SOCMA and EFCG call for more inspections of foreign API facilities

Even though 75-80% of all APIs used by EU and US medicine manufacturers are imported, most of the facilities where they were manufactured have never been inspected to ensure they conform to GMP standards.

Even though 75-80% of all APIs used by EU and US medicine manufacturers are imported, most of the facilities where they were manufactured have never been inspected to ensure they conform to GMP standards.

The threat that this represents in terms of patient safety and national security has led the US-based Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group (EFCG), part of CEFIC, to published a joint position paper entitled Uneven Enforcement Leads to Sub-par Drugs and National Security Risks.

'The EU has no foreign inspection service, no budget, no mandated body, no visible enforcement and therefore offers no deterrent,' said Guy Villax, chairman of the Pharmaceuticals Business Committee of EFCG. 'The authorities simply don't know who makes the APIs. And when the European Directorate for the Quality of Medicines (EDQM) suspends a Certificate of Suitability (COS) because of proven GMP non-compliance, there is no common procedure across the EU: medicines agencies across the EU are not always advised, and medicines made with suspended COS remain on sale.'

And although the FDA has a strict pre-approval foreign inspection service and inspects 100% of API producers for prescription medicines, there is no enforcement of GMP compliance for producers of APIs for otc medicines. Furthermore, FDA inspectors are reputedly the toughest but inspections by FDA abroad are announced in advance and are of short duration.

'This is an appalling state of affairs, considering the amount of medicines and their precursors imported into the US,' said SOCMA president Joe Acker. '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.'

By allowing an uneven playing field in which foreign companies benefit while domestic companies suffer, the suffering companies - if forced to suffer long enough - go out of business, Villax warned. It also implies the loss of a secure domestic source of pharmaceuticals in the event of a disruption in one or more of the countries the US and EU are becoming so dependent upon for their pharmaceutical needs - whether caused by terrorism, civil war, pandemic or natural disaster.

The 'Asianisation' of API production has caught the regulators by surprise, according to EFCG and SOCMA. The change has occurred so fast that the authorities have not yet been able to address the issue.

  • The joint position papers therefore calls for the following:
  • More inspections where GMP compliance is less likely
  • No medicine to be on the market unless its Marketing Application includes a GMP certificate for the API used
  • No loop-holes: all APIs for all medicines should be inspected
  • Inspections should be of same thoroughness independent of location
The paper has now been tabled at meetings in the US with Congress, US Commerce Department and committees with FDA oversight; and in the EU with the the Commissioners for Public Health, Trade, Enterprise and Defense, EMEA and heads of agencies, as well as other trade associations and patient organisations.

Villax warned: 'The competitive pressures are such that, in the absence of enforcement, the least scrupulous operator succeeds.'

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