IPA rejects Ohio University study linking higher adverse events to made in India generics

Pharma

The Indian Pharmaceutical Alliance (IPA), representing 23 leading national pharmaceutical companies, on Wednesday has refuted the findings of a recent Ohio State University study that suggests a link between the manufacturing location of generic drugs and their quality.

A recent study at Ohio State University titled "Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events", alleged that generic drugs manufactured in India are linked to significantly more “severe adverse events” for patients who use them than equivalent drugs produced in the United States, a new study finds. The report stated that adverse events included hospitalization, disability, and in a few cases.

"We strongly disagree with the study's premise that differences in operations and supply chain factors — suppliers, manufacturing and distribution practices by different manufacturers — impact the quality and efficacy of Indian generic drugs," the report said.

IPA also refuted the study's reliance on the FDA Adverse Event Reporting System (FAERS) data, stating that FAERS data is observational and does not prove causation between drugs and adverse events.

"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," IPA statement said.

"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.

Stringent Oversight

The IPA said there is rigorous inspection process followed by the USFDA, both for domestic and foreign manufacturing sites, including those in India.

The FDA has also implemented a Foreign Unannounced Inspection Pilot program to increase unannounced surveillance inspections of foreign drug facilities.

Indian manufacturing facilities, according to the IPA, are subject to even greater scrutiny as they often supply products to multiple geographies and are inspected by various international regulators, including those from the European Union, UK, Australia, Brazil, and Canada.

IPA said it also strongly disagreed with linking quality with cost, emphasizing that India's competitive pricing is due to factors like automated high-production capacity plants, continuous process improvement, and manufacturing synergies.

The IPA also stated that manufacturing addresses are clearly indicated on drug packaging and available in databases like the FDA's Orange Book, contrary to claims of a lack of transparency in the study.