Halal Pharmaceuticals: A Way Forward
Transcript of Halal Pharmaceuticals: A Way Forward
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FAPA 2014 - Kota Kinabalu - Amrahi 1
Amrahi bin Buang Chief Pharmacist,
Pharmacy Department, University Malaya Medical Centre
Halal Pharmaceuticals: A Way Forward
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Patient: Is my medicine halal? Pharmacist, Doctor, Nurse: Yes???.... No???
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http://www.npc.co.uk/med_partnership/resource/our-publications/drugs-of-porcine-origin.html
Content:
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.
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Muslim Patient’s Rights
HALAL PHARMACEUTICALS
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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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Muslim patients’ rights
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Shariah Compliance:
Halalan Toyyiban
HALAL PHARMACEUTICALS
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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
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Quality management
Management responsibity
Halal Assurance System
Fundamentals for halal pharmaceuticals in GMP
Halal Quality Control
Personnel and responsibility
Training
Personal hygiene
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Main Features
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Premise and equipment
Production and control areas
Ancillary areas
Documentation
Production
Materials
Packaging materials
Contract manufacture and analysis
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Main Features
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Self inspection
Legal requirements
Compliance
Halal certificates
Halal certification mark
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Main Features
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Common Non-Halal Substances
Common Non-Halal Excipients
1. Gelatin
2. Stearic
Acid
3. Glycerol
4. Alcohol
5. Enzyme
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Tertiary References
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Proviton Multi-
vitamin Cap (CCM)
API/Excipients*** SourceHalal Status** of
API/Excipient (Yes/No)
Active Pharmaceutical Ingredient
Thiamine Mononitrate SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Riboflavin SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Nicotinamide SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Pyridoxine Hydrochloride SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Cyanocobalamin 0.1 SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Folic Acid SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Coenzyme Q10 (Ubidecarenone) SYes (China - China Islamic
Association)
Biotin SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Inositol S
Lysine Hcl PYes (Belgium - Halal Food
Council Of Europe (HFCE))
Tribasic Calcium Phosphate SYes (Germany - Halal Control
E.K. (EU)
Copper Sulfate SYes (Germany - Halal Control
E.K. (EU)
Magnesium Sulphate S
Potassium Sulphate S
Ferrous Fumarate SYes (Germany - Halal Control
E.K. (EU))
Zinc Sulfate Monohydrate S
Manganese Sulphate Monohydrate SYes (Germany - Halal Control
E.K. (EU))
Potassium Iodide SYes (Germany - Halal Control
E.K. (EU))
Ginseng Dry Extract PYes (Italy - Halal International
Authority (HIA))
Vitamin A Palmitate SYes (Belgium - Halal Food
Council Of Europe (HFCE))
Cholecalciferol (Vitamin D3) SYes (Belgium - Halal Food
Council Of Europe (HFCE))
DL-A- Tocopheryl Acetate (Vitamin
E)
SYes (Netherlands/ Holland -
Control Office Of Halal
Slaughtering B.V. & Halal Quality
Control)
Lecithin SYes (China - China Islamic
Association)
Excipients
Hydrogenated Coconut Oil P
Beeswax Yellow O Wax From Bees Honeycom
Palm Oil P
Soya Bean Oil P
Gelatin Base (Shell)
Gelatin Powder 150 Bloom LA Yes (JAKIM)
Glycerin P Yes (JAKIM)
Ariavit Brown HT S
Ethyl Vanillin Flavour SYes (Belgium - Halal Food
Council Of Europe (HFCE))
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)
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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
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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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A Way Forward
HALAL PHARMACEUTICALS
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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
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Pharmaceutical Industry MEDICINES
HEALTH/DIETARY SUPPLEMENTS • For wellness, immunity and energy
• A preventive healthcare option
They are constantly in demand…… …regardless of economic conditions
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Halal Pharmaceuticals
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Halal Pharmaceuticals
are here
Medicines (Innovators,Generics,
Biosimilars): 1 Trillion USD
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PLENARY SESSION: VACCINES –
FUTURE OUTLOOK FOR THE MUSLIM
MARKET
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• 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
Malaysian Perspective
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FAPA 2014 - Kota Kinabalu - Amrahi
3.2.1.1.6 Halal Medicines
- There shall be strategic partnerships
with the relevant authorities to make
certified halal medicines available in
Malaysia.
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.
National
Medicines
Policy
(DUNas)
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CCM Pharmaceuticals : 97 products
Upha : 120 products
Duopharma: 19 products
Ain Medicare : 30 products
Xorix: 10 products
More….more on the pipeline
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Current Status
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To ALL members of Technical Committee of Halal Pharmaceuticals