A Presentation for Ikatan Apoteker Indonesia

Halal Pharmaceutical from the

perspectives of Industry

Presented by:
Seri Azalina Mohd Ghazalli, Head of Halal & Government Relations Department
Date : 3 August 2022, Tuesday
Content

• Duopharma Biotech – Summary, Brands and Therapeutic

Classes
• An Overview of Halal Industry
• Concept of Halal-certified Pharmaceuticals
• Critical concerns in halal pharmaceuticals
• Duopharma Biotech Halal Journey
• Conclusion

19
Duopharma Biotech Berhad – Summary

Headquarters
Established located in
The No. 1 pharmaceutical company
in 1979 Kuala Lumpur, in Malaysia by volume
Malaysia

Has subsidiary
Owns and
companies in The 1st Malaysian pharma company to obtain the
operates 3
the Philippines
manufacturing Malaysian HALAL certification by JAKIM in 1999
& Singapore
plants in
with a rep.
Malaysia
office in Jakarta

Actively
conduct halal
pharmaceutical
Manufacture
awareness
The 1st Malaysian pharma company to
over 300 successfully complete Phase III biosimilar trial
session with
generic drugs
and biosimilars
healthcare in Malaysia & Korea and commercialize the
practitioner product in 2019.
locally and
globally
Brand Consumer Healthcare

Consumer Healthcare Consumer Healthcare

(Malaysia) (Indonesia)

19
Brand Prescriptive Medicines
Uphadyl, Carinox, Sobenz, V-life,
Respiratory
Semtec
Musculo-Skeletal System
Zolterol, Anarex
Cancer Care Zuhera™, Lebreta, Trevive, Kytron, Trexa,

Specialty Pharmaceuticals
Nervous System Acugesic, Prelica Franchise Artesto
Classic Pharmaceuticals

Systemic Hormones Prednisyn, Penatone

Alimentary Tract & Omesec, Oral Aid Lotion, BD Pen Diabetes Care
Metabolism Needles INSUGEN® , INSUPEN®, BASALOG ONE®
Franchise
Systemic Anti-Infectives Zynomax, Anikef, Unocef, Flonoxin
Dermatology Krisovin, Aqua Cream
Renal Care ERYSAA® , Unihepa , Ranofer, Bi-
Sensory Neo Deca, Nico Eye Drops Franchise Haemosol and Haemosol
Genito-Urinary & Sex
Ravimed, Condep
Hormones
Vascor Acetan, Covasc, Atorvas,
Cardiovascular
Perinace, Bezartan
Various Beazyme
19
OVERVIEW OF HALAL PHARMACEUTICAL
INDUSTRY
Halal Pharmaceutical Industry Globally

Market drivers:
• Estimated in 2021, 1.9 billion Muslims spending USD 100 billion
on pharmaceuticals.
• The global Halal pharmaceuticals market is set to grow to USD
129 billion by 2025.
• Increasing awareness of permissible options for Muslim patients.

Consumers’ increasing awareness and renewed focus on health and

immunity:
• Consumer Healthcare products are considered the major growth
segment within Halal Pharmaceuticals.
Importance of certification to protect consumers’ interest:
• Halal started to be regulated in several countries such as
Indonesia, Saudi Arabia, United Arab Emirates and GCC
Countries.
Standards and conformance:
• SMIIC (standards body for OIC Countries) initiated the
development of OIC standard for Halal Pharmaceuticals
Reference: 2022 State of Global Islamic Economy
7
Report
 An Overview of Malaysia Halal Industry
PROCESS / MANUFACTURING SERVICES

Livestock Food & Beverage

(MS 1500) (MS 1500) Food Service / Warehousing & Logistics
Premise (MS 2400-1, MS2400-2))
(MS 1500)

Cosmetics & Consumer Pharmaceuticals Medical Device Travel & Retail

Personal Care Goods (MS 2424) (MS 2636) Hospitality (MS 2400-3)
(MS 2634) (MS 2200-2) (MS 2610)
*MS = Malaysian Standard

8
 Halal Malaysia Pharmaceutical Journey

Food supplements or Halal Malaysia Ministry of Health Guidelines

Consumer Healthcare Pharmaceutical Certification on administering medicines
products certified Scheme for OTC products was containing non-halal sources
under MS1500 (Halal introduced based on MS and from Islamic
Food) 2424 perspectives

1998 2012 2013 2017 2018 2019

MS 2424:2012, Halal Halal Malaysia MS 2424:2019, Halal

Pharmaceutical – Pharmaceutical Certification Pharmaceutical –
General guidelines, Scheme for Prescription General requirements
was approved and products was introduced (First revision)
published based on MS 2424 Note: The revised MS
2424 incorporated
requirements for vaccine.

9
THE CONCEPT OF HALAL-CERTIFIED
PHARMACEUTICAL

10
Halal Concept for pharmaceuticals

“Halal” for pharmaceutical is applied as a standard to provide a quality alternative for Muslim patients.

“Halalan Toyyiban” means more than permissible for consumption; the word ‘toyyiban’ enhances the
features reflecting the product to be good, pure and wholesome, so it also means good for all segments
of the society and the environment.

“Halal Pharmaceutical” means Pharmaceutical products in finished dosage forms include prescription
and non-prescription medicinal products for human use registered with the Drug Control Authority, or
local health authority that contain ingredients permitted under the Shariah guidelines and fatwa. 11
Halal certification - Quality to the next level

Pharmaceutical products
certified halal must first fulfil the
requirements of GMP before
fulfilling additional prerequisites
for halal certification, which set a
higher benchmark for quality.

