The retail of counterfeit medications or unregistered products is more widespread than ever. In a mass raid throughout the year 2021 to January 2022 facilitated by the Ministry of Health Pharmacy Enforcement Division, unregistered health products worth up to RM 23 million were seized from over 1,330 premises [1]. 

This is one of the many baffling instances where consumers are ignorantly exposed to potential health risks from the sale of unregistered products. So, how can you identify the authenticity of a health product and protect yourself from these harms?  

What are unregistered products? 

All pharmaceutical products are required to be registered under the Drug Control Authority (DCA) before entering the market. Unregistered products include pharmaceutical preparations, health supplements, or traditional medications not registered with DCA. 

Despite claims such as “100% safe” or “no side effects,” these unregistered products are a serious threat to the community. This is because the safety, quality, and efficacy of their formulation have not been checked [2]. 

How to check for authenticity? 

You can check for the authenticity of a medicinal product by three means: registration number, hologram sticker or registered product search. 

1. Registration number 

Firstly, the registration number is unique to each product registered with DCA for safe use in Malaysia. The registration number starts with ‘MAL’, followed by eight numbers, and ending with the letter T,A,X or N. The ending letters describes the category of product as follows [3]:

• T: Traditional Medicines / Natural Products
• A: Controlled medicines
• X: Over the counter medicines (OTC)
• N: Health Supplements

The registration number of a product must be printed on its label or package. Products with registration numbers satisfy all the requirements set by the DCA with respect to safety, efficacy and quality.

2. Security Hologram Label 

Did you know, Malaysia is the first country in the world to implement the single security hologram label technology for all pharmaceutical products sold throughout the country? [4]

The security hologram labels in Malaysia are supplied by Techno Secure Print Sdn. Bhd for all registered products. Only licensed manufacturers and importers of pharmaceutical, traditional medicine, and health supplement products are entitled to purchase the hologram labels.

The security label should be affixed to the outer packaging or the product itself. Checking for the security label is an easy method for consumers to identify the originality of a health product. Any product without a security hologram label is considered an unregistered product. 

Moreover, the Ministry of Health supplies all licensed pharmacies and Pharmaceutical Enforcement Branches with a Meditag decoder. Pharmacists can use this device to verify the authenticity of Meditag hologram labels on the pharmaceutical products purchased. This provides an opportunity for consumers to consult pharmacists to check for the genuineness of a product and get necessary counseling from them [5]. 

3. Registered Product Search

The National Pharmaceutical Regulatory Agency (NPRA) is established to safeguard the nation’s health through scientific excellence in regulating medicinal products and cosmetics. Here’s how you can search for registered products in Malaysia. 

1.Firstly, go to the official NPRA website 

2.Next, navigate to consumers > consumer information > product search. Here you’ll get a pop-up QUEST3+ Product Search tab.  

3. Then, filter your product category search by either pharmaceutical products or cosmetics.  

4. Finally, type down a product name and click search. You could alternatively search for the registration number, notification number, holder name, manufacturer name, or importer name. 

5. Registered products will appear in the search results. You’ll also see pertinent information such as the product registration number and the holder company.  

This government database is updated regularly. That being so, if a product name is not found in this registered product search, it’s safe to say it’s an unregistered product. 

If you encounter the sale of unregistered products, you can lodge a complaint to the Senior Director of Pharmaceutical Services through email (pharmacy1@moh.gov.my) or phone (03-78413200). Alternatively, you can also contact your State Pharmacy Enforcement Branch to notify them about the issue [6,7]

What are the risks of consuming unregistered products? 

Consuming unregistered products is very dangerous because the safety of consumers is at stake. Most unregistered products can be classified into two main categories: adulterated and/or sub-standard [8]. 

Firstly, adulterated unregistered products contain ingredients that may be unsafe or banned. In some cases, these ingredients may be added to enhance the effects of a product and entice consumers to continue consumption. However, taking it for the long-term without medical supervision could worsen your condition and cause serious adverse effects. 

Secondly, sub-standard unregistered products are those manufactured in unhygienic conditions without quality control. The lack of standard operating procedures when manufacturing these products results in an inconsistent amount of ingredients in each batch. This leads to a potential risk of overdosing or poisoning.

In order to avoid the risks of consuming unregistered products, you need to be extra cautious when purchasing a pharmaceutical product. It’s also recommended for you, as consumers, to do your own research and critically review products before purchasing them. 

The role of pharmacists in protecting consumers

Pharmacists play an integral role in preventing the sale and consumption of unregistered products. If you’re unsure of the genuineness of a product, visit your nearest pharmacy outlet to consult a pharmacist on the matter. 

Pharmacists also ensure the quality of medicine supplied to patients. Every product sold on licensed pharmacy premises is safe for human consumption. 

Moreover, various public health campaigns are organized to empower patients to make the right health and medical treatment decisions.

Bottomline 

In 2020, a cross-sectional study was performed to assess the public knowledge, attitude and practice of consuming and purchasing unregistered health products in Malaysia [9].The results of this study uncovered that there’s a significant lacking in the public knowledge of unregistered or unlicensed medications. Majority of the respondents were also unaware of how to identify a registered health product in Malaysia and lodge a formal complaint when necessary.

This shows that the fight against preventing unregistered products is an ongoing effort and a lot of work needs to be done. Avoid bluntly trusting claims made by a product. You should also stray away from making claims that are too good to be true…because they’re most likely not.