Main Subject - Business

Outsourcing! For some it is an economic explosion and for some, an awful nightmare. For years, outsourcing has been a sizzling topic of debate among countries’ politi

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

cians. What exactly is outsourcing and why it has been considered more of an issue rather than an advantage? Let’s find out.

Well, outsourcing is an ongoing practice

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

Examples of combination products may in

of farming out or delegating various jobs outside the country you reside. Or in other words, outsourcing is a trend of global delegation that has ignited a firestorm

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

of controversy, from newspapers to TV channels, magazines to blogs at Internet; you will find enormous discussions on the same.

Nowadays, more and more companies are

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

outsourcing their jobs overseas and taking full advantage of time, cost, and quality. However, disputes on delegation of jobs to an alien country are still firm at th

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

Combination pro

ir place. Let’s consider people who are making out of outsourcing. The companies themselves come at the top of beneficiaries of outsourcing. US companies have to pay

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

comparatively high taxes and wages. Thus, the cost for a product automatically goes high. But if the same company ties up with an Indian company and employs an offsho

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

e dedicated team as the virtual extension of their own staff, it has to pay lower wages, lower taxes, can get products manufactured at a lower cost.

Global outsourci

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

g allows software development companies to take advantage of, talented workforce, specialized knowledge and emerging technologies at relatively lower costs. These com

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

panies hire those who lead an industry, leverage a more competitive advantage in the market place and thus, make more money in the long run. Apart from the companies,

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

consumers too remain at the advantageous side of outsourcing as they have to pay less for the products. Another advantage, you provide jobs to people overseas who oth

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

Following aspects would a

rwise wouldn’t be working.

This example presents a win-win proposition for all; however, reality is something else. To understand the controversy, we need to look at

dd to the challenges in developing combination products:

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

the other face of coin i.e. the American workers who are highly annoyed from outsourcing trend. Well, it is very genuine as more the trend is rising high more jobs a

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

e slipping out of Americans’ hands. They can’t just move to India and even if they do so, wages in India would be nothing compared to what they were getting in US. Th

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

s example gives a clear idea that hundreds of people have suddenly come out of work because of outsourcing. Things don’t end here only. Just broaden the effect and se

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

e. People who have lost their jobs will spend less. Markets, restaurant, malls will be affected as they will be having lesser sales and thus, overall economy may face

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

Professional from academic institutions, pharmaceutical industries, health care indust

recession.

Well, above discussion seems right from both points of views and can not be concluded at a single outcome. But we can’t deny the fact that y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

"http://www.infysolutions.com/it_offshore_outsoucing_and_consulting.html" target="_blank">IT outsourcing has become a multi-billion dollar business for a

.

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

lmost all established software development companies located in major IT countries. It i

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

Companies that provide selfless information through particip

just assumed that firestorm of controversy over outsourcing will subside with time as the trend of outsourcing has bright prospects and is likely to expand in future

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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