The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, has amended the import policy for certain bulk drugs and pharmaceutical inputs, imposing Minimum Import Price (MIP)-linked restrictions on penicillins and their salts, Amoxycillin and its salts, and 6-Amino Penicillanic Acid (6-APA). The changes have been notified through Notification No. 56/2025-26, with immediate effect.
The amendment has been carried out in exercise of powers under Section 3 read with Section 5 of the Foreign Trade (Development & Regulation) Act, 1992, and paragraphs 1.02 and 2.01 of the Foreign Trade Policy (FTP) 2023, by modifying Chapter 29 of the ITC (HS) 2022.
Penicillins and Its Salts: Import Curbs Below CIF Threshold
Under ITC (HS) Code 29411010, imports of Penicillins and its salts continue to remain in the “Free” category. However, the DGFT has introduced a restriction where Penicillin G-Potassium (PEN-G) having a CIF value below INR 2,216 per kilogram will be classified as “Restricted”.
At the same time, the notification provides significant exemptions. The MIP condition will not apply to imports by:
- 100% Export Oriented Units (EOUs),
- Units located in Special Economic Zones (SEZs), and
- Imports made under the Advance Authorisation Scheme,
provided that the imported inputs are not sold in the Domestic Tariff Area (DTA).
All imports of penicillins will also remain subject to registration and regulatory requirements administered by the Drug Controller General of India (DCGI) under the Drugs and Cosmetics Act.
Amoxycillin Imports Face Similar Restrictions
For Amoxycillin and its salts falling under ITC (HS) Code 29411030, imports are also retained under the “Free” category but with a key caveat. Amoxycillin Trihydrate with a CIF value below INR 2,733 per kilogram will be treated as “Restricted”.
As with penicillins, the minimum import price condition will not apply to EOUs, SEZ units, or Advance Authorisation imports, subject to the non-diversion condition into the DTA. Additionally, imports remain subject to Policy Condition No. 08 of Chapter 29, along with regulatory oversight under the Drugs and Cosmetics Act.
6-APA Imports Restricted Below INR 3,405 per Kg
The DGFT has also imposed restrictions on 6-Amino Penicillanic Acid (6-APA) under ITC (HS) Code 29411050. While the import policy remains “Free”, imports of 6-APA with a CIF value below INR 3,405 per kilogram will now be treated as “Restricted”.
Here again, the exemption framework mirrors that applicable to penicillins and amoxycillin, shielding EOUs, SEZ units, and Advance Authorisation imports from the MIP requirement, subject to non-sale in the domestic market.
One-Year Validity, Immediate Effect
The DGFT has clarified that the restrictions will remain in force for a period of one year from the date of publication of the notification and will take effect immediately. The stated intent behind the move is to regulate low-priced imports of critical pharmaceutical intermediates while safeguarding domestic manufacturers, without disrupting export-oriented production chains.
Notification Details
Notification No. 56/2025-26
Date: 29/01/2026
