India Secures Zero US Tariff On Select Speciality Drugs, What Does It Mean For Pharma Companies?

Mumbai: India has secured a favorable exemption from US tariffs on certain specialty pharmaceutical products, with implications for the nation's pharmaceutical sector. This move comes as the US imposes steep duties on specific licensed medicines under Section 232 of the Trade Expansion Act. The exemption applies to select speciality medicines, including those for rare diseases, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapies, antibody-drug conjugates, and certain medicines used against various threats.

It also extends to animal pharmaceuticals and ingredients used in eligible products. This development is particularly significant for India, as generic medicines constitute a major portion of the country's pharmaceutical exports to the US. The US Commerce Department has clarified that Section 232 pharmaceutical tariffs do not apply to generic pharmaceutical products and their associated ingredients.

India, along with several other jurisdictions such as the European Union, Japan, and South Korea, is among the eligible markets for this zero-tariff treatment. Companies can seek tariff relief for products required to address urgent US health needs. Applications for this exemption are assessed individually, requiring details such as product classification, active ingredients, manufacturer, country of origin, and medical necessity.