Strengthening Pharmaceutical Integrity: Indonesia's BPOM Track and Trace Framework

BPOM's innovative approach implements a two-tier barcode system for comprehensive product verification. Identification barcodes (QR codes) have been mandatory since December 2023 for traditional medicines, over-the-counter drugs, cosmetics, and supplements, serving to verify product legality in the market. Authentication barcodes using GS1 2D DataMatrix codes will be phased in by December 2025 for narcotics and psychotropics, and by December 2027 for all prescription drugs, enabling granular serialization with GTIN, batch numbers, and expiry dates.

The regulation encompasses an extensive range of products beyond traditional pharmaceuticals, including traditional medicines, over-the-counter drugs, prescription medicines, biologicals, cosmetics, supplements, processed foods, and certain raw materials. This broad scope ensures that both imported and locally produced products throughout Indonesia's diverse healthcare and consumer markets maintain consistent traceability standards, creating a unified framework for product authentication.

BPOM requires detailed documentation of packaging relationships from sellable units through cases to pallets, establishing clear parent-child connections throughout the packaging hierarchy. Companies must implement aggregation at production lines and report this data to the TTAC system, enabling precise tracking of product movements and supporting efficient recall procedures when necessary.

All traceability documentation and reporting must flow through BPOM's centralized Track and Trace Anti-Counterfeit platform, ensuring real-time monitoring and regulatory compliance. The system also supports the transition to electronic product leaflets (e-leaflets) accessible via packaging barcodes, modernizing how healthcare providers and consumers access critical product information while reducing environmental impact.