The war of Branded Medicines Vs Generic Drugs dates back to the very earliest phase of the modern world of pharmaceutical drugs or medicines, and is currently prevailing in full swing as there are numerous new drugs emerging while many are losing their patent rights. In order to understand the dynamics between these two broad genres of medicines, let us first consider their individual characteristics, followed with a comparative analysis.
What is a Branded medicine?
When a new medicine is discovered and released, it comes with a patent that lasts for about twenty years, and gets sold under a specific brand name; as given by the pharma company which discovers and manufactures it. Such branded drugs are mostly expensive because they’re newer, mostly groundbreaking, and often made for conditions that are difficult to treat.
What is a Generic drug?
However, after a certain period of time, when the patent expires, other pharma companies including OTC products manufacturers; come up to produce generic versions of the same drug, turning those same innovative medicines into generic medicines. The generic versions differ from the branded ones in minor ways, but must have exactly similar levels of quality, safety, efficacy as well as efficiency; according to the laws of the U.S. Food and Drug Administration (FDA) and equivalent organizations in other nations.
The Division of Price Between Branded Medicines and Generics
The most unique proposition of generics is their lower price ranges. This happens for the very obvious reason that the costs of production do not include the cost of development and marketing of the brand name drugs.
Most of the new drugs are priced post considering the cost of research, patency, development, marketing, and promotion; none of which are involved in generic drugs. Thereby making it possible for pharma generic medicine manufacturers in India and abroad, to produce life saving and essential medicines at lower prices and providing the same to the needies.
This is also the same reason, why the law allows the brand name company to recoup its investments during the tenure of patency, before allowing the generics manufacturers to produce and and sell the same medicine.
Are Generics as safe as the Branded ones?
As stated above, according to the stringent and uniform laws of FDA, it is mandatory for the generics to prove that they are bioequivalent to their brand versions; which means the generic should work and provide benefits same as their branded counterparts.
Yet, the trade laws forbid generic drugs to look exactly like the branded drugs. Hence there are differences in appearances of the generics which come from the non-active ingredients used in form of dyes, fillers, preservatives, etc.; insipite of having the same utilities and degrees of success rate. These non-active ingredients bring much difference in terms of size, shape and color.
That is why patients are advised to follow the doctor’s prescription, as the latter is able to match a patient’s history with some of the inactive ingredients in a particular generic drug that may cause adverse reactions, whereas the branded medicine or some other generic version of the same drug might not.
Monitoring a drug’s safety is carried out by FDA, for which they inspect over 3000 drug manufacturing units around the world, annually. The FDA also monitors generic medication safety post the drug’s approval.
In case, FDA discovers any problem with safety or quality, a recall is issued for the affected medication; in order to maintain the safety of the people. For example, if there are reports of any medicine showing side effects or harmful reactions, FDA investigates and acts immediately.
There have been cases of various blood pressure medicines being recalled, along with a heartburn drug, Zantac. These had traces of cancer-causing impurities. FDA issued recalls on them and removed them from the market. Further, FDA also increased the safety checks to prevent contamination issues.
Which one to pick?
As per the Office of Generic Drugs (OGD), all FDA-approved generic drugs are supposed to match their branded counterparts in terms of active ingredients and achieving the same quality, safety, efficacy and efficiency; although they should not be an exact copy, which can be taken care of by playing with the inactive ingredients and bring out different color, shape, size, etc.
Hence choosing the cheaper generics over the costlier branded medicines can be just a matter of personal preferences of the patients. However, some might be allergic to any of the non-active ingredients, and that is why it is always advised to have a consultation from a professional medical practitioner before taking any generic drug.
Doctors sometimes prefer not to switch between medicines that have a very narrow therapeutic index (NTI), or safe range; meaning, there’s a smaller window between the benefits and the harmful effects of the drug. Regular blood tests is required to be assured of the safe window. Some common examples of drugs that fall under such a category include blood thinners, thyroid medications, cardiovascular drugs, and epilepsy or seizures’ medicines.
However, a patient is left with no other choice when there isn’t any generic version available for any particular branded medicine.