GENUINE MEDICINE

Is Your Drug Genuine?

COUNTERFEIT = UNREGISTERED

According to the World Health Organization (WHO), problem of counterfeit prescription drugs has reached a worrisome stage. Online purchase of health products had increased tremendously in view of great convenience and time-saving. This greatly exposes consumers to counterfeit medicines as there is no guarantee on the quality and composition of the product.

Is your drug genuine?

Is Your Drug Genuine?

COUNTERFEIT = UNREGISTERED

According to the World Health Organization (WHO), problem of counterfeit prescription drugs has reached a worrisome stage. Online purchase of health products had increased tremendously in view of great convenience and time-saving. This greatly exposes consumers to counterfeit medicines as there is no guarantee on the quality and composition of the product.

DRUGS IN MALAYSIA

In Malaysia, all types of pharmaceutical products NOT registered under the division of Drug Control Authority (DCA) by National Pharmaceutical Regulatory Agency (NPRA) are considered as COUNTERFEIT. Unregistered drug / product is a silent killer as it may bring damage to human’s well-being. Counterfeit products might be drug with fake hologram / MAL number and traditional / cosmetic products adulterated with poison, or even medicine without active ingredient as printed/ingredient in the product differs from the ingredient stated. Emerging Markets Network (EMHN) reported in 2013 that about 5% of medicinal products in

In Malaysia, all types of pharmaceutical products NOT registered under the division of Drug Control Authority (DCA) by National Pharmaceutical Regulatory Agency (NPRA) are considered as COUNTERFEIT. Unregistered drug / product is a silent killer as it may bring damage to human’s well-being. Counterfeit products might be drug with fake hologram / MAL number and traditional / cosmetic products adulterated with poison, or even medicine without active ingredient as printed/ingredient in the product differs from the ingredient stated. Emerging Markets Network (EMHN) reported in 2013 that about 5% of medicinal products in

Malaysia are not registered. The largest drug seizure recorded in Malaysia was in March 2007 where customs confiscated 142 boxes of fake Viagra (1.4million pills) worth USD4million. Interpol had organised an international operation named PANGEA VIII in various countries back in 2015. Malaysia Pharmacy Enforcement Division had joined this operation throughout the 7 days operation by having inspection to 130 premises and 45,317 parcels at custom. As a result, total seizure worth RM830,663.00 of counterfeit products has been confiscated. In January to November 2017, as many as 43,207 units of unregistered products worth a total of RM75.4million have been con e year of 2016 where only 39,247 units were confiscated, worth RM54.9million. This implicates that consumer’s health and safety is at stake.

Registered Product in Malaysia

Product that need to be registered

  1. All pharmaceutical products
    containing scheduled poison
  2. Over-the-counter (OTC) products
  3. Traditional medicines
  4. Health supplements
  5. Veterinary products

Why must be registered?

  1. All products must pass the product testing for any traces of heavy metals exceeding the safety limit and microbial limit test, ensuring safety of consumers.
  2. To ensure the quality of product by complying to Good Manufacturing Practice (GMP).
  3. To ensure the efficacy of the product is supported by scientific researches / toxicology studies / animal studies.

How to check is the product registered

All registered products will have to display their approved MAL number and meditag hologram on the product. Example:

A valid MAL registration number must fulfill the following criteria:

  • Starts with MAL
  • Followed by 8 number digits
  • Ends with an alphabet which indicates the category of product (A for controlled medicines, X for OTC, T for traditional medicines and lastly N for supplements)

Meditag hologram has been implemented since 2005. However, there are fake meditag holograms being used in the market. Hence, the Ministry of Health had been improving the safety specifications of the hologram since. The latest version Meditag 4 has been launched back in 2017. Meditag hologram sticker must be displayed at all registered medicinal products except cosmetic products.

How to differentiate counterfeit meditag hologram from genuine hologram?

Example of adultered productcs not registered with MOH

(Source: Cawangan Penguatkuasaan Farmasi Kelantan)

  1. Meditag decoder is provided by Ministry of Health to all pharmacies.
  2. Meditag checker app is available for smart phone users for easy verification (refer below picture).
  3. Consumer can also check the product registration on NPRA official website via http://npra.moh.gov.my using their QUEST3+ search system.

 

REFERENCES

  1. Zulkifli NW, Aziz NA, Hassan Y, Hassali MA, Bahrin NAZ, Ahmad A. Are We on the Right Track?: Overview of Unregistered Drugs in Malaysia. J Pharm Pract Community Med. 2016;2(4):107-115
  2. Product Registration. (2015, July 24) Retrieved from http://npra.moh.gov.my/index.php/faq/product-registration
  3. Datuk Dr Noor Hisham bin Abdullah. Unregistered medicines valued at RM 830, 663 seized in Malaysia during Operation PANGEA VIII 2015. (2015, June 23). Retrieved from https://www.pharmacy.gov.my/v2/en/news/23-jun-2015/unregistered-medicines-valued-rm-830-663-seized-malaysia-during-operation-pangea-viii-2015.html
  4. Risk of purchasing medications via Internet. (2015, November 19). Retrieved from https://www.pharmacy.gov.my/v2/en/content/risk-purchasing-medications-internet.html
  5. Alia Mior. (2017, December 13). New Straits Times. Keeping fake products off the shelves with high-tech labels. Retrieved from https://www.nst.com.my/news/nation/2017/12/314002/keeping-fake-products-shelves-high-tech-labels
  6. Tan SC. (2017, December 29) How do you know your drug is legit? Just use this app. Star 2. Retrieved from https://www.star2.com/health/wellness/2017/12/29/how-do-you-know-your-drug-is-legit-just-use-this-app/
  7. Senarai Produk Dikesan Mengandungi Bahan Terlarang Yang Diterima Melalui Pelaporan Kesan Sampingan Ubat. (2017, February 2). Retrieved from http://npra.moh.gov.my/index.php/recent-updates/adulterated-products-unregistered