INSIGHT: EU moving in the right direction on rogue APIs

19 December 2008 17:21  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS news)--Both the consumer and the chemical industry will benefit if tougher control of rogue active pharmaceutical ingredients in Europe is eventually approved, although new rules could take at least two years to come into force effectively.

The influx of counterfeit medicines into the EU is rising and last year topped 2.5m packages.

We have not yet had a major fake drugs scare but, as the European Fine Chemicals Group (EFCG) pointed out last week, the majority of pharmaceuticals are now off-patent and the industry has become intensely global and hypercompetitive.

Never has the need for tougher laws and effective law enforcement been more compelling to ensure the safety of APIs and a level playing field, it said.

Because good manufacturing practice (GMP) has not been effectively enforced on a global basis the growth of non-compliant manufacturing facilities which make substandard active pharmaceutical ingredients (APIs) has been encouraged.

The problem has become steadily worse although calls for pharmaceutical makers and the fine chemicals businesses that supply them on both sides of the Atlantic to do something about it appear to have been heeded.

Most of the APIs consumed in Europe now come from Asia but ‘rogue’ APIs potentially could do much harm to Asian producers as well as their domestic European competitors.

So news of the establishment of an International Cooperative API Inspection programme has been welcomed.

It has been designed, the EFCG and the Active Pharmaceutical Ingredients Committee (APIC) say, to coordinate the use of limited inspection resources, drawn from Europe, the US, and Australia, in higher risk third countries in the immediate short term.

“This extended, global API inspection activity, especially if targeted on higher-risk geographical areas, should begin to stop the inflow of rogue APIs into Europe in the short term for the benefit of EU patients,” the trade groups add.

Comment on the European Commission’s proposals to help tackle the problem of counterfeit medicines has quite rightly focused on the needs of the patient and the potential impact of new labelling and packaging control regimes on the pharmaceuticals industry. But the related API control issues are no less pressing.

The chemical industry is mostly concerned about maintaining the so-called level playing field for its products at a time of great change. 

It says that publication of the legislative draft sends a strong signal to all third countries that unless they begin to harmonise standards and oversights now to match the EU level within a proposed timetable they will not be allowed to sell the ingredients or the pharmaceuticals containing them in the EU.

“This should provide them with a vital incentive to comply and we assume that the EU authorities will be offering them help to do so,” the EFCG and APIC say.

The requirement to match EU GMP standards, inspection and enforcement systems, is central to the proposed amending directive.

This is where the problem lies, though, and begs the question of just who will do the policing, and how. “We believe that this approach represents a considerable political challenge,” the trade groups say. “And without details of how it is to be accomplished, we reserve final judgement on the workability of the proposals.” The proposed approach could also hamper current compliant API supply situations.

The industry does not want the EU to bring too big a stick to bear on the problem but welcomes proposals that could help tackle a growing, and potentially dangerous problem. The sector could probably do more to effectively tackle some of the difficulties faced with non-compliant suppliers. Some have suggested trying to develop closer relationships with suppliers in a country like China.

“Think ‘partner’, not ‘vendor’. Draw on their desire to be your partner and show that you’re willing to work with them to deal with these problems," director of strategic development at Rondaxe Pharma, Brian James has said.

"Start slowly, build confidence in your supply chain, critically evaluate their vendor qualifications and procedures and be wary of cost cutting practices,” he added at the US Drug Chemical & Associated Technologies Association’s (DCAT’s) strategic-sourcing summit in New Brunswick, New Jersey.

The rogue API issue is a critical challenge for the industry and regulators alike and will only be dealt with effectively given the right mix of effective legislation, policing of the rules and supply chain cooperation.

To discuss issues facing the chemical industry go to ICIS connect


By: Nigel Davis
+44 20 8652 3214



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