WR: FDA launches Substandard and Falsified Medicines Communication Campaign

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Communication Campaign
Communication Campaign

As part of its collective commitment to ensure that quality, safe and efficacious medical products are available in the Ghanaian market, the Food and Drugs Authority (FDA) has launched the Western Regional Substandard/Falsified Medicines Communication Campaign in Takoradi to combat substandard and falsified medicines in Ghana.

Speaking at a stakeholders meeting to launch the Campaign, Western Regional Manager of FDA, Mr Abu Sumaila disclosed that studies of the years have shown that substandard and falsified medicines continue to be the bane of the developing world and Ghana has not been an exception.

He indicated that the dangers of substandard and falsified medicines (also called counterfeit medicines) in the Ghanaian market cannot be over emphasized.

According to him, the World Health Organization (WHO) defines substandard medicines (out of specification) as authorized medical products that fail 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 enlightened that substandard and falsified products were by their very nature very difficult to detect, in that they often appear identical to the genuine product and may not cause obvious adverse reaction, however, they often fail to properly treat the disease or condition for which they were intended to and can lead to serious health consequences including death.

“In deed, falsified medicines are not what they are presented to be with respect to content or source. They may contain the following: the wrong or different active ingredient, no active ingredient, too much or too little active ingredient, toxic or hidden/undisclosed substances, or may be 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 divulged that substandard and falsified medicines mostly enter the country through unapproved routes or smuggling and added that the FDA conducts post-market surveillance (PMS) on pharmaceutical products in Ghana by ensuring that registered products conform to their marketing authorisation.
He added that the PMS also ensures 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.

He mentioned pharmacovigilance, product quality monitoring like risk-based sampling and testing of pharmaceutical products, handling of products complaints and investigations, import and export control in offices at major points of entry, safe disposal of unwholesome or unwanted pharmaceutical products, public education on substandard and falsified medical products, and formation of an inter-agency committee for collaboration on substandard and falsified medicines as some of the pre and post market surveillance activities undertaken by the FDA.

However, Mr Glikpo said 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 continues to pose challenges to the Authority in handling substandard and falsified products.

Distribution challenges he stated as courier/door-to-door, social media and internet sales; poor handling, transportation and storage of legitimate consignment (cold chain products); sourcing of products from unauthorized dealers by both public and private sector dealers; multiple sourcing/parallel importation and existence of illicit market for medicines breaching supply chain.

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

Mr Glikpo further implored the radio stations to offer free airtime on their peak time programs to educate and sensitize the public on the dangers of substandard and falsified medical products.

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