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Product recalls

We deserve to know

From Mr J. L. Turner, FRPharmS

Letters from Peter McAuley (PJ, 1 August 2009, p126) and John Sharp (PJ, 8 August 2009, p153) have drawn attention to the many recent batch recalls because of major failures to follow Good Manufacturing Practice guidelines found during inspections of contract manufacturers.

I made a rough count from the Medicines and Healthcare products Regulatory Agency website: in one month, there had been approximately 80 batches of 18 different products from six “manufacturers” recalled.

They rightly query what have the Qualified Persons been doing in certifying these batches as suitable for release. But, there is another question: whose and where are these unsatisfactory manufacturing sites? Do not be fooled by the term “manufacturer”.

In jargon, this is the person “responsible for manufacture” and is often, in reality, a mere importer who may not know a tablet press from a printing press, despite holding a so-called “manufacturer’s licence”.

When there was a similar spate of recalls last year, I pressed the MHRA under the Freedom of Information Act to identify the real manufacturer. It refused to do so, saying it would be against the commercial interests of the companies concerned.

Of course it would, but should this over-ride patients’ interests, not to mention the interests of pharmacists ordering and dispensing these products?

Many medicines licensed for the UK market are now made abroad, maybe in a country with a long established system to ensure compliance with GMP similar to our own — but maybe not. Bernadette Sinclair-Jenkins from the MHRA responded to Mr McAuley with a long discourse on some of the relevant regulatory systems.

What she said about the MHRA inspecting manufacturers in the UK and third countries for compliance with GMP is, of course, correct as far as it went.

However, what she did not say is that the MHRA does not inspect in other EU member states (including those that only recently joined and new to GMP and competent regulation) and in many third countries where reliance is placed on another country’s inspectorate.

Pragmatically, this may be necessary. However, when we know from the media who makes our T-shirts or our toys and, in some cases, how bad they are, is it right that we are not allowed to be told who makes our medicines even when they are made so badly that they need to be recalled?

If the Freedom of Information Act prevents consumers being told by whom and where their medicines are made and, by extension, which authority is responsible for enforcing standards, at least those purchasing medicines in the UK might demand to know from their supplier where they are made so they could avoid reordering from manufacturing sites that have been found to have significantly bad manufacturing practices.

John Turner

Lymington, Hampshire

Citation: The Pharmaceutical Journal URI: 10975785

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