Presentation (CTI)

OBJECTIVES: The present study aims to identify the barriers faced during formulation stage, analytical stage, developmental stage, product evaluation and regulatory submission of complex generics as well as the market opportunities of this class of generics.
METHODS: An exploratory qualitative semi-structured interview with non probabilistic purposive sampled industrial professionals with a minimum of five years of experience in the complex generics in India. A total of fourty in-depth interviews were conducted as per the convenience of the study participants. Interviews were recorded, transcribed, independently analysed and coded by three researchers. Thematic analysis was conducted using Atlas ti software.
RESULTS: The qualitative findings showed that major key barriers identified includes critical quality attribute (CQA) related challenges, critical process parameters (CPP) related challenges, lack of clarity towards regulatory requirements, imbalances in investment and profit, limited access to innovative techniques, and finally lack of collaboration among the various departments of pharmaceutical industry. Proper product lifecycle management, improve technical expertise, implementation of risk evaluation and mitigation strategy, novel analytical tools, modeling and simulation, quality by design approach, enforce collaborative efforts among various departments supports as a successful facilitator to overcome the barriers and improve market opportunities.
CONCLUSIONS: The study revealed a series of interconnected barriers which slowdown the development of complex generics. Addressing the challenges and methods used to overcome those were explored which may significantly enhance the production at a faster rate.