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Indian Generic Drug Company Spanked Again by the FDA

Where was your bottle of generic pills manufactured? Can you trust the FDA to guarantee quality from an Indian Generic Drug company? A new warning!

The Indian generic drug company Wockhardt is in trouble with the Food and Drug Administration…again. This makes the sixth warning letter the company has received. According to FiercePharma (an industry watchdog), seven Wockhardt drug making facilities have gotten into trouble with the FDA. Because of this, three can not ship medicines to the U.S.

Many Indian generic drug firms have gotten into trouble with the FDA over the last several years. They include:

Cadila Healthcare
Canton Labs
Dr. Reddy’s Laboratories
Pan Pharmaceuticals
RPG Life Sciences
Sun Pharma

Such companies have received FDA warnings about quality control or other violations of FDA procedures. Some have been banned from shipping products to the U.S.

Indian Generic Drug Company In the U.S.

We have been intrigued to discover that a number of Indian drug companies have set up shop in the U.S. Jubilant Life Sciences received warning letters from the FDA. A plant in Spokane, Washington had issues regarding cleaning and disinfecting processing areas and equipment. The most recent Wockhardt event involved a plant in Morton Grove, Illinois.

Wodkhardt’s U.S. company is named Morton Grove Pharmaceuticals. According to FiercePharma:

“The FDA has yet to make the letter public, but the plant received a Form 483 in 2014 that was issued after an FDA inspection that went on for 17 days. The plant was criticized for many of the same issues that the FDA had already found in its plants in India.”

Made in the USA?

Many people assume that if their medicine is made in the USA then it must be fine and dandy. That may not always be the case. It can take the FDA a long time to visit every manufacturing facility. There have been reports of serious violations in the U.S. as well as in India and China.

Can You Rely on Generic drugs?

We have been writing about generic drugs for over 40 years. For most of that time we were huge supporters of inexpensive generic medicines because we totally trusted the FDA to monitor quality. We took flak from brand name drug companies for our pro-generic stance. Here is just one example from August 17, 1987:

Q. Your pro-generic drug stance makes me sick. I work for a large drug company and I hate to see you preaching only one side of the story.

Generic drug manufacturers don’t put any money into developing new medicines. The sales of brand name drugs support research into new compounds. You should encourage your readers to stick with products from innovator companies so that they will continue to have better medications in the future.

A. Your argument would carry more weight if the big brand name manufacturers put a larger proportion of their profits into research and development (R&D). In recent years we have watched with horror as prices for prescription drugs have soared. Between July 1985 and April 1987, the overall inflation rate was under 3 percent while medicine jumped more than 12 percent.

Congressman Henry Waxman recently chaired a committee which investigated profits in the drug industry. According to Waxman, “the money was arriving in bucketloads, but was going to R&D in spoonfuls.”

Big brand name drug companies spend an extraordinary amount of money promoting their products to physicians–by some estimates, as much as $9,000 per doctor annually.

The pharmaceutical industry is one of the most profitable businesses in the world. Where does the money go? Last year, many of the leading companies paid their CEOs more than $1 million in salary and bonuses.

Many older people on fixed incomes can barely afford their medicine. Price increases on brand name drugs have been busting patients’ budgets. If generic drugs make medicine more affordable, we’re all for them. It isn’t fair to ask people on Medicare to subsidize free dinners for doctors and mega-salaries for executives, so we still think generic drugs provide quality at an affordable price.

Fast Forward to the Present:

That was 30 years ago. Since then the amount spent on advertising prescription drugs directly to consumers has skyrocketed. You cannot watch TV without seeing commercials for cancer drugs, psoriasis medicine or medications for rheumatoid arthritis. These are all extremely expensive products. CEOs now make a LOT more than a million dollars a year.

The New York Times  & Highest-Paid CEOs of 2016

Leonard Schleifer of Regeneron Pharmaceuticals was reported to pull down over $50 million in 2016.

