Concerned over the Union Commerce Ministry's move to make it compulsory for small scale pharma companies to implement track and trace system for export of pharmaceuticals from April 1, 2017, the Confederation of Indian Pharmaceutical Industry (CIPI) will soon take up the issue with the ministry and the Pharmexcil to exempt the SSIs from its implementation.

CIPI, which time and again made representations to the ministry urging it not to make it mandatory for SSIs to implement barcoding for exports, will once again take up the matter with the ministry. Before that, the CIPI will scrutinise the proceedings of a meeting held by Pharmexcil on implementation of barcoding in Mumbai on May 13, said CIPI executive secretary Sudesh Kumar in a telephonic interaction with Pharmabiz.

Kumar, citing reasons for exempting the SSI units from implementation of barcoding on pharma packs intended for export, said “A huge chunk of small scale pharma companies export drugs to third world countries which lack facility to scan bar code on packaging of pharma products to ensure its authenticity. These countries do not have required manpower and resources to implement track and trace system. Hence there is no mandatory requirement for bar coding on packs of pharma products exported to these low income countries. Given the circumstances, it is futile for us to abide by the ministry's notification.”

On the other hand, establishing parent-child relationship between secondary and tertiary packs of pharma products as per the government norm will put a heavy financial burden on small scale pharma units without serving any purpose. The companies exporting products to developed countries like US and Europe have already implemented track and trace system which is mandatory to export there, he said.

The ministry in a notification earlier had directed small scale pharma exporters to print 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and 2D barcode on secondary packs and 1D or 2D barcode on tertiary packs and maintain the data in the parent-child relationship for all three levels of packaging—primary, secondary and tertiary packaging and their movement in its supply chain from April 1, 2017. However, it is optional to maintain parent-child relationship between primary and secondary packaging. The small scale exporters have also been directed to upload the same in Drug Authentication and Verification Application (DAVA) portal up to March 31, 2017.

Kumar said it is difficult for manufacturers/exporters to upload the data in time ensuring that it is complete and authentic as they would not be aware about details on the end point sale of their products if the products are not properly tracked and the information uploaded on their server.

Manufacturers/exporters are dependent on the supply chain for authenticity of the data so every link in supply chain, whether local or global, should be held responsible to provide the authentic/complete data to the manufacturers/exporters in time so that the manufacturers or exporters can further upload the same on the central portal in time to ensure that the data uploaded is truly correct, he concluded.