New Medicine Regulation Bill being drafted to strengthen Guyana’s FDA

– pharmacies issuing antibiotics without necessary prescription will face penalties

The Health Ministry is currently in the process of drafting a new Medicine Regulation Bill that will bolster the standards of the country’s Food and Drug Administration (FDA) among other benefits.
This was revealed by subject Minister, Dr Frank Anthony during his address at an event to observe Commonwealth Pharmacy Week at the Pegasus Hotel on Sunday.
He stated that the Ministry has been working assiduously with various stakeholders to develop the new Bill while adding that the Pan American Health Organization (PAHO) is assisting with the draft.

“When we look at our current Food and Drug Administration, if we want to move from where we are now to a level three administration, it would mean that we have to meet about 169 different indicators and if we want to go to a level four it means that we would have to do even more. So, we are aiming to move this country’s Food and Durg Administration to a level three” the Minister added.
He further stated that the development of this new Bill is one of the first pieces of framework needed to raise the standard of the FDA. Pharmacovigilance, he noted is one area that the new legislation will target
“When we are using medication in our population, we have to be able to register if there’s any adverse reactions, very often we bring in these products, we use them in the population but we don’t check to see whether there’re adverse reactions.”
According to the Minister, these drugs are sometimes tested in homogeneous settings which does not cater to the diversity in the different types of populations. As such he emphasised the importance of continuously monitoring these drugs to identify possible side effects or adverse effects that weren’t detected during clinical trials.
With the implementation of this new bill, importers of these drugs will be mandated to conduct separate monitoring for adverse reactions and report the necessary information to the Ministry.
Similarly, the Minister noted that the Ministry is clamping down on the importation of counterfeit drugs which is a prominent global problem in the health sector.
“We also want to take a firmer stand on the falsification of medications, one of the challenges if you have counterfeit medication in the system, it can create problems in the management of patients and so this is something that we want to ensure that we are removing from our system or reducing it substantially.”
Additionally, he stated that according to the World Health Organization (WHO), some seven million people die from anti-microbial resistance.
On this note, he stated that there have been cases of anti-microbial resistance in Guyana as such related to that with more stringent laws being developed, pharmacies and doctors who issue antibiotics without the necessary prescription will face serious penalties.
“As we move to put stricter supervision in place, if you don’t change this type of behaviour then we might have to close you down and use the full force of the law. We have had cases in this country where we have seen patients who have developed resistance to many of the medications that we have. We’re not saying that we shouldn’t be using antibiotics but we should use them appropriately.”
In observance of Commonwealth Pharmacy Week, the Guyana Pharmacist Association (GPA) hosted its 21st annual convention at the Pegasus Hotel which saw over 300 pharmacists, technicians, and students in attendance.
During the convention, discussions were held to educate pharmacists on current affairs happening in the pharmaceutical field. Additionally, the GPA conducted several countrywide campaigns to educate the public on issues of safe medication use and donated hundreds of pill boxes.
This year’s Pharmacy Week is being celebrated under the theme, ‘Empowering Pharmacists through Collaboration to Elevate Pharmaceutical Care and Promote Healthy Lifestyles.’