India amends track and trace plans for drug exports again

The Indian government has amended its track-and-trace requirements for exported medicines for the second time in two months.

The latest changes - announced by the Directorate General of Foreign Trade (DGFT) on May 22 - suggest the Indian government has taken into account industry concerns about the timeframes for implementation.

The earlier notice included a deadline of June 30, 2015, for compliance with the revisions, but a number have now been postponed.

There are a number of changes throughout Paragraph 2.89 of the Handbook of Procedure, which describes the track and trace system for exported pharmaceutical formulations. 

At the level of primary level packaging, the requirement to place a serialized, unique code via a 2D datamatrix - exempted until further notice in April - is retained. However adding the serial number in human-readable format - which some commentators suggest could cause space constraint issues - is now optional until further notice.

With regard to secondary level packaging, the coding requirements remain as before but there is a change relating to mono cartons containing one primary pack, with coding now optional until further notification.

Mono cartons were the subject of considerable debate last year after their status was switched from primary to secondary packaging under the regulations, introducing a serialisation requirement.

Aggregation

There are also amendments to the requirements for aggregation - linking the individually coded packaging levels to cartons, cases and pallets used in shipping.

The earlier draft said simply that the manufacturer or exporter "shall maintain the data in the parent-child relationship for all three levels of packaging," but this now carries the rider that data linking primary and secondary packaging is optional until further notice.

The guidance does not include any specific dates for implementing the aggregation requirements, but says reporting will be delayed until October 1, 2015 and drugs manufactured before that date are exempt.

Reporting will be via a central portal that has yet to be set up, according to the DGFT, which says it will issue additional guidance in future on "exemptions, data requirement, maintenance and upload on central portal."

As in the earlier draft, a company can request an exemption if exporting to another country with existing serialization requirements, although tertiary-level packaging will still need an Indian barcode in addition to any required by the target export country.