• VIGNESH M Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India.
  • GANESH GNK Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India.


In India, a Generic drug plays a major role where most of the people afford and depend on it, due to the budget-friendly and easily available widely. However, some of the pharmaceutical manufacturer’s license was terminated due to the unsold or banned products of branded drugs, which are manufactured in USFDA as small plants, were manufactured in India without the approval. There were many misconceptions with the manufacturers, for following the right strategy to bring generic medications, clearing data integrity issues, sales, and marketing aspects of drugs for the successful outcome. India has also been subject to increasing inspections by global regulatory bodies in recent times. There has been an increase in enforcement actions taken by regulatory bodies for cases related to data integrity. From this review, it concluded that what are the current trends involved in the generic drugs and their category based on the license, impact, and issues involved and also provides the recommendations to be followed to prevent further issues in the future.

Keywords: Generic drugs, Current issues, Legal hurdles, Impact, Potential changes, Recommendations


1. Arafat M, Ahmed Z, Arafat O. Comparison between generic drugs and brand name drugs from bioequivalence and thermoequivalence prospective. Int J Pharm Pharm Sci 2017;9:1-4.
2. Medina JR, Cortes M, Romo E. Comparison of the USP apparatus 2 and 4 for testing the in vitro release performance of ibuprofen generic suspensions. Int J Appl Pharm 2017;9:90-5.
3. Kamath A. Prescribing generic drugs using a generic name: Are we teaching it right? Indian J Med Ethics 2016;1:194.
4. Janodia M. Differences in price of medicines available from pharmaceutical companies and “Jan Aushadhi” stores. Value Health 2015;18:A850.
5. National Pharmaceuticals Pricing Authority. Available from: http:// 25.02.2019-Final.pdf.
6. Joshi SS, Shetty YC, Karande S. Generic drugs-the Indian scenario. J Postgrad Med 2019;65:67-9.
7. World Health Organization. International Nonproprietary Names. Available from:
8. Swain S, Dey A, Patra CN, Bhanoji Rao ME. Pharma regulations for generic drug products in India and US: Case studies and future prospectives. Pharm Regul Aff 2014;3:1-6.
9. Rana P, Roy V. Generic medicines: Issues and relevance for global health. Fundam Clin Pharmacol 2015;29:529-42.
10. Money Control. Prescribing Generics. Available from: http://www.
11. Food Drug Administration. Generic Drug Facts. Available from: BuyingUsingMedicineSafely/GenericDrugs/ucm16799.
12. Central Drugs Standard Control Organisation. Revised Checklist for BA/BE NOC. Available from: writereaddata/BABE%20website%202014%20revised%20 document%20required.pdf.
13. Marzo A, Porro E, Barassi A. Generic drugs: Myths, facts, and limitations. Ital J Med 2012;6:146-52.
14. The Telegraph. Generic Prescription Hurdles. Available from: https://
15. Gupta YK, Ramachandran SS. Fixed dose drug combinations: Issues and challenges in India. Indian J Pharmacol 2016;48:347-9.
16. Raghavan P. ET Bureau, Delhi High Court Refuses to Vacate Stay on Drug Ban; 2016. Available from: https://www.economictimes.
17. Singh SK. Bureau of Pharma PSUs of India (BPPI), (Under Department of Pharmaceuticals, Government of India). Message from CEO; 2018. Available from:
18. Pharmaceuticals-Indian Brand Equity Foundation. Available from:
19. Andrade C. Bioequivalence of generic drugs: A simple explanation for a US food and drug administration requirement. J Clin Psychiatry 2015;76:e742-4.
20. Godman B, Shrank W, Andersen M, Berg C, Bishop I, Burkhardt T, et al. Policies to enhance prescribing efficiency in Europe: Findings and future implications. Front Pharmacol 2011;1:141.
21. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Available from: informationondrugs/ucm129662.html.
22. The Telegraph Online Edition. 73 Percent Cut at Fair Price Medicine Shop; 2015. Available from: westbengal/73-per-cent-cut-at-fair-price-medicine-shop/cid/1468788.
