Published Paper Details:

The pharmaceutical industry is one of the most highly regulated sectors worldwide, with regulatory frameworks playing a critical role in ensuring the safety, quality, and efficacy of medicinal products. The import, export, and marketing of pharmaceutical products are governed by diverse regulatory requirements that vary across countries, creating both opportunities and challenges for pharmaceutical companies. India, as one of the world's leading producers and exporters of generic medicines, must comply with both domestic regulations and the regulatory expectations of international markets. This study reviews the regulatory barriers governing the import, export, and marketing authorization of pharmaceutical products in India and selected Rest of the World (ROW) countries. It compares the regulatory frameworks, documentation requirements, registration procedures, quality standards, Good Manufacturing Practices (GMP), labeling, pharmacovigilance, and post-marketing surveillance requirements across different regions. The study also highlights the challenges faced by manufacturers in meeting varying regulatory expectations, including differences in technical guidelines, approval timelines, and compliance requirements.