An Overview of Non- prescription Drug Regulations for India, United States, Australia and Europe

Ranjith, Y and Jagadish, PC and Janodia, Manthan D and Vasantharaju, SG and Shenoy, Gautham G and Udupa, N (2012) An Overview of Non- prescription Drug Regulations for India, United States, Australia and Europe. Inventi Rapid: Pharmacy Practice , 2012 (1). pp. 1-6. ISSN 0976-3848

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Abstract

Non-prescription or over the counter (OTC) medicines can be defined as those which are used for self medication and can be available from pharmacies without a doctor’s prescription. These products usually have many years often decades of experience of safe usage & are used in a large number of countries around the world so these products do not need to be subject to the same extent of regulation as new prescription medicines at the point of registration or in ongoing usage. The substantial knowledge built up under prescription conditions of a medicine’s quality, safety and efficacy profile can be carried over to nonprescription use. The review describes the existing regulations for non prescription drugs in regulated countries like USA, EU, Australia and available regulations for the non prescription drugs in India. Information was collected from legislation, guidance and official documents published by concerned regulatory authorities like USFDA (United States Food and Drugs Administration) in the US, EMEA (European Medicines Evaluation Agency)for European Union, TGA (Therapeutic Goods Administration) for Australia and CDSCO (Central Drugs Standard Control Organization) for India. A comparison made to understand the regulations for registration, marketing & labeling revealed that the OTC regulations vary from country to country.

Item Type: Article
Uncontrolled Keywords: Over The Counter (OTC), Labeling, Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), Prescription Drug User Fee Act (PDUFA), Code of Federal Regulations (CFR).
Subjects: Pharmacy > MCOPS Manipal > Pharmacy Management
Depositing User: KMC Manipal
Date Deposited: 03 Feb 2012 04:21
Last Modified: 03 Feb 2012 04:21
URI: http://eprints.manipal.edu/id/eprint/2913

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