India, a global leader in generic drug manufacturing, supplies 40 percent of U.S. generics and over 20 percent of global exports, with the industry valued at $50 billion. However, a new study raises safety concerns
Published Mar 01, 2025 | 7:00 AM ⚊ Updated Mar 01, 2025 | 7:00 AM
The research covered 107 patients who had developed Ethambutol-induced Toxic Optic Neuropathy, a condition in which the optic nerve is damaged. (Representational Image/Creative Commons)
Synopsis: A new study has raised concerns over the safety of generic drugs manufactured in India. It found a significantly higher number of severe adverse events compared to generic drugs produced in the US. Over the past five years, more than 40 Indian pharmaceutical firms have received warning letters from the USFDA, despite India supplying approximately 60 percent of the world’s vaccines.
India has long been a global powerhouse in generic drug manufacturing, supplying nearly 40 percent of all generic medications consumed in the United States and accounting for over 20 percent of global generic drug exports.
The industry, valued at over $50 billion, plays a crucial role in providing affordable healthcare solutions worldwide.
However, a new study has raised concerns over the safety of generic drugs manufactured in India.
The researchers found a significantly higher number of severe adverse events (SAEs) compared to generic drugs produced in the United States.
A study by researchers from Korea and the US analysed 2,443 generic drugs manufactured in both advanced and emerging economies.
The findings revealed that generic drugs produced in India were associated with a 54% higher rate of severe adverse events, including hospitalisation, disability, and even death compared to their US-made counterparts.
These findings challenge the widely held belief that all generic drugs offer the same safety and efficacy as their brand-name counterparts, a claim consistently upheld by regulatory authorities, including the US Food and Drug Administration (FDA) and the Indian Central Drugs Standard Control Organization (CDSCO).
The study underscores differences in regulatory oversight between advanced and emerging economies.
In the US, FDA inspections of pharmaceutical plants are conducted unannounced, ensuring stringent quality checks.
In contrast, inspections of Indian manufacturing plants are often pre-scheduled, potentially allowing companies to prepare for inspections and conceal deficiencies.
The results show that all generic drugs are not equal, even though patients are often told that they are, said John Gray, co-author of the study and professor of operations at The Ohio State University’s Fisher College of Business, in a statement.
“Drug manufacturing regulation and therefore quality assurance practices differ between emerging economies like India and advanced economies like the United States,” Gray said.
“Where generic drugs are manufactured can make a significant difference.”
“The FDA assures the public that all generics patterned after the same original drug should be equivalently safe and effective, however, this is not necessarily the case when it comes to generic drugs made in India,” added another co-author, George Ball, associate professor of operations and decision technologies at Indiana University’s Kelley School of Business, in a statement.
India’s pharmaceutical industry is one of the largest in the world, with over 3,000 drug companies and 10,500 manufacturing units.
It supplies about 60 percent of global vaccine demand and has been instrumental in lowering the costs of essential medicines, including antiretroviral drugs for HIV/AIDS.
Despite this, there have been past concerns about manufacturing standards, with over 40 Indian pharmaceutical firms receiving FDA warning letters in the last five years for violations related to manufacturing and data integrity.
While the study does not advocate for halting the production of generics in India, it calls for stronger oversight to ensure consistent quality.
“This study serves as a clarion call for the FDA to carefully study the underlying reasons for the important quality risk difference we identify,” write the authors.
“The FDA possesses much more granular data than do academic researchers, and this is precisely what is needed to determine exactly which aspects of the operations and supply chain explain our results.”
The results do not mean that all drugs made in India are of poor quality, or that the US should stop buying generic drugs from foreign producers.
The data included other countries too, but the core finding was “generic drugs made in India, where the majority of emerging economy generic drugs are made, experience significantly more SAEs (serious adverse events) than equivalent generic drugs made in the US, where a majority of advanced economy generic drugs are made.”
What the results do suggest is that the FDA’s claims that generic drugs are interchangeable may not necessarily hold true in all cases.
Generic drugs may have the same active ingredients, the same dosage form, and the same routes of administration, but that does not mean they are made with the same best practices.
Manufacturing operations and supply chain activity could be impacting the quality of these medicines, making it more likely that a patient experiences severe side effects.
“There are good manufacturers in India, there are bad manufacturers in the US, and we are not advocating for ending offshore production of drugs or bashing India in any way,” said Gray, “We believe this is a regulatory oversight issue that can be improved.”
A major breakthrough of the study was its ability to link generic drugs to the specific factories where they were produced.
Typically, this information is not disclosed by the FDA, making it difficult to track the origin of drugs and their associated safety records, said the authors.
The researchers used the Structured Product Labeling dataset to bypass this lack of transparency, providing a clearer picture of manufacturing quality disparities.
It provides data for all drugs on the US market, including the manufacturer name and plant location. Specifically, generic drugs from India that had been on the US market for longer were more likely than US drugs of an equivalent age to be associated with severe side effects, the researchers found.
To ensure public health and to inspire more trust in generic medicine, the authors argue the FDA should make the location of drug manufacturers and their quality transparent for consumers.
With global dependence on Indian generics unlikely to wane, regulatory bodies like the FDA and CDSCO may need to reassess current inspection and compliance mechanisms. Striking a balance between affordability and quality remains a key challenge, and enhanced international collaboration could help ensure that generic drugs remain both cost-effective and safe for patients worldwide, said the authors.
(Edited by Rosamma Thomas)
