India’s Pharma Industry In The Spotlight In The US Over Indian Generic Drugs Being Linked To Deaths. Is The Quality Of Indian Generic Drugs Compromised And Should We Be Cautious?
The Indian Pharma Industry’s generic drugs are under the scanner in the US over a study linking Indian-made generic drugs to a higher risk of serious side effects in the US.
The study has drawn backlash from the industry’s most influential lobby group, even as India moves to defend its dominant market share amid trade tensions under President Donald Trump.
The study, which analyzed more than 2,400 drugs sold in the US between 2009 and 2018, found that Indian generics were associated with a 54% greater risk of serious adverse events, including hospitalization, disability, and death, compared with equivalent domestically made medicines.
The research links operations and supply chain issues in the manufacturing process as “most likely” explaining the findings.
Published last month in the journal Production and Operations Management, the findings prompted a three-page statement from the Indian Pharmaceutical Alliance, which represents two dozen of the country’s largest drugmakers.
We strongly disagree with the study’s premise that differences in operations and supply chain factors – suppliers, manufacturing and/or distribution practices by different manufacturers – impact the quality and efficacy of Indian generic drugs. The industry body said in its response.
Still, last month’s study, led by researchers with experience working with the US Food and Drug Administration, adds to mounting concerns over the quality of Indian-made medicines. India, the world’s largest supplier of generic medicines, produces about a fifth of the global supply and its 752 FDA-compliant factories meet roughly 40% of US demand for non-patented medications.
Between 2018 and 2024, US pharmaceutical imports from India nearly doubled to $13 billion, illustrating the growing influence of the country’s drugmakers. Meanwhile, Trump has warned companies to move production to the US or face tariffs of up to 25%, a move that could further strain pharmaceutical firms with rising costs.
However, regulatory lapses at Indian factories, including unsanitary conditions, poorly trained staff, and shredded paperwork, have raised concerns worldwide, as many countries rely on India for essential medicines.
In 2022, tainted cough syrup was linked to the deaths of dozens of children in Gambia and Uzbekistan, while more recently, contaminated eye drops caused blindness in US patients.
Quality, A Problem?
The study is the first to link a large sample of drugs to their manufacturing plants, using the Structured Product Labeling dataset, which contains detailed information on each drug approved for sale in the US, including its application number and production facility. However, the analysis didn’t associate specific adverse events with particular classes of medications.
Our logic and results together imply that manufacturers in India are, on average, operating in a way that results in more quality risk than those in the US, particularly when the drug has been on the market for a relatively long amount of time, the authors wrote
There is a widespread assumption that generic drugs are the same when they have the same dosage form and route of administration, said study co-author John Gray, a dean’s distinguished professor of operations and business analytics at Ohio State University, in an interview.
The Indian pharma body said it believes that the use of data of adverse events to conclude product quality has limitations such as reporting biases and inability to establish causality.
There has been a significantly greater engagement that the Indian industry and the regulator have had with the FDA in addressing manufacturing and quality operations in the Indian subcontinent,” the Indian pharma alliance said, adding that the FDA’s enforcement of quality through measures including routine inspections is adequate.
The authors urged the FDA to strengthen oversight, particularly through unannounced inspections. The agency has already increased inspections of Indian factories by 46% between 2014 and 2024, with instances of objectionable conditions rising 38% in the same period, according to its database.
“The FDA mandates things, but firms can voluntarily do quite a bit on their own,” the authors noted. Drugmakers should compete on quality and transparency, making it easier for buyers to assess standards. They suggested companies include quality data on labels, benchmark themselves against peers using public records, and leverage superior quality to attract buyers.
The study also called for greater transparency in drug quality, arguing that rewarding better manufacturers with stronger demand and higher prices could help push inferior players out of the market.
Is Cost-Cutting Hurting the Quality of Indian Generic Drugs?
The authors of last month’s study believe that “quality corner-cutting” might be behind the higher risk of serious side effects linked to Indian generics.
