Indian Pharma Faces US Setback Amid Push for Domestic Drug Manufacturing

Indian pharmaceutical companies may encounter significant hurdles in the US following President Donald Trump’s new executive orders aimed at promoting domestic drug production. According to Nuvama Research, these measures could disrupt global supply chains and particularly impact India’s generics exports.

India, known as the “pharmacy of the world,” has long benefited from cost-effective manufacturing, supplying a major share of generic medicines to the US. However, the new directives call for reshoring the production of prescription drugs, APIs, key starting materials (KSMs), and other raw inputs back to the US. This shift could diminish India’s cost advantage and threaten its export position.

The policy also proposes accelerated approvals for US-based manufacturing plants, tighter inspections of foreign facilities, and potentially increased fees for overseas manufacturers. These changes could make it more difficult for Indian drugmakers to maintain competitiveness in the US market.

Another concern is the expected requirement for companies to disclose the origin of their APIs. While many Indian firms produce finished drugs domestically, they remain reliant on China for essential ingredients—raising the risk of regulatory challenges.

Part of a broader biosecurity strategy, the move signals a clear shift in US pharma policy. Although the long-term impact remains to be seen, the Trump administration’s focus on domestic manufacturing could significantly reshape the global pharmaceutical landscape.