New Delhi: The Indian Pharmaceutical Alliance (IPA) has strongly refuted the findings of a study by researchers associated with Ohio State University, which had linked Indian generic drugs to 54 percent higher severe adverse events, compared to drugs made in the US.
The study titled ‘Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events’, was published in Production and Operations Management last month.
Calling the study “ill-researched”, the IPA—a network of 23 leading Indian drugmakers, most of whom are major exporters to the US—dismissed the findings of the study that had claimed lack of transparency in drug manufacturing location of Indian generics.
“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,” IPA said in a statement issued Wednesday.
The alliance insisted that generic drugs manufactured in India comply with global regulatory standards.
“FDA (US Food and Drug Administration) follows a stringent approval process before any generic drug is approved, ensuring that the process, controls, specification of the input API (Active Pharmaceutical Ingredient) and that of the finished product are governed within a window, and are followed throughout the product lifecycle,” the statement read. “The standards applied to the approval of generic drugs within the US and in India are not different, as the study also acknowledges.”
It further noted that Indian manufacturing facilities are subjected to far greater scrutiny as most manufacturers supply products to multiple countries, and are inspected additionally and routinely by the regulators from European Union, UK, Australia, Brazil, Canada and others, all of which hold high quality standards and share findings under mutual agreement.
“The inspection outcome categorisation of Official Action Indicated (OAI) has reduced to 11 percent in 2024 compared to 23 percent in 2014 for Indian companies, in line with the global trend of 14 percent in 2024,” the statement read.
IPA said that the report relies upon the FDA Adverse Event Reporting System (FAERS), the post-marketing surveillance database for adverse events. “FAERS data is observational, and thus captures associations between drugs and adverse events, but does not prove causation. Therefore, a higher rate of serious adverse events (SAEs) for drugs manufactured in emerging economies does not inherently mean manufacturing quality is inferior,” it added in the statement.
The use of FAERS to conclude product quality has limitations—reporting biases, lack of denominator data and inability to establish causality—that make it unsuitable for the purpose, the IPA also said. “The study employs considerate methodologies, but remains constrained by the purpose and limitations of FAERS data.”
The study, published in February, had analysed 2,443 drugs manufactured in the US and emerging economies. While multiple countries were included, the focus was on India, which supplies 93 percent of the generic drugs that the US imports from these regions. Researchers compared the frequency of adverse event reports linked to generic drugs produced in India versus those made in the US, using data from FAERS.
IPA also highlighted that FAERS data often contains multiple reports of the same adverse event from different sources, potentially leading to over-reporting. It said that pharmacovigilance data primarily reflects the properties of the active drug substance and overall drug formulation, regardless of where it is manufactured. Therefore, adverse events cannot be conclusively linked to a specific manufacturing site or producer.
It further noted that under US regulations, all adverse events associated with a drug—regardless of its dosage form or production facility—must be reported under the same Abbreviated New Drug Application (ANDA) number. This requirement applies even if the drug is manufactured outside India.
Additionally, any adverse events cited in medical literature must be reported to the FDA, irrespective of the drug’s origin.
IPA asserted that the FDA’s approval process and routine inspections serve as sufficient safeguards to ensure the quality of generic drugs.
Commenting on the IPA statement, US-based public health activist Dinesh Thakur told ThePrint that the period covered by the study broadly correlates with one of the worst phases for Indian pharma—this was the time period where the USFDA blocked tens of Indian facilities from exporting to the United States because Indian manufacturing facilities were failing inspections at an alarming rate.
“I am therefore not surprised by the conclusions of this study,” he said.
Thakur added that the FARES database which was used for this study is self-reported data by healthcare providers and manufacturers. “A large portion of this data is in fact reported to the FARES database by generic manufacturers. It is disingenuous to say that the data is purely ‘observational’ as the IPA response says; doctors and nurses who see the patient, record patient history, understand the confounding factors such as other medication that the patient is on are all recorded and submitted to the manufacturer,” said Thakur.
He went on to say that initial submission from a healthcare provider has implied causation which is then confirmed by the generic manufacturer. “Expedited ICSR reports data includes an assessment of causality by the ANDA holder. While it is true that in some cases, causation is not directly established (for example, cases from literature searches), it does form the basis of recall decision by the USFDA—the logic being that, if there are enough red-flags from different sources about the drug, there is something likely wrong with the drug formulation warranting a recall from the market,” he said.
Thakur added that if this data is credible enough to trigger recalls, it is credible enough to form the basis of a study such as this. “Whether the situation has improved in recent years is anybody’s guess since the pandemic seriously disrupted inspections by the US FDA in India.”
This is an updated version of the report
(Edited by Mannat Chugh)
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