US Waives Tariffs on Indian Specialty Drugs
India is among 20 jurisdictions eligible for zero tariffs on specified specialty medicines and pharmaceutical ingredients as Washington prepares wider duties on patented drugs.
The United States has exempted certain specialty pharmaceutical products and associated ingredients imported from India from a planned 100% tariff, according to a US Commerce Department notice published ahead of the wider pharmaceutical tariff measures.
The zero-tariff treatment applies to specified categories including medicines for rare diseases, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapies, antibody-drug conjugates and certain medical countermeasures. Eligible ingredients used in these products are also covered.
India is among 20 countries and jurisdictions listed for the zero-tariff treatment. The list also includes the European Union, Japan, South Korea, the United Kingdom, Switzerland and Liechtenstein, among others.
The exemption comes as the US prepares to impose a 100% ad valorem tariff on specified patented pharmaceutical products and associated ingredients under Section 232 of the Trade Expansion Act. The measure applies to covered companies from September 29, with some companies already subject to the tariff from July 31.
Importantly, the new US tariff does not currently apply to generic pharmaceutical products and their associated ingredients. This is significant for India, where generic medicines account for a substantial share of pharmaceutical exports to the US.
The US Commerce Department said specialty products can receive the zero tariff when they originate in jurisdictions with a current or forthcoming trade and security framework agreement with the US. Zero-tariff treatment can also be considered where a product meets an urgent US health need.
Companies seeking relief under the urgent-health-need provision will have to provide information including product classification, active ingredients, manufacturer, country of origin and details of the relevant medical need. Applications will be assessed on a case-by-case basis in consultation with US trade and health authorities.
The latest notice also clarifies the scope of pharmaceutical products covered by the US measures, including finished medicines, active pharmaceutical ingredients and key starting materials used to manufacture those ingredients