WASHINGTON, DC - As a global army of customs officials pledges to fight drug counterfeiters, Italy is launching an effort that may provide an assist. The Italian Medicines Agency is working with drugmakers and the Farmindustria trade group on a drug quality and safety project that it announced at the Italian Embassy in Washington this week.
Guido Rasi, direttore generale at AIFA, says the goal of the project is to develop "an alternative platform to those currently established" for evaluating drug chemicals and drugs' chemical-physical parameters. The platform will be useful not just in identifying counterfeits, but also in analyzing generic and biosimilar drugs for pharmaceutical equivalence or qualitative-quantitative correspondence on active ingredients, he says, as well as bioavailability.
Rasi says in an interview that project teams will analyze currently available technologies, including spectroscopy and chromatography, "to find the best, or the best combination," for drug analysis. AIFA will identify and validate these methods, which he expects will provide both "higher scientific credibility and cost-effective analysis." - George Miller