INTOXICANTS & ANIMAL BASED

PHARMACEUTICAL PRODUCTS

ZHARI ISMAIL FASc, PhD, RPh.

PHARMACEUTICAL CHEMISTRY DISCIPLINE

PUSAT PENGAJIAN SAINS FARMASI

UNIVERSITI SAINS MALAYSIA

CCM HALAL PHARMAPRENEURS WORKSHOP

BANGI-PUTRAJAYA HOTEL

1-2 AUG 2018

CONTENTS

INTRODUCTION

MS 2424: 2018 REVISION

HALAL PHARMACEUTICALS

INTOXICANT PRODUCTS

ANIMAL-BASED PRODUCTS

HALAL PHARMACOPOEIA

CONCLUSION

“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

INTRODUCTION

• 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

EXCERPTS

INFORMED CHOICE

IN MEDICINE TAKING

- THE NPC UK APPROACH

• 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

INTRODUCTION

HALAL BUILT-IN RATHER THAN TESTED IN

HALAL INGREDIENTS MONOGRAPHS

HALAL STANDARDS REFERENCES/DOCUMENTS

HALAL BUILT-IN

Part 1: Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency

In the first part of this comprehensive GMP live training program, we are going to focus on the building blocks of the Quality Management System (QMS).

Those building blocks are to assure that operations are in control and maintained in their validated state. It involves systems of checks and balances, methods of measurement to detect disturbances and systems to assure that changes introduced deliver improvements or are at least neutral in their effects.

All of this is to assure that the products made are what was developed and promised to the regulatory bodies and what is best for the patient. The philosophy is that quality must be built in rather than tested in.

Halal Paradigm

Publications on Halal -Increased and improved

Science & Technology on Halal

Areas on F & B, Consumer Goods (pharmaceuticals,

cosmetics etc)

Services (Hotels, Logistics, etc)

New paradigm & ecosystem

Novel supply chain

Halal Built-in concept

MS 2424:2018 REVISION

MS 2424:2018 REVISION

Halal pharmaceuticals

Products that contain ingredients permitted under

the Shariah law and fulfill the following

conditions:

➢do not contain any parts or products of animals

that are non-halal or not slaughtered

according to Shariah law;

➢do not contain najs according to Shariah law;

➢ safe for consumption, non-poisonous, non-

intoxicating or non-hazardous to health

according to prescribed dosage;

Halal pharmaceuticals

not prepared, processed or manufactured using

equipment contaminated with najs according to

Shariah law;

➢ do not contain any human parts or its derivatives that

are not permitted by Shariah law; and

➢ during its preparation, processing, handling,

packaging, storage and distribution, the halalpharmaceutical products are physically separated

from any other pharmaceutical products that do not

meet the requirements as stated in the item a), b), c), d)

or e) or any other items that nave been decreed as

non-halal and najs by Shariah law.

Do not contain any parts or products of; 1. animals that are non-halal or

2. not slaughtered according to Shariah law;

3. najs according to Shariah law;

4. non-poisonous,

5. non-intoxicating or

6. non-hazardous to health according to prescribed dosage

7. human parts or its derivatives;

3.17 najs

3.17.1 Matters that is impure according to Shariah law and fatwa.

Divided into three types:

a) al-mughallazah which is considered as severe najs which are dogs and

pigs (khinzir) including any liquid and objects discharged from their orifices,

descendants and derivatives.;

b) al-mutawassitah which is considered as medium najs which does not falls

under severe or light najs such as vomit, pus, blood, khamr, carrion, liquid

and objects discharged from the orifices; and

c) al-mukhaffafah which is considered as light najs. The only najs in this

category is urine from a baby boy at the age of two years and below who

has not consumed any other food except his mother’s milk.

3.17.2 Examples of najs are:

a) dogs, pigs and their descendants or derivatives such as sperm and ova;

b) halal pharmaceuticals that are contaminated with matters that are non-halal;

c) halal pharmaceuticals that come into direct contact with matters that are non-

halal;

d) any liquids and objects discharged from the orifices of human beings or animals

such as urine, blood, vomit, pus, excrement and placenta.

NOTE: Human milk, human placenta, human sperm and human ova are not

considered as najs but are prohibited under Shariah law and fatwa to be used in

pharmaceutical products.

e) carrion or halal animals that are not slaughtered according to Shariah law and

fatwa except for aquatic animals and certain insects; and

f) Khamr (an intoxicating substance) and food or beverages or matters which

contain or are mixed with khamr.

