• Chitral Kulshreshtha
  • Venkatesh M. P.
  • Pramod Kumar T.M.


Personalized medicine (PM) has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The way we understand and treat disease is changing rapidly. The traditional form of personalized medicine has been based on the observable manifestations of a disease or treatment, such as a tumour on a mammogram, the appearance of cells under the microscope, etc. But now personalized medicine promises to introduce a new standard of healthcare by using molecular analysis to achieve optimum medical outcomes in the management of a patient’s disease or disease predisposition. PM is providing the right treatment, to the right patient at the right time by using modern biology’s new methods and tools. The objective of this paper is to focus on a realistic scenario for its evolution, and to explore the issues affecting the development and implementation of personalized medicines and various regulatory pathways involved in its regulation. This paper also highlights the roles and applications of personalized medicine. The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies. The common goal: an integrated policy framework that balances patient, industry and scientific interests without hindering advancement of this tremendously important sector. Through these efforts, we can help ensure that personalized medicine is able to fulfil its promise as rapidly as possible.

Keywords: Pharmacogenomics, Pharmacogenetics, Personalized pill, Targeted therapy.


Download data is not yet available.


1. President’s Council of Advisors on Science and Technology, Subcommittee on Personalized Medicine, Priorities for Personalized Medicine: Report [Internet]. Report; 2008 Sept [cited 2014 Dec 26]. Available from:
2. Francis C. The Language of Life. :163
3. Leroy H, Mauricio F. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. Elsevier; 2012. P. 1- 12.
4. Paving the way for personalized medicine: FDA’s Role in a New Era of Medical Product Development; 2013 Oct.
5. Personalized Medicine 101: The Story. [Internet]. Personalized medicine Coalition; 2015 [cited 2014 Dec 22]. Available from:
6. Jain KK. Personalized medicine. Curr Op Mol Ther. 2002; :548-558.
7. Personalized Medicine Timeline. [Internet]. [cited 2014 Dec 21].Available from:
8. The Case for Personalized Medicine. [November 2006]
9. Genetics and Your Health: The Jackson Laboratory, Personalized Medicine and You : Benefits of Personalized Medicine. [Internet]. The Jackson Laboratory; 2014 [cited 2014 Dec 22]. Available at:
10. Ginsburg GS, Willard HF. Genomic and personalized medicine: Foundations and applications. Translational Research : The Journal of Laboratory and Clinical Medicine. 2009;154(6):277-87.
11. Personalised Medicines and Genetics, National Health and Medical Research Council; 2013 Nov.
12. Meyer UA. Pharmacogenetics - Five decades of therapeutic lessons from genetic diversity. Nat Rev Genet. 2004; 5(9): 669-76.
13. Personalized Medicine Coalition. The Case for Personalized Medicine [Internet]. 2010 [cited 2014 June 24]; Available from:
14. Mallal S, Phillips E, Carosi G et al. HLA-B*5701 Screening for Hypersensitivity to Abacavir. New England Journal of Medicine. 2008; 358(6):568-79.
15. Ma Q, AY Lu. Pharmacogenetics, pharmaco-genomics, and individualized medicine. Pharmacol Rev. 2011; 63(2): 437-59.
16. “Briefing Report on Framework for Understanding Personalized Medicine Opportunities for Arizona”. [Internet]. 2010 Feb [cited 2014 Dec 24]; Available from:
17. Karl B. Personalized Medicine : A New Era for Healthcare and Industry; 2013.
18. Personalized Medicine Coalition: The Age of Personalized Medicine Factsheet.
19. The New Science of Personalized Medicine : Translating Promise into Practice; 2009.
20. Jakka S. Rossbach Michael An economic perspective on personalized medicine. The Hugo Journal
21. Clinical Utility of Personalized Medicine, NHMRC Report; 2011. p. 2-6.
22. Personalized Medicine Coalition , Personalized Medicine : An Introduction [Internet]. Personalized medicine coalition; 2015 [cited 2014 Dec 18]; Available from:
23. Personalized Medicine 101: The Challenges [Internet]. Personalized medicine coalition; 2015 [cited 2014 Dec 18]; Available from:
24. American Society of Human Genetics Personalized medicine: Issues affecting adoption of personalized medicine [Internet]. ASHG, Rockville; 2007 March 21 [cited 2014 Dec 23]; Available from:
25. Issa Amalia M. Personalized medicine and Practice of Medicine in the 21st Centuary. Mc Gill Journal. 2007: 53-7.
26. USFDA Personalized Medicine: Select FDA Guidance Documents that Relates to Personalized Medicine. [Internet]. USFDA, Silver spring; 2013 Oct [cited 2014 Dec 12]; Available from:
27. Vogenberg F. Randy Personalized Medicine: Part 2 Ethical, legal and Regulatory issues. Pubmed; 2013.
28. Personalized Medicine Coalition: The Case of Personalized Medicine 2014. [Internet]. Personalized medicine coalition; 2014 [cited 2014 Dec 10]; Available from:
29. Alexandria V. A Research America. Genetic Information Non discrimination Act (GINA ) and personalized medicine: The impact of genetic non discrimination legislation on progress in genetics an d personalized medicine; 2010.
30. Personalized Medicine Coalition : The Case of Personalized Medicine. 3rd Edition [Internet]. Personalized medicine coalition; 2014 [cited 2014 Dec 11]; Available from:
31. Personalized Medicine Coalition, Personalized Medicine Regulation : Pathways for Oversight of Diagnostics.
530 Views | 623 Downloads
How to Cite
Kulshreshtha, C., V. M. P., and P. K. T.M. “THE PATH OF PERSONALIZED MEDICINE: REGULATORY PERSPECTIVE”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 1, Feb. 2018, pp. 14-29, doi:10.22270/ijdra.v3i1.155.

Most read articles by the same author(s)