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| FDA Exposed Unregistered Drugs Flood Market |
10/20/2013 |
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Issues have started popping up over the criteria used by the Food and Drugs Authority (FDA) in clamping down on the activities and operations of local manufacturing companies, especially those in the pharmaceutical business, supposedly under the guise of producing fake medicines.
The FDA is the regulatory body charged with the regulation of food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products.
But some of its recent operations had raised issues of concern among Ghanaians, with the latest being its clamp down on Tobinco Pharmaceuticals Company.
Its actions against Tobinco appear to be a target one as there are other several medicines that are running adverts which are not on the list of registered drugs.
A list of unregistered products as of September 2013 released by the FDA named not less than 14 local and foreign pharmaceutical companies with products on the Ghanaian market for not only manufacturing but selling drugs thought to be ‘fake’ to the general public since they have neither been re-registered or registered with a wide range of drugs
Interestingly, most of these companies have advertisements of those supposed ‘fake’ drugs running on radio, television and in newspapers on daily basis.
The FDA had often proceeded to seize and burn some of these products perceived to be ‘fake’, thereby denting the image and reputations with the case of Frank Paul Ventures (dealers in Yafo-Yafo range of products) and Kingdom Herbal, still fresh on the minds of Ghanaians.
This is what had kept many wondering why Tobinco pharmacy was singled out by the FDA as dealing in ‘fake’ drugs leaving the remaining 14 or so companies, raising issues of victimization.
What baffles many is why and how some of these supposed ‘fake’ products find their way on to the market without the knowledge and approval of the FDA.
Deficiency
Some even believe that to cover their incompetence, the FDA once in a while picks on one of the local companies just to give an impression that it is working.
For some including policy think tank Imani Ghana, this shows the deficiency and incompetence of the regulatory body.
In a statement issued on October 8, 2013, Imani said the FDA could not absolve itself from the apparent retrogressing in quality terms, of products by the pharmaceutical companies as it has failed to ramp up its own internal capacity to lift up Ghanaian pharmaceutical companies.
A statement issued by the think tank therefore called for a panel of inquiry into existing standards at the FDA and how they could be massively improved.
“In fact the same zeal the FDA applies to regulatory enforcement should now be turned onto itself to revamp its service delivery standards, and it should be done for the same reason that medicines are too critical for us to leave to ‘business as usual,” they said.
Probe Committee
Meanwhile, the Minister of Health, Sherry Ayittey had set up a three-member Ministerial Committee chaired by Deputy Minister of Health, Dr Alfred Tia Sugri to review and advise the Minister about the steps to take in order to avoid the recurrence of the current challenge.
The committee shall further review among others, the processes of medicines registration and post-market surveillance in Ghana including, but not limited to, evaluation of documents/dossiers, average throughput time for registration, risk/analytical assessment reports of medicines, the entry and clearance of pharmaceutical products at the points of entry.
By Charles Takyi-Boadu
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