The pharmaceutical exporters in the country are upset with the Pharmaceutical Export Promotion Council of India (Pharmexcil)  as it is mandating each applicant to approach importing country to seek exemption from barcoding. It has called for each applicant to provide information as to ‘Whether importing country has already mandated its own track & trace system, to be implemented or formally notified its intention to mandate’ and also procure copy of such notification.

The Indian Drug Manufacturers' Association (IDMA) has recently urged the Department of Commerce that Pharmexcil should play a proactive role in collecting information regarding barcoding requirements of the importing countries, based on their earlier exercise and upload on their website for easy access to all exporters, instead of asking each and every exporter to approach the importing country.

Pharmexcil was already performing the role of nodal agency earlier while receiving applications from exporters. Pharmexcil had conducted a similar exercise and compiled an initial list of countries wherein barcoding was already implemented and published the list on their website in 2013. So the association has requested that Pharmexcil can make available the list on their website for easy access to all exporters, instead of again asking exporters to start the exercise from the beginning.

An exporter registers a new product with the Ministry of Health (MoH) of the importing country, while doing so, the exporters needs to submit all the data which will be displayed on the labels/cartons. The MoH, only after being satisfied that the exporter is meeting with all the requirements of registration, approves the product for import into their country. These requirements are applicable to all manufacturers. Accordingly if any Indian exporter receives exemption from any country, it can be considered as applicable for all other exporters from India.

The association also demands to exempt the developed countries from the list as most of the developed countries, have well evolved system of regulatory enforcement and have their own requirement about barcoding or similar such requirement. On the other hand, developing or semi regulated countries may not have proper guidelines for barcoding and track & trace requirements nor do they have infrastructure and system in place to ensure effective implementation. Thus even if Indian manufacturers include stringent barcodes for track and trace, it would be a futile exercise as there is no mechanism in place in these countries to verify the same.

The association has urged the DoP to make the exemption as the rule, and stipulate that specific format and markings on labels of pharma packs need only be complied with if desired by any country.