Registering a new drug in Trinidad and Tobago is not for the faint-hearted. I have had more than one potential importer exclaim in dismay, ‘I didn’t know it was so complicated’.
They were in fact referring to the dossier requirements which, admittedly, can appear a bit daunting. But I assure them that this is the easy part, because the drug manufacturers and marketing authorization holders are generally familiar with the process and will make those documents readily available.
The hard part is the submission of documents to the authorities and awaiting the outcome.
Prior to the Covid era, when everything had to be rebooted in safe mode, it was simply a matter of preparing your dossiers and notifying the Chemistry, Food and Drug Division of your readiness and they would assign you a date when you could deliver your documents and have someone verify the contents with you. Of course, there was also a time when you would not hear from them for the next three years, but that is a different story.
During the Covid era, one had to wait for a submission window when you would be invited to submit, and then, the number of dossiers accepted at a time was limited. Submission was purely digital, except for samples of course, and while this process was a welcome step forward, the gains were offset by the frustratingly unpredictable wait for an invitation to submit.
The story is a little different now. But whether for better or worse, is a matter of opinion. You can once again request an appointment for submission, and there is no limit on the number of products submitted. The waiting period for a response is acceptable. But waiting for the actual Notice of Approval could take more than a year.
How does the inefficiency in this process affect our country though? For one thing, it delays access to new drugs which can save lives and prevent unnecessary suffering. On the other hand, the delay might allow much needed post-marketing experience in countries with strict monitoring systems which can forestall the inflow of potentially unsafe drugs in unprepared communities. Drugs like Vioxx comes to mind.
So, does the drug registration process have any impact on the present imbroglio involving the seizure of “unregistered” drugs now taking place in pharmacies? Quite frankly, it should not. Making a claim like that implies that you knowingly and deliberately decided to access medical supplies from a questionable supplier. As unreasonable and tedious as the process may seem, the rules are designed to ensure the identity and quality of these highly regulated products.
There are failures within the drug supply system which has led to confrontation. Pharmacists should know what constitutes an “unregistered drug”, and that this term is not limited to a new product which has not been imported before into the country. The authorities should be more forthcoming with their reasons for deeming a product unregistered, rather than playing the secrecy game, leading to speculation of favoritism and inequity in the application of the law.
We all have so much to learn if we plan to evolve into a just and harmonious society.
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