European API makers are calling on regulators there to get into active pharmaceutical ingredient manufacturing plants in China and elsewhere to insure safety of EU drugs and quit giving their competitors the advantage of not having to meet high standards.
The European Fine Chemicals Group (EFCG) has issued a position paper saying that Europe should have "mandatory inspections of all global API manufacturers" but doesn't have to bear the entire cost. It can work with the U.S. and other countries through mutual recognition agreements, relying on inspections conducted by partners. It is an approach the U.S., Europe, Australia and others are already exploring in the face of the fact that the bulk of API manufacturing is now being done in low-cost countries like China and India that have lagging regulatory watchdog operations.
The EFCG says current rules and a new law that requires drugmakers to audit their suppliers are not going to get the job done.
"Today, about 70% of all APIs consumed in Europe are imported from China and India, where their factories are rarely inspected for compliance with EU standards by EU authorities.
"This has led certain unregulated API manufacturers in developing countries, especially in China and India, to compete aggressively in the market with ~30% lower prices due to lower labor costs and noncompliance with local environmental and safety regulations, for an API quality often less than the required EU standard. Such products can be harmful to health, as they may contain unknown impurities that can provoke side effects or adverse reactions." The paper points to the 80 or more deaths that occurred in the U.S. in 2008 when tainted Chinese heparin got mixed into drugs used in the U.S. Regulators determined that Chinese API makers had used unsuitable ingredients to cut costs.
"There is a big difference in the quality of an audit and an inspection performed by a national authority," the paper says.
The group points out that some players in Europe are worried that when the new audit rule takes effect in July, many API makers will not comply and there will be a shortage of ingredients. But the EFCG says European API makers used to be the key source of ingredients and they are ready to re-open plants and meet whatever demand there is.
- here's a release
- get the position paper here