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Current scenario of drug package inserts in India and the need for their revision

Manali Mangesh Mahajan, Sujata Dudhgaonkar, Swapnil Narayan Deshmukh.

Abstract
Accurate and reliable drug information is essential for safe and effective use of marketed products. The primary source of drug information is a package insert (PI). It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. A good PI contains approved, essential, and accurate information about the drug. It is written in a language that is not promotional, false, or misleading. It is evidence-based and updated time to time as relevant pre-clinical and clinical data become available.

Key words: Package insert, Drug



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