Journal of Developing Drugs
Open Access

Time of change not only by election but also by regulation

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Mazhar Shams

Accepted Abstracts: J Develop Drugs

Abstract :

An Over the Counter (OTC) drug is a human drug that usually have many years - often decades - of experience of safe usage. So there registration, sale, usage and communication for usage should be address separately then the Prescription only Medicines (POMs). Overall, this means that OTC drug and drug product do not need to be subject to the same extent of regulation as POMs at the point of registration or in ongoing usage. For such products there is therefore a special place for the provision of consumer information, and in making patients aware of product choices. Marketplace competition and consumer choice in the self-care sector is principally the basis of the development of brands with manufacturers being free to develop a range of price offerings. Enlistment is one of the necessary or foundation stone in re-regulation of OTC drugs. Two-class system for classifying medicines as prescription or OTC is almost universal. Defining and listing criteria under which a product will have OTC status, is crucial to the two-class system since it governs legitimate public availability to medicines and information for correct use. Pakistan has no regulation and enlistment resultant of which POMs are available as OTC while OTC is available at every point of sale which needs identification and limitation. This will only achieve after the true and practical list of OTC medicine. From a regulatory perspective it is therefore unnecessary to duplicate or ?reinvent the wheel? when it comes to applying some regulatory requirements. There are rarely physiological differences between individuals living in developed and developing countries which justify restricting the availability of OTC products. The ideal regulatory framework should make the major regulatory activities required for the self-medication market to function in a manner that is as transparent, time efficient and least burdensome as possible. Current scenario in Pakistan is such that POMs are easily available at some shops marked with word medical store even without invoice and a lay-man with any educational background even sometimes an illiterate person who handle all kind of medicine either POMs or OTC. So good presentation, mandatory labeling text and visibility of OTC medicines at different point of sales not only informs consumers of the range of products available but can also encourage them to seek information and advice from pharmacists or other health professionals by themselves rather some illiterate person who influence their self care right without the knowledge of consumers? life style and other back ground.