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Secure down to the primary pack

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July 1 this year marks the deadline for all pharmaceutical companies in India to comply with an important mandate from the Directorate General of Foreign Trade (DGFT): to include a 2D barcode all primary packs due for exports. This step is the culmination of the DGFT’s efforts to safeguard consumers from counterfeit and spurious pharma products, which started with a notification in January 2011. Initially DGFT mandated serialisation at all three levels (primary, secondary and tertiary packs) simultaneously but after industry protested, the Ministry decided to implement it in stages.

These norms for primary packaging state that exporters of pharma products will have to adopt a trace & track system by incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding the unique product identification code (GTIN) and unique serial number of the primary pack.

Pharma exporters have complied with the mandate first at tertiary and then at secondary levels and were initially scheduled to do it at the primary level by July 2013 but asked for more time, citing complexity and cost issues. DGFT extended the deadline by a year but while most bigger players have complied or will do so by July this year, there are moves to ask for yet another extension.

Dr PV Appaji, Director General, The Pharmaceutical Export Promotion Council of India (Pharmexcil) indicates that based on complaints from many member companies, the organisation has flagged the issue with Rajeev Kher, Secretary, Department of Commerce who took over this January. The Secretary will be reviewing implementation of the serialisation initiative so far, to determine the extent of roll out (how many companies) as well as the effectiveness at the customs office level. This review process could take two-three months after which the Secretary will decide if further extension of the deadline is required.

“We welcome the decision of the DGFT to implement 2D barcoding on primary packaging for exports, as it will eliminate the threat of spurious and counterfeit drugs making into the supply chain. It will also build the credibility of Indian pharma exports which are expected to cross $ 20 billion by 2020.”
Sarvanan Jeyabalan
Head Packaging Development, Biocon

Most larger exporters are revving up to toe the line. Biocon has already implemented 2D unique identification barcode technology at manufacturing facilities meant for exports, at both secondary and tertiary levels since 2011. Sarvanan Jeyabalan, Head Packaging Development, Biocon indicates that the company is now working with Pune-based Bilcare to extend this technology to primary level of packaging to be in compliance with the DGFT’s latest ruling.

“For smaller packs , it is really a challenge to print the bar code on label. Accordingly DGFT has redefined primary pack as saleable pack, so barcoding should be possible.”
Alok Ghosh
President Technical Operations, Lupin

Alok Ghosh, President Technical Operations, Lupin hails the initiative as a “welcome and progressive move” which if implemented correctly, should make the supply chain process of exported goods fool-proof. He too confirms that Lupin has implemented 2D barcodes in all secondary and tertiary packs meant for exports and will be ready to incorporate 2D barcodes on primary packing by the July 1 deadline.

Ranbaxy introduced these systems for all manufacturing sites in 2012 and all packs meant for exports are compliant to this requirement from January 2013 including at the primary level, according to a company spokesperson.

In fact, the recommendation to use track & trace technology to counter spurious drugs came from industry itself as it suffered a loss of credibility in July 2010, when consignments originating from China were branded as ‘Made in India’ and the Nigerian regulator NAFDAC seized the consignments and designated them substandard/ spurious.

The DGFT’s mandate gets the thumbs up from such players, with the Ranbaxy spokesperson pointing out that India is among the first countries to introduce serialised packaging with unique numbers.

Jeyabalan too hails the move as it will eliminate the threat of spurious and counterfeit drugs making into the supply chain as well as build the credibility of Indian pharma exports which are expected to cross $20 billion by 2020.

Regulatory push

The increasing threat of counterfeit/ spurious drugs has forced regulators and governments across the globe to implement such systems and the move has only picked up speed over the past decade.

“For pharma companies exporting particularly to the US market, we’ve introduced a 360-degree bottle and label code inspection that’s capable of capturing defects, if any, from any direction.”
Harpal Singh
Director-Business Development, ACG Inspection Systems

As Harpal Singh, Director-Business Development, ACG Inspection Systems says, “Worldwide different serialisation guidelines have been defined by national regulatory bodies.” In India, it’s the DGFT, while in the US it is the Healthcare Distribution Management Association (HDMA) which is the national trade association representing primary distributors of prescription medicines and healthcare products in the US.

Similarly, in Europe, the European Federation of Pharmaceutical Industry Associations (EFPIA) chose Sweden to run a pilot serialisation project in 2009. This was the basis for the EU-wide coding and serialisation system, the European Stakeholder Model (ESM) involving EFPIA, the European Association of Euro-Pharmaceutical Companies (EAEPC), Groupement International de la Répartition Pharmaceutique (GIRP), and Pharmaceutical Group of the European Union (PGEU). The system thus brings together all stakeholders: Europe’s research-based manufacturers, the pan-EU licensed parallel distribution companies, wholesalers and pharmacists.

The first step to develop an electronic pedigree involves the serialisation of products at different packaging levels. Singh points out that most serialisation guidelines have one common point that requires each product to be uniquely labelled in order to be easily identified or authenticated. Following complete serialisation of products, companies need to establish a relationship (parent-child) between products at different packaging levels to create a product hierarchy also known as a pedigree. Developing and maintaining a pedigree allows greater transparency and traceability regarding the origins and movements of products throughout the pharma supply chain.

