PRESENTATION 3: MALAYSIAN HALAL PHARMACEUTICAL … · 3 “Halal” is not just about food....
Transcript of PRESENTATION 3: MALAYSIAN HALAL PHARMACEUTICAL … · 3 “Halal” is not just about food....
PRESENTATION 3:MALAYSIAN HALAL PHARMACEUTICAL EXPERIENCE
PRESENTED BY: MR. LEONARD ARIFF ABDUL SHATAR GROUP MANAGING DIRECTOR DUOPHARMA BIOTECH BERHAD
1 APRIL 2019, MONDAY
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Introduction Duopharma Biotech
and Halal Malaysia
1 2 3 4 5
Halal value
proposition for
pharmaceutical
products
Moving ForwardStrengthening the
Halal Pharmaceutical
Value Chain
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“Halal” is not just about food.
“Halal” is applied as a standard.
“Halal Toyyiban” means more
than permissible for
consumption; the word ‘toyyiban’
enhances the features to
something good, pure and
wholesome, so it also means
good for the different segments
of the society and the
environment.
Livestock
Food & Beverages
Logistics
Food Services
Cosmetics & Personal Care
Pharmaceuticals
Medical Devices
Consumer Products
Halal Industry
Ref: “Informed choice in
medicine taking – Drugs
of porcine origin and
clinical alternatives”
published by National
Prescription Centre
United Kingdom (2002)
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Ref: The
Pharmaceutical Journal
(18 Apr 2018)
Informed choice in medicine taking
• 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 proposed
treatment.
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1) The role of pharma industry to research,
develop, produce, market and/or distribute
licensed medicines, including health/ dietary
supplements.
2) A pharma player is subjected to a variety of
strict regulations and law regarding the
patenting, testing and marketing of medicines.
3) The production and distribution of
pharmaceutical products demands a strictly
maintained and sterile working environment.
Innovators (Patented
products)
4) Classifications of pharmaceutical products:
Generics (Off-patent
products) -Prescriptions
Health and food supplements
Traditional Medicines
Consumer Healthcare
1. A growing population
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2017 – 1.8 Billion
Muslims
2060 – 3.0 Billion
Muslims ( 70%)
Ref:State of the Global Islamic Economy Report 2018/2019
2. Increase awareness among
consumers – Muslim and Non-
Muslim
• Halal as the alternative benchmark for
safety, hygiene and quality
assurance.
• Consumers are becoming more
discerning on what they consume –
cautious on what’s written on
product’s label.
Ref:State of the Global Islamic Economy Report 2018/2019
3. Increased spending on
pharmaceutical products by
Muslim consumers
70 72 75 7883
87
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
7
0
20
40
60
80
100
120
140
2017 2032
USD 87 Billion
USD 131 Billion
4. Increase in Halal pharmaceutical 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
Ref:State of the Global Islamic Economy Report
2018/2019
5. Increased investment and interest in the Halal
market by other countries
Among the companies certified Halal by JAKIM:
• DUOPHARMA BIOTECH (incl. DUOPHARMA
MANUFACTURING BANGI, DUOPHARMA MARKETING)
• IDAMAN PHARMA
• PHARMANIAGA
• ROYCE
• HOE PHARMA
• RECKITT BENCKISER
• KOTRA PHARMA
As of end Jan 2019, more than 4,000 pharma products have
been certified Halal under the Halal Malaysia Pharmaceutical
scheme.
Ref: www.halal.gov.my
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Duopharma Biotech Berhad(formerly known as CCM Duopharma Biotech Berhad)
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Providing smarter solutions for a healthier life
A leading Healthcare Group providing quality and innovative solutions
CCM Berhad
Duopharma Innovation Sdn. Bhd.
Duopharma (M) Sendirian Berhad
Duopharma Singapore Pte. Ltd.
100% 100% 100%
100%
100%
DB (Philippines),Inc
Duopharma Manufacturing (Bangi)
Sdn. Bhd.
100% 100%
Duopharma MarketingSdn. Bhd.
Duopharma HAPI
Sdn. Bhd.
Negeri Pharmacy Sdn. Bhd.
100%100%100%Duopharma
Manufacturing (Glenmarie) Sdn. Bhd.
100% 100%
Manufacturing
R&D
Sales & Marketing
Dormant
Depot
DuopharmaBiotech Berhad
Sentosa Pharmacy Sdn.Bhd.
Unique Pharmacy(Penang) Sdn. Bhd.
Unique Pharmacy (Ipoh)
Sdn. Bhd.
