Halal Pharmaceutical Standard - Halal Industry Development ...

Presentation to
WORLD HALAL RESEARCH
SUMMIT 2011
6 th April 2011

THE BENEFITS OF HALAL PHARMACEUTICALS STANDARD -
MS2424
By
MR. LEONARD ARIFF ABDUL SHATAR
Director, CCM Pharmaceuticals Division
CHEMICAL COMPANY OF MALAYSIA BERHAD

HALAL
AND THE PHARMACEUTICAL
INDUSTRY

Primary Objectives of Shariah
Shariah: Islamic Laws & Ways of Life prescribed by Allah s.w.t
Preservation
of Faith
Preservation
of Life
Preservation
of Intellect
Preservation
of Progeny
Preservation
of Property

The Pharmaceutical Industry
It researches, develops, produces, markets and/or distributes
licensed pharmaceutical products which maintain and
restore health by the prevention and treatment of illnesses.
Innovator
MEDICINES
Generics
HEALTH/DIETARY
SUPPLEMENTS
Those provided by the Pharmaceutical Industry
will be of the same standard of Safety, Efficacy
and Quality as defined for medicines and
produced in high hygienic conditions.
Patented products •Off-patent products

Halal Products
Halal certified products not only benefit Muslims but
EVERYONE
because of the WHOLESOMENESS (“THOYYIBAN”) aspects:
SAFE for consumption and use
Assurance of product EFFICACY
QUALITY standard of production &
ingredients/ materials
HYGIENICALLY processed

RATIONALE FOR HALAL
PHARMACEUTICAL STANDARD

IMPORTANCE OF STANDARDS
INDUSTRY’S
PERSPECTIVE
Source of reference for:
CONSISTENCY of operations
SELF-REGULATION
building CONSUMER CONFIDENCE
MULTI-MARKET access
CONSUMER’S
PERSPECTIVE
Independent 3rd party ASSURANCE on:
Consistency product SAFETY,
EFFICACY & QUALITY
HYGIENIC manufacturing process
RESPONSIBLE & ETHICAL
operations
=> INCREASE TRANSPARENCY & RELIABILITY of certification process

Halal Pharmaceutical Standard
HALAL
PHARMACEUTICALS
STANDARD
APPROVED
HALAL MATERIAL
LIST
SHARIAH
ALIGNMENT
GMP
(PIC/S GUIDELINES)

WHY THE NEED FOR HALAL
PHARMACEUTICAL STANDARD?
Facilitate Lobbying for Halal Logo to be on Primary Packaging

WHY THE NEED FOR HALAL
PHARMACEUTICAL STANDARD?
Consumer Demand
source:

*Literary means:”Hopefully it’s Halal, more or less”

DEVELOPING THE MS 2424:
HALAL PHARMACEUTICALS-
GENERAL GUIDELINES

Halal Pharmaceutical Standard:
The Development Process
*Source: Guide to the Malaysian Standards System

Starting point of MS 2424
• Pharmaceutical Inspection Co-operation Scheme (PIC/s)
– The Pharmaceutical Inspection Convention and Pharmaceutical
Inspection Co-operation Scheme (jointly referred to as PIC/S)
are two international instruments between countries and
pharmaceutical inspection authorities, which provide together an
active and constructive co-operation in the field of GMP
• Member Countries
Europe
Non-European
– 28 Countries - Argentina, Australia, Canada
Israel, South Africa, the USA
- MALAYSIA (OIC member)

HALAL STANDARD: COVERGENCE OF MIND
– SHARIAH, SCIENCE & INDUSTRY
As a pre-cursor for the development of the Halal Pharmaceutical
Standard, in 2009, CCM had supported HDC in conducting the:

