India extends aggregation deadline for drug exports again

The Indian government has once again extended a key deadline in its track and trace system for exported medicines.

The latest extension relates to the maintaining the ‘parent-child’ relationship in packaging levels – also known as aggregation – as medicines move through the supply chain and its uploading on the central portal. The deadline has been set forward by six months from October 1 of this year to April 1, 2021.

The new timeline comes amid a complete revision of India’s much-delayed track-and-trace system for exported drugs, which has been in development since 2011.

Earlier this year, the Ministry of Commerce and Industry confirmed that its much-maligned Drug Authentication and Verification Application (DAVA) portal would be replaced with a new portal called iVEDA (integrated Validation of Exports of Drugs from India and its Authentication).

How to Comply with the DSCSA Saleable Returns Verification Requirement

DAVA came in for deep criticism from drugmakers complaining of difficulties in complying with inflexible data uploading requirements, inadequate data security, delays at ports, and erroneous product recalls.

Manufacturers had been required to start using the iVEDA portal from April 1 of this year, but that deadline was also extended to October 1, now just over a week away. A beta version of the portal has been running since June.

In the context of traceability using serial numbers, aggregation involves associating the codes for individual packs of medicine with the codes used on cartons, cases, and pallets used in shipping.

This is the third time that India’s Directorate General of Foreign Trade (DGFT) has extended the deadline for aggregation and reporting.

Image by Pexels from Pixabay