Anti-Malaria Drug Health Alert! FDA Exposes Indian Firm
– GSUNATE Plus Suppository not approved for sale or use in India
The Food and Drugs Authority (FDA) has again warned the general public not to patronize a supposed anti-malarial medicine for children called GSUNATE Plus, a suppository made up of combination of Artesunate 25mg and Amodiaquine 75mg because it cannot guarantee its efficacy.
The FDA in a statement signed by its Chief Executive, Dr. Stephen Opuni and released in Accra over the weekend says 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 with complications?.
According to the Food and Drug enforcement agency, no Clinical Trial study has been conducted on the product GSUNATE Plus, which is manufactured in India by a company called BLISS GVS PHARMA LTD located at 10 Dewan Udyog Nagar, Aliyali Palghar Maharashtra- 401, 404 India.
More disturbing the FDA reveals is that, even though malaria is among the major killer diseases in India, GSUNATE Plus is not on the medicine list approved for sale or use by the India Medicine Regulatory Authority.
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?Investigations conducted by the FDA have revealed that GSUNATE PLUS SUPPOSITORY has not been registered by the Medicine Regulatory Authority in India (i.e. approved for sale or use in India) although malaria is one of the major killer diseases in India?.
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The Authority added that GSUNATE Plus suppository is not registered by the FDA and the drug cannot be guaranteed for the treatment of malaria in children.
It further called on Hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities having in stocks the GSUNATE Plus Suppository to immediately stop dispensing them and handover stocks to the nearest FDA office countrywide for safe disposal.
This is the second time in less than two weeks the Food and Drugs Authority is issuing Public Health Warning on the sale, dispensing and use of GSUNATE Plus Suppository imported from Indian by a Ghanaian drug distribution company, Tobinco Pharmaceutical Ltd.
Meanwhile, according to the statement from the FDA, the importer, Tobinco Pharmaceutical Ltd is still assisting the Food and Drugs Authority (FDA) to ensure a total recall of this drug from the market.
?Information from the general public on persons in any practice possible of endangering public health and safety with respect to FDA?s mandate is most welcome through any of the following contact numbers; 0244337235, 0544863418, 0244571563 or 0244337250,? it advised.
Source:?The Al-Hajj newspaper
