On the outskirts of Hyderabad, India, a scene unfolded that would send shivers down the spine of any patient relying on generic drugs: workers at a major pharmaceutical plant loaded trash bags stuffed with shredded documents onto a truck, apparently eager to erase traces of what lay within. This wasn’t a one-off incident—it’s emblematic of a broader crisis in the global supply chain for generic medicines, one that’s been quietly building for years and now threatens the very trust Americans place in their daily prescriptions.
According to 7News, nearly half of America’s generic medicines now come from India. These drugs fill everything from medicine cabinets in suburban homes to the supply rooms of major U.S. hospitals. But what happens inside the Indian factories that churn out everything from cough syrup to chemotherapy drugs is rarely seen by outsiders. Over the past year, an extensive investigation by 7News followed the trail from U.S. Food and Drug Administration (FDA) files to the factory gates of India’s pharmaceutical hubs, uncovering a troubling pattern of falsified records, unsanitary conditions, and drugs that don’t meet safety standards.
Few people understand the gravity of these findings more than Peter Baker, a former FDA inspector who spent years conducting overseas inspections. When asked if he was surprised by the investigation’s findings—companies concealing evidence, destroying documents, and manipulating lab data—Baker’s response was stark: “No, I’m not surprised. 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.”
Baker’s words carry a chilling implication. When pressed on whether this disconnect between on-paper compliance and actual production is leading to patient deaths, he didn’t hesitate: “Absolutely. No question.”
The investigation’s journey led first to Aurobindo, one of India’s largest pharmaceutical companies and a major supplier of antibiotics and heart medication to the U.S. From the street outside one of their plants, 7News cameras captured workers loading those infamous bags of shredded documents. When staff realized they were being filmed, they demanded the footage be deleted—a request the crew declined.
Baker explained why such scenes are so alarming: “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.”
Unfortunately, Aurobindo is not alone. The FDA flagged its subsidiary, Eugia Pharma, five times in less than a year for falsified records, adulterated drugs, and failure to perform necessary tests. In a particularly damning warning letter, the FDA stated that Eugia’s problems were so severe, the company could not “ensure the safety, effectiveness and quality” of its drugs.
And the pattern doesn’t end there. Other major Indian manufacturers—Dr. Reddys, Zydus, and Granules—have all been cited for similar violations, ranging from cheating on critical tests to keeping inaccurate records and even destroying testing data. These are not minor paperwork errors; they strike at the heart of drug safety and efficacy.
For Dinesh Thakur, a former executive at Indian drug giant Ranbaxy and the whistleblower behind one of the largest pharmaceutical fraud cases in history, the revelations are all too familiar. Thakur’s exposure of data fraud at Ranbaxy led to a half-billion-dollar criminal fine more than a decade ago. Yet, as he told 7News, “I see the same behavior today among other companies. 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.”
Indeed, despite decades of egregious violations documented by FDA inspectors, the U.S. Department of Justice has pursued criminal charges against Indian pharmaceutical companies only once since the Ranbaxy case. The regulatory system, Thakur argues, is fundamentally broken. “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.”
Natco Pharma, another major supplier to the U.S. market, faced two recalls last year—serious enough to pull products from shelves—and was flagged by FDA inspectors this summer for altering test results. The recurrence of such problems raises urgent questions about the effectiveness of current oversight and the safety of medicines reaching American patients.
When confronted with evidence of torn and discarded records, Granules, one of the companies named in FDA reports, offered a detailed explanation. According to Granules, “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.” The company also stated that it had retained independent consultants to review its documentation practices and found no concerns that would indicate destruction of documents.
Granules further emphasized: “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.” The company claims to have updated its policies and is now transitioning to an all-digital platform, aiming for stronger documentation procedures.
Granules also highlighted its adherence to the ALCOA+ principles for data integrity—ensuring data is attributable, legible, contemporaneous, original, and accurate. All work related to current good manufacturing practices (CGMP) is recorded in official notebooks and batch records, reviewed by analysts, supervisors, and quality assurance teams. If inconsistencies arise, an investigation is launched, and data is only accepted or rejected after satisfactory resolution to ensure no adverse impact on product quality or safety.
For American consumers worried about the safety of their medicines, Granules offered reassurance: “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.”
But for those who have seen the failures firsthand, like Peter Baker, the reality is sobering. “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,” he said.
As the investigation continues, one thing is clear: the global pipeline of generic medicines is in urgent need of reform, with lives hanging in the balance.
