E-drug: French drug firm pleads guilty (cont'd)
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Dear friends,
Cefaclor made in Romania? This sounds embarrassingly familiar.
The only possible source is the former state-run plant of
"Antibiotica" in Iasi near the Moldovian border. When I was a
EU/Phare consultant for the "reconstruction of the pharmaceutical
sector in Romania" in 1999-2000, the management of Antibiotica
steadfastly refused to cooperate with the National Drug Policy
programme. Because they produced many sophisticated drugs
which were not needed in this nearly bankrupt country I
recommended to close down most production facilities and let the
manufacturer restrict his activities to penicillin and derivatives; there
was already a huge problem with MSRA so we warned against the
unbridled use of cephalosporins. Several pharmacy professors from
Iasi University were members of our group, and from them I heard
the most horrifying stories about Antibiotica; rats running around in
the warehouses, raw materials lying around on the premises in the
sun, with fluid leaking from the packaging material, etc. We
requested a GMP inspection but were told that the factory had
received a GMP certificate from the Drug Agency in Bucharest, and
that a visit was not opportune.
I do not know how the situation is at present, but the issue should
be taken up by the EMEA if Romania wants to become a honest
member of the EU.
Best wishes,
Dr.L.Offerhaus
Koedijklaan 1a
1406 KW Bussum
The Netherlands
Phone +31-35-6923288
Fax +31-35-6923277 (number changed since 1.11.01)
E-mail: lo@euronet.nl
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