The Indian pharmaceutical industry—often hailed as the "pharmacy of the world"—finds itself at the centre of controversy. A new study alleges that Indian-made generics are linked to significantly higher rates of severe adverse events than their US counterparts. While the findings have raised concerns, industry experts argue the study's conclusions oversimplify a complex issue, potentially serving an agenda to undermine India's dominance in the global drug market. With pharma giants like Cipla and Sun Pharma doubling down on quality assurance, the real challenge lies in separating fact from fear-mongering. Is this scrutiny justified, or is it an orchestrated effort to discredit a global leader?
A study published in Production and Operations Management, which claims that generic drugs manufactured in India are linked to 54 per cent more severe adverse events—including hospitalisation, disability, and death—than their US-made counterparts, has drawn sharp criticism from industry experts.
One of the primary concerns is the study’s methodology and potential bias. The research broadly implies that manufacturing location is a key determinant of drug safety and efficacy, with lead researcher John Gray from Ohio State University stating that “where generic drugs are manufactured can make a significant difference.” However, critics argue that such a conclusion oversimplifies a complex issue, failing to account for the rigorous regulatory oversight Indian pharmaceutical companies undergo, particularly for drugs exported to the US and Europe.
An Indian pharmaceutical executive who did not wish to be named questioned the fairness of the study’s approach, pointing out that “every country has its share of bad manufacturers.” The study, they argue, unfairly targets India while overlooking quality lapses in other regions, reinforcing a biased narrative rather than providing a balanced assessment of global pharmaceutical manufacturing standards.
Additionally, the study does not clarify whether the adverse events reported resulted from manufacturing deficiencies, differences in healthcare reporting standards, or patient-specific factors. Without a deeper examination of these variables, the analyst said the claim that Indian generics are inherently riskier remains unsubstantiated.
The findings are based on an analysis of 2,443 drugs, comparing their safety records using the FDA Adverse Event Reporting System (FAERS) data. Researchers specifically examined older, long-established generic drugs, which are often produced at the lowest cost to maintain market competitiveness.
However, several industry experts have questioned the study’s methodology and intent. “There are bad manufacturers in every country,” says an anonymous Indian pharma executive. “This study paints a broad-stroke picture that unfairly singles out India while ignoring quality lapses in other regions.”
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There are bad manufacturers in every country, this study paints a broad-stroke picture that unfairly singles out India while ignoring quality lapses in other regions
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Despite the study’s findings, domestic brokerages remain optimistic about the future of Indian pharma giants such as Cipla, Sun Pharma, Dr Reddy’s, and Aurobindo Pharma. Analysts argue that these companies are improving quality control measures and remain globally competitive.
“Indian firms are continuously innovating, refining their production processes, and investing in compliance to align with international standards,” a market analyst notes.
Some companies even go beyond regulatory requirements, voluntarily subjecting themselves to more rigorous third-party audits to ensure credibility.
The controversy surrounding this report raises a crucial question: Is the study a wake-up call for Indian pharma to enhance its quality standards, or does it serve a larger agenda to discredit India’s pharmaceutical dominance?
Regulatory reforms, increased transparency, and unannounced inspections at overseas plants—similar to those in the US—could bridge existing gaps. However, demonising an entire industry without addressing global regulatory inconsistencies may not be the answer.
The real test lies in how India’s pharmaceutical sector responds. If companies continue strengthening compliance, investing in supply chain integrity, and prioritising patient safety, they can counteract such allegations with concrete action rather than words.
For now, the world is watching.
