Health News of 2013-12-27

MoH Committee report inaccurate - FDA

The Food and Drugs Authority has described as inaccurate, a report released by the ministerial committee accusing the authority of administrative lapses, during its investigations into the feud between the FDA and Tobinco Pharmaceuticals Limited.

The Committee which was chaired by Dr Alfred Tia Sugri, identified regulatory and administrative lapses on the part of the Food and Drugs Authority (FDA). It said for instance, the Drug Registration Committee (DRC) of the authority met only once in four years.

But the FDA in a release on Friday discounted the claim by the committee, insisting that the DRC meets on regular basis between 2010 and 2013.

According to the release, the DRC approved 3,254 out of 5,033 applications it received in the last three years. Below is the full statement:

RESPONSE TO COMMITTEE’S REPORT/ MOH

The Food and Drugs Authority’s (FDA) attention has been drawn to a report released by the Committee set up by the Ministry of Health to investigate the recent impasse between the Food and Drugs Authority and Tobinco Pharmaceuticals Ltd.

The FDA wishes to state that the content of the report is not accurate hence the decision to set the records straight.

First of all, the FDA Registration Committee meets on regular basis and between 2010 and 2013, a total of about 5033 applications were received out of which 3254 were given approval and the remaining ones were rejected due to the inability for applicants to meet the quality, safety, efficacy or documentation requirements.

Hence the Committee’s report that for the past 4 years there had been only one meeting is UNTRUE. The Registration Committee has for 2013 alone met five times, the last being on the 23rd December 2013.

The general public may visit the FDA’s website www.fdaghana.gov.gh and verify this.

Secondly, with respect to the allegation that products cleared under detention are unprotected with FDA padlocks, the FDA wishes to indicate that 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. Additionally there are some instances where the premises where the detained products are kept has other products that have market authorization hence the FDA’s decision not to add its padlocks unless the FDA suspects the products may be tempered with.

The FDA has 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 he (the client) feels the regulator is “keeping too long?”

With respect to the issue of transparency, the FDA wonders how that allegation was arrived at. The FDA wants to emphatically state that its processes are very transparent. Applicants are communicated to on regular basis on the status of their application (there are piles of document to prove this).

Approvals on registration of products are not made by a SINGLE person but a Committee’s decision.

Lastly, 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 articles; usage of unapproved routes to import medicines into the country; and other importation challenges that need holistic approach involving all stakeholders.