India Restricts Import of Key Chemical Used in Pharma Sector

India Restricts Import of Key Chemical Used in Pharma Sector

India Pharma Outlook Team | Monday, 22 September 2025

According to a notification, India has restricted the import of a chemical used in the pharmaceutical business until September 30 of next year. Imports of "ATS-8 (4r-cis)-1 1-dimethylethyl-6-cyanomethyl-2 2-dimethyl-1 3-dioxane-4-acetate" with a CIF (cost, insurance, freight) value of less than USD 111 per kg are prohibited until September 30, 2026, with immediate effect, according to the Directorate General of Foreign Trade (DGFT).

The compound dimethylethyl-6-cyanomethyl-2,2-dimethyl-1,3-dioxane-4-acetate features a complex organic structure built around a 1,3-dioxane ring, a six-membered ring containing oxygen atoms at positions 1 and 3. At carbon 2, it carries two methyl groups, making it 2,2-dimethyl-substituted, which increases steric bulk.

Also Read: India Eyes Russia, Brazil, Netherlands to Diversify Pharma Exports

At carbon 4, there's an acetate group (–OCOCH?), indicating the presence of an ester, enhancing the compound’s lipophilicity. Carbon 6 holds a cyanomethyl group (–CH?CN), contributing polarity and potential reactivity due to the nitrile.

The dimethylethyl substituent, likely a branched alkyl group such as tert-butyl, adds further complexity and hydrophobic character to the molecule.

However, it said that the MIP (minimum import price) requirement would not apply to goods imported by advanced authorization holders, export-oriented companies, or social economic zones.

China and other nations import the chemical. The ban of pharmaceutical products effective immediately; however it does not apply to inputs imported by SEZs, export-oriented enterprises, or holders of advance authorization.

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