As the success of a global pharmaceutical company to a large part can be attributed to its successful supply chain, companies today are designing the supply chain to be as responsive as possible to reduce entry time to the market thereby increasing profit margins.
Here the new generation of low-cost technologies like Digital Mass Encryption (DME) and Digital Mass Serialization (DMS) have been rated high ahead of barcoding or holograms and have potential to deliver unprecedented value for supply chain management in the pharma sector, according to a study by Frost and Sullivan.
``The new generation of low-cost technologies, combined with emerging software solutions, has the potential to deliver unprecedented value for Supply Chain Management. Healthcare and other allied life sciences sectors are expected to follow the trends observed in the pharmaceutical industry. The reason is that these industries are driven by the need for anti-counterfeiting measures and patient safety enhancements, and not just economics. This is good for the Healthcare industry as it will drive scale, which in turn will drive down costs for all Healthcare constituents. The need of an hour is affordable technology solution that helps improve overall process efficiencies in the Healthcare Industry which in turn shall enable a reduction in delivery costs to the end user, which in this case is the patient,’’ the study on ``Technology in the Pharma Supply Chain – A Focus on Anti-counterfeiting in India’ said.
Some of the key applications of technology today have been in anti-counterfeiting technologies and drug tracking to avoid theft and misuse and ensure timely delivery. The growing global problem of counterfeit medication poses a crippling risk to healthcare systems in developing nations, it says.
``History has shown that by the time such technologies are affordable, resourceful counterfeiters could have copied the technology, turning it into a great risk – consumers can have a false sense of security in "protected" counterfeit products. This trend is evidenced in events that have led to the compromising of microprint, advanced product packaging, security inks, tableting molds, unique blister packs and even holograms as fool-proof product security technologies. There are many technologies adopted by Pharmaceutical companies in India to track and trace product movement and to check counterfeiting across the supply chain,’’ the study said.
Holograms
This category is preferred as a passive technology. The creation of a holographic image, or hologram, requires some technical knowledge and expertise, though a recent explosion of companies and low-cost machinery has made this technology extremely accessible within many sectors of the consumer marketplace. A hologram typically incorporates an image that appears as an illusory 3-dimensional object with vivid depth characteristics.
A security hologram is a special reflective type of hologram that is custom-made for a brand owner. A number of pharmaceutical companies have relied on hologram application as a means to reduce counterfeiting. There are currently a large number of hologram suppliers in the global marketplace.
Advantages: Holograms and security seals are generally low priced, easy to apply, and represent a rapid way of providing a distinguishing feature to a branded product.
Disadvantage: The major disadvantage is this solution is easily replicable by a counterfeiter, and indeed, there have been numerous instances where genuine security holograms have been easily and expertly copied or simulated, leading to the contention that holograms when used alone are less about security and more about sparkle. The fact that fake holograms used by counterfeiters are not easily distinguishable by the consumer because many products available in the marketplace have holograms; it is extremely difficult for consumer to keep up with which products should contain a particular type of hologram or seal.
Electromagnetic taggants (RFID)
The most commonly used and widely known of the active technologies is radio frequency identification, or RFID. These taggants rely on radio signals, which are emitted by an integrated chip or tag. RFID tags can contain significant amounts of information related to the product and can be placed anywhere within a package and in fact can be hidden because the emitted radio signals are able to penetrate through most materials. An RFID reader, which is a specialized instrument that detects the radio signals, can be used to capture the information emitted by the tag.
The information in turn is then transmitted to a software system that coordinates all aspects of the RFID operation. RFID technology, however, has not broken through in terms of its use as a pure anticounterfeiting tool in the pharmaceutical industry. RFID industry has undertaken major efforts to promote this technology as a valid anti-counterfeiting solution.
Advantages: The major advantages of RFID relate to its wireless nature. The tags do not require line-of-sight or any direct human intervention in order to capture the digital information. As a result, RFID tags can be hidden in packages so as to provide a greater level of security. RFID tags can be read from a considerable distance, usually many meters, making it much easier to undertake roaming data capture. The tags can also be read rapidly in bulk, which is ideal for high-throughout supply chain tracking. In some cases, the reader can even write information directly to the tags, thereby making the RFID technology bi-directional in nature.
Disadvantages: Major disadvantages to the use of RFID as an anti-counterfeiting tool are cost, reliability, and privacy. The cost of the tags can vary depending on volume but are generally quite high, which eliminates its use at the product level except for truly expensive brands. RFID infrastructure development and implementation would require huge capital investments. The second factor inhibiting RFID use is reliability, primarily due to reading errors. Radio waves are easily deflected or impeded by metals and liquids. Reading error rates reported in various studies vary in the range of 2.5 percent to 25 percent. RFID has the potential to capture personal information and thereby represents a larger problem for society if RFID is widely adopted. One can gather all sorts of information from any RFID tags that the consumer have on them.
Barcode applications
This category of anti-counterfeiting solutions includes those technologies, which encode individual branded products in an overt digital manner. The digital information can appear on a product as a human-readable code (that is,alphanumeric script) and in terms of a barcode, such as the traditional linear format or the new generation of 2D barcodes.
