InIslam,theHolyQuranprovidesrulesandregulations to guide its followers. A verse fromtheQuran states: “Let the human reflect on the food he eats (80:24).”ThismeansthataMuslimwho adheres to the Islamic religion is watchfuland restrained in his behavior. Every Muslimshould be carefulwith all of his/her actions, nomatterhowtrivial.AMuslimmustknowwhatispermittedandwhatisnot.InIslam,prohibitionsarespecifiedeitherbyaverseoftheQuranoranauthentic and explicit Sunnah of Muhammad,peacebeuponhim(PBUH).TheserulesofShariah(i.e.,Islamiclaw)giveMuslimsthefreedomtoeatanddrinkanything they like as longas it isnotHaram(prohibited). Alcohol, for instance, can lead toaddiction,misbehavior, and negative impacts on health;thus, it is judged Haram for the Muslim. Pigsor any animals thatwere not slaughtered basedon Islamic rules, as well as anything unhealthyor which could cause disease or death, are alsoconsidered Haram. On the other hand, anysubstances including foodstuffs and medicinesthat are permissible and lawful to be consumedareclassifiedasHalal.Thisalsoappliestootherproducts including pharmaceuticals, cosmetics,
SpecialCommunication
Submitted: 2Jul2012Accepted: 14Jun2012
and personal care products. The term likewise,appliestopersonalbehaviorandinteractionwiththe community.Other substanceswhose originsarequestionableordoubtful,andthatfallbetweenthe two extremes, are classified as Mushbooh(1–4). The term applies to situations whereinscholars’opinionsdifferonwhetheraproductisHalalorHaram,orwhenthereareundeterminedingredientsinaparticularproduct.
Halal Pharmaceuticals The aspects ofHalal andHaram should bea determining factor in every Muslim’s actionsand decisions to consume products, includingmedicines. The term ‘Halal pharmaceutical’includes pharmaceutical products which maycontain more than one active ingredient andvarioustypesofexcipients.Halalpharmaceuticalproducts should not only be free from Haramconstituents, but they should also be Tayyib,a termgiven togoodsandproductswhichmeetquality standards. The term Tayyib refers to aparticular good or product that is clean, pureand produced based on standard processes andprocedures. Thus, a pharmaceutical productshouldnotonlybeHalalbutshouldalsobejudged
Exploring the Halal Status of Cardiovascular, Endocrine, and Respiratory Group of MedicationsAzmi Sarriff, Hadeer Akram abdul razzaq
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, 11800 Universiti Sains Malaysia, Pulau Pinang, Malaysia
Abstract Muslimconsumershavespecialneeds inmedical treatment thatdiffer fromnon-Muslimconsumers. In particular, there is a growing demand among Muslim consumers for Halalmedications. This descriptive exploratory study aims to determine the Halal status of selectedcardiovascular, endocrine, and respiratory medications stored in an out-patient pharmacy in aMalaysiangovernmentalhospital.SourcesofactiveingredientsandexcipientsforeachproductwereassessedforHalalstatusbasedonavailableinformationobtainedfromproductleaflets,theMedicalInformationManagement System (MIMS)website, ormanufacturers.Halal statuswas based ontheproducts’sourcesandcategorizedintoHalal,Mushbooh,orHaram.TheproportionsofHalal,Mushbooh,andHaramproductswereat19.1%,57.1%,and23.8%,respectively.Thepercentageofactive ingredientsforcardiovascular/endocrineproductsthatwereassessedasHaramwas5.3%;forrespiratorymedications,itwasonly1.1%.Forexcipients,1.7%and4.8%fallunderthecategoryofHaram for cardiovascular/endocrineproductsand respiratoryproducts, respectively.EthanolandmagnesiumstearatewerefoundtobethecommonsubstancesthatwerecategorizedasHaramandMushbooh.
cleanaccordingtoShariahlaw. Muslims who are directly engaged inmanufacturing, distributing, dispensing, andprescribing medications are responsible forensuringthatpharmaceuticalproductsareHalalandTayyib(5).This isanextremelychallengingtask in foodproduction. It ispossible thatsomepeople believe that medicines are vital andthat Haram substances may be used in certaincircumstances as they were permitted andtolerated in Islam. The lack of awareness andknowledgeofHalalstatusofmedicationsamongMuslim consumers and patients could be therootof thiscomplex issuerelatedtotheconceptof Halal-Tayyib pharmaceuticals. Therefore,in-depth study and search forHalal and Tayyibpharmaceuticalsisnotonlytheresponsiblityofanindividual(fardhu ain)butalsotheresponsibilityof the experts and the community (fardhu kifayah). Thesedays,increasedattentionisgiventotheHalal status of the food thatMuslims consume.ThisisanimportantpartofIslamicpracticesandfaith.Similarly,Muslimconsumersandpatientsare showing a growing interest in referencesconcerning the Halal status of pharmaceuticals(6). Therefore, this study was undertaken inorder to explore the Halal status of commonlyused cardiovascular, respiratory, and endocrinecategories of medications. The Halal statuswas determined for both the active ingredientsand excipients contained in the dosage form ofproductsthatwereassessed.
