Substandard medicines in Guyana: 30 % failed testing, and the fix

One in three samples failed

In August 2020 the Government Analyst – Food and Drug Department (GA-FDD) published the results of an 18-month pilot run with the Medicines Quality Control and Surveillance Department of the Caribbean Public Health Agency (CARPHA). Thirty-six drug samples taken from Guyana's market were tested at an accredited laboratory in Kingston, Jamaica. About three in ten, roughly 30 %, were substandard¹². The classes sampled were anti-diabetic, anticoagulant, diuretic, antibacterial and anti-hypertensive medicines, exactly the drugs that chronic-disease patients take every day¹². The reports did not name the failing brands¹².

The GA-FDD said the rate was "significantly more than the global average" and announced that it would be "stringently enforcing our drug registration requirements"¹. For comparison, WHO's 2017 estimate was that 1 in 10 medicines in low- and middle-income countries failed quality control tests⁹, and a 2018 meta-analysis of 96 studies covering 67,839 samples put the prevalence of substandard or falsified essential medicines in those countries at 13.6 %¹⁰. A 36-sample pilot is small and the confidence interval around 30 % is wide, but the signal was strong enough for the regulator to change its tone.

What a substandard or falsified medicine is

WHO separates two problems. Substandard products are authorised medicines that "do not meet quality standards and specifications"; falsified products "deliberately misrepresent their identity, composition or source"⁹. Guyana's Food and Drugs Act, Chapter 34:03, sets the yardstick for the first: its Second Schedule adopts the International Pharmacopoeia, the British Pharmacopoeia and the United States Pharmacopeia, among others, as the drug standards under section 11⁸. WHO notes that long and complex supply chains with multiple intermediaries increase the risk of tampering and substitution⁹, which is exactly what Guyana's inspectors kept finding.

The 2019 sweep: walk-in traders and caustic soda

On 22 and 23 August 2019 GA-FDD inspectors visited 16 pharmacies and found substandard or falsified products at nine of them³. Kaieteur News reported that the seized goods included 17 boxes of a product labelled "chanca piedra phosmovite", 28 boxes of "Fungabort" and 23 boxes of "Phosferine"; the Canadian manufacturer addresses on the labels were not in the department's database and the barcodes did not match its systems³. The paper reported, citing a source, that one product contained caustic soda³. Retailers had no invoices tracing the stock to a distributor, so the department called in the police, and by 20 September a suspect had been arrested and released on station bail, with the file headed to the Director of Public Prosecutions for advice⁴. Director Marlan Cole said retailers had no traceable paperwork, and the department told pharmacies to stop buying from walk-in salesmen, or "suitcase traders", who refuse to provide invoices or receipts³⁴.

The same year the department detected a counterfeit of the venous-insufficiency drug Daflon 500 mg, with packaging that differed from the original and a manufacturer listed in Turkey or Ukraine instead of France. HGPTV reported the director's warning that "knowingly distributing fake drugs is a criminal offense" and his point that, unlike some countries, Guyana does not limit how many businesses may import drugs⁵.

Registration as the first line of defence

The GA-FDD's answer is registration. In its 2020 release it reminded importers that "no waivers will be granted to any entity for the sale and/or distribution of unregistered drugs/medicines" and that unregistered products found in circulation would be seized under section 21(d) of the Act and Regulations 78 and 80¹². Section 22 adds a border check: an inspector may sample any customs entry, and a drug whose sale would break the Act "shall not be admitted in Guyana"⁸.

Guyana does not review every product from scratch. The GA-FDD said medicines certified by the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, Health Canada or Australia's Therapeutic Goods Administration can be registered in Guyana, and that since joining CARPHA's Caribbean Regulatory System (CRS) in March 2017 it registers products the CRS has assessed and recommended¹². The CRS is a reliance model: it reviews medicines already approved by a trusted regulator, and when it launched it required them to be on the WHO Essential Medicines List⁷. By June 2025 it had recommended 353 products, and Guyana reported registering 164 of them since October 2017, running the CRS route alongside a national process with a 120-day timeline⁶. Acting GA-FDD director Tandeka Barton said: "The CRS is expert-driven and facilitates a transparent review process"⁶.

Why it matters for peptide drugs

The same gaps apply to injectable peptides. In June 2024 the GA-FDD warned that falsified Ozempic (semaglutide) batches might be on the local market, said the product "is not registered here" and urged the public to report anyone offering it for sale¹¹. WHO had traced falsified semaglutide batches to Brazil, the United Kingdom and the United States and warned that such pens may contain another undeclared ingredient, such as insulin¹². Online channels are part of the picture: in 2012 the Guyana Revenue Authority and the Food and Drug Department joined Operation Pangea V, an international action against websites selling fake medicines, with public-awareness campaigns and briefings for customs officers and importers at the wharves¹³. In September 2025 WHO added semaglutide, dulaglutide, liraglutide and tirzepatide to its Essential Medicines List for adults with type 2 diabetes plus cardiovascular or chronic kidney disease and obesity¹⁴, which in principle brings the class within the scope of essential-medicines reliance pathways like the one the CRS started with⁷.