The DGFT has issued Notification No. 41/2025-26, dated October 10, 2025 amending the import policy conditions for Sulfadiazine Active Pharmaceutical Ingredient (API). This amendment, effective immediately, falls under Chapter 29 of the ITC (HS), 2022, Schedule-I (Import Policy), and is set to impact pharmaceutical manufacturers and importers in India.
Under the revised policy, the import of Sulfadiazine API with a CIF (Cost, Insurance, and Freight) value of less than Rs. 1,774 per kg is now classified as ‘Restricted’ until September 30, 2026. This restriction applies specifically to HS codes 29359013 and 29359090, which cover various sulphonamide compounds, including Sulfadiazine. This measure appears to be aimed at regulating the inflow of lower-priced Sulfadiazine API into the domestic market.
However, the notification also provides crucial exemptions. The Minimum Import Price (MIP) condition will not be applicable for imports made by Advance Authorization holders, Export Oriented Units (EOUs), and units operating within Special Economic Zones (SEZs). This exemption is contingent on the condition that these imported inputs are not subsequently sold into the Domestic Tariff Area (DTA). This aims to support export-oriented pharmaceutical production while maintaining a regulated domestic market.
The DGFT’s decision, issued with the approval of the Minister of Commerce & Industry, signifies a strategic move to balance domestic industry protection with the needs of export-focused units. Stakeholders in the pharmaceutical sector are advised to take note of these changes to ensure compliance and adjust their procurement and production strategies accordingly. The detailed notification can be referenced for further specifics regarding the affected HS codes and policy implications.
The Notification can be accessed at: https://a2ztaxcorp.net/wp-content/uploads/2025/10/Notification-No.-41_1.pdf
