FDA’s infractions lead to low quality, uncertified drugs on market – Auditor-General's Report
The 2016 Auditor-General's Report has cited the Food and Drugs Authority (FDA) for infractions that have allowed uncertified and low quality medicines to enter the market.
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The infractions include keeping unregistered drugs at the FDA canteen, keeping detained drugs on the premises of offending companies, failure to register some medicines and allowing importers to import drugs into the country before securing import permits for the drugs.
Per the report, the audit was to find out whether measures were put in place by the FDA to regulate the importation and manufacture of medicines on the Ghanaian market and ensure that medicines were safe and met the required standards for use.
It covered the period from 2010 to 2013.
Drugs in FDA canteen
On the drugs at the FDA canteen, the performance audit report on ensuring safety and quality of medicines in Ghana indicated that some of the drugs had been taken from the canteen and sent to the market.
Besides, it indicated that the canteen was not in good condition, which might have affected the efficacy of the drugs before they were finally released to the owners.
Answering questions before the Public Accounts Committee (PAC) of Parliament yesterday, the acting Chief Executive of the FDA, Mrs Delese Mimi Darko, said the medicines were stored at the canteen due to the lack of a warehouse facility.
She said the drugs were kept for a short time there and indicated that the windows to the canteen were opened to give the medicines the right temperature.
She said the FDA conducted tests on the medicines and okayed their quality before they were released to the owners.
Mrs Darko denied the claim that some of the drugs were stolen from the canteen and taken to the market, saying there was no evidence to that effect.
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Keeping medicines with companies
The report indicated that the FDA kept unlicensed drugs in the warehouses of offending companies, with the drugs ending up on the market.
Mrs Darko said there was no space at the ports or the FDA to detain unlicensed drugs.
Therefore, she said, the authority was compelled, under the circumstance, to keep unlicensed drugs in the warehouses of offending companies.
She said the FDA locked the warehouses and indicated that some of the companies broke the locks.
She said the FDA had now secured two warehouses, one for drugs and the other for food.
She added that the FDA was putting up a warehouse as part of its office project in Tema and said the project was expected to be completed by the end of next year.
Registration failures
The report said certain drugs on the market were not registered but they had ended up on the market.
On that, Mrs Darko explained that some of the drugs were in the process of being registered by the FDA.
She said the drugs were of good quality, except that they were going through the registration process when they found their way onto the market.
Importation
The report revealed that most importers applied for permit after the arrival of consignments at the ports, which presented a high risk of unauthorised medicines entering the market.
Responding, Mrs Darko admitted that the current system of importation was not the best.
She said the FDA was teaming up with the port authorities to ensure that the authority played a central role before the importation of drugs.
She said the FDA conducted spot sampling of drugs at the ports, did market surveillance, conducted pharmaco-vigilance tests and destroyed low quality drugs or got them re-exported.
She said those measures were to ensure that the quality of medicines was maintained.