The Food and Drugs Authority (FDA) has with immediate effect banned the importation and distribution of all medicinal products manufactured by Bliss GVS Pharma Limited, Dombivli (E) 421 201 Dist-Thane, India, into Ghana.
This has been necessary as a result of the manufacturer not adhering to the registration requirements as enshrined in the Public Health Act of 2012, Act 851, a process which assures the quality, safety and efficacy of all medicinal products used in Ghana.
The company manufactured a fake anti-malarial medicine (GSUNATE PLUS SUPPOSITORIES), which was imported onto the Ghanaian market. The efficacy and safety of this anti-malarial medicine has not been ascertained since there has not been any clinical trial study to justify the use of this medicinal product for the treatment of Malaria.
A statement issued and signed by the Chief Executive of FDA, Dr Stephen Opuni, and copied to the Ghana News Agency on Thursday, said the manufacturer has not registered the drug in the country of origin (India) even though malaria was prevalent in India. The manufacturer has therefore without the requisite regulatory authorization using Ghanaian children as clinical trial subjects.
It said the Director of Bliss GVS Pharma Limited India, the company that manufactured Gsunate Plus Suppositories, has confessed to the FDA that the anti-malarial medicine was not used for treatment of malaria in children in India. The Director of Bliss GVS Pharma Limited, India also admitted that the Gsunate Plus Suppository was a fake anti-malarial medicine.
“Malaria is the number one cause of Out Patients Department (OPD) attendance and the highest cause of child mortality (death) in Ghana. The use of fake anti-malarial medicine can result in treatment failures, complications and preventable deaths in children. This poses a threat to the attainment of the Millennium Development Goals Nos. 4 and 6, which seek to reduce child mortality and combat HIV, Malaria and other diseases respectively”.
The statement explained that the company had also manufactured and distributed onto the Ghanaian market many other medicinal products, which have not been evaluated and duly registered as required by law.
It said the quality, safety and efficacy of these medicines manufactured by GVS Bliss Pharma Limited could 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 Public Health and Safety of Ghanaians, the Food and Drugs Authority has therefore blacklisted BLISS GVS PHARMA LTD, INDIA from manufacturing of medicines and other medicinal products for the Ghanaian market”, the statement said.