Industrial Policy & Trade Monitor· 2666 actions· ✨ 90 recent

India's DGFT issued Notification No. 56/2025-26 on 29 January 2026, amending the import policy under Chapter 29 of ITC (HS) 2022 to impose minimum import prices (MIPs) on three antibiotic Active Pharmaceutical Ingredients (APIs): Penicillin G-potassium (₹2,216/kg CIF), Amoxycillin trihydrate (₹2,733/kg CIF), and 6-Aminopenicillanic Acid/6-APA (₹3,405/kg CIF). Imports below these price floors are reclassified from "Free" to "Restricted" status, requiring a DGFT import authorisation before Customs clearance. The measure takes immediate effect and is valid for approximately ten months (until 30 November 2026), with an implied renewal pathway. It is explicitly aimed at preventing very-low-priced imports and supporting domestic manufacturers built under the PLI Bulk Drugs scheme, targeting China's dominant position in global antibiotic-fermentation supply.

India's DGFT issued Notification No. 50/2025-26 on 18 December 2025 (Gazette of India, Extraordinary, Part II, Section 3(ii)), inserting a new Policy Condition No. 08 under Chapter 29 of ITC (HS) 2022, Schedule-I (Import Policy). Imports of diluted Potassium Clavulanate below a CIF value of USD 77/kg, Potassium Clavulanate (KGA) below USD 180/kg, and specified clavulanic-acid-manufacture intermediates below USD 92/kg are reclassified from "Free" to "Restricted," requiring a DGFT import authorisation before Customs clearance. The measure took immediate effect and runs until 30 November 2026. It is aimed at countering low-priced Chinese potassium-clavulanate exports and protecting Indian bulk-drug fermentation capacity (Aurobindo Pharma and other domestic API makers) amid a global potassium-clavulanate supply glut.

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.

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.