INSIGHT: Time to block the rogue APIs

08 February 2008 15:54  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS news)--Will it take an adulteration scare - and one potentially far more wide-reaching and dangerous than the lead in toys or the China toothpaste scandal - to prompt greater urgency on the clampdown on ‘rogue’ active pharmaceutical ingredients (APIs)?

Clampdown is probably the wrong word because despite repeated warnings from the fine chemicals sector safety authorities in the US and Europe seem always to be brushing this issue aside.

No-one knows what the impact might be if chemicals dangerous to human health find their way into generic or over-the-counter drugs. But consumers are potentially facing a very real risk rather than simply a chemicals hazard.

The fine chemicals industry quite rightly wants to avoid scare-mongering but has become acutely frustrated.

The chain from the API maker to the final dosage form manufacturer that actually supplies the generic drug is amorphous to say the least.

Trying to get all participants in that chain to behave is no easy job. Concern has been raised for many years but particularly over the past two about unscrupulous traders who might sell on contaminated material.

The situation also is likely to get worse before it gets better. API manufacture continues to move to Asia, to China and India in particular.

Local authorities are overwhelmed by the need to check production facilities for compliance with international good manufacturing practice (GMP).

In China alone there are estimated to be 3,000 companies supplying APIs and it is believed that as many as 2,000 of these could be supplying rogue products. Regulatory authorities from the EU and US are able to review overseas manufacturers but more often than not choose not to do so.

Industry groups like the European Fine Chemicals Group (EFCG) and the US Synthetic Organic Manufacturers Association (SOCMA) have lobbied hard for change but feel as though they have been stonewalled.

The EFCG, for instance has tried to help EU authorities to put pressure on the supply chain to behave but met little response.

The groups said back in 2006 that a situation had developed where almost anyone could enter the market to produce generics of over-the-counter (OTC) medicines and almost never go through an inspection process.

According to the EFCG, 80% of the volume of off-patent APIs is exported to Europe from China and India and anywhere between 40% and 90% of these imports might at any one time be of rogue material.

The trade groups are trying to work with patients' organisations to bring pressure to bear - first to learn more about the supply chains themselves and second to determine how they might better monitored.

From Europe, the EFCG is working at the national and European levels. It wants to start pulling levers internationally.

SOCMA on Tuesday said it was disappointed that a report on the US Food and Drug Administration did not address the inspection of foreign API manufacturing facilities issue.

“While the report details the need for greater scrutiny of the development of new products and greater post-market surveillance ensuring the general safety of the manufactured drugs, it does not provide enough detail describing the need for inspecting the process of manufacturing drugs and their ingredients after the safety trials are completed and manufacturing is approved,” it said.

“This is particularly noteworthy for OTC medications and generics,” it said.

The authorities in the US and Europe are concerned about the safety of manufactured drugs but generics don’t always seem to fit the bill.

The overview of the supply chain might improve as China and India move away from a focus on low-cost manufacturing towards a higher quality and more knowledge-intensive industrial base. In the meantime, however, their manufacturers have the potential to cause inadvertently or otherwise great harm.

There are pockets of change, but clearly not enough.

In Europe, Italy will demand from 1 January 2009 that all APIs in a medicine will have had to have been produced in a GMP-certificated facility. France is another European country actively researching API manufacture.

A way forward would be to fold the API issue into the controls put in place to battle the counterfeiting of prescription drugs but in Europe at least, that will take time.

The chemicals sector is rightly concerned that too little is known about the supply chains for APIs and that rogue APIs have the potential to cause great harm.

By: Nigel Davis
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