In a significant move aimed at safeguarding domestic pharmaceutical manufacturers, the Central Government has imposed import restrictions on select antibiotics and their key intermediates when imported below specified minimum prices. The restrictions, notified by the Directorate General of Foreign Trade (DGFT), will remain in force for one year with immediate effect.
The decision affects imports of Penicillin G Potassium (PEN-G), Amoxicillin Trihydrate, and 6-Aminopenicillanic Acid (6-APA)—critical raw materials used extensively in India’s antibiotic manufacturing ecosystem.
Minimum Import Price Thresholds Introduced
As per Notification No. 56/2025-26, imports of the following products will be treated as “restricted” if their Cost, Insurance and Freight (CIF) value falls below the prescribed thresholds:
- Penicillin G-Potassium (HS Code 29411010): Restricted if CIF value is below ₹2,216 per kg
- Amoxicillin Trihydrate (HS Code 29411030): Restricted if CIF value is below ₹2,733 per kg
- 6-APA (HS Code 29411050): Restricted if CIF value is below ₹3,405 per kg
While the import policy for these items otherwise remains “Free”, the introduction of Minimum Import Price (MIP)-linked restrictions effectively curbs low-cost imports that may undercut domestic producers.
Exemptions for Export-Focused Units
The notification provides important carve-outs for export-oriented operations. The MIP-based restrictions will not apply to 100% Export Oriented Units (EOUs), units operating in Special Economic Zones (SEZs) and imports under the Advance Authorisation Scheme
However, such exemptions are subject to a strict condition that the imported inputs must not be diverted or sold in the Domestic Tariff Area (DTA).
Continued Regulatory Oversight Under Drugs Law
The DGFT has clarified that imports of Penicillins and related products will continue to require registration and compliance under the Drugs and Cosmetics Act, as administered by the Drug Controller General of India (DCGI). This ensures that quality and regulatory safeguards remain intact alongside the new trade restrictions.
Policy Objective: Counter Dumping and Price Suppression
Although the notification does not expressly cite dumping, the introduction of MIP-linked restrictions signals the government’s concern over cheap imports—particularly of bulk drugs and intermediates—impacting domestic manufacturing viability. Industry stakeholders have long argued that artificially low-priced imports distort the market and discourage indigenous production of essential medicines.
The move aligns with the government’s broader strategy under initiatives such as Atmanirbhar Bharat and the Production Linked Incentive (PLI) Scheme for bulk drugs, which seek to reduce India’s dependence on imported pharmaceutical inputs.
One-Year Validity with Immediate Effect
The DGFT has confirmed that the restrictions take effect immediately from the date of publication and will remain valid for one year, after which the policy may be reviewed based on market conditions and industry feedback
Notification Details
Notification No. 56/2025-26
Date: 29/01/2026
