Pharmaceutical Regulatory Affairs: Open Access

Uganda National Bureau of Standards is mandated to enforce standards in protection of the public against harmful, dangerous and sub-standard products. The enforcement activities are carried out through market surveillance activities while compliance to the standards is handled by Certification function. For the past five years, the Bureau has registered a progressive increase in the performance of these two functions and therefore it was imperative to examine the impact of surveillance activities on the certification services. Data was collected from UNBS database for the performance of these functions in the past five years. Correlation and regression analyses were applied to examine the associations that exist between market surveillance activities and certification services. The findings revealed that a very strong and positive correlation between market surveillance and certification services (r=0.947). It was revealed that 89.6% of certification services are influenced by market surveillance activities (R Square=0.896).

Although the intake of caffeine dates back to the time when various civilisations were just beginning, energy drinks (EDs) were only launched about 40 years ago. Since then, both India and Canada have seen an upsurge in the consumption of caffeinated energy drinks (CEDs). It has been contrasted between the regulatory standards in India and Canada for CED marketing permission. This covers the warnings for caffeinated beverages as well as the Recommended Daily Allowance (RDA) amounts for its ingredients. In order to comprehend the licencing process for caffeinated beverages in terms of manufacturing, distribution and sale, new start-ups and manufacturers will benefit from the comparison. The CED FSSAI guidelines are subject to individual interpretation. While the CEDs regulations in Canada are quite simple. Hence, the present review gives the exact information related to registration process of caffeinated beverages in Canada and India. Also, the standards set by Canada and India for energy drinks are mentioned in this review which helps new organisation and start-ups to explore the regulatory requirements for caffeinated energy drinks.