Centre Extends implementation of Track and Trace System for Export of Drug Formulations to February 1, 2024

The Union Commerce Ministry has extended the implementation of the track and trace system for drug formulation exports until February 1, 2024. According to sources, August 4, 2023, the deadline for implementing a track and trace system for the export of drug formulations in terms of maintaining the parent-child relationship in packaging levels and uploading them to the Central Portal has been extended until February 1, 2024 for both SSI and non-SSI manufactured drugs.

"The date for implementation of track and trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and uploading on Central Portal is extended up to 01.02.2024 for both SSI and non SSI manufactured drugs," the new Notification stated. While applauding the latest Centre's Gazette Notification extending the implementation of the track and trace system for the export of drug formulations until February 1, 2024, industry associations have requested more stakeholder consultations and engagements in order to implement the track and trace system holistically and on time.

The main purpose of the track and trace barcode is to provide quality assurance by means of traceability and ensuring patient safety. Stakeholders involved in the implementation process include regulators, importers, exporters and manufacturers, an industry expert emphasized. They have suggested looking into alternative solutions and simple approaches like the government should provide selective accessibility to the concerned importers to identify the batch numbers of respective drugs available with the Central Drugs Standard Control Organization (CDSCO)’s SUGAM portal to help in track and trace the medicinal product. This is also required as the system has a very high Capex. A comprehensive trial run as a confidence building measure with stakeholders has also been recommended before implementing track and trace.