Generic medicines and their ingredients remain outside the Section 232 pharmaceutical tariffs, according to the US Commerce Department notice.
New Delhi: India is among 20 jurisdictions whose qualifying speciality medicines will enter the United States at zero duty, even as a 100 per cent tariff on specified patented pharmaceutical products was extended to more companies from 29 September, according to a notice from the US Department of Commerce.
The department’s Bureau of Industry and Security listed the eligible jurisdictions in a notice published in the Federal Register on 23 September. The zero rate applies to rare-disease drugs whose approved uses all carry orphan designation, nuclear medicines, plasma-derived therapies, fertility treatments, cell and gene therapies and antibody-drug conjugates, the notice said. Medical countermeasures against chemical, biological, radiological and nuclear threats, animal health products and the ingredients used in these categories are also covered.
Under conditions set in the April presidential proclamation, the department may apply the zero rate when products come from a jurisdiction that has, or is set to sign, a trade and security framework agreement with the US, or when they are needed to meet an urgent US health need. Besides India, the list includes the European Union, the UK, Japan, South Korea, Switzerland and Liechtenstein, Taiwan, Indonesia, Malaysia, Thailand, Vietnam, Bangladesh, Cambodia, Argentina, Ecuador, El Salvador, Guatemala, Jordan and North Macedonia.
The relief is not a blanket waiver for Indian exporters. Patented medicines outside the listed speciality categories still attract the 100 per cent duty unless they qualify for another exemption or tariff treatment, according to the notice. Companies with approved arrangements to move manufacturing to the US may be treated differently under the proclamation.
Generic drugs and their associated ingredients are not covered by the Section 232 pharmaceutical tariffs, the department said. The notice also made technical corrections to the original proclamation, widening the definition of generic pharmaceutical articles to take in unpatented animal health products. It limited the term pharmaceutical articles to finished products, their active pharmaceutical ingredients and key starting materials, leaving out inactive ingredients and excipients.
President Donald Trump announced the tariff on 2 April under Section 232 of the Trade Expansion Act of 1962 as part of a push to encourage drug manufacturing in the US. The duty took effect on 31 July for companies named in one annex of the proclamation and applies to the remaining companies within its scope from 29 September.
Source: Business Standard, 29 September 2026
