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DGFT amends measurement for key inputs under standard input output norms for exporting metformin HCL
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Shardul Nautiyal, Mumbai
December 15 , 2025
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The Directorate General of Foreign Trade (DGFT) has notified amendments in measurement for key inputs or import items under standard input output norms (SION) A-290 for exporting active pharmaceutical ingredient (API) metformin hydrochloride (HCL).
Exercising the powers granted under Paragraphs 1.03 and 2.04 of the Foreign Trade Policy (FTP) 2023, the DGFT has revised the Unit of Measurement (UOM) for specific import items used in the production of metformin HCL. The UOM has been standardized for clarity and uniform application.
According to the DGFT, the revised measurements take immediate effect, streamlining documentation and ensuring greater consistency across export–import operations involving metformin HCL. The amendment aims to enhance transparency, ease compliance for exporters, and support smoother application of SION norms under the FTP 2023.
As per the revised SION A-290 details, for the export of one kg of Metformin HCL, the existing quantity for the import item dicyanodiamide has been amended from 0.567 kg/kg to 0.567 kg. The existing quantity for the import item dimethylformamide (DMF) has also been amended from 0.37 kg/kg to 0.37 kg.
Dicyanodiamide is a crucial starting material and synthesis building block used in the industrial manufacturing process for metformin HCL.
Metformin HCl is typically prepared by reacting dicyanodiamide with dimethylamine (DMA) hydrochloride.
DMF is primarily used as a solvent in the synthesis of metformin HCl. Its use has been a subject of regulatory scrutiny due to its potential to form the carcinogenic impurity N-nitrosodimethylamine (NDMA).
DMF is an effective solvent in this process because it has viscosity insusceptible to temperature and can dissolve key reactants well, which facilitates industrial production and helps achieve high purity of the final product. After the synthesis and purification steps (which typically involve crystallization and drying), trace amounts of DMF may remain as a residual solvent in the final metformin API.
Under certain high-temperature or acidic conditions, DMF can degrade or react to produce DMA, a secondary amine impurity. DMA can then react with nitrosating agents such as nitrites. Nitrites can be present as impurities in other excipients or form under certain storage conditions to form NDMA, a probable human carcinogen.
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