Materials and Methods
A descriptive and exploratory study wasconductedfromSeptember2009toMarch2010atagovernmenthospitalintheNorthernpartoftheMalaysianPeninsula.Pharmaceuticalproductsin the categories of cardiovascular, respiratory,and endocrine medications that were availableat the out-patient pharmacy at the time of thisstudy were selected. Patients were not involvedin the study as all datawere collected from theevaluationsofpharmaceuticaldosageforms.Theavailable product leaflets were sorted to list alltheactiveingredientsandexcipients.Theofficialwebsite of Medication Index for Malaysia andSingapore(MIMS)wasreferredtoforadditionalinformation. The product’s manufacturer wascontacted if the necessary information was notfoundintheproduct’spackageinsertandwasnotstatedinMIMS. The Halal status was categorized as Halal,MushboohorHaram.Thiswasprimarilybasedon
informationregardingthesourcesoftheproduct’sactiveingredientsandexcipients.Similartofoodproducts,thesourcesofalltheingredients—bothactive ingredients and excipients—used in theformulationofaparticulardosageformmustbeaHalal substance. The Halal status of all theingredientsusedintheformulationofaparticulardosage form was based on whether it is fromanimal source or whether it contains alcohol.Otheraspectssuchaspotentialharmfulnessandhygiene of the preparation processes were nottakenintoconsideration. Ethical approval was not required butpermissionwasgrantedbythehospitalauthorityfor data collection from the product packageinserts. The data were computed and analysedusing Statistical Package for the Social Sciences(SPSS) version 18 and descriptive analysis wasconducted.
Results
Out of 221 pharmaceutical products in thecategories of cardiovascular, respiratory andendocrinemedications,only63weresuitableforassessment of the Halal status. These productscontained a total of 240 active ingredients and570 excipients. Lack of information about theproduct’s constituents was the main factorhindering the identification of the Halal status.Furthermore,majorityofthemanufacturerswerenotcooperativeinprovidingdetailedinformationabouttheirproducts. Injectionsandtabletscomprised49.2%and28.6%, respectively, of the dosage forms. Theassessment of the Halal status for the varioustypes of dosage forms is shown in Table 1. Thedistribution of products categorized as Halal,MushboohandHaramisdepictedinFigure1.Thedistribution of Halal status for cardiovascular,endocrine and respiratory medications ispresentedinFigure2. The Halal status could not be assessed for73outof240activeingredients.Thiswasduetothe difficulty in obtaining accurate informationrelated to theirorigins.ThepercentageofactiveingredientscategorizedasHalal,MushboohandHaramwas83.8%(140),13.2%(22),and3%(5),respectively.ThedistributionofHalal status forthecombinationofcardiovascularandendocrinemedicationsaswellasforrespiratorymedicationsispresentedinFigure3. Out of 570 excipients, 54 could not beevaluated due to lack of information. Thedistribution of Halal, Mushbooh and Haramwas at 70% (361), 27.3% (141), and 2.7% (14),
respectively.ThedistributionofHalal status forexcipientscontainedincardiovascular,endocrineand respiratory medications is presented inFigure4. Themostcommontypesof ingredientsthatwere categorized as Haram and Mushbooh arelisted inTable2.Mostof theHaramsubstanceshad ethanol,whichwas used particularly in theformulationofrespiratorymedications.Themost
common substance categorized as Mushboohwasmagnesiumstearate,followedbygelatinandglycerol.
