India's place in the US generic drug supply

When FDA announced a review pilot for US-made generics on Oct. 3, 2025, it put India's role in the drug supply into a single clause. The agency said¹ that "only 9 percent of API manufacturers are in the U.S., compared to 22 percent in China and 44 percent in India." API stands for active pharmaceutical ingredient, the chemical in a tablet that does the medical work.

India's weight is even heavier further down the line, where ingredients become pills. In 2024, plants in India made 60 percent of the solid oral doses (tablets and capsules, counted by unit) sold in the US prescription market, according to an analysis by the US Pharmacopeia², the nonprofit standards body whose Medicine Supply Map tracks where medicines are made.

Those two numbers explain why federal officials keep returning to India when they talk about generic supply. They also hide real differences in what is being counted. This explainer sets out what FDA and USP data show about India's share, how FDA watches Indian plants, and the trade decisions that could change the picture in 2027.

Three ways to count India's share

No federal agency publishes the share of US prescriptions filled with pills made in India. FDA counts registered facilities and inspects them. USP links factory locations to sales volumes. Drug master files, the confidential dossiers ingredient makers file with FDA, offer a third view of where capacity sits. Each method gives a different answer.

FDA's fiscal 2025 Report on the State of Pharmaceutical Quality⁷ found that India posted the largest net percentage increase in sites over the five years through fiscal 2025 among countries with more than 50 sites, ending with 606 sites in the agency's curated catalog. China had 409. The US still had the most sites by far, though about half of US sites in the new count make medical gases such as oxygen. China's role, mostly further upstream, is the subject of a separate GxRadar piece.

Facility counts and volume shares measure different things. A plant that makes one low-volume product counts the same as a plant that ships billions of tablets. USP's volume work fills some of that gap. In a 2026 analysis of active ingredient volumes³, USP found that India and the European Union together account for more than half of the API volume in US prescription medicines, and that US generics "largely rely" on APIs made in India.

India's lead in drug master files is long-standing. In USP's count of active API drug master files⁵, India held 48 percent in 2024, unchanged from 2021. Its share of new filings fell to 43 percent in 2024, when China moved ahead for the first time in more than two decades.

Where the concentration is greatest

The averages blur how lopsided some drug classes are. USP looked at the 10 most-used therapeutic classes⁴ in the US in 2024 and found that generics supplied 97 percent of their API volume. Within those generic classes, India made 95 percent of the API volume for ACE inhibitors, the blood pressure class that includes lisinopril. It made 75 percent for drugs for peptic ulcer and reflux, a class that includes omeprazole and pantoprazole, and more than 60 percent for antiepileptics (USP reported both 62 percent and 64 percent on the same page), the class that holds gabapentin. USP called the findings evidence of "the extent of U.S. dependence on a single country for critical generics."

India's dominance is narrower for finished products than the solid-oral figure suggests. In the same finished-dose analysis², USP found the US led injectable production with 45 percent of volume, and led overall generic finished-dose volume with 38 percent. India's strength is the tablet and capsule, which is most of what a retail pharmacy dispenses.

India also depends on others for its raw materials. In a December 2021 press note on its production-linked incentive scheme, India's Department of Pharmaceuticals said¹¹ the country was "significantly dependent" on imported bulk drugs, with import dependence of 80 to 100 percent for some of them. The scheme set aside Rs 6,940 crore for 2020-21 through 2029-30 to build domestic plants for 41 key starting materials, intermediates and APIs. USP's map of key starting materials⁶, the chemical building blocks of APIs, found that 16 percent of those used in US-approved APIs come only from India, against 41 percent that come only from China. Our explainer on where drug ingredients come from covers that upstream layer and the drug master file system.

How FDA oversees plants in India

FDA opened its India Office⁸ in New Delhi in November 2008. The agency describes India as "one of the largest exporters of drugs and biologics to the United States, as measured by FDA import lines."

Inspection results are the main public measure of how those plants perform. FDA classifies each inspection as no action indicated (NAI), voluntary action indicated (VAI) or official action indicated (OAI), the last meaning serious problems that can lead to a warning letter or import restrictions. FDA's fiscal 2025 report broke those outcomes down by region.

India's OAI rate sat almost exactly on the global average. FDA's statistical test flagged China (fewer OAI outcomes) and the US (more) as departing from the norm, but not India. The same report said 74 percent of the records requests FDA used in place of or alongside pre-approval inspections went to foreign sites, with the largest share, 21 percent, going to India.

The agency has also changed how it inspects. On May 6, 2025, FDA announced¹⁰ it would expand unannounced inspections at foreign plants, building on a pilot program in India and China. It said foreign firms had often had weeks of notice before inspections and that it had still found serious deficiencies abroad more than twice as often as at home. That claim and the fiscal 2025 table above cover different periods and measures, and they do not line up neatly.

Quality concerns have a public record of their own. Writing after a 2023 visit, then-FDA Commissioner Robert Califf⁹ cited deaths of children abroad linked to cough syrups made in India (none in the US) and said FDA investigators had found issues with manufacturing quality systems and with clinical trials run in India to support drug applications. He also wrote that for the US, where more than nine of 10 prescriptions are generics, India is "responsible for a substantial portion of these drugs." For the rules those inspections enforce, see our explainer on CGMP.

Trade policy and the 2027 checkpoint

Generics have so far been left out of the tariffs on imported medicines. Proclamation 11020, signed April 2, 2026, set duties on patented drugs and their ingredients. In it, the President wrote¹², "I have further determined not to adjust imports of generic pharmaceuticals and their associated ingredients, including biosimilar products, at this time." The same proclamation told the Secretary of Commerce to report within one year on any circumstances that might call for action on generic imports. Our explainer on onshoring covers the other federal levers, including FDA's priority review pilot for generics made in the US from US-made ingredients.

That one-year clock runs to April 2, 2027. GxRadar's price pages track NADAC as CMS publishes it.