Tobinco sues FDA

BY: Samuel K. Obour

Tobinco Pharmaceuticals Limited has applied for an interim injunction against the Food and Drugs Authority (FDA) to restrain the FDA from further destroying products of the company until the final determination of the suit.

The Fast Track High Court has thus fixed October 16, 2013 to hear the case.

According to the plaintiffs, the injunction was necessary in order to restrain the FDA from further destroying the company’s products until the products were tested and certified as fake and until the final determination of the suit.

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In its statement of claim, it said the company had been engaged in pharmaceutical business for the past 13 years during which period it established a business relationship with Bliss GVS Pharma in India.

It said under the relationship, Bliss GVS Pharma manufactured pharmaceutical products, which were exported to the plaintiff (Tobinco) for distribution and sale in Ghana.

According to the plaintiff, it complied with all the law in relation to the importation of drugs into the country more particularly the Public Health Act 2012, Act 851.

It averred further that after registration of particular drugs with the FDA, the plaintiff started distribution of the drug throughout the country and added that it was only when the drug had been certified and registered with the FDA that it went ahead to distribute them.

It said registration of each drug was valid for a period of time after the expiration of which the plaintiff put in an application to the FDA for re-registration.

According to the plaintiff, it imported from Bliss GVS Pharma an anti-malaria drug called GSUNATE PLUS, a suppository, this year and that unknown to the plaintiff the said drug had not undergone clinical trials in the country of origin, India.

It indicated that in September, 2013 the FDA (defendants), which detected that the said drug had not gone through clinical trials in India, summoned the plaintiffs and the Indian manufacturer to the defendant’s office and the manufacturer explained that since the GSUNATE had already gone through clinical test, it was thought that the “suppository” needed not to go through further clinical trials.

The defendant, according to the statement of claim, imposed a GH¢40,000 fine on the plaintiff for the importation of unregistered drug, which was duly settled.

It stated that the plaintiff went ahead to recall the GSUNATE Plus from the market as ordered by the defendant and that despite complying with all the sanctions of the defendant, the defendant went ahead to refer the matter to the Bureau of National Investigations (BNI) and was embarrassing the company in the media.

In an affidavit in support of its claim, the plaintiff said the defendant had improperly labelled or described certain unregistered products of the company as fake based on which the defendant destroyed a number of drugs of the plaintiff.

It also accused the defendant of failing to exercise patience to test the said drugs and certify them to be fake or genuine and described the act of destruction of the products as “baseless in law and pharmacy”.

It noted that the destruction was causing the plaintiff grave financial loss that could not be restored when the drugs were finally certified as genuine.

By Sebastian Syme/Daily Graphic/Ghana

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