Substandard APIs: we must tackle the problem together - Pharmaceutical Technology

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Substandard APIs: we must tackle the problem together
Contrary to what some would have you believe, the use of substandard APIs in European medicines puts patient health and pharmaceutical manufacturers' reputations at risk. Most APIs destined for the EU come from Asian plants that have never been inspected by an EU official. To ensure a minimum level of quality, agencies and regulators from both sides of the Atlantic must work together to provide API compliance oversight.


Pharmaceutical Technology Europe
Volume 22, Issue 6

In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple — we were there to raise a red flag.

We were concerned that substandard APIs were a growing problem and, in our opinion, the root-cause lay in break-neck globalization and rogue players taking advantage of the virtual absence of effective oversight on European laws governing minimum quality standards. We were given 20 minutes, by which time it was made abundantly clear to us that we must be from another planet. We were told that all was well, and that "in the EU the architecture of quality of medicines is firmly based around the Qualified Person and that there is no such issue of substandard APIs in the EU". In several other meetings with the Commission and with the EMEA, we were looked at with disbelief and almost horror every time we raised the spectre of noncompliance as a deliberate business strategy. In between the lines we could read "how can the EU's API industry sink so low as to try to make up for its lost competitiveness by scare-mongering".

Living in the past

During the last few years, the EFCG has worked hard to provide the correct data to EU regulators, but it has been a struggle; in part because EU officials and EU medicines agencies hate to leave their comfort zone and explore new territory where values and society are vastly different from those of Socrates, Beethoven, Pasteur, Galileo or Churchill. Even today in 2009, only at the very top of the European Commission or of the EMEA do we find leadership that is cognizant that EU medicines agencies are obsolete in so far as their oversight role is concerned regarding API compliance; the 27 agencies still inspect on proximity and not on risk. In June 2008, when a newspaper quoted me on this and the head of one of the EU medicines agencies was confronted in a public conference on the matter, my comments were dismissed as unfounded and coming from someone that had little understanding of the operations of EU medicines agencies.

Most regulators still live in the 20th century. During the last 25 years, Europe — with the explosion of off-patent medicines — has moved from being the cradle of the pharmaceutical industry, and the dominant player in the fermentation and synthesis of APIs, to a hasbeen; fermentation has virtually disappeared from Europe and the EU API industry is only thriving because of innovators and because of the US market where tough hurdles set up by the FDA separate the wheat from the chaff.


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