Following is a release from the Food and Drug Department
DRUG REGISTRATION REQUIREMENTS AND ENFORCEMENT TO PREVENT IMPORTATION AND DISTRIBUTION OF SUBSTANDARD / FALSIFIED (SF) MEDICINES
The Government Analyst –Food and Drug Department (GA-FDD) wishes to remind the general public, particularly importers and manufacturers of prescription drugs/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 drugs / medicines must be registered with the Department. Registration is the first line of defense against the proliferation of Substandard or Falsified (SF) medicines in our health care delivery system, both at private and public institutions.
The World Health Organization (WHO) in its publication, “A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products” in 2017 (https://www.who.int/medicines/regulation/ssffc/publications/se-study-sf/en/), determined that approximately 1 in 10 or 10% of drugs tested in Low- and Middle-Income countries were falsified or substandard.
To this end, over the past eighteen (18) months the GA-FDD has participated in a pilot project to determine the safety, efficacy and quality of prescription drugs used on our local market. This was done in collaboration with 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 thirty – six (36) drugs sampled and tested from our market, at the MQCSD- laboratory and at our own Drug Testing Laboratory, approximately 3 in 10 or 30% 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% on our local market, which is significantly more than the global average, the Department will be stringently enforcing our drug registration requirements.
Our current Food and Drug Regulations stipulates 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 has signed onto the CARPHA’s Caribbean Regulatory System (CRS) in March of 2017, (https://www.carpha.org/What-We-Do/CRS/Caribbean-Regulatory-System), 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. The GA-FDD has earned the distinction of registering the first (1st) CRS recommended Drugs/ Medicines on the 18th September 2017, taking less than sixty (60) days to complete the process. To date, approximately forty-nine (49) CRS recommended medicines have been registered by the GA-FDD for use in Guyana.
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 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 authorization from the GA-FDD will be seized and removed from premises by Officers/ Inspectors of the Department.