“The Pros and Cons of Generic Medicines: Is Janaushadhi a Boon for the People?”
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Abstract
Generic medicines play a crucial role in expanding healthcare access by offering affordable alternatives to brand-name drugs. This paper explores the pros and cons of generic medicines, focusing on their economic benefits, regulatory challenges, and the impact on public health. Central to this investigation is the Janaushadhi initiative in India, which aims to enhance affordability and accessibility through a network of government-owned pharmacies. By examining the success and challenges of Janaushadhi, this paper assesses its effectiveness in improving healthcare outcomes and public trust in generic medicines.
Generic drugs, as defined by the U.S. Food and Drug Administration (FDA), are pharmaceutically equivalent to brand-name drugs in dosage form, safety, strength, route of administration, quality, performance, and intended use, yet are typically priced significantly lower, enhancing affordability for patients and healthcare systems. This paper examines the regulatory and scientific framework of generics, focusing on bioavailability, bioequivalence studies, and dissolution testing. Bioavailability, critical for drug absorption and efficacy, is assessed through rigorous bioequivalence studies, ensuring therapeutic equivalence with branded drugs. The Drug Price Competition and Patent Term Restoration Act of 1984 (HatchWaxman Act) has streamlined generic drug approvals based on these studies, fostering competition and lowering drug costs. Dissolution testing, adhering to US Pharmacopeia standards, validates the quality and performance of generic solid oral dosage forms. Additionally, the paper discusses the impact of initiatives like the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) in India, emphasizing its role in providing affordable generics and reducing healthcare disparities under strengthened regulatory oversight.
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References
Alam, M., & Tyagi, R. P. (2009). A Study of Out of Pocket Household Expenditure on Drugs and Medical Services. An Exploratory Analysis of UP, Rajasthan and Delhi. Retrieved from http://planningcommission.gov.in/reports/sereport/ser/ser_drug2910.pdf
Bhargava, A., & Kalantri, S. P. (2013). The crisis in access to essential medicines in India: key issues which call for action. Indian Journal of Medical Ethics, 10(2), 86–95.
King, D. R., & Kanavos, P. (2002). Encouraging the use of generic medicines: Implications for transition economies. Croatian Medical Journal, 43(4), 462–469.
Saksena, P., Xu, K., & Durairaj, V. (2010). The drivers of catastrophic expenditure: outpatient services, hospitalization or medicines? Retrieved from http://www.who.int/healthsystems/topics/financing/healthreport/21whr-bp.pdf
U.S. Food and Drug Administration. (n.d.). Bioavailability and bioequivalence studies submitted in NDAs or INDs — General considerations. Retrieved from FDA website.
U.S. Food and Drug Administration. (n.d.). What are generic drugs?. Retrieved from FDA website.
Wagner, A. K., Graves, A. J., Reiss, S. K., Lecates, R. F., Zhang, F., & RossDegnan, D. (2011). Access to care and medicines, burden of health care expenditures, and risk protection: results from the World Health Survey. Health Policy, 100(2-3), 151–158.
Waning, B., Diedrichsen, E., & Moon, S. (2010). A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. Journal of the International AIDS Society, 13(1), 35.
Saksena P, Xu K, Durairaj V. The drivers of catastrophic expenditure: outpatient services, hospitalization or medicines? WHO Report. Published 2010.
Wagner AK, Graves AJ, Reiss SK, LeCates R, Zhang F, Degnan DR. Access to care and medicines, burden of health care expenditures, and risk protection: Results from the World Health Survey. Health Policy. 2011;100(2-3):151–158. doi: 10.1016/j.healthpol.2010.08.004. [PubMed] [CrossRef] [Google Scholar]
Alam M, Tyagi RP. A Study of Out of Pocket Household Expenditure on Drugs and Medical Services. An Exploratory Analysis of UP, Rajasthan and Delhi. Planning Commission Report. Published 2009.
