Track and Trace System for Pharmaceuticals [UPSC Notes]

The Directorate General of Foreign Trade (DGFT) has extended the time for implementing the Track and Trace system for the export of pharmaceutical consignments. In this article, you can read all about the Track and Trace system for pharmaceuticals which is a topic relevant for the IAS exam economy segment.

Track and Trace System

The pharmaceutical track and trace system is a logistical technology that enables the tracking and localization of a drug throughout the supply chain.

  • This system has been on the cards for the past eight years and the decision has been taken now (April 2023) to implement the system for pharma export.
  • The track and trace system will consist of manufacturing data which is based on traceability and the barcode on the packaging will help to identify the source and prevent sabotage.
  • The system is expected to address the manufacture and sale of counterfeit products and product recall challenges.
  • The latest extension is based on a request by the pharma exporters’ body Pharmaceuticals Export Promotion Council of India (Pharmexcil) to the commerce ministry citing difficulties in joining the system.
  • The extension was requested due to various issues including the outbreak of the covid pandemic. 
  • The DGFT notification mentioned the extension of the implementation of the Track and Trace system for the export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on the central portal until 1-08-2023.
  • In order to ensure smooth facilitation the centre also provided a grant of ₹25 lakhs for the barcode machinery to scale industrial undertakings (SSIs) units.
  • The track and trace system will allow the traceability of products and will fortify good manufacturing practices. Pharmaceuticals Export Promotion Council of India (Pharmexcil) assured that there won’t be any further extension or delay in the implementation of the system.
  • Initially, the system aims to cover secondary and tertiary packaging only. Primary packaging will be included at a later stage.

Benefits of Track and Trace System

The benefits offered by the track and trace system for pharmaceuticals are as under:

  • It can help prevent counterfeit drugs from entering the supply chain.
  • It helps increase the efficiency in drug production and sales.

Some of the challenges facing the adoption of this system are as follows:

  • Lack of common standards
  • Security concerns as barcodes can be easily changed
  • Some pharma companies say that this system slows down the production process and increases costs

Export Performance of the Pharma Industry: In the financial year 2022-23, despite the challenges of the Ukraine-Russia war and the rise in raw material prices, the export of pharmaceutical products rose more than 3% to $22.90 billion. It is expected to reach $25 billion by the end of FY23 which is higher than the previous fiscal but is short of the $27 billion target.

Track and Trace System for Pharmaceuticals:- Download PDF Here

Related Links
Bulk drug parks Active Pharmaceutical Ingredients (APIs)
Science and Technology Notes for UPSC UPSC Monthly Magazine for Current Affairs
Drug Controller General of India (DCGI) Drug Price Control Order, 2013

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