India Delays Track-and-Trace Plans for Small and Large Drug Exporters

India is giving drug exporters some breathing space on track-and-trace requirements, with the length of the delay depending on the size of the operation.

In a Jan. 5 notice in the Gazette of India, the Ministry of Commerce and Industry’s Directorate General of Foreign Trade announced that it will push back reporting requirements for large-scale exporters until March 31, 2016, while smaller manufacturers won’t have to fulfill the requirements until March 31, 2017.

The last deadline set for track-and-trace compliance was in October, although India has delayed implementation multiple times since initially adopting its track-and-trace rules in April 2015.

Under the policy revision, companies will not be responsible for packaging oversight and for reporting tracking data on the country’s track-and-trace portal until the revised dates.

Both large- and small-scale operations are exempt from requirements that all individual product packaging include a barcode and a universal global identification code until further notice. However, the ministry requires that individual containers still incorporate information, such as the product’s batch number, expiration date and serial number on an optional basis, even if it is not machine-readable.

The policy change does not apply to product cartons, which still must have barcode scanning, although mono-cartons (such as 3-in-one packages) will only be on an optional basis. Requirements for barcodes and UGI codes on shipping containers and crates of products will not be affected, the notice states.

Read the notice here: — Cameron Ayers


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