There is a widespread and unsubstantiated belief prevalent among the consumers of the pharmaceutical products regarding generic drugs that the generic drugs are of an inferior quality or are not as effective as compared to their brand name counterparts. The reason behind such an opinion is often the idea that since the generic drugs are substantially cheaper than the brand name drugs there must have been a compromise in their quality or the standards of drugs manufacturing.
Generic drugs are an exact replica of the brand name drugs in terms of their active chemical ingredients. There is no difference in their active chemical ingredients or the quality of the medicines.
A brand name medicine is manufactured by a pharmaceutical company after devoting their resources and time. In order to introduce a new drug into the market, the manufacturers have to invest in research, development, testing, marketing and promotion of the drug. Research and development alone costs a fortune to the manufacturers in addition to the time which can range from months to years if not decades. Generally, it takes at least ten to twelve years for a new drug from being invented to being successfully marketed with testing and trials itself taking six to seven years. The cost of research and development of a successful is estimated to be $2.6 billion excluding the additional costs of marketing and promotion. These factors lead to a drastic surge in the price of the medicine when it is finally available in the retail market.
Once the development of a new drug is completed, the manufacturer applies for a patent. A patent protects the manufacturer’s investment in development of the drug. A patent gives a manufacturer the sole right to manufacture the drug for the period of its patent. A patent term is valid for a period of twenty years starting from the time the drug was invented.
However, once the patent is expired, interested manufacturers need to submit the abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA). This has created a compromise in the pharmaceutical industry. The ANDA procedure spares the drug manufacturers the high costs involved in numerous animal and clinical trials given the condition that there is no change in the chemical ingredients or the dosages. The procedure for the determination of dosages and approval of the drug for its safety and efficiency by the FDA is already sponsored by the original manufacturer.
The FDA only approves the generic drugs if it meets their criteria.
The FDA requires the generic drug to:
- contain the same active chemical ingredient as the brand name drug
- be the same in the approved strengths, dosage form and route of administration
- have the same use indications
- be equivalent
- satisfy the same batch requirements for identity, strength, purity and quality
- be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products
Without the burden of initial development and marketing costs, the generic drug companies can afford to manufacture and sell it at a much cheaper price. And when numerous companies start to manufacture and sell the generic drugs, the price is even further reduced due to the competition in order to gain a higher share in the retail market. It is estimated that the customers can save from $2 billion to $8 billion every year in the retail market of the generic drugs.
The opinion that the generic drugs are produced in poor quality infrastructures or that they are of a poor quality is nothing more than a myth and holds no truth. The FDA ensures that the generic drugs are manufactured under strict regulations and safety standards. In fact, the FDA estimates that 50% of the generic drugs are manufactured by the name brand companies. Another misconception that the people usually have is that generic drugs are slow to produce the intended results. This belief too is false as the FDA requires that the generic drugs work as quick and as efficiently as the brand name medicines.
Generic drugs usually have different colors, taste and combination of inactive chemical ingredients than the brand name drugs. This is done in compliance with the trademark laws which dictate that the generic drugs cannot be produced exactly the same as the original drugs.
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