HALAL STANDARD: COVERGENCE OF MIND
– SHARIAH, SCIENCE & INDUSTRY
This FIRST Halal Pharmaceutical Audit Workshop, was attended by key
organisations:
Regulatory Body
Shariah
Standards
Industry
National Pharmaceutical Control Bureau, Ministry of Health,
Malaysia
JAKIM (Department of Islamic Development Malaysia)
1. SIRIM
2. Standards Malaysia
Selected CCM Halal Council and CCM Halal Committee members
Speakers 1. Science scholars from reputable universities
Facilitators
2. Innovax - CCM’s R&D Centre
Halal Integrity Division, HDC

Halal Pharmaceutical Standard:
The Development Process
Request for
New
Standard
Written Request was submitted jointly by CCM and HDC in October 2008
New Work
Item
Registered
August 2009
Working
Draft
Comm
ittee
Draft
August
2010
• Working Group established in September 2009, with
Prof Zhari Ismail of Universiti Sains Malaysia (USM) as
Chairman, HDC as Secretariat and SIRIM as Standards
Writer
• Active members: JAKIM, NPCB* and CCM
ISC I
Accept
ance
September
2010
Verificatio
n
by
Standard
s
Malaysia
Approva
l by
Minister
*NPCB=National Pharmaceutical Control Bureau, Ministry of Health, Malaysia

Halal Pharmaceutical Standard:
The Development Process

Halal Pharmaceutical Standard:
The Official Launch – 6 th April 2011

Halal Pharmaceutical Standard:
Additional Benefits
1. Closer collaboration and cooperation between 2 regulators
– MOH and JAKIM
2. Strengthen relationship between government agencies –
JAKIM, MOH, Standards Malaysia, HDC – covergence of
mind.
3. The MS2424 may be used as a working document.
4. Creation of platform for multiple supporting documentation
e.g. “The Halal Index ©”

...Supporting
Publications
While much have been written on the subject of Halal and Haram
substances found in food, there is no single work which deals
exclusively on Halal and Haram compounds used in the
pharmaceutical sector.
This publication represents a first dealing with pharmaceutical
compounds from porcine (pig based) origins. It is addressed to the
Muslim Ummah and all those who serve this market which is
currently estimated at USD 100 billion per annum.
The content of the book comprises monographs of the compounds
may be manufactured. In addition, the therapeutic categories of the
compounds and brief narratives are included . Additonal information
includes ATC codes, compound synonyms and trade names. The
reader is also guided with an extensive bibliography and references
together with an accompanying website for updated information.
“This index is indispensible for the Halal regulatory bodies, research
and development, manufacturers and a must have item for public
use”
Prof. Dr. Zhari Ismail
Professor in Pharmaceutical Chemistry
Chairman for drafting the Malaysian Standards for Halal
Pharmaceuticals Guidelines
Publication : The Halal Index
Volume 1 Pig Based Pharmaceuticals
Hardcover : 164 pages
Publisher : Phytorex Press Sdn. Bhd. (897389 –K)
No. 21A, Lorong Rahim Kajai 13, Taman Tun Dr. Ismail
60000 Kuala Lumpur, Malaysia.
Language : English
ISBN : 978 – 967 – 0103 – 01 – 3 (vol. 1)
Dimensions : 176 X 250 X 12 mm
Weight : 750g
Genre : Reference
“Ultimately, we hope users of this book will be able to appreciate the
significance and depth of the information to make learned decision in
choosing among the variety of products available”
Y. Bhg. Dato’ Seri Jamil Bidin
Chief Executive Officer
Halal Industry Development Corporation

MS 2424:
WHAT’S NEXT?

The Global Halal Pharmaceutical
Market Potential
GLOBAL MARKET VALUE for PHARMA INDUSTRY:
2006 = US$607b*
2013(e) = US$818b*
2020 (f) = US$1,300b**
>20% of world’s population are Muslims
Source:
*Frost & Sullivan Market Insight 2 April 2008
**PricewaterhouseCoopers Report 13 June 2007
Map from Wikipedia/CIA-The World Factbook

