India's Track&Trace System for the Export of Medicinal Products

Recommendation

9-11 April 2024

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On 1 April the Indian Ministry of Commerce and Industry has supplemented a paragraph that substantiates the actual requirements and the timeline for the implementation of the Track and Trace system for the export of medicinal products. Background is the attempt of the Indian Ministry to make Indian exports of medicinal products and the supply chain more secure.

Medicinal products produced since 1 April 2015 have to exhibit the following codes or labellings:

Primary packaging: The bar code labelling on primary packaging is exempted for the time being. But the 14 digits GTIN along with batch number, expiry date and a unique serial number are to be imprinted in human readable form.

Secondary packaging: The secondary packaging is supposed to present a one or two dimensional (1D or 2D) barcode encoding containing the 14 digits GTIN along with batch number, expiry date and a unique serial number.

Tertiary packaging: The tertiary packaging is supposed to present a one dimensional (1D) barcode encoding containing the 14 digits GTIN along with batch number, expiry date and a unique serial number.

As of 1 July 2015 the Indian manufacturers are obliged to upload these data on the central portal of the Ministry. The manufacturer is responsible for the correctness, completeness and for ensuring timely upload of data on the central portal. Medicinal products having manufacturing date prior to 1 April 2015 will be exempted from this labelling requirement.

You find the detailed information in the new paragraph 2.89 A