The Pharmaceutical Society of Ghana (PSGH) says it is baffled by reports of importation of large quantities of alleged fake drugs into the country.
The society says the impasse between the Food and Drugs Authority (FDA) and the importers of these alleged fake drugs "SMACKS OF A SYSTEM REGULATORY FAILURE AND LACK OF THE TECHNICAL ASSISTANT AND INPUTS INTO REGULATORY DECISION-MAKING."
In a statement issued by the PSGH on Wednesday, it called on government to urgently investigate the current state of alleged fake importation of medicines in the country and punish those who are found culpable.
The society said whiles it endorses �the full application of the law on any person or company actually and scientifically proven to have indeed imported or manufactured fake, substandard or counterfeit medicines illegally into the Ghanaian market since it has the tendency of putting the health of Ghanaians at risk,� the PSGH also "strongly" condemned "unproven and unsubstantiated alerts and allegations on medicines by the FDA or any agency".
"...such �alarmist� information creates unnecessary panic among all stakeholders in the medicines industry including patients and the general populace. It further undermines the integrity and efforts of some pharmaceutical companies as their hard-won reputation and businesses risk public disaffection. The ultimate cost to genuine local business and initiative is irreparable," the statement said.
The PSGH also expressed regret that its attempt to engage the FDA over some of these issues has not materialized and made reference to a letter dated 6th June 2013.
Read the full statement below
PRESS RELEASE BY THE PHARMACEUTICAL SOCIETY OF GHANA (PSGH) ON FDA'S RECENT MEDIA STATEMENTS/ALERTS ON ALLEGED FAKE MEDICINES IMPORTATION AND DISTRIBUTION IN GHANA
Press release by the pharmaceutical society of Ghana (PSGH) on FDA�s recent media statements/alerts on alleged fake medicines importation and distribution in Ghana
Over the last few weeks, the quality, safety and efficiency of medicine circulating in commerce in the country have been brought into question. The Pharmaceutical Society of Ghana (PSGH) has followed with ken interest and concern, the press releases, accusations and counter accusation coming from the Food and Drug Authority (FAD) and some pharmaceutical companies over alleged fake medicines importation and distribution in the country.
At a meeting of the Standing Executive Committee (SEC) of the PSGH on 25th April, 2013 members expressed concern about a similar impasse between the FDA and some importers over alleged fake and unregistered medicine in February this year. Some of the issues that baffled members at the meeting included:
1. How large quantities of the alleged fake medicines were brought into the country and or were cleared from the port of entry without FDA clearance certification documents signed by an FDA official?
2. Whether the importers applications for registration of the alleged fake finished pharmaceutical products were accompanied by quality assurance certificates issued by the competent medicines regulatory authorities of the exporting countries as required by law?
WHAT IS HAPPENING BETWEEN THE FDA AND THE IMPORTERS OF THESE ALLEGED FAKE MEDICINES SMACKS OF A SYSTEM REGULATORY FAILURE AND LACK OF THE TECHNICAL ASSISTANT AND INPUTS INTO REGULATORY DECISION-MAKING. GOVERNMENT NEEDS TO URGENTLY INVESTIGATE THIS AND THOSE FOUND CULPABLE PUNISHED.
The society regrets that its attempt to engage the FDA has not materialized. Specific reference is made to a letter dated 6th June 2013. The FDA is yet to respond to these requests.
The PSGH notes the critical role accessible, affordable, safe, efficacious and quality medicines play in healthcare interventions worldwide, Ghana not being an exception.
Indeed, pharmacists in manufacturing industries, hospital and community practice, academia, research and development, regulation, wholesale distribution and marketing, and policy administration, have all contributed immensely in the past and present to ensure that the Ghanaian public has access to professional pharmaceutical care and services as well as quality medicines. This is the PSGH�s responsibility to the good people of Ghana.
The PSGH therefore endorses the full application of the law on any person or company actually and scientifically proven to have indeed imported or manufactured fake, substandard or counterfeit medicines illegally into the Ghanaian market since it has the tendency of putting the health of Ghanaians at risk.
In the same breadth, the Society strongly condemns unproven and unsubstantiated alerts and allegations on medicines 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. It further undermines the integrity and efforts of some pharmaceutical companies as their hard-won reputation and businesses risk public disaffection. The ultimate cost to genuine local business and initiative is irreparable.
As part of its long term strategy of ensuring the medicines are properly regulated, the PSGH advocated for the setting up of a new medicines regulatory authority in the early 1990�s and worked assiduously with the Ministry of Health (MOH) and the then PNDC government to pass the PNDC Law 305B that set up the Food and Drugs Board which is now the Food and Drugs Authority. Before the passage of PNDC Law 305B by the PNDC, the current functions of the FDA were performed by the office of Chief Pharmacist and Director of Pharmaceutical Services of the MOH with support from the Pharmacy Council Quality Control Laboratory; form where the FDA started.
In view of the press releases, accusations and counter accusations that have the tendency to create panic and loss of confidence in the healthcare system, the PSGH appeals to the Hon. Minister of Health to as a matter of urgency personally intervene to have a full risk assessment of the current situation in order to find out what had gone wrong with our regulatory system; culminating in the �leakage� of large quantities of alleged fake and unregistered medicines into the country by some pharmaceutical importers.
The PSGH is willing to work with the Hon. Minister of Health, the FDA, pharmaceutical importers, pharmaceutical 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 the good people of Ghana.
The PSGH as part of its professional approach to ensuring safety, efficacy and quality of generic medicines fully supports the efforts of the MOH and some development partners for the establishment of a Bioequivalence and Biopharmaceutical Research Centre in Ghana. The Centre will serve the entire West African Region to assure the quality, safety and efficacy of generic essential medicines and hence ensure quality pharmaceutical care and the sustainability of the NHIS in member countries.
The PSGH also wish to use this opportunity to entertain to caution all members of the society that appropriate sanctions will be applied against any member who is found to condone any illicit or unprofessional act in the discharge of his or her duties as a pharmacist. Superintendent Pharmacists of pharmaceutical importers risk facing disciplinary action if they do not supervise and ensure that only registered medicines are imported by their employers.
����.Signed����
PHARM. JAMES OHEMENG KYEI
PRESIDENT
Source: Peacefmonline.com/Ghana
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