Up to 30 per cent of EU generics 'contain falsified APIs'

On Friday, SecuringPharma, published an interesting article on the quality of active pharmaceutical ingredients (APIs) in European generics.

The European Fine Chemicals Group claims that 20 to 30 percent of the APIs come from unapproved sources.

EFCG board member Guy Villax quoted that figure, which he attributed to EU inspectors, at a press conference at the Conference on Pharmaceutical Ingredients (CPhI) held last week in Madrid, Spain.

This causes a huge challenge to the validity and efficiency of the finished product as a single batch of an API can reach from 10,000 to 1,000,000 patients. Currently a manufacturer receives Good Manufacturing Practice (GMP) certification based not only on their own practices, but those of their suppliers as well. If their suppliers are in reality not as they have stated, you can see how this circumvents the inspection process.

Council of Europe is drafting legislation on counterfeit medicines to be reviewed by 40 countries. However, EFCG does not agree with the current wording of the EU's draft directive which suggests that API manufacturers can be inspected by their own domestic authorities, providing their enforcement systems are deemed 'equivalent' by the EU, i.e. they conform to ICH Q7 and are based on regular inspections.

This would work with countries such as the USA, Japan and Australia, said Villax, but he is concerned that equivalence could be granted for political reasons to other countries where the systems may be prone to fraud and corruption.

We at XStream Systems agree that the quality of the finished product is only as good as the quality of the ingredients that are contained therein. In the United States this was only too evident in last year’s case of tainted heparin, where the active ingredient had been tainted by unapproved suppliers and resulted in the death of over 80 people.

To view the entire article visit: www.securingpharma.com.

GOOD, BAD and UGLY

Charles R. Earl, M.A., ABD
CEO, Communication Connections

A recent article on this site described the attempts by the World Health Organization (WHO) to define “counterfeit” pharmaceuticals. The solution to this quandary seems rather obvious to me. Let’s start with the assumption that only flawed pharmas require definition. The “good’ ones are those that maintain compound and quality integrity and function as they were intended to do. The “bad,” on the other hand, are those that either fail to perform or cause harm because their compounds or quality were inadvertently compromised. Finally, the “ugly” are those counterfeits or adulterations that were intentionally created to cause harm to reap unwarranted profits.

So, the essence of the definitions goes to whether or not the faulty pharmaceutical was the result of intentional or unintentional action. These definitions follow the same distinctions as one would encounter when deciding between first degree murder or negligent homicide as descriptions of culpability. One is a result of malice and forethought while the other comes about because of a lack of diligence, human error or equipment malfunction. The definition of the product falls to the intention of the manufacturer or party who alters the product. Clearly, intention should be determined through the judicial process, and the appropriate remedies should be levied at sentencing.

The bottom line, however, is not the intention behind the flawed product, but rather, the detection and elimination of the “bad” and the “ugly” from the supply chain. Policing agencies and courts can deal with the apprehension and adjudication of the actors who traffic the “bad” and the “ugly.” The industry’s role is to insure that counterfeits and adulterated pharmaceuticals are detected and intercepted prior to their arriving near providers and patients. Bad and Ugly will always be around, but if members of the supply chain commit to protecting the Good from the debilitating effects of the Bad and Ugly, then the entire industry, throughout the supply chain, will prosper.

It has often been said that “the perfect shouldn’t be the enemy of the good.” That statement may have some valiance in politics, football and polka dancing, but it could be catastrophic in pharmaceuticals and health care. The good isn’t good enough. Mere perfection is the only standard.