Jan 08, 2017 News
-Food and Drugs chief tells inquiry
The regulator of food and drugs importation has warned Government that a number of critical law changes are necessary to ensure that counterfeit products are not entering the local market.
Marlan Cole, Director of the Government Analyst Food and Drugs Department (GAFDD), made the statements in late November when he appeared before a Board of Inquiry.
The inquiry, headed by Winston Cosbert, Assistant Commissioner of Police (retd.), was convened to investigate leaking of information to suppliers by a staff member of the Ministry of Public Health as well as probe reports of mismanagement and malpractice with the procurement of billions of dollars in drugs and related supplies.
Cole’s department falls under the aegis of the Ministry of Public Health and carries out its statutory responsibility independently as prescribed by the Laws of Guyana.
The report disclosed that the Food and Drugs Department consists of an Inspectorate Division that controls the importation of food and drugs, five laboratories and administrative staff.
The director said that the department is responsible for ensuring food, drugs, cosmetics and medical devices manufacture, exported and or imported into Guyana meet the highest standard and efficacy by extracting regulatory oversight on these items.
It was also disclosed that as it relates to importation of pharmaceuticals (drugs) and medical devices into Guyana for use or release both into the public or private health care system, the department ensures importers are licensed annually.
When this criterion is met, the importer is issued with a Permit to Import.
The director said that the laws make it clear that pharmaceuticals (drugs) must be registered and the registrant issued with a Marketing Authorization before the drug/medical device can be released for sale and/or use on the local market.
“The chemistry lab at the Food and Drugs Department also carries out testing on pharmaceuticals or drugs intended to be imported to Guyana; in relation to medical devices, the Importer and medical devices must be registered.”
It is against this background that Cole expressed his concerns for the requests of repeated waivers. “This has resulted in the drug registration laws being flaunted by some importers/suppliers who are non-compliant with the registration requirements for pharmaceutical (drugs) and medical devices.”
According to the director, over time it was noted that there are weaknesses within his department.
“The Food and Drugs Act and Regulation need to be revised to deal with registration of medical devices and reagents, enforcement aspect relative to cosmetics, improvement in technology, medical products (food supplements that are not synthesized), electronic documentation, blood and blood products.”
Cole also highlighted a shortage of pharmacists to be appointed as Food and Drugs inspectors.
The repeated waiver allows for counterfeit and substandard goods to be imported, Cole warned.
He added that he wrote the former Minister of Public Health, Dr. George Norton, highlighting the importance of importers of pharmaceuticals and medical supplies being registered with the Food and Drugs Department (FDD) in compliance with the Laws of Guyana and the importance of the food and drug department to be involved in the procurement process of pharmaceuticals (drugs) and medical supplies.
He also suggests that the registration of importers be one of the criteria in the bidding document.
The report has also pointed to poor management of the inventory of pharmaceuticals.
The inventory, worth billions of dollars, was last year stored mainly in the state-of-the-art Materials Management Unit (MMU) facility at Diamond, East Bank Demerara and Central Stores Unit (CSU) at Mudflat, Kingston.
Another bond, at Albouystown, has since been established.
The report said that more than 95 percent of the product balances in the Management Accounting System (MAC) Inventory System is incorrect. In some instances they are understated or overstated by the thousands.
The Board of Inquiry was ordered by President David Granger in October.
Among other things, the auditor found that at the new Diamond facility, unauthorized personnel were entering the warehouse and uplifting supplies.
Lacking Internal Controls
“Internal controls are seriously lacking at the facility. Currently random checks are not made to items being dispatched to facilities to ensure the correct quantities or products are dispatched. The dispatches are just prepared as gate passes stating the amount of cartons leaving the warehouse.”
At the Kingston bond, the auditor found that management was also poor. None of the product locations was labelled.
”Like items are stored in multiple locations. Whilst counting the Stationery Store, the department came across a large quantity of items packed on three separate pallets. A query was made, to which the response given was that the items were already sorted, issued by the store, and awaiting shipment to the various regions.”
It was recommended that the current Permanent Secretary (PS) Trevor Thomas, be sacked for failure to properly carry out his duties. He was accused of allowing a major supplier, New GPC, to be overpaid more than $100M in an advance for pharmaceuticals last year.
The PS was also accused of turning a blind eye when it was brought to his attention that a staffer was colluding with a Trinidadian company in leaking information about other suppliers. There was no investigation, yet the staffer was transferred.
The report by the retired senior cop also recommended a shake-up in personnel in the procurement, finance and management departments of the ministry.
The Cabinet of Ministers is set to consider the report next week at its weekly meeting.
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