India Secures Zero US Tariff On Select Speciality Drugs, What Does It Mean For Pharma Companies?
· Free Press Journal
Mumbai: India is among 20 jurisdictions eligible for zero US tariffs on select speciality pharmaceutical products and their associated ingredients, offering relief as Washington moves ahead with steep duties on certain licensed medicines.
The exemption comes amid the US decision to impose a 100 percent ad valorem tariff on specified licensed pharmaceutical products and ingredients under Section 232 of the Trade Expansion Act.
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Speciality Drugs Covered
The zero-tariff treatment is limited to specified speciality medicines and does not cover the entire pharmaceutical trade.
Eligible products include medicines for rare diseases, nuclear medicines, plasma-derived therapies and fertility drugs. Cell and gene therapies, antibody-drug conjugates and certain medicines used against chemical, biological, radiological and nuclear threats are also covered.
Animal pharmaceuticals and ingredients used in eligible products can also qualify for the exemption.
An orphan drug has been defined as a drug or biological product designated for rare diseases or conditions where all approved indications relate to such diseases.
Generics Get Relief
The development is particularly significant for India because generic medicines form a major part of the country's pharmaceutical exports to the US.
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India's drugs and pharmaceutical exports stood at $30.46 billion in 2024-25, with the US remaining one of the industry's key overseas markets.
India Among Eligible Markets
India is included alongside jurisdictions such as the European Union, Japan, South Korea, Switzerland, Taiwan, Thailand, the United Kingdom, Vietnam, Argentina, Bangladesh, Malaysia and Indonesia.
Zero tariffs may apply to products originating from countries that have, or are expected to have, trade and security agreements with Washington.
Urgent Health Exemption
Companies can also seek tariff relief where speciality medicines are required to address an urgent US health need.
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The rules also provide zero-tariff treatment for certain products imported solely for clinical trials, research, development or other non-commercial purposes.