Global and Indian Regulatory Frameworks for Pharmaceutical Excipients, APIs, and Formulations: Challenges and Harmonization Strategies.

Abstract

Pharmaceutical excipients play a critical role in drug formulation, ensuring stability, bioavailability, manufacturability, and patient safety. While India has made progress in aligning with international excipient regulations, significant regulatory gaps persist, including inconsistent enforcement, lack of mandatory GMP compliance, and inadequate impurity testing standards. These challenges create quality inconsistencies and potential safety risks, particularly for high-risk excipients. Indian excipient manufacturers face difficulties meeting international regulatory expectations, such as FDA, EMA, and PMDA requirements, due to differences in documentation, quality control, and risk assessment standards. Case studies highlight successful compliance strategies, including supplier qualification, in-house impurity testing, and risk-based categorization. To strengthen excipient regulation, mandatory GMP certification, a risk-based excipient categorization system, and alignment with IPEC-PQG, WHO, and ICH Q7 guidelines are recommended. Additionally, CDSCO must enhance oversight through advanced impurity testing and improved traceability requirements. Ensuring regulatory harmonization with global standards will enhance India's competitiveness in the excipient supply chain, facilitate international market access, and improve overall drug safety and efficacy. This review underscores the urgent need for structured regulatory reforms to streamline compliance, ensure excipient quality, and strengthen India's position in the global pharmaceutical industry.