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Govt imposes price-linked import restriction on sulfadiazine API until Sept-2026 to curb substandard imports
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Shardul Nautiyal, Mumbai
October 14 , 2025
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In a significant regulatory development aimed at controlling substandard imports, the Government of India has imposed price-based import restriction on sulfadiazine API, a key active pharmaceutical ingredient (API), until September 30, 2026 to curb substandard imports with immediate effect.
Sulfadiazine API refers to the API of sulfadiazine, an antibiotic that prevents the growth of bacteria. It is used to treat infections, most notably with pyrimethamine for toxoplasmosis. It also exists in the form of silver sulfadiazine, which is used topically for burns and wounds.
Sulfadiazine API falls under Chapter 29 of the ITC (HS), 2022 classification.
The Government of India has announced a new amendment to the import policy concerning sulfadiazine through a notification issued by the Directorate General of Foreign Trade (DGFT) under the Union ministry of commerce & industry.
As per the notification, any import of sulfadiazine API valued at less than Rs. 1,774 per kilogram on a Cost, Insurance, and Freight (CIF) basis will now be classified as ‘Restricted’ until September 30, 2026. This move is expected to curb the influx of low-cost, potentially lower-grade pharmaceutical raw materials into the Indian market, thereby safeguarding both the domestic industry and public health standards.
The revised import condition has been executed under the powers conferred by Section 3 and Section 5 of the Foreign Trade (Development & Regulation) Act, 1992, and aligned with Paragraphs 1.02 and 2.01 of the Foreign Trade Policy (FTP) 2023. According to officials, this reflects the government’s firm stance on ensuring that imported pharmaceutical inputs adhere to robust value and quality benchmarks.
The Notification also provides a critical exemption. Imports of Sulfadiazine API by holders of Advance Authorization Holders, Export Oriented Units (EOUs), and units operating within Special Economic Zones (SEZs) will not be subjected to the Minimum Import Price (MIP) condition, provided that the imported inputs are not sold into the Domestic Tariff Area (DTA). This exception is designed to support India’s export manufacturing ecosystem, ensuring uninterrupted access to necessary inputs for units primarily focused on global markets.
This policy shift is likely to have wide-ranging implications for pharmaceutical manufacturers, importers, and traders dealing in APIs. By setting a floor price for imported sulfadiazine, the government is not only filtering out low-cost, potentially inferior imports but also nudging the industry toward higher compliance and better manufacturing practices.
“The notification, issued under the DGFT, is aimed at regulating trade in the pharmaceutical sector with precision, ensuring both quality assurance and policy clarity. The immediate implementation of the revised import condition signals the urgency and importance the government attaches to this regulatory intervention,” according to an industry expert.
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