Quality concerns: when clinicians question generic manufacturing

When a doctor prescribes a generic drug, most patients assume it’s just as safe and effective as the brand-name version. After all, the FDA says so. But behind the scenes, many clinicians are starting to ask harder questions - especially when the drug comes from a factory halfway across the world.

Why the doubts are growing

Generic drugs make up over 90% of prescriptions in the U.S. They’re cheaper, they’re widely available, and they’re supposed to be identical to brand-name drugs. But identical doesn’t always mean the same. The active ingredient? Yes, it matches. But what about the fillers? The coating? The way it dissolves in your body? Those details matter - and they’re harder to control when manufacturing is spread across six different countries.

A 2023 study from Ohio State University looked at over 1.2 million adverse event reports in the FDA’s database. They found that generic drugs made in India had a 54% higher rate of serious side effects - including hospitalizations, disabilities, and deaths - compared to the exact same drug made in the U.S. The researchers didn’t blame the drug itself. They blamed the manufacturing.

The problem isn’t just one factory. It’s the whole chain. One company makes the active ingredient in a plant near Hyderabad. Another company in Shanghai blends it with inactive ingredients. A third in Mexico coats the pills. A fourth in Pennsylvania bottles them. Only one name appears on the label. The patient, the pharmacist, even the doctor - none of them know which factories actually made the pill they’re holding.

Inspections that aren’t really inspections

The FDA claims it inspects every facility that makes drugs sold in the U.S. That’s true - but only if you ignore how they do it.

In the U.S., inspectors show up unannounced. They walk into a plant, check records, watch the machines, and talk to workers. No warning. No time to clean up.

Overseas? That’s different. The FDA schedules inspections months in advance. Manufacturers know exactly when they’re coming. They fix the broken equipment. They polish the floors. They hide the problems. It’s like a school inspection where the kids know the inspector is coming next Tuesday. Of course, the classroom looks perfect.

Professor Robert S. Gray, who led the Ohio State study, put it bluntly: “If you give a manufacturer a heads-up, they can hide what’s really going on.”

Older drugs, bigger risks

The problem gets worse with older generics. These are drugs whose patents expired years ago - things like metformin, lisinopril, or amoxicillin. Because they’re cheap, competition is fierce. Manufacturers slash prices to win contracts. To stay profitable, they cut corners.

Some factories use outdated machinery. Others skip quality checks. One lab might use a 30-year-old mixer that doesn’t blend ingredients evenly. Another might skip stability testing because “it’s just a generic.” The FDA doesn’t require these older drugs to meet the same modern standards as new ones.

That’s why the Ohio State study found the biggest gap in adverse events wasn’t between countries - it was between new and old generics. The older the drug, the higher the risk.

Why the U.S. isn’t making more

You’d think the solution would be simple: make more generics in the U.S. But it’s not that easy.

Building a modern drug plant costs hundreds of millions of dollars. The equipment alone - automated mixers, real-time sensors, sterile filling lines - is expensive. And the payoff? Low margins. A bottle of generic metformin sells for $4. If you’re a manufacturer in India, you can make it for $0.10 a pill and still turn a profit. In the U.S., the cost might be $0.30. You can’t compete on price alone.

That’s why most U.S. manufacturers stopped. Today, only 14% of the active ingredients in generic drugs come from American labs. The rest come from India, China, and a handful of other countries with lower labor and regulatory costs.

Advanced manufacturing could change everything

There’s a better way - and it’s already being used. Advanced manufacturing technologies (AMTs) like continuous production and real-time monitoring are being adopted by a small group of U.S.-based companies. These systems can detect a problem in seconds - a wrong ingredient, a temperature spike, a clogged nozzle - and stop the line before a single bad pill is made.

Over 80% of drugs made with AMTs are produced in the U.S. And here’s the kicker: once the initial investment is paid, these systems actually lower the cost per pill. They reduce waste. They cut downtime. They’re more reliable.

But the industry isn’t rushing to adopt them. Why? Because the current system works - for the manufacturers. As long as they can keep paying $0.10 a pill and still win government contracts, there’s no incentive to spend $200 million on new equipment.

What clinicians are seeing in practice

Dr. Iyer, a pharmacist in Ohio, started noticing something strange a few years ago. Patients on the same generic blood pressure medication were having wildly different reactions. One person felt fine. Another had dizziness, nausea, and a spike in blood pressure. He switched them to a different batch. Same thing.

He started tracking. He found that the problematic batches all came from the same manufacturer - one that had recently changed its supplier of inactive ingredients. He reported it. Nothing happened.

He’s not alone. Pharmacists across the country are quietly keeping notes. They’re swapping stories about generics that “just don’t work” the same way. They’re calling manufacturers. They’re asking for batch numbers. They’re learning to read between the lines on the label.

Who’s responsible?

The FDA says the system works. AccessibleMedicines.org says patients are safe. But the data tells a different story. The NIH published a paper titled “Is the Quality of Generic Drugs Cause for Concern?” and answered with a simple “yes.”

The real question isn’t whether generics are safe. It’s whether we’re willing to pay for safety.

If you want higher quality, you have to be willing to pay more. And right now, the system is designed to reward the lowest bidder. That’s not a flaw in the FDA. It’s a flaw in the market.

What can be done?

Some experts are pushing for transparency. The Ohio State researchers suggest the FDA should label every generic drug with its country of manufacture. Not just “Made in India,” but which factory. Which batch. Which inspection report.

Imagine if your pharmacy could tell you: “This metformin is from a U.S. facility with a perfect inspection score. This one is from a plant in India that had three warning letters last year.”

That kind of transparency would change everything. Doctors could choose. Pharmacies could stock better options. Patients could ask. And manufacturers would have to compete on quality - not just price.

Others say the answer is domestic production. The University of Wisconsin School of Pharmacy argues that if more manufacturing happened in the U.S., we’d see fewer shortages, fewer quality issues, and more reliable supply chains.

It’s not a perfect fix. It won’t solve everything. But it’s a start.

The bottom line

Generic drugs saved billions in healthcare costs. That’s undeniable. But we’re now paying a hidden price - in patient safety, in drug shortages, in lost trust.

The system isn’t broken. It’s working exactly as designed: to make drugs as cheap as possible. But cheap doesn’t always mean safe.

Clinicians aren’t against generics. They’re against the lack of accountability. They’re against the blind trust in a system that hides where drugs come from and how they’re made.

The next time you fill a prescription, ask yourself: Do you really know what’s in that pill? And who made it?