Study of Indian Drug Product Recalls in US Market

An attempt was made to review the reason/s of drug recalls of Indian Pharmaceutical products since last 15 years in US market. It was observed that from 2010 to 2025, India’s pharmaceutical industry underwent significant transformations, solidifying its position as the "Pharmacy of the World." Known for providing affordable medications to over 200 countries, India houses more USFDA approved manufacturing sites than any country outside the U.S. However, this period also saw a rise in drug recalls, predominantly due to contamination, inaccurate data, and noncompliance with current Good Manufacturing Practices (cGMP). This review explores the reasons behind these recalls, highlighting improvements in India's regulatory landscape and quality assurance frameworks. Initially, many Indian manufacturers struggled with cGMP adherence, resulting in companies like Ranbaxy and Aurobindo faced scrutiny for data handling and contamination issues. However, between 2017 and 2023, Indian companies began to embrace proactive quality measures like Quality by Design (QbD) and Quality Risk Management (QRM). The government updated regulations to align with WHO and EU standards, emphasizing cleaner manufacturing environments and stringent procedures. The recalls followed three main trends: early recalls were largely contamination issues, the emergence of nitrosaminerelated impurities led to major global recalls in 2018, and labelling issues contributed to Class II and Class III recalls. While Class II recalls raised concerns without immediate life threats, they highlighted ongoing issues within quality systems. The impact of these recalls was profound, affecting laws, the economy, company reputations, and most importantly, patient trust. High-profile cases, like the 2013 sanctions against Ranbaxy, prompted significant overhauls in compliance and quality processes across the industry. In summary, through regulatory enhancements and a shift in quality culture, the Indian pharmaceutical industry is working to restore global confidence and enhance patient safety.