Forbes said John Martin of Gliead scored $43.2 million, a real let down from his compensation in 2013, which was reported at $180 million.

Robert Hugin of Celgene “only” took in $22.5 million.

Alex Gorsky of Johnson & Johnson was reported to make $21.1 million while Kenneth Frazier of Merck received $19.9 mil.

CEOs at generic drug companies have also done well. Heather Bresch, who got into trouble because of the high price of EpiPen, was reported to have received $18.2 million in 2016.

What About Generic Drugs?

We firmly believed that the FDA was doing a fabulous job approving and monitoring generic drugs. That began to change in the spring of 1998. Here is what we wrote on May 18, 1998:

How good are generic drugs? For years, brand name manufacturers complained that cheaper knock-offs were inferior to their pricey products.

The Food and Drug Administration countered that generic drugs had to meet the same standards as the originals before they could be marketed.

Two letters from readers of this column make us wonder how well the FDA monitors generics after they have been approved:

“I have suffered from migraines for many years and taken Fioricet for most of that time. Recently I was in the midst of a killer migraine and asked my doctor for a refill on a prescription.

“The pharmacist had taken the liberty of giving me a generic to save me money even though I had not asked for it. I was disgruntled, but took the pills rather than be unpleasant.

“As soon as I took them they knocked out the headache and put me into overdrive. I was stimulated beyond belief–typing letters and sending faxes at 3:00 am. I was bouncing off the walls. The next day I was a complete wreck, definitely sleep deprived and with a horrible hangover effect.

“When I went to the pharmacy and mentioned the incident I was accused of eating chocolate or drinking coffee before bedtime. I assured the pharmacist I had done nothing of the sort.

“When I contacted the FDA it was a joke. Some clerk-type with no interest or knowledge finally called back a couple days later, promised an investigation and hung up. He called back the next day to tell me there was nothing wrong with the tablets, even though I never sent them to be tested.”

We have no way of determining exactly what was in those headache pills or why this patient reacted so strongly. But another reader had a bad experience with a different medication:

“I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.

“By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn’t sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self. Why should this drug have affected me so?”

There are no easy answers, but these symptoms suggest that this reader might have gotten too high a dose of thyroid hormone.

Generic drugs are supposed to be chemically identical to their brand name counterparts. Hospitals, managed care organizations and insurance companies have embraced generic medications as a cost saving measure.

We are beginning to wonder whether that faith is always justified. People need to be as vigilant as these two readers were. If a switch leads to unusual symptoms it makes sense to contact the doctor and the pharmacy without delay.

As you can tell, we were starting to get suspicious. This Q&A was also published in our syndicated newspaper column in 1998:

Q. My mother was switched from Lasix to a generic furosemide for heart failure. Her feet started to swell and she had trouble breathing. As soon as we got her back on Lasix she got better. Any comment?

A. Your involvement might have kept your mother out of the hospital. Any change in medication requires close monitoring.

Where We Stand Today on Generic Drugs:

Since the spring of 1998 we have received thousands of complaints about generic drug quality. The FDA maintains that all is well and the agency has everything under control. The FDA brags about the number of generic drugs it is approving each year.

We remain concerned, however. Most generic drugs are now made abroad, in countries like Brazil, China, Hungary, India, Mexico, Slovakia, Thailand and goodness knows where else. Many of these plants may be perfectly fine, but when the FDA closely scrutinizes foreign generic drug companies it often finds problems. That is certainly what happened in India.

What Can You Do?

Do not assume your bottle of generic medicine was made in the U.S. under ideal conditions. Many foreign drug manufacturers have come up with very friendly names that seem home grown in the U.S. Again, we have nothing against foreign-made generic drugs if the quality is perfect. But our confidence has been shaken.

To learn much more about the FDA and its generic drug approval process, authorized generic drugs and brand name drugs sold in Canada at much more affordable prices, we offer our Guide to Saving Money on Medicine.

