The Central Government has amended the import policy for important antibiotic raw materials and drugs. The amendment covers Penicillins and its salts, Amoxicillin and its salts, and 6-APA. These products fall under ITC (HS) Codes 29411010, 29411030, and 29411050 of Chapter 29 of ITC (HS), 2022.
The notification has been issued under the Foreign Trade (Development & Regulation) Act, 1992, and the Foreign Trade Policy (FTP) 2023. The objective of this amendment is to protect domestic manufacturers and ensure fair pricing in the pharmaceutical sector. The revised rules take effect immediately and will remain valid for one year from the date of publication.

Minimum Import Price Introduced for Penicillin, Amoxicillin and 6-APA

Under the revised import policy, a Minimum Import Price (MIP) has been introduced for selected products. Imports below the notified price will fall under the “Restricted” category. Penicillin G-Potassium (PEN-G) under ITC HS Code 29411010 will remain free for import. However, imports with a CIF value below ₹2,216 per kilogram will be treated as restricted.
Amoxicillin Trihydrate under ITC HS Code 29411030 will also remain under the free category. Imports with a CIF value below ₹2,733 per kilogram will be restricted. 6-APA under ITC HS Code 29411050 will stay free for import, but imports with a CIF value below ₹3,405 per kilogram will be restricted.
These measures aim to stop very low-priced imports that may harm the Indian pharmaceutical industry.

Exemptions for EOUs, SEZ Units and Advance Authorisation

The amended import policy provides clear exemptions for specific categories. The Minimum Import Price condition will not apply to imports made by 100% Export Oriented Units (EOUs). Units located in Special Economic Zones (SEZs) also receive exemption.
Imports made under the Advance Authorisation Scheme remain exempt from the restriction. However, a strict condition applies. The imported inputs must not be sold in the Domestic Tariff Area (DTA).
In addition, all imports will continue to follow registration and regulatory requirements administered by the Drug Controller General of India under the Drugs and Cosmetics Act.

Impact on Pharmaceutical Imports and Industry

This import policy amendment will directly impact pharmaceutical imports in India. The restriction supports domestic production of Penicillin, Amoxicillin, and 6-APA. The policy also encourages price stability and fair competition.
The one-year restriction period allows the government to review market conditions and industry performance. Importers, manufacturers, and traders must closely follow the revised import policy to avoid compliance issues.

The notification has been issued with the approval of the Minister of Commerce and Industry. The amendment marks a significant step in strengthening India’s pharmaceutical supply chain under FTP 2023 and safeguarding national manufacturing interests.