Transcript Presentation by Bale Mwamba Provincial

MeTa, Solwezi
27 August,2013



A branded- name drug product is originally
discovered and developed by a
pharmaceutical company.
Branded-name drugs are marketed
exclusively by the innovator company.
A branded drug is an intellectual property
,therefore it is patented. A Patent may have
duration of up to 20 years.



Branded-name drugs are labelled under
Trade/Proprietory names and the
manufactures name.
Coartem(Artemether/Lumefantrine)-Novartis
Viagra(Sildenafil Citrate)-Pfizer


Generic drugs are copies of branded-name
drugs with the same high
quality,purity,strenghth and intended use as
branded-name drugs.
The term Generic drug also referrers to any
drug marketed under its chemical name
without advertising.


Generic drugs are labelled under an adopted
name(non-proprietary name) and the
manufacturers name.
Generic drugs are manufactured and Sold by
other pharmaceutical companies, after the
patent for the innovator company has
expired.





Contain the same active ingredient.
Have the same strength
Same dosage form(tablet, suspension or
injection).
Same route of administration(oral, injectable)
Both attain the same blood concentration
after intake(Bioequivalent).

Branded-name and Generic drugs have to
pass through the same quality standards
required by the drug regulation authority.
Inactive ingredients
 Shape
 Colour
 Taste
 Preservatives
 Packaging
 labelling

1.Advantages
 Easily accessible.
 Affordable.
 Inc
 increase access to health care for the
majority.
2.Disadvantages
 Not all branded name drugs have generic
counterparts

Some patients are brand-name specific



Substandard medicines are products whose
composition and ingredients does not meet
correct scientific specifications and which are
consequently ineffective and often dangerous
to the patient.
Causes of Substandard medicines
Negligence during manufacture, distribution
and storage.




Human error
Insufficient human resource
Financial resources
Counterfeiting



Counterfeit medicines are Substandard
medicines that are deliberately and
fraudulently mislabelled with respect to
identity and/or source.
All counterfeit medicines are substandard,
but not all substandard medicines are
counterfeit.
Types of counterfeit medicines;





Products with correct active ingredient but
fake packaging.
Products with wrong
ingredients(active/inactive).
Products without active ingredients.
Products with insufficient active ingredients.
Counterfeiting can apply to both Brandedname and Generic medicines.




Poverty-high prices of medicines and high
price differentials between identical.
High demand.
Low production costs.
Absence of deterrent legislation.





In developed countries:
New drugs
Expensive lifestyle medicineshormones,steroids,antihistamines
In developing countries;
Those that are used to treat life threatening
conditions such as Malaria,Tuberculosis and
HIV/AIDs.


The internet is also becoming one of the
major sources of counterfeit medicines.
Of all drugs in the world,Viagra is the most
counterfeited medicine.



Treatment failure.
Drug resistance-resulting from drug resistant
pathogens.
Most cases leading to death.



Counterfeit medicines make up 10% of the
global medicines market and are present both
in developed and developing countries.
25% of the medicines consumed in poor
countries are counterfeit or substandard.
Global earnings from counterfeit medicines is
over $32 billion dollars annualy.







Where ;
Drug regulation and control is weak.
Enforcement scarcity
Supply of medicines is erratic
Drug markets are unregulated
Medicine prices are unaffordable
The countries include those in Africa, south
America and south east Asia.



Lack of regulation and enforcementsmuggling and illegal importation.
increasing national and international trade in
alternative medicines/herbal medicinesherbal medicines are highly unregulated
Some policy makers believe drug regulation
presents unnecessary barrier to trade and
should be reduced to minimum.

Medicines exported from industrialised
countries are not regulated to the same level
as those consumed domestically.


Establishing competent national drug
authorities with necessary human and other
resources to control the
manufacture,importation,distribution and
sale of medicines.
Government to develop strategies to reduce
corruption and criminal activity and promote
intersectoral cooperation between regulatory



authorities, the police,customes services and
the judiciary to effectively control the drug
market and enforce regulation.
Increasing public awareness.
Harmonizing measures between trading
countries.
Pre-qualification-Assessing products and
manufactures and ,providing a list of those
meeting WHO guidelines to countries and
procurement agencies, in order to promote
procurement of quality medicines.