[e-drug] WHO prequalification withdrawals and bio-tests. A total

["Francisco Rossi" <francisco_rossi@hotmail.com>]

confusion
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E-drug: WHO prequalification withdrawals and bio-tests. A total
confusion
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Dear e-druggers:

I was very uncomfortable about the announcements of WHO, delisting of 
Ranbaxy products from the prequalification system. On one hand it is a 
message for the public opinion in the world. Generic products (you can
add 
from India) have quality problems. And it is very useful for some 
international strong campaigns questioning the quality of generics in 
general, and generic ARVs. The intricate issues about bioequivalence are

not matter of public domain, and it was the main message.

In the other hand, WHO announcement is very confusing.  Products were
removed 
from the list, and WHO recommend ..,"not buying, and products ordered
-but 
not received- should be not accepted".  At the same time, WHO explains
in 
the same document, that products "May or may be not bioequivalent (it is
the 
reason for the withdrawal)  BUT DO NOT HAVE QUALITY PROBLEMS". In 
consequence, WHO recommend to countries with people under treatment with

these drugs, not to suspend or change the products.  Very contradictory!

So, Bioequivalence is not a quality test? Not for ARV? This is the point

of view of some of regulatory authorities in the world. I stress this
point 
several times in this network. The more one concept is complex and hard
to 
understand, the more it is misused for interested parts.

But one must ask some questions. As far as I know, one ARV product from
CIPLA, 
that was withdrawn a few months ago, IS NOW RE-LISTED. I didn't 
see any press release with the same emphasis then than when the product
was 
withdrawn. It is not fair with the public image of generics.

But it means that a CIPLA product was OK until WHO detected the problem
in 
the bio-lab, was substandard for a few months, and now is OK again?  Is
it 
serious?  What is expected to happen in a few months, when Ranbaxy 
re-present new Biostudies? If products are OK, WHO generated a major 
problem to supply systems in a lot of countries, eroded the image of
generic 
drugs in the world, and unnecessarily concerned people under treatment
with 
these drugs.  Some of these side effects may be do not ever roll back.

If they are not bioequivalent, what is the final decision? They do not 
have quality problems but they are not bioequivalent, and can be
recommended 
for HIV AIDS programs?  In this case, the prequalification system was 
misusing bioequivalence tests unnecessarily. As I think they are. And it
was 
very useful for the innovators.

Maybe it is important to point out that the Brazilian program against
AIDS, 
probably the best program in the world, is using NON- bioequivalent ARV.

With well known results. I just confirmed this information with ANVISA
and 
MOH.

It may also be interesting to share with the people of e-drug, 
an information from PAHO-Colombia. They were consulted by an insurance 
company (in charge of HIV-AIDS patients as a part of the national social

security system) because GlaxoSmithKline is looking for HIV patients,
and 
delivering to each one, a copy of the WHO press release ithdrawing 
"generic"products from the list. WHO, of course, is not reponsible for
the misuse of this kind of decisions. 
But the confusion and technical dificulties are not helping generics
image.

A final question. In the past WHO prequalification system reported
several 
times that the number of products was very low, because they do not have

personnel and time enough to inspect every lab (GMP, GCP, GLP) and to
revise 
the robust documentation. But, they have the time to inspect a
contracted 
lab (the one contracted for the Bioequivalence test) to revise detailed
GCP 
and GLP? It is very unclear. Maybe some phone call?

Francisco A. Rossi. B.
IPR and access to drugs project
International Poverty Center
UNDP - IPEA
SBS. Ed BNDES, 10 andar
70076-900 Brasilia D.F. Brazil
(55 61) 2105 -5005

[Not all regulatory authorities require bioequivalence for all generic
products, only for certain products with small therapeutic window. KM]

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