USFDA Speeds Up Approval for Generics Made in the US – Impact on Indian Manufacturers

The US Food and Drug Administration (USFDA) has introduced a new pilot programme aimed at fast-tracking generic drug approvals for products made and tested entirely within the United States. This initiative seeks to strengthen domestic pharmaceutical manufacturing and reduce reliance on foreign suppliers, particularly from India and China.

What the Pilot Programme Entails?

Under this pilot, Abbreviated New Drug Applications (ANDAs) for generics that are manufactured, tested, and sourced from US-based suppliers are eligible for priority review. Applicants must demonstrate bioequivalence by comparing their generic drugs to branded formulations in the US and ensure that active pharmaceutical ingredients (APIs) are sourced domestically.

While the programme does not guarantee a shorter timeline to market, it provides an expedited review pathway for qualifying applications. The USFDA states that the initiative is intended to incentivise investment in US drug manufacturing and research, as well as to strengthen the domestic supply chain.

Implications for Indian Drugmakers

India supplies over 44% of APIs used in US medicines and accounts for 34.5% of US generic drug imports. Indian pharmaceutical exports reached $30.5 billion in FY25, with the US alone importing $8.72 billion worth of medicines. The country hosts the largest number of FDA-approved manufacturing plants outside the US, and many companies derive a significant portion of their revenue from the American market.

Indian generics now account for 42% of all prescription drugs in the US, up from 21% in 2013. This growth has been driven by lower production costs, regulatory compliance, and a strong pipeline of complex generics and biosimilars.

The USFDA pilot introduces a potential challenge for Indian firms. Bioequivalence testing and API sourcing in the US are generally more expensive than in India. Regulatory experts note that only 9% of API manufacturers are based in the US, and in vivo bioequivalence testing can cost less abroad than using US-based Contract Research Organisations (CROs).

Balancing Opportunity and Risk

If the pilot gains traction, US-based generics could receive faster review timelines, potentially giving them an advantage in entering the market sooner. However, Indian companies continue to benefit from 60–80% lower manufacturing costs, which maintains a competitive edge despite the pilot.

The programme may also encourage Indian drugmakers to expand their US presence through acquisitions, partnerships, or new facilities. Several Indian firms have already invested in US operations, particularly in complex generics and specialty drugs, to align with regulatory expectations and maintain market share.

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Conclusion

The USFDA’s fast-track pilot aims to boost domestic manufacturing and reduce reliance on foreign suppliers. While it may create short-term challenges for Indian drugmakers, cost advantages and strategic investments in US-based facilities can help maintain competitiveness. The evolving landscape may prompt Indian firms to adapt while continuing to supply affordable generics to the US market.

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