The Shift Towards Generic Medicine: A Pragmatic Approach by Indian Doctors
Abstract
The pharmaceutical industry worldwide has witnessed a significant positive shift in recent years. In India, the discourse surrounding generic medicines has gained momentum, albeit with some challenges. The cost of research and development invested in the development of a drug makes it costly and unaffordable for most of the patients.
The Government of India has made various steps to introduce affordable drugs. However, it has not become very popular amongst patients. Various doubt and lack of confidence among doctors and patients regarding potency, efficacy, and quality is still a concern. There is a need for correct awareness to be spread amongst doctors and patients regarding generic medicine. The pharmaceutical industry also needs to be in the picture and promote positive awareness.
This article aims to shed light on the perspective of Indian doctors as they navigate the complexities of prescribing generic medicines without sufficient government support and limited patient awareness. This article also tries to shed light on the present scenario of how generic medicines are perceived by patients.
Downloads
References
2. Shah US. Regulatory strategies and lessons in the development of biosimilars. In: Pharmaceutical sciences encyclopedia. Wiley; 2010.
3. Mastan S, Latha TB, Ajay S. The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE) studies-an overview. Comp Eff Res. 2011;1:1–25.
4. Generic Drug Facts [Internet]. US FDA; 2018. [cited 2024 Apr 2]. Available from:
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm16799.
5. Swain S, Dey A, Patra CN, Bhanoji Rao ME. Pharmaregulations for generic drug products in India and US: Case studies and future prospectives. Pharmaceut Reg Affairs. 2014;3:2
6. Janodia M. Differences in price of medicines available from pharmaceutical companies and "Jan Aushadhi" stores. Value Health. 2015;18:A850.
7. Singh SK. Bureau of Pharma PSUs of India (BPPI), (Under Department of Pharmaceuticals, Government of India). Message from CEO; 2018 [Internet]. janaushadhi.gov; 2018 [cited 2024 Apr 2]. Available from:
http://www.janaushadhi.gov.in/mesgceo.aspx.
8. The Hans India [Internet]. The Hans India; 2017 [cited 2018 Apr 12]. Available from:
https://www.thehansindia.com/the-hans-india/2017
9. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14:1.
10. Andrade C. Bioequivalence of generic drugs: A simple explanation for a US Food and Drug Administration requirement. J Clin Psychiatry. 2015;76:e742-4.
11. Gota V, Patial P. Toward better quality of anticancer generics in India. Indian J Cancer. 2014;51:366.
12. Amaral Silva D, Löbenberg R, Davies N, Are Excipients Inert? Phenytoin Pharmaceutical Investigations with New Incompatibility Insights. J Pharm Pharm Sci. 2018;9745
13. Zhang W, Li Y, Zou P, Wu M, Zhang Z, Zhang T, The Effects of Pharmaceutical Excipients on Gastrointestinal Tract Metabolic Enzymes and Transporters-an Update, APPS J. 2016;18:830–843.
14. Singhal G.L., Kotwani A., Nanda A. Jan Aushadhi Stores in India and Quality of Medicines Therein. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(1):1-4.

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM