MINUTES OF 203RD MEETING OF THE REGISTRATION BOARD HELD ON.docx
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MINUTES OF 203RD MEETING OF THE REGISTRATION BOARD HELD ON.docx
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MINUTESOF203RDMEETINGOFTHEREGISTRATIONBOARDHELDON
MINUTESOF203RDMEETINGOFTHEREGISTRATIONBOARDHELDON
23RDDECEMBER,2006(IMPORTEDHUMAN/VETERINARYDRUGS).
The203rdmeetingoftheDrugRegistrationBoardwasheldon23rdDecember,2006intheCommitteeRoom,MinistryofHealth,Islamabad,undertheChairpersonshipofMaj.Gen.(R)ShahidaMalik,DirectorGeneral(Health).ItcommencedwiththerecitationofversesfromtheHolyQuranandwasattendedbythefollowingmembers:
-
1.
Maj.Gen.®Nasir-ul-Islam,
Physician,
Rawalpindi.
Member
2.
Lt.Col.AslamKhan,
Pulmanologist,
ArmyMedicalCollege,
Rawalpindi.
-do-
3.
Prof.Dr.MuhammadJamshaid,
Principal,
UniversityCollegeofPharmacy,
UniversityofthePunjab,
Lahore.
-do-
4.
Mr.AbdulLatifSheikh,
DirectorPharmacy,Nutrition&CSSDServices,
AgaKhanUniversityHospital,
Karachi.
-do-
5.
Dr.IjazAhmed,
AssociateProfessor,
UniversityofVeterinaryandAnimalSciences,
Lahore.
-do-
6.
Dr.I.U.Beg,
ConsultantSurgeon,
FederalGovernmentServicesHospital,
Islamabad.
-do-
7.
Dr.R.H.Usmani,
AnimalHusbandryCommissioner,
MinistryofFood,Agricultural&Livestock,
GovernmentofPakistan,Islamabad.
-do-
8.
Dr.Jalil-Ur-Rehman,
DirectorGeneralHealthServices,
GovernmentofNWFP,
Peshawar,
-do-
9.
AssistantChief,
MinistryofIndustries&Production,
GovernmentofPakistan,
Islamabad.
-do-
10.
Mr.MuhammadSaadQureshi,
DeputySecretary,
MinistryofLaw,Justice&HumanRights,
Islamabad.
-do-
11.
Mr.Amanullah,
CostAccountant,
MinistryofHealth,
GovernmentofPakistan,
Islamabad.
-do-
12.
Dr.FarnazMalik,
DrugsController,
MinistryofHealth,
GovernmentofPakistan,
Islamabad.
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.
1.
M/s.BoschPharmaceuticals,Karachi/
TobeimportedinnakedvialfromM/s.ShanghaiWanxingBio-PharmaceuticalCo.Ltd.,Shanghai,ChinaandLabeling&Packingwillbelocally.
Alferon-3Injection.
Eachvialcontains:
-
RecombinantHumanInterferonAlfa-2bequivalentto3MIUofInterferonalfa-2b
Rs.890.00/Pervial.
2.
-do-
Alferon-5Injection.
Eachvialcontains:
-
RecombinantHumanInterferonAlfa-2bequivalentto5MIUofInterferonalfa-2b.
Rs.1250.00/Pervial.
3.
-do-
Alferon-10Injection.
Eachvialcontains:
-
RecombinantHumanInterferonAlfa-2bequivalentto10MIUofInterferonalfa-2b.
Rs.3000/Pervial.
4.
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.
5.
-do-
Jipailin3,000IU/0.3mlInjection.
Each0.3mlcontains:
-
Gensparin….3000IU.
Rs.396.00/1’s.
Rs.1980.00/5’s.
6.
-do-
Jipailin4,000IU/0.4mlInjection.
Each0.4mlcontains:
-
Gensparin…..4000IU.
Rs.528.00/1’s.
Rs.2640/5’s.
7.
-do-
Jipailin5,000IU/0.5mlInjection.
Each0.5mlcontains:
-
Gensparin….5000IU.
Rs.660.00/1’s.
Rs.3300.00/5’s.
8.
-do-
Jilifen300ug/1.2mlInjection.
Each1.2mlcontains:
-
RHG-CSF300ug.
Rs.3700/1’s.
Rs.18,500/5’s.
9.
-do-
Jilifen450ug/1.8mlInjection.
Each1.2mlcontains:
-
RHG-CSF450ug.
Rs.5550/1’s.
Rs.27,750/5’s.
10.
M/sHoffmannHumanHealthPakistanLimited,Lahore/
M/s.LGLifeSciencesLtd,Korea.
Espogen10,000IU/mlInjection.
Eachmlcontains:
-
Recombinanthumanerythropoietin10,000I.U.
Rs.4800/vial.
Rs.14400/3vials.
