Food and Drug Analyst introduces new rules for drug importers

The Government AnalystFood and Drug Department (GA-FDD) has announced that all drugs imported into Guyana must be registered with the Department in compliance with a New Drug Registration requirement, Food and Drug Act Chap 34:03-Regulations 1977, Regulation 78.

The Department is reliant on full drug assessment for safety, efficacy and quality from the listed reference authorities such as the United States of America, Canada, United Kingdom, and Australia.

This is according to Food and Drug Regulations No. 10 of 1977 Cap. (34:03), Part III, Regulation 78:2 (K).

Characteristics of the drugs assessed are the Active Pharmaceutical Ingredient (A.P.I), Clinical trials, Bioavailability, Stability, Bioequivalence inter-alia. In cases where UK, US, Canada and Australia compliance are not met, the department would be reliant on PAHO/WHO system of prequalification/recommendation from recognized reference authorities via the Caribbean Regulatory System (CRS), a statement from the Department said. “In addition, the brand and generic name, the address of the manufacturer and the patient information leaflet must be stated in English language on all finished product packages.

This is prescribed for according to the Laws of Guyana, Food and Drug Act Chapter 34:03 Part II Section 6, Subsections 1&2 and the Food and Drug Regulations Part (II) Regulation 18.

“All drugs (prescription and over the counter) that are labelled in a foreign language will be seized and removed from premises.”

The GA-FDD stated that consumers are advised to purchase drugsPrescription and over the counter medicines that are adequately labelled according to the Food and Drug Regulation 18, having a Brand and GenericName, the list of ingredients, storage instructions, Expiry Date, the Address of Manufacturer, the Country of Origin and this information must be the English Language.

(Kaieteur News Online)