The Indian pharmaceutical sector is well-known for being the world's largest provider of affordable and high-quality generic drugs, meeting the needs of more than 150 nations. However, compliance with strict international regulatory standards has become a major challenge for the Indian exporters, especially in regulated markets like the US and the EU. This dissertation examines the various compliance issues that Indian generic drug producers have while exporting to these regulated countries, as well as how companies are adjusting to changing regulatory requirements. The primary goal of this research is to investigate the challenges Indian pharmaceutical companies have when trying to adhere to the stringent US FDA and EMA standards. This involves examining how the evolving regulatory requirements like Good Manufacturing Practices (GMP), increased focus on data integrity expectations, and pharmacovigilance are affecting the Indian pharmaceutical industry. The study also evaluates how these companies create and apply different strategies to ensure compliance and keep access to markets. A qualitative research methodology was used, with the main source of data being semistructured interviews with professionals in the pharmaceutical industry ranging from QA specialists to regulatory affairs officers. From the interview transcripts, recurrent themes and patterns were found using thematic analysis. The secondary data was also gathered from official regulatory reports, academic papers and case studies. The results showed Indian pharmaceutical companies experience a variety of compliance challenges, such as data integrity, poor documentation practices and inadequate inspection readiness. Participants pointed out that significant investment in training, digital infrastructure and proactive risk management is necessary to adjust to changing global standards. Companies with efficient regulatory affairs departments and digital QMSs showed increased market stability and resilience. This study emphasizes how important it is for Indian pharmaceutical companies to strengthen their internal compliance systems and quickly adjust to shifting international regulatory requirements. Maintaining India's competitive advantage in foreign markets requires investment in digitalisation, regulatory training, strengthening the quality systems. In an increasingly complicated global pharmaceutical environment, this study offers Indian pharmaceutical manufacturers important insights to ensure long-term compliance and export success.