Track and trace system implementation for export of drugs extended

The Directorate General of Foreign Trade (DGFT) extended the implementation of a track and trace system for the export of pharmaceutical products with respect to maintaining the so-called ‘parent-child relationship’ in packaging levels and its uploading on concerned the Central portal till April 1, 2023, for both small scale industries (SSI) and non-SSI manufactured drugs.

The Directorate General of Foreign Trade (DGFT) has issued a public notice in this regard. According to the previous order by same, the track and trace system was to be implemented starting from April 1, 2022.

That is a massive relief to drug exporters, notably pharma Micro and Small & Medium Enterprises (MSMEs), reeling under the covid-19 pandemic shock. Pharma Micro, small & Medium Enterprises (MSMEs) are not in a position to raise the requisite infrastructure involving huge funds needed to implement the trace and track system. They had sought deferment of the obligatory implementation.

Welcoming the Directorate General of Foreign Trade (DGFT)’s decision to defer track and trace system implementation for the export of drug formulations, the chairman of the Small and Medium Pharma Manufacturers Association (SMPMA), Nipun Jain, asserted: “The pharma MSMEs are grappling with pandemic aftershocks. There has been a significant decline in the capital base since the outbreak of the Covid-19 pandemic. Small and medium firms lack the resources to create the requisite infrastructure for a drug authentication system. On the other hand, major importing countries have not required barcoding on pharma products.”

Earlier Small and Medium Pharma Manufacturers Association (SMPMA) which is a pan India Association of Micro, Small & Medium Enterprises pharmaceutical companies, had requested the Directorate General of Foreign Trade (DGFT)  to defer the implementation of this track and trace system for the export of drug formulations given the infrastructure and financial constraints faced by the industry ever since the Covid-19 pandemic outbreak and claiming that major importing countries do not require for such system.

Echoing his view, the secretary at MP Small Scale Drug Manufacturers Association, Amit Chawla, asserted, “MSMEs are considered the pillars of the Indian economy due to their considerable contribution to GDP, exports, and employment generation. They have made a significant contribution to ensuring the availability of affordable drugs in India and other low-and medium-income countries. The MSMEs are facing challenges of running a business amidst a pandemic and the rising cost of raw materials and packing materials. Earmarking funds for implementing a drug authentication system has become a herculean task for them. The DGFT’s year-long extension of track and trace system implementation has provided a timely relief to pharma MSMEs.”

Federation of Pharmaceutical and Allied Products Merchant Exporters has also hailed this step. “We insist on postponing implementation until track and trace are universally implemented for domestic consumption and exports products,” said Sandeep Modi, their secretary.

Earlier the commerce ministry of India, through the Centre for Development of Advanced Computing (C-DAC), was to launch the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal for Authentication and tracking and tracing of the drug supply from April 1, 202o. It had got extended till October 1, 2020, due to the Covid-19 pandemic.

The Directorate General of Foreign Trade (DGFT) had extended its implementation again till April 1, 2021, following similar appeals. It further extended the timeline for track and trace system implementation until April 1, 2022, and it got extended by one year yet again.

The manufacturers and exporters are supposed to barcode their products using GS1 standards. They are also to upload data on barcodes on secondary and tertiary packaging of exported drugs on the iVEDA mentioned above portal, which is supposed to replace the Drugs Authentication and Verification Application (DAVA) portal.