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Halal Pharmaceuticals: A Way Forward

Amrahi bin Buang Chief Pharmacist, Pharmacy Department, University Malaya Medical Centre

FAPA 2014 - Kota Kinabalu - Amrahi

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Patient: Is my medicine halal? Pharmacist, Doctor, Nurse: Yes???.... No???

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INFORMED CHOICE IN MEDICINE TAKING The Medicines Partnership Programme was established by the Department of Health, United Kingdom in 2002 and has promoted the concept of concordance – or shared decision-making - as an approach to help patients to get the most from their medicines.

Content:

http://www.npc.co.uk/med_partnership/resource/our-publications/drugs-ofporcine-origin.html FAPA 2014 - Kota Kinabalu - Amrahi

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HALAL PHARMACEUTICALS

Muslim Patient’s Rights FAPA 2014 - Kota Kinabalu - Amrahi

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Muslim patients’ rights  Right to have halal medication  Right to have non-najs medication  Right to be informed of medication  Right to choose medication  Right to give consent for usage of non-halal medication

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HALAL PHARMACEUTICALS

Shariah Compliance: Halalan Toyyiban FAPA 2014 - Kota Kinabalu - Amrahi

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MS 2424:2012

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MS 2424:2012 Halal Pharmaceuticals General Guidelines 1.0 Scope 2.0 Normative references 3.0 Terms & definitions

4.0 Requirements 5.0 Compliance 6.0 Halal certificates

7.0 Halal certification mark FAPA 2014 - Kota Kinabalu - Amrahi

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Main Features  Quality management  Management responsibity  Halal Assurance System  Fundamentals for halal pharmaceuticals in GMP  Halal Quality Control  Personnel and responsibility  Training  Personal hygiene FAPA 2014 - Kota Kinabalu - Amrahi

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Main Features  Premise and equipment  Production and control areas  Ancillary areas  Documentation  Production  Materials  Packaging materials  Contract manufacture and analysis FAPA 2014 - Kota Kinabalu - Amrahi

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Main Features  Self inspection  Legal requirements  Compliance  Halal certificates  Halal certification mark

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Common Non-Halal Substances 1. Gelatin

5. Enzyme

Common Non-Halal Excipients

4. Alcohol FAPA 2014 - Kota Kinabalu - Amrahi

2. Stearic Acid

3. Glycerol 14


Tertiary References

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Proviton Multivitamin Cap (CCM) AQ - Aquatic Animal; LA (state) - Land Animal eg. LA (Bovine); P - Plant; S Synthetic; SM - Semi-synthetic; M Mineral; MO - Microorganism; NC Natural Chemical; GMO - Genetically Modified Organism; O - Others (Pse state)

FAPA 2014 - Kota Kinabalu - Amrahi

API/Excipients***

Source

Active Pharmaceutical Ingredient Thiamine Mononitrate

S

Riboflavin

S

Nicotinamide

S

Pyridoxine Hydrochloride

S

Cyanocobalamin 0.1

S

Folic Acid

S

Coenzyme Q10 (Ubidecarenone)

S

Biotin Inositol Lysine Hcl

S S P

Tribasic Calcium Phosphate

S

Copper Sulfate Magnesium Sulphate Potassium Sulphate Ferrous Fumarate Zinc Sulfate Monohydrate Manganese Sulphate Monohydrate

S

Potassium Iodide

S

Ginseng Dry Extract

P

Vitamin A Palmitate

S

Cholecalciferol (Vitamin D3)

S

DL-A- Tocopheryl Acetate (Vitamin E)

S

Lecithin Excipients Hydrogenated Coconut Oil Beeswax Yellow Palm Oil Soya Bean Oil Gelatin Base (Shell) Gelatin Powder 150 Bloom Glycerin 16 Ariavit Brown HT Ethyl Vanillin Flavour

S

S S S S S

P O P P LA P S S

Halal Status** of API/Excipient (Yes/No) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (China - China Islamic Association) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Germany - Halal Control E.K. (EU) Yes (Germany - Halal Control E.K. (EU)

