Industrial Policy & Trade Monitor· 2662 actions· ✨ 89 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 11 March 2025 the European Commission published its proposal for a Critical Medicines Act (CMA), pillar of the broader EU pharmaceutical-resilience agenda alongside the EU Critical Raw Materials Act (filed: 2024-05-23-eu-crma-entry-into-force) and the IRA-style industrial-policy stack. The proposal targets supply security of an EU "Union List" of critical medicines (antibiotics, anti-thrombotics, oncology, cardiovascular, insulin, painkillers) by introducing four mechanisms: (1) Strategic Project status with expedited funding access for critical-medicine manufacturing or active-substance production; (2) public-procurement preferences favouring resilient supply chains and — in defined cases — EU-based production; (3) collaborative cross-Member-State procurement to address fragmented small markets; (4) state-aid framework guidance + international-partnership diversification to reduce single-country (often China-routed) API dependency.

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.