A counterfeit medicine as defined by the World Health Organization (WHO) “is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with incorrect quantity of active ingredients or with fake packaging”.
The existence of several facilitating factors, especially in countries where the manufacturing, importation, distribution, supplying and selling of drugs are not adequately protected by laws and regulations and stringent enforcement has led to the “encouragement” and “upward development” of counterfeiting. In such a case scenario, counterfeiters are better organized and the activities are usually orchestrated by highly sophisticated syndicates, who conceal themselves behind multiple layers that make the task of tracing the actual source a virtual impossibility. They are further well equipped with the latest, state-of-the-art counterfeiting technology, i.e. labeling and packaging methods for example, which makes it even more difficult to detect.
In some instances, due regard is not paid to quality assurance as the prices of medicines are exorbitant and the public usually revert to the already existing, cheaper and convenient alternatives, such as products advertised on the Internet that can be purchased online with a credit card, where unscrupulous people would take advantage for their own personal gain without due regard to public health.
In addition, sentences imposed by courts may not reflect the seriousness of the problem, since it is often compoundable by an imposition of a fine. As such, there is lack of deterrence against repetitive or continual offences. This is further evidenced by the delay of the courts in hearing and disposing off such related matters.
Malaysia is determined to ensure that the quality, efficacy and safety of pharmaceutical products marketed for local consumption are properly verified and scrutinized to the highest standards in order to minimize the occurrences of counterfeiting activities. Many activities and campaigns have been launched to create consumer awareness, tighten legal provisions and increase the level of market surveillance with the primary objective of combating problems that relate to the uncontrolled rampant presence of unregistered products.
On top of the stringent test conducted by the National Pharmaceutical Control Bureau (NPCB) under the Pharmaceutical Regulatory Control (a division of the Pharmaceutical Services under the Ministry of Health), a mandatory requirement for the registration of a pharmaceutical drug under the Control of Drugs and Cosmetics Regulations 1984, the use of the “serialised Meditag” security label for pharmaceutical products and traditional medicines registered with the Malaysian Drug Control Authority was enforced in Malaysia at mid-2005.
With the introduction of this “label”, it would now be easier for consumers and enforcement authorities to verify or authenticate the status of registration of a particular medicine product by identifying it with the hologram on the product label. In addition, the process of tracing the company responsible or marketing the product in order to enable appropriate actions be taken against companies marketing adulterated and unregistered products is also made easier through the presence of such a security device.
Malaysia has seen a tremendous increase in figures of seized counterfeit medicine products. In 2005, 12,242 products were seized; and from January to September 2006, 23,263 unregistered products valued at RM5.5 million have been seized. Prior to the introduction of the use of “Meditag, the Pharmacy Enforcement Division seized 7,704 products with a market value of RM20.62 million.
Meanwhile, officers under the Enforcement Division are routinely conducting large scale raids nationwide to identify fake and unregistered medicinal products, as well as selecting products from active trade on a random basis to evaluate the extent of counterfeiting. For instance, according to the report published on 31 March 2007 by a popular local daily, The New Straits Times, police have raided and seized amphetamine-type stimulant pills worth more than RM320, 000, in the state of Johor alone!
Strict guidelines as to advertising have also been implemented in order to cultivate responsible and accountable advertising, especially where self-medication is concerned. It is vital to educate the public advertising and marketing via the Internet in order to discourage self-medication purchases online without a proper doctor’s prescription.
Concurrently, the Pharmaceutical Services Division are also conducting various programmes to educate the public to be more careful and aware when it comes to purchasing medicine through various channels, such as electronic and printed media, exhibitions and post-card distributions. Meanwhile, other relevant public bodies such as the Malaysia Pharmaceutical Society are publishing general announcements to combat this concern, an example of which is readily available to the public at www.mps.gov.my, which provides detailed guidelines to the public with regards to evaluating product sources and detection of counterfeit medicine.
The Pharmaceutical Services Division have also implemented a “people-centered” initiative known as the “Integrated Drug Dispensing System”, which allows patients to obtain their follow up medications in hospitals and clinics of their choice even if they have been treated elsewhere. A patient therefore need not return to the place where the first treatment was sought for his follow-up medicine.
Conclusion – Towards a Healthy Future
Malaysia in on track as far as addressing strategically the threat counterfeit medicine poses to public health and human life. Measures taken by the Health Ministry clearly reflect that the Government is very serious in eradicating this problem to ensure that public health and the safety of Malaysian citizens are neither undermined nor compromised through the negative effects of such products. And this would inevitably attract and encourage more investment and trade activities of foreign pharmaceutical giants like Novartis and Ranbaxy, who definitely view Malaysia as a definitive platform of marketing their health products in this part of the region.