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Tobinco drug saga: FDA bans Indian company

Shibroor N. Kamath — MD of Bliss GVS Pharma Limited (left) and Dr Stephen Opuni — CEO of FDAThe Food and Drugs Authority (FDA) has, with immediate effect, banned the importation and distribution of all medicinal products manufactured by Bliss GVS Pharma Limited of India into Ghana.


A press release issued by the FDA in Accra yesterday said the company manufactured a fake anti-malaria medicine, Gsunate Plus Suppository, which was imported onto the Ghanaian market.

Efficacy

It said the efficacy and safety of the medicine had not been ascertained, since there had not been any clinical trial study to justify the use of the product for the treatment of malaria.

In addition to that, the release said, the manufacturer had not registered the drug in India, although malaria is prevalent in that country.

The manufacturers, it said, were, therefore, without the requisite regulatory authorisation, using Ghanaian children as clinical trial subjects.

According to the release, the Director of Bliss GVS Pharma Ltd India, the company that manufactured Gsunate Plus Suppository, had confessed to the FDB that the anti-malarial was not used for the treatment of malaria in children in India and also admitted that the product was a fake anti-malaria medicine.

Malaria is the number one cause of Outpatient Department (OPD) attendance and the highest cause of child mortality (death) in Ghana.

“The use of fake anti-malaria medicine can result in treatment failures, complications and preventable deaths in children. This poses a threat to the attainment of  Millennium Development Goals (MDGs) 4 and 6, which seek to reduce child mortality and combat HIV, malaria and other diseases,” the release stated.

Evaluation

It said Bliss GVS Pharma had also manufactured and distributed onto the Ghanaian market many medicinal products which had not been evaluated and duly registered as required by law.

“The quality, safety and efficacy of these medicines manufactured by GVS Bliss Pharma can, therefore, not be guaranteed, as they could pose a threat to public health and safety.

“Due to the above reasons, and in order to ensure utmost protection of the public health and safety of Ghanaians, the FDA has, therefore, blacklisted Bliss GVS Pharma from manufacturing medicines and other medicinal products for the Ghanaian market,” it added.

Apology

Meanwhile, the Chairman of Tobinco Pharmaceuticals Ltd and the Director of Bliss GVS Pharma-India have apologised to the FDA for importing Gsunate Plus Suppository to Ghana to treat malaria in children.

A statement signed by Dr Stephen Opuni, the Chief Executive of the FDA, said in two separate letters, the Chairman of Tobinco Pharmaceuticals, Mr Samuel Tobbin, and the Director of Bliss GVS Pharma, India, Mr S. N. Kamath, had signed an undertaking not to import or distribute unregistered or fake medicines onto the Ghanaian market.

Tobinco Pharmaceuticals imported into Ghana unregistered anti-malaria medicine for children called Gsunate Plus which is manufactured in India by BLISS GVS Pharma.

The FDA statement claimed that the Director of Bliss GVS Pharma allegedly confessed to the FDA that “Gsunate Plus Suppository is fake and that no clinical trial study has been conducted on it, and also admitted that it is not used to treat malaria in children in India, although malaria is prevalent in India”.

Daily Graphic/Ghana


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