24 Oct 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Ghana's Health Ministry has set up a three-member Ministerial Committee to investigate the import of an anti-malarial medicine for children from India.
The Country's Food and Drugs Authority (FDA) had recently banned the drug, Gsunate Plus and the health ministry's statement mentioned that this committee would investigate the import and distribution of the medicine manufactured by Indian company Bliss GVS Pharma Limited.
The FDA has last month accused that the company located in Central India's Maharashtra state had, "No clinical trial study had been conducted on the product which is made up of the combination of Artesunate 25 mg and Amodiaquine 75 mg."
The drug regulator had further claimed that the product had neither been registered nor approved by the Indian drug regulatory authority for sale or use.
FDA's Chief Executive, Mr Stephen Opuni had said in a statement, "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 and complications."
Soon after hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities immediately stopped dispensing Gsunate Plus and handed over stocks of the same to the FDA offices countrywide for safe disposal.
Both Bliss and Tobinco have denied any impropriety. The ministry's statement said that the committee would review the processes of medicines registration and post-market surveillance in Ghana, including, but not limited to, evaluation of documents/dossiers, average throughout time for registration, risk/analytical assessment reports of medicines, the entry and clearance of pharmaceutical products at the points of entry.