QUALITY AND AFFORDABILITY OF AMOXICILLIN GENERIC PRODUCTS: A PATIENT CONCERN
Keywords:
Amoxicillin, Generic, Substandard, Drug Quality, AffordabilityAbstract
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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Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, et al. the Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 2001;357:1933–6.
Heyman ML, Williams RL. Ensuring global access to quality medicines: the role of the US pharmacopeia. J Pharm Sci 2011;100:1280–7.
King DR, Kanavos P. Encouraging the use of generic medicines: implications for transition economies. Croat Med J 2002;43:462–9.
WHO. Medicines: spurious/ falsely-labelled/ falsified/ counterfeit (SFFC) medicines. World Health Organization; 2012. Available from: http://www.who.int/ mediacentre/ factsheets/fs275/en/. [Last accessed 15 Jan 2015].
Newton PN, Green MD, Fernández FM. The impact of poor-quality medicines in the ‘developing’ world. Trends Pharmacol Sci 2010;31:99–101.
PSM. Counterfeit Drug Incident Encyclopedia. Partnership for Safe Medicines; 2013. Available from: http://www. safemedicines.org/counterfeit-drug-incident-encyclopedia.html. [Last accessed on 12 Jan 2015].
Khan AN, Khar RK. Current scenario of spurious and substandard medicines in india: a systematic review. Indian J Pharm Sci 2015;77:2–7.
PSM. Proposed methodology to conduct a study on the extent of spurious drugs in the supply chain of Indian market. India. 2010 Available from: http://www.safemedicinesindia.in/ pdf/Methodology.pdf.
Suleman S, Zeleke G, Deti H, Mekonnen Z, Dichateau L, Levecke B, et al. Quality of medicines commonly used in the treatment of soil-transmitted helminths and giardia in ethiopia: a nationwide survey. PLoS Neglected Trop Dis 2014;8:e3345.
WHO. WHO Medicine Strategy: Countries at the core. Geneva; 2007. Available from: http://apps.who.int/medicinedocs/ pdf/s5416e/s5416e.pdf.
World Bank. Poverty Headcount Ratio India 2011. World Bank; 2015. Available from: http://data.worldbank.org/ indicator/ SI.POV.2DAY/countries/IN?display=graph. [Last accessed on 22 Oct 2015].
PIB. Bill on Mandatory Usage of Generic Names of Medicines. Press Information Bureau of India; 2013. Available from: http://pib.nic.in/newsite/PrintRelease.aspx?relid=93018. [Last accessed on 16 Dec 2014].
The World Medicines Situation; 2004. Available from: http://apps.who.int/medicinedocs/pdf/s6160e/s6160e.pdf. [Last accessed on 16 Dec 2014].
NIH. Antibiotics. US. National Library of Medicine. Available from: https://www.nlm.nih.gov/medlineplus/antibiotics.html. [Last accessed 12 Feb 2015].
Bauters TGM, Nguyen BT, Buyle F, Schelstraete P, De Cock P, De Jaegar A, et al. Clinical pharmacy and pediatrics: Why focus on antibiotics? Pharm World Sci 2006;28:3–5.
Kotwani A, Wattal C, Joshi PC, Holloway K. Irrational use of antibiotics and role of the pharmacist: an insight from a qualitative study in New Delhi, India. J Clin Pharm Ther 2012;37:308–12.
Delepierre A, Gayot A, Carpentier A. Update on counterfeit antibiotics worldwide; public health risks. Médecine Maladies Infect 2012;42:247–55.
Rossignoli A, Clavenna A, Bonati M. Antibiotic prescription, and prevalence rate in the paediatric outpatient population: analysis of surveys published during 2000-2005. Eur J Clin Pharmacol 2007;63:1099–106.
NIH. Amoxicillin Capsule. U. S. National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/ drugInfo.cfm?setid=649d285c-8fcb-48dd-aa5e-2f34128102f5. [Last accessed on 10 Jun 2015].
Indian Pharmacopoeia Commission. Amoxicillin Capsule. The Indian Pharmacopoiea Commision, Ghaziabad; 2010. p. 813–4.
Indian Pharmacopoeia Commission. Indian Pharmacopoeia, Sixth. Ghaziabad: The Indian Pharmacopoeia Commission; 2010.
CDSCO. Guidelines for taking action on samples of drug declared spurious or not of standard quality in the light of enhanced penalties under Drug and Cosmetic (Amendment): New Delhi; 2008. Available from: http://www.cdsco.nic.in/ write read data/DCC Guidelines on NSQ Drugs.pdf. [Last accessed on 20 Aug 2015].
Government of India. National list of essential medicines of India. New Delhi; 2011. Available from: http:// pharmaceuticals. gov.in/nlem.pdf. [Last accessed on 20 Aug 2015].
NPPA. Production Details 2005-2008. The government of India. Available from: http://www.nppaindia.nic.in. [Last accessed on 10 Oct 2014].
Kotwani A, Holloway K. Trends in antibiotic use among outpatients in New Delhi, India. BMC Infect Dis 2011;11:99.
Grover A, Citro B. India: access to affordable drugs and the right to health. Lancet 2011;377:976–7.
NPPA. Ceiling price of scheduled medicines fixed/revised under DPCO, 2013. MCF, Government of India; 2014. Available from: http://www.nppaindia.nic.in. [Last accessed on 10 Jan 2015].
Amoxicillin Dosage; 2015. Available from: http:// www. drugs.com/dosage/amoxicillin.html. [Last accessed on 14 Mar 2015].
Indian Pharmaceutical Association. Good Pharmacy Practice Guidelines. Mumbai; 2002. Available from: http://www. ipapharma.org/html/GPP_Guidelines_IPA2002.pdf. [Last accessed on 20 Aug 2015].