Discussion
Until recently, there were no specificguidelinesavailableinthelocalcontextforpatientsand healthcare providers in understanding
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Halal medications. There are numbers ofwebsites, documents and guidebooks dedicatedfor consumers to describe and explains issuesrelatedtoHalalfoods(7,8).Thisstudy,aimedtofill thegapinliteratureonHalalmedicationsbyhighlightingtheHalalstatusofmedicationsusedfor the treatment of cardiovascular, respiratory,andendocrineproblems. ItisimportanttonotethattheHalalstatusoftheactiveingredientsandexcipientsofaparticulardosage form was based on animal or alcoholsource.Halalstatusisdependentonthenatureoftheproductandhowitwasmade,amongothers.Other aspects such as potential harmfulnessand the hygiene of preparation processes werenot taken into consideration. These aspects arenormally addressed by competent authoritiessuch as the Halal certification body and StateIslamic Religious Department or Council.Competent certifying authorities examine allmaterials and processes used in the productionof the pharmaceuticals. The safety and hygieneaspectsofthemanufacturingprocessneedseriousconsideration as there are reports related toethical issues pertaining to the use of deadmaterials (slaughtering and using of animalsnotbasedonShariahlaw)inproducts(9).SomeIslamic governments have even started askingpharmaceuticalcompaniesaboutthelabellingoftheirproductsandthesourcesoftheiringredients.TheCompetitionCommissionofPakistan(CCP)hasmandatedthatallpharmaceuticalcompaniesthatsupplythemeningitisvaccineuseonlyHalalmaterials(10). In the last decade, awareness of Muslimson the use of Halal medications has improved(11–19). Several local studies on this issue havebeen published (20,21). Most recently,the Department of Standards Malaysia, incollaboration with religious authorities anduniversity researchers, produced a final draftof the Malaysian Standard related to HalalPharmaceuticals, known as MS 2424. ThisMalaysian Standard describes the generalguidelines in the manufacturing and handlingof Halal pharmaceuticals. It serves as a basicrequirement for Halal pharmaceuticals inMalaysia (22). TheMS 2424 can be consideredasastartingpointforthecertificationprocessofpharmaceuticalproducts.However,thestandarddoesnotnecessarilycontainalltherequirementsfor certification. Halal certification may besought by fulfilling the requirements set by thecompetent Islamic authorities in Malaysia. Themanufacturershavetofurnishtheauthoritywith
complete information on their products neededforHalalcertification.Similarly,intheUKandintheUS,pharmaceuticalcompaniesaremandatedbytheirgovernmentstoprovidefullinformationabouttheirproducts(23). When it comes to religiousmatters relatedtomedicines, especiallyHalal-Haram, there is awidedivergenceofopinionwhichcouldbearecipefor controversy.Thus, some truths on theHalalstatusofpharmaceuticalsneedtobehighlighted.Forinstance,majorityofpharmaceuticalproductscontainsomeconstituentsofethanolandanimalderivatives, which cannot be considered Halal.Although products can contain ingredientsderivedfromanimals(exceptnon-halalanimals),these have to be prepared according to ShariahLaw which dictates procedures for slaughteringandpreparinganimals. An example of an ingredient which isnot Halal is dibasic sodium phosphate, whichoriginates from several sources includinganimal bones or bone ash. Likewise, aprotininis obtained frombovine lung, and the animal ismost likelynot slaughteredaccording to Islamicinstructions. Similarly, other compounds suchas beractant, sodium biphospahte and sodiumphosphatedehydrate areof bovineorigin and itis unsure whether the manufacturer complieswithShariahLawduringtheprocessingofthesesubstances.Sincethereisnodefiniteinformationand consensus on thismatter, these substancesarecategorizedasMushbooh. It was a challenge to convince themanufacturers to furnish detailed informationregarding the sources of substances used in theformulation of pharmaceutical products. Asshown in Table 1, some formulations in tabletformwerecategorizedasHaramforthisreason.
Conclusion
This exploratory study provides insightinto the issue of Halal status of cardiovascular,respiratory, and endocrine medications. Ashighlighted earlier, 23.8% of products surveyedwere categorized as Haram, while more thanhalf (57.1%) were evaluated as Musbhooh. ItaddstotheexistingresearchneededtomeettheHalal requirements of the Muslim communityin consuming Halal pharmaceutical productscontainingchemicalsubstances.Astherearefewreferencesonthetopic,thereisaneedforfurtherinvestigation and exploration for alternativeproducts.
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Acknowledgement
We are grateful to the Universiti SainsMalaysia (USM) for providing the ResearchUniversity(RU)granttofundthisstudy.
1. Consumers association of Penang. Halal andHaram Food Product [Internet] Penang (Malaysia):Consumer Association of Penang; 2006 [cited 2011Sep30]Availablefrom:http://www.thereligionislam.com/islamicreformism/halalandharamfoodproducts.htm.
