CCM's Halal Presentation - Halal Industry Development … · •HYGIENICALLY processed ... • Pharmaceutical Excipients: –Solvents/co-solvents ... Industry Selected CCM Halal Council

Presentation to

WORLD HALAL RESEARCH

SUMMIT 2010

23rd June 2010

CCM : Championing Halal Pharmaceuticals

By

LEONARD ARIFF ABDUL SHATAR

Director, CCM Pharmaceuticals Division

CHEMICAL COMPANY OF MALAYSIA BERHAD

PHARMACEUTICAL INDUSTRY

Pharmaceutical Industry

• The Pharmaceutical Industry researches, develops, produces, markets and/or distributes licensed medicines.

• Medicine is a substance used to prevent or cure disease or to relieve pain, anxiety or any form of perceived discomfort, categorised as:

– Prescriptive (Ethical) and

– Over-The-Counter (OTC).

MEDICINES 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.


Patented products •Off-patent products

The Global Halal PharmaceuticalMarket 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**

• Pharmaceutical Industry is HIGHLY REGULATED.

• Companies in this industry are subjected to a

variety of laws and regulations relating to their

products:

– Research & Development (R&D) activities,

– testing methods,

– manufacturing processes,

– marketing, sales and distribution.


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.

HALAL PHARMACEUTICALS:

AN OVERVIEW

Primary Objectives of Shariah

Preservation

of Faith

Preservation

of Intellect

Preservation

of Progeny

Preservation

of Property

Objectives

of

Shariah

Preservation

of Life

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

Definition of Halal Pharmaceuticals

SOURCE:

DRAFT MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

DEFINITION OF NAJS

(Pharmaceutical Context)

SOURCE:

DRAFT MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

Halal Products

Halal certified products not only benefit Muslims but

EVERYONE

•SAFE for consumption and use

•HYGIENICALLY processed

•QUALITY standard of production & ingredients/ materials

•Assurance of product EFFICACY

because of the WHOLESOMENESS (“THOYYIBAN”) aspects:


INDUSTRY PERSPECTIVE

Halal Pharmaceuticals

source:

Uniqueness of the Pharmaceutical Industry

Consistency in:

products‟ Safety, Efficacy and Quality.

facilities‟ Hygiene standard.

Good Manufacturing Practice (GMP)

Good Hygiene Practice (GHP)

Good Clinical Practice (GCP)

Good Laboratory Practice (GLP)

Good Storage Practice (GSP)

Good Engineering Practice (GEP)

Strictly governed by International Standards of:

Uniqueness of the Pharmaceutical Industry

LAWS OF MALAYSIA

Act 366

POISON ACT 1952

Act 368

SALE OF DRUGS ACT 1952

Act 290

MEDICINES (ADVERTISEMENT AND SALE) ACT 1956

SALE OF FOOD AND DRUGS ORDINANCE 1952

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984

http://upload.wikimedia.org/wikipedia/commons/2/26/Coat_of_arms_of_Malaysia.svg

GMP requirements:

Safety

Efficacy

Quality

Tested


Tested

Tested

TestedTested

Tested

Tested

Tested

What is the source for these

gelatin capsules?

What is the source for vaccines,

insulin, heparin, etc.?

(Bovine, ovine, porcine, etc.)


Halal Pharmaceuticals: Traceability

Pharmaceutical Research & Development Process

Chemical Process

Chemicals: The whole range of organic and inorganic chemical products for chemical process and reaction

Catalyst


Formulation of Final Products

• Pharmaceutical Excipients:– Solvents/co-solvents

– Gel forming agents

– Lubricant, Binder & Disintegrant

– Preservatives

– Dye & pigment

– Minerals, etc


Rate-limiting Step in Vitamin Production

To prepare Liquid Vitamin into Free-flowing

powders for compressed Tablet or Capsule

Step 1: To mix with combination of:

- Active material (emulsion containing active vitamin material)

- Gelatin + water + gum acacia + sugar and/or starch

Step 2: Collection of individual droplet in a mass of starchy form

Converting emulsion to droplet form

Step 3: Separating the vitamin-active particles from starchy collecting

powder

• 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.

