Latest update November 26th, 2024 1:00 AM
30 of drugs in Guyana are sub-standard
The Government Analyst –Food and Drug Department (GA-FDD) has warned against the sale of sub-standard/fake drugs after a study found that approximately 30 percent of the drugs sold locally have been classified as sub-standard.
According to information released by the GA-FDD, in considering the risks associated with the distribution of such elevated numbers of substandard drugs; 30% on the local market, which is significantly more than the global average, the department has moved to stringently enforce the drug registration requirements.
The GA-FFD noted that according to the Laws of Guyana, Food and Drug Act, Chapter 34:03 and the Food and Drug Regulations: Regulations 78 and 80, all new drugs/medicines must be registered with the department.
Further, the department outlined that the current food and drug regulations stipulate that medicines manufactured in any country can be registered by the GA-FDD after being certified by the United States-Food and Drug Administration (US FDA), the Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom (UK), Health Canada (HC) or the Australian
GA- FDD Director, Marlan Cole
Government Department of Health – Therapeutic Goods Administration (TGA).
Additionally, the GA- FDD said that Guyana has signed onto the CARPHA’s Caribbean Regulatory System (CRS) in March of 2017, where prescription medicines manufactured in any country are assessed by CARPHA’s-CRS electronically after being certified for use in Brazil, Mexico, Chile, Colombia, Cuba, or Argentina.
With CRS’s recommendation, that these drugs are then registered by the GA-FDD for use in Guyana. The GA-FDD has earned the distinction of registering the first CRS recommended Drugs/ Medicines on the 18th September 2017, taking less than 60 days to complete the process.
“To date, approximately 49 CRS recommended medicines have been registered by the GA-FDD for use in Guyana,” the GAFDD said in a statement.
As such, importers and manufacturers are being reminded to ensure compliance with the registration procedures if products are to be released for sale and use in our health care delivery system.
The Department reiterated that no waivers will be granted to any entity for the sale and/or distribution of unregistered drugs/medicines in Guyana.
The GA-FDD noted that in the best interest of consumer protection and safety in accordance to the laws of Guyana Food and Drug Act Chapter 34:03, Section 21 (d), hereby warns that any unregistered drugs/medicines in circulation or those found on the premises of local distributors without authorization from the GA-FDD will be seized and removed from premises by Officers/ Inspectors of the department.
The department noted that registration is the first line of defense against the proliferation of substandard or falsified medicines in our health care delivery system, both at private and public institutions.
Over the past 18 months, the GA-FDD has participated in a pilot project to determine the safety, efficacy and quality of prescription drugs used on the local market.
“The project was facilitated by the Caribbean Public Health Agency’s (CARPHA) – Medicines Quality Control and Surveillance Department’s (MQCSD) – accredited laboratory located in Kingston, Jamaica.”
During this sampling and testing exercise, it was discovered that of 36 drugs sampled and tested from Guyana’s market, at the MQCSD- laboratory and at local drug testing laboratory, approximately 3 in 10 or 30% of the drugs tested which ranged from anti-diabetic, anti-coagulant, diuretic, anti-bacterial and anti-hypertensive drugs were sub-standard.
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