Aimed at dispelling the doubts and apprehensions of the industry over the bar-code implementation for mono cartons, the Pharmexcil is organising an interactive meeting with GS1 India to discuss the issue in detail. The meeting is scheduled to be held on February 6, 2014 at Orchid Hotel, in Mumbai.

Earlier the Director General of Foreign Trade (DFGT) under government of India had notified the mono cartons containing strips, vials, bottles as primary level packaging vide through a public Notice no 31 (RE-2013)/2009-2014, dated October 17, 2013. With regard to this, many companies have raised doubts and apprehensions over the issue and are seeking clarifications on the container to be considered as mono carton.

In view of this, the central government has directed GS1 India to review the status of mono carton for implementation of bar code system and asked it to discuss the issue with the industry stake holders and submit a report on the same.

“This meeting is mainly aimed at dispelling the doubts and apprehensions of the industry over the bar-coding implementation for mono cartons. Many of them wants to have clear view as to what kind of containers constitute mono cartons to be considered under primary packaging,” informed Raghuveer Kini, executive director, Pharmexcil.

Earlier last year in January, the DGFT had made it mandatory to have 2D bar coding for the secondary level of packaging. This is part of the DGFT's plan to have track and trace mechanisms at the primary, secondary and tertiary levels of packaging for all export products. The new regulations are aimed at safeguarding India's pharma exports from drug counterfeiters.

The major reason for implementing bar-coding is because India's pharma supply chain has been breached by the drug counterfeiter in the past. For example, in November 2011, counterfeit anti-malarial drugs with a 'Made in India' labels but actually originating from China, were seized by Nigerian port authorities. The loss of reputation resulting from this incident and other similar incidents resulted in the DGFT opting for track and traceability systems like bar-codes in the hope that counterfeiters would find it more difficult to infiltrate the pharma supply chain.

Even though the industry appreciates the rationale behind the DGFT's stance, over the past year, they have asked for and got extensions of the deadlines as smaller players were finding it difficult to arrange finances to put in place the 2D technology required for the secondary level of packaging.

In view of recent doubts among the industry players over the mono cartons for implementation of bar-coding, Pharmexcil is seeking industry members to participate in the meeting and get the necessary clarifications on implementation of trace and track system and also present their opinion on the status of mono carton.