India’s pharmaceutical sector is not only a cornerstone of its national economy, but it’s also a pivotal player on a global stage. As of 2023, India ranked as the third-largest producer of drugs and pharmaceuticals by volume, with a 20% global share in the export of generic drugs. Currently valued at US$50 billion, the country has an ambitious goal for the sector: to grow its value to US$450 billion by 2047.

Drug stability data that deviate from an expected trend when compared to other stability batches or historical data collected during stability studies are considered out-of-trend (OOT) results. According to the US Food and Drug Administration’s “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry,” OOT results should be limited and scientifically justified.

What does it take to stay ahead in the volatile and fast world of pharmaceutical manufacturing? How do we ensure to invest smartly into the future? Join ISPE at the 2025 ISPE Europe Annual Conference, in London, United Kingdom, to hear about why the industry needs to look beyond just acquiring the latest, cutting-edge technology.