Health Ministry: No delays in drug registration process

THE Ministry of Health (MoH) says there are no delays in the drug registration process through the Chemistry Food and Drug Division (CFDD), contrary to claims in the public domain. It said it was regrettable the process was being misrepresented.

In a statement, the ministry said the process was primarily aimed at protecting the nation’s health by ensuring drugs approved for sale and consumption in Trinidad and Tobago are safe, effective and meet international regulatory standards.

It said the CFDD and the Drug Inspectorate, Ministry of Health routinely did drug inspections as required.

It said over the past nine years, one of the major reasons why there might be delays in the processing of new drug applications was the inability or unwillingness of applicants to provide the necessary regulatory documents so that the population’s health and safety could 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.”

The ministry quoted two statements in the public domain which it said had no basis in truth.

The first was a statement by Private Pharmacy Retail Business Association president Glenwayne Suchit, on December 9, 2024, at the La Joya Complex, St Joseph, where matters relating to the public health-care system were discussed and where allegations against the CFDD were reportedly made.

It also said an article in the Express newspaper on December 16 titled Complaints over pharmaceutical drug cartels quoted attorney Jagdeo Singh 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 (in) getting permits and these are people who want to do things the right way and not bring things by suitcase trade.”

The ministry said Health Minister Terrence Deyalsingh gave an update on the issue on November 14 in Parliament, responding to a question from Mayaro MP Rushton Paray, who asked how the ministry intended to address the backlog and delays in drug registration and inspection.

Deyalsingh said as of November 18, all drug registration applications were 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 180 days.

He said during the period January 1-November 18, 831 drug applications were received, and of these, 503 were approved by the Drug Advisory Committee (DAC) and 270 are in the process of being gazetted.

Deyalsingh said from October 1-November 18, 141 applications were received, pre-screened and are currently undergoing a detailed assessment. He said that meant a detailed review of the dossiers is being done to ensure the applications meet the required safety, quality and efficacy, before submission to the DAC for final review.

He said the applications were expected to be considered at the next sitting, number 245, of the DAC. These meetings were held monthly or as required, and the last was held on November 14.

He said another 126 applications were sent back to applicants requiring additional information and 61 applications were rejected for not meeting the requirements.

On December 13, a Fair Trading Commission statement said it would be examining recent concerns about competition and regulatory practices in the pharmaceutical sector that have been expressed in the public domain.

“Enterprises are encouraged to report anti-competitive practices such as cartels, abuses of monopolies and anti-competitive agreements to the commission if they are aware of or have reasonable grounds to believe that other enterprise(s) are engaging in such behaviour. Any information provided to the commission will be treated as confidential.”

The commission can be contacted by phone at (868) 623-2931 ext. 2202/2209/221; its hotline: (868) 765-9939; e-mail: tandtftc@gmail.com; and website: www.tandtftc.org.