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US Waives 100% Tariff On Indian Specialty Medicines: Which Drugs Qualify?

India is among 20 jurisdictions whose qualifying specialty pharmaceutical products and related ingredients can receive a zero per cent US tariff, according to a new notice from the US <span>Commerce Department</span>.

The exemption comes as the US begins applying a 100 per cent tariff on certain patented pharmaceutical products and associated ingredients from September 29.

The tariff measures stem from a presidential proclamation issued in April under Section 232 of the Trade Expansion Act, which sought to address US dependence on imported pharmaceuticals and encourage greater domestic production.

<h2>Which Medicines Are Covered By The Exemption?</h2>

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The waiver applies to specific pharmaceutical categories rather than the wider drug trade.

<ul><li>Rare-disease medicines, including qualifying orphan drugs</li><li>Fertility and infertility medicines</li><li>Nuclear medicines</li><li>Plasma-derived therapies</li><li>Cell therapies</li><li>Gene therapies</li><li>Antibody-drug conjugates (ADCs)</li><li>Certain medical countermeasures for chemical, biological, radiological and nuclear threats</li><li>Animal health pharmaceuticals</li></ul>

The provision also covers qualifying ingredients associated with these products.

The Commerce Department said products from the listed jurisdictions can receive the zero tariff because those jurisdictions have a current or forthcoming trade and security framework agreement with the US.

The exemption therefore applies based on both the type of pharmaceutical product and the applicable country-level conditions.

The move comes against the backdrop of the US administration's broader effort to increase domestic pharmaceutical production and reduce reliance on imported medicines and pharmaceutical ingredients.

The 100 per cent tariff on specified patented pharmaceutical products and ingredients began applying to companies identified in one category from July 31, while the measure extends to additional covered companies from September 29.

Read More: <a href="https://www.healthandme.com/health-news/iarc-says-low-dose-ct-can-cut-lung-cancer-deaths-aiims-expert-explains-why-india-needs-its-own-screening-evidence-article-156242249" data-type="tilCustomLink">IARC Says Low-Dose CT Can Cut Lung Cancer Deaths: AIIMS Expert Explains Why India Needs Its Own Screening Evidence</a>

<h2><span rel="noindex">Generic Drugs</span> Remain Outside Section 232 Tariffs</h2>

The Commerce Department notice also makes clear that generic pharmaceutical products, biosimilars and their associated ingredients are not currently subject to the Section 232 pharmaceutical tariffs.

This means the latest exemption should not be interpreted as a broad tariff concession covering India's entire pharmaceutical industry.

The guidance also makes technical changes to the Harmonized Tariff Schedule and clarifies the treatment and definitions of pharmaceutical articles and generic pharmaceutical products under the tariff framework.

Companies seeking an exemption on the basis of an urgent US health need can apply through a process established by the Commerce Department.

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India's inclusion in the zero-tariff category is relevant to pharmaceutical companies that export <span>specialty medicines</span> and their associated ingredients to the US.

However, the exemption is not a blanket waiver for medicines manufactured or exported from India.

Only products that fall within the specified categories and satisfy the applicable conditions are covered. Other pharmaceutical products remain subject to the tariff rules that apply to them.

For Indian drug makers, the distinction is important because the new provision specifically concerns specialty pharmaceutical categories, while generic medicines and biosimilars are already outside the current Section 232 pharmaceutical tariffs.

The impact on individual Indian pharmaceutical companies will therefore depend on the types of products they export to the US and whether those products meet the criteria set out under the new rules.

Besides India, the zero-tariff category covers Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland, Liechtenstein, Taiwan, Thailand, the UK and Vietnam. 

<strong><em>(With inputs from PTI)</em></strong>

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India is among 20 jurisdictions whose qualifying specialty pharmaceutical products and related ingredients can receive a zero per cent US tariff, according to a new notice from the US Commerce Department.The exemption comes as the US begins applying a 100 per cent tariff on certain patented pharmaceutical products and associated ingredients from September 29.The tariff measures stem from a presidential proclamation issued in April under Section 232 of the Trade Expansion Act, which sought to address US dependence on imported pharmaceuticals and encourage greater domestic production.Which Medicines Are Covered By The Exemption?Also read: US FDA Recalls India-Made BP Drug For The Second Time In 3 Months: Here's WhyThe waiver applies to specific pharmaceutical categories rather than the wider drug trade.Products covered by the notice include:Rare-disease medicines, including qualifying orphan drugsFertility and infertility medicinesNuclear medicinesPlasma-derived therapiesCell therapiesGene therapiesAntibody-drug conjugates (ADCs)Certain medical countermeasures for chemical, biological, radiological and nuclear threatsAnimal health pharmaceuticalsThe provision also covers qualifying ingredients associated with these products.Why Are These Medicines Exempt?The Commerce Department said products from the listed jurisdictions can receive the zero tariff because those jurisdictions have a current or forthcoming trade and security framework agreement with the US.The exemption therefore applies based on both the type of pharmaceutical product and the applicable country-level conditions.The move comes against the backdrop of the US administration's broader effort to increase domestic pharmaceutical production and reduce reliance on imported medicines and pharmaceutical ingredients.The 100 per cent tariff on specified patented pharmaceutical products and ingredients began applying to companies identified in one category from July 31, while the measure extends to additional covered companies from September 29.Read More: IARC Says Low-Dose CT Can Cut Lung Cancer Deaths: AIIMS Expert Explains Why India Needs Its Own Screening EvidenceGeneric Drugs Remain Outside Section 232 TariffsThe Commerce Department notice also makes clear that generic pharmaceutical products, biosimilars and their associated ingredients are not currently subject to the Section 232 pharmaceutical tariffs.This means the latest exemption should not be interpreted as a broad tariff concession covering India's entire pharmaceutical industry.The guidance also makes technical changes to the Harmonized Tariff Schedule and clarifies the treatment and definitions of pharmaceutical articles and generic pharmaceutical products under the tariff framework.Companies seeking an exemption on the basis of an urgent US health need can apply through a process established by the Commerce Department.What Does This Mean For India?   India's inclusion in the zero-tariff category is relevant to pharmaceutical companies that export specialty medicines and their associated ingredients to the US.However, the exemption is not a blanket waiver for medicines manufactured or exported from India.Only products that fall within the specified categories and satisfy the applicable conditions are covered. Other pharmaceutical products remain subject to the tariff rules that apply to them.For Indian drug makers, the distinction is important because the new provision specifically concerns specialty pharmaceutical categories, while generic medicines and biosimilars are already outside the current Section 232 pharmaceutical tariffs.The impact on individual Indian pharmaceutical companies will therefore depend on the types of products they export to the US and whether those products meet the criteria set out under the new rules. Which Countries Are Included?Besides India, the zero-tariff category covers Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland, Liechtenstein, Taiwan, Thailand, the UK and Vietnam. (With inputs from PTI)

us waives 100% tariff on indian specialty medicines: which drugs qualify?

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