Among the developing countries of the world India has made its own identity in the health care department or in the pharmaceutical department. Currently India is considered to be a world of pharmacy of generic medicines. Generic drugs are those drugs which are same as the branded one. This is mandatory that generic drugs only manufactures after expiry of innovative drug’s patent. Generics have an important role to play in public health as they are well known for their affordable prices. After expiry of the patent it is open to manufacture and marketing generic by everyone. According to WHO there is no precise legal definition for widely available worldwide, generic drugs play an efficient role in pharmaceutical expenditures. Generic medicines stay in trend because these are available on a reasonable price in the market which is easy to grab for the Indian market. The healthcare system of India offer generic drugs 20-90% cheaper than original branded drugs. Objective of this study is to provide a high description of what generic drugs are and how these drugs are different from branded or innovative drugs, and what the regulatory and legislative levels of generic drugs are, here we initiate the study from the historical and current regulation of the generic medicines.
- Arafat MO, Ahmed ZA and Arafat OS. “Comparison between generic drugs and brand name drugs from bioequivalence and thermoequivalence prospective”. Int. J. Pharm. Pharm. Sci 9 (2017): 1-4.
- Jan Aushadhi: An Initiative of Government of India | Generic Medicine Campaign Improving Access to Medicines. Janaushadhi.gov.in.
- Alfonso-Cristancho R., et al. “Definition and classification of generic drugs across the world”. Applied health economics and health policy 13.1 (2015): 5-11.
- Al-Gedadi NA and Hassali MA. “Pharmacists' views on generic medicines: a review of the literature”. Journal of Generic Medicines 5.3 (2008): 209-218.
- Approval of Generic Drugs.
- Barbour RS. “Checklists for improving rigour in qualitative research: a case of the tail wagging the dog?”. Bmj 322.7294 (2001): 1115-1117.
- Baumgärtel C. “Myths, questions, facts about generic drugs in the EU”. Generics and Biosimilars Initiative Journal (GaBI) 1.1 (2012): 34-8.
- Canadian Drug Manufacturers Association. Pharmaceutical patent. The review of Bill C-19. Submitted by the Canadian Drug Manufacturers Association to the Standing Committee on Industry. Toronto: CDMA (1997).
- Chadha A. “Daiichi Sankyo's generic (mis) adventure: the Ranbaxy takeover”. Emerald Emerging Markets Case Studies 2.8 (2012): 1-10.
- Code of Federal Regulation, 21, Food and Drugs, Part 314.94, Content and format of an abbreviated application (1995): 134.
- Davit BM., et al. “Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration”. Annals of Pharmacotherapy 43.10 (2009): 1583-s1597.
- Dhamija P, Sharma PK and Kalra S. “Only generics (drugs/names): Is India ready?”. Indian journal of endocrinology and metabolism 19.5 (2015): 541.
- Dighe SV. “A review of the safety of generic drugs”. In Transplantation Proceedings 31.3 (1999): 23S-24S.
- Dipiro JT. Pharmacoeconomics: Principles, methods and applications, Pharmacotherapy: A pathophysiologic approach, 8th edition.
- Dunne S., et al. “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 Pharmacology and Toxicology 14.1 (2013): 1.
- European Generic Medicines Association. Percent of generic medicines: EU member states (1999).
- European Medicines Agency. CPMP/EWP/QWP/ 1401/98 Rev.1. Guideline on the investigation on bioequivalence.
- Gaither CA., et al. “Consumers' views on generic medications”. Journal of the American Pharmaceutical Association 41.5 (2001): 729-736.
- Gallelli L., et al. “Safety and efficacy of generic drugs with respect to brand formulation”. Journal of pharmacology & pharmacotherapeutics 4.1 (2013): S110.
- Garattini L and Tediosi F. “A comparative analysis of generics markets in five European countries”. Health policy 51.3 (2000): 149-162.
- Generic Drugs.
- Generic Drugs: Overview of ANDA Review Process.
- Grabowski HG and Kyle M. “Generic competition and market exclusivity periods in pharmaceuticals”. Managerial and Decision Economics 28.4‐5 (2007): 491-502.
- Hakonsen H., et al. “Generic substitution: additional challenge for adherence in hypertensive patients?”. Current medical research and opinion 25.10 (2009): 2515-2521.
- Hassali MA., et al. “Physicians' views on generic medicines: a narrative review”. Journal of Generic Medicines 7.1 (2010): 30-9.
- Himsmel W., et al. “What do primary care patients think about generic drugs?”. International Journal of Clinical Pharmacology & Therapeutics 43.10 (2005).
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