Ghana FDA probes fake antiretroviral drugs

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The Ghanaian Food and Drugs Authority (FDA) has been assigned by the Ministry of Health to conduct an investigation into media reports that fake antiretroviral drugs have been dispensed to some people living with HIV/AIDS in Ghana.

A statement released by the Ministry of Health and signed by Alex Segbefia said, ‘FDA has been duly notified of the occurrence of the side effects and the Authority is conducting its own investigations into the incident using the existing pharmacovigilance protocols.’

It said, ‘The leadership of the Association of Persons Living with HIV and AIDS in Greater Accra Region has also been informed to monitor and report any further information regarding the use of the said medication by their members.’

According to the Ministry of Health, investigations conducted so far into the reports revealed that the, ‘drugs were donated to the ministry by the West Africa Health Organisation (WAHO)’ in response to, ‘our appeal for support after the fire incident at the Central Medical Stores on 13th January 2015’.

The statement indicated that in line with the donation policy of the ministry, ‘this product was duly tested and approved by the FDA before distribution to facilities for use’.

It continued: ’We are aware that the manufacturer of the said product was found to be World Health Organization (WHO) Good Manufacturing Practice (GMP) compliant in April 2014 by the WHO Prequalification team.’

‘From this information, the product cannot be classified as ‘fake’ because it does not fall under the WHO definition of the sub-standard, spurious, falsified, falsely-labelled or counterfeit product,’ the statement added.

It indicated, ‘mindful of the fact that there are many other factors that could result in adverse events associated with the use of any medication, the outcome of the on-going investigation by the FDA will provide guidance for the next steps.’

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