Their reasoning is that cost pressures could be the problem. The longer a drug has been on the market, the more manufacturers might feel the squeeze to reduce operational and supply chain costs, potentially compromising quality along the way.
Interestingly, both the Drugs Controller General of India and the US FDA have stayed silent on the matter, offering no official response to the research.
What makes this study unique is that it’s the first to track a large number of drugs back to their manufacturing plants using detailed US drug approval data. However, it stops short of linking specific adverse effects to certain types of medications, meaning it’s not pointing fingers at any one class of drugs, just the overall trend.
What If the Allegations Against Indian Generics Are True?
For decades, India has been celebrated as the “pharmacy of the world,” supplying affordable generic medicines to millions across the globe. But what if the recent allegations – linking Indian generics to a higher risk of serious side effects, hospitalizations, and even deaths – are actually true? If the study’s findings hold up under scrutiny, we could be staring at a public health crisis of massive proportions.
Are We Playing with Lives?
The crux of the study suggests that Indian drug manufacturers, pressured by cost-cutting, may be compromising on quality. If this is accurate, the implications are disturbing. It means that millions of patients, often the most vulnerable. are taking medications that might not just be ineffective but actively harmful.
A 54% higher risk of serious side effects, is the difference between a life saved and a life lost! And, if long-marketed drugs are more prone to issues, it signals deterioration in quality over time, likely due to cost pressures, supply chain shortcuts, and manufacturing lapses.
Regulatory gaps, especially in an industry as critical as pharmaceuticals, could mean that dangerous drugs are making their way into hospitals, clinics, and pharmacies unnoticed – until tragedy strikes.
What Happens to India’s Pharma Reputation?
The Indian pharmaceutical industry has built a global reputation, supplying nearly 40% of the US market’s generics and countless other nations. If these allegations are true, that trust could crumble overnight.
Countries that rely on India for affordable medicine may start pulling back, imposing tighter restrictions, or turning to other markets (like China).
International regulators, especially the US FDA and European agencies, could increase surprise inspections, leading to mass product recalls and manufacturing bans.
Indian pharma companies, already under scrutiny, could face billions in lawsuits, much like what happened to opioid manufacturers in the US.
What It Means for Patients Worldwide
If Indian generics are indeed riskier, the consequences will be felt hardest by those who depend on them the most – patients in low- and middle-income countries.
Many African, Asian, and South American nations rely on Indian medicines for everything from HIV/AIDS treatment to life-saving antibiotics. If these drugs are unreliable, what happens to their healthcare systems?
Drug prices could skyrocket if alternatives from Western manufacturers become the only trusted source, making essential medicines unaffordable for millions.
The damage wouldn’t just be medical, it would be economic. A global withdrawal from Indian pharma could cripple one of India’s most profitable industries, costing millions of jobs and billions in exports.
Immediate Steps Needed
If these findings are even partially true, then urgent reforms are needed, not just defensive statements from pharma lobby groups.
Stricter Oversight: India’s drug regulators must take these concerns seriously and tighten inspections at every stage of manufacturing.
Greater Transparency: Companies should be forced to disclose quality reports, ensuring that doctors and patients know exactly what they’re taking.
Accountability for Violations: If quality shortcuts are being made for profit, then those responsible should face severe consequences, including legal action.
Another Angle
Of course, there is another angle to consider. Could this be part of a larger geopolitical game to undermine India’s dominance in the global pharma industry? With rising trade tensions and calls for reshoring US drug manufacturing, one can’t ignore the politics at play.
But if even a fraction of these allegations are true, brushing them off as Western bias would be reckless. Because at the end of the day, medicine is about saving lives not cutting corners to save costs.
The Last Bit
The authors believe the FDA needs to step up its game, particularly through surprise inspections. In fact, the agency has already increased inspections of Indian pharma plants by 46% between 2014 and 2024. But what’s worrying is that violations flagged for “objectionable conditions” have also risen by 38% in the same period.
Still, the researchers argue that quality enforcement shouldn’t just come from regulators, it should be a competitive advantage.
It’s time for India’s pharma industry giants to prove their credibility, not just through words, but through action.
