Update: India amends track and trace plans for pharma exports

The Indian government has introduced controversial new serialisation and reporting requirements for pharmaceutical exports.

Pharma exporters have just three months - until June 30, 2015 - to comply with the revisions, according to an April 1 notice from India's Directorate General of Foreign Trade (DGFT).

In a nutshell, the insertion of Paragraph 2.89 A in the Handbook of Procedure for the track and trace system means that labelling - covering the Global Trade Item Number (GTIN), batch number, expiry date and a unique serial number - has to be available on the primary packaging in human-readable form. 

The need to incorporate the data in a bar code has been exempted until further notice, but companies have already expressed concerns about the short timeframe for compliance, the cost and necessity of including this data on primary packaging and possible space constraint problems associated with the printing of human-readable data.

The requirements for secondary level and tertiary level packaging remain as before. For secondary packaging (which since July 2014 has included mono cartons), since January 2014 manufacturers have had to print a 1D or 2D barcode encoding the GTIN with batch number, expiry date and a unique serial number.

Tertiary packaging requirements came into effect in 2012 and specify a 1D barcode with GTIN, batch number, expiry date and a unique serial number (the Serial Shipping Container Code or SSCC).

Aggregation and reporting

The amendment now introduces a mandate for aggregation - in other words a means linking the individually serialised pack to cartons, cases and pallets used in shipping.

"The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging … and their movement in its supply chain," says the notice.

In addition, the DGFT also indicates for the first time how data generated in the scheme will be reported, saying it will be "uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs for sale or distribution."

Further details on the data formats, maintenance and upload will be covered in future guidance, says the DGFT, and for now it has not indicated when the reporting facility will come into operation.

Drugs manufactured after April 1 this year must carry the coding on secondary and tertiary packs, although the uploading requirement will not become mandatory until June 30. Products made before April 1 are exempt.

India's Pharmaceuticals Exports Promotion Council (Pharmexcil) was due to hold a public meeting this week to provide a forum to discuss the changes.

"The DGFT mandate is a significant development and provides clear measure that the Indian government wishes to harmonize its regulatory requirements with emerging global standards," commented Avi Chaudhuri, chief business officer of serialization specialist Kezzler.

"The USA, EU, and various other countries have adopted serialization and traceability measures to protect its medicines and consumers. The DGFT rule will impose strict requirements in terms of code uniqueness, package aggregation, data upload to a central repository, and compliance enforcement."

The DGFT has sent a very clear signal that Indian pharma companies need to get this done right and work with solution providers capable of delivering a complete global traceability solution, added Chaudhuri.