30% of medical drugs sold on local market substandard – GA-FDD

The Government Analyst-Food and Drug Department (GA-FDD) has unearthed substandard medical drugs being sold in local markets during a pilot programme to detect such an occurrence.
Director of the Department, Dr Marlan Cole on Tuesday via a release explained that they would have partnered with the Medicines Quality Control and Surveillance Department (MQCSD) of the Caribbean Public Health Agency (CARPHA) over the past 18 months to determine the safety and quality of prescription drugs on the local markets.
During the pilot project, the accredited laboratory in Kingston, Jamaica, tested 36 drug samples from Guyana. The results showed that approximately three in 10 or 30 per cent were substandard.
“Drugs tested so far ranged from anti-diabetic, anti-coagulant, diuretic, anti-bacterial and anti-hypertensive drugs. In considering the risks associated with the distribution of such elevated numbers of substandard drugs; 30 per cent on our local market, which is significantly more than the global average, the Department will be stringently enforcing our drug registration requirements,” the GA-FDD divulged.
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 Government Department of Health – Therapeutic Goods Administration (TGA).
Additionally, Guyana had 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, these drugs are then registered by the GA-FDD for use in Guyana. To date, approximately forty-nine (49) CRS recommended medicines have been registered by the GA-FDD for use in Guyana.
As such, importers and manufacturers are reminded to ensure compliance with the registration procedures if products are to be released for sale and use in our healthcare delivery system. If these inferior substances are found, they will be seized and destroyed.
“The Department reiterates that no waivers will be granted to any entity for the sale and/or distribution of unregistered drugs/medicines in Guyana. The GA-FDD; in the best interest of consumer protection and safety and according 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 authorisation from the GA-FDD will be seized and removed from premises by Officers/Inspectors of the Department.”
Dr Cole also reminded the general public, particularly importers and manufacturers of prescription medicines, of the importance and legal requirement for drug registration compliance.
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 medicines must be registered with the Department. Registration is the first line of defence against the proliferation of Substandard or Falsified (SF) medicines in our healthcare delivery system, both at private and public institutions.