Ipca is an established Indian pharmaceutical company manufacturing over 350 formulations and 80 active pharmaceutical ingredients for various therapeutic segments. Headquartered in Mumbai, Ipca manufactures and sells branded and generic formulations, APIs and intermediates to 120+ countries. As one of the world’s largest drug manufacturers, they are inspected by US-FDA, UK-MHRA, EDQM- Europe, WHO-Geneva, PMDA and many other regional regulatory bodies.
Ipca had performed a rigorous assessment of their current drug safety process, regulatory requirements, system requirements (both current and future scale up) and observed that there were opportunities for improvements across processes, systems and their vendor engagements.
Following were some of the key challenges for Ipca:
- The two safety databases were not integrated, resulting in omissions, redundancies and leading to compliance challenges
- There were unmet needs such as advanced signal detection/ management and automation of case submission with agencies via gateway
- Inefficient management of global operations as each region was following a different workflow for case management. Case processing was challenging resulting in missed timelines and increased costs.
- Reporting, insights and signaling was challenging due to lack of right tools and due to separate databases