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FPME calls for trial run ahead of February 2025 track and trace implementation
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Shardul Nautiyal, Mumbai
July 22 , 2024
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The Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) has made an urgent call for action to the Government to conduct a comprehensive trial run of the track and trace system before its full-scale implementation. This call aims to build confidence among stakeholders and ensure a smooth transition to the new system.
The Directorate General of Foreign Trade (DGFT) had extended the deadline for implementing the track and trace system for drug formulations export to February 1, 2025. This extension applies to both small scale industries (SSI) and non-SSI manufactured drugs. DGFT had stated that the initiative aims to enhance transparency and accountability in drug formulation exports. Stakeholders are encouraged to seek clarifications via email at dgft@nic.in.
The extension was aimed at providing pharmaceutical companies with the necessary time to integrate the required technological infrastructure, ensuring seamless track and trace implementation. The government's emphasis on quality control and traceability is expected to strengthen India's position in the global pharmaceutical market.
The FPME has highlighted the necessity for a thorough trial run to ensure all stakeholders, including manufacturers, merchant exporters, customs officers, and Custom House Agents (CHA), are well-prepared for the track and trace implementation. The primary objective of the track and trace system, marked by barcode implementation, is to enhance quality assurance through traceability, thereby ensuring patient safety.
Sandeep Modi, joint secretary of FPME, emphasized the importance of adhering to proper guidelines and providing a comprehensive trial run to all involved parties. This will facilitate successful implementation and data maintenance.
FPME members already provide detailed information for traceability in export shipments, including product details, batch numbers, manufacturing and expiry dates, and exporter and importer information. These details are uploaded to the ICEGATE portal and authenticated by the relevant authorities.
According to FPME, recipient countries currently rely on human-visible information for traceability, as barcode scanning and data uploading to the DAVA/iVEDA portal are not practiced universally. Implementing track and trace without a recipient country mandate could impose financial burdens.
Many products sourced by FPME from local manufacturers, traders, and distributors lack barcodes at various levels. Adding stickers would contravene the Drugs & Cosmetics (D&C) Act. FPME seeks a mechanism to implement track and trace by barcoding until it becomes universally applicable.
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