A barcode is an optical machine-readable representation of data whose technological origins can be traced back to the 1930s but adopted in mass retail settings only by the 1970s. Since then, virtually every purchasable item now contains a barcode. The most commonly used barcodes are the linear or 1D (onedimensional) pattern of lines. The coding system that is widely used, the so-called Universal Product Code (UPC), maps the data contained in the barcode to a standardized system of information representation.
A new generation of barcodes has been recently developed that provide a 2- dimensional (2D) way of representing information. The biggest advantage to the 2D barcode technology is that much greater information can be encoded within a single barcode. 2D barcodes can contain a mini-database themselves, and therefore encode much greater information on the product.
Advantages: The 2D barcode technology has now surpassed RFID as the most prominent track and trace technology for pharmaceutical applications. The European Federation of Pharmaceutical Industries and Associations (EFPIA) have clearly come down on the side of 2D barcode. The cost of 2D barcodes is very low compared to all other technologies. 2D barcodes offer similar functionalities to RFID at only a fraction of the cost. Consumer convenience and empowerment will soon be possible because the emergence of mobile decoders allows consumers to directly interact with the codes and obtain immediate validation.
Disadvantage: All barcode technologies were originally developed as an inventory and supply chain management tool and not as anti-counterfeiting applications. As a result, a robust system of encoding products for authentication and brand protection via a universal standard was never put in place. The development of 2D barcodes, however, has now paved the way for their use as an anti-counterfeiting tool. In this regard, two new technologies have emerged that take advantage of the power of 2D barcodes and the rapid growth and sophistication of mobile telephony.
Digital Mass Serialization (DMS)
Digital Mass Serialization is the process by which a unique number or code is assigned to each product sold in the marketplace. It can be generated in a random, pseudo-random, or sequential manner. Once a batch of codes is generated, it is transferred to the pharmaceutical company so that they can be printed directly on the packages during the production process. Alternatively, the code itself can be pre-printed on a label and then affixed to the product in a manner similar to a hologram or security seal.
The technology provider generates a code; it is entered into a database that can be used later at the verification stage. The database itself is managed and maintained either by the technology provider or the brand owner. The code is printed in human-readable form as well as a 2D barcode directly on the product or on a label. The codes themselves can be numeric, alphabetical, or alphanumeric in nature. The consumer can visually read the printed script code whereas a barcode scanner can capture the 2D barcode. The emergence of mobile phones with barcode scanners now allow consumers to even use their mobile phones to directly read the 2D barcode.
The authentication process involves matching the unique code on a product to those stored in the database. If the code is present in the database, then it is deemed to be authentic and so is the product. Several DMS providers have bundled this technology with their own SMS short-code number. Thus, all the consumer has to do to authenticate a product is to enter the code in the SMS field, send it to the short-code number, and then wait for the verification message, which either provides confirmation of the product’s authenticity or raises a flag if the code is not found in the database. The cumbersome act of manually entering the code in an SMS field can be bypassed by phones containing barcode readers.
Advantage: DMS technology directly empowers consumers to verify a medical product. A well-designed DMS system, however, will itself flag any failed authentication efforts and communicate this information to the brand owner, along with the date, time, place, and mobile number of the consumer who had made the verification attempt.
Disadvantage: The major disadvantage to the DMS technology concerns the operational characteristics and security of the database containing the serial codes. It is well known that the larger a database becomes, the greater the time needed to find an individual item within it. Thus, a database containing hundreds of millions (or evenbillions) of codes for a major brand owner’s annual drug production requirements becomes problematic in terms of database management and speed optimization. The brand owner will have to adopt extremely high-end database software systems well-suited for the purpose, which adds significant cost of the solution.
Digital Mass Encryption (DME)
Digital Mass Encryption (DME) is similar to DMS in all respects except for one major difference — the DME technology does not operate on a database system. As such, it offers all the advantages of DMS but avoids its major drawbacks—requirement for database management, verification bottleneck at high volumes, and data security. DME can therefore be considered to be a more advanced and highly secure version of DMS. The core technology used in DME solution through which the codes are created and authenticated is fundamentally different from DMS whereas serialized codes are generally created by random number generators, encrypted codes are produced by a cryptographic algorithm. The DME algorithm is also responsible for the decoding process involved in the authentication step.
The encrypted alphanumeric code is unique, unpredictable, and non-repetitive for eternity. The code can be used not only for authentication (anti-counterfeiting) purposes but also for hierarchical tracing in a complex supply chain operation. As such, DME is fully compliant with all regulatory standards, including the emerging pedigree requirements for pharmaceutical products in some countries. In the whole process a database is not created or required either by technology provider or Pharma Company.
The DME code itself can be used by anyone with a mobile phone to authenticate the product at the point of sale, either through SMS or by way of mobile internet. The reply message sent by the Pharma Company provides verification on the authenticity of the product, as well as any other information that the brand owner wishes to transmit to the consumer (for example, expiry date, MRP, usage cautions, etc). The communication aspects of this technology can also be of significant importance in the event of a recall since it allows highest degree of granularity, that is, right now to the consumer level.
The code generated in a DME system is valid for only one authentication. Multiple authentications attempts of the same code will raise an alert. Multiple failed authentications of the same code will raise a flag and when confirmation is made that a particular code has been replicated on duplicate products that code itself serves as a tag by which the duplicate products can be identified. In such instances, consumers are directly warned about the duplicate product and they should report this case along with other pertinent information to the Pharma Company.