NOTES:

1. Khamr is liquor or any liquid that intoxicates and is prohibited according to

Shariah law and fatwa.

2. Synthetic ethanol is not considered as najs.

3. Pharmaceutical intoxicants (e.g.: psychotropics, tranquilizers, hypnotics and

anesthetic agents) for medical use are not considered as najs.

3.18 pharmaceuticals

Pharmaceutical products in finished dosage forms, including both prescription

and nonprescription medicinal products for human use which are registered with

the Drug Control Authority, Ministry of Health Malaysia.

NOTE. Examples may include biopharmaceuticals (including vaccines,

recombinant products, monoclonal antibody products, gene therapy products

etc), radiopharmaceuticals, health supplements, traditional medicines and

investigational medicinal products.

HALAL INGREDIENTS ORIGIN

GREEN LISTS:

synthetic,

plants,

semisynthet

ic

microbes,

recombina

nt DNA

RED LISTS

(HARAM):

•PIG BASED

•Gelatin

•Insulin

•Enzymes

•Hormones

•Etc.

GREY LISTS

(MASBOOH):

•Non zabihah

animals,

•Human

source,

•insects,

•etc.

Medicines Sources

Chemicals Plants

Medicines Sources

Animals Biotechnology

4.15 Materials

All materials used in manufacturing of halal pharmaceuticals include

starting and packaging materials. Materials may be from

synthetically or naturally derived sources. All najs are prohibited.

4.15.1 Synthesized materials

The sources and processing of synthesized materials shall comply with

halal requirements. The usage of synthetic alcohol is permissible.

4.15.2 Natural materials

The usage of all natural materials that are poisonous, intoxicating or

hazardous to health may be used as allowed by the competent

authority.

4.15.2.1 Plants

All types of plants and plant products and their derivatives are halal

except those prohibited by the competent authority.

4.15.2.2 Animals

Animals can be divided into two categories and are described as follows:

a)Land animals

All land animals are halal for pharmaceutical purposes except the following:

i. animals that are not slaughtered according to Shariah law;

ii. najs al-mughallazah animal, i.e. pigs, dogs and their descendants;

iii. animals with long pointed teeth or tusks which are used to kill prey such as tigers, bears, elephants, cats, monkeys, etc.;

iv. predator birds such as eagles, owls and etc.;

v. pests and/or poisonous animals such as rats, cockroaches, centipedes, scorpions, snakes, wasps and other similar animals;

vi. animals that are forbidden to be killed in Islam such as bees (al-nahlah), woodpeckers (hud-hud), etc.;

vii. creatures that are considered repulsive such as lice, flies, etc.;

viii. farmed halal animals which are intentionally and continually fed with najs; and

ix. other animals forbidden to be eaten in accordance to Shariah law such as donkeys and mules; and

x. all of the above and other animals that prohibited by the competent authority.

4.15.2.2 Animals

Animals can be divided into two categories and are described as follows:

b) Aquatic animals

Aquatic animals are those which live in water and cannot survive outside it, such as fish.

All aquatic animals are halal except those that are poisonous, intoxicating or hazardous to health. Animals that live both on land and water such as crocodiles, turtles and frogs are not halal.

Aquatic animals which live in najs or intentionally and/or continually fed with najs are not halal.

4.15.2.3 Minerals

Minerals are any non-organic homogenous solid substances of the earth’s crust. All minerals are halal except those prohibited by the competent authority.

4.15.2.4 Micro-organisms

Microscopic organism ranging from 10-6 μ to 10-9 μ of medical interest include bacteria, rickettsiae, viruses, fungi and protozoa. All micro-organisms are halal except those prohibited by the competent authority

4.15.2.5 Natural chemicals

All natural chemicals are halal except those prohibited by the competent authority.

4.15.2.6 Genetically modified organisms (GMO)

Products and/or by-products of genetically modified organisms (GMOs) or ingredients made by the use of genetic material of animals that are decreed as halal by Shariah law.

INTOXICANT PRODUCTS

The Psychoactive Substances Act 2016

is a law in the United Kingdom intended to restrict the production, sale and supply of a new class of psychoactive substances often referred to as "legal highs". The bill was passed given Royal Assent on 28 January 2016,[3] and came into force on 26 May 2016 across the entire United Kingdom.