12
 Halal Certification requirements - Overview
All materials shall be clearly defined
with evidence complying with the
Shariah Law and National Fatwa

Processing line shall be for halal

Products must not come into
pharmaceuticals only
physical contact with any non-
halal products (segregated)
Equipment not contaminated
with najs

Premises and facilities adhere to Shariah guidelines

Reference: MS 2424:2019, Halal Pharmaceuticals – General requirement (First Revision).

For more information, visit https://halal4pharma.com/
13
CRITICAL CONCERNS IN HALAL

PHARMACEUTICAL

14
Gelatine in Halal Pharmaceuticals

Gelatin used in halal pharmaceutical

capsule is halal if it :

• derives from halal sources; and

• is approved by recognised halal

certification body by JAKIM and the
Department of Veterinary Services,
Malaysia.

15
Glycerine in Halal Pharmaceuticals

Another common ingredients used for fats and oil in

pharma and cosmetics products are triglycerides of
fatty acids and glycerine.

• Glycerin can derive from animal (lard and tallow)

and plants (camelia oil and palm oil).

• For any halal certified products, glycerine used

must derive from halal sources; and approved
by JAKIM as well as the Department of
Veterinary Services, Malaysia.

16
Alcohol in Halal Pharmaceuticals

Based on the decision of the National Fatwa Council’s Committee

(JAKIM) during the Special Muzakarah dated 14th–18th July 2011
on “Alcohol in Food, Drinks, Fragrances and Medicines” ethanol
(alcohol) :

• Used as pharmaceutical ingredients must not derive from the

manufacturing of any alcoholic beverages;

• As industrial alcohol or denatured alcohol is not najs and can be

used as one of the ingredients; and

• Used as an excipient in halal pharmaceutical products is

controlled within limits set by the Ministry of Health, Malaysia

17
Use of Animal Placenta pharmaceutical products

IRSYAD AL-FATWA SERIES 281 : ISLAMIC RULING ON PLACENTA

INJECTIONS

Cosmetic treatment using human placenta is prohibited to avoid the

exploitation and invasion of humans’ honour.

However, if there is a medical need to treat diseases using human

placenta then it is permitted only in exigent or desperate situations.

The usage of halal animal placenta that has been slaughtered

according to Islamic law is permitted for beautification or medical
purposes.

The usage of animal placenta that are najs is prohibited for cosmetic
purposes or beautification but permitted in exigent or desperate
Ref: muftiwp.gov.my
situations.

18
DUOPHARMA BIOTECH HALAL JOURNEY AND
ACCOMPLISHMENTS

19
Duopharma Biotech Halal Certification Milestones
First pharmaceutical
company to obtain the
Malaysian HALAL
certification - health Obtained HALAL
supplements under the Certification from Korea
brands CHAMPS, Flavettes, Obtained HALAL Muslim Federation for
Proviton and Naturalle – MS certification from Renal Medicine
1500 LPPOM MUI Indonesian (ERYSAA)
2013 2017

1999 First pharmaceutical

2014
company to obtain the
Malaysian HALAL certification
– MS 2424:2012 for OTC
products
2020
First pharmaceutical
company to obtain the
Malaysian HALAL certification
for Prescriptive Medicines
based on MS 2424:2012

20
Duopharma Biotech Halal Policy

Duopharma Biotech Berhad Group of Companies (“Duopharma Biotech”) is

committed to producing high-quality halal products for the society while
adding value for our stakeholders. We are committed to:

• Uphold the integrity of our entire halal supply chain through the concept of
“Halal Built-in, Not Tested For”.

• Uphold the development and manufacturing of halal pharmaceutical and

medical device products in premises with high standards of safety, efficacy,
quality and hygiene.

• Ensure our compliance to the current halal requirements, ISO Quality

Management System standards, Good Manufacturing and Distribution
Practice Guidelines as well as other relevant requirements on the
manufacturing, warehousing and logistics of halal pharmaceuticals and
medical devices as required by the competent halal authorities and other
related regulatory authorities.

21
Halal Built-In, Not Tested For
HALAL CONTROL

2
Sales &
Marketing
Ingredients
Finance

R&D
Packaging Storage &
Management (incl. Registration Purchasing Packaging
Materials Distribution Legal
sourcing)

Other Human
Materials Resource

SAFETY AND Internal Audit

EFFICACY CONTROL
Administration,
etc
QUALITY CONTROL

PRE-PRODUCTION PRODUCTION POST-PRODUCTION

22
Duopharma Biotech – Halal Assurance commitments

• Duopharma Biotech manufacturing facilities have been producing

100% halal compliant products since 1998.

• Our products have been Halal-certified by the Department of Islamic

Development Malaysia (JAKIM) since 1999.

• Also obtained Halal certification from JAKIM Recognised Foreign

Halal Certification Bodies:

✓ Indonesian Halal certification from Majelis Ulama Indonesia

(LPPOM MUI) for Consumer Healthcare Products since 2014.

✓ Korea Muslim Federation (KMF) for ERYSAA since 2020.

23
SUMMARY AND CONCLUSION

24
Halal is a Universal Value
HALAL IS AN INCLUSIVE
CONCEPT FOR ALL

Source:sdgs.un.org/goals
Conclusion

• Duopharma Biotech’s Fardhu Kifayah (legal obligation that must

be discharged ) Commitment

• Assurance & Compliance: Production of “Safe”, “Efficacy”, “High

Quality” and “Hygienic”

• Confidence for public to have confidence that what they are

consuming is safe and produce in high standard of hygienic
environment

26
 TERIMA KASIH

halal4pharma.com
https://www.facebook.com/halal4pharma/
Email: halal-admin@duopharmabiotech.com