2D Barcoding must for pharma exports from Jan 1

After a delay of one year, the Directorate General of Foreign Trade (DGFT)’s mandate on 2D barcoding at the secondary level of packaging came into force from January 1, 2013.

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.

India’s pharma supply chain has been breached 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 barcodes in the hopes 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.

The initial deadlines for incorporation of track and trace systems was October 1, 2011 for primary packaging, January 1, 2012 for secondary level packaging, and October 1, 2012 for tertiary level packaging.

Over the past year, Pharmexcil has been conveying the viewpoints of its members with the Government and was told to discuss it with Wipro and GS1, as they are also key to the project. Through its latest circular, Dr PV Appaji, Director General, Pharmexcil informs members that the Government of India has decided not to extend the deadline. He mentions that members can familiarise themselves with the system by signing up for the webinars and workshops being organised by GS1 as per schedule given on their website.

Ground realities

Many of the larger pharma and biopharma companies have already implemented these systems. Goose Technologies, one of the solution providers, recently introduced Goose ‘Tracker’, a cost effective new generation 2D serialisation bar code for the drug industry with a choice to choose online or an offline solution to secure and protect both consumers and the pharma companies. According to product literature, its multi-level authentication features allow tracking of product throughout the distribution channel including warehouse to customer retail chain. The company informs that pharma companies like Strides Arcolab, Indoco Remedies and Macleods Pharmaceuticals have already implemented and adopted Goose Tracker for to comply with the DGFT’s mandate.

“The industry is still contemplating the need to implement bar coding on secondary packaging as there is no customer requirement as yet.” Archana Dubey Mitra VP – International Marketing, Bal Pharma

The capital expenditure associated with implementing such solutions is still an issue with one section of the industry. As Archana Dubey Mitra, Vice President-International Marketing, Bal Pharma points out, “There is no standardised software available for capturing all the required data on the barcode. Every programmer develops their own parameters to create the programme. The industry is still contemplating the need to implement bar coding on secondary packaging as there is no customer requirement as yet.” The pharma industry is a customer driven industry and manufacturers generally react to customer requirements, is her point. Moreover, as the industry is well spread at multiple levels, she also points to the practical hurdle of implementing such technology on a mass scale.

As she explains, ‘Implementing this at all levels requires capital investments which could be very high making it difficult for all companies to implement at one go. The technology is still not economically priced. Accuracy factors also need to be high while output remains low.”

Mitra suggests that ideally the Government should have mandated free software to begin the process of implementation in a phased manner giving time and experience for all to implement.

The Government has meanwhile indicated that it would try to consider reimbursing partial cost to small exporters, provided Pharmexcil furnishes adequate data on this subject.

“We feel that the Government should extend its time for applying because of the small-scale players who will face issues for arranging capital to install such machines as well as the costs of running them.” Didier Lacriox Sr. VP International Sales & Mktg., Cognex

As the mandate falls into place, things may be looking up on the technology front. Didier Lacriox, Senior VP International Sales and Marketing, Cognex comments, “After the announcement it is seen that many small companies were ready to provide the required 2D bar-coding solutions at reasonable rates. But we feel that the Government should extend its time for applying because of the small-scale players who will face issues for arranging capital to install such machines as well as the costs of running them. Also for bar coding, exporters will have to register their products with the importing country and take necessary approvals from their regulators and comply with the norms. Implementation of bar code will require them to make changes in their registration that will involve committing a time line of at least a year. “He stresses, “The initiative is a positive one and will reduce chances of counterfeit drugs being exported in India.” Here’s hoping the all pharma exporters keep this end goal in mind and invest today to reap profits tomorrow.

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