Credibly information reaching The Chronicle has revealed that the General Secretary of the National Democratic Congress (NDC), Johnson Asiedu Nketia, has intervened to bring to an end the ongoing media war between the Food and Drugs Authority (FDA) and Tobinco Pharmaceuticals Limited.

Mr. Asiedu Nketia, known in political circles as ‘General Mosquito’, was said to be worried about the impasse between the two institutions, and therefore, decided on Monday to mediate and bring to an end the conflict that has ensued between the FDA and Tobinco Pharmaceuticals Limited.

General Mosquito, according to some workers of the FDA who saw him enter their premises, was accompanied by the Chairman of the Church of Pentecost, Apostle Dr. Opoku Onyinah, and some staff of the pharmaceutical company.

Efforts to get him (Nketiah) react to why he made the move to broker peace between the two institutions proved futile, as his cell phone was switched off or out of coverage area. A text message sent to him was also not responded to.

The FDA and Tobinco Pharmaceuticals Limited have, for the past two weeks, 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.

Red alert

While arguing on the matter, the FDA, on September 12 and 24, 2013, respectively, issued a red alert, cautioning Ghanaians about the dangers involved in consuming the Gsunate Plus Suppository medicine, since its efficacy level could not be guaranteed.

The FDA hinted that its investigations have revealed that the Gsunate Plus Suppository medicine had not been registered by the Medicine Regulatory in India, “although malaria is one of the major killer diseases in India.”

“The efficacy of the combination of artesunate and amodiaquine, through the rectal route, has not been established, and therefore, treatment of malaria in children with this drug could lead to therapeutic failures with complications.” It added, “Gsunate Plus Suppository is not registered by the FDA, and the drug cannot be guaranteed for treatment of malaria in children.”

Blacklisting

Following the consumer alert, the FDA, on October 2, 2013, went further to inform the general public of blacklisting Bliss GVS Pharma with immediate effect, for not adhering to the registration requirements as enshrined in the Public Health Act of 2012, Act 851.

“The FDA, as mandated by the Public Health Act, 2012, Act 851, has with, immediate effect, banned the importation and distribution of all medicinal products manufactured by Bliss GVS Pharma Limited, Dumbivli (E) 421 201 Dist-Thane, India into Ghana.”

Hit Man Condoms

It further went ahead in a statement issued on October 3, 2013, to, again, caution the general public about the use of Hit Man Condoms imported into the country from Universal Prophylactic Pvt Limited, Aurangabad-India, by Tobinco Pharmaceuticals Limited.

The FDA argued that the importation of the condoms was in contravention of part 7 of the Public Health Act of 2012, Act 851. “Tobinco Pharmaceuticals Limited was directed by the Food and Drugs Authority to quarantine and not offer for sale the Hit Man Condoms until they had been tested by the FDA’s Medical Device Laboratory to ascertain their quality. Tobinco Pharmaceuticals Limited violated the directives of the FDA, and distributed the Hit Man Condoms,” noted the FDA.

Apology

In the midst of the tussle, Tobinco Pharmaceuticals, and it partner, Bliss GVS Pharma, issued separate undertakings, apologising to the FDA for their conduct, and not to import fake malaria medicines into the country. The undertaking from Tobinco Pharmaceuticals Limited, signed by its Chairman, Samuel Tobbin, and dated September 26, 2013, in part read, “I Mr. Samuel Amo Tobbin, the Executive Chairman of Tobinco Pharmaceuticals Limited, on this day, Thursday, September 26, 2013, solemnly undertake never to import any unregistered and/or unlicensed medicines and other medical products into Ghana. I sincerely apologise for bringing in a fake anti-malaria drug (Gsunate Plus) for children into Ghana.”

That of Bliss GVS Pharma, signed by its Director, S. N. Kamath, in part, also read, “I Mr. S. N. Kamath of Bliss GVS Pharma Limited, on this day, Thursday, September 26, 2013, solemnly undertake never to export any unregistered and/or unlicensed medicines and other medical products into Ghana. I sincerely apologise for exporting a fake anti-malaria drug (Gsunate Plus) for children to Ghana.”

Legal action

Alarmed by the stance of the FDA, Tobinco Pharmaceuticals Limited took legal action against the FDA, and prayed to the court to restrain the regulator from further destroying their products until the final determination of the suit.

However, following the intervention by NDC General Secretary, which The Chronicle learned resulted in fruitful discussions, Tobinco Pharmaceuticals has rendered an unqualified apology to the FDA, and gone further to withdraw its suit, and opted for an out of court settlement.