E-DRUG: A suggestion for improving Access to genuine drugs (6)
I thank Magnus Ajong for his suggestions and statements; I agree that African
nations must institute sustainable production quality-assured medicines. But,
it is not true that nothing is being done.
In Tanzania, the St. Luke Foundation / Kilimanjaro School of Pharmacy teaches a
Professional Certificate Program in Drug Development, cGMP and Quality
Assurance. The program consists of four, two-week courses taught by myself,
Stephen Byrn of Purdue University and Sister Zita Ekeocha. Attendees are from
African Pharmaceutical companies, National Drug Regulatory Authorities and
University faculty. We have graduated 23 Professionals through this Program in
2-1/2 years (6 sessions). With funding from the GTZ and UNIDO; SLF/KSP has
built classrooms and a drug development laboratory (50L scale) for finished
product production. Most industrial attendees have 50% support and academics
100% from the GTZ.
In 2011 we hope to be offering an expanded program towards an MSc degree.
Professor Byrn and I have a great deal of real-life experience with global
pharma, Indian and Chinese generic companies, ICH and the US FDA. The end
objective of this training is to enable companies to achieve WHO PQ, making
them eligible to sell to International Donor Agencies. I love seeing the
companies we train progress towards WHO PQ.
We are certainly not alone in aiming for international standards of cGMP in
Africa. BUT, African countries need some funding (eg, from the Global Fund)
directed to training National Drug Regulators and assuring quality for African
companies and for imported drugs. This is not a lot of funding, but it is not
going to happen unless these are defined as NATIONAL PRIORITIES.
Feedback from the Global Fund, is that they are ready and eager to incorporate
such training into their Programmatic Support, provided that countries
recognize and articulate these needs.
All of you out there who might be able to assist with this ---- those who have
access to their respective National Global Fund Boards --- what are your
thoughts on this?
Joseph M. Fortunak
Chemistry and Pharmaceutical Sciences
525 College Street NW
Washington, DC 20059 USA
+1 202 806 6880 (office)
+1 301 928 7568 (mobile)