[e-drug] Innovator Pharma companies with Generic manufacturing business (2)

["Michele Forzley" <mforzley@comcast.net>]

E-DRUG:  Innovator Pharma companies with Generic manufacturing business (2)
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Dear Bonface,
Most innovator companies have some sort of arrangement to produce generic
drugs - either the ones they developed or those of others. There is no
complete data base of this information, though it can be organized on  a
country by country basis.  Some donor funded activities such as the MeTa
project are aiming to collect and organize such information, but to date
this has not been done. Your question is but one that could be answered by
such a database.  

The status of a drug in a particular country in terms of 
	1. whether it is on patent or available in generic form, AND
	2. whether a particular dose, formulation and strength of a drug is
registered in the country are two pieces of critical information  necessary to know before a drug can be imported. I refer to imported drugs as most countries do not produce
sufficient quantities of drugs to be free from having to import.

Regrettably this information is not readily available even at the country
level never mind at any other.  It is considered good pharmaceutical
practice to make this information available easily, but in practice
countries do not maintain an electronic searchable list. 

This state of affairs makes the process of any global drug program such as
the Global Fund, SCMS, DNDI, TB Alliance and all the others more difficult
than it has to be, yet for some reason no funding has been made available to
organize this information along with the legal and regulatory information
one must be able to access as well.  There has been a call for this
information too. As the project director of database that is designed to
collect the legal and regulatory material, I certainly hope this situation
can be addressed soon. I wish you luck in your search and if you find
something, please let me know. 

Yours,
Michele Forzley, JD, MPH
Director IPHLIP
Forzley & Associates - Global Public Health Lawyers and Consultants
301-565-0680
Silver Spring, MD USA 
"Michele Forzley" <mforzley@comcast.net>