Rs.28800/6vials.
11.
M/s.BiomedicsMedicalSystem,Rawalpindi/
M/s.AINMedicareSDN.BHD.,Malaysia.
Heparinol5000SterileSolutionforInjection.
Eachmlcontains:
-
HeparinSodiumBovine5000IU.
Rs.115/Pervial.
12.
-do-
Heparinol1000SterileSolutionforInjection.
Eachmlcontains:
-
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:
-
S.#
NameofImporter/
Manufacturer.
NameofDrug(s)/
Composition.
Demanded
PackSize.
Price.
1.
M/s.U.M.Enterprises,Karachi/
M/s.MalaysianVaccinesandPharmaceuticalsSDNBHD,Malaysia.
IBDV877Vaccine.
(InfectiousBursalDiseaseVaccine).
1000dosesvial.
1000dosesx10vials.
De-controlled.
2.
-do-
MyVACK811Vaccine.
(NewCastleDiseaseVaccineB1Type,LaSotaStrain).
1000doses(500ml).
1000dosesx10vials.
-do-
3.
-do-
MyVAC102Vaccine.
(NewCastleDiseaseVaccineB1Type,LaSotaStrain).
1000dosesvial.
1000dosesx10vials.
-do-
iii).TheDrugRegistrationBoardconsideredandrejectthefollowingdrugsasperreasonsmentionedagainsteach:
-
S.#
NameofImporter/
Manufacturer.
NameofDrug(s)/
Composition.
Recommendationofthepanel.
1.
M/s.Pearl&PearlRawalpindi/
M/s.VINSBioproductslimitedIndia.
SnakeVenomAntiserumI..P.(Lyophilized)
Facilitywasclosedduetosomeup-gradationworksocompliancetocGMPcouldnotobserved.Re-inspectionsuggested.
2.
M/s.Hakimsons(Impex)(Private)Limited,Karachi/
M/s.GreenCrossCorporation,Korea.
VaricellaVaccine–GCCInjection.
Eachvial(0.7ml)contains:
-
Liveattenuatedvaricellavirus........NLT1,400PFU.
Theapplicationsforregistrationoftheapplicantfirm’smaybedisposedoffasrejectedastheyhavenotarrangedforinspectionoftheirprincipalfirmsasdirectedbyMinistryofhealth.
3.
M/s.GeneTechLaboratories,Karachi/
M/s.BeijingKawinBio-TechCo.Ltd.Beijing,China.
Kaferon3MIUInjection.
Eachvialcontains:
-
Interferonalpha2b(rhIFNb2-b)3MIU.
-do-
4.
-do-
Kaferon5MIUInjection.
Eachvialcontains:
-
Interferonalpha2b(rhIFNb2-b)5MIU.
-do-
5.
M/sHighnoonLaboratoriesLtd.Lahore/
M/sShanghaiSLLC-SMUBiotechCo,Ltd.Shanghai,China.
RecombinantStreptokinaseforInjection1.5MIU/Vial.
Eachvialcontains:
-
RecombinantStreptokinase
1,500,000IU.
-do-
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:
-
S.#
NameofImporter/
Manufacturer.
NameofDrug(s)/
Composition.
Demanded
Price&PackSize.
1.
M/s.CCLPharmaceuticals(Pvt)Ltd.,Lahore/
M/s.ServycalS.A.,Argentina.
Mebrexel80mgInjection.
Eachvialcontains:
-
AnhydrousDocetaxel80mg.
+
Eachvialofdiluentcontains:
-
Ethanol95%0,780ml.
Waterforinjection5,22ml.
Rs.30500.00/
Pervial.
2.
-do-
Mebrexel20mgInjection.
Eachvialcontains:
-
AnhydrousDocetaxel20mg.
+
Eachvialofdiluentcontains:
-
Ethanol95%..0,195ml.
Waterforinjection1,305ml.
Rs.9345.83/
Pervial.
3.
-do-
Oncoplatin50mgInjection.
Eachvialcontains:
-
Cisplatin…..50mg.
Rs.885.09/Pervial.
4.
-do-
Doxocin10mgInjection.
Eachvialcontains:
-
DoxoribicinHCl10mg.
Rs.699.37/Pervial.
5.
-do-
Doxocin50mgInjection.
Eachvialcontains:
-
DoxoribicinHCl50mg.
Rs.2170.10/
Pervial.
6.
-do-
Lymphoside100mgInjection.
Eachvialcontains:
-
Etoposide0.100gm.
Rs.794.25/Pervial.
7.
-do-
Cytotecan100mgInjection.
Each5mlvialcontains:
-
TryhydratedIrinotecanHCl100mg.
Rs.13348.80/
Pervial.
8.
-do-
Leucofolate50mgInjection.
Eachvialcontains:
-
CalcicLeucovorinequivalentto50mgbase
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