Dear Syed Rizwanuddin,
Thank you for you interest to know more about what has been
discussed at ICDRA 8. The conference discussed many issues.
To mention a few:
Tripartite harmonization - International Conference on
Harmonization (ICH) which involves three groups of developed
countries: USA, Japan and the European Community;
Agreement on Trade Related aspects of Intelectual Property Rights;
The mission of drug regulatory authorities in a changing environment:
consequences for structure and financning;
Counterfeit drugs;
Computer assisted registration, the challange of biotechnology,
regulatory control and assessment of herbal medicines.
Registration requirements for interchangeable multi-source products
(generics), etc.
The Conference also made recommendations at the end of the meeting.
With regard to counterfeit drugs: participants' presentions were
made on country studies which reflected the existence of
counterfeit drug in both developed and developing countries. Methods
for detecting counterfeit drugs (thin layer chromatography) as well
as other methods of countering counterfeit drugs were presented and
discussed. The workshop also discussed some of the contributing
factors, such as the manufacturing and distribution of drugs in free
ports/free trade zones, counterfeiting of packaging materials, and
relabelling of expired drugs and exporting them to developing
countries as important issues from developing countries perspective.
The meeting recommended that in order to prevent counterfeiting of drugs
the creation of a world-wide network of competent techncial people
will be necessary and there should be adequate exchange of
information between reponsible offers on counterfeit drugs and
countermeasures.
The meeting also acknowleged the need for cooperation between DRAs
and law enforcement offices in each country and the commitment of
political leaders in combatting the problem. As far as WHO is
concerned, a project is currently being undertaken. the
objectives of this project are to assess the problem in
selected countries and to develop countermeasures to combat. So far
a study has been undertaken in one country and a second is planned for
1997. More than 4 consultations of experts have been organized to
develop guidelines which could be used by countries in combatting
counterfeiting. These include, simplified methods for screening
counterfeit drugs; inspection guidelines for detecting counterfeit
drugs, educational guidelines for training analysts and inspectors,
and national implementation guidelines for combatting counterfiet
drugs.
These guidelines are expected to serve as tools in undertaking
corrective measures at national level. It is also planned to conduct worshops for decision makers to create awareness and to
training programmes for analysts and inspectors in 1997.
I hope the above brief information will shade some light on what was
discussed at the conference and what WHO is doing at the moment. In
case you need further information please don't hesitate to contact us.
Also if you have any information please forward it to us. We are all
against a common enemy.
Sincerely yours,
Eshetu Wondemagegnehu
WHO/DAP
email: wondemagegnehue@who.ch