ZAMRA raises red flag on fake drugs

THE illicit business of substandard and falsified medical products in the world looms large and countries like Zambia have not been spared of the consequences on public health and the economy.A wide range of counterfeit goods from other parts of the world have flooded the African markets, subsequently disadvantaging local manufacturing industries and the general economic growth of respective countries.
Substandard and falsified products disadvantage inventors, trademark and copyright owners of their financial benefits from their inventions and discoveries.
Furthermore, governments are robbed of revenue due to fake products, mostly entering the country illegally and usually of inferior quality compared to genuine products.
Measures have been debated on what affected countries like Zambia could do to curb the influx of fake products from flooding the market, but the battle seems far from being over.
The most worrisome among all counterfeits are medicines and other health-related products, simply because they tamper with people’s health and lives.
According to the Zambia Medicines Regulatory Authority (ZAMRA), the impact of substandard and falsified drugs on society are increased mortality and morbidity, loss of confidence in the health care providers and health systems, higher disease prevalence and progression of antimicrobial resistance.
Other socio-economic effects include lost productivity, lost income, lack of social mobility, increased poverty, economic loss and wasted resources, among others.
Alas! Manufacturers of substandard and falsified medicines do not seem to care at all as long as they make profits.
Nonetheless, the burden of proof of counterfeit medicines on the Zambian market seem to be a daunting factor with both regulatory authorities and the general public being vulnerable to this illicit business.
“I brought my ailing mother from the village a few months ago to access better treatment here [in Lusaka], but all the prescribed medicines we were buying from these pharmaceuticals just worsened her condition. I suspect they were these fake drugs people are talking about,” Mr Andrew Njovu of Lusaka’s Zingalume area said.
Another Lusaka resident, Ngawa Milimo, attributed patients’ vulnerability to counterfeit drugs on the Zambian market to shortages of certain medicines in some public health facilities.
Ms Milimo observed that once a patient is given a prescription from a government health facility, they become vulnerable to fake drugs.
“When a prescription is given to a patient, chances of them buying fake drugs are very high because it is difficult for an ordinary person to distinguish a fake drug from a genuine one,” she said.
The World Health Organisation (WHO) estimates that over 100,000 deaths in Africa annually are linked to counterfeit drugs.
However, ZAMRA acknowledges that substandard and falsified medical products are a threat to every country. The authority points out that all medical products are vulnerable to falsification, ranging from medicines from all therapeutic categories vaccines; medical devices; expensive or low-cost, generic or innovator, and that Sub-Saharan Africa contributes to over one third of all reports of substandard and falsified products.
ZAMRA public relations officer Ludovic Mwape said falsified medical products may not contain active ingredients, but could have wrong active ingredients or the wrong amount of the correct active ingredients. Substandard and falsified medical products have been toxic in nature with either fatal levels of the wrong active ingredient or other toxic chemicals.
Responding to a press query on what was being done to curb the influx of substandard and falsified drugs on the Zambian market, Mr Mwape said ZAMRA was doing everything possible within its mandate of ensuring that medical imported products or those manufactured locally meet the required standards.
ZAMRA was established to protect public health and promote access to affordable, safe, efficacious and quality medical products.
“As such, ZAMRA regulates the industry by registering products that can be marketed in the country and screening imported medical products at points of entry. ZAMRA has inspectors at Kenneth Kaunda International Airport (KKIA), Nakonde border, Chirundu border, Kazungula border and Simon Mwansa Kapwepwe International Airport. The role of these inspectors is to ensure that all medical products imported into the country are imported legally and are of good quality to protect public health,” he explained.
ZAMRA, through its Post Marketing Surveillance (PMS) unit, conducts sampling activities of all medical products in public and private health institutions, pharmaceutical retail and wholesale outlets across the country.
Mr Mwape said the assessment includes labelling surveillance and analysis of samples at the National Drug Quality Control Laboratory. The authority’s Good Manufacturing Practice (GMP) unit conducts inspection of both local and international manufacturing companies, including assessing operational procedures to ensure the end products are of good quality.
Mr Mwape further said the Medicines and Allied Substances Act No. 3 of 2013 Section 59 (1) (2) (3) prohibits the manufacture, import export of substandard, counterfeit or adulterated medicines or allied substances.
“A person who contravenes this section commits an offence and liable, upon conviction, to a fine not exceeding two million penalty units or to imprisonment for a period not exceeding four years, or to both. The whole idea of supplying falsified medical products borders on deceit. Section 61 (1) (2) of the Medicines and Allied Substances Act No. 3 of 2013 prohibits deceptive acts,” he said.
A person who contravenes the aforementioned clause commits an offence and is liable, upon conviction, to a fine or imprisonment for a period not exceeding three years, or to both.
With all these measures and pieces of legislation in place, it can only be hoped that security measures and penalties to the offenders can be enforced in order to safeguard the lives of ordinary citizens.

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