The Pharmaceutical Society of Ghana (PSGH) has backed calls for investigations into operations of the Food and Drugs Authority (FDA) due to what it describes as a “systemic regulatory failure” at the Authority.
The PSGH says a lack of technical assessment and inputs into regulatory decision-making at the FDA is the cause of the recent allegations of fake drug importation and distribution between FDA and some pharmaceutical companies.
PSGH’s call for a scrutiny of FDA’s operations will be the third of such calls from a recognised body this week in the wake of a media row between the FDA on one hand and Tobinco Pharmaceuticals and Bliss GVS Pharma Limited on the other.
Policy think tank, IMANI-Ghana revealed on Tuesday October 8 that its survey of importers of pharmaceutical products and key industry players show that FDA has failed to live up to its responsibility of ensuring that local pharmaceutical companies abide by quality standards and regulations.
IMANI-Ghana says the FDA cannot absolve itself from the apparent retrogression of the quality of pharmaceutical products on the Ghanaian market because it has failed to ramp up its own internal capacity to lift up Ghanaian pharmaceutical companies.
Kwame Sarpong Asiedu, a UK-based Ghanaian Pharmacist, has also petitioned government to investigate the activities of FDA in the wake of numerous reports of fake drugs on the market.
Mr Asiedu noted that the situation is even more dire concerning the FDA’s own admission – in a statement – that some of the fake drugs have found their way to hospitals in Ghana.
Meanwhile, a press release signed by PSGH President, James Ohemeng Kyei, says the society’s attempts to engage the FDA have been unsuccessful, adding “the FDA is yet to respond to the society’s request [to collaborate with them] since June 6”, 2013.
“The society strongly condemns unproven and unsubstantiated alerts and allegations on medicine by the FDA or any agency, as such alarmist information creates unnecessary panic among all stakeholders in the medicines industry including patients and the general populace” the PSGH statement said in reaction to a FDA directive to hospitals and pharmaceutical companies to return all Bliss BVS products suppliers because they are fake.
Bliss GVS Pharma Limited, an Indian pharmaceutical company, is alleged to have imported and distributed Gsunate Plus Suppository, a fake anti-malarial drug for infants, into the country. The FDA subsequently banned the importation and distribution of all medicinal products manufactured by the Indian company.
The statement by PSGH said that such alarms further undermined the integrity and efforts of some pharmaceutical companies and appealed to the Minister of Health (MOH), Madam Sherry Ayitey, to intervene,
PSGH says there is the need for a full risk assessment of the current situation at FDA in order to find out what had gone wrong with the regulatory system, culminating in the leakage of large qualities of alleged fake and unregistered medicines into the country.
PSGH says it is willing to work with MOH, the FDA, pharmaceutical importers and manufacturers, and other stakeholders, as it had done in the past to ensure availability of quality, safe and efficacious medicines that are affordable and meet the health needs of Ghanaians.
The Pharmaceutical Society of Ghana says it is surprised how the alleged counterfeit medicines were cleared from the ports of entry without FDA clearance certification documents signed by an accredited official of the Authority, and assured that they would not renege in their responsibility to ensure that the Ghanaian public have access to professional pharmaceutical care, services and quality medicines.
“The PSGH therefore endorses the full application of the law on any person or company actually and scientifically proven to have indeed imported manufactured fake, substandard or counterfeit medicines illegally into the Ghanaian market,” the statement added.