IPA questions FAERS data interpretation in the Ohio State University study
The Indian Pharmaceutical Alliance (IPA) states that a higher rate of serious adverse events (SAEs) for drugs manufactured in emerging economies does not inherently mean manufacturing quality is inferior
The Indian Pharmaceutical Alliance (IPA) questions the reliance on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) in the Ohio State University report titled, “Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events.” IPA stated that FAERS data captures associations between drugs and adverse events but does not establish causation.
IPA noted that FAERS data includes multiple reports of the same adverse event from different sources, leading to over-reporting. The organisation stated, “PV (pharmacovigilance) events are generally a reflection of the properties of the active drug substance and the drug product, irrespective of where it is manufactured. Thus, it cannot be conclusively linked with the manufacturing site or manufacturers.”
IPA also pointed out that US regulations require adverse events related to any dosage form of a drug to be reported under the same Abbreviated New Drug Application (ANDA) number, even if the product is manufactured at a different facility or outside India. It added that adverse events reported in medical literature must also be submitted to the FDA, regardless of the product’s manufacturing location.
The organisation concluded that FAERS data has limitations, including reporting biases, lack of denominator data, and inability to establish causality, making it unsuitable for assessing product quality. IPA stated, “We believe that FDA’s mechanism of product approvals and enforcement of quality through various measures, including routine inspections, adequately address product quality.”
IPA reaffirmed that Indian generic drugs meet global regulatory standards and that quality standards applied to generic drug approvals in India and the US are identical. It stated that the FDA approval process ensures the manufacturing process, controls, and specifications of active pharmaceutical ingredients (APIs) and finished products are governed within a set framework and maintained throughout the product lifecycle. IPA disagreed with the study’s assertion that differences in manufacturing and supply chain practices impact the quality and efficacy of Indian generic drugs.
On the pricing of generics, IPA stated, “While generics are priced lower than the corresponding brands, it is unfair and unacceptable to link quality with cost.” It attributed India’s cost advantage to high-production capacity plants, process improvements, economies of scale, and backward integration in manufacturing.
IPA also addressed concerns regarding transparency in drug manufacturing locations. It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDA’s Orange Book database. Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin.
The United States Food and Drug Administration (FDA) conducts rigorous inspections of both domestic and foreign manufacturing facilities, including those in India. The FDA has an established office in India overseeing the number of qualified manufacturers supplying generic medicines to the US. It has also introduced the Foreign Unannounced Inspection Pilot programme, conducting multiple unannounced and short-term notice inspections in India since March 2022.
In the last decade, there has been increased engagement between Indian pharmaceutical manufacturers and the FDA to address manufacturing and quality operations. Inspection categorisation of Official Action Indicated (OAI) for Indian companies has decreased to 11 per cent in 2024 from 23 per cent in 2014, aligning with the global trend of 14 per cent in 2024. Indian manufacturing facilities also undergo routine inspections by regulatory authorities from the European Union, the United Kingdom (MHRA), Australia (TGA), Brazil (ANVISA), Health Canada, and others.
IPA reiterated that the Indian pharmaceutical sector has strengthened quality systems to align with global regulatory expectations and remains committed to maintaining high standards in manufacturing and patient safety.
