THE next time you buy a medicinal product, check if it has a registration number and a hologram security image on its packaging. If none, or only one of the features is visible, it is an unregistered or fake product. Unregistered products are not registered with the Drug Control Authority of Malaysia. All pharmaceutical and medicinal products must be registered prior to being marketed in Malaysia.
Fake products are imitation or illegal copies of registered products. A fake product may look very similar to the original but its content is unknown as it has not been officially tested. In Malaysia, fake products are classified and treated as unregistered products under the Sale of Drugs Act 1952.
Health Ministry Forensic Pharmacy (pharmaceutial enforcement division) deputy director Mazlan Ismail says registered pharmaceutical and medicinal products have gone through stringent quality control tests with the Health Ministry to make sure they are safe. They are evaluated in terms of safety, quality and efficacy.
Traditional medicines are also evaluated and tested for safety and quality. “Once they have been evaluated, they are deemed to be a registered product. The objective of the evaluation is to ensure they do not contain prohibited ingredients, including scheduled poisons. “Registered products have received the government’s guarantee on quality and safety so the public do not have to worry about side effects.”
Mazlan says with thousands of medicinal and pharmaceutical products in the market, it is up to consumers to make sure they are not buying unregistered items. This is because despite various raids by the Health Ministry, these products are still being sold due to demand. He says the main difficulty faced by the pharmaceutial enforcement division is tracking unregistered products, especially those imported from Indonesia, China, Myanmar and India.
As of November last year, 43,207 unregistered products were seized, valued at RM75.4 million. From 2012 to October last year, 1,575 unregistered medicinal products that were sold online valued at RM4 million were seized. These products were seized for being unregistered or counterfeit; adulterated or laced with controlled substances or containing harmful or dangerous substances; containing scheduled poisons sold by unlawful persons or at unlicenced premises; or having product registrations which had expired or been cancelled.
IN HIGH DEMAND
Mazlan says the highest number of products seized are traditional medicines, especially those for weight loss or those that act as sexual stimulants. These usually contain poisons and can have dangerous side effects when taken in large quantities. For example, some weight-loss products contain sibutramine, an appetite suppressant that can increase the risk of heart attacks and strokes, he says.
Many traditional medicines are either manufactured at home or in a factory that is not licenced. Registered products must be manufactured in a factory with good manufacturing practices, says Mazlan. “They don’t want to set up a manufacturing plant because it costs millions. They also have to reveal the ingredients in the products. So they make and sell the products without getting registered. “The products may not contain prohibited ingredients but they must still be registered. Maybe the amount of the ingredient is too small to have an immediate effect but the long-term impact will be there.”
All registered pharmaceutical and medicine products will have registration numbers that start with the word “MAL”, followed by eight numbers, and ending with either the letter A for controlled medicines, X (over-the-counter medicines), T (traditional medicines) or N (supplements). In addition, the products are also labelled with the Meditag security hologram, which was implemented in 2005. The latest version is Meditag 4, introduced in October last year to replace Meditag 3.
In addition, the products are also labelled with the Meditag security hologram, which was implemented in 2005. The latest version is Meditag 4, introduced in October last year to replace Meditag 3. Meditag 4 is equipped with the latest security features incorporating second and third level controls to make it difficult to be fully copied or imitated. Unlike the previous security hologram, a unique feature is implemented on the Meditag 4 that allows consumers to verify the security hologram’s originality using the checker app. The app can be downloaded from Apple App Store or Google Play Store.
Mazlan says with the checker app, consumers can find out whether the products are registered with a simple step. “All one needs to do is run the app across the hologram. If it is genuine, the app will show green. If the hologram is fake, it will be red. “The additional functions in the checker app also allow consumers to directly report unregistered products to the Ministry,” he says.
As for products that are still using Meditag 3, consumers can check the authenticity of the hologram using the Meditag decoder. The decoder is currently available at all licenced pharmacies or government hospitals and clinics throughout Malaysia. Consumers can also check the product’s registration status at the National Pharmaceutical Regulatory Agency website at www.npra.moh.gov. my. If the registration number or product details are different from the one listed on the website, it could be a fake product. Registered products have received the government’s guarantee on quality and safety.
1. Ensure authenticity of medicines. New Straits Times (April 2018). Available at: https://www.pressreader.com/malaysia/new-straits-times/20180403/282488594289563. Accessed on: 20 March 2020.