No, absolutely wrong. In term of safety for OTC, it is strictly restricted within the direction of specification. People simply take usually safe medicines in increasing amounts every day, those drugs build up in their systems causing the risk of injury or death. The abuse of over the counter medications is a growing problem, with intentional and accidental overdoses increasing every year. for instance, Vitamin C is an essential nutrient for humans and certain other animal species, in which it functions as a vitamin, and hence regard as safety. On the ground of historical researches, Dietary Reference Intake (DRI) recommend a daily dietary reference amount of Vitamin C, a continuing overdose of which may cause some untoward effects such as Abdominal pain, Diarrhoea, even urate and/or oxalate stones.

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Medicine is such an exceptional commodity that includes a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness.

Until the 1960s, in the hope of improving safety and control on the sales of virulent and habit-forming substance, most of drugs of abuse were designated as prescription-only medicines under the laws or regulations promulgated by the regulatory agencies in each country. Presently every country has realized the importance of the medication classification management for safety and effective use of medicine. WHO has advised the developing countries to implement this management system, even, in1989 suggested every country to involve it in the provision of their medicinal regulations or laws.

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It is allowable for prescription medicine to introduce them on medical science, pharmacy science specialty publication jointly specified by the Minister of Health and State Food and Drug Administration, but is prohibited to advertise on mass communication media or any other media to public.

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When an ingredient is first introduced as an OTC medicine, it typically has been marketed as a prescription first. Then, after a sufficient amount of time has passed to enable to gather appropriate scientific information on the product, it may elect to submit a new drug application to SFDA so that it may be considered for OTC status. FDA experts review the application and determine if that product has a high enough safety profile and if labeling can be developed so that the medicine can be marketed safely and effectively as an OTC medicine.

A high enough safety profile, however, is not easy to reach. Those with approved effective would still not be considered if it either lacks of approved safety assurance, or inconvenience to use. Typically, it would take the new indigenous RX 3-5 years to be qualified to apply for switching to OTC.

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In China, there are over ten thousands of botanical or chemical drugs in the market, some of which consumers legally have access without a prescription, by over-the-counter purchase is approved a switch by State Food and Drug Administration (SFDA), P.R. China. On the ground of the principal of safety assurance, definite efficacy, assured quality and convenient to use, the list of ingredients that have made the switch from Rx to OTC is generated and published by SFDA from the drugs available in domestic market. When apply the registration with SFDA, the proposed import drug, if is approved a switch overseas, is eligible to apply for OTC immediately.

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