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FDA launches campaign against substandard, fake medicine

The Food and Drugs Authority (FDA) has launched the Western Regional Substandard/Falsified Medicines Communication Campaign in Takoradi aimed at combating substandard and falsified medicines in the country.

The launch formed part of the Authority’s collective commitment to ensure quality, safe and efficacious medical products are available on the Ghanaian market.

Speaking at a stakeholders meeting to launch the campaign, Western Regional Manager of FDA, Mr Abu Sumaila said studies over the years have shown that substandard and falsified medicines continued to be the bane of the developing world and Ghana was no exception.

He indicated that the dangers of substandard and falsified medicines also called “counterfeit medicines” on the Ghanaian market cannot be over emphasised.

According to him, the World Health Organisation (WHO) defines substandard medicines (out of specification) as authorised medical products that failed to meet either their quality standards or specifications or both, while falsified medical products are those products that are deliberately or fraudulently misrepresented in their identity, composition or source.

Mr Sumaila stated that substandard and falsified products were by their nature very difficult to detect, in that they often appeared identical to the genuine product and may not cause an obvious adverse reaction.

However, they often failed to properly treat the disease or condition for which they were intended to and could lead to serious health consequences including death.

“Indeed, falsified medicines are not what they are presented to be concerning content or source, they may contain the following: the wrong or different active ingredient, no active ingredient, and too much or too little active ingredient, toxic or hidden/undisclosed substances, or maybe supplied with inaccurate package labeling or origin”, he pointed out.

Mr Glikpo, Head for Product Quality Monitoring Unit at the FDA in a presentation said Section 123 of the Public Health Act 2012 (Act 851) deals with substandard and falsified medicine in Ghana and mentioned antimalarials, analgesics, antibiotics, anthelmintics, and uterotonics as medicines mostly observed in Ghana as substandard and falsified medicines.

He noted that such substandard and falsified medicines mostly entered the country through unapproved routes.

According to him, FDA conducts post-market surveillance (PMS) on pharmaceutical products in Ghana by ensuring that registered products are confirmed to their marketing authorisation.

He added that the PMS also ensured that unregistered products were removed from the market to ensure public health and safety as well as making sure that only quality, safe and efficacious medicines were available to the Ghanaian consumer.

Mr Glikpo noted with concern that, “trade liberalization policy which gives no limit to the number of brands or dealers with current legislation which does not support confiscation of proceeds from dealing in counterfeit medical products continued to pose challenges to the Authority in handling substandard and falsified products”.

He, therefore, called for sustained collaboration among stakeholders to rid the Ghanaian market of these products and that there should be prosecution and severe sanctions on offenders whereas public education and sensitization should be intensified.

 


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