WASHINGTON, D.C. (7News) — Thousands of miles away from the pharmacies we trust, Indian pharmaceutical companies produce the drugs that fill our medicine cabinets and hospitals. What happens inside those plants that make everything from cough syrup to cancer drugs is rarely seen.
Nearly half of America’s generic medicines now come from India. We got a glimpse inside the global medicine pipeline from those who know it best – warning that a system we’re forced to trust may be putting us at risk.
For more than a year, we’ve followed the trail from FDA files to factory gates in one of India’s pharmaceutical hubs.
We sent a crew to Telangana, one of India’s hubs for pharmaceutical drugs and medicines sold in the US (Photo: SBG)
We obtained hundreds of pages of inspection records and warning letters and over and over again, we found the same pattern: manufacturers cited for falsified data, filthy conditions and incorrectly made medicines – all tied to the global pharmaceutical pipeline.
Few know it better than Peter Baker, who handled overseas inspections for the FDA for years. We wondered if he was surprised by what we unearthed in years of FDA inspection reports detailing companies concealing evidence, destroying documents and obfuscating lab information.
“No, I’m not surprised,” Baker said. “That appears to be the norm rather than the exception. The problem that we have is we have high quality on paper, but poor quality in reality.”
Peter Baker told us there is “no question” that patients are dying because of poor quality drugs made in India (Photo: Riley Griffin)
We asked if that is leading to patient deaths.
“Absolutely,” Baker said. “No question.”
We sent a crew to the outskirts of Hyderabad, Telangana, one of India’s hubs for pharmaceutical drugs and medicines sold in the United States.
Our investigation led us first to one of the biggest names in India’s pharmaceutical industry: Aurobindo.
From antibiotics to heart medication, Aurobindo supplies millions of doses to the United States every year.
From the street outside one of their manufacturing plants, our cameras captured workers loading trash bags filled with shredded documents onto a truck.
When staff discovered our crew filming, they ordered the footage deleted.
It wasn’t.
Baker said that incident immediately sets off alarm bells for him, as he reflects on his time as an inspector and similar situations he encountered.
Dozens of bags of shredded records sit outside the Aurobindo facility (Photo: SBG)
Staff told our crew to delete the footage of trash bags being loaded on to a truck (Photo: SBG)
“Absolutely,” Baker said. “That’s one of the first things that an FDA investigator will do during an inspection is go to the waste stream. More likely than not, the investigator’s going to find documents in there that were relevant to a product that’s intended to be exported to the U.S. that’s going to demonstrate a problem with contamination, a problem with cleaning, a problem with sterility, or other issues that could cause serious adverse events.”
He said scenes like this can be warning signs of a deeper problem: paperwork that can’t be trusted to prove a drug is safe.
“The cost of compliance, which means proper record keeping and doing investigations when products don’t meet specifications, the cost required for doing that the right way appears to be too much,” Baker said. “And so as a result, companies have defaulted to taking shortcuts to still provide those products at rock bottom prices.”
In less than a year, the FDA flagged the Aurobindo subsidiary Eugia Pharma five times. Eugia supplies injectable drugs to the United States.
An FDA warning letter revealed falsified records, adulterated drugs and failure to perform necessary tests.
The FDA said the problems found at Eugia were so bad, the company cannot “ensure the safety, effectiveness and quality” of its drugs (Photo: SBG)
It was a common thread we found in FDA reports citing other major Indian manufacturers like Dr. Reddys, Zydus and Granules – all with violations for record-keeping from cheating critical tests, to keeping inaccurate information and tearing up testing data.
This leads us to question whether the FDA’s actions are having the desired results.
“I wish I could say yes, but no, I don’t think so, because if they were having the desired effect, you wouldn’t see people shredding documents making false representations. You would not see that,” said Dinesh Thakur, a former executive at the Indian drug maker, Ranbaxy.
Dinesh Thakur has said he’s “dismayed” that so little has changed since he blew the whistle on Ranbaxy (Photo: Alex Brauer)
Thakur blew the whistle on data fraud at Ranbaxy that led to one of the largest criminal fines in pharmaceutical history – half a billion dollars.
That was more than a decade ago and Thakur said it seems nothing has changed.
