"A Critical analysis of Banned Drug Combinations: Insights from FDA and Government of India Decisions Through Drug Profile, Case Studies & Pharmacovigilance"

This study analyzed banned drug combinations in India, examining data from the FDA, CDSCO, DTAB, and other sources. It focused on fixed-dose combinations (FDCs) banned due to safety concerns and lack of therapeutic justification. The study investigated drug profiles, regulatory decisions, case studies, and pharmacovigilance data to assess public health impacts. Results showed that banned FDCs included combinations of antibiotics, NSAIDs, antihistamines, cough/cold medications. Case studies highlighted potential adverse drug reactions (ADRs) associated with these drugs, such as liver damage and gastrointestinal bleeding. It also emphasizes the crucial role of stringent regulatory oversight, including continuous evolution of FDCs, pharmacovigilance, and robust data analysis. Advancements in pharmacovigilance, stricter regulations, and increased public awareness are crucial for improving drug safety and promoting safer medication practices.