The three member committee set up by the Minister of Health to investigate the impasse between the Food and Drugs Authority (FDA) and Tobinco Pharmaceuticals has indicated that the products imported by Tobinco entered the country with the full knowledge of the FDA.
The Committee stated that the FDA gave Tobinco written permit to clear the drugs under a “Release and Detention” arrangement from the harbour.
Also, the Committee established that the Registration Committee of the FDA met only once in four years, which paved way for business persons to do all the wrong things to get drugs imported into the country.
The process of drug registration, however, was also found to be pregnant with many challenges including lack of transparency, where applicants were not given enough information about the status of their applications for registration of products for months without any communication.
The committee amongst others recommended that the Health Ministry should have a monitoring system and request for regular briefs from the FDA to forestall arbitrariness and curb disturbances in the pharmaceutical regulatory environment, pointing out that only dedicated and committed officers of the FDA should be posted to the ports and be held solely responsible when regulations are violated at the entry points.
The Minister of Health, Sherry Ayitey who received the committee’s findings, promised the recommendations will be worked on immediately and that the Ministry will meet with officials of the Customs Excise and Preventive Service (CEPS) to release executive instrument to halt such practices.
Tobinco Pharmaceuticals and the FDA have been in disagreement over the quality of the drugs and how the drugs entered the Ghanaian market.
In view of that a Committee was set up about a month ago to investigate how substandard drugs entered the country without FDA certification and make recommendations to the Ministry.