E-DRUG: Demand for 2 originator ARVs could soon exceed supply (3)
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It is reported that both Cipla and Ranbaxy have registered Stavudine 30 mg
and 40mg in Malaysia which is a PICS country. If so, these products would
be eligible for purchase through the Global Fund and World Bank, via their
"stringent registration" quality standard. As PICS-approved drugs, they
should also be eligible for purchase under the PEPFAR program, which at
least originally was willing to accept registration by other stringent
regulatory authorities. Perhaps we should double-check whether PEPFAR
considers these two products eligible for purchase despite not being FDA
approved (fast track or otherwise).
Professor Brook K. Baker
Northeastern U. School of Law
Boston, MA 02115
USA
Tel +1-617-373-3217
B.Baker@neu.edu