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26 November 2013

Tobinco appeals for President Mahama’s intervention in impasse with FDA.

 
Tobinco Pharmaceuticals Company Limited has appealled to President John Dramani Mahama to personally intervene in the impasse between the company and the Food and Drugs Authority (FDA).


The impasse, the company said, had led to a situation where its warehouses had been locked up, while its drugs had also been banned.
The cumulative effect of the actions of the FDA was that the fortunes of the company and health care for many people were being undermined, it said.
A member of the Tobinco Communications Team, Dr Peter Tobin, made the call when he addressed a news conference at the company’s subsidiary, Entrance Industries Limited and Research Centre, off the Spintex Road in Accra, yesterday.

Reasons for impasse
He attributed the standoff between Tobinco and the FDA to a “misjudgement and delay action” on the part of Tobinco in registering a product, saying it “had nothing to do with the integrity of our products”.
Dr Tobin said even the “penalty imposed by the authority in connection with the registration issues has been duly paid”.
For instance, he said, the company had paid GHc40,000 for importing the Gsunate plus.
He categorised the problems between Tobinco and the FDA into two.

Reasons
First, he said, the problem had to do with the importation of the Gsunate plus suppository, an anti-malarial (Artesunate/Amodiaquin) without clinical trials by the Indian manufacturer.
The second issue, he said, related to the importation of medicines pending registration and re-registration.
In its attempt to resolve the issues amicably, Dr Tobin alleged that the FDA insisted that the CEOs of Tobinco and Bliss GVS of India, the company that manufactures the drugs, should write a letter of apology to the authority.
He alleged that when the letter was prepared, Dr Opuni insisted that the statement should include “I sincerely apologise for importing a fake anti-malaria drug into the country”, which they did include under duress but added that they later realised that the letter should not have included such a statement of admission.

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