The concept of generic medicine is based upon the premise that no human being must be precluded from leading healthy life. Generic medicines theoretically are same as branded ones, i.e, there active ingredient composition is same, which means that the composition of salt etc which matters is same in both and also the bio equivalence factor as well. Generic medicine is equivalent to branded medicine in terms of safety, efficacy, dosage and use. However there could be some differences between inactive ingredients like that of color shape etc which are not of much significance though.
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The drugs which are protected by patents are known as branded drugs. Patent is granted when the formulation is originally researched and innovated by someone. Pharmaceutical company which sought patent has to show that the drug so produced for some specific ailment or disease was originally innovated by it. When Patent is applied, the company is duty bound to give step by step procedure of formulation. The application must incorporate in itself all the salts, chemicals, combinations etc which resulted in the development of such drug. The company is allowed to sell off its product into the market with the price considering the efforts put by it into research, innovation, development and manufacturing. In other words the company can quote the price in order to award to itself for the research and innovation which cannot be calculated, thus resulting in higher prices of the drugs.
Generic Medicines are those which are copy of branded medicines. Intellectual property rights act and patent act of India gives an authority to the government to transfer the idea of technology, procedure etc to other companies allowing them to manufacture the same medicine as an original one. This happens in two cases mainly:
1. When the original patent is expired.
2. When such exigency arises that it becomes important in the interest of general public welfare to let that technology or procedure be made available to public domain. This is done by way of compulsory licensing.
The exclusive rights of manufacturing the drugs to the exclusion of others cease to exist and therefore other companies after applying to the controller general patents can get the procedure of manufacturing such drugs. Now only cost that would incur in this case will be that of developing and distributing. This results in the depreciation of cost price without compromising with the quality of the drug. Generic Drugs cannot straight way be allowed to be marketed. Unless the drug quality control authority do not approve of such drugs, they cannot be allowed to be sold off to public. They have to undergo stringent test to ensure a quality product reaches to the general public. Generic Drugs are therefore are cheaper and effective alternative to branded ones which can comparatively be easily afforded by the public.
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India is a largest producer of Generic Drugs which are exported to other nations as well, like that of USA, Europe and many African countries. But irony is that the concept has not been well accepted in our own country. Reasons are manifold which include prejudiced approach of doctors prescribing those, Major MNCs misleading the public and making them to believe that Generic are not effective and The procedure as to keep the check upon the pharma companies producing generic medicines.
The major responsibility lies upon the doctor who prescribes the medicines. It is very much important that they should educate themselves as to the benefits of the generic of medicines. Let not the health care be made a luxury to few. There are allegations of such drugs being substandard which I believe are quite misplaced. Every branded drug after an expiry of patent is copied not by one single pharma company but many. On an Average there are around 20 to 40 generic versions of such medicine and not all are ineffective, though in some cases as in cardiovascular diseases, hypertension, diabetes it is advised that not to switch to other medicines than which has already been prescribed. It is true for both branded and generics. Had Generic medicines been substandard in quality, the countries like USA would not have established authorities like that of FDA to promote same. In India the problem is that we do not have a proper quality control mechanism and in absence of such mechanism it is difficult to bring in to the knowledge of the people the benefits of Generic medicines.
Second thing which has been complained of is that some Generic Medicines are expensive than their branded counterparts. It is true and a detailed report has also been made by some organizations like that of Forbes with regard to this issue. It is more of like a conspiracy made by MNCs manufacturing branded medicines. It has been noticed that initially such branded medicines are actually expensive while they are under the patent protection and in that period they earn enough profits out of the sale of those branded meds but as soon as the patent is expired and generic versions are made then in order to beat the competition they device the strategy of minimum profit and no loss. This is passed on as a wrong message to the public making them believe that the generics are expensive, oblivious to the fact that the same medicine was sold off by the same company, triples the price on which they are selling it now.
The dream of enshrining a right to health shall remain unrealized if no proper steps are being taken to let public have an access to cheaper and effective medicines. The details of this concept has also been raised and formulated by Sh. Shanta Kumar while being the chairman of the committee for the promotion of generic medicines and he till today is aggressively pursuing the issue with the government to promote same and is trying to come up with ideas as to plug in the loopholes and improving the grey areas of this policy. Doctors should refrain themselves from taking commissions in order to promote branded medicines and MCI should direct them to prescribe only generic medicines and where if they are not available then branded. A commitment is necessary to let not a man die for the want of medicine. Millions of people do not have an access to health care just for this one single reason which is that they cannot afford the cost of medicines. Rather criticizing the concept we should raise voice to improve the mechanism to ensure the quality of generic medicines. Drug control authority of India Should be made in line with that Of FDA in US.
Author: Pranav Ghabroo,