New SION notified for sodium citrate to boost pharma exports
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Shardul Nautiyal, Mumbai
June 13 , 2025
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In a significant development aimed at streamlining the export-import framework within the pharma sector, the Directorate General of Foreign Trade (DGFT) has announced the fixation of a new Standard Input Output Norm (SION) for sodium citrate. This move, authorized under paragraph 1.03 of the Foreign Trade Policy (FTP) 2023, marks a vital step in simplifying trade procedures and ensuring material efficiency.
This newly notified SION entry, A-3686, is categorized under the ‘Chemical and Allied Products’ group (Product Code 'A'), and sets the standard material input required for manufacturing and exporting 1 kg of sodium citrate, thereby allowing 0.740 kg of citric acid monohydrate as the permissible input quantity.
This notification sets a clear and precise norm for exporters and manufacturers involved in the production and international trade of sodium citrate, a key pharmaceutical ingredient. Under this norm, 0.740 kg of citric acid monohydrate will be permitted as the input required to produce 1 kg of sodium citrate.
This notification reinforces the government's commitment to support the export industry by providing precise, updated norms under the FTP.
The fixation of this input-output norm brings multiple benefits like regulatory clarity. Exporters now have a defined ratio of permissible input, helping avoid procedural ambiguity while applying for advance authorizations.
It will also ensure Ease of Doing Business (EoDB). This will further reduce compliance burden by standardizing the materials required for production under the FTP.
Micro, small, and medium enterprises (MSMEs) exporters, who rely on advance authorizations (AAs), will particularly benefit from a transparent and structured input-output framework. It will help in trade facilitation and help to expedite customs clearance processes by providing a benchmark for quantity assessments.
The SION for the export product 'sodium citrate' under the Chemical & Allied Product Group is being notified to streamline and facilitate exports under the Advance Authorization (AA) scheme. This notification is aimed to support India’s export competitiveness and facilitate global trade by aligning policy frameworks with industry needs.
The introduction of SION A-3686 represents a significant regulatory development under the FTP 2023. Exporters and industry stakeholders have been advised to take note of this update and align their documentation and production processes accordingly.
Sodium citrate is a versatile compound with applications in pharmaceutical formulations, acting as a buffer, emulsifier, and sequestering agent. Sodium citrate can be used in pharmaceutical formulations to maintain the pH of medications, ensuring their stability and effectiveness.
It helps in creating stable mixtures of oil and water, which is crucial in some liquid formulations. Sodium citrate can bind to metal ions, preventing them from interfering with drug activity or causing adverse reactions. It can serve as a standard for analyzing the concentration of sodium citrate in raw materials, food, and pharmaceutical products.
In medicine, it's used to alkalinize urine, which can help prevent kidney stones. Sodium citrate is also a blood thinner, used in blood collection tubes to prevent clotting.
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