The QMN Weekly Bulletin

India Puts Track-and-Trace Plans on Backburner

March 25, 2016

India is giving drug exporters a one-to-two year reprieve on track-and-trace requirements, depending on the size of the operation.

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, 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 2015, although India has delayed implementation multiple times since initially adopting its track-and-trace rules back in April 2015.

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. Requirements for barcodes and UGI codes on shipping containers and crates of products will be unaffected, the notice states.

More than 150 countries will require pharma track and trace regulations over the next 10 years. Order out webinar Preparing for Global Track & Trace Regulations and hear from track and trace expert Bill Fletcher of Pharma Logic Solutions tackle the numerous issues and misconceptions surrounding new track and trace requirements.