A lose-lose situation

Counterfeiting is a lose-lose situation for consumers, the government, and legitimate manufacturers. Avinash Mandale analyses the roles we play and techniques available for prevention

Counterfeiting has significant social and economic consequences. To begin with, consumers don't get the safe and effective products that they pay for. Instead, they may be at risk. A fake drug could interact with other medications that a patient is taking and create potential health issues. Counterfeiting, in reality, "hijacks" the brand.

Measures to check the phenomenon

Several researchers have emphasised that it is critical to public safety that the growing trend of counterfeit drugs is reversed. Buzzeo (2005) argues that the problem must be approached from multiple angles. Consumers should be more wary about the drugs they take. At the same time, drug manufacturers should employ available technologies and work with the government on public education programs.

Because the capabilities of counterfeiters continue to evolve rapidly, there is no single "magic bullet" technology that provides any long-term assurance of drug security. However, the issue is a grave one and different bodies have important roles to play in the matter.

Role of government: Cockburn (2003) asserts the need of national action to address substandard and counterfeit medicines. Governments need to develop strategies to reduce corruption and criminal activity and promote inter-sectoral cooperation between regulatory authorities, police, customs services and the judiciary to effectively control the drug market and enforce drug regulation. There is a need to strengthen accountability within the drug distribution system through tougher enforcement and penalties.

Role of the WHO:The goal of WHO support has been to promote the regular availability and accessibility of affordable essential medicines of good quality. WHO provides support to countries to strengthen pharmaceutical legislation including strengthening drug procurement. WHO also works with countries to ensure that quality assurance is built into the entire drug supply chain. Given the rising demand for assistance from countries, WHO is intensifying work in the areas of anti-counterfeiting, quality and safety control of medicines as part of its task of promoting greater access to safe, effective treatment.

Role of legislation: Legislation can determine the basis for drug regulation. Medicines need to be safe, effective and of a good quality in order to produce the desired effect. However, such measures require the creation of competent national drug regulatory authorities with the necessary human and other resources to control the manufacturing, import, distribution and sale of medicines. There is a growing need of increased criminal penalties to deter counterfeiting and more adequately punish those convicted.

In China last year, for instance, the State Drug Administration closed 1,300 illegal factories and investigated cases of counterfeit drugs worth $57 million.

The Confederation of Indian Industry (CII) and pharmaceutical companies, in order to protect their earnings and credibility, have proposed several steps to cut down the efforts of counterfeiters. India plans to introduce the death penalty for the sale and manufacture of fake and counterfeit medicines that cause grievous harm. The move follows widespread concern that existing regulations pose little deterrence to unscrupulous drug vendors.

Creating awareness

It is imperative that the industry not only needs to build awareness, it also needs to make sure that the avenues for obtaining drugs are clear and safe for consumers. The government in conjunction with drug manufacturers also needs to enhance educational programs aimed at physicians, pharmacists and other health professionals about their role in identifying, minimizing exposure to and reporting counterfeit drugs. Ultimately, educating consumers about counterfeit drugs and how to avoid them will help minimise their risks when buying medications.

Individuals purchasing prescription drugs should buy only from state-licensed pharmacies or similarly licensed e-pharmacies. It is necessary to ensure that the products consumer receives are untainted, safe and effective, and that the information online is accurate. Consumers should be educated to be aware of noticeable differences in their medication, the packaging, or any adverse events.

Consumers must understand the important role that their pharmacist and healthcare providers can play in identifying, reporting, and responding to counterfeit drug events. However, care should be taken in any education campaign to not unnecessarily alarm the public. It is critical to focus awareness, and education programs on issues that consumers can control.

Tamper evident packaging

One of the most effective measures to curb counterfeit drugs is tamper evident packaging i.e. unit dose packs - blister packaging with authentication techniques. It would be beneficial for manufacturers and marketing organisations to consider this for products likely to be counterfeited or newly approved products, where the benefits of prevention are equal or outweigh the costs.

Available authentication techniques

Overt measures include measures such as color shifting inks, holograms, fingerprints, taggants, or chemical markers embedded on label. The use of one or more of these measures may be considered as part of an effective anti-counterfeiting strategy, provided patients could check for these holograms, colour shifting inks, and watermarks. However, the practical response with these overt techniques is not very encouraging as they are relatively easy to copy and therefore do not provide a fool- proof solution against counterfeiting. Furthermore, the current overt measures do not check counterfeit because:

• The patient does not know what to expect when purchasing a prescription product.
• The features are not prominent and therefore do not register in the patient's mind.
• All genuine brands do not use these measures.

Covert techniques encompass "track and trace" methods that are not made public, and require special equipment or knowledge for detection. There have been rising efforts to incorporate a taggant, chemical marker or other unique characteristics during the manufacturing process on the packages that are only identifiable with the use of sophisticated readers. These can be used for those products at high risk of being counterfeited and where the introduction of counterfeit product poses a serious health risk. Radio Frequency Identification (RFID) tagging of products by manufacturers, wholesalers, and retailers appears to be a promising method. It is a sought-after approach to reliable product tracking and tracing. By clearly identifying and tracking products, cartons, and pallets companies can maintain much tighter control over legitimate shipments and ensure that they aren't hijacked or stolen. This can prevent counterfeit as these products will be easily detected as fakes. The potential benefits included the ability to control inventory and conduct rapid, efficient recalls during the manufacturing and distribution process. Although RFID as a covert measure is being cited as the technology with potential for securing the supply chain, it is still not ready for widespread commercial in pharma. RFID is a security system that the patient cannot access and is difficult to implement in a country like India at the various levels of the distribution channel.

The Indian context

It is observed that in a country like India, anti-counterfeit measures like holograms are not seen as consumer discernable brand identity features. Moreover, patients understand the genuineness of the medicines with the 'colour identity' of its packaging, for example, identification responses — hara rang ka patti. In rural markets 'colour branding' seem to score over 'brand name' because for some products the patients were not aware of the brand name but could relate with the colour of its pack. (dip-stick survey done by author). Some of the fake brands also use duplicate holograms.

The author is Vice-President Innovation Solutions, Bilcare, a company that specialises in packaging solutions