Tuesday, July 5, 2011
Bar Coding on Pharmaceutical Packaging in India-Implications of the New Government Order and High speed, Anti-Counterfeit Labeling Solutions.
The Government of India also realized the importance of barcodes. In 1996 the Ministry of Commerce, promoted GS1India, a joint initiative of the Government of India and industry, to educate the trade and industry on the use of GS1 numbering system for unique identification of products, services and locations in line with international practices of using them as standards for barcodes. Over the years the Government has been advocating the widespread usage of barcodes. Various steps taken in this direction are;
In 2007 the ministry of micro, small and medium enterprises announced a financial assistance scheme to support the micro and small enterprises in implementation of barcodes.
On 20th October 2009, The Ministry of health and family welfare, made GS1 barcodes mandatory on all drugs, devices and other medical supplies to Govt. of India w.e.f. 1st April 2010, this was later deferred to be implemented in a phased manner. The implementation will start from October 2011 and final implementation will have to be made by April 2012. With the implementation of this order the Government wants to take decisive action against the menace of substandard and spurious medicines being pumped into the public healthcare system. If this endeavor enables the government procurement agencies to pinpoint and trace the culprits who supplied spurious medicines, it will definitely improve the reliability in public healthcare.
In an effort to safeguard Indian pharmaceutical exports from the bad name they were given when some spurious medicines in Africa, were found labeled "made in India", on 10th January 2011, DGFT, under the Ministry of Commerce, made it mandatory for exporters of pharmaceutical products to build track and trace capability for their export products by using barcodes as per GS1 global standards. The bar codes were to be employed at primary, secondary and tertiary level packagings. The above order was slated to come into force on the 1st of July 2011 but owing to representations made by trade and industry the implementation was deferred. The order will now be implemented in a phased manner and the final application of barcodes on primary packaging will become mandatory from 1st July 2012. Once the order is implemented, a package going out of a factory will have an identifying bar code and unique number that can be read at any point in the supply chain right up to the retail shop. These can then be matched with the batch number and other manufacturing details stored in a central database to find out if the package is genuine or not. The image can be captured in any cell phone and transmitted to get the verification from the database in seconds.
1. It will make their products costlier.
2. They tend to lose sales due to already existing tough competition.
3. The cost of implementation according to some exporters is almost one crore, though this appears to be exaggerated.
4. The cost of barcode per strip or vial will make the product unsalable.
5. The whole process of barcode generation and application will need computerization and automation but the SMEs have mostly manual packing facilities.
Given the resolve of the government and the benefits of this order, it is a matter of time that this order will be fully implemented. Drug regulating authorities in most foreign countries are also making bar coding mandatory and exporters to these markets, whether big or small will have to comply with these regulations.
High Speed Anti-counterfeiting Labeling solutions:
Definition of counterfeiting is, " A deliberate attempt to deceive consumers by copying and marketing goods bearing well known trademarks, so that they look like the original products made by a reputed manufacturer ". Counterfeits in pharmaceuticals have far reaching damaging effects on the unsuspecting patients. With time, manufacturers and marketers have tried to develop various anti-counterfeiting solutions to counter this deception of consumers by counterfeiters. There is constant work being done in this field but at the same time these criminals who fake the products work overtime to copy these solutions to cheat the consumer. Counterfeiting is one of the fastest growing financial crimes, threatening jobs and endangering public health and safety. The World Customs Organization estimated annual global trade in illegitimate goods at about $600 billion (2004), which is expected to rise to $1.7 trillion by 2015, representing 5% to 7% of all worldwide trade. The size of global fake drugs industry is estimated some t 90 billion US Dollars. Estimates vary on the number of fake drugs made in India. The Indian government says that 0.4 percent of the country's drugs are counterfeit and that substandard drugs account for about 8 percent, but independent estimates range from 12 to 25 percent drugs to be fake.
I list many of the anti counterfeiting technologies available, all or most of them can be converted to self adhesive labels to be dispensed on high speed labeling machines. Some of these solutions are overt and others covert. The overt solutions are visible and verifiable by the end users but the covert ones are not visible;
2. Security Graphics: This involves printing technologies like the ones used for banknote printing. The security can be further enhanced using special designs like micro text and latent images.
3. Transfer labels: These are similar to the tattoos. The printed image is directly transferred to the product
4. VOID labels: These labels have special features built into them, such that they show hidden text when they have been removed and reapplied. The classic example is the label which when removed leaves the message VOID behind. Labelstock can be designed such that the residual message VOID can be customized to customer needs. It can show a brand, an emblem or a message. It can even change color when removed.
5. Destructible label: Destructible labels are another form of tamper evident labels. Such labels fragment into small pieces when attempted to be removed. These labelstocks can be top coated for accepting barcode printing and also adding more security features.
6. On product markings: On-product marking technologies allow for special images or codes to be placed on conventional oral dosage forms. These overt technologies can be difficult to replicate and offer a security technology at the pill level. This added layer of security is effective even when products are separated from the original package.
