Ghana's drug regulator blacklists India's Bliss GVS Pharma

Under fire for supplying fake medicines, Indian pharmaceutical firm Bliss GVS Pharma has been banned by Ghana's health watchdog from importing and distributing medicinal products to the African country.

The Maharashtra-based company was found to be selling fake and unregistered malaria drugs in Ghana, along with a local company named Tobinco Pharmaceuticals.

"The Food and Drugs Authority (FDA)... has with immediate effect banned the importation and distribution of all medicinal products manufactured by Bliss GVS Pharma Limited," FDA Ghana chief executive Stephen K Opuni said in a statement.

The African nation watchdog, which regulates the country's over $300 million drug market, said the step has been taken as a result of the manufacture and distribution of medicinal products by Bliss GVS Pharma into the country without adherence to the registration requirements.

Top officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children, according to Ghana's Food and Drug Administration (FDA).

"The company manufactured a fake antimalarial medicine (Gsunate Plus Suppositories) which was imported into the Ghanaian market. The efficacy and safety of this antimalarial medicine has not been ascertained since there has not been any clinical trial study to justify the use of this medicinal product for the treatment of Malaria," Mr Opuni said.

Bliss GVS Pharma has not registered this drug in the country of origin (India) even though malaria is prevalent in India and the manufacturer is therefore without the requisite regulatory authorisation using Ghanaian children as "clinical trial subjects", he added.

In recent months, some Indian drug makers have received warning letters from global regulators, including from the US, for issues related to manufacturing norm violations.

The Rs 400-crore Bliss GVS Pharma was incorporated in 1984 as a public limited company and its shares are listed on India's leading bourses BSE and NSE.