By Prior Beharry
HEALTH Minister Terrence Deyalsingh should have consultations on the registration of drugs in Trinidad and Tobago instead of saying that the process was being misrepresented.
This according to a small drug supplier who wished to remain anonymous for fear of victimization.
On Monday, the Health Ministry issued a release stating that the role of the Chemistry Food and Drug Division (CFDD) in the drug registration process was being misrepresented.
It stated, “It is regrettable that this process, which is primarily aimed at protecting the nation’s health by ensuring that drugs approved for sale and consumption in Trinidad and Tobago are safe, effective and meet international regulatory standards, is now being misrepresented.”
The release referred to Leader of the Opposition Kamla Persad-Bissessar’s Town Hall meeting on healthcare at La Joya in St Joseph on December 9.
It quoted attorney Jagdeo Singh in an December 16, 2024 Trinidad Express article as saying, “ As a lawyer, I have received numerous complaints from clients who have all said that they have tried to import pharmaceuticals but when they apply for the permits to do so it is being stuck in the Food and Drug, Chemistry Division. There have been undue and long delays for getting permits and these are people who want to do things the right way and not bring things by suitcase trade”.
The release referred to a question in Parliament where Deyalsingh answered saying that 503 applications were approved by the Drug Advisory Committee and 141 applications were received from October to November 18, 2024.
But, a small supplier said for the past five years he has been registering a line of vitamins from the United States with Chemistry Food and Drug Division.
He said, “I have had my challenges but I have always been able to get through even though I have had to make my US suppliers bend over backwards to provide the necessary documentations to which they seem to be surprised at the Trinidad and Tobago requirements for vitamins with no claims.”
He said he had to wait three months to get an appointment for two of his new formulations of the same brand that he had brought into the country for the past couple of years to submit for registration with CFDD.
He said, “As I sat down waiting, a young lady who I never met came and attended to me… I gave her my samples, dossiers, forms A B & C (which were in more detail as previously done), flash drive with the same info and copy of a receipt of $1,500.”
He said he was then told that there were deficiencies as listed:
1) Certificate of Analysis for Each Excipent (fillers, flavoring ingredients in a tablet);
2) Good Manufacturing Practice Certificate of each active ingredient & Excipients;
3) Adverse Event Reports/Statement/Risk Management Plan;
4) Pharmcovigilance Plan/Post Marketing Surveillence Plan;
5) Ink & Printing Composition & Saftey;
The division also stated, “The Drug submission was incomplete then the unit is requesting the documents be provided and obtained and submission can be obtained for a later date then they returned everything to me.”
He said this was for a vitamin with no claims manufactured by an approved FDA facility from the USA in the USA.
He said, “Before this, I had other products approved without what they are asking from me now… so it begs the questions why are these issues cropping up.”
He added, “The chief medical officer has stated in many meetings that there is no backlog for registration of items.
“It is very clear now because before it reaches you or to the committee it was possibly rejected.
“I seriously believe that some action needs to be taken to address these issues.”
He said, “This process is keeping back people’s business and livelihoods. It already a hassle for small business owners like myself to get Forex, deal with customs backlog and now being rejected after months to register a vitamin.”
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