DGFT Amends Import Policy for Key Pharmaceutical Chemicals

The Directorate General of Foreign Trade – DGFT of India has issued a notification of amending the imports rule for few pharmaceutical chemicals covered under Chapter 29 of ITC (HS) 2022, Schedule-I (Import Policy).

Timeline of Change - The amendment will be enforced with immediate effect from 18th December a up to 30 November 2026, unless further notice given by DGFT.

Amendment

As per this amendment, DGFT has also introduced Policy Condition No. 08 under Chapter 29, placing import restrictions based on Minimum CIF value for specific pharmaceutical products, those linked to the manufacture of Clavulanic Acid and Potassium Clavulanate.

New rules will be applicable as below

1. Diluted Potassium Clavulanate - Import is restricted if the CIF value is below USD 77 per kg.

2. Potassium Clavulanate (KGA) - Import is restricted when CIF value is below USD 180 per kg.

3. Specified Intermediates Used in Clavulanic Acid / Potassium Clavulanate - Imports is restricted if CIF value is below USD 92 per kg.

• Tertiary Butylamine Salt – Potassium Clavulanate

• Tertiary Octylamine Salt – Potassium Clavulanate

• Tertiary Butylamine Salt – Intermediate of Clavulanic Acid

• Tertiary Octylamine Salt – Intermediate of Clavulanic Acid

Exemptions for Export-Oriented Units

The above restrictions are not applicable for imports made by:

• Advance Authorisation holders

• Export Oriented Units (EOUs)

• Units located in Special Economic Zones (SEZs)

However, this exemption is subject to the strict condition that the imported inputs are not sold in the Domestic Tariff Area (DTA).

The import policy for multiple ITC (HS) codes under Chapter 29 has been revised. While most items continue to remain under the “Free” category, they are now subject to Policy Condition No. 08.

Key product categories affected include:

• Potassium compounds of unsaturated acyclic monoacids

• Potassium compounds of aromatic monoacids

• Certain carboxylic acids

• Pharmaceutical chemicals and intermediates

• Antibiotics such as Amoxicillin, Rifampicin, Cefadroxil, and others

For several ITC (HS) codes, a specific condition continues to apply for ATS-8 (4R-Cis-1,1-Dimethylethyl-6-cyanomethyl-2,2-dimethyl-1,3-dioxane-4-acetate) the restriction is applicable till 30th September 2026

Import of ATS-8 is restricted if CIF value is below USD 111 per kg

Restriction valid till 30.09.2026

Above data taken from DGFT India website.

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