Tobinco denies importing fake drugs

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Tobinco Pharmaceutical Company has denied importing fake and unwholesome drugs into Ghana.

“Our drugs that were and are being destroyed by the FDA are not fake drugs”, the company’s Chief Executive, Samuel Tobbin, has said in a statement.

Recent post-market surveillance exercises conducted by the FDA revealed that Tobinco Pharmaceuticals Limited had imported and distributed fake and unregistered medicines onto the Ghanaian market.

The identified medicines numbering over 100 were manufactured by BLISS GVS PHARMA Limited, located at 10 Dewan Udyog Nagar, Aliyali Palghar Maharashtra- 401, 404 India.

A statement issued and signed by the Chief Executive of FDA, Dr. Stephen Opuni, said the fake and unregistered medicines had been supplied to regional medical stores, hospitals and pharmacies nationwide.

It said the medicines posed a serious threat to public health and safety, since they had not been evaluated for their quality, safety and efficacy by the Authority.

The FDA has, in the meantime, detained all the fake and unregistered medicines found in the premises of Tobinco Pharmaceuticals and has directed those already distributed be immediately recalled countrywide in order to protect public health and safety.

Out of the over 100 medicines imported and distributed by Tobinco Pharmaceuticals Limited, only seven 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.

The statement advised regional medical stores, hospitals, clinics, pharmacies, licensed chemical sellers, maternity homes and other health facilities to avoid purchasing medicines imported by Tobinco and manufactured by BLISS GVS PHARMA Limited, which are not among the seven registered medicines for disbursement to the public.

It urged the listed facilities to hand over stocks of the medicines to the nearest FDA office for safe disposal.

However, Tobinco says “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.

It explained that: “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 company says: “The health and wellbeing 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”.

It explained that: “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”.

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