Overseas API Inspections Should Be Mandatory
5 CommentsBy Ed Silverman // December 8th, 2009 // 9:06 am
The increasing reliance on active pharmaceutical ingredients from overseas - notably, China - is prompting a row in Europe, where the Active Pharmaceuticals Ingredients Committee, a trade group, wants the European Commission to require repeated, mandatory inspection of overseas API facilities, Outsourcing Pharma reports.
The debate comes amid ongoing concerns over the safety of APIs emanating from China, where reports of counterfeit or diluted ingredients has caused a repeated ruckus, such as with the Heparin scandal last year (some background). Recently, AstraZeneca disclosed plans to rely on China for APIs (see here).
The European Commission excluded overseas mandatory inspections from a draft directive because they would be too expensive. However, this was based on a figure that Chris Oldenhof, president of the APIC, described as “entirely absurd,” Outsourcing Pharma writes. Industry groups believe mandatory inspections are needed to keep falsified products out of the European Union. However, European inspectors only visited non-Western drug factories 19 times in 2008, Bnet writes.
Another industry group, the Committee on Industry, Research and Energy, ITRE, believes that 40 inspectors at the EU level would be needed for the inspection programs, although APIC conceded its’ not feasible to inspect every site, particularly those that are unapproved. US citizens aren’t likley to fare any better. The FDA has just two inspectors in China and an agency spokeswoman tells us and Bnet that there are no plans to add more.
Bunbo
Good idea. I think the inspection would include excipient as well.
Pharm79
API from overseas is the rule, not the exception. Part of what Europe is doing is protecting European interests. That being said, I think US should do the same. The constant pressure for lower priced drugs in the face of increased regulatory demands is driving some companies to cut corners. It’s no suprise many of the companies that are gone/under regulatory scrutiny are Indian with API ties to India. The FDA can’t adequately regulate North American companies right now.
Addicus Homiem
Damn right,
EU companies do not respect, or just choose to
be blissfully ignorant about US GMP compliance. I’ve seen a window (to
OUTSIDE) in a European mfg plant.
That’s bad. Really bad..,
~ Ad Homiem
M. Black
So what happens when a company outsources poor farmers to, say … CANADA, to extract an API which only is available from the urine of a pregnant horse. How solid would you assume that what is required by law, is enen remotely followed, or better yet, have the knowledge of?
M. Black
M. Black
Give up? The FDA will pretend to give a rat’s @$$, insist the company stop extracting hormones from these horses, and put a 10-gauge slug in the mare’s skull, since she is of no use to pharma anymore. The the company will throw BS in our face, indicating that they found a chemical alternative.
Yeah - right. Even if a chemical alternative was equivalent, it’s still way more expensive and far less controlled (chaos to an auditor)
So what could occurr? What may have occurred (hint: 10 year coverup) ?
Have some economically endowed people who are experts in the pharma to run horse horse farms in the US, “behind closer doors” and supply the interested buyer in any chaotic way these choose.
Ok…… Read:
PREgnant MAre uRIne = Premarin, which was combined with Provera to make Prempro. Again. 10 year coverup.
Hormones are made by the pancreas. It logically follows that drugs that tinker with hormone levels have some sort of effect on the pancreas.
Why the F&@K does everyone have their pants in a bunch about breast cancer, yet completely ignoring the more apparent risk to the pancreas and pancreatic cancer? Are pink ribbons that we all see just as much as bird droppings necessary. Breast cancer is in a state in which, if you go for the recommended screenings, you will live.
If you have pancreatic cancer, you will die.
You will suffer, then you will die. That’s all……
Any ideas about that? I personally would love to hear them.
~ M. Black