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.

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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.