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Generic medicines existed for many years, and even just in the last six have resulted in a saving to the NHS of over a billion and a half euro. However, only since 2013, the barriers of distrust towards these products have started to lower
Despite a lower market penetration to other European countries, their consumption is starting to gear even in India, where today, according to the latest report on the use of the medicines for more than 70% of doses of medicines that we take every day is made up of products patent expired. Generic medicines are the copies of designer medicines that can enter the market only once finished their patent protection.
But what exactly are generics are they really safe and because they cost less than other medicines here is a quick guide to understanding how these products and know them better.
When a drug is generic says-
It defines generic copy of a specific drug already on the market once this has finished its patent protection a deal that guaranteed him a kind of exclusive, protected him from the possibility of being imitated and that in Italy (not only for medicines but for all other inventions) lasts 20 years from the date on which the application was filed.
The generic is, in fact, the so-called alternative medicines, the medicines to which the manufacturers during the patent protection conferred, at its discretion, a fancy name. You just cannot use the same name (or another fantasy), but exclusively that of its active ingredient, i.e. the substance with the therapeutic function in that drug.
An example Paracetamol, an active ingredient that carries the action to lower the fever and soothe the pain, is the basic ingredient of Tylenol, a medicinal product, and at the same time also the name of the generic medicines it inspired.
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What requirements must comply?
In order to enter the market, the generic must prove to be bioequivalent to the corresponding registered medicinal product i.e. it must demonstrate that it can achieve, with the same dose and route of administration through the same, the same as the active ingredient concentration profile of the original drug to 'body inside (referring in particular to blood concentration).
Therefore, it must necessarily contain the same active ingredients, respecting the dose and, of course, the therapeutic indications; must be in the same pharmaceutical form (for instance, be in tablet, syrup, solution for injection if the specialty is compressed, in the syrup or solution for injection) and have identical route of administration.
And as regards excipients, i.e. substances with no therapeutic properties but necessary to convey the active ingredient and to render the formulation stable Take, for example, binders, surfactants, preservatives, coatings of capsules and tablets, dyes and the correction of taste in general need not be the same as the corresponding medicinal product, as long as it respected the bioequivalence.
Manufacturers must also comply for generic medicines the same quality requirements as those with the brand the active ingredient must have the same purity, and in its final form, the product should be equipped with the same stability and a suitable packaging.
If it meets all of these conditions, it is extremely unlikely that the generic can induce significant differences in terms of efficacy and safety front.
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The security-
A Generic medicine is safe as Brand Of course, because (as happens with all medicines) before entering the market it must demonstrate that the substances from which it is composed are not harmful at the doses at which it will use in clinical practice.
Being copies of products already on the market, and therefore composed of molecules already tested in the case of generic medicinal products is not necessary that a repetition of the pre-clinical evaluation, that animal studies preparatory to those in humans. It would be entirely unjustified (and unethical) conduct new tests of safety by sacrificing still a large number of animals when, in the case of generic, both the active substance which is already on the market and excipients of common use in humans for several years.
Why in the process of entering into the generic business is not required to the documentation for further preclinical testing, but simply the bibliographic account of already conducted studies for the reference medicinal product?
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Generic or equivalent-
The generic and equivalent is the same thing. Following some controversy, then (namely since 2005) it was decided to replace the term generic with equivalent, with explicit reference to the characteristics of the bioequivalence of the drug this is because define generic could awaken in people the impression that it was less effective products, poor quality or not specific to therapeutic action than the corresponding specialties available in pharmacies. Today, in fact, the two terms are used in an alternative way and are both in common use.
Why does generics cost less?
The Italian legislation provides for generics a reduced price at least 20% compared to the corresponding reference medicinal product substantial savings for both the individual citizen pockets both in the case of reimbursable medicines, for the National Health System.
Are the same production costs, moreover, to be lower the companies that sell them, not having to deal with the expenses of a complete search, have much lower costs to enter their medicines on the market? In fact, no need to meet the development costs of new molecules or take charge of the toxicity studies, as well as those to prove their therapeutic efficacy (in fact, is not expected clinical trial but only the evidence of bioequivalence), with a substantial reduction in time and a huge saving from the economic point of view.
Generic medicines are not fake
A counterfeit medicine is a medicine which is deliberately labeled fraudulently, and whose origin or composition you give false. Counterfeiting can happen on generic medicines as well as on pharmaceutical products, and in no circumstances be permitted by law.
