A PRAGMATIC WAY TO SUSTAIN IN GENERIC PHARMA ENVIRONMENT: PLCM THROUGH REGULATORY STRATEGIES

  • Tripathy S.
  • Murthy P. N.
  • Patra B. P.
  • Dureja H.
  • J. K. Badjatya

Abstract

Most thoughtful way to sustain in this competitive highly regulated Pharma generic industry environment is depended on understanding the concept of the product life cycle management (PLCM). Fact is a very less number of Pharma professionals have been familiarized them with this fascinating strategic concept. So, it’s the time now to convey that what does this PLCM means and how to put it into work. The objective of this article is to convey the use of PLCM as a strategic concept for enhancing drug’s sustainability in market for a long time, making better business decisions, enhancing profitability and finally delivering affordable, quality embedded generic drugs to customers. Also, in this manuscript an attempt has been made to compare corresponding regulatory agencies (US, EU, Canada and India) insights and view on preference of PLCM application. By careful analysis, it’s revealed that US provides most favourable environment to employ various PLCM strategies, wherein EU is equally good, nonetheless national polices could be a barrier, Canada is difficult to comprehend due to stringent laws and limited exclusivity and as of now India has least scope for PLCM application.

Keywords: Product Life Cycle Management (PLCM); Regulatory strategies; Pharma generic industry.

Downloads

Download data is not yet available.