Description

The law defines as a "psychoactive substance" anything which "by stimulating or depressing the person’s central nervous system ... affects the person’s mental functioning or emotional state". The law bans all such substances but exempts alcohol, tobacco or nicotine-based products, caffeine, food and drink, medicinal products and any drug that is already regulated under the Misuse of Drugs Act 1971.[4]

The Psychoactive Substances Act 2016

The Act:

makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess on custodial premises, import or export psychoactive substances; that is, any substance intended for human consumption that is capable of producing a psychoactive effect. The maximum sentence will be seven years’ imprisonment[3]

excludes substances, such as food, alcohol, tobacco, nicotine, caffeine and medical products from the scope of the offence, as well as controlled drugs, which continue to be regulated by the Misuse of Drugs Act 1971[3]

exempts healthcare activities and approved scientific research from the offences under the act on the basis that persons engaged in such activities have a legitimate need to use psychoactive substances in their work[3]

includes provision for civil sanctions – prohibition notices, premises notices, prohibition orders and premises orders (breach of the two orders will be a criminal offence) – to enable the police and local authorities to adopt a graded response to the supply of psychoactive substances in appropriate cases[3]

provides powers to stop and search persons, vehicles and vessels, enter and search premises in accordance with a warrant, and to seize and destroy psychoactive substances[3]

The act also makes those offences punishable by a fine, or by up to a year in prison (six months in Northern Ireland) if convicted as a summary offence, or up to seven years if convicted under indictment. The Act also defines an offence of possession in a custodial institution (prison, young offenders institution etc.) which has the same penalties as the other offences, except the maximum prison term if convicted under indictment is two years.

The Act also describes a series of aggravating factors which judges or magistrates are obliged to consider in sentencing. These are:

the offence taking place in, or in the vicinity of, a school during, or within one hour of, the school's operational hours

the use of a courier aged under 18

the offence taking place in a custodial institution

Legal intoxicants

also known as legal drugs or, more commonly, as legal highs, are those intoxicating drugs which are either completely legal or not commonly prohibited by various drug laws.

The most widely consumed legal intoxicant is alcohol—legal throughout the vast majority of the world's countries—but a wide array of other drugs are also not specifically banned in many international jurisdictions: these may vary from native intoxicating plants historically used by indigenous cultures to foodstuffs eaten in various parts of the world, to modern compounds and designer drugs that have not been defined as illegal, or even long-standing medicines that have intoxicating or anesthetic side effects.

Where legislation imposes a general ban on psychoactive substances (as in Ireland), legal intoxicants are limited to those substances specifically exempted.

Legal intoxicants1. Stimulants

1.1Mephedrone

1.2Caffeine

1.3Nicotine

1.4Ephedrine

1.5Betel

1.6Calamus root

1.7Khat

1.8Propylhexedrine

2. Psychedelics

2.1Magic truffles

2.2Mexican calea

2.3Hawaiian baby woodrose

2.4Peruvian Torch cactus

2.5San Pedro cactus

2.6Blue Egyptian water lily

2.7Fly agaric

2.8Peyote

2.9Colorado River toad

3. Cannabinoids

3.1Cannabis

3.2Synthetic cannabis

4. Dissociatives

4.1Salvia divinorum

4.2Mugwort

4.3African Dream Root

4.4Dextromethorphan

4.5Nitrous oxide

4.6Methoxetamine

5. Deliriants

5.1Mandrake

5.2Diphenhydramine and dimenhydrinate

5.3Datura

5.4Nutmeg

6. Depressants

6.1Alcoholic beverages

6.2Kava

6.3Diethyl ether

7. Inhalants

7.1Nitrites

8. Opioids

An assortment of psychoactive drugs—

street drugs and medications:

1.cocaine

2.crack cocaine

3.methylphenidate (Ritalin)

4.ephedrine

5.MDMA (Ecstasy)

6.mescaline (cactus)

7.LSD blotter

8.psilocybin mushroom (Psilocybe

cubensis)

9.Salvia divinorum

10.diphenhydramine (Benadryl)

11.Amanita muscaria mushroom

12.Tylenol 3 (contains codeine)

13.codeine with muscle relaxant

14.pipe tobacco

15.bupropion (Zyban)

16.cannabis

17.hashish

INTOXICANTS IN PHARMACEUTICALS

A psychoactive drug, psychopharmaceutical, or psychotropic is a chemical substance that changes brain function and results in alterations in perception, mood, consciousness or behavior.[1]

These substances may be used medically, recreationally, to purposefully improve performance or alter one's consciousness, as entheogens, for ritual, spiritual, or shamanic purposes, or for research.

