Further US FDA Approvals Secured for PEPFAR

The US FDA continues to approve antiretroviral (ARV) drugs for distribution under the US government's US$15bn anti-HIV/AIDS initiative, PEPFAR. The role of international generics makers is becoming an increasingly important factor in the scheme, which grants accelerated generic drug approvals for use outside the US.

In South Africa, foreign joint ventures between local companies and international generics makers have allowed the domestic sector to play a greater role in both government and international efforts to combat the disease. South Africa's Aspen PharmaCare, following a recent ARVs production joint venture with India's Matrix Laboratories, will now be able to boost output significantly. Indeed, the US FDA recently certified Matrix's Indian active ingredients manufacturing facility, reportedly one of the largest in the country.

Although there has been a welcome increase in of the low-cost medicines needed to supply HIV/AIDS pandemic areas, there will be suspicions that major international orders for the companies involved in PEPFAR and other schemes, which include Indian generics giant Ranbaxy, may have possibly unforeseen side-effects. Indeed, very few generics makers are exclusively devoted to ARVs manufacturing, and international ARV supply programmes could be seen as an opportunity to enter new markets for generics in other therapeutic areas.