Yes (Germany - Halal Control E.K. (EU)) Yes (Germany - Halal Control E.K. (EU)) Yes (Germany - Halal Control E.K. (EU)) Yes (Italy - Halal International Authority (HIA)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Belgium - Halal Food Council Of Europe (HFCE)) Yes (Netherlands/ Holland Control Office Of Halal Slaughtering B.V. & Halal Quality Control) Yes (China - China Islamic Association)

Wax From Bees Honeycom

Yes (JAKIM) Yes (JAKIM)

Yes (Belgium - Halal Food Council Of Europe (HFCE))


The official Halal Logo of Malaysia

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Current DCA’s Policy on HALAL Allows HALAL labels on:  Cosmetics  Traditional Medicines  Health Supplement  OTC Why?  There is a choice Must label if it is from animal source either bovine or porcine FAPA 2014 - Kota Kinabalu - Amrahi

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Halal Certificate - Malaysia

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CCM & MS2424: 2012

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Gelatin source is certified Halal by JAKIM

Gelatin for capsule : Halal certified Bovine source

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First paracetamol to have Halal Logo

New Halal Logo - MS2424 : 2012

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Halal Logo for OTC products

New Halal Logo - MS2424 : 2012

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HALAL PHARMACEUTICALS

A Way Forward FAPA 2014 - Kota Kinabalu - Amrahi

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Halal Products Halal certified products not only benefit Muslims but

EVERYONE because of the WHOLESOMENESS (“THOYYIBAN”) aspects:

•SAFE for consumption and use •HYGIENICALLY processed •QUALITY standard of production & ingredients/ materials •Assurance of product EFFICACY FAPA 2014 - Kota Kinabalu - Amrahi

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Pharmaceutical Industry MEDICINES

HEALTH/DIETARY SUPPLEMENTS

They are constantly in demand…… …regardless of economic conditions

• For wellness, immunity and energy • A preventive healthcare option

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Halal Pharmaceuticals

source:

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Medicines (Innovators,Generics, Biosimilars): 1 Trillion USD

Halal Pharmaceuticals are here

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PLENARY SESSION: VACCINES – FUTURE OUTLOOK FOR THE MUSLIM MARKET

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Malaysian Perspective • There is a greater emphasis on Halal pharmaceutical as the Muslim market grows more affluent and demand rises – replacing animal-based ingredients such as gelatin, enzymes and emulsifiers with plant-based ingredients • Malaysia is the ONLY country with standard Halal Pharma guidelines • Halal Pharma complied with MOH Guidelines, GMP and PICS. • Global Halal supply is meeting only 3% of the global Halal demand worth about USD82 billion • Supporting ETP NKEA, National Medicines Policy; Reference to Halal Pharmacopoeia & Alternative listing FAPA 2014 - Kota Kinabalu - Amrahi

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3.2.1. Availability of Medicines - The availability of medicines shall be achieved through the appropriate selection of medicines, improvement in the management of medicines procurement and the supply chain network, and through optimal utilization of available financial resources to ensure sustainability.

3.2.1.1.6 Halal Medicines - There shall be strategic partnerships with the relevant authorities to make certified halal medicines available in Malaysia. FAPA 2014 - Kota Kinabalu - Amrahi

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National Medicines Policy (DUNas)


Current Status  CCM Pharmaceuticals : 97 products  Upha : 120 products  Duopharma: 19 products  Ain Medicare : 30 products  Xorix: 10 products  More….more on the pipeline FAPA 2014 - Kota Kinabalu - Amrahi

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To ALL members of Technical Committee of Halal Pharmaceuticals

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Profile for Kamarul Aznam

Halal Pharmaceuticals: A Way Forward  

The Islamic achievements in medieval medicine were groundbreaking. Muslim scholars spearheaded the impressive growth and discoveries in many...

Halal Pharmaceuticals: A Way Forward  

The Islamic achievements in medieval medicine were groundbreaking. Muslim scholars spearheaded the impressive growth and discoveries in many...

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