DRUG LEGISLATION AND

REGULATION
Walter Moyo
(BScNMid student, year III 2013), under supervision
of Mrs E. Chilemba.
objectives
 Describe drug legislation/regulation
 Describe some drug regulations in Malawi
 Explain the drug approval process
 Describe systems of drug naming
 Discuss the drug schedules
Drug Legislation
 Drug legislation refers to enactment of laws
and regulations that help in controlling drug
production and use.
 It helps to regulate, authorize, declare and

restrict use of different drugs, thereby

protecting public health.
 Different countries have different laws that

relate to drug use (e.g. In Netherlands, Indian

Hemp is legal).
drug legislation contd…
 The control of drugs is exercised at different
levels: international, national, regional,
institutional, etc.
 Drugs are regulated in terms of their efficacy,

safety and risks and benefits- (

www.ncbi.nlm.nih.gov).
Drug legislation in Malawi
 The regulatory body for drug production and
use in Malawi is the Pharmacy, Medicines &
Poisons Board. It developed the Pharmacy,
Medicines and Poisons Act, which provides
for different aspects of drug handling such
as: running of pharmacies, handling of
medical/medicinal products, list of poisons,
inspection of drugs, etc.
drug legislation in Malawi contd…
Examples of provisions in the Act:
i) When a drug is being marketed, all its
necessary details should appear on its data
sheet (such as its names, side effects,
directions for use, dosages,
contraindications, etc)
ii) Operators of commercial pharmacy
businesses should be well qualified and
registered with the board.
drug legislation in Malawi contd…
iii) Permission should be sought from the
board before any drug can be tested
iv) Prescription-Only-Medicines should not be
sold anyhow or by anyone.
v) Premises carrying out pharmacy businesses
shall meet minimum requirements of storage
facilities, staffing, etc.
… and many other regulations (refer to the
Pharmacy, medicines and Poisons act).
Drug Approval Process
 It is the process through which any new drug
should pass before it is accepted for
manufacturing/use.
 It has four main phases: discovery, pre-

clinical research stage, clinical research stage

and New Drug Application review.
i) Discovery: This is when scientists find out
new agents that can be of therapeutic/clinical
use. Discovery may be accidental or not.
drug approval process contd…
ii) Pre-clinical research stage: This is when the
drug is first tested (usually on non-human
organisms), to determine its mechanisms of
action, effectiveness, etc. Permission-seeking
mostly begins at this stage.
iii) Clinical research stage: This is when the
drug is tested on human beings. Several
ethical issues come into question at this
stage.
drug approval process contd…
Iv) New Drug Application review
This is when the national regulatory body
reviews the application made by the
proposers working on the new drug. The
application includes the methods used in
testing the drug, the duration of the process,
etc.
Drug Nomenclature
 This refers to systems for naming different
drugs and other pharmaceutical substances.
 Its purpose is to help prescribers,

manufacturers and users of drugs (and also

the general populace) to communicate about
drugs.
 There are 3 main names for drugs: i) chemical

name ii) generic name (nonproprietary name)

and iii) brand name (trade name)
drug nomenclature contd…
i) Chemical name: It describes the
composition and structure of the drug at
molecular level. It is usually complicated
and not practically usable, except among
chemists.
ii) Generic name: It is a simpler name, and is
derived from the chemical name. It may
contain some prefixes or suffixes of the
chemical name. It is the most widely used.
drug nomenclature contd…
iii) Brand name: It is the name which the drug
manufacturing company uses to market the
drug. It may or may not be derived from the
chemical/generic names. This name is usually
a registered trademark of the manufacturing
company.
DRUG’S CHEMICAL GENERIC NAME BRAND NAMES
NAME

N-acetyl-p-aminophenol acetaminophen Panadol, curamol,

tylenol

(R-S)-2- (4- ibuprofen Brufen, bufen,

methylpropylphenol) iprofen, motrin
propanoic acid)
A B C
Drug Schedules
 These are classifications that have varying
qualifications for a drug to be included in
each. They vary from country to country.
Different countries have different drug
schedules, however some countries may use
scheduling systems of other countries. Some
countries have 5 drug schedules, others 8,
and others 10. In general, the schedules
contain such classification systems as:
drug schedules contd…
 Controlled drugs, over the counter drugs
(OTC), prescription-only medicines (POM),
etc.
conclusion
 Drug legislation is important to protect
people from improper drug use.
 Drug legislation is carried out at different

levels.
 Drugs pass four stages before being

approved.
 Drugs have 3 major naming systems.
 Drugs are categorised into schedules as

defined by the national laws.

references
 Malawi Pharmacy, medicines and Poisons Act
 www.ncbi.nlm.nih.gov).
Any questions?
“Keep healthy and let that be
your medicine”- Hippocrates