-5Injection.
-
RecombinantHumanInterferonAlfa-2bequivalentto5MIUofInterferonalfa-2b.
Rs.1250.00/Pervial.
Alferon-10Injection.
RecombinantHumanInterferonAlfa-2bequivalentto10MIUofInterferonalfa-2b.
Rs.3000/Pervial.
M/s.Dow-ConvatecPakistanLtd.,Lahore/
M/s.HangzhouJiuyuanGeneEngineeringCo.,Ltd.,Hangzhou,China.
Jipailin2,000IU/0.2mlInjection.
Each0.2mlcontains:
Gensparin..2000IU.
Rs.264.00/1’s.
Rs.1324.00/5’s.
Jipailin3,000IU/0.3mlInjection.
Each0.3mlcontains:
Gensparin….3000IU.
Rs.396.00/1’s.
Rs.1980.00/5’s.
Jipailin4,000IU/0.4mlInjection.
Each0.4mlcontains:
Gensparin…..4000IU.
Rs.528.00/1’s.
Rs.2640/5’s.
Jipailin5,000IU/0.5mlInjection.
Each0.5mlcontains:
Gensparin….5000IU.
Rs.660.00/1’s.
Rs.3300.00/5’s.
Jilifen300ug/1.2mlInjection.
Each1.2mlcontains:
RHG-CSF300ug.
Rs.3700/1’s.
Rs.18,500/5’s.
Jilifen450ug/1.8mlInjection.
RHG-CSF450ug.
Rs.5550/1’s.
Rs.27,750/5’s.
M/sHoffmannHumanHealthPakistanLimited,Lahore/
M/s.LGLifeSciencesLtd,Korea.
Espogen10,000IU/mlInjection.
Eachmlcontains:
Recombinanthumanerythropoietin10,000I.U.
Rs.4800/vial.
Rs.14400/3vials.
Rs.28800/6vials.
M/s.BiomedicsMedicalSystem,Rawalpindi/
M/s.AINMedicareSDN.BHD.,Malaysia.
Heparinol5000SterileSolutionforInjection.
HeparinSodiumBovine5000IU.
Rs.115/Pervial.
Heparinol1000SterileSolutionforInjection.
HeparinSodiumBovine1000IU.
Rs.110/Pervial.
13.
M/s.CirinPharmaceuticals(Pvt)Ltd.,Hattar,Distt.Haripur/
M/s.HumanBiologicalInstitute,India.
Abhayrab
EachImmunizingdose(0.5ml)
contains:
PurifiedVeroCellRabbiesVaccine
Antigen(Inactivated)>
2.5IU.
HumanSerumAlbumin12mg.
Maltose40mg.
Thiomersal0.01%.
Rs.820/Pervial/
dose.
14.
M/s.Hakimsons(Impex)(Pvt)Ltd.,
Karachi/
M/s.CadilaHealthcareLimited,India.
LyssavacN
Eachdosecontains:
Rabiesinactivatedvirusatleast107LD50atleast2.5I.U.
Rs.745/Pervial.
ii).ThedrugRegistrationBoardconsideredandapprovedthefollowingveterinarydrugs:
PackSize.
Price.
M/s.U.M.Enterprises,Karachi/
M/s.MalaysianVaccinesandPharmaceuticalsSDNBHD,Malaysia.
IBDV877Vaccine.
(InfectiousBursalDiseaseVaccine).
1000dosesvial.
1000dosesx10vials.
De-controlled.
MyVACK811Vaccine.
(NewCastleDiseaseVaccineB1Type,LaSotaStrain).
1000doses(500ml).
MyVAC102Vaccine.
iii).TheDrugRegistrationBoardconsideredandrejectthefollowingdrugsasperreasonsmentionedagainsteach:
Recommendationofthepanel.
M/s.Pearl&
PearlRawalpindi/
M/s.VINSBioproductslimitedIndia.
SnakeVenomAntiserumI..P.(Lyophilized)
Facilitywasclosedduetosomeup-gradationworksocompliancetocGMPcouldnotobserved.Re-inspectionsuggested.
