From Ghana Business News
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.
Read more at ghanabusinessnews.com