Health related issues have always become a prime concern for government bodies and organisations all over the world. In recent times, counterfeiting and adulteration in food and pharmaceuticals have resulted in big loss of lives all over the world, and have become a serious menace for authorities. Governments all over the world are active in formulating and implementing stricter laws to arrest this menace. However, as we all know, prevention is better than cure, and the Malaysian government followed this adage very effectively. This article explains the Malaysian government’s initiatives in curbing pharmaceutical counterfeiting through its Meditag™ label. In fact, in May 2013, Ministry of Health Malaysia Pharmaceutical Enforcement Department even received the Global Anti-Counterfeiting awards for its programme to combat illicit medicines using the Meditag™™ label.
The Malaysian Government introduced “Meditag™ (a self adhesive holographic sticker)” in 2005 in response to increase of counterfeiting incident in the country. The market surveillance conducted by the Pharmacy Enforcement Division, Ministry of Health (Malaysia) identified the existence of pharmaceutical products using fake registration numbers or registration numbers that belong to other products. As the registration numbers are copies easily, it becomes difficult for consumers and enforcement authority to identify the authenticity of the product.
To overcome this problem and to restore the consumers' confidence, the Government decided to introduce Meditag™ hologram sticker on all pharmaceutical products in 2005. The Meditag™ is a self adhesive holographic label measuring 8mm x 16 mm and contains three layers of security, overt (visible to naked eyes), covert (visible with hand held readers/instrument) and forensic features (features that are only visible in a laboratory, using hi-tec equipment).
The Meditag™ label was affixed on to outer packaging of the product on the front panel of the product label. Where there is no outer packaging, it was applied to the immediate packaging, i.e. the bottle label. The hologram are sold to licensed manufacturers and importers to avoid abuse by irresponsible parties. All registered products must then display their product registration number and Meditag™ hologram security label on its packaging. This hologram was later upgraded to the second version in 2006 and third in 2012 with enhanced security features and tools to enable easier verification by consumers.
Consumer education From the start of this program, the MoH has enable consumers in their drive against counterfeiters. To enable consumers to verify the authenticity of the Meditag™ hologram label, MOH has supplied a device called Meditag™ decoder to all licensed pharmacies and pharmaceutical Enforcement Branches across the country since 2006. These decoders can be used by the consumer to verify the authenticity of Meditag™ hologram label on the pharmaceutical products purchased. Consumers are also encouraged to purchase health-related products from legitimate premises such as licensed pharmacies. The pharmacists would be able to provide consumers with proper advices and counselling before purchasing any product to avoid confusion due to similarity in appearance or indication of certain medication.
To stay ahead of the counterfeiters, an improvement was made on the second version of the hologram. On November 1, 2012 the third version of the hologram (Meditag™ III) with the latest security features and more user-friendly features was launched. The latest Meditag™ III is supported by Meditag™ Checker, a new smartphone app. Meditag™ Checker allows users to verify the authenticity of the holographic labels used. The app provides a 3D gyroscopic enhanced reality representation of the holographic label. The label can be seen from various angles to help the verification process.
Enforcement efforts Law and enforcement plays a key link in any anti-counterfeiting strategy. In 2006, the Malaysian Sale of Drugs Act 1952 was (retrospectively) amended in 2006 with new regulations defining a label as “a display of information, safety marks or features, referring to any kind of security tools/technology such as hologram, imprints or even micro chips and the amendment put legal provisions in place to ensure effective implementation, giving legislative weight to the MOH’s programme.
Anyone who fails to abide by this law will be subject to a fine, imprisonment, or both. First-time offenders will be fined up to RM25,000 (US$6,632) and/or jailed for up to 3 years. Second-time or subsequent offenders will be fined up to RM25,000 (US$6,632) and/or jailed for up to 5 years. Any corporate entity failing to abide by this law will be charged a fine of RM50,000 (US$13,264) for first-time offenders or RM100,000 (US$26,529) for second-time or subsequent offenders.
Increase in seizuresSince the Ministry of health introduced Meditag™ in 2005, instances of un-registered medicines (which are often counterfeit) in the market has fallen by up to one-third. The Meditag™ was introduced in mid-2005, and the seizures went up by 300 per cent between 2004 (the last full no Meditag™ year) and 2006 (the first full Meditag™ year) and over 23000 items were seized in that period.
Conclusion “Where there is a will there is a way” Counterfeiting can be curbed to a large extent if there is a strong will to tackle the problem. Malaysia provides a positive case study of the value of new technologies. The Malaysian Ministry of Health (MOH) in Malaysia had taken the preventive step and set an example of “Usage of anti-counterfeiting solutions with proper enforcement that has successfully curbed counterfeiting to a large extent”. An effective anticounterfeiting strategy is the one that has consumer verifiable features with strong enforcement. And if implemented well, this will almost always deliver results.
The author is the President of Hologram manufacturers Association of India (HOMAI) and Board member of International Hologram Manufacturers Association (IHMA).