23. Biowaivers: Criteria and Requirements-MOPH; 2015. Available from:
24. Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Available from: drugs/guidances/ucm070237.pdf.
25. Revised Checklist for BA/BE NOC Effective; 2014. Available from: 2014%20revised%20document%20required.pdf.
26. Wouters OJ, Kanavos PG, McKEE M. Comparing generic drug markets in Europe and the United States: Prices, volumes, and spending. Milbank Q 2017;95:554-601.
27. Gota V, Patial P. Toward better quality of anticancer generics in India. Indian J Cancer 2014;51:366-8.
28. Generic Drug Facts; 2018. Available from: Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/ GenericDrugs/ucm16799.
29. Srinivas I. The myth of branded generics. Econ Polit Wkly 2014;49: ???.
30. Davis JS, Barrett T, Harris L. Knowledge of proprietary and generic drug names among hospital prescribers: Time to mandate generic prescribing? Intern Med J 2017;47:959-62.
31. Thapar K. Generic Drugs Truth; 2019. Available from: https://www.
32. Mishra R, Sathyaseelan B. Generic drug distribution in India-issues and challenges. J Pharm Care Health Syst 2019;6:1-4.
33. Rohit RS, Nilesh BL, Ravikiran BK, Pallavi MC, Pramod VK, et al. The Indian pharmaceutical industry; evolution of regulatory system and present scenario. Int Res J Pharm 2012;5:49-55.
34. Dubey N, Sharma RK, Gupta H, Dubey N, Dubey N, et al. Performance of the Indian pharmaceutical industry pre and post TRIPS era: A study. Asian J Pharm Life Sci 2011;1:187-94.
35. Gani MO. Distribution system of pharmaceuticals products: A study on square pharmaceuticals. D U J Mark 2016;16:31-40.
36. Narayana SA, Pati RK, Vrat P. Research on management issues in the pharmaceutical industry: A literature review. Int J Pharm Healthc Mark 2012;6:351-75.
37. Mühlebach S. Regulatory challenges of nanomedicines and their follow-on versions: A generic or similar approach? Adv Drug Deliv Rev 2018;131:122-31.
38. Pareek M, Prakash M. Providing Generic Medicines to the Poor in India: An Overall Assessment of Government-Run Generic Medicine Scheme Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) with Reference to the Experience of Store Owners in the City of Jaipur; 2019. Available from:
39. Asher MG. Social Protection Initiatives in India. Singapore: Lee Kuan Yew School of Public Policy Research; 2014. p. 17-2.
40. Dixit A, Kumar N, Kumar S. Use of generic medicines. J Health 2018; ???:???.
41. Bell RG, DeStefano A, Jeiven M, Kak N, Kancijanic S, Kaul A, et al. Improving the Quality of Generic Drugs. United States: University Research Company; 2015.
42. Mckinsey. India Pharma 2020 Propelling Access and Acceptance, Realising True Potential; 2018. Available from: https://www. industry/procurementofdrugs.
43. Evens RP, Kaitin KI. The biotechnology innovation machine: A source of intelligent biopharmaceuticals for the pharma industry--mapping biotechnology’s success. Clin Pharmacol Ther 2014;95:528-32.
44. Iyer R. Making the Case for Indian Generic Drug Manufacturing; 2019. Available from: making-the-case-for-Indian-generic-manufacturing.
45. Gangadhar BN. The brand of generic prescriptions. Indian J Med Ethics 2018;3:84-5.
46. Srivastava P, Roy S, Emamezi SE. Comparative analysis of generic drugs over proprietary counterparts in Indian market. J Clin Epigenet 2017;3:40.
47. Ahire K, Shukla M, Gattani M, Singh V, Singh M. A survey based study in current scenario of generic and branded medicines. Int J Pharm Pharm Sci 2013;5:705-11.
48. Rathe J, Larsen P, Andersen M, Paulsen M, Jarbøl D, Thomsen J, et al. Associations between generic substitution and patients’ attitudes, beliefs and experiences. Eur J Clin Pharmacol 2013;69:1827-36.
49. Bindu Shajan Perappadan. No Country for Generic Medicines; 2019. Available from:
50. Handoo S, Arora V, Khera D. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. Int J Pharm Investig 2012;2:99-105.
27 Views | 41 Downloads
How to Cite
M, V., and G. GNK. “GENERIC PRESCRIPTION IN INDIA – A REVIEW”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 9, July 2020, pp. 20-24, doi:10.22159/ajpcr.2020.v13i9.38428.
Review Article(s)