Dr Bibiana Campos-Seijo

The good news is that with mounting concerns from industry bosses comes pressure for EU regulators to take tougher action. Consequently, the European Commission (EC) has decided to finally sit down and write up draft legislation that will regulate the imports of APIs into Europe, curbing substandard APIs. Here, however, we are dealing with two issues at the same time: imported drug products and substandard products.

With regard to imported products, EU legislation obliges EU drug manufacturers to use APIs prepared according to GMP standards, regardless of their country of origin. However, while EU plants are subjected to regular inspections, audits are rarely conducted in sites outside the EU. Therefore, Chinese and Indian manufacturers are exporting APIs, which they claim to be GMP compliant, into Europe without their sites, systems and processes ever being under scrutiny. It is only fair that the EC, at risk of stretching its resources, has promised to conduct more audits in foreign API manufacturing plants to validate their claims.

An example of this is the much talked about heparin case, where contaminated heparin was traced back to deficient (substandard?) intermediates in the early stages of production. If you are hoping to establish a trading relationship of some sort, it is very foolish (and irresponsible) to knowingly supply substandard products to a Western buyer that is very likely to discover any deficiencies. It is business suicide! My impression of the story is that the product supplied was simply substandard rather than counterfeit, as the intention of the supplier was not to defraud the buyer. Am I being naïve?

Send your questions and comments by email to bcampos.seijo@advanstar.com