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Friday, October 25, 2013

Ghana committee to probe import of India-made drug

Accra (Ghana) -- Ghana's health ministry has set up a ministerial committee to investigate the import from India of an anti-malarial medicine for children, Gsunate Plus, recently banned by the country's Food and Drugs Authority (FDA).

A statement here by the ministry said a three-member ministerial committee has been set up to investigate the import and distribution of the medicine manufactured by Indian company Bliss GVS and imported by a local company, Tobinco.
Last month, FDA said its investigations had revealed "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 and manufactured by Bliss GVS Pharma Limited, located in Maharashtra, India".
The FDA also claimed that the product had neither been registered nor approved by the Indian drugs regulatory authority for sale or use.
"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," said FDA's chief executive Stephen Opuni.
It ordered "hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities having stocks of Gsunate Plus suppository to immediately stop dispensing them, and hand over stocks to the FDA offices countrywide for safe disposal".
Both Bliss and Tobinco have denied any impropriety. 
The ministry of health said the ministerial committee chaired by the Deputy Minister for Health, Alfred Tia Sugri, is to review and advise the minister the steps to avoid recurrence of such issues.
The ministry said its decision to investigate the matter is "to ensure that both the FDA as the national regulator, as well as all importers of pharmaceuticals get an excellent platform to perform their individuals tasks".
"The committee shall further review, among others, the processes of medicines registration and post-market surveillance in Ghana, including, but not limited to, evaluation of documents/dossiers, average throughput time for registration, risk/analytical assessment reports of medicines, the entry and clearance of pharmaceutical products at the points of entry," the statement said.
"The Ministry of Health reiterates that Substandard, Spurious, Falsified, Falsely labelled and Counterfeit (SSFFC) pharmaceuticals are inimical to our health system and will continue to do its utmost to halt their circulation," it added.

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