Stronger authentication needed as fake medicines swamp market

Stronger authentication needed as fake medicines swamp market

Malaysia needs better tools to fight the real dangers of counterfeit products, with new technology such as tax stamps that offer new safeguards.

Patients are urged to buy medicines only from licensed pharmacies and registered healthcare facilities to avoid paying for counterfeit products. (Bernama pic)
PETALING JAYA:
Counterfeit and unregistered medicines are no longer a marginal issue, but an escalating public health threat in Malaysia, says the Malaysian Medical Association (MMA).

MMA president Dr R Thirunavukarasu noted that the health ministry conducted over 4,000 raids nationwide from 2023 to 2025 and seized more than RM108 million worth of unregistered health products.

“These figures reflect the scale of the problem, but they likely underestimate its true extent, especially (if) online sales (are also taken into account),” he told FMT.

The World Health Organization has estimated that 10% of medical products in developing countries are fake or substandard. Globally, fake products account for 10% of all medical products, rising to 30% in parts of Asia and nearly 50% in some African regions.

Last year, Malaysian authorities seized more than RM7 million worth of illegal health products under Operation Pangea, an annual global bust coordinated by Interpol.

Thirunavukarasu said the issue now goes beyond supplements. There already are reports of unregistered vaccines, including for typhoid, being smuggled into the country and used in some clinics.

“When patients enter a clinic, they trust that what is administered is registered, properly stored, and safe. That trust must never be compromised,” he said.

Thirunavukarasu said patients who unknowingly consume unregistered medicines may face anything from ineffective treatment to serious harm.

He said these products could include undeclared substances or may have been contaminated, rendering treatment ineffective, thereby introducing safety concerns.

“The risks are even more serious when it comes to vaccines,” he said.

“An unregistered or improperly stored vaccine may offer no protection at all. Patients may believe they are protected — when they are not,” he added.

Strengthening technological defences

Francisco Mandiola, a global traceability expert with the International Tax Stamp Association, said stronger authentication and track-and-trace systems are needed, as counterfeit medicines are increasingly sold online.

He said phygital systems — combining physical and digital security features — can offer stronger security.

“Purely digital systems can be vulnerable to hacking, while physical systems alone are increasingly easy to replicate. When you integrate both, you significantly strengthen security,” he told FMT.

Mandiola said linking physical security features with encrypted databases helps regulators enforce the law while allowing consumers to verify authenticity of the products.

“Today, technology allows larger volumes of data to be analysed more efficiently, providing better information to support enforcement,” he said.

Brazil, Tanzania and Kenya are among the first few countries to use secure authentication systems to combat the sale of illicit tobacco before expanding coverage to medicines and other regulated products.

In contrast, Malaysian authorities rely on registration numbers, holograms, and manual inspection methods that are increasingly being sidestepped by counterfeiters.

Mandiola added that some countries are also rolling out track-and-trace systems, which enable patients to authenticate and report discovery of fake medicines instantly via QR scanning or SMS authentication.

“Modern mobile phones can read complex QR codes and detect overt and covert security features.

“When connected to government systems, they don’t just empower consumers — they significantly support enforcement,” Mandiola said.

Thirunavukarasu urged consumers to check MAL registration numbers and buy only from licensed pharmacies or registered healthcare facilities.

The MAL is a series of numbers, issued by the Malaysian Drug Control Authority, that appears on the packages of all medication sold at pharmacies or other healthcare facilities.

“When in doubt, do not proceed. Every patient has the right to safe, registered and properly handled medicines,” he added.

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