Pharmaceutical manufacturer is increased in nowadays, but the success behind the pharmaceutical manufacturing is people switching to an OTC product rather than the prescription product. The OTC products are produced in a natural way and it becomes one of the part of the pharmaceutical industry in nowadays because of the FDA Consultants. The compound annual rate for the pharmaceutical products in the global market was 4 percent between the year 2004 and 2008. But the global OTC market grows at a rate of 3.9 percent in the year 2008 and reach the value of up to 104.2 billion dollars. Therefore, supplying the OTC form gives greater access to the public as well as this product gives the choice in medication for the common and the minor ailments. While the choice in the medication gives the public, the greater opportunity for the self diagnosis treatment and this will result in the decreased burden on the health care providers.
Overview of the OTC product
There are more than 300,000 people in the United States are marketed for the OTC drugs products in more than 80 categories. The center for drug evaluation and Research regulates that the OTC drugs ensure that all the drugs are properly labeled. If all the drugs are properly labeled, then only the products are approved by CDER. The FDA Consultants legally marketed the pharmaceutical drugs under the New Drug Application. While, the OTC product is new to the market, all the drugs are regulated under the NDA process along with the FDA approval is required for the prior marketing. For example, if the drug is previously available one of the prescription and this drug can be marketed as an OTC product, it is approved under an RX to OTC switch. All the drugs under the FDA application may require the clinical studies along with the user fee and this drug also get the post approval maintenance certificate also. The labeling plays the unique role in all the types of marketing drugs and it must be the main feature for the marketing exclusivity. The legal marketing is in compliance with the OTC drug monograph. The monographs are based on the active ingredients that is opposed to the NDA. If there is no final monograph established in the OTC drug product, then there is a need to follow the NDA procedure.
Safety and effectiveness of OTC product
The consumers use the OTC products and having the ability to self diagnose the product safety. The consultants can assist the consumers by understanding the appropriate usage of the product and the labeling contains the specific standardized requirements on what is required in the product and how this information is to be presented. The format of the label is called the Drug facts and requires the knowledge as well as the practical experience of the OTC regulations. The marketing consultants have the knowledge about the varying OTC regulations in the different countries also to understand well about the OTC monograph system in the USA.