Current scenario of drug package inserts in India and the need for their revision
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20150398Keywords:
Package insert, DrugAbstract
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.References
Ved JK. Package inserts in India: need for a revision. Int J Pharm Sci Res. 2010;1(11):454-6.
The Drugs and Cosmetics Act and Rules. Ministry of Health and Family Welfare, Government of India; 2003: 312. Available at http://www.cdsco.nic.in/html/copy%20of%201.%20d & cact121.pdf. Accessed 15 March 2013.
Kalam A. Drug package inserts in India: current scenario. World J Pharm Pharm Sci. 2014;3(4):385-92.
Government of India. Ministry of Health and Family Welfare. Drug and Cosmetics Rules; 1940: 312. Available at http://www.cdsco.nic.in/html/Drugs and CosmeticAct.pdf. Accessed 28 July 2012.
Basak SC, van Mil JW, Sathyanarayana D. The changing roles of pharmacists in community pharmacies: perception of reality in India. Pharm World Sci. 2009;31(6):612-8.
Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts. Patient Educ Couns. 2007;67(1-2):157-68.
Pander Maat H, Lentz L. Improving the usability of patient information leaflets. Patient Educ Couns. 2010;80(1):113-9.
Dual labelling on drug packs made voluntary. Available at http://www.financialexpress.com/news/dual-labelling-on-drug-packs-madevoluntary/187841/0. Accessed 21 July 2012.
Dowse R, Ehlers M. Medicine labels incorporating pictograms: do they influence understanding and adherence? Patient Educ Couns. 2005;58(1):63-70.
