After careful analysis, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has submitted recommendation to the government seeking exemption to five pharma companies from barcoding for exports. The exemption was granted to the respective companies exporting to the US after they had furnished all the requisite documents on barcoding requirements in the US, along with copy of approval received by the company from the US authority.

Council is further examining and reviewing proposals from other companies as well in this matter. Interestingly, most of the applications they received for review are from companies exporting to EU and US. To get exemption from the barcoding, these companies have to submit the importing country's mandate for barcoding, along with their approval letter to respective exporter allowing import.

The Centre recently had directed Pharmexcil to grant exemptions to the companies from implementing barcoding in cases where the importing country has its own mandate for barcoding or serialization, with prior approval of the government. It has called for each applicant to provide this information and also procure copy of such notification.

“We do understand the difficulties faced by the exporters over this matter, that is why we are taking all the requisite measures to carefully review the applications within a short time frame. We urge the companies to come forward and submit their application for exemption wherever needed so that we can review it at the earliest. Exports should not be affected due to any procedural delay,” stressed Dr P V Appaji, director general of Pharmexcil.

The Directorate General of Foreign Trade (DGFT) had issued the procedure for implementation of the track and trace system for exports of pharma and drug consignments. While the notification exempts requirement of barcode labelling and data uploading on central portal for exports of the drugs that were manufactured before April 1, 2015, it clearly states that from July 1, 2015, all drugs that were manufactured on or after April 1, 2015 can be exported only if both the tertiary and secondary packaging carries bar coding as applicable. It also insists that all the relevant data as prescribed by DGFT should be uploaded on the central portal.

However, following repeated representation from the stakeholders, the DGFT has provided some reprieve to the small-scale industry (SSI) exporters by exempting them from aggregation of parent-child relation between secondary and tertiary packings. SSI exporters are also exempted from uploading the same in the Drug Authentication and Verification Application (DAVA) portal until March 31, 2017, while non-SSI exporters have to comply with the rule if the importing countries do not have their own barcoding that they have to comply with, informed Dr Appaji.