Some categories of psychoactive drugs, which have therapeutic value, are prescribed by physicians and other healthcare practitioners. Examples include anesthetics, analgesics, anticonvulsant and antiparkinsonian drugs as well as medications used to treat neuropsychiatric disorders, such as antidepressants, anxiolytics, antipsychotics, and stimulant medications.

Some psychoactive substances may be used in the detoxification and rehabilitation programs for persons dependent on or addicted to other psychoactive drugs.

Psychoactive substances often bring about subjective (although these may be objectively observed) changes in consciousness and mood that the user may find rewarding and pleasant (e.g., euphoria or a sense of relaxation) or advantageous (e.g. increased alertness) and are thus reinforcing. Substances which are both rewarding and positively reinforcing have the potential to induce a state of addiction –compulsive drug use despite negative consequences. In addition, sustained use of some substances may produce physical or psychological dependence or both, associated with somatic or psychological-emotional withdrawal states respectively. Drug rehabilitation attempts to reduce addiction, through a combination of psychotherapy, support groups, and other psychoactive substances. Conversely, certain psychoactive drugs may be so unpleasant that the a person will never use the substance again. This is especially true of certain deliriants (e.g. Jimson weed), powerful dissociatives (e.g. Salvia divinorum), and classic psychedelics (e.g. LSD, psilocybin), in the form of a "bad trip".

Psychoactive drug misuse, dependence and addiction have resulted in legal measures and moral debate. Governmental controls on manufacture, supply and prescription attempt to reduce problematic medical drug use. Ethical concerns have also been raised about over-use of these drugs clinically, and about their marketing by manufacturers. Popular campaigns to allow certain recreational drug use (e.g. cannabis) are also ongoing.

Commonly used psychoactive drugs

and groups: Psychoactive drugs are divided into different groups according to their

pharmacological effects.

Anxiolytics (Example: benzodiazepines, barbiturates)

Empathogen–entactogens (Example: MDMA (Ecstasy), MDA, 6-APB,

AMP)

Stimulants ("uppers"). This category comprises substances that wake one

up, stimulate the mind, and may cause euphoria, but do not affect

perception. (Examples: amphetamine, caffeine, cocaine, nicotine)

Depressants ("downers"), including sedatives, hypnotics, and opioids. This

category includes all of the calmative, sleep-inducing, anxiety-reducing,

anesthetizing substances, which sometimes induce perceptual changes,

such as dream images, and also often evoke feelings of euphoria.

(Examples: ethanol (alcoholic beverages), opioids, barbiturates,

benzodiazepines.)

Hallucinogens, including psychedelics, dissociatives and deliriants. This

category encompasses all those substances that produce distinct

alterations in perception, sensation of space and time, and emotional

states [15] (Examples: psilocybin, LSD, Salvia divinorum and nitrous oxide.)

MEDICAL USES OF

INTOXICANTS

Anesthesia

• General anesthetics are a class of psychoactive drug used on people to block

physical pain and other sensations.

• Most anesthetics induce unconsciousness, allowing the person to undergo

medical procedures like surgery without the feelings of physical pain or emotional

trauma.[16]

• To induce unconsciousness, anesthetics affect the GABA and NMDA systems. For

example, halothane is a GABA agonist,[17] and ketamine is an NMDA receptor

antagonist.[18]

MEDICAL USES OF

INTOXICANTS

Pain management

Psychoactive drugs are often prescribed to manage pain.

The subjective experience of pain is primarily regulated

by endogenous opioid peptides.

Thus, pain can often be managed using psychoactives that

operate on this neurotransmitter system, also known as opioid

receptor agonists.

This class of drugs can be highly addictive, and

includes opiate narcotics, like morphine and codeine.[19]

NSAIDs, such as aspirin and ibuprofen, are also analgesics.

