Presentation to

WORLD HALAL RESEARCH

SUMMIT 2011

6th 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

Preservation

of Faith

Preservation

of Intellect

Preservation

of Progeny

Preservation

of Property

Preservation

of Life

Shariah: Islamic Laws & Ways of Life prescribed by Allah s.w.t

HEALTH/DIETARY

SUPPLEMENTS

Innovator Generics

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.

The Pharmaceutical Industry

Patented products •Off-patent products

MEDICINES

It researches, develops, produces, markets and/or distributes

licensed pharmaceutical products which maintain and

restore health by the prevention and treatment of illnesses.

Halal Products

Halal certified products not only benefit Muslims but

EVERYONE

SAFE for consumption and use

Assurance of product EFFICACY

QUALITY standard of production & ingredients/ materials

HYGIENICALLY processed

because of the WHOLESOMENESS (“THOYYIBAN”) aspects:

RATIONALE FOR HALAL

PHARMACEUTICAL STANDARD

IMPORTANCE OF STANDARDS

INDUSTRY’S

PERSPECTIVE

CONSUMER’S

PERSPECTIVE

Source of reference for:

CONSISTENCY of operations

SELF-REGULATION

building CONSUMER CONFIDENCE

MULTI-MARKET access

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 GMP

(PIC/S GUIDELINES)

ALIGNMENT

WHY THE NEED FOR HALAL

PHARMACEUTICAL STANDARD?

Facilitate Lobbying for Halal Logo to be on Primary Packaging

source:

WHY THE NEED FOR HALAL

PHARMACEUTICAL STANDARD?

Consumer Demand

*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)

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 National Pharmaceutical Control Bureau, Ministry of Health,

Malaysia

Shariah JAKIM (Department of Islamic Development Malaysia)

Standards 1. SIRIM

2. Standards Malaysia

Industry Selected CCM Halal Council and CCM Halal Committee members

Speakers 1. Science scholars from reputable universities

2. Innovax - CCM’s R&D Centre

Facilitators Halal Integrity Division, HDC

HALAL STANDARD: COVERGENCE OF MIND – SHARIAH, SCIENCE & INDUSTRY

Halal Pharmaceutical Standard: The Development Process

Comm

ittee

Draft

ISC I

Accept

ance

Approva

l by

Minister

Verificatio

n

by

Standard

s

Malaysia

Request for

New

Standard

New Work

Item

Registered

Working

Draft

Written Request was submitted jointly by CCM and HDC in October 2008

August 2009

• 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

August

2010

September

2010

*NPCB=National Pharmaceutical Control Bureau, Ministry of Health, Malaysia

Halal Pharmaceutical Standard: The Development Process

Halal Pharmaceutical Standard: The Official Launch – 6th 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©”

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

...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

“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

>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

GLOBAL MARKET VALUE for PHARMA INDUSTRY:

2006 = US$607b*

2013(e) = US$818b*

2020 (f) = US$1,300b**

Halal Pharmaceuticals: Traceability

Value Chain Analysis

Higher value activities

Current focus of local pharmaceutical industry

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.

• 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)

Halal Pharmaceuticals: Industry Impact

INFORMED CHOICE

IN MEDICINE TAKING

- THE NPCB MALAYSIA APPROACH

NPCB = National Pharmaceutical Control Bureau

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

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

KNOWLEDGE = COMMITMENT & SINCERITY

CCM’s Key Focus: Halal Integrity

CCM’s Halal Journey

2009

1999

= 44 products NOW

= 177 products

INCREASING HALAL CERTIFIED PRODUCTS

CAPACITY

BUILDING

HALAL INTEGRITY

MARKETING

“FARDH KIFAYAH”

SHARED RESPONSIBILITY

CCM’s Halal Initiatives: Key Focus

INFORMED

CHOICE

CCM Pharmaceuticals Division: Manufacturing Facilities - Capacity

Oral Solid

Dosage (OSD) Capacity

Tablets 3 billion

Capsules 300 million

Softgel 144 million capsules

Sterile Production Capacity

Ampoules 36 million ampoules

Dental cartridges 7.4 million vials

Vials liquids 3.6 million vials

Eye drops 168,000 litres

Haemodialysis 5 million litres

Irrigation solution 3 million litres

Penicillin Capacity

Tablets 55 million

Capsules 115 million

Powder 72,000 kg

Cephalosporin Capacity

Tablets 144 million

Capsules 36 million

Powder 72,000 kg

SVI vials 2.5 million vials

Other Dosage

Form Capacity

Liquid 2 million litres

Cream 72,000 kg

1

st

1

st 1st

IBC The

only

in

ASEAN

OTHER SIGNIFICANT 1ST IN MALAYSIA

1st SVI (Small Volume Injectibles)

1st Dental Cartridge

1st Soft Gel

1st Patent

• Controlled Release mini-tabs in capsules

1st state-of-art IBC plant

COMING SOON

1st Halal Vaccines F& F

1st Halal Bio-similar

INCREASING HALAL CERTIFIED PRODUCTS

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