Health Ministry committee report on Tobinco-FDA impasse inaccurate – FDA
The Food and Drugs Authority (FDA), on Thursday described the report released by the Ministry of Health’s (MOH) Committee set up to investigate the recent impasse between the FDA and Tobinco Pharmaceuticals as inaccurate.
Mr James Lartey, FDA’s Public Relations officer in an interview with the Ghana News Agency (GNA), debunked the part of the report which indicated that the FDA’s Registration Committee met only once in the last four years, describing the assertion as “untrue”.
He said the Registration Committee met on regular basis and for 2013 alone it had met five times, the last being on the 23rd December 2013.
He added that the committee met regularly to evaluate all documents to ensure that the Dossier presented by pharmaceutical companies did not contain forged documents.
“Between 2010 and 2013, a total of about 5,033 applications were received out of which 3254 were given approval and the remaining ones were rejected due to the inability of applicants to meet the quality, safety, efficacy or documentation requirements.
“All these are done to ensure that only good quality, efficacious and safe medicines are approved to be on the market.
“The Law that governs medicine regulation in this country was passed by Parliament; the Committee in the MOH cannot change the law”, he added.
In response to the allegation that products cleared under detention were unprotected with FDA padlocks, Mr Lartey said: “At anytime products are allowed to be cleared under detention pending market authorization, the FDA officer and the importer/ applicant signs the detention form after the quantity of the consignment has been determined by both parties”.
“This then becomes a binding legal document between the parties. It must be noted that once the detention notice is signed, the consignment is not to be touched until further notice is given.”
Mr Lartey noted that the FDA had on several occasions detained medicinal products at the Central Medical Stores without locking up the place, otherwise Ghanaians would have been deprived of government’s supply of medicines.
“It must however be noted that once a detention notice is given, the client has no right whatsoever to touch the product until the Authority has released the products or otherwise.
“Is it being suggested that the client has the right to go for his products if the client feels the regulator is “keeping too long?, he questioned.
On transparency, the FDA wondered how the allegation was arrived at and stated that its processes were very transparent and that applicants were communicated to on regular basis on the status of their application, with piles of documents to prove it.
“The FDA wishes to state that there have been instances where importers have concealed unregistered medicines in a consignment of registered medicines, concealed medicines in second-hand vehicles and fridges and in other items; usage of unapproved routes to import medicines into the country; and other importation challenges that needed a holistic approach involving all stakeholders.
“Approvals on registration of products are not made by a single person but by a Committee’s decision”, he stated.
Source: GNA