Excipients unregulated and unacceptable

By Anna Lewcock

- Last updated on GMT

Related tags Excipients Active ingredient

The European Fine Chemicals Group (EFCG) has called for stricter
regulation of pharmaceutical excipients in a bid to prevent
substandard and potentially dangerous products ending up in
medicinal drugs.

The EFCG presented its position paper on excipients used in pharmaceutical manufacturing at a press conference held during last week's CPhI meeting in Milan, saying that there was a distinct need to " level the playing field " among excipient manufacturers and enforce good manufacturing practice (GMP) standards.

Although an existing EU directive dictates that the manufacture of (as yet unspecified) 'Certain Excipients' must comply with GMP regulations in the same way that active pharmaceutical ingredients (APIs) must, the majority of excipients are left completely unregulated and uncontrolled - a state of play the EFCG wants to see rectified.

"There is currently no binding regulation for excipients, only IPEC [International Pharmaceutical Excipients Council] guidance," Arnulf Heubner, chairman of the EFCG Pharmaceutical Business Committee (PBC) said on Wednesday.

"In view of the increasing globalisation of the pharmaceutical industry and harmonisation of pharmaceutical registration requirements, we propose GMP requirements for common excipients based on the amended general chapter of the USP

[US Pharmacopeia]."

The USP chapter Heubner refers to is currently under review, but combines the requirements of a number of guidelines, including principles from the World Health Organization's GMP guidelines for excipients, the 2006 guidance from IPEC and International Organisation for Standardisation (ISO) quality standards.

The IPEC good practice guide published last year was a good start in establishing a touchstone by which manufacturers could confirm their process standards but, as Heubner emphasised, a guide is all it is: "These guidelines are not certifiable, they cannot represent a legal basis," he said.

"They rather form something like a manual for orientation for an excipient manufacturer."

The creation of formal regulations for excipient manufacture in Europe has been on the cards for quite some time, but the plans have drawn a mixed response from the industry, always alert to the cost implications of increased regulatory control.

In March this year the European Commission (EC) launched an industry-wide consultation to ascertain industry opinion and concerns on the proposed guidelines that were drawn up last December.

The EFCG issued last week's position paper as its response to the EC enquiry, fully backing the plans to enforce GMP regulations on excipient manufacture.

With good manufacturing requirements already existing for many other aspects of the pharmaceutical production process, it is argued that leaving excipients uncontrolled and unregulated is somewhat illogical and can leave the quality and safety of pharmaceutical products in doubt.

"The reason why this is important is that the majority of what's inside a tablet is an excipient - 90 per cent or more of the solid dosage form," said Hovione CEO Guy Villax, a past chairman of the EFCG's PBC.

"So it doesn't really make much sense to have incredible regulation on the 10 per cent [active ingredient], and then a free-for-all on the rest."

The EC's open survey closed for comment at the end of July, aiming to give excipient manufacturers, users and distributors a chance to have their say in influencing any future legislation that could be issued on the subject.

However, as well-founded and legitimate as the EFCG's assertions in favour of GMP regulations for excipients are, there has been some anxiety in the industry regarding the impact that enforcing such regulations could have.

A key concern is based around the fact that within the excipient manufacturing sector, only a relatively small fraction of products tend to be destined for pharmaceutical applications, with more significant customers in the form of the food and chemical industries.

As such, there would perhaps seem little incentive for manufacturers to implement a whole barrage of dedicated standards and procedures for such a small segment of their business, which runs the risk of some firms deciding to pull out of serving the pharma market altogether.

Other parties, however, see the proposed regulations in a more positive light, not only in terms of ensuring patient safety, but as a tool for improving competitiveness on a worldwide scale.

Already suffering from the heated cost competition generated by low-cost locations such as Asia drawing customers away from the European market, an added guarantee that excipients have been manufactured to legally enforced standards would provide reassurance to manufacturers using these products in their drugs.

Heubner brought up the recent cases of tainted pet food, toys, and toothpaste and cough syrup contaminated with diethylene glycol, all of which were traced to back to 'low cost' areas such as China.

"This suggests that low cost manufacturing often comes with a hidden price tag," said Heubner.

"[However] I expect that leading Chinese and Indian suppliers of pharmaceutical raw materials that do follow GMP, as well as the European and US authorities, would like the playing field levelled."

To allay any fears that this landscaping will end up costing customers looking for the added quality guarantee, Heubner is firm in his assertion that enforcing such legislation would have almost no impact on the price of final drug formulations.

"We hear a lot that enforcing legislation will increase prices - that is not true," he stressed at last week's meeting.

With the European excipient industry forecast to reach revenues of $1.39bn (€0.98bn) in 2008 according to consultants Frost & Sullivan, it is a significant player in the pharmaceutical sector and enforcing regulations upon it will no doubt have at least some impact on the drug firms using these products in their formulations.

With such legislation looming ever closer, however, it is likely to be a matter of looking on the bright side as products should emerge at a more consistent level of quality, certified by regulatory bodies and doing away with any niggling worries about manufacturing standards.

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