PRESENTATION 3:MALAYSIAN HALAL PHARMACEUTICAL EXPERIENCE

PRESENTED BY: MR. LEONARD ARIFF ABDUL SHATAR GROUP MANAGING DIRECTOR DUOPHARMA BIOTECH BERHAD

1 APRIL 2019, MONDAY

2

Introduction Duopharma Biotech

and Halal Malaysia

1 2 3 4 5

Halal value

proposition for

pharmaceutical

products

Moving ForwardStrengthening the

Halal Pharmaceutical

Value Chain

3

“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)

4

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.

5

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

6

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

8

Duopharma Biotech Berhad(formerly known as CCM Duopharma Biotech Berhad)

9

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.

11

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%

-15.0%

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12

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%

+2.…

-13.2%

+5.1%

+9.5% +12.3%

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+7.7%

+13.9%

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13

14

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

15

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:

16

• 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

17

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

18

19

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

20

(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

21

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

22

1 2

23

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

24

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

26

27

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.

28

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

29

❑ 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

30

❑ 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.

31

❑ Halal Pharmapreneur

32

• 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

33

34

• 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

35

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)

36

37

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

38

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….

39

Phone contact –

+603-8924 2188 ext. 2403

halal-admin@duopharmabiotech.com

Suite 18.06, Level 18, Kenanga InternationalNo. 26, Jalan Sultan Ismail50250 Kuala LumpurWilayah Persekutuan, Malaysia