Industry Odisha Bureau, Sep 29: India joins 19 other nations and jurisdictions eligible for zero-tariff access on certain speciality drugs. The carve-out sits within Washington’s wider 100% tariff on patented medicines. It does not cover every Indian medicine.
Washington’s new pharmaceutical tariff regime does not treat every medicine the same way. Certain speciality drugs from India will face no US tariff at all. That holds even as a 100% tariff hits specified patented pharmaceuticals. India is among 20 countries and jurisdictions on the Commerce Department’s zero-tariff list. The list was published in the Federal Register.
What the carve-out covers
The zero-tariff treatment targets specific speciality pharmaceutical categories. These include medicines for rare diseases and infertility treatments. Cell therapies and gene therapies also qualify. So do antibody-drug conjugates, or ADCs, and animal pharmaceuticals. Components used in these qualifying products can receive the same zero-tariff treatment.
Generics sit outside the ne
Generic medicines follow a different logic. They are not part of this speciality drug tariff exemption. Instead, generic pharmaceutical products and associated ingredients sit outside Section 232 pharmaceutical tariffs. The Commerce Department notice makes this clear. It also amends the definition of generic pharmaceutical articles. That definition now explicitly includes unpatented animal health products.
The 100% tariff framework
The broader measure stems from President Donald Trump’s April proclamation. It targets imports of patented pharmaceuticals, biologics and associated ingredients. The legal basis is Section 232 of the Trade Expansion Act. The stated aim is encouraging greater pharmaceutical production in the United States.
The levy is an ad valorem tariff. It is charged as a percentage of an import’s monetary value. Companies named in one annex have faced it since July 31. Other covered companies face it from September 29.
The notice also clarifies what counts as pharmaceutical articles. The term covers finished products and their active pharmaceutical ingredients, or APIs. Key starting materials used to make those ingredients are included too.
Why India qualifies
Eligibility rests on trade and security frameworks with the United States. The Commerce Department notice links zero-tariff access to such agreements. Qualifying jurisdictions have either a current or forthcoming framework agreement. India’s fellow entrants include the European Union, Japan, South Korea and Britain. Switzerland, Taiwan, Vietnam and Indonesia also feature.
What the policy does not mean
The zero-tariff list is not a blanket exemption for India. Not every Indian pharmaceutical export receives special treatment. Only eligible speciality products qualify for zero-tariff access. Specified patented medicines outside the carve-out remain within the tariff’s scope. Generics, meanwhile, sit outside these Section 232 tariffs altogether. For the Indian pharmaceutical industry, that distinction matters.
A more selective tariff map
US pharma tariffs now work on a tiered structure. Specified patented drugs face a 100% levy. Certain speciality drugs from India and 19 other jurisdictions face none. Generics fall outside the framework entirely. Across the pharmaceutical supply chain, each product’s category now shapes its tariff exposure.
