Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.
So far there have been companies that “were able to ship the products without barcodes or unique alphanumeric codes on their packages on some excuses of not having enough capacity to implement them quickly yet,” Alok Garg, associate director of marketing at PharmaSecure, an Indian bar coding company, told in-Pharmatechnologist.com.
But he added that it seems as though the Directorate General of Foreign Trade could apply heavy penalties for non-compliance. PharmaSecure has seen an uptick in the number of applications for exporters looking to protect their products with bar codes.
Chinu Srinivasan, co-convener of the All India Drug Action Network, told in-Pharmatechnologist.com that the penalty for not complying with the new requirements is that these exporters will not be able to ship their product outside of India.
But the costs to industry are not prohibitively expensive, Garg said, adding: “They are well priced to suit the paying capacity of the clients.”
The new bar code requirements were implemented on January 1 and only apply to drugs manufactured in 2013.
The added rules came despite numerous calls for a delay to their implementation by the Pharmaceutical Export Control Council of India (Pharmexcil), which said they will be onerous and expensive for Indian exporters.
Pharmexcil and the Indian Drug Manufacturers Association filed a case in the high court of Chennai in mid-December calling for the deadline to be delayed, but the request was denied.
Primary packaging for all drugs exported from India also will have to carry one- or two-dimensional bar codes before July 1. The bar codes must contain a unique product identification code, batch number, expiry date and serial number.
In addition to the cost concerns, there has been some confusion among industry on a manual published by GS1 India, which deals with the status of mono cartons as secondary packing. After followup by Pharmexcil, GS1 revised the manual and clarified that mono cartons would not require bar codes.
Drugs exported to countries that currently have a national track-and-trace program will also not need bar codes, according to Pharmexcil.