Delese Mimi Darko (6th from left), CEO of  FDA, with some stakeholders and participants
Delese Mimi Darko (6th from left), CEO of FDA, with some stakeholders and participants

Stakeholders discuss fake drugs menace

Stakeholders in the pharmaceutical industry have met in Accra to deliberate on the protection of citizens against fake and substandard drugs. 

The two-day technical meeting which began yesterday was organised by the Food and Drugs Authority (FDA) to allow all sector actors to discuss the nation’s Pharmaceutical Traceability Strategy (PTS).

This is a document which enables the authority to track and trace the movement of pharmaceutical products throughout the supply chain by verifying the history, location, manufacturer or application of drugs, among others, by means of documented identification.

The strategy was launched in December last year and spans 2023 to 2028.

It aims to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or in any way harmful.

Therefore, the participants will exchange views on the guidelines and make recommendations to improve the strategy in a productive and efficient manner.

The engagement which was on the theme; “External Stakeholders Meeting on Draft Guidelines for Pharmaceutical Traceability”, was organised with support from the World Health Organisation (WHO).

The Chief Executive Officer (CEO) of the FDA, Delese Mimi Darko, said her outfit in the past years had expended a lot of resources in combating substandard medical products in Ghana.

She said in spite of those efforts, the war on such medical products was far from over since their production and trafficking had become a multimillion-dollar business.

“The lure of huge profits from this venture has enabled all manner of unscrupulous persons into this business.  

No doubt the implementation of traceability of medical products will enable the FDA to rid the country of /minimise the incidence of SF medical products on Ghana’s market,” Mrs Darko stressed. 

She further explained that the improved strategy would also facilitate effective recall of non-conforming products from the market, identify legitimate medical products in the supply chain and gather reliable data to inform policy formulation on medical products.

Level Four

Mrs Darko said the authority was currently listed as a WHO "Maturity Level Three Regulatory Agency, one of the few countries in the WHO African Region to attain such a level in the four-tier WHO classification of National Medicines Regulatory Systems.

Therefore, in order to attain Maturity Level Four, she said it was required for National Regulatory Authorities to have legal provisions and regulations that placed a unique identification code on the outer packages of medical products.

“The implementation of the pharmaceutical traceability guidelines will enable the FDA to meet these requirements through serialisation of the product packaging. These codes will serve as a unique identifier for each single package of the medical product,” the FDA boss explained. 

No alarm

The Deputy CEO of the authority in charge of Technical Operations, Dr Akua Amartey, urged the public not to be alarmed to think the engagement was being held because there had been an influx of fake and substandard drugs into the country.

Rather, she said, the authority was taking input from its partners in the industry and the sector so that it could improve and strengthen its operations in delivering on its constitutional mandate.

“It is something that is being done globally.

Currently, FDA is at the maturity Level Three by WHO standards, and about to get to Level Four, these are some of the things you need to get in place,” Dr Amartey stressed.

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