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Indian Pharma Industry Challenges US Study on Generic Drug Safety

“We categorically reject the premise that differences in supply chains, manufacturing, or distribution practices compromise the quality and efficacy of Indian generics,” the IPA stated in an official response issued on Wednesday.

• By PharmaNews Live Desk
• New Delhi
• Mar 18, 2025

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The Indian Pharmaceutical Alliance (IPA) has firmly contested the findings of a recent study by researchers affiliated with Ohio State University, which suggested that Indian-manufactured generic drugs are linked to a 54% higher incidence of severe adverse effects compared to those produced in the United States.

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. The research alleged that a lack of transparency in drug manufacturing locations and variations in supply chain practices could impact the quality and safety of Indian generics.

However, the IPA—a consortium of 23 leading Indian pharmaceutical companies, many of which are major exporters to the U.S.—has dismissed the study as “flawed and misleading.” The group emphasized that Indian-made generics comply with stringent global regulatory standards and that the study’s conclusions were based on observational data that failed to establish causation.

IPA Rebuts Study’s Claims

“We categorically reject the premise that differences in supply chains, manufacturing, or distribution practices compromise the quality and efficacy of Indian generics,” the IPA stated in an official response issued on Wednesday.

The alliance highlighted that all generic drugs, including those made in India, must undergo rigorous approval processes under the U.S. Food and Drug Administration (FDA) before entering the American market. These regulations ensure consistency in the active pharmaceutical ingredients (API) and finished product specifications throughout the drug’s lifecycle.

“The FDA applies the same stringent approval process for generic drugs regardless of whether they are manufactured in India or the United States, a fact even acknowledged by the study itself,” the IPA pointed out.

Moreover, Indian pharmaceutical facilities are subjected to extensive scrutiny by global regulatory bodies, including agencies from the European Union, the UK, Australia, Brazil, and Canada, which uphold high-quality manufacturing standards.

The IPA also noted a significant drop in regulatory violations among Indian firms. The FDA’s ‘Official Action Indicated’ (OAI) classification, which flags non-compliance issues, declined from 23% in 2014 to 11% in 2024, mirroring a global downward trend to 14%.

Criticism of Study’s Data and Methodology

The IPA strongly contested the study’s reliance on the FDA’s Adverse Event Reporting System (FAERS), a post-marketing surveillance database that collects reports on drug-related side effects.

“FAERS data is observational and cannot establish a direct causal link between manufacturing location and adverse events,” the IPA explained. “An increase in reported adverse events for drugs from emerging markets does not inherently indicate inferior quality.”

The industry body further highlighted key limitations of FAERS data, including potential reporting biases, duplication of adverse event reports, and the absence of denominator data (the total number of drug users). The IPA emphasized that adverse reactions are generally tied to the drug’s chemical composition rather than the facility where it was produced.

Additionally, under U.S. regulatory requirements, adverse events associated with a drug—regardless of where it is manufactured—must be reported under the same Abbreviated New Drug Application (ANDA) number. This ensures uniform reporting, even if a drug is produced at multiple sites.

Findings of the Study and Industry Response

The study analyzed 2,443 generic drugs manufactured in both the U.S. and emerging markets between 2009 and 2018, with a primary focus on India, which supplies 93% of the generic drugs the U.S. imports from these regions. Researchers found that Indian generics had a 54% higher rate of reported severe adverse effects compared to those produced domestically and attributed this discrepancy to potential cost-cutting measures affecting operational and supply chain quality.

The study suggested that as drugs remain on the market for longer periods, manufacturers may face increased financial pressure to reduce costs, which could compromise quality control.

However, the IPA refuted these claims, arguing that robust global regulatory mechanisms ensure that quality standards are maintained. “The Indian pharmaceutical industry has significantly strengthened its engagement with the FDA to enhance manufacturing and quality practices,” the IPA asserted. “The agency’s stringent oversight, including routine and surprise inspections, provides an adequate safeguard against quality lapses.”

Call for Greater Transparency in Drug Manufacturing

Despite the IPA’s strong rebuttal, the study’s authors advocated for increased transparency in the pharmaceutical sector. They urged drugmakers to disclose quality data on labels, benchmark manufacturing standards using public records, and implement stricter internal quality checks.

The researchers also called for more unannounced FDA inspections, noting that surprise inspections of Indian pharmaceutical plants had increased by 46% between 2014 and 2024, with reports of non-compliant conditions rising by 38% over the same period.

“The FDA has the authority to enforce stringent regulations, but manufacturers should also proactively compete on quality and transparency,” the study’s authors wrote. They suggested that rewarding companies with superior compliance records through higher demand and better pricing could help eliminate substandard players from the market.

While the debate over the quality of Indian generic drugs continues, industry experts stress that India remains a key player in global pharmaceutical supply. With nearly 40% of U.S. generic drug demand met by Indian manufacturers, regulatory oversight and industry collaboration will be crucial in addressing concerns while ensuring the continued availability of affordable medicines worldwide.