Halal Pharmaceuticals: Traceability

Value Chain Analysis
A pharmaceutical industry value chain analysis dictates that the highest
value activity resides at the upstream end of the chain.
Presently, the local generics manufacturers (including CCM), are only
focused in Finished Products manufacturing, Sales and Marketing, and
Distribution.
Current focus of local pharmaceutical industry
Higher value activities

Halal Pharmaceuticals:
Industry Impact
• Recognition by ingredient suppliers of the
Muslim market
• Recognition that alternatives can be sought
‣ There was a move from bovine into porcine research as
base materials for majority of pharmaceutical products due
to the BSE/mad-cow disease and the porcine based
materials are easily available because of its organised
supply chain for their animal parts in developed countries.
• Sensitizing international agencies on concept
of informed choice, e.g. NPC (National
Prescribing Centre, United Kingdom)

INFORMED CHOICE
IN MEDICINE TAKING
- THE NPCB MALAYSIA APPROACH
To declare by Sept ’09
Source/Origin for :
1.API and Excipients
2.Hard (Empty) Gelatin Capsules
3.Soft gelatin capsules
Findings:
1. Capsules declared as non-animal sourced contained bovine/
porcine elements
2. Capsules declared as bovine-sourced contained porcine or
combination of bovine and porcine elements
NPCB = National Pharmaceutical Control Bureau

CCM’s Key Focus: Halal Integrity
KNOWLEDGE = COMMITMENT & SINCERITY
TRAINING/KNOWLEDGE SHARING
CCM’s Halal Awareness Programme:
1. Halal Awareness Roadshows & Workshops for
Employees
2. Halal Awareness Seminar for Suppliers
3. Halal Talks for Customers
4. Dialogue Sessions with regulatory authorities/
related bodies

CCM’s Halal Journey
2009

INCREASING HALAL CERTIFIED PRODUCTS
1999
= 44 products NOW
= 177 products

CCM’s Halal Initiatives: Key Focus
“FARDH KIFAYAH”
SHARED RESPONSIBILITY
INFORMED
CHOICE
MARKETING
CAPACITY
BUILDING
HALAL INTEGRITY

CCM Pharmaceuticals Division:
Manufacturing Facilities - Capacity
Oral Solid
Dosage (OSD)
Tablets
Capsules
Softgel
Other Dosage
Form
Liquid
1 st
IBC
1
st
Capacity
3 billion
300 million
144 million capsules
Capacity
2 million litres
Ampoules
Dental cartridges
Vials liquids
Eye drops
Haemodialysis
Irrigation solution
Sterile Production Capacity
The
only
in
ASEAN
36 million ampoules
7.4 million vials
3.6 million vials
168,000 litres
5 million litres
3 million litres
1
st
Cream
72,000 kg
Cephalosporin
Capacity
Penicillin
Tablets
Capacity
55 million
Tablets
Capsules
144 million
36 million
Capsules
115 million
Powder
72,000 kg
Powder
72,000 kg
SVI vials
2.5 million vials

INCREASING HALAL CERTIFIED PRODUCTS
OTHER SIGNIFICANT 1 ST IN MALAYSIA
1 st SVI (Small Volume Injectibles)
1 st Dental Cartridge
1 st Soft Gel
1 st Patent
• Controlled Release mini-tabs in capsules
1 st state-of-art IBC plant
COMING SOON
‣ 1st Halal Vaccines F& F
‣ 1st Halal Bio-similar

Halal Pharmaceuticals
• Healing is achieved by medicine when the soul
readily accepts it and believes in its usefulness
and in the blessing of healing which Allah s.w.t.
has put into it.
• What is beneficial is that which is blessed and the
most beneficial is that with the greatest blessing.
• And blessed among the people is he from whom
benefit comes wherever he may be.
Ibn Qayyim Al-Jawziyya: Medicine of the Prophet

Conclusion
1. Halal Pharmaceutical is the emerging growth sector
in the Halal industry.
2. There are still a lot of matters to address in terms of
Halal compliance in this industry, and also the
acceptance of the necessity of its Halal certification,
but with good collaboration:
Together
Everyone
Achieves
More