US waives 100% tariff on select Indian speciality drugs - The Indian Express
India is among 20 nations that will be eligible for a zero per cent US tariff on certain speciality pharmaceutical products and their associated ingredients, according to a notice issued by the US Commerce Department. The waiver comes as the US prepares to impose a 100% tariff on specified licensed pharmaceutical products.
This move comes after an official announcement issued by US President Donald Trump on April 2 to adjust pharmaceutical imports and encourage greater domestic production.
The zero-tariff waiver is applicableΒ to specific categories of speciality medicines rather than the wider pharmaceutical trade. These include drugs which are used to treat rare diseases, along with nuclear medicines, plasma-derived therapies and fertility drugs.
The waiver also covers cell and gene therapies, antibody-drug conjugates (ADCs) and some medicines used to deal with chemical, biological, radiological and nuclear threats. Animal medicines are also covered under this, according to the news agency, First Post reports.
The ingredients used in these products are eligible for the same treatment. The Commerce Department defines an orphan drug as a drug or biological product designated for one or more rare diseases or conditions where all approved indications are for such diseases.
The US had announced a 100% ad valorem (according to value) tariff on certain licensed pharmaceutical products and ingredients from September 29 under Section 232 of the Trade Expansion Act. The tariff came into effect on July 31 for companies listed in one annex to Trumpβs announcement and is scheduled to apply to other covered companies from September 29.
However, the Commerce Department said the Section 232 pharmaceutical tariffs do not currently apply to generic pharmaceutical products and their associated ingredients.
This is important for India because a large part of its drug exports to the US are generic medicines.
According to the Pharmaceuticals Export Promotion Council of India, India exported drugs and pharmaceutical products worth $30.46 billion in 2024-25, with the US among its major markets.
The Commerce Departmentβs Bureau of Industry and Security said the products can get a zero tariff if they come from countries that have, or are expected to have, a trade and security agreement with the US.
The waiver can also apply where the Commerce Department determines that a product meets an urgent US health need.
India is listed alongside Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom and Vietnam.
The Commerce Department has also allowed companies to seek tariff relief for speciality drugs needed to address an urgent health need in the US.
Applications are required to include details such as the productβs classification, active ingredients, manufacturer, country of origin and the medical need involved. Commerce will consider such requests on a case-by-case basis in consultation with the US Trade Representative and the Department of Health and Human Services.
The latest notice also makes some changes to the US tariff rules, including clarifying what counts as a generic drug and allowing zero tariffs on certain products imported only for clinical trials, research, development or other non-commercial use.
PTI also reported that the zero tariff provision covers speciality drugs and associated ingredients used to treat rare medical conditions, along with medicines for infertility, cell and gene therapies, ADCs and animal pharmaceuticals.
