The overwhelming majority of your generic drugs are now made abroad. That’s the conclusion of the United States Pharmacopeia (USP). This independent organization is over 200 years old. It sets standards for the quality of medicines sold in the United States. The USP Medicine Supply Map (Nov. 6, 2024) reveals that only 4% of our active pharmaceutical ingredients (APIs) come from US manufacturing facilities. When you read about drug recalls because of data falsification or contamination, does it make you wonder about pharmaceutical quality?
The USP Medicine Supply Map:
I don’t know about you, but I was shocked to see the latest analysis from the USP about where most medicines are made. The APIs are the key ingredients in medications. When you hold a pill like the cholesterol-lowering drug atorvastatin in your hand, what you often see is a tablet that contains the API plus excipients. The active drug, atorvastatin, has a chemical name: “(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate calcium trihydrate.” That is the API.
The other ingredients in your pills are called excipients. They are the binders, fillers, flavorings, diluents, coloring agents and coatings that surround the prime actor: atorvastatin. Most patients and health care professionals have no clue where the ingredients in pills come from.
According to the USP, the bulk of the APIs come from India. That country is responsible for 50% of the active pharmaceutic ingredients. China is not far behind at 32%. The European Union supplies 10%. That’s a big change since 2000. Back then, European countries like France, Germany, Switzerland and Denmark supplied 42% of the APIs. Now, it’s 1/4 of that. We are speculating, but we suspect that cost is crucial. We imagine that it is more affordable to manufacture pharmaceuticals in China and India than the US, France or Germany.
Do You Know Where Your Medicines Are Made?
If you buy a shirt or a pair of pants, there is a very good chance you will find a tag telling you where the garment was manufactured. Buy a can of beans or an apple and the same is true. When you get your medicine through the mail or from your pharmacy, you have no idea where the API came from or where the finished pills were made. In other words, the excipients and API might have been made in China but the tablets and capsules could have been manufactured in India and then shipped to the US.
Do not rely upon the name on the label. A drug company name might sound as if it originated in Europe or America. The parent company, however, could easily be located abroad. Although the subsidiary could be a US company, the pills might well have been manufactured abroad.
One example is Prinston Pharmaceutical. Here is the company profile:
“Prinston is a generic pharmaceutical company that develops, manufactures and markets generic pharmaceuticals products.”
The company has a subsidiary, Solco Healthcare. It labels itself as a leader in marketing and distributing generic drugs.
Prinston Pharmaceutical, Inc has US headquarters at 700 Atrium Drive in Somerset, NJ. Solco Healthcare US is located at 700 Atrium Drive, Somerset, NJ. The parent company of both Solco and Prinston is Zhejiang Huahai Pharmaceutical located in Linhai, Zhejiang Province, China.
Another example of a foreign drug company is Sun Pharmaceutical Industries Limited. It has headquarters in Princeton, NJ. Sun Pharma has headquarters in Mumbai, India. It acquired another Indian generic drug company, Ranbaxy, which had to pay $500 million in fines and civil claims because of generic drug problems in the US.
Are You Aware of Drug Recalls?
There have been so many recalls of pharmaceutical products in the US over the last decade or two that many Americans pay little, if any, attention.
A publication called FIERCE Pharma reports on the pharmaceutical industry. Here are just a few examples of drug recalls it has documented:
“Sun recalls yet another med made at troubled Halol plant.” (Sept. 3, 2015)
“According to the most recent FDA Enforcement report, Sun is voluntarily recalling three lots of bupropion hydrochloride extended-release tablets that were manufactured at its plant in Halol, in Gujarat, India. The drugmaker says that the med failed dissolution testing at 18 months because its drug-release results were not on the mark at the 4-hour time point. It is recalling 35,235 bottles of its generic of the antidepressant Wellbutrin XL”
Another headline from Fierce Pharma describes these drug recalls:
“Generic drugmakers Viatris and Aurobindo have initiated new product recalls, the FDA revealed this week.
“Viatris is asking for the return of one lot of octreotide acetate injection because of the possible presence of glass particles.
“As for the Aurobindo recall, it concerns two batches of quinapril and hydrochlorothiazide tablets due to high nitrosamine levels.”
FIERCE Pharma reported on April 4, 2023:
“Camber recalls pneumonia drug, citing possible microbial contamination”
“Camber Pharmaceuticals issued a voluntary recall of one lot of atovaquone oral suspension used to treat a form of pneumonia. The recall is due to the potential of microbial contamination of Bacillus cereus.”
Camber Pharmaceuticals is located in Piscataway, NJ. The parent company is Hetero Drugs of Hyderabad, India.
Other Drug Recalls:
Two other large Indian drug companies received bad news from the U.S. Food and Drug Administration. Dr. Reddy’s Laboratories had to deal with drug recalls for certain lots of a heart medication containing amlodipine and atorvastatin as well as the anti-seizure drug divalproex.