Halal Pharmaceuticals: Industry Impact


CONSUMER PERSPECTIVE

“Research shows that some 50% of

medicines prescribed for long term

conditions are not taken as

prescribed ”

From Compliance to Concordance

Royal Pharmaceutical Society of Great Britain, 1997

A Question of Choice:Compliance in Medicine Taking

• Patients not taking medicine is still a major cause of

unnecessary ill health and death.

• Such non-compliance is mostly intentional and

results from a considered decision made by patients

about the benefits and disadvantages of medicines,

rather than just „forgetfulness”

• Patients are much more likely to follow treatment if

they have been active partners in prescribing

decisions and their views and preferences have been

recognised and taken into account.

Task Force on Medicines Partnership 2003

A Question of Choice:Compliance in Medicine Taking

http://www.npc.co.uk/med_partnership/resource/our-publications/drugs-of-porcine-origin.html

Content:

INFORMED CHOICE IN MEDICINE TAKING

The Medicines Partnership Programme was established by the Department of Health, United

Kingdom in 2002 and has promoted the concept of concordance – or shared decision-making

- as an approach to help patients to get the most from their medicines.

INFORMED CHOICE IN MEDICINE TAKING

- THE NPC UK APPROACH

EXCERPTS

NPC UK = National Prescribing Centre (United Kingdom)

EXCERPTS

INFORMED CHOICE

IN MEDICINE TAKING

- THE NPC UK APPROACH

NPC UK = National Prescribing Centre (United Kingdom)

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

• Consumers are now more knowledgeable/

discerning

• Information on Halal and health matters are

easily accessible on the internet

• Halal agenda is gaining greater prominence

Halal Pharmaceuticals:Consumers’ Informed Choice


CCM‟S ROLE

About CCM: History

1930s

1960s

Incorporated on 7th August 1963 as a subsidiary of ICI PLC

Listed on the Main Board of Bursa Malaysia since 1966

Trading arm

1990s

2000s

Became a full-fledged Malaysian company

in 1994 via a Management-Buy-Out (MBO)

exercise

Became a subsidiary

of PNB in 2005

http://www.icipaints.com/index.jsp

http://www.icipaints.com/index.jsp

69.54%

10.02%

Others

CCM’s Current Equity Structure

CCM is one of

Malaysia‟s Top GLCs(Government Linked Companies)

1.97%

As at 31st May 2010

Manufactures and

markets general and

specialty chemicals,

as well as provides

services to the public

and manufacturing

sectors

Manufactures and

markets a complete

range of fertilizers

for all crop needs

and conducts soil

testing and progress

developments that

benefit farmers

Develops, manufactures

and markets generic

medicines and over-the-

counter (OTC) health/

dietery supplements &

healthcare products

Supports focused

markets:

•Singapore

•Indonesia

•Thailand

•Philippines

•Vietnam

CCM Group Structure

CCM’S HALAL INITIATIVES

“FARDH KIFAYAH”[COLLECTIVE OBLIGATION/DUTY]

CCM’s Halal Journey

2009

CCM:

CHAMPIONING THE HALAL PHARMACEUTICALS

THE GUIDING PRINCIPLE

A formalised framework to spearhead the Halal Strategy

CCM’s Halal Initiatives

TASK DESCRIPTION RESPONSIBILITY OF:

Stewardship Custodian of the Halal agenda CCM‟s Chairman &

Board of Directors

Ownership &

Leadership

Strategic decision makers that:

validate and own the strategy to boost the

Halal agenda

provide strategic guidance for the

implementation process

CCM Halal Council

chaired by

Group Managing

Director

Performance

Driver

Core Team that:

plans and executes development plans

guides and facilitates development of

action plans

monitors implementation progress

CCM Halal

Committees

chaired by

Division Directors

CCM Halal Policy

Commitment to manufacture,

import and distribute

consumable products that

comply with Halal

requirements.

Assurance that the non-

consumable products which we

manufacture, import and

distribute meet the same high

standards.

Assurance that our production

and supply chain processes

adhere to the high standards.

