Main Subject - Finance

The latter part of the 20th century and now the 21st century has seen a global economy that required annual growth to keep the system running smoothly. This growth is engineered by the consumption of mor

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

e and more goods and services. Provided this consumption is high enough, it will ensure economic growth at the right percentage, which in turn will ensure that the world’s economy shows certain positive

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

Examples of combination products may in

ndicators, such as reasonable inflation rates, solid property values, currency strengths, subdued unemployment figures and more. To ensure this growth in consumption however, the consumer has to spend at

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

a certain rate regardless of whether the consumer’s earnings are up to the task.

Global trade feeds on this need for consumption. Economies will no longer grow at the required rate, if local consumptio

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

is the only driving force. This has forced countries into promoting global trade. It seems however that countries find it difficult to balance these trades and the imbalance of the costs of the imported

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

Combination pro

goods to the exported goods, in many countries, is huge. The United State’s trade deficit, that is they spend more money on imports than they receive on exports, is in sums that are not comprehensible a

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

ymore.

Not only do countries find it difficult to balance trade budgets internationally, but they are unable to balance their internal budgets. Governments discuss their country’s budget mentioning huge

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

figures that they will be short every year. That means government, which supposedly represents its citizens and should act as a good example, is unable to balance its budgets. The monies that come into

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

he government coffers via taxes, customs and other state revenue are not sufficient to cover the expenses the government has. Every year, the short fall of revenue towards expenses increases. This forces

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

governments to borrow ever increasing amounts while at the same time having to cut its offer of benefits to its tax paying citizens and in many cases increasing the tax burden to the individual and comp

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

nies.

Of course local government such as county, provincial or state, juggle budgets in the same way and as inefficiently as the others. Local taxes add to the burden of the individual and companies. An

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

Following aspects would a

whatever the budge, it seems that local government officials, are as incapable of balancing the revenue coming in with the expenses that are required to be paid out.

Likewise, companies borrow huge amo

dd to the challenges in developing combination products:

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

unts of money to build new factories, develop and manufacture new products or buy out other companies, which they think could add value to their organisations. Many times companies borrow money just to b

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

able to pay salaries. The larger companies post some extraordinary losses, for instance currently the American motor industry is again having a difficult time. One actually wonders how they manage to fu

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

nd those levels of losses. After all, that loss means that the company did not earn enough money to pay for its expenses and had to borrow the money. It is surprising to see how willing financial institu

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

ions are to lend out large sums of money such as these.

With other words, everything runs on debt. Countries, governments both national and local and businesses, are unable to contain their spending wit

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

Professional from academic institutions, pharmaceutical industries, health care indust

hin the revenue they receive. Is this all part of the consumption based economy? Or is this a particular malaise of the past two or three generations, where instant gratification has led to this kind of

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

ccumulation of debt which seeps right through society, touching everybody. Possibly it really started with the big wars, or the great recession, where people realised that all could be lost in a matter o

.

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

f years/months or even weeks. Why work and save for something if bombs could wreck your property, or you had to leave your home due to political and personal safety circumstances. Or you lost your house

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

Companies that provide selfless information through particip

ecause the bank that holds your mortgage has had to close its doors. Whatever the reasons, the sums involved in terms of global debt whether for countries, business or individual are beyond comprehension

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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Although we like to think that we know exactly what we want, and that we are capable of choosing our preferred product, as inexperienced consumers we are in fact notoriously inefficient, which is why as a society we have traditionally always been happy to have “professionals” do the selection process for us.

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