Genuine Medicines: Getting It Right
By Joshua Ng (Pharmacist, Caring Pharmacy) | Malaysia | Fri Apr 13, 2018 6:25pm
The World Health Organisation has three main working definition1. Substandard is defined as authorized medical products that fail to meet either their quality standards or their specifications or both. Unregistered or unlicensed is defined as a medical products that have not undergone evaluation and/or approval by the National or Regional Regulatory Authorities for the market in which they are marketed or distributed or used, subject to permitted conditions under national or regional regulation and legislation. Falsified is defined as medical products that deliberately or fraudulently misrepresent their identity, composition or source.
In Malaysia, the Sale of Drug Act 1952 has a provision under Drugs and Cosmetics Regulations 1984 which requires all medicinal products to be registered with National Pharmaceutical Control Bureau of the Ministry of Health (MOH) before entering the market. It also requires a stringent evaluation and final approval by the Drug Control Authorities (DCA)2. Therefore any medicinal product that does not conform to this law cannot be considered genuine.
THE IMPORTANCE OF CHOOSING GENUINE MEDICINES
Safety and quality is assured in genuine medicines. Avoid fake medicines as they may have the following harmful effects:
- The active ingredient of the product may be of an incorrect quantity or dosage
- The active ingredient may not be present at all
- The active ingredient could be a different ingredient altogether
- The product may be contaminated with harmful ingredients
STATISTICS ON FAKE MEDICINES
- Based on a 2016 statistics report, RM54.9 million worth of illegal medicinal products were confiscated during raids and checks by the Malaysian customs. Illegal medicinal products are seized mainly from food factories, private homes, street vendors and private vehicles. Surprisingly, Illegal medicinal products are also seized from clinics, hospitals and even community pharmacies3.
- Based on the same report, illegal medicinal products commonly seized by the Malaysian customs are unregistered medicinal products and substandard products. Unlicensed sexual stimulation drugs and counterfeit poisons were also seized3.
- The Royal Customs of Malaysia in 2007 seized a large amount of counterfeit sexual stimulation drugs. The estimate worth of the seizure was 14 million Ringgit4.
- The International Criminal Policing Association stated in a 2013 news report that more than a million people die each year from counterfeit drugs5.
- A 2013 report by Emerging Markets Network stated that approximately 5% of medicines in Malaysia are counterfeit drugs, and the value is increasing in trend6.
- A 2017 case of counterfeit milk formula was reported in Malaysia, causing a huge scare among consumers of a popular milk formula brand7.
HOW TO IDENTIFY FAKE MEDICINES
- Fake products might bear the following telltale signs:
- Registration number (MAL number) is false or not present at all
- Registration number that does not correspond (i.e. belonging to other products or cancelled)
- Meditag hologram sticker is false or not present at all
- Ingredient which differ from the registered original formula
- Information on the packaging which differ from the approved version
- The medicine with a different texture and color compared to the usual product
MAL numbers are issued to that products registered with the DCA. The stringent requirements of DCA ensures the product is safe to be taken by the public. Products registered with the DCA has two main features, the registration number and genuine hologram sticker. The registration number starts with 'MAL', followed by eight numbers, and ending with the letter T,A,X or N8.
In efforts to overcome counterfeit medications, MOH introduced Meditag holograms in 2005. All registered medicinal products had to be labelled with a Meditag hologram sticker. This sticker features a security hologram which can be visually verified by both consumers and pharmacy enforcement officers. Meditag decoders were supplied to all licensed pharmacies in Malaysia (See figure 1). These decoders can be used by the consumer to verify the authenticity of the Meditag hologram label on the pharmaceutical product purchased. The decoder would enable customer to also see a registration number on the hologram9. A smartphone application has also been launched to verify the Meditag hologram registration number (See figure 2). It is available for download from Apple Store and Google Playstore9.
Online Portal for National Pharmaceutical Control Bureau (NPRA)
The official website is a useful tool to verify the MAL number and the registration number on the Meditag Hologram8,9. The website is http://www.bpfk.gov.my. Any MAL registration number that does not exist in the system might be fake. This online portal also enables consumers to report suspected counterfeit medical products.
Choose genuine medications. It is important to pay attention to the quality of the products purchased. Always look out for irregularities. Ensure that you purchase your medicines from licensed and reputable outlets. If you suspect that you might have purchased a fake medicinal product, speak to your pharmacist or doctor immediately and report it online to the NPRA.
- Definitions of substandard and falsified medical products. Working definitions document approved by the the World Health Assembly. WHO (2017). Weblink: http://www.who.int/medicines/regulation/ssffc/definitions/en/
- Are we on the right track?: Overview of unregistered drugs in Malaysia. NW Zulkifli, NA Aziz, A Ahmad et al. Journal of pharmacy practice and community medicine (2016)
- Laporan statistic program farmasi 2016. Ministry of Health. Slide 152. Weblink available for PDF slides: https://www.pharmacy.gov.my/v2/sites/default/files/statistic/Statistik%20Farmasi%202016.pdf
- 4. News Report: Malaysia seizes fake Viagra. News24archives. (2017) Weblink: http://www.myhealth.gov.my/en/counterfeit-medicines-2/
- News Report: Counterfeit drugs kill 1 million people annually. Insight Crime (2013). Weblink: https://www.pharmacy.gov.my/v2/en/content/new-hologram-meditag.html
- News Report: 5tudy: Fake drugs a growing problem in Malaysia. The Edge (2013). Weblink: http://www.theedgemarkets.com/article/study-fake-drugs-growing-problem-msia
- News Report: Fake baby formula scare hits Malaysia. BBC news (2017). Weblink: http://www.bbc.com/news/business-42348254
- How to identify medicines that are registered with MOH? Pharmaceutical services programme. Ministry of Health Malaysia (2018). Weblink: https://www.pharmacy.gov.my/v2/en/faq/how-identify-registered-drugs-or-pharmaceutical-products.html
- Current Meditag hologram security sticker. NI Hanafi and M Muhammad. MyHealth (2016). Weblink: http://www.myhealth.gov.my/en/current-meditagtm-hologram-security-sticker/
1. ‘Check the authenticity of your product by using MeditagTM Decoder available at the nearest pharmacy.’ (2016) photograph, Current MeditagTM Hologram Security Sticker. M Muhammad, Malaysia. Viewed 21st March 2018 <http://www.myhealth.gov.my/en/current-meditagtm-hologram-security-sticker/>
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