[Ip-health] The Lancet: The important world of drug prequalification

[Sean.HEALY@geneva.msf.org]

THE LANCET
Volume=A0364,=A0Number=A09448=A0=A0 =A0=A020=A0November=A02004

         =A0Editorial


The important world of drug prequalification


On Nov 9, Ranbaxy Laboratories in India voluntarily withdrew all its seven
antiretroviral drugs from WHO's prequalification scheme. This list of drugs
is a little known (outside the world of essential drugs) but vital part of
drug delivery in the developing world. Earlier this year, three of
Ranbaxy's and two of Cipla's (also in India) antiretrovirals were also
de-listed.


What is the prequalification scheme, and why is it important? The scheme is
run by the Quality Assurance and Safety: Medicines (QSM) team, part of
WHO's Essential Drugs and Medicines Policy department. Much of QSM's work
is the development, harmonisation, and promotion of international standards
to ensure quality, safety, efficacy, and rational use. In particular, QSM
manages the prequalification of drugs and manufacturers for antiretrovirals
for WHO, UNICEF, UNAIDS, and UNFPA, antituberculosis drugs for WHO and the
Stop TB Partnership, and antimalarials for WHO and Roll Back Malaria.


Both the drug and the manufacturing site have to be prequalified. Once on
the list, the drug and manufacturer are considered eligible to supply
drugs. Manufacturers are inspected for compliance with good manufacturing
practices. The inspectors are from drug regulatory authorities from the
European Union, Canada, and Switzerland, and they work with regulators from
the developing countries where the medicines will be used. The
prequalification assessment also evaluates in-vivo bioequivalence tests
done by the manufacturer, and QSM also provides local training.


Ranbaxy withdrew its antiretrovirals after finding discrepancies in the
documentation about the drugs' bioequivalence. The company hopes to
resubmit new data by the end of this year. The withdrawals earlier this
year came after inspections at contract research organisations showed
serious discrepancies between the original bioequivalence data and the
results presented, and because of non-compliance with good clinical and
laboratory practices.


WHO is, of course, presented with an immediate dilemma, because an
alternative supplier is not always available. Thus WHO recommends that
patients continue using the de-listed product, because the risk of
withholding treatment is higher than that of providing medicines whose
bioequivalence is not proven but which have otherwise been prequalified. A
switch to non-prequalified drugs is not recommended.


So the latest news of the withdrawal of much-needed antiretrovirals from
the prequalification list is both bad and good. Bad, obviously, for the
patients and health carers affected locally. But good news because it shows
that this little known part of WHO is effective and has teeth that can bite
rapidly. QSM is a small team at WHO's headquarters that knows the
importance of training local drug regulatory authorities, and has the
ability to use international inspectors in local sites. And
prequalification status means that some of the most important drugs are
being made safely available in parts of the world where they are most
needed. * The Lancet

****************************************
Sean Healy
Information Officer
Campaign for Access to Essential Medicines
M=E9decins Sans Fronti=E8res
Geneva, Switzerland
tel ++41-22-8498 401
fax ++41-22-8498 404
mobile tel ++41-79-239 9271
sean.healy@geneva.msf.org
www.accessmed-msf.org