India Pharma Outlook Team | Tuesday, 14 October 2025
In a significant regulatory action against substandard goods, the Government of India has made an immediate announcement and imposed price-based import restrictions on substandard Sulfadiazine API.
This speculation comes with an effective date and an end date of September 30, 2026. It places restrictions on the importation of low-priced, substandard pharmaceutical raw materials into the Indian market.
According to the latest DGFT notification under the Ministry of Commerce & Industry, any imported Sulfadiazine API, a key antibiotic component for treating both bacterial infections and toxoplasmosis that has a CFR (cost and freight) price of less than ?1,774 per kilogram will be classified as "Restricted".
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This action has now been committed under sections 3 and 5 of the Foreign Trade (Development & Regulation) Act 1992, and the FTP of 2023, and further emphasizes the assured regulation of quality and support of domestic industry.
Sulfadiazine API is classified under Chapter 29 of the ITC (HS), 2022 edition, and is mostly used in various pharmaceutical formulations, consisting of silver sulfadiazine which is used for burn and wound medications. The new rule does not apply to Advance Authorization holders, EOUs, or SEZ units, however, these imports can only be imported (and not sold) under this minimum import price condition.
Industry experts view this as a strategic move to ensure high-quality pharmaceutical imports while supporting export-driven manufacturing. The immediate enforcement of this rule underscores the government’s intent to uphold stringent value and safety standards in India’s pharmaceutical supply chain.
