Wan Amir-Jeffery Wan Abdul Majid
Chief Operating Officer
Duopharma Biotech Berhad
2 March 2019
Addressing the Muslim Market Demand of Halal Pharmaceuticals
Key topics
Introduction Halal Malaysia
Industry and
Duopharma Biotech
Halal Milestones
1 2 3 4 5
Halal value
proposition for
pharmaceutical
products
Duopharma
Biotech Halal
Initiatives
Strengthening the
Halal Pharmaceutical
Value Chain
2
Introduction
• Differentiating Factor
• Market opportunities
• Confidence for Muslim
consumer through Informed
Choice.
• Duopharma Biotech’s Fardhu
Kifayah Commitment
• Production of “Safe”,
“Efficacy”, “High Quality”,
“Hygienic” and “Halal”
Products
3
Increased awareness on different communities requirements
Ref: Informed choice in
medicine taking – Drugs
of porcine origin and
clinical alternatives”
published by National
Prescription Centre
United Kingdom (2002)
State of Queensland
Health, Healthcare
providers’ handbook
on Muslim patients
Informed choice in medicine taking
• Medicines advise for patients observing a halal diet.
• Patients want and need to understand about the
origins of their proposed medication. It is part of
“Informed Consent” and a first step of showing
respect to their beliefs
• Patients should be encouraged to make informed
decisions regarding their treatment.
4
Halal Pharmaceuticals Industry – a sustainable growth
Factors supporting growth of Halal Pharmaceutical industry:
Ref:State of the Global Islamic Economy Report 2018/2019
2017USD 87 Billion
2032USD 131 Billion
1. Increased spending on
pharmaceutical products by Muslim
consumers 70 72 75 78
8387
0
10
20
30
40
50
60
70
80
90
100
2013/2014 2014/2015 2015/2016 2016/2017 2017/2018 2018/2019
State of the Global Islamic Economy Report (USD Bn)
Pharmaceuticals
Overall, State of the Global Islamic Economy Reports observed a steady
growth on Muslim spending on pharmaceutical products
5
Halal Pharmaceuticals Industry – a sustainable growth
Factors supporting growth of Halal Pharmaceutical industry:
Ref:State of the Global Islamic Economy Report 2018/2019
2. Increased in Halal pharma certified products
• Dong-A ST (South Korea) and Rooyan Darou (Iran) partnership
in biopharmaceuticals
• Ildong Pharmaceuticals (South Korea) product, Biovita was first
certified Halal by the Korea Muslim Federations
• MC Biotech (under Mitsubishi Corporation, Japan) announced
interest to be certified Halal for Brunei market
3. Increased investment and interest in the Halal
market by other countriesAmong companies certified Halal by JAKIM: DUOPHARMA
BIOTECH, UPHA PHARMACEUTICALS, IDAMAN PHARMA,
PHARMANIAGA, XEPA-SOUL PATT,ROYCE, HOE PHARMA,
RECKITT BENCKISER, SANOFI-AVENTIS, KOTRA PHARMA
As of end Jan 2019, more than 4,000 pharma products
certified Halal under the Halal Malaysia Pharmaceutical
scheme.
Ref: www.halal.gov.my
6
Halal Malaysia and Duopharma Biotech Halal Milestones
First pharmaceutical company to obtain the Malaysian HALAL
certification - health supplements under the brands CHAMPS,
Flavettes, Proviton and Naturalle –MS 1500
Obtained HALAL
certification from LPPOM MUI
Indonesia
First pharmaceutical company
to obtain the Malaysian HALAL
certification – MS 2424:2012 for
OTC productsFirst pharmaceutical company to
obtain the Malaysian HALAL
certification for Prescriptive
Medicines based on MS 2424:2012
Duopharma Biotech Halal Milestones
Halal Malaysia
MS 1500:2000
Halal Food MS 2424:2012
Halal PharmaceuticalHalal Industry Master
Plan 2008-2020
MS 2200:Part 2:2015
Islamic Consumer Goods
(Animal bone, skin and
hair)
MS 2400:2010
Halal Logistics
MS 2200: Part 1:2012
Islamic Consumer
Goods (Cosmetics and
Personal Care)
Halal Malaysia
Certification Procedure
Manual
Establishment of Majlis
Halal Malaysia
1999 2000 2005 2008 2010 2012 2013 2014 2015 2016 2017 2019
Expecting
new Halal
standard on
Medical
Device
7
Adherence to strict requirements
• Malaysia’s highly regulated industry - Strict Certification Process by 2 Government Bodies
Primary Assurance: Safety,
Efficacy and QualityAssurance of Shariah, Halal, Toyyib
(Hygiene)
The Pharmaceutical Inspection Convention
and Pharmaceutical Inspection Co-operation
Scheme – international organisation
harmonize inspection procedures through a
common GMP standards
Malaysia was the 1st OIC country and 2nd
ASEAN country admitted as PIC/S member in
2002
GOOD MANUFACTURING
PRACTICES FOR
PHARMACEUTICALS
MS 2424
Malaysian Standard on Halal
Pharmaceuticals developed
by Department of Standards,
Malaysia
8
Halal Built-in, Not Tested For
2
ManagementR&D
(incl.
