WORLD JOURNAL OF ADVANCE
HEALTHCARE RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Review Journal for Medical Science and Pharma Professionals

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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ISSN 2457-0400

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  All Since 2020
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Indexing

Abstract

BANNED DRUG AND DRUG RECALL PROCEDURE: REGULATORY FRAME WORK AND CHALLENGES FACED

*Suman Maji, Ashrubindu Bhunia, Dr. Beduin Mahanti

ABSTRACT

The term “drug” originates from the Greek word droughe, meaning herb. Medicines are essential for preventing and treating diseases-life saving or supportive benefite, while others provide supportive benefits. However, despite their therapeutic value, drugs can cause adverse drug reactions, which may be short-term or long-term. In some cases, even drugs approved through clinical trials can lead to serious health issues when widely used. A notable example is Diclofenac, which caused a severe decline in Gyps vulture populations in South Asia. Due to its harmful environmental effects, the Indian government banned it in 2006. Additionally, 328 fixed-dose combination (FDC) drugs were later banned because they lacked sufficient therapeutic benefits and posed health risks. Drug safety is ensured through Pharmacovigilance, which involves monitoring adverse effects and evaluating the risk–benefit ratio of medicines. Sometimes, harmful effects arise only when drugs are combined, leading to bans on specific combinations rather than individual drugs. Despite regulations, some banned drugs continue to be available in India due to limited awareness and regulatory gaps. Therefore, strengthening drug laws, improving monitoring systems, and increasing public awareness are essential steps to ensure drug safety and protect public health.

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