Share your own story in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I just read the book China RX. It will explain how the big us drug companies sold out to overseas drug companies where the FDA has little or no access to perform. Inspection. It tells about unsanitary conditions where these drugs are made, and in some labs labs workers have no bathroom facilities and relieve themselves in a bucket. It will make you sick.

Re: The conversation about the woman and fioricet staying up wired until 3am. Fioricet has caffeine in it.

It is unfortunate these facilities cannot be monitored satisfactorily.

I’ve been taking hydrocodone for years for severe back pain from a wreck. Pinched nerve, slipped disc, cracked neck, and arthritis. Now over the last several months I’ve had all kinds of things going on. That’s when the drug store changed pharmaceutical companies. Chills, hot flashes, extreme thirst, being tired, hands numb and tingling, muscle and joint pain. I was tested for lupus, which my sister has. All blood work normal. It felt like my body was adjusting or fighting something off.

I stopped eating wheat, sugar and dairy. No change. I started googling withdrawal from hydrocodone. Bingo. I had been going through withdrawal while taking it, evidently. I took one the next morning and none the rest of the day. Nothing happened. My back hurts but none of the other symptoms. It’s my opinion that people on generic pain medication are not getting consistent doses, and that is where a majority of the whole overdose problem lies. I still can’t believe I didn’t go through withdrawal of any kind when I stopped.

I have experienced being ill several times from medications made in India and China. Also a brand medication from Canada.
Several years ago newborn babies died from Enfamil Formula made in China and recently a number of cancer patients died from drugs made in China, as well as pets from pet snacks made in China.

I found out a fast food restaurant who sold me a hamburger that made me sick bought the meat from China. Currently I read all labels on the over the counter medications and cosmetics to see where they are made.

How do we know about the generic drug pharmas? My husband has been on simvastatin 40 (generic for Zocor) for some years. When he was taking Teva’s product he did fine. Switched to North Star, his cognition and memory have slipped significantly. North Star is apparently made in China for the health plan – convalescent home – hospital market. It has a United States address but makes a great many generics, many (most?) of which are said to be made in China.

I feel better about India than China… What do you think?

Since last year I have gotten sick 4 times from medicine made in India. One time I was so sick I had to go to the ER. I have never gotten sick from medicine made in the US. Also It is very hard to get generics not made in India, SO I have to get them from My insurance pharmacy.

I was on Inderal and it worked. Then, I was switched to generic propranalol which did nothing. My blood pressure shot up. Some of the generics I have taken seem to be “duds”. Something needs to be done.

The way I see it, generic or not, many of us are taking simply too many drugs. We have become a society of drug takers. A true drug culture. Many of the drugs that are prescribed are unnecessary. Simple changes in diet can work wonders. Simple solutions can be more effective and with fewer harmful effects.

Pharmaceutical companies made $8 billion, per year, from the sale of ulcer treatments even though, in 95 percent of cases, the symptoms came back within a year. Once the drug companies stopped fighting the truth, it was finally acknowledged that H. pylori bacteria caused 80 to 90 percent of gastric ulcers. A simple solution for a problem that many, many folks were convinced they needed a pill for. And with good reason.

I took one of these same OTC medications for indigestion for years, until I found that simply cutting out my daily intake of soda pop eliminated my need for this artificial chemical to make me feel better.

Now, with the research showing that long-term statin use may only prolong your life by about 30 days, and only for 1.1% of users, it may be time to severely question everything the doctors tell you.

And it may be time to consider giving up the drugs – after, of course, getting full counseling from your doctor, who probably learned all he knows about that hot new Rx while visiting one of the many resorts in Hawaii, Acapulco, or the Caribbean, that are sponsored by the drug companies. Just something I picked up, over a decade ago, while working at one of these “resources” used by drug companies to present their “educational” programs to the medical community.

More conversation that I can handle! What is your bottom line here?

Thankfully, the endocrinologists at VA Atlanta recognize this. The pharmacy has Synthroid rather than generic Levothyroxine. It does eliminate one possible area of concern and variable.

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