Recommendations for Enhancing Quality and Capability of Indian Biopharmaceutical Industry: Summary of a Workshop

Abstract

The biopharmaceutical industry is undergoing an evolutionary phase with the rise of advanced manufacturing technologies. The regulatory and customer requirements are shifting towards the development of personalized or targeted medicines. With this changing landscape, industry must evaluate the relevance of quality management systems. Over the past two decades, Indian companies have played a significant role in generating access and reducing costs of medicines. The quality management systems that enable the development and manufacturing of biopharmaceuticals require companies to adapt to regulatory requirements of process development, clinical trials, production, and life cycle management. To better understand the status and potential opportunities to enhance the quality management systems of manufacturing biopharmaceuticals, a workshop was organized by United States Pharmacopeia (USP) and Association of Biotechnology Led Enterprises (ABLE). This paper summarizes the recommendations by the panel and participants of the workshop to industry stakeholders, governance bodies, and policymakers. Following points were proposed to strengthen the culture of quality processes in Indian biopharmaceutical industry: i) Inculcating a culture of quality; ii) Effective training programs on quality processes; iii) Focus on quality beyond compliance; iv) Focus on automation and digitization. v) Enhance processes for pharmacovigilance and product life cycle management. vi) Understanding global regulatory processes.

Keywords: Biopharmaceuticals; Biosimilars; Capability; Quality; Regulatory; United States Pharmacopeia (USP).