Importance of Generic Drugs: A Review

Abstract

A drug is a chemical substance which is used to treat or diagnose a disease. Its takes many years to discover a new drug as it has to undergo many tests, clinical trials etc., in order to pass the USFDA standards. Only if the drug is approved in the USFDA it is permitted to get manufactured in the pharma industries. Once the drug passes the stag of USFDA s’ approval it is then manufactured and the discoverer of the drug gets the patent for that drug. As the drug research is too costly based on the expenditure of the research, the discoverer decides the price for the drug which is too high, at least not affordable by common man. For this reason the introduction to generic drugs has introduced.

Introduction

A generic drug is a pharmaceutical drug which is equivalent to a brand-name product in dosage, route of administration, strength, quality, Kinetics, and its intended use. It may also refer to any drug which is marketed under its chemical name without advertising [1-12]. For getting the approval to market the generic drug an abbreviated new drug application termed as ANDA is to be submitted by the drug companies. The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, allowed ANDAs to be possible by making a compromise in the drug industries [13-28]. Hence, the generic drug gained access to the market for the prescribed drugs and discoverer companies gained restoration of patent of their products. Any new drug is developed under patent protection. This patent protects the investments involved in the development of the drug by allowing the company to have the right to sell the drug while the patent is in the effect. The manufacturer can apply to the FDA for the selling of generic version after the expiration of the patent period. Further, the ANDA process doesn’t require the sponsor to repeat test animals, ingredients or dosage forms which are already approved for the safety and its effectiveness.

In many countries generic drugs are subjected to the government regulations. However, it has been already introduced in our country yet its uses and value is still not known by many people. The significance of these drugs is not known by the common man, it is the responsibility of all the aware individuals to help people understand and spread its awareness about its safety and its effects.

Are Generic Drugs as Good as Brand-Names

As similar to the brand drugs these generic drugs also need to get approval from FDA mentioning the composition, administration dosage, drug kinetics is same as to the brand named drugs [1,7,9]. The FDA needs the generic drugs to be high in quality, and same as pure, strong and stable as brand name drugs. The have same active ingredients, same risks, and same benefits as the brand-name drugs. Following the regulatory agencies and manufacturing techniques the tests are performed. To get approval, the criteria of dissolution rate of both the brand and generic drug should be same along with same safety, dosage and efficacy [29-47].

why do generic drugs look different than the brand-name product?

As per the US based trading laws the generic drugs must not resemble as same as to that of the original brand drugs, so only the colour and shape varies. Maintaining its effectiveness, colours, flavours, and few certain other inactive ingredients can be different [48-63].

Jan Aushadhi Yojanam

Over the last few years even our country has developed in producing quality generic drugs in most of the thereupatic categories. However, these generic drugs are available at reasonable prices but still most of the population of our country is still unable to afford these drugs [64-90]. In our country, generic drugs are developed in most of the therapeutic categories. Even though, these generic drugs are made available at reasonable prices, most of the population is still unable to access the generic drug usage. So, in order to make it available to layman, the government has introduced the Jan Aushadhi Scheme, making the availability of generic drugs and helping to get medicines at affordable prices. This Jan Aushadhi stores are presents all over the country enabling the availability of drugs at reasonable prices having 600 plus drugs. The Jan Aushadhi stores are licensed under the roof of pharmaceutical products of India [91-100] Table 1.

Table 1. Jan Aushadhi Yojanam scores.

Conclusion

So, in a country like India which is still under that stage of developing we need to bring awareness and help the people know the value and use of these generic drugs. As the drugs are with same composition and provide the same therapeutic effect at reasonable prices these should be promoted to a larger extent.

References

1. Salim M, et al. The Current Perspective of Community Pharmacists towards Pharmacovigilance. J Pharmacovigil. 2015;3:180.
2. Manoj Kumar Sethi. Pharmacovigilance: Challenges in India. J Pharmacovigil. 2016;4:194.
3. Gildeeva GN and Yurkov VI Pharmacovigilance in Russia: Challenges, Prospects and Current State of Affairs. J Pharmacovigil. 2016;4:206.
4. Reis CD, et al. Pharmacovigilance in Cabo Verde: Measuring the Awareness and Knowledge of Consumers. J Pharmacovigil. 2016;4:200.
5. Sanaa A, et al. Awareness and Perception of National Pharmacovigilance Center among Lebanese Medical Staff. J Pharmacovigilance. 2016;4:199.
6. Karampola MI and Emmanouilides CE Pharmacovigilance for Biosimilars. J Pharmacovigil. 2016;4:196.
7. Mishra H and Kumar V. Pharmacovigilance: Current Scenario in a Tertiary Care Teaching Medical College in North India. J Pharmacovigilance. 2013;1:108.
8. Wertheimer AI. The Curious Path of Pharmacovigilance. J Pharmacovigilance. 2013;1:e109.
9. Preda A.Pharmacovigilance and Beyond. J Pharmacovigilance. 2013;1:e114.
10. Agrawal P. Drug Discovery and Development: An Insight into Pharmacovigilance. J Pharmacovigilance. 2014;2:e120.
11. De Wolf J, et al. Evolution of Drug Utilization in Nursing Homes in Belgium. Clin Pharmacol Biopharm. 2014;3:124.
12. González EM, et al. In Vitro Antioxidant Capacity of Crude Extracts and Acetogenin Fraction of Soursop Fruit Pulp. Pharm Anal Acta. 2016;7:484.
13. Permender R, et al. Novel Statistically Designed Qbd Methodology for Quantitative Analysis of Nisoldipine in Pharmaceutical Dosage Forms. Pharm Anal Acta. 2016;7:489.
14. Abass SAE, et al. Development and Validation of Spectrophotometric and Pre-column Derivatization HPLC Method for Determination of Famotidine in Pharmaceuticals by Reaction with Sodium Nitroprusside; Application to Combined Tablets. Pharm Anal Acta. 2016;7:476.
15. Ranjna C, et al. Pharmaceutical Analysis and the Growing Disciplines. Pharm Anal Acta. 2016;7:478.
16. Sohel D, et al. Bioavailability Study of Sustain Release Preparations of Three Widely used NSAIDS Available in Bangladesh. Pharm Anal Acta. 2016;7:482.
17. Lee S, et al. Lifetime Assessment of POCT Strips through Accelerated Degradation Test. Pharm Anal Acta. 2016;7:475.
18. Kogawa AC, et al. Quantification of Doxycycline in Raw Material by an Eco-Friendly Method of Infrared Spectroscopy. Pharm Anal Acta. 2016;7:463.
19. Shimodaira S, et al. Quality Verification of Dendritic Cell-Based Cancer Vaccine. Pharm Anal Acta. 2016;7:465.
20. Hassali MA, et al. Role of Pharmacists in Health Based Non-Governmental Organizations NGO: Prospects and Future Directions. Pharm Anal Acta. 2016;7:467.
21. Vergeire-Dalmacion G. Usefulness of Cost Effectiveness: Evidence versus Applicability. Pharm Anal Acta 2016;7:456.
22. Wang C. Application of In Vitro Models in Developmental Neurotoxicity and Pharmaceutics Research. J Mol Pharm Org Process Res. 2015;3:e122.
23. Lyubchenko YL. Nanoimaging for Molecular Pharmaceutics of Alzheimer’s and other Neurodegenerative Disorders. J Mol Pharm Org Process Res. 2013;1:e107.
24. Skalko-Basnet N. Note on the “Molecular Pharmaceutics and Organic Process”. J Mol Pharm Org Process Res. 2013;1:e104.
25. Foldvari M. Nanopharmaceutics Innovations in Gene Therapy: Moving Towards Non-Viral and Non-Invasive Delivery Methods. J Nanomedine Biotherapeutic Discov. 2014;4:e135.
26. Qumbar M, et al. DOEBased Stability Indicating RP-HPLC Method for Determination of Lacidipine in Niosomal Gel in Rat: Pharmacokinetic Determination. Pharm Anal Acta. 2014;5:314.
27. Abbas-Aksil T, et al. Matrix Tablets from Algerian Lyophilized Berries LB Arbutus unedo L. Date Phoenix dactylifera L.0020Nat Prod Chem Res. 2016;4:207.
28. Oshizumi Y et al. Dynamics of Swallowing Tablets during the Recovery Period following Surgery for Tongue Cancer. Otolaryngology. 2016;6:218.
29. Tolentino MJ. Macular Supplements Containing Zinc and Vitamin A Should Be Replaced with Meso-Zeaxanthin, Lutein and Zeaxanthin: An Ophthalmic Need for Pharmacovigilance. J Pharmacovigil. 2016;4:195.
30. Toklu HZ, et al. The Knowledge and Attitude of the Healthcare Professionals towards Pharmacovigilance and Adverse Drug Reaction Reporting in Northern Cyprus. J Pharmacovigilance. 2016;4:193.
31. Obara T, et al. Knowledge of and Perspectives on Pharmacovigilance among Pharmacists in the Miyagi and Hokkaido Regions of Japan. J Pharmacovigilance. 2016;4:192.
32. Magyar I. An Overview on the Third Annual Pharmacovigilance Forum. Clin Pharmacol Biopharm. 2015;5:e122.
33. Kaur I, et al. Effective Reporting by Pharmacist in Pharmacovigilance Programme of India. Adv Pharmacoepidemiol Drug Saf. 2015;4:197.
34. Hama R. The Mechanisms of Adverse Reactions to Oseltamivir: Part II. Delayed Type Reactions. Clin Microbiol. 2015;4:224.
35. Kowalski CJ and Mrdjenovich AJ. Pharmacovigilance Observed: Why Watchful Waiting will Work. J Clin Diagn Res. 2015;3:114.
36. Calapai G, et al. Systematic Review of Tranexamic Acid Adverse Reactions . J Pharmacovigilance. 2015;3:171.
37. Marisol HSO, et al. Implementation of a Robust Pharmacovigilance Method for Filgrastim Non-Innovator Products in Cancer Patients in Routine Clinical Practice Complying With Mexican Regulations for Biocomparables. J Pharmacovigilance. 2015;3:174.
38. Reis CD, et al. Illegal Market of Medicines in Cabo Verde: Characterization for Action. J Pharmacovigil. 2015;3:178.
39. Napoleone E and Scasserra C. Pharmacovigilance in Pediatric Age: The Role of Family Pediatricians-Medicines for Children Research Network (FP-MCRN). J Pharmacovigilance 2015;3:168.
40. Abjaude SAR, et al. Strategies to Stimulate Actions for Pharmacovigilance Decentralization 2015;3:165.
41. Kalaivani M, et al. Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission. Adv Pharmacoepidemiol Drug Saf. 2015;4:184.
42. Kalaiselvan V, et al. Indian Pharmacopoeia Commission's Partners for Promoting Public Health. Adv Pharmacoepidemiol Drug Saf. 2015;4:181.
43. Swain S and Patra CN. Impact of Pharmacovigilance in Healthcare System: Regulatory Perspective. Pharmaceut Reg Affairs. 2014;3:e143.
44. Shankar PR, et al. Teaching pharmacovigilance to medical students and doctors. Indian J Pharmacol.2006;38:316-319.
45. Swart J, et al. OP0217 Adjudication of Infections in The Pharmacovigilance in Juvenile Idiopathic Arthritis Patients (Pharmachild) Treated with Biologic Agents and/or Methotrexate. Ann Rheum Dis. 2016;75:139.
46. Jourde-Chiche N, et al. Antimalarial ototoxicity: an underdiagnosed complication? A study of spontaneous reports to the French Pharmacovigilance Network. Ann Rheum Dis 2012;71:79
47. Simon LS. Pharmacovigilance: towards a better understanding of the benefit to risk ratio. Ann Rheum Dis 2002;61:88-89.
48. Pirmohamed M, et al. Pharmacovigilance in developing countries: requires collaboration between stakeholders to develop novel models of funding. BMJ. 2007;335: 7618.
49. Lareb. Inhaled and intransal fluticasone propionate and haematoma. Internet Document. 2008;5:100-104.
50. Hasford J, et al. Pharmacovigilance and Patient Safety — Results of the German Net of Regional Pharmacovigilance Centers. Drug Safety. 2008;10:885–885.
51. Sassi M, et al. Comparability of “Enoxamed” a Tunisian Generic Enoxaparin with the Originator Product: Non-clinical and Clinical Studies. J Bioequiv Availab. 2016;8:249-253.
52. Jawhari D, et al. Pharmacokinetic Comparison and Bioequivalence of a New Generic Formulation of Lenalidomide 25 mg Capsules versus Revlimid in Healthy Volunteers under Fasting Conditions. J Bioequiv Availab. 2016;8:214-219.
53. Trudel E, et al. Bioequivalence of Generic Drugs Commercialised on the Canadian Market. J Develop Drugs. 2016;5:150.
54. Okabe T, et al. Bioequivalence Studies of A Generic Formulation (SW651K) to the Brand Drug S-1 in Tumor-Bearing Rat Models. J Bioequiv Availab. 2016;8:112-117.
55. Mallu UR, et al. Impact of API (Active Pharmaceutical Ingredient) Source Selection on Generic Drug Products. Pharmaceut Reg Affairs. 2015;4:136.
56. Mallu UR, et al. API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors. Pharm Anal Acta. 2015;6:364.
57. Tawde SA Generic Pharmaceuticals: Is Pharmacovigilance Required?. J Pharmacovigil. 2014;2:e124.
58. Jawhari D, et al. Bioequivalence of a New Generic Formulation of Erlotinib Hydrochloride 150 mg Tablets versus Tarceva in Healthy Volunteers under Fasting Conditions. J Bioequiv Availab. 2014;6:119-123.
59. Jimbo H, et al. Comparative Study of the Free Radical Scavenging Activities of Original and Generic Edaravone Determined by Electron Spin Resonance. J Neurol Disord. 2015;3:245.
60. Boubaker H MD, et al.Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab. 2015;7:225-228.
61. James Kirkpatrick C, et al. Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients. Pharmaceut Reg Affairs. 2013;2:109.
62. Navaratne R, et al. Generic Framework for Multi-Disciplinary Trajectory Optimization of Aircraft and Power Plant Integrated Systems. J Aeronaut Aerospace Eng. 2013;2:103.
63. Semdé R, et al. Evaluation of the Bioequivalence Documentation Required For Registration of Generic Drug Products in Burkina Faso: Methodology of Implementation and Impact. J Bioequiv Availab. 2012;4:134-138.
64. Bandichhor R. Research Perspective in Academia and Generic Pharmaceutical Industry. Organic Chem Current Res. 2012;1:e104.
65. Feher A, et al. Generic Statins in Cardiovascular Medicine. J Bioequiv Availab. 2011;S2.
66. Jawhari D, et al. Bioavailability of a New Generic Formulation of Imatinib Mesylate 400mg Tablets Versus Glivec in Healthy Male Adult Volunteers. J Bioequiv Availab. 2011;3: 161-164.
67. Mahatthanatrakul W, et al. Bioequivalence of a Generic Quetiapine (Ketipinor®) in Healthy Male Volunteers. J Bioequiv Availab. 2011;3:108-113.
68. Sharrad AK and Hassali MA. Knowledge and Perceptions of Final Year Medical Students in Iraqi Universities about Generic Medicines. J Bioequiv Availab. 2011;3:086-091.
69. Rossi GCM, et al. Effect of Glaucoma Medications on Quality of Life Examined by Generic and Vision Specific Instruments. J Clinic Experiment Ophthalmol. 2010;1:106.
70. Tamboli AM, et al. An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. J Bioequiv Availab. 2010;2:086-092.
71. Silva Solon LG, et al. Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats. J Bioanal Biomed. 2010;2:048-054.
72. Saleh TA. Nanomaterials for Pharmaceuticals Determination. Bioenergetics. 2016; 5:226.
