India Pushes Back Deadline for Barcodes on Primary Drug Packages Again

08-Apr-2013 - Last updated on 19-Aug-2019 at 08:05 GMT

Related tags Barcode

India’s Directorate General of Foreign Trade (DGFT) has pushed back the deadline again for adopting new barcodes to track pharmaceutical exports by one year.

The new July 1, 2014 deadline, announced late last week, will allow the industry an extra year to comply with the rules for GS1 2D data matrix barcodes to improve the traceability of pharmaceuticals in a country that has been accused of manufacturing and distributing counterfeits. The barcodes are expected to include a unique product identifier, batch number, expiry date and serial number.

Under the track and trace system that India is looking to use to identify counterfeits, manufacturers would be required to maintain serialized records of exported pharmaceuticals for a minimum of six months after the expiry date of the product, according to the initial DGFT notice.

Authentication features will be added and integrated with the trace and track system and the Indian government is expected to set up a central portal for tracing and tracking pharma exports.

According to PharmaSecure, a company looking to help manufacturers adhere to the new barcoding rules, the challenges of complying with the new barcode rules are manifold. For instance, due to a lack of space and the reflective nature of primary packaging material, “there can be difficulty achieving 100% read rates of codes on primary packaging using standard processes.”

The transfer of codes to the printer also needs to be a secure process that can be difficult to accomplish with only a few available open file formats, such as .csv or .xls.

Previous Deadlines

The DGFT initially set a deadline of July 1, 2011 to implement the barcodes on primary packages but the directorate did not clarify the reason behind the extension to 2014. Secondary and tertiary packages are already required to include bar codes, but some industry insiders said those rules are being skirted in certain instances.

Pharmexcil (Pharmaceutical Expert Control Council of India) and the Indian Drug Manufacturers’ Association previously called for an extension to the deadline for secondary packages that was denied by the high court of Chennai.

Questions to the DGFT over why the deadline was extended for primary level packages again were not answered by press time.