Michael White, professor and department head from the University of Connecticut School of Pharmacy, talks about some of the risks associated with generic drugs manufactured by Ranbaxy.
Below are some questions with answers provided by White.
Which generic company’s products should people be concerned about?
India is the source of $4.23 billion in drug sales to the United States and Ranbaxy is the largest Indian generic drug manufacturer. This month the company issued a recall for 64,000 bottles of 10-milligram atorvastatin tablets because some of the bottles could contain a higher dose. That is the generic for the blockbuster cholesterol reducer Lipitor. This is in addition to a recall for generic Lipitor after glass particles were found in their tablets in 2012. This is the latest in a series of issues that gives me serious reservations about the full line of products manufactured by the company for sales in the United States. Last May the company agreed to pay a $500 million fine to resolve allegations of good manufacturing deficiencies at two of their plants and making false claims to the FDA. A commonly used antibiotic drug, a seizure drug and an acne drug were specifically mentioned in the settlement with the US Department of Justice at that time. Four of their manufacturing plants in India have been prohibited from producing drugs for the United States, the latest in January of 2014 because of lapses in good manufacturing practices.
What kind of lapses of good manufacturing practices are we talking about here?
Flies in sample storage rooms, windows that could not be closed, broken cabinets and the use of uncalibrated equipment. Uncalibrated equipment means the readings the equipment was giving out might not be correct.
What about making false claims to the FDA, what was that about?
It is reported that the company presented studies to the FDA saying that their generics were close matches to the brand name products they were supposed to mimic but in some cases the data was falsified. Even in January 2014, the FDA still found that their computer system did not prevent people from accessing and falsifying data in the computer system. Clearly the problems at Ranbaxy are systemic. While no one should abruptly stop their medications without speaking to their doctors, if I was a consumer, I would ask my pharmacist whether my generics were from Ranbaxy or not and if there were alternatives.
What does this say about other generic manufacturers, are generics safe?
Generic medications are by and large safe, effective, and a great value for patients. It is critically important that people should not abruptly stop their medications without speaking to their physicians first. Just going cold turkey off their medications is a bad idea and can result in hospitalization or death. The FDA is dramatically stepping up worldwide surveillance of manufacturing plants because of this, an action they should have engaged in over a decade ago. Something as important as establishing trust in lower cost generic products should have been a top priority all along.