TOBINCO DENIES IMPORTING FAKE DRUGS … Runs to Mahama for succor

TOBINCO DENIES IMPORTING FAKE DRUGS

… Runs to Mahama for succor

By Mohammed Awal

The management of Tobinco Pharmaceutical Limited (TPL) has denied claims by the Food and Drugs Authority (FDA) that they have been trading in substandard pharmaceutical products on the Ghanaian market, arguing that the FDA’s claims were not based on any thorough clinical test to scientifically prove their assertions.

“The FDA has not brought any scientific proof on the assertions that it has made regarding Tobinco’s product,” management noted. “To Tobinco, therefore, there was no scientific basis for FDA’s declaration of its medicines as ‘fake’.

The Head of Communication at TPL, Dr. Peter Ebo Tobbin, made this known to the media at a press conference to brief the media about the latest development on the impasse between TPL and FDA.

Reiterating, TPL’s commitment to public health safety, Dr. Ebo Tobbin said that the health and priority concerns of the nation would continue to be their priority adding that TPL would continue to contribute its quota through the provision of quality medicines. “We will continue to maintain the quality, safety, and efficacy of our products,” he added.

MISJUDGEMENT

According to Dr. Ebo Tobbin, the assertions by the FDA that TPL imported into the Pharmaceutical market fake, substandard and unregistered drugs has been a misconception and judgment.

“What has led to the recent state of fairs about registration of products with the Food and Drugs Authority is a misjudgment and a delayed action on our part, and has nothing to do with the integrity of our products,” he revealed.

Dr. Ebo Tobbin further added that the fact that TPL has circulated millions of doses of anti-malaria medicines over the last three years without any reported treatment failures, does to some extent, attest to the efficacy and safety of its products.

Facts of The Impasse

The FDA and Tobinco Pharmaceuticals Limited have, for the past months been engaged in a media war, accusing each other of wrongful acts in the importation of fake drugs from Bliss GVS Pharma of India into Ghana by the latter.
While the regulator insists there have not been any clinical trial studies to justify the use of the anti-malaria drug, Gsunate Plus Suppositor, as well as register it in India and Ghana, and so was right to destroy the said product, the importer argues that there was no basis to warrant such an action, since the FDA had not conducted any scientific tests on the product to prove otherwise.
According to the FDA, since Tobinco had not met the requisite regulatory requirement to ascertain its efficacy level, it had no authorisation to use the drug on Ghanaian children as clinical subjects.
But Tobinco insisted that even though the Gsunate Plus Suppository drug was not registered by the regulator, they were not fake, and that they, and their Indian partner, Bliss GVS Pharma, produce and distribute quality medicines.

FDA’s Actions Illegal

Questioning FDA’s banning of TPL’s operations, Dr. Tobbin said the FDA’s actions was illegal and  a breach of section 116 of the Public Health Act 2012, Act 851, arguing that  “it is only the Minister who  may, by executive instrument, prohibit  the importation, manufacturer, exportation, advertisement or sale of a drug.”

Registration

The TPL said it wrote to the FDA to seek approval for extension of the re-registration of its medicines in view of the planned opening of the ultra-modern pharmaceutical manufacturing plant in Ghana.

According to TPL, the FDA, being aware of the progress of the manufacturing plant, granted Tobinco a waiver and extension on the re-registration until the factory was completed.

However, the TPL noted the plan for commissioning of the plant has been delayed due to their quest to meet international quality standards.

“It is worth noting that for these registration issues, a fine of GH¢40.000.00 was imposed on Tobinco,” which it duly paid, stated Dr. Ebo Tobbin. He further revealed that their suppliers, GVS Bliss, paid an amount US$ 57.000 for re-registration of 28 medicines in 2011 to FDA account.

Unfortunately, according to TLP, cracks in communication between it and FDA around that time delayed the submission of the supporting documents and samples of the medicines to expedite the re-registration process.

 Forced to Apologize and Threats

TPL accused the FDA of forcing its CEO, Dr. Samuel Tobbin and the CEO of Bliss GVS to sign the letter of apology. According to Dr. Ebo Tobbin, the letter came about through the insistence of Dr. Stephen Opuni, boss of the FDA. 

According to Dr. Ebo Tobbin, Dr. Stephen Opuni further insisted that: “I sincerely apologize for importing fake (Gsunate plus) anti-malarial into the country,” be included in the apology letter.

Dr. Ebo Tobbin, further alleged that the FDA boss threatened to bring down TPL. He quoted Dr. Opuni as saying that: “You wait, I am not done with you yet, if you do not know, I am a merciless being and will bring Tobinco down.”

He further accused the FDA boss, Dr. Opuni, of using communist inferior tacticts to frustrate the  efforts  of Tobinco in resolving the impasse at stake.

On several occasions, he stated that Management of TPL approached the Dr. Opuni for peaceful resolution of the issue, but the latter declined.

Tobinco further alleged that the FDA, with the support of EOCO, embarked a further onslaught on Tobinco by locking up its warehouses, and in the process physically assaulting staff members of the company.

TPL, therefore, called on the Mahama government to intervene to protect indigenous companies. “We are, therefore, appealing to the President of Ghana, His Excellency John Dramani Mahama to use his good offices to intervene in this matter.”