DGFT Withdraws Track and Trace System for Pharma Exports, Aligns with MoH&FW Regulations

The move aims to eliminate duplication, reduce compliance burdens on exporters, and ensure consistency with global serialization standards.

The Directorate General of Foreign Trade (DGFT) has announced the withdrawal of the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP), streamlining regulations in alignment with the Ministry of Health & Family Welfare (MoH&FW). The move aims to eliminate duplication, reduce compliance burdens on exporters, and ensure consistency with global serialization standards.

Background of the Track and Trace System

The Track and Trace System, introduced through a Public Notice dated January 10, 2011, required barcoding at tertiary, secondary, and primary packaging levels to enhance pharmaceutical traceability.

Tertiary-level barcoding was successfully implemented in 2011 

Secondary-level barcoding was enforced in 2013 

Primary-level barcoding and parent-child data uploading faced repeated operational delays, with the last extension valid until February 1, 2025

Key Reasons for Withdrawal

The DGFT’s decision to discontinue these provisions is based on several critical factors:

MoH&FW's Existing QR Code System:

• Since August 1, 2023, the Drugs Rules, 1945, require barcode/QR codes for 300 key drug brands.
• MoH&FW plans to expand QR code implementation to cover a broader range of pharmaceuticals.

 Global Serialization Standards:

• Many export destinations already have stringent serialization norms, ensuring product traceability.
• Additional domestic requirements create redundant compliance burdens for exporters.

 Unified Oversight by MoH&FW & CDSCO:

• The Central Drugs Standard Control Organization (CDSCO) serves as the primary regulatory body, ensuring a harmonized approach.
• A unified system prevents overlapping regulations and streamlines industry compliance.

Impact on the Pharmaceutical Export Industry

 Improved Ease of Doing Business: Reducing compliance burdens will enhance the competitiveness of Indian pharma exports. 

Regulatory Clarity: With CDSCO as the central authority, exporters will have a clear, singular regulatory pathway. 

Cost Efficiency: Eliminating redundant track-and-trace requirements will reduce compliance costs for pharma manufacturers and exporters.

Implementation & Next Steps

As part of this regulatory shift, the provisions under Para 2.76 of the Handbook of Procedures (HBP) 2023 have been officially withdrawn. DGFT will continue to collaborate with MoH&FW and CDSCO to align India's pharmaceutical regulations with international best practices.

Industry stakeholders, including pharmaceutical exporters, regulatory experts, and trade associations, have welcomed this step, highlighting its potential to boost export efficiency and strengthen India’s position as a leading global pharmaceutical supplier.