These agents also reduce eicosanoid-mediated inflammation by

inhibiting the enzyme cyclooxygenase.

MEDICAL USES OF

INTOXICANTSMental disorders

Psychiatric medications are psychoactive drugs prescribed for the management of mental and emotional disorders, or to aid in overcoming challenging behavior.[20]

There are six major classes of psychiatric medications:•Antidepressants treat disorders such as clinical depression, dysthymia, anxiety, eating disorders and borderline personality disorder.[21]

•Stimulants, used to treat disorders such as attention deficit hyperactivity disorder and narcolepsy, and for weight reduction.•Antipsychotics, used to treat psychotic symptoms, such as those associated with schizophrenia or severe mania, or as adjuncts to relieve clinical depression.•Mood stabilizers, used to treat bipolar disorder and schizoaffective disorder.•Anxiolytics, used to treat anxiety disorders.•Depressants, used as hypnotics, sedatives, and anesthetics, depending upon dosage.

In addition, several psychoactive substances are currently employed to treat various addictions.

These include acamprosate or naltrexone in the treatment of alcoholism, or methadone or buprenorphine maintenance therapy in the case of opioid addiction.[22]

Exposure to psychoactive drugs can cause changes to the brain that counteract or augment some of their effects; these changes may be beneficial or harmful.

However, there is a significant amount of evidence that relapse rate of mental disorders negatively corresponds with length of properly followed treatment regimens (that is, relapse rate substantially declines over time), and to a much greater degree than placebo. [23]

Medicines from animal origin in the British

Pharmacopoeia.

ANIMAL-BASED PRODUCTS

BP 2012 contains around 3200 monographs.

Only 129 considered as haram substances.

Most vaccine, blood preparations, and homeopathic

preparations considered as Mushboh.

27 monographs prepared from porcine or pig only (red list).

13 monographs prepared from Bovine.

55 monographs prepared from animal sources (all

mammalian and include porcine and bovine).

There are some medicines we called them

red to green medicine which have a halal

alternative now but we still have the haram

source.

The halal source come from chemical

synthesis and analogues (44 monographs)

And from recombinant DNA technology (11

monograph)

2 monographs from insects.

13 monographs from animals without killing the animal

(bear, horse, rabbit).

13 monographs from human (woman urine and bloodplasma).

1 monograph from bird and chicken.

There are few monographs from halal sources and we

mention here because it’s from animal sources:

16 monographs from marine sources (fish, salmon, shark,

shrimp, and crab).

• The most important Pig based

pharmaceuticals

Pig part Drug derived picture

Brain

ACTH

Brain Natriuretic Peptide

Follicle-stimulating hormone

LH-RH

Luteinizing hormone

Lypressin

Oxytocin

Prolactin

Somatostatin

Somatotropin

TRH

Vasopressin

Cephalins

Pig part Drug derived picture

Heart Prostacyclin

Liver

Arachidonic acid

Uricase

Calcifediol

Pig part Drug derived picture

StomachPepsin

Mucins

Small intestine Trypsin

Pig part Drug derived picture

Bone, cartilage

Gelatin [bone]

Iseganan [bone marrow]

Chondroitin sulphate

[cartilage]

Fat

Glycerol

Stearic acid

Lard

Pig part Drug derived picture

Intestinal mucosa

Castle’s intrinsic factor

Dalteparin

Danaparoid

Enoxaparin

Enterogastrone

Heparin

Nadroparin

Reviparin sodium

Sulodexide

Tinzaparin

Pig part Drug derived picture

BileCholic acid

Chenodiol

Duodenum Secretin

Pig part Drug derived picture

Thyroid Calcitonin

LungsDefribrotide

poractant alfa

Pig part Drug derived picture

OvariesEstradiol

Relaxin

Submaxillary glands Kallikrein

Pig part Drug derived picture

Pancreas

Amylase

Chymotrypsins

Glucagon

Insulin

Kallikrein

Lipase

Parathyroid hormone

Pancrealipase

Semi-synthetic human

insulin

Pig part Drug derived picture

nervous system,

connective tissue,

general organs

Gelatin

Gangliosides

Cephalins

NEXT- THE HALAL PHARMACOPOIEA

Halal Ingredients Standards

Halal built in, rather that tested for

Detail scientific & technical features

Emphasis on origin of compound

Authentication procedures

Halal standards for regulatory, industry and research

Fiqh issues- Haram to Halal

Istihalah =transformation physical & chemical (eg. gelatin issue)

