Health News of Thursday, 10 October 2013
Dr Kwame Sarpong Asiedu, member of the Royal Pharmaceutical Society of Great Britain and Mr Franklyn Cudjoe of IMANI Ghana has blamed the Food and Drugs Authority (FDA) for the flooding of Ghanaian market with fake drugs.
Dr Sarpong Asiedu, who is also a Member of the Pharmaceutical Society of Ghana, has therefore petitioned President John Dramani Mahama to institute an investigation into the FDA’s activities.
In a statement signed by Dr Sarpong Asiedu and copied to the Ghana News Agency in Accra noted that the frequency of FDA reports on fake drugs points to a potential regulatory failure.
He, therefore, described the fake drug saga, as “systemic and leadership failings in the regulation of medicines by the FDA” and an attempt to shift the blame onto the importers solely.
Dr Sarpong Asiedu, also a Member of the Institute of Pharmacy Management UK and Institute of Directors of the United Kingdom, therefore, urged the President to “act as part the quest to rid Ghana of corruption, negligence of duty and possible incompetence.
“I will humbly suggest that the regulatory investigation is started from the very top to ascertain whether these systemic failings are an indication of poor leadership practice”.
He noted also that, as a result of these failings, importers are abusing the system with impunity… “I agree that the importers may have broken the law and need to be dealt with severely.
“However, the responsibility for this level of regulatory failure must rest solely with the leadership of the medicines regulator: the FDA”.
He noted that the FDA Act mandates it to have provisions in place for the importation of pharmaceuticals into Ghana.
“These provisions should aim at ensuring the integrity of Ghana’s drug delivery system; ensuring drugs available to the average Ghanaian are safe and minimizing drug treatment failure due to unwholesome medicines.
“As part of these provisions, the FDA issues clearance certification documents before any medicines can be cleared at any port of entry in Ghana. This certification is signed by an official of the FDA, and the medicine consignment needs to be inspected by officials of the FDA at the port of entry,” he noted.
He explained that the FDA Act also stipulates that where a drug, cosmetic, device or chemical substances is imported as a finished product, an application for registration of the drug shall be accompanied by a quality assurance certificate issued by the competent drug controlling authority of the exporting country.
The former lecturer at the Department of Pharmaceutical Chemistry, Faculty of Pharmacy, KNUST, alleged that the FDA also failed to adhere to the World Health Organization (WHO) conventions, which governs the movement of drugs in international commerce.
Dr Sarpong Asiedu also noted that for a pharmaceutical company to tender for supply of medicines to the Ghana Health Service, they need to provide evidence of FDA certification.
This, points to the fact that Tobinco Pharmaceutical Limited may have in their procession certification documents for the said medicines and thus were able to tender.
“In my view, it needs to be established, the authenticity or otherwise of these certification documents, and if found to be authentic, the identification of the official or officials who authorized these documents for otherwise unwholesome medicines,” he stated.
Meanwhile, IMANI, in a related statement copied to the Ghana News Agency also blamed recent events surrounding the withdrawal of some drugs from the Ghanaian market on the issue of medicine regulation in this country.
IMANI noted that “fake drugs,” incidents both highlight the human security and preventive nature of the FDA’s work as the Authority is there to ensure we are not swallowing poisons thinking we are taking medicine.
“This is classic law enforcement and security management work”.
The IMANI statement said the FDA has an equally important mandate to develop the pharmaceutical sector in this country to ensure that safe medicines are available to all.