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So many business leaders and MBA professors say that cutting prices actuall

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

y hurts profits and it hurts the industry and no one wins. This may be well

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

Examples of combination products may in

documented in industries where price competition was not applied correctly

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

or one company started dumping into the market in order to increase market

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

share, but if a company is truly on the ball and has their systems, supply

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

Combination pro

hains, manufacturing processes and management under control and they are op

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

erating as efficiently as possible, then their business model should allow

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

them to win a price war.

In fact in reality; There is nothing wrong with w

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

nning on Price! And there is nothing wrong with winning. Artificial market

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

or industry price boosting actually can be a bad thing, because it makes co

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

panies weak and fat, instead of lean and trim and ready to complete the mar

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

Following aspects would a

athon at a record breaking pace. I would like to state for the record that

dd to the challenges in developing combination products:

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

if you cannot beat your competition on price if they start a price war, the

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

you are not as efficient as you should be.

In that case you are too fat a

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

nd no longer have the agility of a start up in the market place and have sl

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

pped into a micro-managed stodgy, bureaucracy and well, in that case, my De

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

Professional from academic institutions, pharmaceutical industries, health care indust

ar Sir, I am not impressed, because I think you are weak and have lost your

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

competitive edge and therefore my friend you better check six, because the

.

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

whole nine yards are loaded and we plan to win, using any and ALL methods p

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

Companies that provide selfless information through particip

ossible including perhaps cutting price to do so. Consider all this in 2006

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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