Istihlak (halaka) or "extreme dilution“ (vaksin production)

Istislah, or maslaha(h), can be translated from Arabic as "public interest;"

it is a basis of Islamic law. According to necessity and particular

circumstances, the practice of maslaha(h) or Istislah, consists of

prohibiting or permitting something on the basis of whether or not it

serves the public

Istiḥsan (Arabic: استحسان )is an Arabic term for juristic "preference". In its

literal sense it means "to consider something good". Muslim scholars may

use it to express their preference for particular judgements in Islamic law

over other possibilities.

Jalalah animals =haram feeds on halal animals

Umum balwa= 'general al-balwa', ie an accident or difficulties prevalent

and difficult to avoid.

ISTIHALAH AND ISTIHLAK IN PERSPECTIVE

LATIF, Mariam Abdul

December 2013

International Journal of Health & Nutrition;2013, Vol. 4 Issue 3, p14

ABSTRACT

The halal food industry is unique and is so diversified that standards need to be developed to set as a reference where Islamic values need to be maintained throughout the whole food supply chain. Often issues on sources of halal ingredients had been very complicated and new terminologies such as "Istihalah" and "istihlak" further compounded

the confusion. Basically, the concept of Istihalah (hala) refers to "substantial change" or "complete transformation" when

a substance is converted into a new substance, the lawfulness of the new substance is not determined by the lawfulness of the original substance. This is the case when a dead pig is buried under an apple tree, the apples from that tree are lawful (halal) for Muslim

consumption. The term Istihlak (halaka) or "extreme dilution" is when a prohibited substance is diluted in a lawful medium to the extent that none of the known properties of the prohibited substance are noticeable in the lawful medium. An example is when an animal urinates in a lake, the water of the lake is still lawful for drinking and ablution (wudhu'), so long as the colour, odour, and taste of the water are unchanged by the urine. As such, the need for more scientific research to clarify the halal status on sources of halal ingredients is very important before a standard on this subject can be drafted, to provide guidance to the industry and the regulatory agencies.

“Istihalah” Application Issues Overview

No

.

Raw material

origin

Process change

(Transformation??)

Product/s Status

1 Carbohydrates

(fruits, cereals

etc.)

Fermentation →

oxidation CH3CH2OH +

O2 → CH3COOH + H2O

Alcohol →

Acetic acid

Haram to halal

2 Livestock feed

(carbohydrates,

proteins, fats,

etc.)

Digestion →

absorption→

metabolism→ storage→

elimination

Milk, body fluids,

blood, excreta,

etc.

Halal & Haram

3 Animal hides,

bones,

connective

tissues

Water Extraction(H+/OH-)→

evaporation →separation → isolation

Collagen,

gelatin

Halal or Haram

based on

source animal.

4 Animal

organs/parts

Extraction→ separation-

→ isolationInsulin, heparin,

enzymes,

hormones, etc.

Halal or Haram

based on

source animal.

5 Blood Extraction → separation

→ isolationbiopharmaceuti

cals

CONCLUSION

Halalan Toyyiban paradigm

Halal built-in rather that tested in

Halal ingredients standards references

Global Halal Pharmacopoeia

Grey lists issues to be resolved amongst Ulama

To insure the Halalness of medicines requires in depth study

of the origin of each ingredient and to assure contamination of

any prohibited material or Haram substance.

Halal is unlimited while Haram is limited and there are

available alternatives to be sought.

The Haram is the exception and everything else is Halal as a

rule.

Haram substances usually from animal sources while the

plant, mineral, and synthetic chemicals considered as Halal.

From around 7000 monographs investigated:

140 red list

260 grey list

Others are considered halal

Even though the number of the haram and masbooh

ingredients are small but the number of the haram or masbooh

in pharmaceutical products are more than 3000.

Gelatin for example is found in 60% of all pharmaceutical

products

The majority of pharmaceutical products can be certified

halal by introducing a halal certification system for the

manufacturers and ensuring halal raw materials are used whilst

preventing the usage of haram raw materials

The introduction of Halal Pharmaceuticals Standards

(Pharmacopoeia) is the first step in fulfilling the Halal Built-in

or Halal by design concept.

THANK YOU