It’s been a rough start to 2025 for Indian pharmaceutical giants. Four of India’s biggest generic drug producers issued product recalls in the last three months.
In January, Glenmark Pharmaceuticals started things off when they recalled a massive 1.4 million bottles of the attention deficit disorder drug called atomoxetine. Glenmark makes this at its lab in the Arabian Sea coastal city of Goa.
Sun Pharmaceuticals was the second to issue a recall. They recalled 10,000 bottles of the painkiller morphine sulphate extended release tablets on Feb. 6. A week later, Zydus Pharmaceuticals recalled 38,871 vials of the chemotherapy injectable nelarabine. The chemo drug was manufactured at the company’s Ahmedabad, India lab.
More recently, on March 13, Dr. Reddy’s Laboratories recalled around 1,000 levetiracetam infusion bags that had been shipped to the U.S. in November. Levetiracetam is an anti-epileptic medication used primarily to treat seizures.
The Glenmark drug was recalled due to capsules containing cancer-causing impurities (nitrosamines) exceeding acceptable limits. When a drug fails an impurity test, usually conducted by the manufacturer itself, it means the drug has higher than allowable levels of unwanted substances set by the FDA. These impurities can arise during manufacturing or storage of the drug. In worse case scenarios, these impurities can impact a patient's health and cause harm.
Sun and Zydus drugs were recalled due to impurity and dissolution problems, and Dr. Reddy’s products seem to have been recalled because of incorrect labelling instructions on the infusion bags.
The generic drugs Americans take daily are usually made in labs overseas. Around 90% of over-the-counter antiviral and antibiotic medications are reliant on active pharmaceutical ingredients (API) not found in the U.S. Some 83% of the top 100 prescribed generic medications are imported.
In January 2024, the Active Pharmaceutical Ingredient Innovation Center, a consortium of biotechnology industry, policy and academic leaders, said that reshoring generic pharmaceuticals was “urgently needed.”
It is worth nothing that these recalls are conducted by the companies themselves, often at great expense and damage to the company’s reputation. No one here is looking over India’s shoulders. That begs the question: how many labs are missing these errors in labeling and extra carcinogens in drugs, and how many keep quiet about it should they find a problem they deem too small (and possibly too expensive) to correct?
Earlier this year, professors from Ohio State, Indiana University, Brigham Young University and two universities in Korea wrote a research paper that showed not all generic drugs are created equal. They found that generic drugs manufactured in India, where a majority of emerging economy generic drugs are made, were “associated with significantly higher instances of serious adverse events than equivalent generic drugs made in the U.S.”
The working paper is with the Productions and Operations Management Journal, a peer review publication in the field of operations research, supply chain management, and business analytics. The authors said “there is growing anecdotal evidence that some generic drugs on the market have a greater quality risk than others, and that these differences can have clinical impact. The main reason for any systemic quality differences in supposedly interchangeable generics is driven by operations and supply chain factors—that is, differences in supplier, manufacturing, and/or distribution practices by these manufacturers.”
They added that despite the ingredients and “recipe” for making the generic drug being known, “there is increasing anecdotal evidence that points to manufacturers in countries, particularly India, producing in ways that do not consistently result in truly interchangeable drugs.”
Beyond Recalls: Shortages and Import Dependence
The United States consumes more medications than any other country in the world. Our reliance on imported generic drugs—from daily-dose prescriptions to lifesaving oncological injectables—means that when the FDA uncovers serious violations at foreign labs, such as unsanitary equipment or poor ventilation filled with pigeon feathers (yes, that has happened), regulators often allow those facilities to continue selling to the U.S. to prevent drug shortages. Only in the most extreme cases does the FDA impose import bans on foreign manufacturers.
Branded pharmaceutical companies like Eli Lilly focus on developing innovative drugs that they can sell under patent and at high prices to recover the expense of trial and error research. But it is the off-patent generic medicines like those being recalled above that are the foundation of America’s drug market and health care.
Injectable anesthetics like Propofol used for patients undergoing surgery is a generic. Amoxicillin is a generic antibiotic used to treat pneumonia. When those items are in short supply, the FDA will err on the side of supply rather than on the side of caution, unless the drug is obviously harmful.
Despite their essential role in global healthcare, manufacturing issues, weak supply chains and low pricing have combined to create a “broken market” for generic medicines that makes them unattractive to produce and vulnerable to supply shocks, quality defects or surges in demand that lead to shortages, the Financial Times reported this week.
For patients, shortages can also translate into less effective treatment.
The U.S. relies on foreign labs to police themselves and will seldom ban imports, including from labs that have a bad track record and have had product recalls year after year.
Last April, the FDA visited Zydus’ lab in Gujarat state and found 10 discrepancies that run afoul of the FDA’s required good management practices for selling drugs in the U.S. Some issues may seem fastidious, like proper management of an office computer. But others could easily lead to poorly made drugs, either lacking efficacy or containing contaminants, like equipment not cleaned properly, or procedures to prevent microbial contamination not followed.
