China and India Manufacturing: Risks and FDA Monitoring in Pharmaceuticals

When you take a pill for high blood pressure, antibiotics, or diabetes, there’s a good chance it was made in China or India. These two countries produce over 80% of the world’s active pharmaceutical ingredients (APIs) and nearly 40% of all finished generic drugs sold in the U.S. But behind the low prices and high volumes lies a complex reality: manufacturing quality isn’t the same across the board. The FDA doesn’t treat them equally. And for patients, that difference matters more than most people realize.

Why the FDA Watches China More Closely

China dominates the API market. It makes the raw chemical building blocks for over 80% of the world’s generic drugs. That’s not just a big number-it’s a choke point. One factory shutdown in Shanghai can ripple through supply chains from New York to Nairobi. But scale doesn’t equal safety.

Since 2018, the FDA has issued more import alerts against Chinese drug facilities than any other country. In 2023, 37% of Chinese pharmaceutical plants faced import alerts-reasons ranged from falsified test results to poor sanitation and unapproved process changes. These aren’t rare mistakes. They’re systemic. One 2022 FDA inspection report found a Chinese facility that had been producing insulin for years without proper sterilization procedures. The drug was shipped to U.S. pharmacies anyway.

The problem isn’t just corruption or negligence. It’s structure. China’s pharmaceutical industry is built on a massive network of small and mid-sized factories, many of which operate with little oversight. While large state-backed companies like Sinopharm meet global standards, hundreds of smaller suppliers don’t. And because APIs are shipped in bulk, mixing high-quality and substandard batches is easy. The FDA can’t inspect every facility. So it flags the ones with the worst track records-and blocks their imports.

India’s Compliance Edge

India has 100+ FDA-approved drug manufacturing plants. China has 28. That’s not a typo. India’s lead in certified facilities isn’t luck-it’s strategy.

After the 1970 Patents Act allowed local production of generic drugs, India built an entire ecosystem around compliance. Companies like Dr. Reddy’s, Sun Pharma, and Cipla didn’t just learn FDA rules-they mastered them. Their labs follow 21 CFR Part 211 to the letter. Their data systems are digital. Their staff train in English-speaking regulatory environments. When the FDA sends inspectors, they know what to expect.

Between 2020 and 2023, Indian facilities received 30% fewer Form 483 observations (the FDA’s official list of violations) than Chinese ones. That’s not because Indian workers are better. It’s because their systems are designed to prevent errors before they happen. Digital batch tracking. Automated documentation. Real-time environmental monitoring. These aren’t luxuries-they’re standard practice in India’s top factories.

That’s why global pharma companies are shifting production to India under the "China+1" strategy. It’s not about cutting costs. It’s about cutting risk. A single FDA warning can delay a drug launch for a year. For a $500 million product, that’s a $100 million loss. India’s reliability makes it the safer bet.

The Hidden Weakness in India’s Model

But here’s the catch: India doesn’t make most of its own APIs.

In 2024, India imported 72% of its bulk drug ingredients from China. That means even the cleanest Indian factory might be processing raw materials from a Chinese plant with a questionable audit history. It’s like buying organic flour from a trusted bakery-but the wheat came from a field sprayed with banned pesticides.

This dependency creates a single point of failure. If China restricts exports over trade tensions, or if a Chinese API plant gets shut down by the FDA, India’s drug supply chain stumbles. The U.S. government has tried to fix this. In 2023, India launched a $3 billion incentive program to boost domestic API production. But building a chemical plant takes years. And the Chinese suppliers are still cheaper.

The result? India is stuck between two worlds. It’s the gold standard for finished drug manufacturing-but it still leans on China for the foundation. Until that changes, the safety of Indian-made drugs is only as strong as China’s weakest factory.

What the FDA Actually Does

The FDA doesn’t approve drugs from China or India. It approves facilities. That’s a crucial distinction.

When a U.S. company wants to import a drug made in Pune or Shanghai, the FDA inspects the factory first. They check: Are the workers trained? Are the machines calibrated? Is the water clean? Are records real? If the inspection passes, the facility gets a green light. If it fails, the FDA issues a warning or blocks imports.

But inspections aren’t random. The FDA uses a risk-based system. Factories with past violations get more visits. Factories with clean records get fewer. That’s why Indian facilities-despite producing more volume-get inspected less often. Their compliance history gives them trust.

The FDA also tracks every shipment. If a batch of metformin from China shows signs of contamination, the FDA can flag all future shipments from that plant. They don’t need to test every pill. They test patterns. And over time, those patterns reveal which countries, and which companies, are reliable.

Cost vs. Control: The Real Trade-Off

You might think: "Why not just make everything in the U.S.?"

Because it’s not affordable. Making a single tablet of amoxicillin in the U.S. costs 10 times more than in India. Labor, energy, environmental regulations-it all adds up. For low-margin generics, that’s not an option.

So the choice isn’t between safe and unsafe. It’s between controlled risk and uncontrolled risk. China offers lower prices but higher uncertainty. India offers higher prices but more predictability. For chronic disease drugs taken daily, predictability matters.

Big U.S. pharmacies like CVS and Walgreens don’t care where the drug is made. They care if it’s on the shelf. But hospitals and insurers do. A 2023 study by the U.S. Pharmacopeia found that 68% of hospital pharmacists would switch suppliers if they learned a drug came from a facility with an FDA warning-even if the drug tested fine.

That’s the real cost of cutting corners: loss of trust.

What’s Changing in 2025

India’s 2023 revision of Schedule M-its national drug manufacturing rules-is pushing factories toward EU and FDA standards. New requirements include mandatory electronic records, real-time environmental monitoring, and stricter validation of cleaning procedures. These aren’t optional upgrades. They’re mandatory.

China, meanwhile, is trying to climb the value chain. It’s investing heavily in biologics, biosimilars, and gene therapies. But those are high-risk, high-cost areas. For now, it still dominates low-cost APIs.

The FDA is also expanding its overseas staff. In 2024, it opened new inspection teams in Bengaluru and Shanghai. These teams don’t just check compliance-they train local regulators. The goal? Build long-term capacity, not just catch violations.

The big shift? More companies are now asking: "Can we trust this supplier to stay compliant for the next 10 years?" That’s not a question you can answer with a price quote. It’s a question of culture, systems, and track record.

What Patients Should Know

You can’t tell where your drug was made just by looking at the bottle. The label won’t say "Made in China" or "Made in India." But you can ask your pharmacist. And you can check the FDA’s website for import alerts on specific manufacturers.

If you’re on a critical medication-like blood thinners, insulin, or seizure drugs-don’t assume all generics are the same. Some are made in factories with clean records. Others come from facilities under investigation. The FDA doesn’t ban every batch from a flagged plant. But it does flag the ones that fail.

The best protection? Stick with brands you trust. If your pharmacy switches your generic to a new maker, ask why. And if you notice a change in how the drug works-side effects, effectiveness, even how it looks-tell your doctor. That’s not paranoia. That’s vigilance.

Final Reality Check

China and India aren’t enemies in this story. They’re two parts of a broken system. China provides the raw materials. India turns them into medicines. The U.S. and Europe rely on both.

The real problem isn’t geography. It’s lack of oversight. A drug made in India with Chinese APIs is only as safe as the weakest link. And right now, that link is still in China.

The solution isn’t to stop buying from either country. It’s to demand transparency. To fund local API production. To hold every factory to the same standard-no matter where it is.

Because when it comes to your health, the country on the label shouldn’t matter. What matters is whether the pill inside is safe. And right now, the FDA is the only thing standing between you and the risks you can’t see.