The Bureau of National Investigations (BNI), yesterday moved in on officials of the Tobinco Pharmaceuticals Limited and of Bliss GVS Pharma Limited of India, over the importation and distribution of some fake and unregistered medicines in the country.
Two officials of the two companies, Nana Samuel Amo Tobin and Shibroor N. Kamath, Chairman of Tobinco Pharmaceuticals Limited and Managing Director of Bliss GVS Pharma Limited respectively, yesterday spent some time with BNI operatives assisting them with their investigation into how unapproved medicines came into Ghana.
Investigations conducted by the Food and Drugs Authority (FDA), have revealed that the medicines including, GSUNATE Plus Suppository for the treatment of malaria in children, have not been tested, approved and registered by the Medicine Regulatory Authority in India, although malaria is one of the major killer diseases in India.
The Herald learnt from FDA that the Managing Director of Bliss GVS Pharma Ltd, S.N Kamath has admitted manufacturing the medicines, which have not been approved in India for sale in Ghana.
Mr. Kamath, is in the country over the presence of the fake and unregistered medicine in Ghana. He is said to have since apologized to the FDA officials, who are most likely to push for criminal prosecution.
Also assisting the BNI are some officers of the FDA.
Meanwhile, the Authority has blacklisted more medicines imported into the country by Tobinco Pharmaceuticals Limited and has also begun an exercise to retrieve all these unregistered and fake medicines for destruction.
The medicines, have been supplied to regional medical stores, hospitals and pharmacies nationwide, according to the FDA pose a serious danger to public health and safety of consumers.
Dr. Stephen Kwabena Opuni, Chief Executive Officer of FDA, explained in a press release that the medicines have not been evaluated for their quality, safety and efficacy before they were brought into the country and distributed throughout the country.
Out of over 100 medicines manufactured by the Indian company, Bliss GVS Pharma Ltd, imported and distributed by Tobinco Pharmaceuticals, only seven have duly been given approval by the Authority.
The approved medicines are Nifin 20-R Tablets, Slipizem 2.5mg Suppository, Slipizem 5mg Suppository, Lonart tablets, Lonart Forte Tablets, Lonart Oral Suspension and Ciprotab Tablets.
The unapproved ones are to be retrieved and destroyed by the FDA.
The statement revealed that the FDA identified the importation and distribution of the fake and unregistered medicines manufactured by Bliss GVS Pharma Ltd, located at 10 Dewan Udyog Nagar, Aliyali Palghar Maharashtra- 401, 404 India, following its post market surveillance exercise throughout country.
The FDA, “Has in the meantime detained all the fake and unregistered medicines found in the premises of Tobinco Pharmaceuticals and has directed that those already distributed be immediately recalled countrywide in order to protect public health and safety”, Dr. Opuni said.
It further revealed that “Regional medical stores, hospitals, clinics, pharmacies, licensed chemical sellers, maternity homes and other health facilities are advised to avoid purchasing these and other fake/ unregistered medicines for disbursement to the public and to hand over stocks of these medicines to the nearest FDA office for safe disposal”.
Meanwhile, the importer, Tobinco Pharmaceutical Ltd and the manufacturer, Bliss GVS Pharma Ltd of India are assisting the FDA to ensure a total recall of these fake/unregistered medicines from the market, as well as health facilities nationwide.
Additionally, 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.