As FDA Seizes Two Containers Of More Fake Medicines At Tema Harbour
The Herald has intercepted two letters written and signed by Nana Samuel Tobbin, the Chief Executive Officer (CEO) of Tobinco pharmaceutical and their Indian suppliers, in which they both confessed to supplying a fake malaria medicine, Gsunate Plus Suppository to consumers in Ghana.
The said medicine is for the treatment of malaria in children, and is administered through the anus. The two companies failed to produce any documentation on the components of the medicine, which is currently in circulation in both state and private health facilities in the country.
Both the chairman of Tobinco Pharmaceuticals Ltd, Nana Samuel Tobbin and the Managing Director of Bliss GVS Pharma, India, Shibroor. N. Kamath have apologised to the Food and Drugs Authority (FDA) and signed an undertaking not to repeat same.
The letters were dated Saturday, September 26, 2013 and addressed to Dr. Stephen Opuni, Chief Executive of the FDA shortly after the Bureau of National Investigation (BNI) arrested the two for questioning over the situation which resulted in many deaths.
Meanwhile FDA has seized for destruction two heavy-loaded twenty-footer containers at the Tema Habour brought into the country by the troubled Ghanaian medicine seller, Tobinco Pharmaceuticals Limited, from India.
According to the FDA, the two containers are holding large consignments of medicines recently labelled as unregistered and fake, hence have been seized for destruction, to save the lives of innocent Ghanaians as the efficacy, safety and quality of the medicines cannot be guaranteed.
The seizure follows discoveries by the FDA that over a 106 medicines imported into the country and sold to both state and private health facilities in Ghana by Tobinco Pharmaceuticals Limited were not registered and tested by the Indian drugs authorities before they were exported to Ghana by their manufacturers Bliss GVS Pharma-India.
Additional information available to The Herald is that Ghana’s FDA is in the process of blacklisting the manufacturer Bliss GVS Pharma of India, to the World Health Organization (WHO), meaning none of its medicines could be prescribed, sold and consumed in Ghana for the treatment of any illness.
The discovery of the two containers comes days after the Chairman of Tobinco Pharmaceuticals Ltd and the Director of Bliss GVS Pharma-India, apologised to the FDA for importing fake Malaria Medicine (Gsunate Plus Suppository) to Ghana to treat malaria in children.
A press release signed by the FDA boss, Dr. Opuni, admitted the receipt of the two separate letters from the chairman of Tobinco, Mr. Tobbin and the Managing Director of Bliss GVS Pharma of India, Mr. Kamath.
It said they had “signed an undertaking not to import or distribute unregistered or fake medicines onto the Ghanaian market”.
“Tobinco Pharmaceuticals Ltd imported into Ghana a fake anti-malarial medicine for children called GSUNATE Plus, a suppository which is manufactured in India by BLISS GVS PHARMA LTD, located at 10 Dewan Udyog Nagar, Aliyali Palghar Maharashtra- 401, 404 India”.
The FDA boss said “the Managing Director of Bliss GVS Pharma confessed to the FDA that GSUNATE PLUS SUPPOSITORY is fake and that no Clinical Trial has been conducted on it and also admitted that it is not used to treat Malaria in children in India although malaria is prevalent in India”.
“The FDA has seized the fake malaria medicines for destruction”, Dr. Opuni revealed.
Additionally, out of over 100 medicines imported and distributed by Tobinco Pharmaceuticals Ltd, only seven (7) have duly been given approval by the FDA. The approved medicines are; Nifin 20-R Tablets, Slipizem 2.5mg Suppository, Slipizem 5mg Suppository, Lonart tablets, Lonart Forte Tablets Lonart Oral Suspension and Ciprotab Tablets.
Apart from this approved list of medicines, the FDA is cautioning the general public not to patronise any other medicines from Tobinco Pharmaceuticals Ltd and Bliss GVS Pharma-India, since there are doubts about their efficacy, safety and quality.
The FDA has, therefore, seized and destroyed large consignments of unregistered medicines from various Regional Medical Stores and hospitals in the following Regions; Volta Region, Upper West Region, Western Region, Ashanti Region and Eastern Region.
It confirmed that the Executive Chairman of Tobinco Pharmaceuticals Ltd and the Director of Bliss GVS Pharma were arrested and cautioned by the BNI, and were also assisting the FDA and the BNI in investigations into the situation.
Meanwhile, Tobinco Pharmaceutical Company has in a reaction, assured the public that it will continue to maintain the quality and integrity of its products as it embarks on resolving certain issues with the FDA and clearing its good name.
“Our drugs that were and are being destroyed by the FDA are not fake drugs”. The Chief Executive emphasized.
The company states clearly that in its thirteen years in the pharmaceutical industry, it has operated honestly and complied with all regulatory requirements and completely rejects allegations of dealing in unwholesome products. “We can say without doubt that the company has always imported quality pharmaceutical products contrary to what has been put out.
“What has led to the recent state of affairs with regards to registration of products with the Food and Drugs Authority is a misjudgment and delayed action on our part, and has nothing to do with the integrity of the products. A penalty imposed by the Authority in connection with the registration issues has been duly paid and further discussions are ongoing.”
“The health and well being of the nation are our priority concerns and we will continue to contribute our quota through the provision of quality drugs and establishing world class manufacturing facilities in Ghana that will also create jobs.
“We must state that some of the medicines which are being destroyed were passed under our previous registrations by the FDA whilst some are in the process of registration and cannot be described as “fake”. Thus, we are not in violation of the provisions of the Public Health Act 2012, Act 851, subsection 123, on fake (counterfeit) products”.
“Since product registration is for a period, after which the product must be re-registered upon the submission of the relevant supporting documentation, samples and payment, we have duly been pursuing re-registration in respect of all the products we distribute. Indeed the requisite registration payments have been made and documentations are being prepared for the attention of FDA”.
“We therefore wish to assure the general public that Tobinco is committed to ensuring public health and safety and have never and will not compromise on this”.
“We appreciate the support of our clients and customers who have sympathized with us in these trying times and assured them that they can continue to count on us to uphold our integrity and continue to provide quality service to them”.