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How are prescription drugs changed to OTC category?

Q: Why are drugs changed from prescription drugs category to OTC category. What is the process that is followed in India. How will this effect the sales of drugs like PEPFIZ of Ranbaxy?

A:Drugs that can be purchased without a prescription are referred to as over-the-counter (OTC) drugs. Common OTC medicines include pain relievers, laxatives, cold- relieving preparations and antacids and they are consumed rather indiscriminately by millions of people. In the USA, the Food and Drug Administration (FDA) determines whether medicines fall under the prescription or non-prescription categories while in India it is the Drug Controller General of India (DCGI). The term prescription (Rx) refers to medicines that can be dispensed by the chemist only under a doctors orders. In contrast, non-prescription (OTC) drugs are medicines that the FDA decides are safe and effective for use without a doctors prescription. In general, OTC drugs must be useful for an ailment which is mild and easily self-diagnosable: the treatment should be of limited duration: the drug must be unlikely to produce hazardous side-effects or induce addiction: and the products labelling and instructions should be easy to follow. Most of the pharmaceutical majors are looking at the $49.8 billion OTC market which is growing at an average rate of 3per cent, to increase the life of their molecules by getting the Food and Drug administration (FDA) to convert their patented prescription drugs to over-the-counter just prior to the patent expiry. The main reason why most of these companies are doing this is to give tough competition to small companies entering the market with generics if they switched from ethical marketing to OTC marketing thus entering the free markets. The industry figures that the product life cycle of a product extends when it shifts from a prescription to OTC category. Switching of prescription to OTC has two sides. On one hand it can be beneficial to all concerned but it also has some drawbacks for the manufacturers. Advantages are that as FDA favours the switch, the drug becomes available at a comparatively lower price thus reducing cost of treatment. Secondly, in countries like the US where most of the medical expenses are covered by health insurance schemes, OTC drugs are out of their purview. Thirdly, it benefits the consumer too as good quality drugs are available at lowest possible cost due to competition. Lastly, the producer has an advantage as it protects their molecule even after patent expiry. The FDA has to critically examine the safety profile and side effects of potential OTC drugs as OTC products are taken without consulting a doctor. This is of utmost importance in a country like India where overall literacy level is low.

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