DGFT Defers Implementation of Track & Trace System for Pharmaceutical Exports

The implementation date of the Track and Trace or barcoding system for export of drug formulations has been extended to November 15, according to the Commerce Ministry.

In a recent notification, the Directorate General of Foreign Trade (DGFT) said the deadline for the implementation, of the system that aims to maintain “parent-child relationship in packaging levels and its uploading on central portal,” was being extended up to November 15. It would apply to drugs manufactured by both small scale and non-SSI units.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) had highlighted the problems faced by its member-exporters with regard to its implementation to the government. It had sought for extension of time for uploading of data by the exporters on the Drug Authentication and Verification Application (DAVA) portal.

Export issues

The non-compliance of stipulations – barcoding on secondary and tertiary packing as well as uploading of the data on the portal – had resulted in the exporters facing problems at Customs, the council had pointed out.The track and trace system, incorporating barcode technology as per GS1 global supply standards, applies for all drugs and pharmaceutical products exported from the country. The barcoding system had been mandated as a measure to address counterfeit and in-effective product recall challenge, which, the DGFT said, affects the entire healthcare supply chain from manufacturers to patients, wholesalers, distributors, exporters and healthcare providers.

Exporters/manufacturers were facing problems in uploading their products’ data on the DAVA portal for two level of packaging i.e. secondary and tertiary maintaining parent-child relationship as the central portal was not functioning properly.

At a meeting held by Commerce Ministry in New Delhi on April 24, representatives from Indian Drug Manufacturers’ Association (IDMA) and Pharmexcil had raised the difficulties faced by exporters/manufacturers while uploading data on the central portal. Taking serious note of it, Commerce Secretary, Ms. Rita Teaotia had directed DGFT to put the implementation of bar-coding on pharmaceutical consignment for export on hold for six months and resume its execution after six months when NIC resolves shortcomings of the central portal.