The decision by the Food and Drugs Authority
(FDA) to declare drugs imported from India by Ghanaian Pharmaceutical
giant, Tobinco Pharmaceutical Limited, as fake and their subsequent
destruction after the arrest of the owner by the Bureau of National
Investigation seems to have riled the company, which has also asked 600
workers to go home.
According to the Financial Controller, Isaac Obed Brown,the workers have become redundant following the
branding of its imported drugs as fake by the FDA and that there was no
need to keep them when there are no work to be done. The FDA in its
recent statement accused the local pharmaceutical giant of importing a
fake anti-malarial medicine for children, called GSUNATE Plus, a
suppository which is manufactured in India by BLISS GVS PHARMA LTD.
According to the FDA, after the seizure and destruction of the drugs,
the Director of Bliss GVS Pharma, the exporter, confessed to the FDA
that GSUNATE PLUS SUPPOSITORY was fake and that no Clinical Trial study
had 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.
After hinting that the Executive Chairman of Tobinco Pharmaceuticals
Ltd and the Director of Bliss GVS Pharma have been arrested and
cautioned by the BNI, the FDA went ahead to caution the public not to
patronize any other medicines from Tobinco
Pharmaceuticals Ltd and Bliss GVS Pharma-India, which has not been
certified by them, since their Efficacy, Safety and Quality cannot be
guaranteed.
In a reaction, Tobinco Pharmaceutical Company assured the public that
it will continue to maintain the quality and integrity of its products
as it embarks on resolving issues with the Food and Drugs Authority and
clearing its good name.
"Our drugs that are being destroyed by the FDA are not fake drugs". The Chief Executive emphasized.
The company states clearly that in its thirteen years in the
pharmaceutical industry, it has operated honestly and complied with all
regulatory requirements and completely rejects allegations of dealing in
unwholesome products.
"We can say without doubt that the company has always imported
quality pharmaceutical products, contrary to what has been put out.
"What has led to the recent state of affairs with regards to
registration of products with the Food and Drugs Authority is a
misjudgment and delayed action on our part, and has nothing to do with
the integrity of the products.
"A penalty imposed by the Authority in connection with the
registration issues has been duly paid and further discussions are
ongoing.
"The health and wellbeing of the nation are our priority concerns and
we will continue to contribute our quota through the provision of
quality drugs and establishing world class manufacturing facilities in
Ghana that will also create jobs.
We must state that some of the medicines which are being destroyed
were passed under our previous registrations by the FDA whilst some are
in the process of registration and cannot be described as 'fake'. Thus,
we are not in violation of the provisions of the Public Health Act 2012,
Act 851, subsection 123, on fake (counterfeit) products.
Since product registration is for a period, after which the product
must be re-registered upon the submission of the relevant supporting
documentation, samples and payment, we have duly been pursuing
re-registration in respect of all the products we distribute.
Indeed, the requisite registration payments have been made and
documentations are being prepared for the attention of FDA. We therefore
wish to assure the general public that TOBINCO is committed to ensuing
public health and safety and have never and will not compromise on this.
Both FDB and the Ministry of Trade are yet to react to the decision to ask the workers to go home.
No comments:
Post a Comment