Industrial Policy & Trade Monitor· 2663 actions· ✨ 89 recent

On 2 April 2026 President Trump issued a Presidential Proclamation under Section 232 of the Trade Expansion Act of 1962 ("Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States") imposing a 100% ad valorem tariff on imports of patented pharmaceutical products listed in the FDA Orange Book and Purple Book, together with the active pharmaceutical ingredients (APIs) and key starting materials used to make them. The base rate takes effect at 12:01 a.m. EDT on 31 July 2026 for the 17 manufacturers identified in Annex III, and on 29 September 2026 for all other companies. The proclamation adopts findings of the Section 232 investigation initiated by the Department of Commerce on 14 April 2025 into pharmaceuticals and APIs as a national- security supply-chain risk. The instrument is structured around a multi-tier rate ladder rather than a flat tariff: concessionary 15% rates for EU/Japan/South Korea/Switzerland/Liechtenstein under reciprocal-deal tracks, 10% for the UK with a pathway to 0% under the pending UK pharmaceutical agreement, a "+20%" surcharge for companies operating under a Commerce-approved onshoring plan (until 2 April 2030), and a 0% pathway for companies that combine an approved onshoring plan with an MFN-pricing agreement with HHS (until 20 January 2029). Generics, biosimilars and their ingredients, orphan drugs, nuclear medicines, plasma-derived therapies, fertility treatments, and cell/gene therapies are carved out.

On 13 August 2025 President Trump signed an Executive Order ("Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve", Federal Register Doc. 2025-15823, published 19 August 2025) directing the HHS Assistant Secretary for Preparedness and Response (ASPR) to refill and operationalise the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). Within 30 days, ASPR must compile an initial list of 26 essential drugs, account for available funding, and acquire and maintain a six-month supply of the corresponding APIs. Within 90 days, ASPR must deliver an expanded list of up to 86 essential medicines and medical countermeasures plus a plan to source those APIs from domestic manufacturers, and within 120 days (subject to appropriations) ready the existing SAPIR repository and submit a proposal and cost estimate for opening a second repository. The order prioritises domestically manufactured APIs in federal procurement and reserve build-out and directs interagency coordination across HHS/ASPR, FDA, DoD (Industrial Base Fund / Defense Production Act Title III), and the Department of Commerce.

Belgium's Loi du 29 février 2024 (published in the Moniteur Belge on 27 May 2024, entering into force 1 June 2026) establishes the first comprehensive federal authorisation and traceability regime for pharmaceutical raw materials used by pharmacists in extemporaneous and magistral preparations. Manufacturers, importers, and distributors of covered materials must obtain AFMPS authorisation and comply with Good Manufacturing Practice and Good Distribution Practice standards; pharmacists may only source materials from authorised actors. The statute was enacted during Belgium's EU Council Presidency (H1 2024) and directly parallels the EU Critical Medicines Alliance architecture launched in Leuven on 24 April 2024, positioning Belgium as the first EU member state to operationalise a national supply-chain control layer for pharmaceutical compounding raw materials ahead of the forthcoming EU Critical Medicines Act.

The Department of Pharmaceuticals notified the Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs), Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) on 21 July 2020 via Gazette Notification, with an outlay of Rs 6,940 crore (~USD 920m) over FY 2020-21 to FY 2027-28. The scheme covers 41 identified critical bulk-drug products across four target segments — fermentation-based (Key Fermentation; Niche Fermentation) and chemical synthesis-based (Key Chemical Synthesis; Niche Chemical Synthesis) — paying 20% incentive on incremental sales for fermentation-based products (years 1-4) tapering to 15% (year 5) and 5% (year 6), and a flat 20% over 5 years for chemically-synthesised products. The stated objective is to reduce India's ~70% bulk-drug import dependence on China by establishing greenfield domestic manufacturing capacity with at least 90% domestic value addition for fermentation products and 70% for chemical-synthesis products.