The Indian Pharmaceutical Alliance (IPA) has strongly refuted a report by Ohio State University, which linked Indian-made generic drugs to a higher incidence of severe adverse events (SAEs) compared to their US-manufactured counterparts. IPA emphasized that quality standards are not region-dependent and that Indian generics adhere to stringent global regulatory norms.
USFDA Ensures Stringent Oversight of Indian Manufacturers
IPA highlighted that the United States Food and Drug Administration (USFDA) applies the same rigorous inspection process to manufacturing sites, whether in the US or in emerging economies like India. The FDA even has an established office in India to oversee local manufacturers qualified to supply generics to the US.
Industry experts also pointed out that since India supplies nearly 50% of the generic drugs exported to the US, the absolute number of reported adverse events is proportionally higher.
Disputing the Study’s Claims on Manufacturing Transparency
The report, titled “Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events,” claimed that lower production costs and opaque supply chains contributed to lower quality standards in Indian generics.
However, IPA rejected this claim, stating that Indian-made generics meet global regulatory benchmarks and undergo frequent inspections. Indian pharmaceutical companies export to multiple geographies, making them subject to even greater scrutiny. The percentage of Official Action Indicated (OAI) inspections for Indian companies has declined from 23% in 2014 to 11% in 2024, aligning with the global trend of 14% in 2024.
Additionally, IPA dismissed allegations of lack of transparency in drug manufacturing locations, emphasizing that:
- Every generic product distributed in the US legally displays the complete manufacturing address on its packaging.
- This information is also available in USFDA databases, such as the Orange Book.
- Cost Efficiency Does Not Mean Compromised Quality
IPA strongly opposed the assumption that lower costs imply inferior quality. The affordability of Indian generics results from:
- Automated, high-capacity production plants
- Continuous process improvements
- Cost advantages in manpower
- Economies of scale
- Backward integration of active pharmaceutical ingredients (APIs) for better cost efficiency
Adverse Event Data Does Not Prove Poor Quality
IPA also criticized the study’s reliance on the FDA Adverse Event Reporting System (FAERS), a post-marketing surveillance database that only identifies associations between drugs and adverse events but does not establish causation.
“A higher rate of SAEs for drugs manufactured in emerging economies does not inherently indicate lower manufacturing quality,” IPA asserted.
As reported by business-standard.com, IPA addressed these misconceptions and reaffirmed that Indian generics meet the highest international quality standards. They also emphasized their crucial role in making affordable medicines accessible worldwide.
