Halal Pharmaceuticals: A Way Forward

FAPA 2014 - Kota Kinabalu - Amrahi 1

Amrahi bin Buang Chief Pharmacist,

Pharmacy Department, University Malaya Medical Centre

Halal Pharmaceuticals: A Way Forward

2 FAPA 2014 - Kota Kinabalu - Amrahi

Patient: Is my medicine halal? Pharmacist, Doctor, Nurse: Yes???.... No???


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.


Muslim Patient’s Rights

HALAL PHARMACEUTICALS


Right to have halal medication

Right to have non-najs medication

Right to be informed of medication

Right to choose medication

Right to give consent for usage of non-halal

medication


Muslim patients’ rights

Shariah Compliance:

Halalan Toyyiban




MS 2424:2012


MS 2424:2012 Halal Pharmaceuticals

General Guidelines

1.0 Scope

2.0 Normative references

3.0 Terms & definitions

4.0 Requirements

5.0 Compliance

6.0 Halal certificates

7.0 Halal certification mark


Quality management

Management responsibity

Halal Assurance System

Fundamentals for halal pharmaceuticals in GMP

Halal Quality Control

Personnel and responsibility

Training

Personal hygiene


Main Features

Premise and equipment

Production and control areas

Ancillary areas

Documentation

Production

Materials

Packaging materials

Contract manufacture and analysis


Main Features

Self inspection

Legal requirements

Compliance

Halal certificates

Halal certification mark


Main Features

Common Non-Halal Substances

Common Non-Halal Excipients

1. Gelatin

2. Stearic

Acid

3. Glycerol

4. Alcohol

5. Enzyme


15

Tertiary References

FAPA 2014 - Kota Kinabalu - Amrahi

16

Proviton Multi-

vitamin Cap (CCM)

API/Excipients*** SourceHalal Status** of

API/Excipient (Yes/No)

Active Pharmaceutical Ingredient

Thiamine Mononitrate SYes (Belgium - Halal Food

Council Of Europe (HFCE))

Riboflavin SYes (Belgium - Halal Food


Nicotinamide SYes (Belgium - Halal Food


Pyridoxine Hydrochloride SYes (Belgium - Halal Food


Cyanocobalamin 0.1 SYes (Belgium - Halal Food


Folic Acid SYes (Belgium - Halal Food


Coenzyme Q10 (Ubidecarenone) SYes (China - China Islamic

Association)

Biotin SYes (Belgium - Halal Food


Inositol S

Lysine Hcl PYes (Belgium - Halal Food


Tribasic Calcium Phosphate SYes (Germany - Halal Control

E.K. (EU)

Copper Sulfate SYes (Germany - Halal Control

E.K. (EU)

Magnesium Sulphate S

Potassium Sulphate S

Ferrous Fumarate SYes (Germany - Halal Control

E.K. (EU))

Zinc Sulfate Monohydrate S

Manganese Sulphate Monohydrate SYes (Germany - Halal Control

E.K. (EU))

Potassium Iodide SYes (Germany - Halal Control

E.K. (EU))

Ginseng Dry Extract PYes (Italy - Halal International

Authority (HIA))

Vitamin A Palmitate SYes (Belgium - Halal Food


Cholecalciferol (Vitamin D3) SYes (Belgium - Halal Food


DL-A- Tocopheryl Acetate (Vitamin

E)

SYes (Netherlands/ Holland -

Control Office Of Halal

Slaughtering B.V. & Halal Quality

Control)

Lecithin SYes (China - China Islamic

Association)

Excipients

Hydrogenated Coconut Oil P

Beeswax Yellow O Wax From Bees Honeycom

Palm Oil P

Soya Bean Oil P

Gelatin Base (Shell)

Gelatin Powder 150 Bloom LA Yes (JAKIM)

Glycerin P Yes (JAKIM)

Ariavit Brown HT S

Ethyl Vanillin Flavour SYes (Belgium - Halal Food


AQ - Aquatic Animal; LA (state) - Land

Animal eg. LA (Bovine); P - Plant; S -

Synthetic; SM - Semi-synthetic; M -

Mineral; MO - Microorganism; NC -

Natural Chemical; GMO - Genetically

Modified Organism; O - Others (Pse

state)


The official Halal Logo of Malaysia


Current DCA’s Policy on HALAL

Allows HALAL labels on:

Cosmetics

Traditional Medicines

Health Supplement

OTC

Why?

There is a choice

Must label if it is from animal source either bovine or porcine


19

Halal Certificate - Malaysia


CCM & MS2424: 2012


Gelatin source is certified Halal by JAKIM

Gelatin for capsule : Halal certified Bovine source


First paracetamol to have Halal Logo

New Halal Logo - MS2424 : 2012


Halal Logo for OTC products

New Halal Logo - MS2424 : 2012


A Way Forward



Halal Products

Halal certified products not only benefit Muslims but

EVERYONE

because of the WHOLESOMENESS (“THOYYIBAN”) aspects:

•SAFE for consumption and use

•HYGIENICALLY processed

•QUALITY standard of production & ingredients/ materials

•Assurance of product EFFICACY


Pharmaceutical Industry MEDICINES

HEALTH/DIETARY SUPPLEMENTS • For wellness, immunity and energy

• A preventive healthcare option

They are constantly in demand…… …regardless of economic conditions


Halal Pharmaceuticals

source: FAPA 2014 - Kota Kinabalu - Amrahi 27


Halal Pharmaceuticals

are here

Medicines (Innovators,Generics,

Biosimilars): 1 Trillion USD

29

PLENARY SESSION: VACCINES –

FUTURE OUTLOOK FOR THE MUSLIM

MARKET


30

• There is a greater emphasis on Halal pharmaceutical as the

Muslim market grows more affluent and demand rises –

replacing animal-based ingredients such as gelatin, enzymes

and emulsifiers with plant-based ingredients

• Malaysia is the ONLY country with standard Halal Pharma

guidelines

• Halal Pharma complied with MOH Guidelines, GMP and PICS.

• Global Halal supply is meeting only 3% of the global Halal

demand worth about USD82 billion

• Supporting ETP NKEA, National Medicines Policy; Reference

to Halal Pharmacopoeia & Alternative listing

Malaysian Perspective



3.2.1.1.6 Halal Medicines

- There shall be strategic partnerships

with the relevant authorities to make

certified halal medicines available in

Malaysia.

3.2.1. Availability of Medicines - The

availability of medicines shall be

achieved through the appropriate

selection of medicines, improvement in the management of medicines

procurement and the supply chain

network, and through optimal utilization

of available financial resources to

ensure sustainability.

National

Medicines

Policy

(DUNas)

31

CCM Pharmaceuticals : 97 products

Upha : 120 products

Duopharma: 19 products

Ain Medicare : 30 products

Xorix: 10 products

More….more on the pipeline


Current Status


To ALL members of Technical Committee of Halal Pharmaceuticals

Documents

Halal Pharmaceuticals: A Way Forward