The SOCMA-EFCG statement specified that the level of foreign inspections has not kept pace with changing API supply patterns.
In 2005, the associations specified that FDA conducted 163 inspections of foreign API manufacturers, of which 14 (9%) were
in China and 23 (14%) were in India, which was not proportional to the quantity of APIs being imported (3).
A similar concern exists in the EU, where the European Directorate for the Quality of Medicines inspected about 80 API
manufacturing sites during a seven-year period, with roughly half of those inspections in China and India (3).
1. P. Van Arnum, "The Changing Fortunes of APIs," Pharm. Technol. 31 (1), 52–58, 2007.
2. R. Silver, "A Wall Street Perspective on Generics," Generic Pharmaceutical Association Annual Meeting, Phoenix, AZ, Mar.
3. "Uneven Enforcement Leads to Sub-par Drugs and National Security Risk," European Fine Chemicals Group (EFCG, Brussels,
Belgium) and the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC), Aug. 22, 2006.
4. G. Villax and C.Oldenhof, "Global API Sourcing: What is Next for Suppliers to the European Union," Pharm. Technol. Sourcing and Management 2 (7), e10–e19 (2006).
5 P. Van Arnum, "EFCG Looks to Add Muscle to New EU Directive on APIs," Pharm. Technol. Sourcing and Management 2 (3), e14–e20 (2007).