India’s pillars of trust: CDSCO’s role in drug development and quality assurance

Le résumé fourni par la source

India’s pharmaceutical industry is a global beacon, delivering affordable medicines under the watchful eye of the Central Drugs Standard Control Organization (CDSCO). This narrative review dives into CDSCO’s world, exploring its structure, workforce, testing labs, licensing, certifications, exports, and challenges. Drawing from CDSCO reports, government documents, and recent analyses (2024-2025), it traces milestones like the 2019 New Drug and Clinical Trial (NDCT) Rules, 2024 Uniform Code of Pharmaceutical Marketing Practices (UCPMP), and 2025 biosimilars updates, showcasing India’s alignment with global standards. Despite strides, reliance on Chinese APIs poses risks. Recommendations include AI-driven monitoring, expanding local API production, and fostering partnerships to strengthen CDSCO’s mission, ensuring India remains a trusted pharma powerhouse for safe, effective care. Aims: This review explores CDSCOs structure, functions, workforce, testing labs, licensing, certifications, exports, and challenges, emphasizing its role in drug development and quality assurance, with a focus on 2024-2025 updates like biosimilars guidelines and the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). Methods: This narrative review synthesizes insights from recent government reports, peer-reviewed journals, news outlets, and industry platforms, credible sources were synthesized, covering regulatory policy, pharmacovigilance, and API dependence, with cross-verification for accuracy in a narrative review format. Results: CDSCOs robust regulatory framework, supported by zonal and port offices, enforces good manufacturing practices and expands pharmacovigilance and testing infrastructure, aligning with global standards. However, reliance on Chinese APIs remains a challenge. Recommendations include AI-driven monitoring and local API production to strengthen Indias global pharmaceutical leadership.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.