Editor’s Note
This article details recent regulatory changes by India’s Directorate General of Foreign Trade concerning the import policy for key pharmaceutical raw materials, including Penicillin-G and Amoxycillin. Readers in the pharmaceutical manufacturing and international trade sectors should take note of these amendments, which are effective from the notification date of January 29, 2026.
The Directorate General of Foreign Trade (DGFT) has issued Notification No. 56/2025-26 dated January 29, 2026, announcing amendments to the import policy and policy conditions for certain key pharmaceutical raw materials, namely Penicillin-G (PEN-G), 6-Amino Penicillanic Acid (6-APA), and Amoxycillin and its salts falling under ITC (HS) Codes 29411010, 29411050 and 29411030, respectively.
These amendments are made under the powers conferred by Section 3 of the Foreign Trade (Development & Regulation) Act, 1992, and in line with the Foreign Trade Policy (FTP) 2023, as amended.
Penicillin-G (ITC HS 29411010)
- Import policy remains Free.
- New restriction: Import of Penicillin G-Potassium (PEN-G) with CIF value less than ₹2,216 per kg is now Restricted.
- Exemptions from Minimum Import Price (MIP):
- 100% Export Oriented Units (EOUs)
- Special Economic Zone (SEZ) units
- Imports under Advance Authorization Scheme, provided goods are not sold in the Domestic Tariff Area (DTA)
Amoxycillin and its salts (ITC HS 29411030)
- Import policy remains Free. Earlier subject to Policy Condition 08 of Chapter 29.
- New restriction: Import of Amoxycillin Trihydrate with CIF value less than ₹2,733 per kg is now Restricted.
- Exemptions (same as above) for EOUs, SEZ units, and Advance Authorization imports not entering DTA.
6-APA (ITC HS 29411050)
- Import policy remains Free.
- New restriction: Import of 6-APA with CIF value less than ₹3,405 per kg is now Restricted.
- Exemptions for EOUs, SEZ units, and Advance Authorization imports (not entering DTA).
The newly introduced import restrictions on PEN-G, Amoxycillin Trihydrate, and 6-APA will remain in force for a period of one year from the date of publication of the notification.
However, these restrictions do not apply to:
- 100% Export Oriented Units (EOUs)
- SEZ units
- Advance Authorization Scheme imports, as long as the products are not diverted to the Domestic Tariff Area (DTA).
This amendment introduces Minimum Import Price–based restrictions to support fair trade practices and ensure the stability of domestic pharmaceutical manufacturing while safeguarding export-oriented and special-scheme units.
