Detection of Substandard Medicines in Sudanese Market by Assessing Pharmaceutical Equivalences of Five Brands of Lisinopril 10mg Tablets

Counterfeit medicines resemble a silent murderer when used to treat life threatening conditions and people of lower-income segment are at greater risk of purchasing and consuming unsafe counterfeit products. The aim of this study is to examine if substandard medicines are circulating in the regulated supply chain of Sudan and to assess the enforcement of law and regulations by drug regulatory authority taking Lisinopril 10mg brands, fully registered in Sudan, as a model drug. The quality of Zestril, P1, P2, P3 and P4 were evaluated by qualifying tablets for harness, friability, disintegration time, dissolution and assay according to pharmacopoeial methods. All brands have passed the official tests, however two of them failed to pass the friability and hardness tests and Zestril failed to pass only the hardness test. The results might be attributed mainly to the variations in excipients used. The formulation that contains only maize starch as binding agent totally failed to pass both hardness and friability tests and was therefore of substandard quality. The studied showed that circulating pharmaceutical alternatives and equivalence in Sudanese market may need more efficient system to assess their quality before and after circulating on the Sudan’s market to safeguard the health of the population.