sourcing)
Registration PurchasingPackaging
MaterialsPackaging Storage
Other
Materials
Ingredients
Sales &
Marketing
Finance
Legal
Human Resource
Internal Audit
Administration,
etc
PRE-PRODUCTION PRODUCTION POST-PRODUCTION
HALAL CONTROL
QUALITY CONTROL
SAFETY AND EFFICACY CONTROL
9
Halal products not only benefit Muslims but benefits EVERYONE
✓ SAFE for consumption and use
✓ Assurance of product EFFICACY
✓ QUALITY standard of production & ingredients/materials
✓ HYGIENICALLY manufactured
Because of the WHOLESOMENESS (“THOYYIBA”) :
SAFETY & QUALITY REQUIREMENTS
Halal value proposition for pharmaceutical products
10
• Biological Target Identification
• Screening• Optimization• Patent Application
Storage & Distribution
• Product Storage• Product
Distribution
Sales & Marketing
• Sales to Consumers• Customer Support• Regulatory Support
• Formulation Development
• Dosage Form Manufacturing
• Packaging
• Formulation Development• Pre-clinical and Clinical Trials
(Phases I, II & III)• Submission for Approval• Phase IV
ManufacturingClinical & Product
DevelopmentDrug Discovery
HALAL ISSUES AND CHALLENGES
HALAL PHARMACEUTICAL VALUE CHAIN
Managing
perception on
Halal
PharmaceuticalsDevelopment of alternatives
Restriction on use of Halal Logo -
as to date, halal logo is allowed
for Food Supplements, and OTC
as indicator for products that is
halal compliant
Market Access – Halal legislation
in importing countries
Market Access –
Trend and
acceptance
Technology developments
Availability of raw materials
e.g. gelatine
Strengthening the Halal Pharmaceutical Value Chain
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Proposed initiatives to be strengthened
INITIATIVES
FOCUSSED ON HALAL
PHARMACEUTICALS
OBJECTIVES
❑ Awareness /
knowledge sharing
platforms
❑ Communication
campaign
DESIRED OUTCOME(1) Wider acceptance of Halal pharmaceuticals
(2) Strengthening the Halal supply chain
✓ Increase awareness
✓ Development of
KOLs
✓ Develop capable vendors
and suppliers
✓ Develop halal centric
community pharmacy
✓ Applied R&D
✓ Address
Shariah issues
✓ Halal
Pharmacopoeia
❑ Industry-Academia
R&D
❑ Industry-Shariah
Roundtable
❑ Industry enablers
❑ Vendor Development
Program
❑ Halal Knowledge and
Capacity Building Program
(for pharmacists,
entrepreneurs)12
Duopharma Biotech Halal Initiatives
❑ Halal Pharmaceutical Symposium & Forum
Some of key takeaways from the Halal Pharmaceutical
Symposium held in 2016 and 2018:
• Muslim patient rights and informed choice – Tuan Haji Amrahi
Buang, President Malaysia Pharmaceutical Society
• Consumers are getting more aware and paying more attention
to the ingredients of their medicine – Brigadier General Dato’
Dr A Halim Hj Basari, Health Services Division, Malaysian
Armed Forces
• Halal Pharmaceuticals is the new frontier for Malaysia’s global
halal hub – Halal Industry Development Corporation
• Halal logo as a “marketing tool”, “market value”, “trade” for
industries and “informed choice” for consumers – Hub Halal
Division, JAKIM13
Duopharma Biotech Halal Initiatives
❑ Bumiputera Vendor Development Program ❑ Halal Pharmapreneur
• Collaboration with M’sian Productivity Corp, CEDAR
and Koperasi Farmasi Muslim in 2017
• Introduced in 2017 to equip community pharmacists
with better financial, human resources, marketing and
other soft skills in order to improve their business
performance
• In third year and third batch of implementation
• Duopharma Biotech as Anchor Company to support
Government’s efforts to help develop successful Bumiputera
entrepreneurs and businesses
• Focused on strengthening Halal Pharmaceutical Supply
Chain.
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Duopharma Biotech Halal Initiatives (3)
❑ Duopharma – Academia Collaboration
Activities:
▪ GSB-UKM Halal Pharmaceutical Business Initiatives – Applied
research on Halal Pharmaceuticals.
▪ Jalinan Antara Universiti Dan Industri (“JATI”) – To train and groom
pharmacy undergraduates on entrepreneurship in community retail
pharmacies
▪ CEO@Faculty –to intensify industrial sector participation in the
system of higher education by sharing the experiences and expertise
of industry leaders.
▪ UMP – Study on Improving the Integrity of Halal Supply Chain
Management Through Blockchain Technology
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Conclusion
❑ Halal is a standard that enhances the quality of pharmaceutical
products.
❑ Halal Pharmaceutical is a competitive advantage to the national Halal
Agenda.
❑ Collaborative effort is important in raising awareness towards wider
acceptance of Halal Pharmaceuticals.
❑ We have only just begun….
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