CAPACITY

BUILDING

HALAL INTEGRITY

MARKETING

“FARDH KIFAYAH”

SHARED RESPONSIBILITY

CCM’s Halal Initiatives: Key Focus

INFORMED

CHOICE

HALAL INTEGRITY

Operating in a socially responsible and ethical manner

Convergence of Minds – Shariah and Science

RITUAL CLEANSING

(SAMAK/SERTU)

This exercise is to ensure that all our equipment used in

production operations are clean and certified pure as per

the Shariah/Halal requirement whilst still meeting GMP*-

Pharmaceutical premise requirements.

CCM’s Key Focus: Halal Integrity

*GMP = Good Manufacturing Practices

Strategic collaboration with key Halal Industry Organisations:

• Relevant Ministries– Prime Minister‟s Office- Department

of Islamic Development (JAKIM), Health Ministry, Trade

Ministries (Domestic and International)

• Government Bodies/Agencies – Standards Malaysia, Halal

Industry Development Corporation (HDC), SIRIM

• Malaysian Universities – UPM, USM, IIUM, UM

• World Halal Forum

• IHI Alliance


As a pre-cursor for the development of the Halal Pharmaceutical

Standard, CCM had recently supported HDC in conducting the:


This FIRST Halal Pharmaceutical Audit Workshop, was attended by key

organisations:

Regulatory BodyNational Pharmaceutical Control Bureau, Ministry of Health,

Malaysia

Shariah JAKIM (Department of Islamic Development Malaysia)

Standards1. 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


1. The 1st Technical Committee meeting, chaired by the Director-General

of JAKIM was held on 29th September 2009. CCM is a member.

2. Sub-committee was formed to draft the standard, comprising members

from Ministry of Health, Pharmacy Scholars, Pharmaceutical Industry

players. CCM is also a member.

3 meetings had been held to date :

16th October 2009 – initiator, science scholars & regulatory

authorities

4th November 2009 – regulatory authorities & science scholars

5th November 2009 – industry players, regulatory authorities &

science scholars

14th June 2010 - industry players, regulatory authorities &

science scholars

3. The Halal Pharmaceutical Standard is drafted with reference to the

PIC/S* GMP** Guidelines.

*PIC/S = Pharmaceutical Inspection Co-operation Scheme

** GMP = Good Manufacturing Practices


Halal Pharmaceutical Standard

HALAL

PHARMACEUTICALS

STANDARD

APPROVED

HALAL MATERIAL

LIST

SHARIAHGMP

(PIC/S GUIDELINES)

ALIGNMENT

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


CAPACITY BUILDING

Increasing range of Halal

certifiable products

CCM Pharmaceuticals Division: Manufacturing Facilities - Sites

Klang

Shah Alam

Bangi

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

st1st

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

CHEMICAL &

ANALYTICAL

DEPT

FORMULATION &

BIO-PHARMACEUTICAL

DEPT

QUALITY

DEPT

DRUG INFORMATION

PIPELINE

DEPT

HEAD[Medical Doctor with PhD/Doctorate

in Pharmacology]

Core competency in research &

development of special oral

dosage forms/ in-drug delivery

system:

Controlled Release (CR)/

Sustained Release (SR)

CCM Pharmaceuticals Division: R&D Centre

1999

= 38 productsNOW

= 178 products

INCREASING HALAL CERTIFIED PRODUCTS


THE WAY FORWARD


MEDICINESHEALTH/DIETARY

SUPPLEMENTS• For wellness, immunity and

energy

• A preventive healthcare option

They are constantly in demand……

…regardless of economic conditions


• 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


“Indeed Allah s.w.t. sent down both illness and

medicine, and for every illness He gave remedy. So

carry out medical treatment, but do not use therein

anything unlawful”Saying of the Prophet Muhamad – Hadith of Abu al-Darda

“The Messenger of Allah s.w.t. forbade medication

with impure medicines ”Sunnah of the Prophet Muhamad – from Abu Hurayra

“Allah s.w.t. did not place your healing in anything

which has been made unlawful for you ”Saying of the Prophet Muhamad – Hadith of Ibn Mas’ud

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

Documents

CCM's Halal Presentation - Halal Industry Development … · •HYGIENICALLY processed ... • Pharmaceutical Excipients: –Solvents/co-solvents ... Industry Selected CCM Halal Council