2. Halal Faundation. A guide to Halal food selection[Internet].America(US):IslamicFoodandNutritionCouncil of America; 2009. [cited 2009 July 30]Available from: http://www.cookeryonline.com/Vegetarian/halal.html.
3. Guerrero-Legarreta I, Alarcón-Rojo AD, AlvaradoC. Handbook of Poultry Science and Technology,PrimaryProcessing.1sted.UnitedStates(US):JohnWiley&Sons;2010.p.183.
4. MohamedRahman.IntroductiontoHalal[Internet];2009. [cited 2009 July 30]. Available from: http://deqku.multiply.com/journal/item/12/what_in_your_food? &show_interstitial=1&u=%2Fjournal%2Fitem.
5. YunusAM,WanChikWMY,MohamadM.Theconceptof halalan tayyiba and its application in productsmarketing: A case study at Sabasun HyperRuncitKuala Terengganu, Malaysia. IJBSS. 2010;1(3):239–248.
6. Hashim DM. Chemical Status: PharmaceuticalIngredients. The First Gulf Conference on HalalIndustryanditsServices.Kuwait;2011.p.11.
8. Riaz MN, Chaudry MM. Halal Food Production. 1sted.UnitedStates(US):CRCPress;2004.
9. Subramanian N. For safe ayurvedic drugs, lawsneed to be strengthened [Internet]. India (IN):Business Line; 2006 [cited 2010 Oct 10]. Availablefrom: http://www.thehindubusinessline.com/2006/01/06/stories/2006010600830800.htm.
11. NorakashaR,HashimDM, CheMan YB, ShuhaimiM. Potential Use of Amino Acids Analysis forDistinguishing Bovine and Porcine Gelatins.Proceedings of the 3rd IMTGT InternationalSymposium on Halal Science and Management;2009.A06.
12. Abdul Rohman, Che Man YB, Ismail A, Puziah H.Monitoring the Presence of Lard in Virgin CoconutOil (VCO)usingFourierTransform Infrared (FTIR)Spectroscopy for Halal Authentication Study.Proceedings of the 3rd IMT-GT InternationalSymposium on Halal Science and Management;2009.A22.
13. Indrasti D, Chin ST, Che ManYB, Shuhaimi M.,Dzulkifly MH. Profiling of Mono-and Diglyceridefrom Edible Fats by GCxGC-TOF-MS for Halalauthentication. Proceedings of the 3rd IMT-GTInternational Symposium on Halal Science andManagement;2009.A14.
14. ErwantoY.,AbidinMZ,RohmanA,Sismindari.PigSpeciesIdentificationinMeatballsUsingPolymeraseChain Reaction Restriction Fragment LengthPolymorphismforHalalAuthentication.Proceedingsofthe3rdIMT-GTInternationalSymposiumonHalalScienceandManagement;2009.A29.
15. HafidzRNRM,CheManYB,AnuarN.ComparisonofBovineandPorcineSkinGelatinbasedonAminoAcidComposition,PolypeptidePatternandGelStrength.Proceedings of the 3rd IMT-GT InternationalSymposium on Halal Science and Management;2009.A33.
16. SitiAisyahMB,MatHashimD,ShuhaimiM.SolGelTransition of Konjac Glucomannan. Proceedings ofthe 3rd IMT-GT International SymposiumonHalalScienceandManagement;2009.A37.
17. Shafie SB, Othman MB. The Halal Certification onPharmaceuticals: a Policy Issue. Proceedings of the3rd IMT-GT International Symposium on HalalScienceandManagement;2009.A03.
18. Aliman NK, Othman MN. Purchasing Local andForeign Brands: What Product Attributes Metter?.Proceedings of the 13th Asia Pacific ManagementConference.Melbourne,Australia;2007.p.400–411.
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www.mjms.usm.my 75
19. Hussain-Gambles M. Chemical Status: CosmeticIngredientsandProductionRequirements.TheFirstGulfConference onHalal Industry and its Services;2011Jan24-26.Kuwait;2011.p.8.
20. Noorizan Abd Aziz, Yahaya Hassan, Hadeer AkramAbdulAlRazzaq.AssessmentofNonHalalSubstancesinMedications.Malaysian J Pharm.2009;1(7):S110.
21. Noorizan Abd. Aziz, Yahaya Hassan, HadeerAkram Abdul AlRazzaq. Halal Medication Issues:Status and Challenges. The 8th Saudi InternationalPharmaceutical Conference and Exhibition; 2009;PO-CP-19:143.