M/s.Hakimsons(Impex)(Private)Limited,Karachi/
M/s.GreenCrossCorporation,Korea.
VaricellaVaccine–GCCInjection.
Eachvial(0.7ml)contains:
Liveattenuatedvaricellavirus........NLT1,400PFU.
Theapplicationsforregistrationoftheapplicantfirm’smaybedisposedoffasrejectedastheyhavenotarrangedforinspectionoftheirprincipalfirmsasdirectedbyMinistryofhealth.
M/s.GeneTechLaboratories,Karachi/
M/s.BeijingKawinBio-TechCo.Ltd.Beijing,China.
Kaferon3MIUInjection.
Interferonalpha2b(rhIFNb2-b)3MIU.
Kaferon5MIUInjection.
Interferonalpha2b(rhIFNb2-b)5MIU.
M/sHighnoonLaboratoriesLtd.Lahore/
M/sShanghaiSLLC-SMUBiotechCo,Ltd.Shanghai,China.
RecombinantStreptokinaseforInjection1.5MIU/Vial.
Eachvialcontains:
RecombinantStreptokinase
1,500,000IU.
ITEMNO.II.DRUGSDEFERREDBYTHEREGISTRATIONBOARDINTHE202NDMEETINGHELDON8TH&
9THDECEMBER,2006.
ThemembersoftheBoardwhohasinspectedthefirmsinArgentinaapprisetheBoardregardingthesysteminArgentina,informedthatM/s.LaboratoriosIMAS.A.I.C.,Argentinaisonlyresponsibleforthemanufacturingofpharmaceuticalproductsforhislicencedholdersandisnotresponsibleforanylegalmatter.However,M/s.ServycalS.A.,Argentina,M/s.LaboratorioDosaS.A.,ArgentinaandM/s.LaboratorioVarifarmaS.A.,ArgentinaarethelicenceholdersforM/s.LaboratoriosIMAS.A.I.C.,Argentinaandthelicenceholdersareresponsiblefortherawmaterial,packagingmaterial,finishedgoodsandqualitycontrolofthefinishedproducts.InspectionofM/s.LaboratoriosIMAS.A.I.C.,ArgentinaandM/s.ServycalS.A.,Argentinahasalreadybeenconductedbythepanelandthepanelrecommendsimportofappliedproducts.AfterdetaileddiscussiononthemattertheBoardhasalsodecidedthatifanyimportersubmitrequestfortheregistrationofproductsfromamanufacturerhavingdifferentlicenceholders,thepanelwillinspectthepremisesofmanufactureraswellasthelicenceholdertoverifythefacilityandcGMPpractice.TheRegistrationBoardapprovedtheregistrationoftheproductsappliedbyM/s.CCLPharmaceuticals(Pvt)Ltd.,Lahore,BoardalsoapprovedtheregistrationoftheproductsappliedbyM/s.GhaniBrothers,KarachisubjecttoinspectionoflicenceholdertoverifythefacilityandcGMPcompliance:
M/s.CCLPharmaceuticals(Pvt)Ltd.,Lahore/
M/s.ServycalS.A.,Argentina.
Mebrexel80mgInjection.
AnhydrousDocetaxel80mg.
+
Eachvialofdiluentcontains:
Ethanol95%0,780ml.
Waterforinjection5,22ml.
Rs.30500.00/
Pervial.
Mebrexel20mgInjection.
AnhydrousDocetaxel20mg.
Ethanol95%..0,195ml.
Waterforinjection1,305ml.
Rs.9345.83/
Oncoplatin50mgInjection.
Cisplatin…..50mg.
Rs.885.09/Pervial.
Doxocin10mgInjection.
DoxoribicinHCl10mg.
Rs.699.37/Pervial.
Doxocin50mgInjection.
DoxoribicinHCl50mg.
Rs.2170.10/
Lymphoside100mgInjection.
Etoposide0.100gm.
Rs.794.25/Pervial.
Cytotecan100mgInjection.
Each5mlvialcontains:
TryhydratedIrinotecanHCl100mg.
Rs.13348.80/
Leucofolate50mgInjection.
CalcicLeucovorinequivalentto50mgbase
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