Tuesday 7 February 2012

What is the meaning of OTC drugs or OTC formulation?


Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
 The term over-the-counter may be somewhat counter-intuitive, since, in many countries, these drugs are often located on the shelves of stores like any other packaged product. In contrast, prescription drugs are almost always passed over a counter from the pharmacist to the customer. Some drugs may be legally classified as over-the-counter (i.e., no prescription is required), but may only be dispensed by a pharmacy employee after an assessment of the patient's needs and/or the provision of patient education. In many countries, a number of OTC drugs are available in establishments without a pharmacy, such as general stores, supermarkets, gas stations, etc. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.

Market Definition

The OTC pharmaceuticals market consists of the retail sale of traditional medicines, cough and cold preparations (tablets, mixtures, lozenges, topical remedies, inhalers), vitamins and minerals (multi-vitamins, single minerals, single vitamins, tonics, cod liver oil), indigestion preparations (tablets, powders, mixtures), analgesics (Paracetamol, Ibuprofen, Aspirinand other analgesics), and medicated skin products (anti-bacteria's, acne treatments, anti-fungal, disinfectants and other), topical OTC medicines (anesthetic products, anti-itch products, antibiotic creams/gels), plasters & bandages (adhesive bandages/plasters, first aid tape, gauze pads/rolled gauze, liquid bandages and other tape or bandage), first aid kits and other (anti-smoking aids, rectal medications, eye/ear drops, sleeping aids, and motion sickness).

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