Sun Pharmaceutical Industries is India’s largest drug manufacturer. It supplies many generic medications to the U.S. market. But the giant is once again in trouble with US regulators.
FDA Warning to Sun Pharmaceutical:
The Food and Drug Administration has issued another warning letter to the company because one of its major manufacturing plants has fallen short on quality control. The problems the FDA noted in its most recent communication are very similar to those named in a letter sent earlier this year.
Sun Pharmaceutical purchased another large Indian generic drug maker, Ranbaxy, which also ran afoul of FDA on quality control problems. Ranbaxy agreed to pay $500 million in fines in May 2013 after pleading guilty to making false statements and violating drug safety laws.
More Trouble in India:
Another Indian generic drug manufacturer, Dr. Reddy’s Laboratories, has also been the target of FDA scrutiny. The company received a warning letter last month because of quality control problems, especially data integrity.
Indian drug makers provide at least 40 percent of the generic drugs Americans take each year. This is not the first time we have written about trouble with poor quality control in certain Indian manufacturing plants. You can read more here and here.
The FDA and Foreign-Made Drugs:
The message we hear repeatedly from the FDA about generic drugs is that the agency has everything under control and there is nothing to worry about. Nevertheless, we keep reading about violations in India and other countries. Unfortunately, the FDA rarely reveals which medications have been affected.
There is no “country of origin” label on your prescription bottle so you have no way of knowing whether your medicine was made in China, Thailand, Brazil or West Virginia. And you have no way of knowing if the pills you are taking for high blood pressure, depression, cholesterol control or acid reflux were made in a top-notch pharmaceutical company with excellent quality control or a facility where cleanliness is not such a high priority and workers fudge data.
We all want affordable medicine but we also want an absolute guarantee that our pills are made under proper conditions and will perform exactly as the brand name medicine. The latest trouble in India does not instill confidence that such is the case.
Stories from Readers:
Leo, a pharmacist with years of experience:
“I am a registered pharmacist and have worked in the generic and brand pharmaceutical industry for 31 years. I guess the rules for drug integrity have changed. I am presently working in a chain pharmacy and have seen drugs on the shelves coming from all over the world; why, because they are cheap and that’s what we want in this country. I have drugs from: Island of Malta, Slovenia, Croatia, India, China, Taiwan and Poland just to name a few.
“It is a joke to believe that the FDA has been to these countries to truly perform inspections of the manufacturing plants.
“Pharmaceutical companies moved production to India, China and other countries because of economic reasons due to the fact that there is no EPA or OSHA, and minimal, if any, oversight from any government regulatory group.
“If supermarkets are required to label fish, poultry, and meat as to country of origin, then prescription labels should also be required. This may help make the public aware of what is actually going on. The FDA is under-staffed, overloaded and short on cash to do an effective job.”
This comes from a patient in New Mexico:
“I used Coreg for 15 years for blood pressure control and my heart condition and loved it. I was put on carvedilol because Medicaid would not pay for Coreg. The generic instantly proved it didn’t work. I’ve complained for a year.
“My insurance company has refused to agree with my doctgor to give me back brand name Coreg. Today. I’ve been told to try at least one more generic for Coreg. There’s not another generic just another distributor. The generics come from India.
“Tomorrow starts a new generic. Hopefully the bad results show quickly and I can demand that I get my Coreg back. These insurance companies are slick.”
Eileen in Missouri:
“Wellbutrin XL 300 mg – was switched to the generic bupropion – horrible reactions. Insurance would no longer pay for the brand name.
“Fortunately I found a reputable, licensed Canadian pharmacy – need a prescription just like in the U.S. – and now I am getting 90 brand name tablets for way less than $200 which for me is a 3 month supply. It would be way over $1,000 if I had to pay out of pocket at a U. S. pharmacy. This pharmacy has been reliable and it is the same Brand name as I would get in the U. S.”
How sad it is that Americans have to buy brand name products from Canada to save money because they cannot rely on generic drugs imported from India and other countries.
Share your own experience and thoughts below in the comment section and please vote on this article at the top of the page.