Pharmaceutical drugs are one of the biggest components of the U.S. trade deficit. Last year, the U.S. recorded a roughly $140 billion pharma deficit with the world in both branded and generic medications.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
Drug Safety Concerns: Four Indian Pharma Companies Issue Recalls in Last Three Months
It’s been a rough start to 2025 for Indian pharmaceutical giants. Four of India’s biggest generic drug producers issued product recalls in the last three months.
In January, Glenmark Pharmaceuticals started things off when they recalled a massive 1.4 million bottles of the attention deficit disorder drug called atomoxetine. Glenmark makes this at its lab in the Arabian Sea coastal city of Goa.
Sun Pharmaceuticals was the second to issue a recall. They recalled 10,000 bottles of the painkiller morphine sulphate extended release tablets on Feb. 6. A week later, Zydus Pharmaceuticals recalled 38,871 vials of the chemotherapy injectable nelarabine. The chemo drug was manufactured at the company’s Ahmedabad, India lab.
More recently, on March 13, Dr. Reddy’s Laboratories recalled around 1,000 levetiracetam infusion bags that had been shipped to the U.S. in November. Levetiracetam is an anti-epileptic medication used primarily to treat seizures.
Sun and Zydus drugs were recalled due to impurity and dissolution problems, and Dr. Reddy’s products seem to have been recalled because of incorrect labelling instructions on the infusion bags.
The generic drugs Americans take daily are usually made in labs overseas. Around 90% of over-the-counter antiviral and antibiotic medications are reliant on active pharmaceutical ingredients (API) not found in the U.S. Some 83% of the top 100 prescribed generic medications are imported.
In January 2024, the Active Pharmaceutical Ingredient Innovation Center, a consortium of biotechnology industry, policy and academic leaders, said that reshoring generic pharmaceuticals was “urgently needed.”
It is worth nothing that these recalls are conducted by the companies themselves, often at great expense and damage to the company’s reputation. No one here is looking over India’s shoulders. That begs the question: how many labs are missing these errors in labeling and extra carcinogens in drugs, and how many keep quiet about it should they find a problem they deem too small (and possibly too expensive) to correct?
Earlier this year, professors from Ohio State, Indiana University, Brigham Young University and two universities in Korea wrote a research paper that showed not all generic drugs are created equal. They found that generic drugs manufactured in India, where a majority of emerging economy generic drugs are made, were “associated with significantly higher instances of serious adverse events than equivalent generic drugs made in the U.S.”
The working paper is with the Productions and Operations Management Journal, a peer review publication in the field of operations research, supply chain management, and business analytics. The authors said “there is growing anecdotal evidence that some generic drugs on the market have a greater quality risk than others, and that these differences can have clinical impact. The main reason for any systemic quality differences in supposedly interchangeable generics is driven by operations and supply chain factors—that is, differences in supplier, manufacturing, and/or distribution practices by these manufacturers.”
They added that despite the ingredients and “recipe” for making the generic drug being known, “there is increasing anecdotal evidence that points to manufacturers in countries, particularly India, producing in ways that do not consistently result in truly interchangeable drugs.”
Beyond Recalls: Shortages and Import Dependence
The United States consumes more medications than any other country in the world. Our reliance on imported generic drugs—from daily-dose prescriptions to lifesaving oncological injectables—means that when the FDA uncovers serious violations at foreign labs, such as unsanitary equipment or poor ventilation filled with pigeon feathers (yes, that has happened), regulators often allow those facilities to continue selling to the U.S. to prevent drug shortages. Only in the most extreme cases does the FDA impose import bans on foreign manufacturers.
Branded pharmaceutical companies like Eli Lilly focus on developing innovative drugs that they can sell under patent and at high prices to recover the expense of trial and error research. But it is the off-patent generic medicines like those being recalled above that are the foundation of America’s drug market and health care.
Injectable anesthetics like Propofol used for patients undergoing surgery is a generic. Amoxicillin is a generic antibiotic used to treat pneumonia. When those items are in short supply, the FDA will err on the side of supply rather than on the side of caution, unless the drug is obviously harmful.
Despite their essential role in global healthcare, manufacturing issues, weak supply chains and low pricing have combined to create a “broken market” for generic medicines that makes them unattractive to produce and vulnerable to supply shocks, quality defects or surges in demand that lead to shortages, the Financial Times reported this week.
For patients, shortages can also translate into less effective treatment.
The U.S. relies on foreign labs to police themselves and will seldom ban imports, including from labs that have a bad track record and have had product recalls year after year.
Last April, the FDA visited Zydus’ lab in Gujarat state and found 10 discrepancies that run afoul of the FDA’s required good management practices for selling drugs in the U.S. Some issues may seem fastidious, like proper management of an office computer. But others could easily lead to poorly made drugs, either lacking efficacy or containing contaminants, like equipment not cleaned properly, or procedures to prevent microbial contamination not followed.
Pharmaceutical drugs are one of the biggest components of the U.S. trade deficit. Last year, the U.S. recorded a roughly $140 billion pharma deficit with the world in both branded and generic medications.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
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