The FDA has blocked the import of generic drugs from India's Ranbaxy Laboratories, based on regulatory compliance issues involving two of its plants--one in Dewas and another in Paonta Sahib. Specifically, FDA inspections earlier in 2008 revealed violations that could result in formulation problems and therefore instructed the company to take steps toward resolving the issues, which Ranbaxy failed to do.
The company makes generic versions of much used drugs like Zocor, which physicians prescribe to treat high cholesterol, and Cipro, an antibiotic. The FDA first noted quality problems with Ranbaxy in 2006. The agency has now decided to take "proactive measures" by blocking at least 30 drugs, including the antiviral drug, acyclovir, the antibiotics, ciprofloxacin and clarithromycin, the diabetic med, metformin, and cholesterol drugs, pravastatin and simvastatin.
The FDA has not blocked sales of the drugs in the U.S. and even told consumers they could keep using the drugs they had at home. Although the agency said the quality problems could lead to contamination, adverse reactions and additional troubles with the medications and pharmaceutical ingredients manufactured at the plants, repeated testing has not revealed any such problems yet. As far as whether Americans will be able to get the medications they need, the FDA seems to feel confident that other manufacturers will step up to the plate.
This adds to Ranbaxy's problems with the FDA, which also has a separate criminal investigation underway regarding whether Ranbaxy submitted fraudulent data to the agency.
As for its role in monitoring imported medications, the FDA has not visited about two-thirds of factories outside of the U.S. that import medications to the U.S.
- check out the FDA release
- read the letters the FDA sent to Ranbaxy (Letter l Letter)
- see the complete list of blocked Ranbaxy products
- view the FDA's consumer Q&A
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