Tax, GST & International Trade Blog

The Central Government has amended the import policy for certain antibiotic Active Pharmaceutical Ingredients (APIs) under the Foreign Trade (Development & Regulation) Act, 1992, read with the Foreign Trade Policy (FTP) 2023.
Through a notification issued under Section 3 read with Section 5 of the Act, import conditions for Penicillin G-Potassium (PEN-G), Amoxicillin Trihydrate, and 6-APA have been revised by introducing Minimum Import Price (MIP) based restrictions for a specified period.

These changes impact imports falling under ITC (HS) Codes 29411010, 29411030, and 29411050 and are effective immediately from the date of publication.

Legal Framework of the Notification

The amendment has been issued in exercise of powers conferred under:

• Section 3 and Section 5 of the Foreign Trade (Development & Regulation) Act, 1992
• Paragraphs 1.02 and 2.01 of the Foreign Trade Policy (FTP) 2023
• Schedule-I (Import Policy) of ITC (HS) 2022

Revised Import Policy – Product-wise Analysis

1. Penicillin G-Potassium (PEN-G) – ITC (HS) 29411010

Import Policy Status: Free (with conditions)

Revised Policy Condition

• Import of Penicillin G-Potassium (PEN-G) having a CIF value below INR 2,216 per kg is classified as “Restricted.”

Exemptions

The Minimum Import Price condition does not apply to:

• 100% Export Oriented Units (EOUs)
• Units located in Special Economic Zones (SEZs)
• Imports under the Advance Authorisation Scheme

Subject to the condition that the imported inputs are not sold into the Domestic Tariff Area (DTA).

Regulatory Compliance

Imports continue to be subject to:

• Registration and other requirements administered by the Drug Controller General of India (DCGI) under the Drugs and Cosmetics Act.

2. Amoxicillin Trihydrate – ITC (HS) 29411030

Import Policy Status: Free (with conditions)

Revised Policy Condition

• Import of Amoxicillin Trihydrate with a CIF value below INR 2,733 per kg is “Restricted.”

Exemptions

The MIP restriction is not applicable to:

• 100% EOUs
• SEZ units
• Imports under the Advance Authorisation Scheme

Provided the imported goods are not diverted to the DTA.

Additional Condition

• Imports remain subject to Policy Condition No. 08 of Chapter 29 of ITC (HS).

3. 6-APA – ITC (HS) 29411050

Import Policy Status: Free (with conditions)

Revised Policy Condition

• Import of 6-APA having a CIF value below INR 3,405 per kg is classified as “Restricted.”

Exemptions

The Minimum Import Price restriction does not apply to:

• 100% EOUs
• SEZ units
• Imports under the Advance Authorisation Scheme

Subject to the condition that the inputs are not sold in the Domestic Tariff Area.

Validity Period of the Restriction

• The restrictions take effect immediately
• They shall remain in force for one year from the date of publication of the notification

Effect of the Notification

As a result of this amendment:

• Imports of:
  • Penicillin G-Potassium (PEN-G) below INR 2,216/kg
  • Amoxicillin Trihydrate below INR 2,733/kg
  • 6-APA below INR 3,405/kg
• Falling under the specified ITC (HS) codes are “Restricted” for one year.

However, EOUs, SEZ units, and Advance Authorisation imports continue to enjoy exemption from the MIP condition, subject to non-diversion to the DTA.

Note for Importers and Trade Professionals

• “Restricted” classification implies that imports below the notified CIF values would require specific authorisation under the Foreign Trade framework.
• Importers must carefully assess transaction value, import scheme eligibility, and end-use compliance before shipment.
• DCGI registration and Drugs & Cosmetics Act compliance remain mandatory wherever applicable.

Conclusion

The introduction of Minimum Import Price-based restrictions for select antibiotic APIs reflects a calibrated policy intervention under the FTP framework. While imports remain categorised as “Free,” the newly prescribed CIF thresholds effectively regulate low-value imports for a defined period.
Importers, exporters, and pharmaceutical manufacturers should align procurement strategies with the revised conditions and ensure strict compliance with end-use and authorisation requirements to avoid regulatory disruptions.

Notification Reference:  DGFT
Notification No. 56/2025-26
29 /01 /2026