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Published in: DGFT

DGFT Extends Implementation Of Track And Trace System For Export Of Drugs Till February 1,2025

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To keep the world protected from counterfeit and adulterated products, mostly all countries are trying to implement the Track and Trace system. On January 10, 2011, the Directorate General of Foreign Trade (DGFT), the regulatory agency of India, issued a public notice. It announced the implementation of the Track and Trace system incorporating barcode technology as per GS1 standards for the export of Pharmaceuticals and drugs products from India.

The policy has been updated and amended from time to time and the implementation has been delayed a few times. Recently, the DGFT published a notice mentioning that the deadline for implementation of the Track and Trace system for the export of Pharmaceuticals and drugs products has been extended up to 1st February 2025. It will be mandatory to maintain a Parent-Child relationship in packaging levels and upload the data on Central Portal for both SSI and non-SSI manufacturers. The delay has been made for the implementation because the companies are facing challenges in uploading the post-production XML files on the iVEDA portal.

The stakeholders of iVEDA have mentioned that it will take them approximately 8 months to program, build, test, and validate the system. Subsequently, the procedure will be updated and implemented. These steps will help to avoid any disruptions in the production and supply of medicines.

To implement the Track & Trace system, serialization of all the saleable units is mandatory. Serialization means giving a unique identification number to each saleable product whose data will be accessible to the Government. Following are the regulations to be followed as per GS1 standards:

For Secondary Level Packaging (a group of primary packages containing a single item)

  • Incorporation of the GS1 Data Matrix for the secondary level packages.
  • Incorporation of the GS1-128 or GS1 Data Matrix on remaining secondary level packages.
  • Barcodes should be encoded with a GTIN, expiry date, batch number, and serial number.

Illustration:

Typical Packing and Printing hierarchy

Image of Presentation:

For Tertiary level Packaging (containing more than one primary/secondary level package):
  • If the package is homogenous (containing only one type of item with the same batch number and expiry date), then two GS1-128 barcode images should be printed on the label.
    • The first one should be encoded with a GTIN, expiry date, and batch number.
    • The second one should have SSCC encoded.

 If the package is heterogeneous (containing one type of item with a different batch number or expiry date), then only one GS1-128 barcode should be printed and encoded with the SSCC to uniquely identify the logistical unit.

Illustration

Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services to protect your products and supplies. We are also a leading Solutions Provider for Vision-Based Inspection Systems for products, especially in the Healthcare, Food & Beverage as well as Automobile Industries. With Global Trade becoming seamless, the need for increased security & traceability of products is imperative for product authenticity. Kevision partners with clients to provide a robust & secure solution to meet product & client safety as well as regulatory compliance.

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