The small scale pharmaceutical units are in a fix since last week as their consignments are stuck at Jawaharlal Nehru Port Trust due to non-compliance with track and trace requirements for exports as mandated by the Directorate General of Foreign Trade (DGFT).

Subhash Agrawal, Commissioner of Customs, Jawaharlal Nehru Customs House in a letter to pharmaceutical manufacturers and exporters on April 13, 2018 stated that if the barcoding is not proper on secondary and tertiary packaging of export consignment, such consignments cannot be allowed to be exported and have to be ordered back to town by the competent authority. Further, in case of such export consignments/shipping bills which comply with the proper barcoding as per the DGFT guidelines on secondary and tertiary packaging, but are short of verification of their data on Drug Authentication and Verification Application (DAVA) portal for want of uploading the same, the same cannot be allowed to be exported.

Customs' notification has taken its toll on the export consignments of SSI units as they have yet not complied with barcoding norms as per DGFT guidelines which made it compulsory for them to put in place barcoding on tertiary and secondary packaging carrying one or two dimensional (1D or 2D) barcode encoding unique and universal “global product identification code” in the format of 14 digits global trade item number (GTIN) along with batch number, expiry date and a unique serial number of the secondary or tertiary pack from April 1, 2017. Further, the relevant data is also required to be uploaded on the central portal by the manufacturers and exporters.

Due to low awareness among customs officials about the said rules, it was not strictly implemented at JNPT and SSI units were able to export products without fulfilling barcoding requirements.

The said barcoding norms for non SSI units came into force from April 1, 2016.

Bhavin Mehta, director-Kilitch Co.(Pharma) Ltd said, “Because of the customs' circular, export consignments are getting stuck at JNPT and there is now a backlog of goods and people are worried about export. Two years back the government's proposal was to ensure that non SSI units implement barcoding on tertiary and secondary packs of pharma products and once they comply with barcoding norms, it will be extended to SSI units. The irony is that even non-SSI units have not yet complied with DGFT's barcoding norms and the barcoding norms have been extended to SSI units.”

Mehta, who is also the joint secretary of Indian Drug Manufacturers' Association (IDMA) further said, “The government has exempted drug companies exporting to regulated markets from implementing barcoding on secondary and tertiary packs but made it mandatory for companies exporting to unregulated markets such as African countries where barcoding is not required by their governments. SSI units don’t have the money to comply with DGFT's barcoding requirements. More importantly, it adds no value to the quality of the product.”

He said if an exporter is seeking to avail exemption from bar coding prescribed by the government of India, he needs to submit a letter issued by the said country where the products are being exported claiming that it does not require barcoding on products. Most of the SSI units export to Africa where it is not possible for an individual company or companies to get the government's letter in this regard.

Besides this, exporters/manufacturers are facing problem in uploading data on DAVA portal as the central portal is still not functioning properly.

Meanwhile, the Union commerce ministry has called a meeting of stakeholders-- IDMA and the Pharmaceuticals Export Promotion Council (Pharmexcil) on April 24, 2017 to discuss exemption of SSI units from implementation of barcoding.