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Counterfeit products and materials are knock-off, bootleg, pirated or other illegally produced materials that are produced and sold in violation of the Intellectual Property Rights of oth

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ers or in a manner that fraudulently represent their quality or origin. Under English Common Law, counterfeiting was referred to as 'palming off'. This was perhaps conceived from the id

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ea that a counterfeiter 'palms off' a counterfeit product as the genuine product by a ruse with regard to the origin and/or content of the product. The counterfeiter, in the process, the

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

refore usurps the goodwill, recognition, niche and brand name of the originator (i.e. owner of the trademark/brand) in marketing and creating a ready consumer for the counterfeit product,

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

which obviously is a fraud.

Although, counterfeiting is often used to describe trademark infringement, it may also involve any/all aspect of Intellectual Property Right (IPR) violation,

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

which includes patents, copyrights, trade secrets etc. The effect of counterfeiting activities has been known to be quite debilitating for the IPR owner, the consumer and the nation at

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

large. This fact is arguable from the perspective that counterfeit goods are generally of lower quality and most often, lower priced. Thus by confusing or misleading the consumer and by

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

providing a lower priced opportunity for what appears to be the same commodity, counterfeiters tend to eat into the IPR owner's market and the value of its Intellectual capacity, while a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

t the same time putting the consumer at health and safety risks, because of the sub standard product being consumed.

The business of counterfeiting has become especially profitable and s

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ophisticated, with the involvement of several organized crime groups in the business. The problem is therefore expanding alarmingly and becoming more pervasive. The range of counterfeit

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

materials and products cuts across a wide range of consumer products. In recent times, almost everything from counterfeit copies of Microsoft Windows, to improperly produced baby formul

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

a, pharmaceuticals, aircraft and automobile parts are available in the market. For instance, a report in the American 'Chemical and Engineering News' says, "just a few years ago, America

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ns could boast with confidence that they had the safest prescription drug supply in the world. Now, they cannot be so sanguine".

Even the FDA acknowledges the growth and spread of count

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

erfeiting as it affects prescription medications and other consumables. This is evident from the four-fold increase in counterfeit drug investigations carried out by the FDA from five ti

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

mes per year in the 1990s to twenty times from 2000. In response to the threat of counterfeit, the Commissioner for Food and Drugs established a Counterfeit Taskforce in July 2003.

The

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

impact of the increasing rate of counterfeiting can be broadly seen from two perspectives. The first, which is obviously the most direct and alarming effect on the populace, is the healt

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

h hazards and other is personal safety concerns associated with consumption of counterfeit drugs and other consumables. The second direct impact has to do with the reduced customer welfa

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

re that accompanies counterfeiting, since a counterfeiter doesn't care what happens to its customers after purchase has been made.

The message here is that despite the improved monitorin

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

g and surveillance technology of the developed world, counterfeiting is still a growing menace. The world is not really as safe as you and I would want it. The best we can do is to wake

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

up to the challenge. Be sure you purchase drugs, food items and other consumables from recognized stores; if for whatever reason you doubt the originality of any item, then don't buy it

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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