… As PAC Scrutinizes Auditor General’s Report
Hundreds of drugs seized by the Food and Drugs Authority (FDA) and kept in its canteen for noncompliance of safety and quality standard have disappeared from its premises in the last four years and the chief executive claims she is unaware of that.
This was disclosed when officials of the FDA appeared before the Public Accounts Committee (PAC) of Parliament in Accra yesterday.
It was also disclosed that several drugs seized from manufacturers and importers and kept at clients’ warehouses over similar offence of nonconformity with the safety and quality standard have gone missing from the warehouses.
The Performance Audit Report of the Auditor General on ensuring safety and quality of medicines in the country was carried out in four regions, namely Greater Accra, Volta, Ashanti, and Brong Ahafo.
The auditing done between 2010 and 2013, and carried out from June 2013 to March 2014 by the Auditor General also revealed that, over 11,568 drugs were imported without permits and have been detained by FDA since September 2013.
While answering questions from the PAC members, Ms Mimi Darko, the acting chief executive officer of the FDA, named Coartem, Procold, Zentel and Amodiaquine Suspension as some of the unregistered drugs imported into the country.
The acting FDA boss stated that, the forbidden drugs are those medications often used for the treatment of malaria, flu and other sicknesses, commonly recorded in various hospitals and other health facilities nationwide.
She also denied knowledge of some series of medicines stored in FDA canteen having gone missing, pledging that she would seek further information from her officials as to how such a thing happened.
The Auditor General, in its report, raised concerns about the safety and quality of medicines imported into the country.
The PAC and its chairman, Hon. James Klutse Avedzi, also were not happy drugs of pharmaceutical companies seized for not meeting FDA standards over a period vanished from warehouses and possibly got sold to the unsuspecting public.
The committee identified several lapses in the FDA’s control system, which allowed medicines to be imported without the requisite licences and also how some pharmaceutical products produced locally are not registered with the FDA.
Hon. Richard Quarshigah, MP for Keta and member of the committee, pointed out that, some importers bring in the medicines before they apply for a permit prior to inspection and clearing.
The committee also questioned the FDA on why confiscated drugs are allowed to be detained in the culprits’ warehouses, instead of the FDA’s own warehouse, noting that such actions pave the way for the disappearance of seized drugs.
The auditors discovered that when an importer brings in unregistered products, FDA issues a detention notice, restraining the importer from use of the products while being kept at the importers’ warehouse pending further regulatory action.
But the acting CEO said, importers are fined an administrative charge and allowed to go through the product registration process, but when the products are found not to be of the required quality, the FDA orders their return or supervises their destruction, following safe disposal procedures.
For instance, she said, per the laws, importers who fail or refuse to comply by the FDA standard and are fined to pay not less than GHS25,000 and GHS50,000, adding some of the culprits are either with the police pending further investigation or at the law courts facing trials.
Ms Darko further told the committee, though the circumstance under which importers apply for permit when consignments arrive at the ports, presents a high risk of unauthorised medicines entering the country, the FDA is under-resourced and also lacks the control, as it has no powers at the importation sources.
She said, the FDA faces several weaknesses in its operation and therefore needs collaboration from the security services, Customs at the ports and resources to build its own warehouses to be able to fight illegal drugs in the system.
The Auditor’s Report also raised concern that the permit acquisition process, which is a control measure to confirm product registration, is done after products have already reached Ghana’s ports, stating, “The audit team found through review of import documents that various unregistered medicines were imported into the country between 2012 and 2013.”
“These medicines which were brought in by licensed importers could have been prevented from entering the country if it was mandatory for importers to obtain import permit before importing consignments,” the report added.
The audit team, therefore, recommended that the FDA would need to strengthen its collaboration with port agencies to monitor and control the importation of medicines.
Inspections carried out at 10 warehouses of pharmaceutical companies confirmed that FDA keeps detained medicines at the clients’ warehouses.
According to the FDA officials, when medicines are detained, they record details of each medicine, including its name, quantity and batch number, and officials of the Drug Enforcement Department regularly use these details to check if any of the products have reduced in quantity or have been tampered with.
But the report said the system of keeping detained medicines within the warehouses of pharmaceutical companies limits FDA’s control over the medicines and makes them less secure.
It added that there have been instances where detained medicines in clients’ warehouses have reduced in quantity and have found their way onto the market.
“For instance, review of PMS documents by the audit team revealed that on 27 November 2013, the Drug Enforcement Department of FDA found through inspections that medicines previously detained under the seizure notice at a client’s warehouse had reduced in stock,” it stated.
Interviews with FDA officials revealed that the pharmaceutical companies whose medicines were found to have reduced in stock were fined by the authority.
However, the FDA was unable to provide the audit team with the total amount realised from fines within the period under review.
The report stated that, detained medicines are not stored under controlled temperatures as required, so when finally certified by FDA and released unto the market they would have less efficacy.
This, the PAC members said, could increase the number of expired medicines in the system when such medicines find their way back into the market.
They also requested the FDA to furnish them with the number of medicines or companies that have been sanctioned on fined and have been banned from the importation of medicines.
The report concluded that the FDA had not been effective in ensuring that the medicines on the market are safe and of good quality.
“FDA has challenges in the system of control of importation, the management of the security of detained medicines, and the collaboration with other border agencies to control the entry of medicines on the market which were not registered and were not found on FDA’s database,” it said.
Source: therepublicnewsonline.com/ Felix Engsalige Nyaaba