THE Ministry of Health says there are no bureaucratic delays or “red tape” preventing the approval of “Ozempic” or any other drug.
In a release on Wednesday, the ministry responded to Wednesday’s editorial in the Express newspaper regarding the drug “Ozempic”.
The Ministry categorically stated that no bureaucratic delays are preventing the approval of “Ozempic” or any other drug.
It stated, “The registration of pharmaceutical products in Trinidad and Tobago is governed by the Food and Drugs Act, Chapter 30:01 and Regulations made thereunder, Division 3–New Drugs, which outlines the requirements to register a drug.
“This includes the completion and submission of an application form along with technical drug documentation. It must be noted that the onus for submission of an application lies with the Importer/Distributor and not the MOH.
“Submissions undergo a rigorous screening process to ensure compliance with safety, quality and efficacy standards before any drug is approved for public use.”
The ministry stated that there were no application from the local registered distributor for Novo Nordisk for the registration of “Ozempic”.
It stated, “However, an application for a generic version has been received. To safeguard the public’s interest, the MOH, as part of its standard operating procedure when questions of patents arise, has been communicating with the local Intellectual Property Office, the manufacturer, Novo Nordisk and its local distributor Alstons Marketing Company Limited (AMCO). This is to determine whether or not a patent exists at this time in Trinidad and Tobago for ‘Ozempic’.”
It stated, “The public is reminded that the Ministry of Health remains the competent authority responsible for ensuring the safety, quality, and efficacy of all medications available in Trinidad and Tobago and we urge the media to exercise due diligence when disseminating information to the public.”
