Anna Shimbulu
Nadine Mouton
What are counterfeit medicines?
Substandard and falsified medicines are collectively referred to as counterfeit medicines. The substandard medicines are manufactured below the acceptable standard of safety, quality or efficacy. Falsified medicines are intentionally and fraudulently mislabeled in a way that misrepresents their identity, composition or source, and are often produced under unregulated conditions with the actual manufacturer usually unknown.
Counterfeit medicines, therefore, include products with insufficient active ingredients, with the correct ingredients but fake packaging, and with the wrong ingredients or without active ingredients.
How are medicines counterfeited?
A counterfeiter can add extra ingredients with the aim of bulking the components of the medicines. The resultant product is, therefore, impure, has reduced active ingredients and will have an improper dose. Sometimes, the counterfeiter can get the original medicine and packaging with the intent to fraudulently use them.
For example, they may change the expiration date, batch numbers or product labelling, causing harm to the consumer. In addition, they might copy the legitimate medicine but use different ingredients. This will affect patient safety, as the resulting medicine is fake or of lower quality.
Which medicines can be counterfeited?
The branded and generic products can be counterfeited. Furthermore, unscheduled (accessible in supermarkets) and scheduled medicines (available over the counter issued by pharmacists or requiring a doctor’s prescription) can be counterfeited. In developing countries, the most counterfeited medicines have been those used to treat life-threatening conditions such as malaria, tuberculosis (TB) and HIV/AIDS. However, any medicine can be counterfeited, including vaccines.
Consequences
These products are associated with many health risks, such as worsening of the patient’s health condition or therapeutic failure, unexpected adverse events, antimicrobial resistance, and the occurrence of serious adverse effects or even death.
Combatting counterfeit medicines
Combating counterfeiting activities requires a strong commitment from the regulatory authorities, governments, pharmaceutical industries, health facilities and the general public.
The Namibia Medicines Regulatory Council (NMRC) has a mandate to ensure that medicines are authorised before entering the country. This warrants that they are manufactured according to internationally acceptable standards. The authority also requires that importers of medicines are licensed.
The pharmaceutical importers and suppliers should, therefore, ensure they only supply authorised medicines from approved manufacturers. Health facilities should also source medicines from authorised suppliers within the country to ensure the patients receive products that are safe, efficacious and of good quality. The medicine supply chain in Namibia is considered stringent, provided the key players adhere to good distribution practices.
The healthcare workers play a critical role in combating counterfeiting activities and should, therefore, report any suspicious medicinal products as well as unexpected adverse events or lack of efficacy with the use to the NMRC. The public is also urged to access medicines from authorised health facilities (i.e. pharmacies and doctor’s practices).
Counterfeit medicines found on the local market
This unscheduled product was found to be circulating in Namibia and marketed as herbal sex booster for men. The manufacturer as well as the batch number were not indicated on the labelling. The NMRC laboratory tested the product and found that it contained sildenafil, a scheduled active ingredient found in Viagra® tablets.
Sildenafil is used in the treatment of erectile dysfunction and primary pulmonary hypertension and should only be available on a doctor’s prescription. The use of this product in an uncontrolled manner has risks of hypotension and heart palpitations. It is also contraindicated in certain groups of people, including those with a history of heart disease. This product was reported to have been manufactured at an illegal laboratory in South Africa.
This product is marketed as an energy drink, manufactured by Revin S.A.R.L (Zambia). It was found on the market and was also found to contain sildenafil. The packaging on the drink clearly states that it “increases libido” and it is an “aphrodisiac”. It also claims to “revitalise the body and mind”.
The above-mentioned products should not be sold in Namibia. Any person found in possession of these products will be prosecuted and the products confiscated.
Counterfeit Covid-19 vaccines
On 16 August 2021, the WHO alerted on falsified CovishieldTM Covid-19 vaccines, whose authentic manufacturer is the Serum Institute of India. These vaccines were reported to be circulating in Uganda and India. One of the vaccines had a similar batch number (B121Z040) to the genuine product; however, the expiry date (10.08.2021) was falsified. The reported falsified vaccine came in a volume of 2ml, of which the actual manufacturer does not produce this volume. This vaccine has not been detected in Namibia; however, vigilance is required from the pharmaceutical wholesalers/distributors, pharmacists and healthcare workers who are vaccinating as well as the general public.
If you would like us to write on any topic of medicines information, please email us at info.TIPC@mhss.gov.na. Please also report any suspected counterfeit medicines to the inspectorate pharmacists at 061 203 2400 and any adverse events due to medicines to 061 203 2406.
* The authors Nadine Mouton and Anna Shimbulu are medicines information and safety pharmacists from Namibia Medicines Regulatory Council (NMRC).