Regulation

Guyana's Medicines Regulation Bill and a new pharmacovigilance centre

Guyana still regulates medicines under a 1971 law. In 2026 the government put a Medicines Regulation Bill on its legislative agenda, and with PAHO it began building a national pharmacovigilance centre at the GA-FDD. What changes for physicians.

Published November 7, 2026 · 4 min read · 14 sources

A 1971 law and a regulator under pressure

Guyana's core medicines statute is the Food and Drugs Act, Chapter 34:03, passed as Act 12 of 1971. In its 1998 revised text, a first summary conviction carries a fine of $6,500 to $32,500 and one to three months in prison, and conviction on indictment $65,000 to $325,000 and one to three years7. Regulations made under the Act can carry a fine of $6,500 or three months for a breach (section 25(2))7. The law gives inspectors wide powers to enter premises, sample and seize, but it says nothing about pharmacovigilance, the systematic collection of adverse-event reports7.

Pressure on the regulator has grown with the market. In April 2026 President Irfaan Ali flagged the risks of rising Mounjaro (tirzepatide) use; HGP Nightly News reported that public demand was moving faster than the ability of the Government Analyst – Food and Drug Department (GA-FDD) and the Medical Council to regulate and monitor it14. In 2024 the GA-FDD had to warn that fake batches of Ozempic (semaglutide) might be on the local market, a product it noted was not registered in Guyana12.

The Medicines Regulation Bill: what has been promised

Health Minister Dr Frank Anthony first described the bill in June 2024. Guyana Times reported that the Ministry, assisted by the Pan American Health Organization (PAHO), was drafting a Medicine Regulation Bill to strengthen the national regulator, with pharmacovigilance, counterfeit medicines and antibiotic misuse as targets4. He said the goal was to move the regulator to Level 3, which requires meeting about 169 indicators4. Demerara Waves and Kaieteur News reported the same week that importers would have to do their own monitoring of adverse effects and report to the Ministry, and that pharmacies selling antibiotics without prescriptions could be shut down56.

We also want to take a firmer stand on falsification of medications.
Dr Frank Anthony, Minister of Health, June 20245

On 7 February 2026, Kaieteur News reported that Attorney General Mohabir Anil Nandlall listed more than 40 bills and regulations for the National Assembly, including the Telehealth Bill, Medicines Regulation Bill and Ambulance Services Bill3. None of these reports gives the bill's text, penalties or timeline.

1971year of the Food and Drugs Act still in force7
169indicators cited for reaching Level 34
40+bills on the 2026 legislative agenda3
1 in 10medicines in low- and middle-income countries substandard or falsified (WHO)11

July 2026: building a pharmacovigilance system

In July 2026 a three-day PAHO technical mission to Guyana worked with the Ministry of Health and the GA-FDD on pharmacovigilance, market control and surveillance2. Participants mapped a national notification flow for adverse drug reactions, adverse events following immunization and incidents involving substandard or falsified products, and Guyana began the process of establishing a National Post-Market Surveillance System2. PAHO said preparations advanced for VigiFlow, the national pharmacovigilance platform offered by the Uppsala Monitoring Centre210. VigiFlow consolidates safety reports from health workers, the public and marketing authorisation holders into a single national database10.

Two days later PAHO reported that Guyana is advancing a National Pharmacovigilance Centre at the GA-FDD, which would also serve as a post-market surveillance system for substandard and falsified products1. The GA-FDD has completed an assisted self-assessment with the WHO Global Benchmarking Tool, WHO's main method for evaluating national regulators on a maturity scale from 1 to 4, and PAHO noted progress on the new Medicines Regulation Bill19.

Pharmacovigilance is not optional. It is essential to what we do.
Dr Frank Anthony, Minister of Health2

GA-FDD acting director Tandeka Barton said "Pharmacovigilance is a shared responsibility," and PAHO/WHO Representative Dr Kim Eva Dickson called the centre "a critical investment in patient safety and public health"1.

What it means for physicians

For doctors, the practical change is a reporting channel. PAHO's March 2026 alert on GLP-1 misuse asked countries to strengthen exactly this kind of system so adverse events, including those from off-label use or unauthorized sources, are detected and reported quickly13. The existing rules for pharmacists already treat dispensing prescription medicines without a prescription as professional misconduct under section 20 of the Pharmacy Practitioners Act, Chapter 32:078; the new bill is expected to add sanctions on the sale side56. WHO estimates that at least 1 in 10 medicines in low- and middle-income countries is substandard or falsified11. A functioning national database is how a small market detects those products before they spread.

Sources

  1. Pan American Health Organization. Guyana advances establishment of National Pharmacovigilance Centre. 24 July 2026. paho.org ↗
  2. Pan American Health Organization. PAHO supports Guyana in establishing a National Post Market Surveillance System for medicines and vaccines. 22 July 2026. paho.org ↗
  3. Kaieteur News. Over 40 bills to be tabled as Govt. advances sweeping legislative agenda – AG Nandlall. 7 February 2026. kaieteurnewsonline.com ↗
  4. Guyana Times. New Medicine Regulation Bill being drafted to strengthen Guyana's FDA. 24 June 2024. guyanatimesgy.com ↗
  5. Demerara Waves. New law to go after sale of unprescribed antibiotics, fake medicines. 23 June 2024. demerarawaves.com ↗
  6. Kaieteur News. Guyana to introduce stricter laws to combat sale of unprescribed antibiotics, fake drugs. 25 June 2024. kaieteurnewsonline.com ↗
  7. Laws of Guyana. Food and Drugs Act, Chapter 34:03 (Act 12 of 1971), sections 21, 22, 25 and 33. L.R.O. 3/1998 text published by the Ministry of Home Affairs. moha.gov.gy ↗
  8. Laws of Guyana. Pharmacy Practitioners Act, Chapter 32:07 (Act 9 of 2003), section 20. L.R.O. 1/2012. Ministry of Legal Affairs. mola.gov.gy ↗
  9. World Health Organization. Global Benchmarking Tools. who.int ↗
  10. Uppsala Monitoring Centre. VigiFlow. who-umc.org ↗
  11. World Health Organization. Substandard and falsified medical products (fact sheet). 3 December 2024. who.int ↗
  12. Caribbean Broadcasting Corporation. Guyana issues warning against fake Ozempic. 26 June 2024. cbc.bb ↗
  13. Pan American Health Organization. PAHO calls for strengthened pharmacovigilance following reports of misuse of GLP-1 medicines. 3 March 2026. paho.org ↗
  14. HGP Nightly News. Rising use of Mounjaro sparks call by President for faster health oversight. 25 April 2026. hgptv.com ↗

Informational article. It summarizes news, official statements and published studies; it is not medical or legal advice. Sources were checked on the publication date.

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