Last night we told you about a Quality Assurance review that the Ministry of Health did on pharmaceutical products at the KHMH. They found a number of sub-standard or defective medicines. Fortunately, most of them had not reached patients. And while there will sometimes be be medicines that do not meet the mark or are improperly stored, earlier this week on the Monday Morning Beef, our news Director Jules Vasquez said that this is what happens as a consequence of the Ministry of Health abandoning the standard for Good Manufacturing Practices as a pre-requirement for the importation of pharmaceuticals.
Well, even though that was a decision taken by his predecessor….today in San Pedro, the current Minister of Health responded to that comment, clarifying that the suppliers are being held to GMP standards, and it is because of the Quality Assurance Unit's attentiveness that the defective pills were found.
Kevin Bernard, Minister of Health
"Let me answer that question directly and I will answer Jules who was at his morning gripe. I will call it that way on Monday mornings. Let me make a correction and I hope that the other media houses can make this correction, because on his talk show he mentioned that the former minister, through an amendment took out the GMP requirement. He's either being disingenuous or plain liad, to be honest with you. Because the amendment and I will share with the media which I have right here clearly states in here that a valid good manufacturing practice or good distribution practice certificate and they also added where notwithstanding sub regulation 1, which I read just now - an application for a drug register with national authority shall only be accompanied by the following. And it highlights right in there that the ministry as the regulatory body for KHMH. Remember KHMH being a statutory body. Now what this is proving to you and the nation is that the ministry who now has a senior drug inspectorate in charge of the whole inspection unit is doing their job. It's the responsibility as the regulatory body for the ministry of health to go and inspect every facility."
"Now, I cannot tell you and I have not spoken to KHMH in terms of asking them whether these medications were procured this year, last year, two years ago or whenever. So what has to happen and is customary now we have instructed our drug inspectorate that they must go out at every facility to go and check. And this is the reason why I will say this: on this new tender cycle, medications that are just coming in, as you know we had some delays October, November, December - we are starting to get in. Serious and intense inspections are done at the suppliers. The insinuation is oh we are buying inferior quality medications, oh because we don't have the GMP - that's a farce and it is something that I need to clarify at the ministry. We have made it absolutely clear. The new tender cycle that will come very soon, we will be putting out a new tender request. We are doing the final forecasting and we will make it absolutely clear that we are going to request suppliers to provide the same requirements that is set out in the SI in 2021."
