Port-of-Spain, December 16, 2024: The Ministry of Health (MOH) notes recent statements on the role of the Chemistry Food and Drug Division (CFDD) as it relates to the drug registration process. 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 MOH notes the recent statements made by Mr. Glenwayne Suchit, President of the Private Pharmacy Retail Business Association, on December 9, 2024, at the La Joya Complex, St Joseph, where matters pertaining to the public healthcare system were discussed and where allegations against the CFDD were made.
The MOH takes further notice of an article published in the Express newspaper on December 16, 2024 titled “Complaints over pharmaceutical drug cartels” which quotes attorney Jagdeo Singh 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”.
Both these statements have no basis in truth.
As recent as November 14, 2024, the Honourable Terrence Deyalsingh, Minister of Health, responding to question Number 24 posed by the Member of Parliament for Mayaro, Mr. Rushton Paray, in which it was asked,
b) how does the Ministry intend to address the backlog and delays in drug registration and inspection;
Stated;
(a) As of November 18, 2024, I am advised that all drug registration applications are current as required by the Food and Drugs Act, Chapter 30:01, where the applicant shall be notified of the status of the application by one hundred and eighty (180) days.
During the period January to November 18, 2024, eight hundred and thirty-one (831) drug applications were received, of which:
i. Five hundred and three (503) drug applications were approved by the Drug Advisory Committee (DAC), of which two hundred and seventy (270) are in the process of being gazetted;
ii. From October to November 18, 2024, one hundred and forty-one (141) applications were received, pre-screened and are currently undergoing a detailed assessment. This means a detailed review of the dossiers is being conducted to ensure the applications meet the required safety, quality and efficacy, before submission to the Drug Advisory Committee for final review;
These drug applications are anticipated to be considered at the next sitting of the DAC (#245). The DAC meetings are held monthly or as required, and the last meeting was held on November 14, 2024;
iii. one hundred and twenty-six (126) applications were deferred to applicants requiring additional information and
iv. sixty-one (61) applications were rejected for not meeting the requirements.
Regarding drug inspections, the Chemistry, Food and Drugs Division and the Drug Inspectorate, Ministry of Health routinely conduct inspections as required.
It is worth repeating that over the past nine years, one of the major reasons why there may be delays in the processing of new drug applications is the inability or unwillingness of applicants to provide the necessary regulatory documents so that the population’s health and safety can be protected. The population is therefore advised that the MOH and by extension its regulatory department, the CFDD will not give in to undue pressure by those who do not have the population’s interest at heart.
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