PROCAARE: Release of Antiretrovirals, India

[procaare@usa.healthnet.org]

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.]

KEYWORDS: Therapy, Drug Formulation, Saquinavir, Release, Marketing, India
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