Indian Pharma Association Defends Generics Amid US Tariff Threats

In response to concerns raised in the United States regarding the quality of generic medicines sourced from India and China, the Indian Pharmaceutical Alliance (IPA) has firmly defended its industry. Following a sharp decline in share prices linked to the potential for US tariffs, the IPA presented a detailed rebuttal to a US Senate Special Committee on September 17, 2023. This body comprises 23 leading Indian generic drug manufacturers, including major players such as Sun Pharma, Cipla, Dr Reddy’s, and Zydus Lifesciences.

The IPA emphasized its commitment to maintaining high-quality standards for medicines, asserting that Indian generics have contributed significantly to the US healthcare system. According to the IPA, these medications saved approximately $219 billion in 2022 alone. Over the past decade, the cumulative savings from Indian generics have exceeded $1.4 trillion, underscoring their vital role in providing affordable healthcare options.

Concerns regarding the quality of generics intensified following claims from US activists and experts who suggested potential national security risks due to reliance on Indian and Chinese pharmaceuticals. In its rebuttal, the IPA argued that punitive measures such as tariffs would not enhance US medicine security. Instead, they would likely drive generics from the market and increase reliance on China, which benefits from state-backed subsidies to dominate global health.

To bolster its position, the IPA highlighted the progress of Indian manufacturers in adhering to stringent quality standards. Recent reports from the Food and Drug Administration (FDA) confirm that Indian facilities are performing comparably to their US counterparts in inspection outcomes. For instance, a study funded by the Department of Defense (DoD) in April 2025 revealed that nearly two-thirds of generics tested received the highest quality ratings, with some Indian suppliers achieving perfect scores.

Economic Impact and Industry Transformation

The IPA outlined how the Indian generic drug sector has evolved significantly, driven by initiatives like the production-linked incentive (PLI) program. This program aims to enhance domestic production of active pharmaceutical ingredients (APIs) and key starting materials (KSMs), thereby reducing dependence on Chinese imports. The IPA has also proposed a partnership with the US government, titled the US-India Affordable Medicines Partnership, aimed at joint investment in APIs and KSMs to strengthen supply chain resilience.

Indian pharmaceutical companies have made considerable investments in US operations, boasting 31 FDA-approved facilities across 14 states. These operations not only create jobs for American workers but also contribute to local economies through a wider supply chain network.

Despite these advancements, a study published in February 2023 raised concerns about the safety of generics from India, claiming they posed 54% more severe adverse events compared to US-made generics. These events included hospitalizations and, in some instances, fatalities. This backdrop of concern has prompted ongoing discussions among US lawmakers about the safety and reliability of drug supply chains, especially for aging Americans.

Future Prospects and Collaborative Efforts

The IPA’s response to the US Senate committee reflects a broader strategy to engage with US policymakers as a trusted ally. By promoting collaboration rather than confrontation, the IPA aims to secure a stable and affordable supply of medications for American patients. The association believes that incentives, partnerships, and effective oversight will ensure continued access to high-quality generics.

As debates around tariffs and drug safety continue, the IPA stands firm in its assertion that the Indian pharmaceutical industry plays a crucial role in the global healthcare landscape. With significant savings and ongoing investments in quality improvement, Indian generics are positioned as a key component in the effort to enhance healthcare affordability and reliability in the United States.