Bhargava A, Kalantri SP. The crisis in access to essential medicines in India: key issues which call for action. Indian J Med Ethics. 2013;10(2):86–95. [PubMed] [Google Scholar]
Waning B, Diedrichsen E, Moon S. A lifeline to treatment: the role of Indian generic manufacturers in supplyin g antiretroviral medicines to developing countries. J Int AIDS Soc. 2010;13:35. doi: 10.1186/1758-2652-13-35. [PMC free article] [PubMed] [CrossRef] [Google Scholar]
King DR, Kanavos P. Encouraging the use of generic medicines: implications for transition economies. Croat Med J. 2002;43(4):462–469. [PubMed] [Google Scholar]
Ozawa, S., Shankar, R., Leopold, C., & Orubu, S. (2019). Access to medicines in low- and middle-income countries. Health Policy and Planning. Retrieved from https://academic.oup.com/heapol/article/34/Supplement_3/iii1/5670624
World Health Organization. (2004). Equitable access to essential medicines: A framework for collective action. Geneva: Author.
Selvaraj, S., Farooqui, H. H., Karan, A., et al. (2018). Quantifying the financial burden of out-of-pocket payments on medicines in India. BMJ Open. Retrieved from https://bmjopen.bmj.com/content/8/5/e018020
Muralidharan, V., Vaidyanathan, G., Sundaraman, T., et al. (2020). National samplesurvey on healthcare in India. Economic and Political Weekly. Retrieved from https://www.epw.in/journal/2020/37/special-articles/invest-more-publichealthcare-facilities.html
Government of India. (2013). Drugs (Prices Control) Order. Ministry of Chemicals and Fertilizers. Retrieved from http://www.nppaindia.nic.in/DPCO2013.pdf
Government of India. (2021). NPPA sets ceiling prices for medicines. Ministry of Chemicals and Fertilizers. Retrieved from https://pib.gov.in/PressReleseDetail.aspx?PRID=1739468
Pilla, V. (2019). Explainer: How drug prices are regulated in India. Moneycontrol. Retrieved from https://www.moneycontrol.com/news/business/explainer-howdrug-prices-are-regulated-in-india-4606751.html
Selvaraj, S., Hasan, H., Chokshi, M., et al. (2012). Pharmaceutical pricing policy critique. Economic and Political Weekly. Retrieved from https://www-epwin.tiss.remotlog.com/journal/2012/04/commentary/pharmaceutical-pricing-policycritique.html
All India Drug Action Network, Jan Swasthya Abhiyan, et al. (2014). Drug price control in India. Economic and Political Weekly. Retrieved from https://www-epwin.tiss.remotlog.com/journal/2014/35/letters/drug-price-control.html
Majumdar, P. (2017). Generic manoeuvre. Economic and Political Weekly. Retrieved from https://www-epw-in.tiss.remotlog.com/journal/2017/35/commentary/generic-manoeuvre.html
(2018). Balancing affordability with access [Editorial]. Economic and Political Weekly. Retrieved from https://www-epw-in.tiss.remotlog.com/journal/2018/34/editorials/balancing-affordabilityaccess.html?0=ip_login_no_cache%3D8f13d28adf6c522a14beebc5d0a2f72b
Thawani, V., Mani, A., & Upmanyu, N. (2017). Jan Aushadhi Scheme: Challenges and potential. J Pharmacol Pharmacother. Retrieved from https://doi.org/10.4103/jpp.JPP_38_17
Roy, V., & Rana, P. (2018). Prescribing generics: All in a name. Indian Journal of Medical Research. Retrieved from https://doi.org/10.4103/ijmr.IJMR_1940_17
Public Health Foundation of India. (2012). Rapid assessment and scale-up of the Jan Aushadhi Scheme. India: Author.
Wirtz, J., Hogerzeil, V., Gray, L., et al. (2017). Essential medicines for universal health coverage. The Lancet. Retrieved from https://doi.org/10.1016/S01406736(16)31599-9
Gupta, Y. K., & Ramachandran, S. S. (2016). Fixed dose drug combinations in India: Issues and challenges. Indian Journal of Pharmacology. Retrieved from https://doi.org/10.4103/0253-7613.186200
World Health Organization. (2005). Health Action International methodology manual. Retrieved from Geneva: Author.
Ministry of Health and Family Welfare. (2015). National List of Essential Medicines. Government of India. Retrieved from https://www.nhp.gov.in/NHPfiles/NLEM%2C%202015