“I see the same behavior today among other companies,” Thakur said. “So, then I have to ask myself, what has changed? Why is it that these companies continue to do this and there’s only one of two reasons: either they look at it as the cost of doing business, or they don’t believe that they’ll actually get prosecuted.”
Ranbaxy faced $500 billion in criminal fines for data fraud (Photo: Reuters)
In fact, despite decades of documented, egregious violations by FDA inspectors, the U.S. Department of Justice has only once since Ranbaxy pursued criminal charges against Indian pharmaceutical companies that have been responsible for deaths, injuries and illnesses.
Another big supplier to the U.S. market is Natco Pharma, which makes generics of everything from cough syrup to chemotherapy drugs.
Last year, the company was the subject of two recalls, serious enough to pull products from shelves, and just this summer, FDA inspectors flagged the company for violations for altering test results.
We asked Thakur what it tells him when these problems keep repeating themselves.
“This model that the U.S. FDA uses to enforce our compliance with the regulations — it’s broken. It was broken when Ranbaxy was an issue. It was broken five years ago,” Thakur said.
For those who’ve seen it firsthand, the failures aren’t abstract, leaving inspectors like Peter Baker to confront a harsh reality.
“It is pretty demoralizing because you know that these products are going to be consumed by people across the world, not just in the U.S., that are not fit for human consumption,” Baker said.
Our investigation involved sifting through hundreds of pages of FDA inspection reports and warning letters (Photo: Alex Brauer)
We reached out to the companies mentioned in this report. Only Granules responded, claiming there was “no data destruction” and that it had fixed protocols for record-keeping. You can read their full answers to our questions below.
There is much more to come in our 4-part investigation into foreign drug manufacturing, as we continue to trace the dangers of our reliance on Indian-made medicines and bring the problem to our nation’s leaders, who are promising change.
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What is your explanation for US FDA inspectors discovering “A large amount of torn CGMP records in at least 15 plastic waste bags during the inspection, including analytical balance printouts and worksheets containing manufacturing and testing data.”
Granules takes quality seriously, and we continuously work to improve our quality systems across all manufacturing facilities. Granules has been manufacturing and distributing pharmaceutical products to the US market for several decades and has gone through multiple FDA inspections at all our facilities.
During the FDA inspection that was conducted at our Gagillapur facility in 2024, the FDA inspector asked to inspect three garbage trucks that were leaving the facility as part of a regularly scheduled pick-up. The inspector went through the disposed product and upon inspection of several bags in one truck, several documents were found alongside other trash. Upon review with Granules personnel, it was determined that several sheets of documentation were torn and disposed because they did not properly print out. Duplicate printouts were made and were filed away after the initial set was discarded. In addition, all the data in the disposed printouts was entered into a digital platform. The torn documents, the duplicate print-out and digital data were all reviewed and verified to be the same and accurate. Granules retained independent consultants to review our documentation practices and they did not find any concerns that would lead to destruction of documents.
Why were those critical records being destroyed?
Records were never destroyed at Granules and there was no instance of data destruction. Due to a printing error, documents were disposed and reprinted, which were then filed away. Data was also stored electronically and was verified. Granules has updated its policy so there is stronger documentation procedures and the Company will also be transitioning to an all-digital platform.
What is your protocol for maintaining accurate manufacturing and testing data?
All Granules’ personnel undergo training on recording data following the principles of ALCOA+. This is a framework for maintaining data integrity and it stands for attributable, legible, contemporaneous, original and accurate. Additionally, the data must be complete, consistent, enduring and available. All work that is related to CGMP (current good manufacturing practices) is recorded in official notebooks, batch records and any other documents that are reviewed by the analyst performing the work and his/her supervisor followed by Quality Assurance to ensure the data is accurate and complete. If there are any inconsistencies, there is an investigation and only upon satisfactory conclusion to the investigation the data is accepted or rejected to ensure there is no adverse impact to the quality or safety of the product.
What’s the message you would give to American consumers concerned about the safety and efficacy of the drugs you manufacture?
Granules is unwavering in its commitment to delivering safe, effective, and high-quality medicines to patients and consumers in the United States. Our facilities and processes are rigorously designed to meet the standards set by the FDA and other global regulatory authorities. We undergo frequent internal and external audits, continuously strengthen our quality systems, and prioritize a culture of accountability and excellence at every step. American consumers can be confident that every product we manufacture reflects our decades-long dedication to safety, efficacy, and trust.
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