US exempts India, 19 others from 100% speciality drug tariffs:Rare-disease, fertility and gene therapies spared

The United States has exempted select speciality medicines and pharmaceutical components originating from India and 19 other partner jurisdictions from import duties, according to an official notice issued by the US Commerce Department. The exemption comes as Washington moves ahead with a 100% tariff on specified patented pharmaceutical products and related items under Section 232 of the Trade Expansion Act. Rare disease, fertility and gene therapies included The zero-duty framework covers medicines used to treat rare diseases, fertility treatments, advanced cell and gene therapies, antibody-drug conjugates (ADCs) and veterinary pharmaceuticals. Key components used to manufacture these products are also covered by the tariff exemption. The other jurisdictions included in the list are Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland, Liechtenstein, Taiwan, Thailand, the UK and Vietnam. 100% tariff on specified patented drugs The latest changes follow an April directive by US President Donald Trump that revised tariffs on imported pharmaceuticals and chemical components under Section 232. An April 2 proclamation imposed a 100% duty on specified patented drugs, biologics and related ingredients as part of efforts to promote pharmaceutical manufacturing in the US. The tariffs took effect on July 31 for companies listed in an initial annex and are being extended to additional listed companies from September 29. Generic medicines remain exempt The US Commerce Department also clarified that generic medicines and their ingredients remain exempt from the Section 232 pharmaceutical tariffs. Recent changes have also updated the definition of “generic pharmaceutical articles” to include unpatented animal-health products. The department further clarified that “pharmaceutical articles” covers finished medicines, active pharmaceutical ingredients and key starting materials.