November 2006 - Pharmaceutical Technology

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November 2006

Pharmaceutical Technology


INSPECTIONS

EFCG and SOCMA Urge More Inspection of Foreign API Makers

CPhI Worldwide, Paris (Oct. 3)—The Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC, http://www.socma.org/) and the European Fine Chemicals Group (EFCG, Brussels, http://www.efcg.cefic.org/) have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field.

SOCMA and EFCG issued a joint position paper about the need for more inspections of foreign API manufacturing facilities (1). The move follows the submission of a citizen petition to the US Food and Drug Administration (Rockville, MD, http://www.fda.gov/) by SOCMA's Bulk Pharmaceuticals Task Force, which also asks the agency to increase inspections of drug manufacturing facilities located outside the United States. SOCMA is the US-based trade association representing chemical batch and custom manufacturers.

The EFCG also has taken an active role in raising concerns over the preparedness of European Union (EU) and the European national regulatory authorities in implementing recent EU legislation. The law requires that all medicines marketed in the Union be made with APIs that comply with the harmonized GMP standard ICH Q7. EFCG had drawn attention to the need for increasing foreign-inspection resources and improving enforcement measures by EU and national authorities (2, 3). EFCG is part of the European Chemical Industry Council (Brussels, http://www.cefic.org/), the European trade association representing chemical manufacturers. EFCG consists of 200 companies and six trade associations representing European fine chemical companies.

Specifically, SOCMA and EFCG are calling for increased foreign inspections based on the changing pattern of API supply into the United States and the EU.

"Globalization has caused unprecedented pressure on prices and margins and has driven ... generic and OTC companies to buy their APIs at the lowest cost, often from plants that have never been inspected by any health authority from the EU or US," assert SOCMA and EFCG.

The joint statement further says that the level of foreign inspections has not kept pace with changing supply patterns. "In 2005, FDA conducted 163 inspections of foreign API manufacturers, of which 14 (9%) of the API inspections were in China, 23 (14%) were in India, which is not proportional to the quantity of API being imported," says the SOCMA–EFCG statement. The groups estimate that more than 80% of APIs used by US manufacturers are imported, with about half of the imported volume originating from India and China (1).

"This is an appalling state of affairs considering the amount of medicines (and their precursors) imported into the United States," said Joe Acker, president of SOCMA. "The lack of inspections could mean a large number of unsafe medicines. On top of it all, less enforcement equates to less regulation and provides foreign firms a competitive advantage over US and EU firms that follow the rules."

A similar concern exists in the EU, where the European Directorate for the Quality of Medicines inspected about 80 API manufacturing sites over a seven-year period, with roughly half of those inspections in China and India (1). "The EU is unable to account for the number of manufacturing facilities importing into the Union, without considerations to the number of inspections performed," said the EFCG and SOCMA in a joint statement.

Guy Villax, chairman of EFCG's Pharmaceuticals Business Committee and CEO of Hovione (Lisbon, Portugal, http://www.hovione.com/), addressed recent action by the European Parliament over this issue. "Recently a group of Members of the European Parliament expressed their concern by tabling a Written Declaration requesting the EU to make inspections of manufacturers and importers of APIs mandatory to ensure higher safety standards are met and qualified by a GMP Certificate," said Villax. "I have much sympathy for the authorities here in Europe. They are charged with the responsibility of protecting our citizens' health but are not given enough resources to send inspectors to countries such as India and China to ensure European standards are being met."


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