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Duopharma Biotech
is the No. 1 Pharma
company in
Malaysia
IQVIA REPORT OCTOBER 2018
42.64
29.12
18.6416.32
11.91 11.258.02 7.80 6.97 6.31
+9.5%
-2.1%
-14.1%
+1.5% +6.0%
+16.4%
+6.5%
-1.3%
+12.2%+8.8%
-20.0%
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Duopharma Biotech
is the fastest
growing Pharma
company in
Malaysia
IQVIA REPORT OCTOBER 2018
578
444 439
348 345 311308
242 237197
+12.4%+15.4%
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Duopharma Innovation Sdn Bhd
- R&D Facility
Established
Workforce
• 2008
• 48 people
Duopharma (M) Sdn Bhd (Klang)
Established
Workforce
Types of
Products
• 1979
• 491 people
• Oral solids dosages,
Haemodialysis & SVI Products,
LVI – Irrigation solution
products, dental cartridge and
sterile cephalosporin
Duopharma HAPI Sdn Bhd (Glenmarie)
- Oncology
Established • 2019
• [Operational in Q3]
Duopharma Manufacturing (Bangi)
Sdn Bhd
Established
Workforce
Types of
Products
• 1976
• 702 people (including
Duopharma Sales &
Marketing teams)
• Ethical and Consumer
Healthcare Products –
mainly in oral solid
dosages, soft gels, liquids
and cream forms
Facilities
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Duopharma Biotech’s core competencies in the pharmaceutical industry includes Manufacturing,
Research & Development and Commercialisation & Marketing of over 300 generic drugs:
Dermatological
General
Anti-infectives
Systemic
Genito-urinary
System & Sex
Hormones
Hospital
Solution
Musculo-
skeletal System
Sensory
OrgansRespiratory
SystemParasitology
Nervous
System
Systemic
Hormonal
Preparations
RenalCardiovascular
SystemDiabetes Oncology
Alimentary
Tract
& Metabolism
Blood &
Blood-forming
Organs
Duopharma Biotech is proud to be associated with key partners who support our commitment
in delivering the best quality of pharmaceutical products to Malaysia and the world:
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• Differentiating Factor
• Market opportunities
• Confidence for Muslim
consumers through Informed
Choice
• Duopharma Biotech’s Fardhu
Kifayah Commitment
• Production of “Safe”,
“Efficacy”, “High Quality”,
“Hygienic” and “Halal”
Products
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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
Consumer Healthcare 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
Malaysia Halal Council
1999 2000 2005 2008 2010 2012 2013 2014 2015 2016 2017 2019
Expecting
new Halal
standard on
Medical
Device
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Board of Directors
Halal Committee
Halal Strategy Committee Halal Monitoring Committee
Halal Site (Bangi) Halal Site (Klang) Halal Site (Glenmarie)
PROVIDING STEWARDSHIP TO
DUOPHARMA GROUP
COORDINATE AND REVIEW
IMPLEMENTATION AND INTEGRITY
OF HALAL SUPPLY CHAIN
STRATEGIC
COLLABORATION AND
PROJECTS, MARKET
ACCESS, BRANDING
DESIGN, DEVELOP, DOCUMENT, IMPLEMENT, RECORD AND MONITOR
CONFORMANCE
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(1)
Strengthen the core of organisational resources,
capabilities and supply chain
(2)
Leverage Halal status as competitive advantage in
expanding market segments
(3)
Reinforce external stakeholders awareness
activities through partnership proposals, events and trainings.
FOCUS AREAS
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Primary Assurance: Safety,
Efficacy and QualityAssurance of Shariah, Halal, Toyyib
and Hygiene
The Pharmaceutical Inspection Convention
and Pharmaceutical Inspection Co-operation
Scheme – international organisation
harmonise 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
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1 2
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Do not contain:
• Parts or products of animal that are non-halal
• Najs or Unclean substance
• Products contaminated or in direct contact with non-halal
materials
• Liquid discharged from humans and animals such as urine,
blood, vomit, placenta, etc.
• Khamar (fermented alcohol)
1. Materials 2. Process, Packaging and Distribution
• Pharmaceutical products certified halal cannot be
prepared, processed or manufactured using
equipment that has been contaminated with najs.
• Premises and facilities adhere to Shariah
guidelines.
• Products must not come into physical contact with
any non-halal products
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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
Who is it for?
What does it mean?
How do you define
the quality?