7. Embedded image: An invisible image can be embedded within the graphics on the pack. It can only be viewed using a special filter, and cannot be reproduced by normal scanning.
8. Security inks (UV sensitive): Creating security features into labelstocks or labels using security inks is possible in many diverse ways. This is possible due to the wide variety of inks available e.g. UV sensitive inks which glow under UV light or change color when exposed to sunlight and Metameric inks that are similar in day light condition but change under different light sources. One can print an invisible message which becomes readable when light conditions change, such images cannot be photocopied.
9. Thermochromic inks: These inks change color with change of temperature.
10. Micro-Taggants in labels: Microtaggants are microscopic Identification Particles that are traceable and play an important part in anti-counterfeit technology. Microtaggants are highly versatile in their use and application. In basic form, Microtaggants are a unique numeric code sequence in a multiple colored layer format. In more complex forms, Microtaggants deliver multiple layers of security through the incorporation of several taggant technologies. These can be used in inks coatings, adhesives and paper making. The simplest form of taggants can be identified from their different colours. Other taggants can be energy sensitive, fluorescent, magnetic, etc.
11. DNA Taggants: These are DNA-embedded biotechnology security applications. These are proprietary formulations and processes and can be verified by laboratory DNA analysis. This is used for very high level of security and anti counterfeiting measures.
12. Security threads and fibres: . UV sensitive fibres can be incorporated into the pulp by the paper mill or in the adhesive during production of labelstock. Such fibers can be seen under the UV light.
13. Barcodes: As explained earlier, these are high-density linear or 2 dimensional bar codes. A 2D code can typically be 1cm square or smaller, and yet contains up to 1 Kb of data. Linear bar codes may used where space is not a constraint. The codes are printable by on-line methods including inkjet or digital printing, allowing direct computer control and transfer of records to the central database. Systems have been developed whereby the label on a shipping case is linked to the identities of all its contents, and this can be further extended up to the pallet labels.
14. Consecutive or sequential numbering: Consecutive and sequential numbering is done as a part of the label printing or finishing process. This does not provide a very high level of security. The main disadvantages of sequential numbering are that the sequence is predictable and easily replicated. Infact it is generally used as a security enhancing process. A label that has other security features is given this numbering to further enhance the level of security. One of the biggest users of this process is the state excise departments who apart from having various security features in their seals also number them in an evident effort to keep a track on the labels in the supply chain.
15. Serialisation: The Track and Trace label may not be difficult to copy, but its security is greatly enhanced by the inclusion of unique and apparently random serialisation, or non-sequential numbering, ideally at individual item level. If the serialisation was sequential, then the level of security would be very low as the sequence is predictable, whereas “random” serialisation using a highly secure algorithm or method of encryption overcomes this. Individual packs may still be copied, but the database will identify duplicates or invalid serials, as well as those which have been cancelled or expired, or which appear in the wrong market, or with invalid product details.
16. RFID: An RFID tag comprises of an antenna with a microchip at its centre. This tag has specific and batch information which can be scanned at a distance, and without requiring line of sight (unlike bar codes). The radio frequency used determines the range and sensitivity, but no, one specification suits all applications. Some systems are able to capture multiple records for a mixture of different products, but there are some issues around orientation of the tags and absorbance of the radio signal by liquids and foils. But one clear advantage of RFID is that it has the potential to be fully automated in warehouses and even through to pharmacies, without requiring manual intervention.
17. Water mark paper: These are marks that you can see as an image in the paper when you hold it against light. These are built into the paper at the paper making stage in a paper mill.
18. Laser coding: This process of putting batch and variable details by laser coding requires special and expensive equipment. Laser codes can be applied to cartons, labels, plastic and metal components.
19. Odor: Micronic capsules containing distinctive odors can be applied as an additive to an ink or coating to provide a novel covert or semi-overt feature.
The scope of security labels and brand protection solutions are wide and no, one solution can be a permanent solution. The development and innovation does not come about quickly due to hesitation on the part of the users in avoiding to spend more. Another step required to defeat the counterfeiter is to keep upgrading the security labels but the manufacturers resist this and want a solution that would last them at least five years. This is not possible as the counterfeiter works overtime to make duplicates and fakes. Continuous innovations are required to produce security solutions that become a deterrent for them. Giving them so much time would make us fall into a trap facilitated by the time that we ourselves give to the counterfeiters. Designing a security label needs application of mind, time and money. We have to reconcile to the fact that providing security solutions is an ongoing process. Application of security labels is only one part of the exercise, educating customer to check its authenticity is the more important part. What good is a security label if it cannot protect the duplication and if you do not know how to check if it is a genuine product?
Presentation made at PackPlus South in Hyderabad 2011 on 2nd July, 2011 by Harveer Sahni, Managing Director, Weldon Celloplast Limited, New Delhi-110008, India