Main Subject - Business

Machiavelli said that “The first opinion which one forms of a prince, and of his understanding, is by observing the

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

men he has around him; and when they are capable and faithful he may always be considered wise”.

Similarly the se

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

Examples of combination products may in

ection of the employees in the modern organization is critical as they are the most valuable assets of the organiza

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

tion. Machiavelli proposed that those should be hired who believe in the grandness of the task and greatness of the

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

leader rather than who are simply driven by other factors like money and reputation (Knowledge@Wharton, 2003). As p

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

Combination pro

r him the people looking for money and reputation will leave the moment they will get it better somewhere else.

Se

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

condly all the employees and subjects should be armed as the power of prince will considerably increase with their

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

umber. This can be easily translated into providing more opportunities to employees in the work place. This will no

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

only prepare them for bigger task but also improve their loyalty toward the organization.

End Justify the Means

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

The word ‘Machiavellian’ in English is now widely referred as ‘the political doctrine of Machiavelli: any means (ho

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

ever unscrupulous) can be used by a ruler in order to create and maintain his autocratic government’. The book time

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

Following aspects would a

and time again mentions that it is prudent for a ruler to use cunning and necessary evil activities, either to inst

dd to the challenges in developing combination products:

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

igate fear among his opponents or to protect his kingdom.

The philosophy today is as outdated today as media plays

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

an increasing role in public life and people have zero tolerance toward unscrupulousness. Even in the business worl

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

anything unethical is looked down upon and there are strict regulations against it.

Time and time again we have w

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

itnessed how the companies which adhere to unscrupulous methods to justify the means are punished not only by autho

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

Professional from academic institutions, pharmaceutical industries, health care indust

ities but also by the stakeholders. Nike has seen customer protest and product boycott against employment of child

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

abor in its vendors factories in South Asia. Wal-Mart is criticized for not allowing its employees to form labor un

.

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

ion and making illegal workers clean stores to cut costs.

The biggest of all is the rigorous punishment to CEO’s o

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

Companies that provide selfless information through particip

Enron and WorldCom who were found guilty in manipulating accounting practices and fattening profits of the company

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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