How Reliable Are Your Generic Drugs From India?

For decades the FDA has told Americans that generic drugs are absolutely identical to brand name medicines. Physicians, pharmacists and insurance companies reassure patients that a $4 generic prescription is the same as a brand name medicine that costs over $150 for the same number of pills.

The only problem is that some generic drugs are now skyrocketing in price for lack of competition. It is puzzling why so many generic drug manufacturers have stopped making certain products. It is almost as if the industry has divvied up the market.

The results are appalling. This is how we ended up with Martin Shkreli at Turing Pharmaceutical jacking up the price of one drug 5,000%. But he isn’t the only one. Other companies are also abusing the American public by raising generic drug prices into the stratosphere. Read more about this scandal at this link.

Give Us More Generic Drugs!

Congress is anxious to see the FDA approve more generic drugs faster. Our legislators want to save money on medicines. After all, federal programs like Medicare, Medicaid and the Veterans Administration spend a lot on prescription drugs.

Private and nonprofit hospitals also want to spend less on medicine. And of course insurance companies are desperate to get people taking cheaper generic medicine. No one seems to be concerned about quality.

Heck, we didn’t worry about quality either. Starting with our first book, The People’s Pharmacy (published in 1976), we told people that very same thing. For over 25 years we believed that the FDA was totally on top of both the approval and monitoring of generic drugs. We never even stopped to think about manufacturing problems. Of course in those days most generic drugs were made in the U.S.A That all has changed.

Where Your Generic Drugs Come From:

Now that 88 percent of all prescriptions are dispensed as generic medications, the quality of such drugs is more important than ever. But the vast majority of them now come from abroad, where FDA oversight has historically been dismal.

The active pharmaceutical ingredients (APIs) and the so-called inactive ingredients now come primarily from all over the world: Brazil, China, India, Mexico, Slovakia, Thailand, Turkey and goodness knows where else. Historically, the FDA hasn’t even known where all the chemicals in your medicine originated. There is no requirement to put country of origin on the drug label.

What the FDA has Found in India:

In the last few years, though, FDA inspectors have been active in India, where so many inexpensive generic drugs are manufactured for the American market. What they have found is frightening.

In just the last few weeks, the FDA reprimanded the Indian drug manufacturer Wockhardt for hiding unwelcome test results and deleting data. This is not the first time Wockhardt has run into trouble. Since April of last year the company has recalled hundreds of millions of tablets and capsules. They included popular blood pressure medicines such as amlodipine and lisinopril as well as the antibiotic azithromycin and the sleeping pill zolpidem.

Wockhardt is not the only Indian pharmaceutical firm to run afoul of the FDA. Other Indian companies that have received warning letters over the last several months include Aurobindo, Dr. Reddy’s Laboratories, IPCA and Sun Pharmaceutical Industries.

Ranbaxy Laboratories, one of the largest of the Indian generic pharmaceutical firms, has had multiple run-ins with the U.S. Food and Drug Administration. A few years ago this company pleaded guilty to felony charges after being accused of falsifying data. The company paid $500 million in fines.

An interesting note on the Ranbaxy mess: Sun Pharmaceuticals of India acquired Ranbaxy for $3.2 billion last year, making Sun Pharma India’s biggest drug company. Sun has itself come under FDA scrutiny. A Bloomberg report noted that Sun Pharma employees had faked test results.

How Many Companies Have Run Into Trouble?

Over the last five years the FDA has banned products from 44 different Indian drug-making facilities. That should give insurance companies some cause for alarm when they insist that their customers must use generic rather than brand name drugs.

What About China?

India is not the only place that is coming under increased scrutiny by the FDA. For years, the agency only had a few inspectors on the ground in China. Now that there are more, they are discovering shortcomings in Chinese plants too.

Warning letters have been sent to a number of companies in recent months. Even brand name companies have been tainted. Pfizer’s Chinese partner, Zhejiang Hisun, was accused of systemic problems associated with “data manipulation.”

That is a sanitized way of saying employees were cooking the books and violating the rules of good manufacturing practices. Customers had been complaining about drugs not measuring up to standards between 2012 and 2014.

What Should You Do?

Patients are the ultimate customers of foreign-made pharmaceuticals. We have been receiving complaints about generic drugs that do not work as well as their brand name counterparts for more than a decade:

Problems with Generic Prilosec for Reflux:

We have been hearing about this particular problem for years:

Kathi in Milwaukee:

“I became so ill after my pharmacy plan switched me to generic omeprazole that my MD ordered an endoscopy to make sure I did not have esophageal cancer. I was sick for almost 3 months, and am still having issues almost a year later.”

Linda in Los Angeles:

“I have been taking Prilosec by AstraZenca for 20 years and have had no GERD problems at all. As of November 1, 2015, I was advised by my pharmacy that I would now have to take a generic. I have taken a generic omeprazole (20mg) for 40 days now, and it is NOT the same. I am burping all the time and have reflux and choking, something I never had with the brand name Prilosec. I am fortunate that my insurance has paid 80% of the cost (over $200 month).”

Men on Flomax for Frequent Urination:

Men who have to get up at night to go to the bathroom know pretty quickly how well their medicine is working:

Henry in Nevada:

“My first generic flomax (tamsulosin) was barely tolerable. In the second prescription the pharmacy changed manufacturers and this generic was far worse and not as effective. If the FDA is not directly monitoring these drugs then they are unlikely to have the necessary ingredients to be effective.”

BK on other ingredients in tamsulosin:

“My husband has been taking Flomax for a few years, when just last month, a generic form came to the market. Due to the inert ingredients, he ended in the hospital with gastritis. My insurance company will not pay for Flomax, only the generic tamsulosin. We cannot afford the high price of Flomax.

“I asked them to make a one-time exception to override the cost for a one-month supply of Flomax, just to wean him off the alpha blocker as needed due to severe side effects, but was denied.

“I could not believe the inert ingredients are so different. Drug companies should be aware of up coming law suits they are causing!”

Just think of the extra cost of hospitalization because of the generic substitution. How short-sighted of the insurance company in our humble opinion.

How to Report Generic Drug Problems to the FDA:

The FDA is starting to pay attention to our frequent messages of generic manufacturing problems. Anyone who would like to report a drug problem may do so at www.FDA.gov/MedWatch.

Patients can also share their experiences below in the comment section. Please try to find the name of the generic drug manufacturer on the label of the bottle so we can let the FDA know which companies have frequent customer complaints.