• Mr. Gopal S Raut
• Dr. Shivshankar Mhaske
• Prof Prashant Ingle
• Mr. Rushikesh Tangade
• Mr. Pavan Jadhav

The availability of drugs banned in other countries due to safety, efficacy, or ethical concerns but still marketed in India is a significant public health issue. Various factors contribute to this disparity, including regulatory gaps, differing standards for drug approval, and inadequate post-marketing surveillance. Drugs like Ranitidine, Pioglitazone, and certain fixed-dose combinations (FDCs) have faced scrutiny globally, with bans or restrictions in place in nations like the United States, European Union, and Japan due to severe adverse effects, including carcinogenicity, organ toxicity, or lack of therapeutic efficacy. India's drug regulatory framework, overseen by the Central Drugs Standard Control Organization (CDSCO), has been criticized for slower updates to regulations, weak enforcement, and influence from pharmaceutical companies. Efforts have been made in recent years to address this gap, such as the 2018 ban on several irrational FDCs and initiatives to align Indian pharmacovigilance with global standards. This abstract highlights the need for strengthened regulatory mechanisms, better alignment with international norms, and robust pharmacovigilance systems to ensure the safety and efficacy of drugs available in India. Policymakers must prioritize harmonizing India's drug approval processes with international best practices to protect public health and restore confidence in the regulatory system.

"The Persistence of Risk: Analysing Banned Drugs in India’s Healthcare System", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 1, page no.f37-f52, January-2025, Available :http://www.jetir.org/papers/JETIR2501506.pdf

"The Persistence of Risk: Analysing Banned Drugs in India’s Healthcare System", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 1, page no. ppf37-f52, January-2025, Available at : http://www.jetir.org/papers/JETIR2501506.pdf