Quality of Labels of Some Locally Manufactured Medicines in Ghana

Background: Labelling plays an important role in informing healthcare providers and patients on appropriate information on drugs and how to optimize their therapeutic effects whilst minimizing potential side-effects. For these reasons, drug regulatory bodies have specifications which drug manufacturers are required to conform to in the labelling of their products.

Aim: The purpose of the study was to find out whether locally manufactured medicines on the Ghanaian market meet the specifications set out by the Ghana Standards Authority.

Place and Duration of Study: The study was carried out in Kumasi, Ghana, between April 2018 and September 2018.

Methodology: The labels of one hundred locally produced drugs were assessed based on the general labelling rules for drugs outlined in the Legislative Instrument, L.I. 1541. Some parameters used for the assessment were dates of manufacture and expiry, batch number, indications, active ingredients, handling precautions, etc.

Results: Results obtained indicated that 17% of the products did not have date of manufacture; 10% did not bear expiry dates; 23% did not have batch numbers; 54% did not have indications; and 24% did not specify the active ingredients. It was also observed that 15% of the products did not have handling precautions.

Conclusion: Such products may present a serious health threat to users, as for instance, drugs without expiry dates may be consumed even after it has expired; and for those without batch numbers, it may be difficult to recall when a problem arises. Additionally, products without indications may be wrongly used. Based on the results, it is recommended that the appropriate regulatory bodies take a critical look at the labels on drugs in the market.