Peptide drugs and the Third Schedule in Trinidad and Tobago

How a drug is approved: a Legal Notice

In Trinidad and Tobago a new drug does not reach the market by a letter to the importer alone. The Minister of Health publishes an approval in the Gazette. Legal Notice No. 235 of 2025, titled "Approval in respect of New Drugs", was dated 1 July 2025, signed by the Minister, Dr Lackram Bodoe, and published on 8 July 2025¹. It states that it is issued on the recommendation of the Drug Advisory Committee, in accordance with paragraph 7, Division 3 of the Second Schedule of the Food and Drugs Regulations¹. The notice runs from page 867 to page 896 of the Legal Supplement and lists, for each product, the trade name and form, the manufacturer, the country of origin and a condition of sale¹.

The technical work sits with the Chemistry, Food and Drugs Division (CFDD). Its 2022 notice to importers says its Drug Registration Unit acts on behalf of the Drug Advisory Committee, that "The DRU does not act as a consultant for importers", and that registration costs TT$750 per drug². The result of that process is what the public can now search: in March 2026 the Ministry launched an online database with "more than 10,000 drugs approved for use within the country"³⁵.

Five peptides in one notice

Most of Legal Notice No. 235 of 2025 is ordinary pharmacy stock. Melatonin, vitamin and probiotic products appear with the condition "Freely"; enoxaparin from India and the thrombolytic Actilyse appear as "Third Schedule"¹. Among the peptide drugs, every entry is marked "Third Schedule". Two come from Ferring: "Gonapeptyl Daily Solution for Injection 0.1 mg/mL", manufactured by Ferring GmbH of Kiel, Germany, with the Czech Republic as country of origin and listed with updates to its product information and artwork, and "Duratocin Solution for Injection 100 µg/mL"¹. Three are insulins: the Humalog Mix 25 KwikPen and Humalog KwikPen from Lilly France, and the Toujeo SoloStar 300 U/mL pen from Sanofi-Aventis Deutschland¹.

Triptorelin, the active ingredient of Gonapeptyl, is a gonadotropin-releasing hormone (GnRH) agonist, a "potent inhibitor of the synthesis of testosterone (in men) and estrogen (in women)"⁶. The Swedish product information describes Gonapeptyl 0.1 mg/mL as a prefilled syringe of 1 mL containing 100 micrograms of triptorelin acetate, equal to 95.6 micrograms of triptorelin, indicated for down-regulation and prevention of a premature luteinising hormone surge in women undergoing controlled ovarian hyperstimulation for assisted reproduction⁷. It is a fertility-clinic drug.

Carbetocin, the active ingredient of Duratocin, is "a synthetic analogue of oxytocin" with a longer duration of action, used to prevent bleeding after childbirth⁸. A review in the Drug and Therapeutics Bulletin noted that the heat-stable form "can be stored at room temperature" and that its higher cost compared with oxytocin "is a limiting factor"⁸. In the WHO CHAMPION trial of 29,645 women giving birth vaginally, blood loss of at least 500 mL or use of extra uterotonics occurred in 14.5 % of women on heat-stable carbetocin and 14.4 % on oxytocin (relative risk 1.01), consistent with non-inferiority; for blood loss of at least 1,000 mL the confidence interval crossed the non-inferiority margin⁹. The gazette entry does not say which formulation Duratocin is, so that trial should not be read as describing the local product¹⁹.

What "Third Schedule" means

The condition of sale is the practical rule for a pharmacist. The Ministry's Regulated Medicines and Substances Portal defines a Third Schedule drug as prescription-only, while non-prescription drugs, "classified as freely sold", may be sold without a prescription under a pharmacist's supervision³. The database itself sorts listings into antibiotics, narcotics, controlled substances, third-schedule drugs, veterinary products and over-the-counter medicines⁵.

The legal source is older. Part II of the Third Schedule of the Food and Drugs Act (Chap. 30:01) mixes named drugs with broad classes, among them "Oral hypoglycaemic drugs for the control of diabetes", "Adrenocortical hormones", "Sex Hormones" and "Thyroid"⁴. It does not name peptide classes such as insulins, GnRH agonists or GLP-1 agonists; their status comes from the condition of sale set for each product when it is approved¹⁴. A note in the consolidated Act explains why the master list of approved new drugs stops in 1977: it was consolidated as at 31 December 1977 because the list is "so voluminous and changes to it so frequent" that "it is not practicable to update it annually"⁴. Later approvals live in individual Legal Notices such as No. 235 of 2025¹.

Why this matters for peptide drugs

Peptides are a growing share of medicine: "more than 80 peptide drugs have reached the market" since insulin, according to a 2021 review in Nature Reviews Drug Discovery¹⁰. Each one that enters Trinidad and Tobago does so as a named product with a named condition of sale, not as a class¹². That is also why the GLP-1 debate is about registration. In January 2025 the Ministry said Novo Nordisk's local distributor had not applied to register Ozempic, although an application for a generic version had been received¹¹. The same month the Ministry's principal pharmacist, Anisa Doodnath-Siboo, told a parliamentary committee that "the advertising of the Third Schedule is definitely a breach of the Food and Drug Act", in a hearing on Ozempic offered on social media¹².

What it means for practice

For physicians and pharmacists the steps are simple. Check that the product is in the Ministry's database, read its category there, and treat a Third Schedule product as prescription-only, whatever a seller online says³⁵. A peptide product that has not been approved has no condition of sale at all¹³. Suspected falsified or substandard products can be reported to the CFDD on its public form¹³.