The Government of India has amended the Import Policy conditions for certain pharmaceutical products and intermediates under Chapter 29 of the ITC (HS) 2022, Schedule I (Import Policy), with immediate effect.
The amendments have been notified by the Directorate General of Foreign Trade (DGFT), Department of Commerce, Ministry of Commerce & Industry, vide Notification No. 50/2025–26 dated December 18, 2025, issued in exercise of powers under the Foreign Trade (Development & Regulation) Act, 1992.
Key Highlights of the Notification:
- A new Policy Condition No. 08 has been introduced under Chapter 29 of the ITC (HS), 2022.
- Import of diluted Potassium Clavulanate having a CIF value of less than USD 77 per kg has been placed under the ‘Restricted’ category till 30th November 2026.
- Import of Potassium Clavulanate (KGA) having a CIF value of less than USD 180 per kg has also been restricted till 30th November 2026.
- Import of certain intermediates used in the manufacture of Clavulanic Acid or Potassium Clavulanate, having a CIF value below USD 92 per kg, has been restricted till 30th November 2026. These intermediates include:
- Tertiary Butylamine Salt – Potassium Clavulanate
- Tertiary Octylamine Salt – Potassium Clavulanate
- Tertiary Butylamine Salt – Intermediate of Clavulanic Acid
- Tertiary Octylamine Salt – Intermediate of Clavulanic Acid
- The above restrictions shall not apply to imports made by Advance Authorisation holders, Export Oriented Units (EOUs), and units in Special Economic Zones (SEZs), subject to the condition that the imported inputs are not sold in the Domestic Tariff Area (DTA).
Amendments to ITC (HS) Codes:
Several ITC (HS) codes relating to potassium compounds, carboxylic acids, antibiotics and pharmaceutical products — including Amoxicillin, Rifampicin, Cefadroxil and related salts — have been made subject to Policy Condition No. 08 of Chapter 29, thereby aligning them with the revised import restrictions.
Effect of the Notification:
As a result of this notification, the import of diluted Potassium Clavulanate, Potassium Clavulanate (KGA), and specified intermediates shall be regulated under the revised policy conditions with immediate effect and will remain in force till 30th November 2026.
The Notification can be accessed at: https://a2ztaxcorp.net/wp-content/uploads/2025/12/Notification-No-50-English_0001.pdf
