The Indian Pharmaceutical Alliance (IPA) has rebuffed the findings of a study conducted by a U.S. university that suggested differences in operations and supply chain factors — suppliers, manufacturing, and/or distribution practices by different manufacturers — can impact the quality and efficacy of generic drugs.

Disagreeing with the argument, which could cast doubts over the quality of generic medicines supplied from India to the U.S., the IPA said that the U.S. drug regulator, the USFDA, follows a stringent process of inspections for manufacturing sites both within the U.S. and in emerging geographies, including India. The IPA also pointed out that the USFDA has established an office in India to oversee the number of Indian manufacturers qualified to supply generic medicines to the U.S. The FDA has also implemented a Foreign Unannounced Inspection Pilot Programme to increase unannounced surveillance inspections of foreign drug facilities and has conducted several unannounced and short-notice inspections in India since March 2022.

The study questioned by the IPA, titled “Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events,” was conducted by Ohio State University. The 23 IPA member Indian pharmaceutical companies account for 80% of India’s drug and pharmaceutical exports, 64% of domestic market sales, and 85% of private sector investment in pharmaceutical R&D.

The IPA said that the study appears to be poorly researched, as it claims a lack of transparency in the drug manufacturing location for Indian generics. “The complete manufacturing address, by law, is indicated on every single pack of generic products distributed in the U.S. market, besides being available on the FDA’s database, such as the Orange Book. An exception to this rule is over-the-counter (OTC) products distributed by private label distributors like Walmart, even those which indicate India as the country of origin,” the IPA stated.

The report relies on the FDA Adverse Event Reporting System (FAERS), the post-marketing surveillance database for adverse events. The IPA clarified that 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 argued.

“The Indian pharmaceutical sector has made significant strides in strengthening quality systems in response to evolving global regulatory expectations. There have been recent developments in Quality Maturity (adherence to regulatory standards, risk-based approaches, and a proactive quality culture) in India. The Indian pharmaceutical industry is committed to upholding the highest standards in quality and prioritising patient safety and well-being,” the IPA stated.