Volume 3 Issue 2 - 2019
Effective and Economical, Generic Drugs
Assistant Professor, Department of Pharmacology, University of Karachi, Pakistan
*Corresponding Author: Shadab Ahmed, Assistant Professor, Department of Pharmacology, University of Karachi, Pakistan.
Received: February 26, 2019; Published: March 04, 2019
Generic drugs are alternatives of research based original medicines having same pharmacological profile, dosage form, indications, adverse effects, efficacy and quality as the original medicine. As it were, their pharmacological actions are actually equivalent to those of their branded versions.
The generic medicines got the same active pharmaceutical ingredient
however it might differ in formulation, process of manufacturing, additives and packaging aspects. Generic Pharmaceutical Association revealed that in 2014 only in United States, approx. 88% of the 4.3 billion prescriptions contain generic drugs.
In spite of the fact that these products may not be related with a specific pharmaceutical company, generic medicines are typically subject to fulfill guidelines approved by ministries of health at governmental level. They must contain generic non propriety name along with the name of the manufacturer. With respect to pharmacokinetic and pharmacodynamics profile, FDA requires generic drugs to be similar or within an acceptable bioequivalent range of their brand name versions.
For example a generic medicine is omeprazole that is commonly used to treat hyperacidity where as its original research brand is Prilosec. Brand names are typically promoted in comparison of generic names for marketing purposes from pharmaceutical companies. Another example of generic medicine utilized for hypertension is Propranolol, though a brand name for a similar medication is Inderal. It is another common misbelief that as the generic medications are relatively cheaper than the branded drugs hence their efficacy and quality have been compromised to make them more affordable.
However The FDA necessitates that generic medications must have similar efficacy and quality as brand-name drugs. As a matter of fact, generic medicines are less expensive in light of the fact that the manufacturer have not shared the initial research, developmental and marketing investments.
At the point when a research based organization brings new molecule into the market, the firm has effectively spent considerable amount of money on research, development, promotion and marketing. In order to compensate, the parent company would be given a patent that authorize it to produce and market the said molecule (new drug) as long as the patent expires. Until medicine patent lasts, a research based organization can fix the price of the medicine that boosts company’s financial benefits. Usually this benefit significantly surpasses the developmental and promotional expenses of the medicine, enabling the company to offset the innovative work expenses of different other medicines that don't pass clinical testing or not financially beneficial.
Near the patent expiration, generic product manufacturer can apply to the FDA or other health regulating authorities for permission to produce and market generic version of such medicines so without initially spending too much on research and development, they can stand to produce and market it more economically. At the point when different organizations start producing and marketing a medication, the challenge among them can likewise drive the cost down much further.
The overall cost of generic drugs are frequently inexpensive for patients dwelling in less-prosperous regions and countries. For instance, India is a leading exporter of generic drugs from where Thailand has imported millions of units of platelet de-aggregator drug Plavix (generic clopidogrel) i.e. used for prevention of heart attacks at an expense of 3 US cents for a dose however the original Plavix brand is too much expensive. Numerous medications presented by generic manufacturers have just been available for 10 years or more and may as of now be notable to patients and suppliers, albeit frequently under their propriety name.
This is generally not true that generic drugs are manufactured in quality compromised facilities without cGMP requirements (current Good manufacturing practices) or brand name drugs are of superior quality in every aspects. The FDA applies similar guidelines for all pharmaceutical production plants and numerous organizations make both brand-name as well as generic medicines.
Indeed, the FDA evaluates that half of generic medications are prepared by brand-name pharmaceutical companies. Another doubt is that generic medications take more time to produce therapeutic response. The FDA necessitates that generic medications must be equally effective and produce timely response like original brand drug.
In most countries, the generic manufacturers has to prove their formulations are bioequivalent to their branded versions however bioequivalence does not mean generics must be exactly same to branded drugs in all aspects, however, the pharmacological impact of the both the medications must be equivalent.
Shadab Ahmed. “Effective and Economical, Generic Drugs”. Chronicle of Medicine and Surgery 3.2 (2019): 339-340.
Copyright: © 2019 Shadab Ahmed. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.