E-drug: Release of Antiretrovirals, India
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(copied from PROCAARE discussion list with thanks)
I am a physician involved in HIV/AIDS care at a large tertiary
referral hospital. Recently a substantial number of patients are
willing to take three drug combinations inspite of the expense.
Except ZDV all the drugs have to be procured from the underground
market.
Recently Roche registered it's protease inhibitor Saquvinavir in
India. The recent federal guidelines have included saquvinavir only in
alternative regimens due to the current hard gel formulation having
only 4% bioavailability. In fact Roche itself is now bringing out a
soft gel formulation which seem to be showing promising results. This
may have lead to decreased use of the hard gel formulation in the
West. In spite of saquvinavir existing for around three years, why is
the hard gel formulation being registered in India now? Even if it is
an alternative drug the cost remains the same as that of other
protease inhibitors. In addition having saquvinavir alone has no
meaning because only other drug available is ZDV. This would lead to
improper combinations or may even be used as monotherapy. I think
seperate policies need to be developed to scrutinize the launching of
antiretrovirals in developing countries.
It is important to develop a mechanism through which antiretrovirals
no longer popular in the west be prevented from being dumped in the
developing world. Also the most important issue of cost also needs to
be taken into considration by the companies. I would like to hear
more about these issues.
Dr.Sanjay Pujari
HIV Clinic
Ruby Hall Clinic
Pune
India
e-mail: pmrf@giaspn01.vsnl.net.in
[Who decides what drugs are released and when? The Indian government?
Roche? What incentives can be provided to drug companies to release
their
antiretrovirals to all markets globally? - Mod.PROCAARE]
KEYWORDS: Therapy, Drug Formulation, Saquinavir, Release, Marketing,
India
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