73. Naeem F, et al. Development, Testing and Reporting of Mobile Apps for Psycho-social. J Med Diagn Meth. 4:1000191.
74. Ali SM, et al. Bioequivalence Study of Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and DOXIL® in Ovarian Cancer Patients: Physicochemical Characterization and Pre-clinical studies. J Nanomed Nanotechnol. 2016;7:361.
75. Kojima S, et al. Broadband Terahertz Time-Domain and Low-Frequency Raman Spectroscopy of Crystalline and Glassy Pharmaceuticals. Pharm Anal Acta. 2015;6:401.
76. Atkinson HC, et al. A Pharmacokinetic Analysis of a Novel Fixed Dose Oral Combination of Paracetamol and Ibuprofen, with Emphasis on Food Effect. J Bioequiv Availab. 2015;7:150-154. 
77. Ahmad A, et al. Nanosomal Paclitaxel Lipid Suspension Demonstrates Higher Response Rates Compared to Paclitaxel in Patients with Metastatic Breast Cancer. J Cancer Sci Ther. 2015;7:116-120. 
78. Sheikh S, et al. A New Topical Formulation of Minoxidil and Finasteride Improves Hair Growth in Men with Androgenetic Alopecia. J Clin Exp Dermatol Res. 2015;6:253.
79. Tawde SA. Particulate Matter in Injectables: Main cause for Recalls. J Pharmacovigil. 2015;3:e128.
80. R Rajender, et al. Regulatory requirements for generic drugs (ANDS) in Canada. J of dev drugs. 2015.
81. Canada H  Drug Product Database Online Query. Drug and Health Products. 2013.
82. Canada S. Recherche de produitspharmaceutiques en ligne.Médicamentsetproduits de santé. 2013.
83. Canada S (2014)Lignedirectrice.Monographie de produit. Canada.
84. Canada S. Incluant les renseignements pour les patientssur les medicaments.Annexe E - Modèle de monographie de produit - Norme. 2014
85. IMS Health. Canadian Pharmaceutical Industry Review. IMS (Canada) 2013.
86. Association CGP. The Canadian generic Market. Generic drugs same quality low price. 2014.
87. ICIS. Les facteurs de coûtassociés aux dépenses en medicaments d’ordonnance –Un rapport méthodologiqueDépenses en médicaments au Canada 2013.
88. Argent DP. La RAMQ confirmesapréférence pour le médicamentgénérique. TVA Nouvelles 2014.
89. Québec OdPd. Guide sur la substitution en pharmacie 1994.
90. Canada S. LigneDirectrice, Normes en matièred'études de biodisponibilité comparatives: Formespharmaceutiques de médicaments à effetsystémiques. Avis 2012.
91. 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. Ann Pharmacother. 2009;43:1583-1597.
92. Liu CT, et al. Development and evaluation of an integrated pharmaceutical education system. Int J Med Inform. 2004;73:383-389.
93. Van der Meersch A, et al. Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review. PLoS One. 2011;6:e23611.
94. INESSS-INdeeSeeSS. Avis au minister. Institut national d’excellence en santé et en services Sociaux 2014.
95. Heller FR. Dupont AG Generics: need for clinical concern? Acta Clin Belg. 2009;64:415-422.
96. Kumet R and Gelenberg AJ. The effectiveness of generic agents in psychopharmacologic treatment. Essent Psychopharmacol. 2005;6:104-111.
97. Kalodiki E and Fareed J. New and generic anticoagulants and biosimilars: safety considerations. Clin Appl Thromb Hemost. 2011;17:136-139.
98. Genazzani AA and Pattarino F. Difficulties in the production of identical drug products from a pharmaceutical technology viewpoint. Drugs R D. 2008;9:65-72.
99. Al-Jazairi AS, et al. Brand and generic medications: are they interchangeable? Ann Saudi Med. 2008;28: 33-41.
100. Choudhry NK and Shrank WH. Four-dollar generics--increased accessibility, impaired quality assurance. N Engl J Med. 2010;363:1885-1887.