Divalproex sodium ER is the generic name for a long-acting epilepsy medicine sold under the brand name Depakote. Apparently the generic formulation from Dr. Reddy was too strong. On the other hand, the heart medicine containing amlodipine and atorvastatin, sold under the brand name Caduet, was not strong enough, hence the drug recalls of this sub-potent combination product.
Dr. Reddy’s manufacturing process has been questioned before. The company recalled thousands of bottles of the heart medicine metoprolol succinate, a beta blocker sold under the brand name Toprol XL. That’s because the generic formulation failed dissolution tests. Other problems at Dr. Reddy have included recalls of ranitidine (Zantac) and pantoprazole (Protonix).
The FDA has also had problems in the past with another Indian drug company, Emcure Pharmaceuticals. The plant in Hinjewadi failed to meet quality standards for good manufacturing practices. Trying to find out about such drug recalls is challenging since the FDA does not always make that information readily available.
We are hoping that all the drug recalls listed above have been corrected. Please do not stop any medicine without checking first with your physician or pharmacist!
Generic Drug Recalls: Tip of the Iceberg
The generic drug recalls mentioned above are just a few of a long list of problems. As mentioned, one of the largest generic drug manufacturers in the world, Ranbaxy of India, was found to have fabricated data at a number of plants. Dozens of drug products had to be pulled from U.S. pharmacy shelves because of the fraud. Eventually, the company paid $500 million in fines and penalties.
Sun Pharma eventually bought Ranbaxy. It too had gotten into trouble because of disclosure issues and manufacturing problems. Zydus Cadila, Aurobindo, Wockhardt, Amsal Chem, RPG, Kamud Drugs, Posh Chemicals and Yag Mag Labs have all had problems with the FDA.
There are hundreds of drug manufacturing plants in India making products for the U.S. market. The agency has surprisingly few investigators to cover the entire country. China also has hundreds of drug manufacturing plants making products that will end up in the U.S. market.
In the fall of 2024 the AP reported a “massive backlog of factory inspections.”
“Most of the overdue plants are in the U.S., but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost U.S. prescriptions.
“Last year, tainted eyedrops from an Indian factory led to an outbreak of antibiotic-resistant bacteria that sickened more than 80 Americans, killing four of them and blinding more than a dozen others. The plant never registered with the FDA.
“In China, political tensions have made inspections even more challenging. Just two fulltime FDA inspectors are based in the country, where about 185 factories are overdue. Former FDA officials say the Chinese government has withheld visas from inspectors unless the U.S. reciprocates for Chinese nationals seeking to enter the U.S.”
From our perspective, the FDA is woefully understaffed abroad, so it is hardly any wonder that there might be problems with generic drugs made in India, China, Slovakia, Brazil, or goodness knows where.
An Even Bigger Generic Drug Disaster:
More alarming than the manufacturing mess-ups and drug recalls is the possibility that clinical research organizations (CROs) that conduct generic drug studies may not be meeting quality standards. These are the companies that give generic drugs to dozens of volunteers and then measure their blood levels to determine if the generic drug is getting into the blood stream at the same rate and amount as the brand name drug that is being copied. This is the very first step in getting generic drugs approved by the FDA.
The World Health Organization discovered serious problems at one of the largest organizations, GVK Biosciences in India. The European Medicines Agency accused the company of faking data on roughly 700 different generic drugs from dozens of generic drug companies over a five-year period. As a result of the investigation, European regulators disallowed hundreds of generic drugs based on those clinical trials.
We suspect that the FDA has also relied on data supplied by GVK Biosciences. We asked the agency about these problems and have not received an adequate response. The FDA has not been very forthcoming about generic drugs it might have approved based on GVK data. We don’t understand why the FDA hasn’t disallowed most of the generic drugs tested in GVK facilities. If the European regulators doubt the accuracy of the data, shouldn’t we?
A different company, Quest Life Sciences, was also warned about defective trials. Once again the FDA did not made its investigations public.
The Bottom Line:
The FDA is opaque when it comes to revealing generic drug problems. If a company gets busted for fraud or bad manufacturing practices, the U.S. Food and Drug administration often redacts critical information from its official forms. That means the feds black out key data such as which medicines are involved in a recall or what the specific problems were.
Problems with Proprietary Data:
The agency also hides the bioequivalence data used to support its generic drug approvals. The justification seems to be that the data is “proprietary.” Why is the FDA so concerned about protecting drug companies? Health care professionals and patients should be able to see the data that the FDA uses to approve generic drugs.
We do not get the FDA’s position. If there are quality concerns about some generic drugs, we should be able to know the details so we can pass them along to you. And we believe that every generic drug the FDA approves should have its bioequivalence curves and data made available for public scrutiny. We also think the country of origin should be listed on every drug product sold in the U.S. If you are informed about where your shirt is made or where the pears you eat are grown, why not the manufacturing location of the medicines you purchase?
It is time for the FDA and the generic drug industry to make everything transparent so doctors, pharmacists, nurses and patients can see what’s going on for themselves. Until that happens, we fear the American public will have serious doubts about generic drug quality.
Your Story:
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