References

1. Carter JC. Developing a Generic Drug Product; Carter pharmaceutical consulting [Internet]. 2006 [cited 2014 January 23]. Available from:
http://www.carterpharmaceuticalconsulting.com/articles/developing-a-generic-drug-product.html
2. FDA. Quality by Design for ANDAs: An Example for Modified Release Dosage Forms; [Internet]. FDA; 2011 [cited 2014 Jan 26]. Available from:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ UC M286595.
3. The five myths of generic competition [Internet]. Thomson reuters; 2009 [cited 2014 Jan 30]. Available from:
http://thomsonreuters.com/content/science/pdf/ls/pharma/generic/myths.
4. Zannou EA, Li P, Tong W. Product Lifecycle Management (LCM). Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice. 1st ed. USA: Academic Press; 2009. P. 911-20
5. Why Quality by Design? [Internet]. Ceruleanllc; 2008 [cited 2014 Feb 15]. Available from:
http://www.ceruleanllc.com/wpcontent/articles/eReport_QbD_Executive_Guide_CERULEAN.pdf.
6. Question-Based Review (QbR) for Generic Drugs An Enhanced Pharmaceutical Quality Assessment System [Internet].FDA; 2009 [cited 2014 Feb 23]. Available from:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120973.htm
7. Alasandro, M., Gentry, A., Choudhury, D., Baertschi, S., Zahn, M. Global Stabitliy Workshop Summaries [Internet]. Pharmalytik; 2007 [cited 2014 March 7]. Available from:
http://pharmalytik.com/images/stories/PDF/stability%20workshop%20summary%20highlights_12sep07.pdf
8. Kvesic DZ. Product Lifecycle Management: Marketing Strategies for the Pharmaceutical Industry. Journal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing. 2008; 8: 293-302.
9. Federal Food, Drug, and Cosmetic Act, 21 USC §355 U.S. Code› Title 21› Chapter 9› Subchapter V› Part A› [Internet]. Cornell University; 2014 [cited 2014 May 9]. Available from:
http://www.law.cornell.edu/uscode/text/21/355.
10. Pinco RG, Binzak BA. Pioneer and Generic Drugs: Balance between Product Life Cycle Extensions and Anticompetitive Behavior. In: Berry IR. The Pharmaceutical Regulatory Process. New York: Marcel Dekker; 2005. P. 257-322.
11. Lamote A, L'Ecluse P, Longeval C. Generic entry - a challenge to traditional EU competition law [Internet]. Practical Law; 2010 Nov [cited 2014 March 8]. Available from:
http://ipandit.practicallaw.com/8-500-7752? source= relatedcontent.
12. Pharmaceutical Sector Inquiry: Preliminary Report; [Internet]. European Commission; 2008 [cited 2014 March 11]. Available from:
http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf.
13. Coles JE, DeGagné J. Canadian Patent Litigation as Part of a Global Enforcement Regime [Internet]. American Intellectual Property Law Association; 2010 [cited 2014 March 12]. Available from:
http://www.aipla.org/learningcenter/library/papers/SM/2010-Spring-Meeting-Speaker-Materials/ Documents/ED_2010_SM_DeGagne_PPR.pdf.
14. Mittal A. Patent Linkage in India: Current Scenario and Need for Deliberation. Journal of Intelectual Property Rights. 2010; 15(3): 187-96.
15. Agarwal AK. Whither Patent Litigation in India? [Internet]. Indian Institute Of Management Ahmedabad; 2011 [cited 2014 March 15]. Available from:
http://www.iimahd.ernet.in /assets/snippets/ working paperpdf /3119363442011-03-05.pdf.
16. Guidance for Industry: Immediate Release Solid Oral Dosage Forms Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation [Internet]. FDA; 1995 [ cited 2014 March 30]. Available from:
http://www.fda.gov /downloads/Drugs /Guidanc eComplianceRegulatoryInformation/Guidances/ucm070636.
17. Guidance for Industry: Revising ANDA Labelling Following Revision of the RLD Labelling [Internet]. FDA; 2010 [cited 2014 March 26]. Available from:
http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances /UCM0 72891
18. Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products [Internet]. European Commission; 2008 [cited 2014 March 27]. Available from:
http://ec.europa.eu/health/files/betterreg/pharmacos/ classification _guideline _adopted.
19. Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products [Internet]. European Commission; 2008 [cited 2014 March 28]. Available from:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:334:0007:0024:en:PDF
20. Guidance Document: Post-Notice of Compliance (NOC) Changes - Quality Guidance Appendix 1 for Human Pharmaceuticals [Internet]. Health Canada; 2011 [cited 2014 April 2].Available from:
http://www.hc-sc.gc.ca/.
21. Guidance for Industry: Post approval changes in biological products: Quality safety and Efficacy Documents. [Internet]. CDSCO; 2014 [cited 2014 Apr 2]. Available from:
http://cdsco.nic.in/CDSCO-GuidanceFor Industry.
22. Guidance For Industry on Preparation of Common Technical Document for Import/Manufacture and Marketing Approval of New Drugs for Human Use (New Drug Application - NDA); [Internet]. CDSCO; 2010 [cited 2014 April 2]. Available from:
http://cdsco.nic.in/CTD_Guidance%20-Final.pdf.
23. The Drugs and Cosmetics Act, 1940. Part – XA. Import or manufacture of new drug for clinical trials or marketing. Rule 122A. Application for permission to import new Drug [Internet]. dbtbiosafety [cited 2014 May 26], available from: http://dbtbiosafety.nic.in/act/schedule_y.pdf.
24. Kumar M, Jethwani H. The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway [Internet]. Regulatory focus; 2010 [cited 2014 April 30]. Available from:
http://www.amarexcro.com/articles/docs/RAPS_Focus_505b2_Apr2010.pdf
25. Guidance for Industry: Applications Covered by Section 505(b)(2) [Internet]. FDA; 1999 [cited 2014 April 14]. Available from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf.
26. Notice to Applicants: Volume 2A: Procedures for marketing authorisation, Chapter 1, Market Authorisation [Internet]. European commission; 2005 [cited 2014 April 28]. Available from: http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_2005-11_en.pdf.
27. Notice to Applicants: Volume 2A, Procedures for marketing authorisation, Chapter 1, Market Authorisation [Internet]. European commission; 2005 [cited 2014 April 22]. Available from: http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_2005-11_en.pdf.
28. Progressive Licensing Project [Internet]. Health Canada; 2012 [cited 2014 May 9]. Available from:
http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/develop/proglic_homprog_qual_top2-eng.php.
29. The Drugs and Cosmetics Act, 1940. Part – XA. Import or manufacture of new drug for clinical trials or marketing. Rule 122A. Application for permission to import new Drug [Internet]. [cited 2014 May 26] Available from:
http://books.google.co.in/
30. Draft Guidance on Approval of Clinical Trial & New Drugs [Internet]. CDSCO; 2011 [cited 2012 May 30]. Available from:
http://cdsco.nic.in/Guidance_for_New_Drug_Approval-23.07.2011.pdf.
31. Cha M. Pharma-Biotech Alliances: A Case Study [Internet]. Harvard University; 2004 [cited 2014 May 23].Available from:
http://leda.law.harvard.edu/leda/data/625/Cha_redacted.html
32. Federal Food, Drug, and Cosmetic Act, 21 USC §355 [Internet]. FDA; 2014 [cited 2014 May 25]. Available from: http://books.google.co.in/
33. Pinco RG, Binzak BA. Pioneer and Generic Drugs: Balance between Product Life Cycle Extensions and Anticompetitive Behaviour. In: Berry IR. The Pharmaceutical Regulatory Process. New York: Marcel Dekker; 2005. P. 257-322.
34. Notice to Applicants: Volume 2A, Procedures for marketing authorisation, Chapter 1, Market Authorisation; [Internet]. European commission; 2005 [cited 2014 April 23]. Available from:
http://ec.europa.eu/health/files/eudralex/vol-2/a/vol 2a_chap1_2005-11_en.pdf.
Statistics
547 Views | 518 Downloads
How to Cite
S., T., M. P. N., P. B. P., D. H., and J. K. Badjatya. “A PRAGMATIC WAY TO SUSTAIN IN GENERIC PHARMA ENVIRONMENT: PLCM THROUGH REGULATORY STRATEGIES”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 2, Feb. 2018, pp. 31-48, doi:10.22270/ijdra.v2i2.130.