Notification No. 56/2025-26, Dated 29-01-2026
The Directorate General of Foreign Trade (DGFT) has issued a notification amending the import policy and policy conditions applicable to certain pharmaceutical active ingredients, namely Penicillins and their salts, 6-APA, and Amoxycillin and its salts. These products fall under ITC (HS) Codes 29411010, 29411050, and 29411030 of Chapter 29 of the ITC (HS), 2022 – Schedule I (Import Policy).
1. Import Policy Status – Free with Value-Based Restrictions
While the import policy for these items continues to remain classified as ‘Free’, the amendment introduces minimum CIF value-based restrictions. Imports below the prescribed CIF thresholds are not permitted, effectively placing a price-based control on low-value imports.
The minimum CIF values prescribed are:
- Penicillin G-Potassium (PEN-G) – INR 2,216 per kg
- Amoxicillin Trihydrate – INR 2,733 per kg
- 6-Aminopenicillanic Acid (6-APA) – INR 3,405 per kg
2. Continued Regulatory Oversight under Drug Laws
Imports of these products remain subject to registration and other statutory requirements administered by the Drug Controller General of India (DCGI) under the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. Importers must ensure full compliance with pharmaceutical regulatory approvals, quality standards, and documentation requirements.
3. Applicability of Policy Condition No. 08
In addition to the revised CIF restrictions, imports will continue to be governed by Policy Condition No. 08 of Chapter 29, which lays down specific conditions applicable to pharmaceutical and chemical products under the ITC (HS) framework.
4. Effective Date and Validity Period
The amended import restrictions are effective immediately from the date of publication of the notification. The measures will remain in force for a period of one year, unless extended, modified, or withdrawn earlier by the DGFT.
5. Regulatory Implications
The move is aimed at preventing low-priced imports, ensuring quality compliance, and safeguarding domestic manufacturing interests, while maintaining availability of essential pharmaceutical inputs through a controlled ‘Free’ import regime.
