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

Siddhi Choudhari , Asef Shaikh , Yashwant Padwal

CDSCO, DTAB, FDA, banned drugs, Fixed-Dose Combinations (FDCs).

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.

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"“A Critical analysis of Banned Drug Combinations: Insights from FDA and Government of India Decisions Through Drug Profile, Case Studies & Pharmacovigilance”", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.10, Issue 5, page no.a230-a242, May-2025, Available :https://ijsdr.org/papers/IJSDR2505029.pdf

Volume 10 Issue 5, May-2025

Pages : a230-a242

Paper Reg. ID: IJSDR_302462

Published Paper Id: IJSDR2505029

Downloads: 000404

Research Area: Pharmacy All

Country: Dharashiv, Maharashtra , India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2505029

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2505029

DOI: https://doi.org/10.56975/ijsdr.v10i5.302462

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition