Counterfeiting  is  increasing  in  various  sectors,  but,  the  increase  of  illegal  products  in  pharmaceutical  sector  is  alarming.  With  800  illegal  products  circulating  in  the  global  market  with  a  value  of  close  to  $200  billion,  counterfeit  drugs  are  costing  the  pharmaceutical  industry  billions  of  dollars  in  legitimate  revenue  and  affect  the  well-being  of  the  consumers  who  consume  such  counterfeit  medicine.  

Fortunately,  this  increasing  menace  has  also  energised  the  anti-counterfeiting  solution  providers  to  up  the  ante  and  develop  solutions  that  allow  the  brand  owners  to  help  consumers  identify  a  genuine  medicine.  Today,  there  are  over  100  product  security  technologies  (holograms,  digital  watermarks,  DNA  taggants,  security  inks,  serialisation  etc.)  used  by  pharmaceutical  manufacturer  to  combat  counterfeiting.  Such  solutions  can  be  applied  on  the  primary  or  secondary  packaging.  

For  a  pharmaceutical  manufacturing  company,  it  is  challenging  to  understand  the  scope  and  efficacy  of  each  of  these  technologies.  The  technology  has  to  be  understood,  the  right  features  have  to  be  identified,  the  cost  of  adopting  the  solution  has  to  be  looked  as  also  the  logistics  affecting  the  deployment  of  the  solution  all  across  the  markets  that  the  brand  is  present  in.  

This  article  attempts  to  help  the  pharmaceutical  companies  in  selection  of  the  best  suited  solution.    

The selection of a security technology is a complex process and necessitates the review of a number of factors regarding the role and implementation of the technology. Not all security technology solutions and features are appropriate for all applications. It is important to understand the strengths and limitations inherent to different technologies, as well as between similar features supplied by different manufacturers.  

Purpose of using security technology
The pharmaceutical organisation needs to understand the purpose of using security technology. As a first step most organisations should assess the risk to their brand such as
i)    Is the product already being counterfeited or is it is likely to get counterfeited?  
ii)    If it is already being counterfeited, then is it in form of tampering, pilfering, duplication or, by misleading the consumer by adopting a look-a-like form of identification;
iii)    Is the risk of counterfeiting in the form of digital or non-digital?
iv) What is the impact such a solution may have on the brand?
v) Once the purpose is clear, the organisation can evaluate the security technologies and security features based on various parameters.  

Selection of security technologies
In today’s fast changing technological world, scores of different security technologies are available in the market. Some are proven authentication technologies like security inks, taggants, Optically Variable Image Devices such as holograms, and some others are perceived to be an authentication technology. Bar Codes and serialisation are two examples of such perception. A bar code is a very good technology for tracking, logistics and inventory management solutions, but it is not an authentication technology. This has also been corroborated by the ISO:12931, which is a new standard that deals with counterfeiting of material goods. This standard clearly states that a serialization and bar coding technology as a stand-alone is not an authentication technology. While serialisation solutions such as bar-code can help in identification and tracking, authentication solutions will help in differentiating a genuine product against a fake product.  

These days, two families of authentication solutions are in use - physical and logical security solutions (see figure 1). The selection of security solution may call for some trade-off between security and usability. The selected technology solution should be carefully weighed against the problem, and appropriately designed to ensure smooth deployment and easily identifiable by the target audience.

Basic property
The solutions should be extremely difficult to copy and be tamper evident3;

Audience
The brand owner must create an awareness of the features, so that the consumer is aware of such features. And the technology has to be robust enough to withstand the rigours of the Indian conditions and allow the target audience to easily identify the features.)

Authentication layers
The solutions should provide multiple levels of authentication. Generally most of the authentication solutions provide one or two level of authentication layers. However, solutions such as high security hologram can provide three authentication layers for different users. Each level of security hologram is designed for a specific purpose. Level one feature can be Overt (verification by human eye) and can be used for identification by the consumer. Level two, Covert (verification by a predetermined device or a tool) can be used by manufacturer or their channel partners as the second level of verification. The third level is highly sophisticated and can be used by forensic experts and can be useful to law enforcement and for evidence in case of litigation.

