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