ENSURING DRUG SAFETY: A REVIEW OF PHARMACEUTICAL QUALITY ASSURANCE PRACTICES (KEY IJP************469)

• Likitha A R,Dr K Selvakumar,Samarth Sj

Abstract

Drug safety is paramount in-patient care and pharmaceutical law, aiming to ensure medication efficacy while minimizing adverse effects. This dual goal is critical for safeguarding patients from adverse drug reactions (ADRs), which can range from mild to fatal. Effective drug safety practices improve patient outcomes, enhance confidence in prescribed treatments, and foster adherence, leading to better health and quality of life. For pharmaceutical companies, maintaining a robust drug safety profile is essential for preserving reputation, consumer confidence, and legal standing. Historical events, such as the thalidomide tragedy, underscore the severe consequences of inadequate safety measures. Companies must adhere to stringent regulations and conduct continuous risk surveillance throughout a drug's lifecycle to protect consumers and reinforce trust in their brand. Regulatory frameworks, including those from the FDA, EMA, and WHO, play a crucial role in ensuring drug safety and efficacy, shielding companies from legal issues and market withdrawals. Adhering to these regulations is vital for the industry's integrity. In summary, drug safety is fundamental in protecting patient health by reducing ADRs and ensuring treatment efficacy, while also bolstering the pharmaceutical industry's reputation, market share, and compliance with regulatory standards.