….the misconceptions
….Halal products are
only for Muslims
…Halal just means it
doesn’t contain pork
or alcohol
…Not as good as imported
brand or product
…FALSE!25
Halal products not only benefit Muslims but benefits EVERYONEBecause of the WHOLESOMENESS (“THOYYIBA”) :
✓ SAFE for consumption and use
✓ Assurance of product EFFICACY
✓ QUALITY standard of production & ingredients/materials
✓ HYGIENICALLY manufactured
SAFETY & QUALITY REQUIREMENTS
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New Proposal
Approval of New
Proposal
Technical Committee /
Working Group
Public Comment
Review Public
Comments
Final Draft for Acceptance
Approval as Malaysian Standard
Malaysian Standard Development Process
(Standard development process adapted from Department of Standards Malaysia - www.jsm.gov.my)
Participation by the relevant stakeholders*:
- Government (DVS, MinDef, MOH, JSM)
- Development Agency (HDC)
- Authorities (NPRA, JAKIM)
- Pharmaceutical Industry (Duopharma, Ain Medicare,
Pharmaniaga)
- Academic (IIUM, CUCMS, UKM, USM)
- NGO (MPS, PPIM, MOPI, PHAMA)
*Not limited
The Halal Pharmaceutical
Standard pragmatic for
industry to apply and to
achieve desired
objectives.
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Step1: Preparation of Special Clay Solution
‘SERTU CLAY’ STERILISE : To remove microbial contamination (e.g. via autoclave,
drying & radiation)
DILUTE: Sufficient to make a change to the
water appearance
Step 2: Cleansing Post-GMP
Cleaning
SPRAYING: For immobile heavy
machine with water sensitive
electronic components
WASHING: For machine with automatic washing
system (CIP).
RINSING: For utensils, small containers,
loose machine part and large equipment
without water sensitive parts
1. Sanitisation
2. Cleaning
Validation
3. Quality Control
Pre-GMP
Cleaning
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❑ 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 – A study by 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, JAKIM
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❑ Vendor Development Program
• An initiative in collaboration with Ministry of
Entrepreneur Development.
• Duopharma Biotech as Anchor Company to support
Government’s efforts to help develop successful
national entrepreneurs and businesses.
• Focused on strengthening Halal Pharmaceutical
Supply Chain.
• Ultimate outcome is to establish more champions.
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❑ Halal Pharmapreneur
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• An initiative in collaboration with Malaysia
Productivity Corporation (MPC), Center of
Entrepreneur Development and Research
(CEDAR) and Muslim Pharmacist Cooperatives 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 its third year and third batch of implementation
❑ Duopharma Biotech – 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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• 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 OPPORTUNITIES
HALAL PHARMACEUTICAL VALUE CHAIN
Managing
perception on
Halal
PharmaceuticalsDevelopment of alternatives
Integration with industry best
practice – GMP, GDP, GCP, GSP, etc.
Market Access –
Trend and
acceptance
Supply of critical raw
materials e.g. gelatine
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Pharmacopoeia for halal
starting materials
Market Access – Legislation in
importing countries
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
✓ Halal
Pharmacopoeia
✓ Applied R&D
✓ Address
Shariah issues
❑ Industry-Academia
R&D
❑ Industry-Shariah
Roundtable
❑ Industry enablers
❑ Vendor Development
Program
❑ Halal Knowledge and
Capacity Building Program
(for pharmacists,
entrepreneurs)
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Healthcare practitioners must equip with the knowledge to assist patients choose the right medicines.
Consumers / Patients are smarter and increasingly curious about their medicines (Thanks to Dr. Google!).
Ref 1: To guide health professionals who have to
treat patients with medicine containing ingredients
not permissible in Islam.
Ref 2: To provide explanation to health professionals
and to serve as a reference to Muslims on the
aspect of use of medicine according to Islam to
avoid doubts and confusion
Guidelines in administering medicines (Islamic Perspectives) developed by Ministry of Health, Malaysia
1 2
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Informed choice
Beyond GMP and Hygienic
Ethical and Authentic product
Extending the value “Halal” for pharmaceuticals:
❑ Halal is a standard that enhances the quality of pharmaceutical
products.
❑ Halal Pharmaceutical is a competitive advantage to the national and
global Halal Agenda.
❑ Collaborative effort is important in raising awareness towards wider
acceptance of Halal Pharmaceuticals.
❑ We have only just begun….
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Phone contact –
+603-8924 2188 ext. 2403
Suite 18.06, Level 18, Kenanga InternationalNo. 26, Jalan Sultan Ismail50250 Kuala LumpurWilayah Persekutuan, Malaysia