Maharashtra-based Bliss GVS Pharma is in trouble.
The company has been alleged by African nation Ghana's health watchdog to be supplying ‘fake’ medicines in the country.
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
In recent months, some Indian drugmakers have received warning letters from global regulators, including from the US, for issues related to manufacturing norm violations.
"Tobinco Pharmaceuticals had imported into Ghana a fake antimalarial medicine for children called GSUNATE Plus, a suppository which is manufactured in India by Bliss GVS Pharma," FDA Ghana said.
"The director of Bliss GVS Pharma confessed to the FDA that GSUNATE Plus suppository is fake and that no clinical trial study has been conducted on it and also admitted that it is not used to treat Malaria in children in India although malaria is prevalent in India," the regulator said.
FDA has seized the face medicine for destruction, it said, while cautioning the general public not to use any medicines, other than seven approved by FDA, from Tobinco and Bliss GVS Pharma-India, "since their efficacy, safety and quality cannot be guaranteed".
The regulator further said that Tobinco and Bliss GVS Pharma have given an undertaking "not to import or distribute unregistered or fake medicines into the Ghanaian market".
The FDA said it has seized and destroyed large consignments of unregistered medicines from various regional medical stores and hospitals in the country.
Bliss Gvs Pharma was incorporated in 1984 as a public limited company and its shares are listed on the BSE and NSE in India.
The photograph is used for representational purpose only
