QUALITY AND AFFORDABILITY OF AMOXICILLIN GENERIC PRODUCTS: A PATIENT CONCERN
Keywords:Amoxicillin, Generic, Substandard, Drug Quality, Affordability
Objective: Antibiotics save millions of lives from infectious diseases worldwide. Failing treatment, serious adverse effects, and antimicrobial resistance are constantly reported mainly from developing nations due to lack of quality of antibiotics medicines. In India quality of medicines remains a major regulatory challenge and patients concern. Thus, a pilot study to explore the quality of generic amoxicillin products and associated price along with their burden on patients was evaluated.
Methods: 46 amoxicillin trihydrate generic products with the label claim of 250 mg amoxicillin were procured from open market of Northern India without prescription. Identification and quantitative evaluations of these generic products were estimated using Indian Pharmacopoeia (IP) 2010 recommended High-Performance Liquid Chromatography (HPLC) method. And assay value was compared with the maximum retail price per unit dosage. Affordability was estimated in general for the population who daily live on less than Indian rupees Rs. 144 and `88.6.
Results: Out of 46 products, 28.26% were found to be out of IP specification, including 13.04% products which were of substandard quality. Fishers' exact test with p-value 0.87 showed products quality gaps were irrespective of their price. Ceiling price of Rs. 3.04 per unit dosage pose a high burden on the patients who are on amoxicillin treatment.
Conclusion: Situation demands the evidence of safety before approval and thereafter too. However, the situation may become worst if the price and quality could not be controlled. Thus Indian drug regulatory bodies need to be entreated to counter these critical issues.
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