LAXMI G. RAO, VIJAYAVITTHAL T. MATHAD*
*Corresponding author
Megafine Pharma (P) Ltd Nashik, Department of Research and Development, 422 202, India

Abstract

Challenges faced to implement the basic scientific knowledge to Chemical Process Research and Development (CPR&D) of generic drugs targeted for global market is getting complex like never before due to continuously emerging patent landscape, increased competition, regulatory hurdles and the cost pressure. The “need for innovation” scenario is more “driven and dictated by Intellectual Property (IP), which has thereby compelled scientists to think out of the box to overcome these challenges. In this report, we present envisaged hurdles that the scientists in the CPR&D section of generic pharmaceutical industry may face to withstand the “patent storm” and the strategies employed to emerge out as a global leader.

 PHARMACEUTICAL RESEARCH & DEVELOPMENT: A LIFE CYCLE

Pharmaceutical research and development begin with “drug discovery’ resulting in the birth of the drug substance and the product along with the “first chemical route (process)”. Subsequent to the approval of the drug by regulatory authorities, the second phase of CPR&D begin with exploration of several possible synthetic routes, key intermediates, reaction steps, polymorphism, impurity profile, particle size and shape eventually leading to the development of an improved, economic, efficient and scalable process for the drug substance both by innovators and generic manufacturers. The development of various synthetic schemes or chemical processes continues until “complete generic commercialization” of the drug as depicted in Figure 1. The figure also depicts milestone activities involved in the journey of pharmaceutical R&D to achieve the ultimate goal of marketing the generic version of drug substance/drug product, wherein the scope, activities, targets, limitations associated with each of these phases may vary throughout the product life cycle (1).