It is important to consider that packaging requirements on imports differ from country to country. Ghosh clarifies that as per DGFT rules, if importing countries have specific rules for tracking genuineness of any product, then DGFT rules will not be applicable. For example, in the US, National Drug Codes (NDC) are followed which identify the manufacturer along with products at the SKU level. France has a mandatory rule that all imported products should have 2D barcodes. Thus while exporting to the US and France, DGFT rules as they exist today will not be applicable.

Thus for a smaller player it could be costly to implement different systems for each destination country. The technical complexities of the process adds to the cost as well. Ghosh admits that for smaller packs, it is really a challenge to print the barcode on the label. DGFT then redefined primary pack as saleable pack to address the space constraint problem.

Technical complexity

“Bilcare’s non-ClonableID technology uses pre-printed non-clonable tags which need to be directly stuck onto the primary packs. Each 12x12mm tag has pre-printed barcodes, with GTIN and unique serial number, as well as an authentication feature on the lower side.”
Avinash Mandale
Vice President, Global Business Development, Bilcare

Early attempts to implement barcoding at primary pack level faced difficulties due to the limitations of the most common system used at this level, the in line printing system. Giving more details, Avinash Mandale, Vice President, Global Business Development, Bilcare says, “The problem of using in line printing on primary packs, especially on high speed packaging lines, is that it becomes extremely difficult to not just print a barcode but also scan and upload this information into the system.”

Further, considering that the bulk of primary packs are blister packs, this system results in the formation of nearlings, which are small bubbles/dots between the aluminium and plastic film of the strips, which makes scanning difficult, says Mandale.

Bilcare’s solution, called the nonClonableID technology, which is currently being installed at Biocon, uses pre-printed non-clonable tags which need to be directly stuck onto the primary packs. Each 12x12mm tag has pre-printed barcodes, with GTIN and unique serial number, as well as an authentication feature on the lower side. (See Table: Comparative analysis of some key features of various technologies against non-clonable id technology)

Comparative analysis of some key features of various technologies against non-clonable ID technology
Key Feature Requirement
SMS
Technology
RFID
Serialised
barcode
Non-clonable ID technology
Clone-proof
No
No
No
Yes
Anytime Anywhere Authentication  & Track-n-Trace
No
No
No
Yes
Consistency & Accuracy
End-user dependent
~ 95%
~99.9%
~99.9%
Privacy
No
No
No
Yes
Affordability & Ease of Deployment
Yes
No
Yes
Yes
Implied needs
No
No
No
Yes
Source: Bilcare

 Mandale says the primary pack tags are supplied in a roll form and can be applied on-line on blisters, strips etc. on packing lines. A specialised application system affixes these tamper-evident primary pack tags, which get scanned on-line post application on primary packs. Once the data gets uploaded in the system a parent-child relationship also gets established on-line.

Verif-i, a track and trace solution developed by ACG Inspection Systems, can be used for tertiary, secondary as well as primary packaging levels. Within primary packaging, products supported include bottles, mono cartons, labels and blisters.

Singh mentions that for pharma companies exporting particularly to the US market, his company has introduced a 360-degree bottle and label code inspection that’s capable of capturing defects, if any, from any direction.

Giving details of the process (See flow chart: Components of the verif-i solution) , he explains, “At the primary level, the Verif-i primary solution interacts with Verif-i server that generates random serialisation numbers. After this, the Verif-i primary solution prints the serialised data/GTIN number in a 2D datamatrix or as per regulatory guidelines for primary packaging. A GS1 compliant camera-based system is used to inspect printed or pre-printed data.”

Components of the verif-i solution
The Verif-i solution consists of a Verif-i server, hardware such as cameras and printers for primary, secondary and tertiary packaging levels, and an external server (for example, EPCIS repository). As seen in the figure, the Verif-i solutions at different packaging levels (primary, secondary and tertiary) capture and report the appropriate (commissioning or aggregation) events. The data is reported to a plant server where is it stored until the product is shipped from the site. When the product is shipped, a transfer shipment event is triggered and data is uploaded to an EPCIS repository. The reports for each packaging level are available both at the client as well as the server systems. The server system allows the user to obtain the production report for any packaging level from any plant.

A stitch in time …

Given that the pharma industry in India is very fragmented and has a number of SME players, it is understandable why associations like Pharmexcil have been swamped with pleas to delay the process. Ghosh of Lupin says the overall cost (of implementing such a system) would go up and some small players may find this prohibitive but turnkey solutions are easily available and being provided by various vendors. The Ranbaxy spokesperson too agrees that the initial investments are high and may require skilled technicians to run the equipment but the system will definitely benefit the Indian pharma industry in the long term.

Singh says that they’ve been working closely with several of the customers to ensure 100 per cent compliance but does agree that there could be several barriers while setting up track & trace systems. However, he opines that it ultimately proves to be a value vs. cost argument. “A lapse in ensuring maximum level of tracking and traceability could leave major pharma companies at the risk of huge loss to brand value, massive lawsuits and product recalls, and, most importantly, patient safety,” he points out.

Many players have taken similar precautions to safeguard their products in the domestic market. Ghosh for instance reveals that Lupin has already implemented an SMS based system in the domestic market as an anti-counterfeiting measure taken by the company. Given these examples of successful implementation, the DGFT may not delay the final stage of this process. After all, at stake is India’s hard won reputation as a global source of reliable, safe and quality medicines.

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