RESUMEN
Drug counterfeiting and production of substandard drug is a global problem. Substandard or counterfeit drugs are threat for the effective treatment of diseases and highly worsen the quality of life of patients. This study was aimed to assess the pharmaceutical quality of ranitidine hydrochloride tablets manufactured in Bangladesh. Tablets were collected from different parts of Bangladesh and quality parameters were evaluated according to the United States Pharmacopoeia and the British Pharmacopoeial methods. The potency of tablets was measured spectrophotometrically. Weight variation and disintegration time were performed according to pharmaceutical monographs. Among 43 brands tested, 8 failed to comply with the USP specification (active ingredient: 90±10%) due to containing of less amount of ranitidine of which 6 brands were spurious and 2 were substandard in nature. Two brands did not comply with the specification for weight variation of tablets whereas all brands passed disintegration time test. The findings clearly demonstrate the production of substandard ranitidine tablets in Bangladesh. The drug control authority of Bangladesh should take effective steps to prevent the production of substandard drugs to secure public health.
RESUMEN
Counterfeit drugs have emerged as a major global problem. This issue has been brought to the centre of the Indian media due to the death of 15 women attending a sterilization camp in Chhattisgarh. India’s pharmaceutical industry exports drugs worth 15 billion dollars, which means a high prevalence of counterfeiting in India’s drug industry has global repercussions. However, accurate figures on the extent of counterfeit drugs in India are not available. The scientific literature as well as media reports often quotes figures of 10-35%, though studies done by the Indian Government dispute this. Counterfeit drug numbers have been known to be under represented by Governments due to fear of undermining their economy and health systems. On the other hand, rival companies in other countries may have an incentive to over hype India’s counterfeit problem to dent India’s growing status as the leading global supplier of generic medicines. Lack of clear definitions and differences between laws of countries further complicate reporting. A high prevalence of counterfeit drugs has a large impact on both health and economic indicators. Additionally, counterfeit drugs provide significant challenges to Pharmacovigilance programmes. Hence, here we discuss the significance of use of counterfeit drugs in India and challenges faced by Pharmacovigilance due to the extensive use of counterfeit drugs.