Environment factors
The solution should work well in different environmental situations (heat, cold, humidity, water, fire, chemical exposure, etc.) For example, polyester based security holographic excise adhesive label (HEAL) are used by excise authorities in India as they do not get damaged during transit, handling or in contact with water and work well in various environmental and climatic conditions. The security features incorporated in HEAL does not varnish when it comes in contact with water, dust, heat, moisture, etc. because a hologram is not made by printing inks.

Easy integration
Authentication solutions should have the feasibility to be integrated with the automated production and packaging lines especially where the volumes are large.

While selecting authentication solutions it is always recommended to adopt a layered approach combining use of overt, semi-covert, and / or covert technologies to provide a solution that is easy to identify and extremely difficult to replicate.  

Selection of vendor providing authentication solutions  
Once the solution is identified, the next stage is to identify an ethical vendor.  The selection of vendor is as important as selection of authentication solution. The ethical vendor will work as your authentication partner, will understand and identify your problem areas and concerns and will suggest the optimised solution. Your authentication solution provider is your partner. So it is important to share the exact nature of the problem with him, and he should also clearly understand your target audience. This will help him suggest the best authentication technology or a mix of technologies for you.  The brand owners can evaluate authentication solutions provider (vendor) on following parameters;

Good corporate practices  
Evaluate the vendor on its corporate practices. Ideally, the vendor should have adopted good corporate practices, behave in ethical manner and should be following the prescribed Code of Conduct of its industry association.  

Being innovative
Being one step ahead is the mantra in anti-counterfeiting industry. Most of the ethical vendors upgrade their facilities and solutions to keep themselves & their customer one step ahead of counterfeiters. They can suggest & provide various solutions according to brand protection objectives and the changing times.  

Secure environment
The vendor should have an in-house facility to produce these solutions under a secure environment. The vendor must take all possible measures and precautions for maintaining adequate security and secrecy within their own premises.

Reference and experience
Vendor should have good experience of providing authentication solutions.  A vendor reference should always be taken from his existing customers, or you can get the help from trade industry association.

In case your vendor is security hologram manufacturers, you can add two more steps such as:

Member of HoMAI / IHMA
He should be a member of trade bodies such as Hologram Manufacturers Association of India (HoMAI) or International Hologram Manufacturer Association (IHMA).

Registered hologram under HIR
The Hologram Manufacturers Association of India has an arrangement with Counterfeit Intelligence Bureau (CIB)8, London so that each HOMAI member can register their security hologram with CIB. The hologram industry is the only authentication technology that keeps a database of the security images produced by the industry.  

The selection & usage of solutions can be a complex and time consuming process, however, the selection and proper implementation of the right technologies will invariably lead to long term benefits to the brand owner.  

As a further step, the pharmaceutical brand owner / authorities can also adopt a new ISO Standard ISO: 12931 titled “Performance criteria for authentication tools used in anti-counterfeiting or material goods”. This is a very useful standard for a brand owner wishing to adopt globally accepted good business practice and systems to fight the menace of counterfeiting.

Conclusion
All effective solutions, broadly speaking, help in identifying and authenticating the original from counterfeit. They deepen the divide between genuine products and their counterfeits by making a genuine product distinguishable in some manner that is difficult to replicate using commercially available manufacturing processes. However, it is very important that a market surveillance program is in place, so that as soon as an infringement is identified, it is immediately tackled using administrative and/or legal recourse to punish the guilty.   

We have no doubt that if the few points mentioned above are taken into consideration, the pharmaceutical industry would be able to fight counterfeiting in an effective manner and protect innocent lives. We are happy to respond to any specific queries.

You can contact us at info@homai.org