"Public standards for such medicines are urgently needed to help ensure that patients in all parts of the world have access to good quality medications," said Roger L. Williams, M.D., USP executive vice president and CEO. "These international standards will make it easier for healthcare organizations in countries without sufficient regulatory and pharmacopeial resources of their own to ensure the quality and purity of medications."
The World Health Organization estimates that 1 billion people -- one sixth of the world's population -- suffer from neglected tropical diseases. Widespread counterfeiting and distribution of sub-standard drugs has worsened this situation.
The initial two drugs included in the International Standards program are used in the treatment of HIV-AIDS: Abacavir Sulfate, and Efavirenz. These monographs are posted in draft form, with a 90-day period for public comment that ends on April 30, 2007. Instructions for submitting comments are at http://www.usp.org/internationalStandards/. Monographs for drugs used to treat malaria will be added shortly as part of the ongoing program.