E-drug: Country of origin (cont)
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[copied back from "RegAffairs" <RegAffairs@ade5.pa.man.ac.uk>]
Dear Dr. Reggi:
In your excellent response you several times question why a company
would manufacture a drug in country A, package in country B, and sell in
country C.
In my extensive world-wide auditing/consulting I see this many times and
for many reasons. I have seen:
bulk active drug manufacture in country A
exceipeint manufactures in countries B, C, D
final tablet dosage form (uncoated), country E
final table spray coating, country F
final blister packaging, country E
final packaged product sold in country G
Reasons for the above are (pick any one or all, I've seen these in play at
various times in various situations):
a. the spray coating technology was unique and proprietary, but it did not
pay to replicate the technology in country E (where the tablets were made)
b. the company has established "centers of excellence" and finds better
quality is achieved by utilizing these "centers" (e.g. country F)
c. country F has an ultra-cheap labor pool and no taxes for in-process work
that will be exported out of the country (eg Mexico and its maquiladora
arrangements for processing of US"in-process" materials)
d. the company is playing the old "intercompany transfer markup" game,
adding "cost" at each transfer which "justifies" an exorbitant final sales
price
e. taking advantage of tax concessions and maximizing profits to the company
Often reasons d.+ e. above are the dominant motivations for these
situations. These practices are not just restricted to the large
multi-nationals, but are employed by some midsize companies
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Michael Anisfeld Specialists in mock-FDA and GMP audits,
Interpharm Consulting Quality Assurance System Design, Training
1358 Busch Parkway *** web-site: www.interpharm.com ***
Buffalo Grove IL 60089, USA Ph: USA +1+847 459 8480 Fx: +1+847 459
6644
e-mail: anisfeld@ix.netcom.com
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