Advice You - Business

There is too much talk about outsourcing of even the high caliber jobs to Asian c

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

ountries especially India. What’s the point in snatching jobs from your own citiz

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

Examples of combination products may in

ns and outsourcing to others. Every common person thinks that it is truly injusti

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

e on the part of business enterprises to outsource the jobs and deprive their fel

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

ow citizens. Will outsourcing produce quality output than home? Sympathy with suc

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

Combination pro

issues may help you getting some respect but nothing more than this.

However, f

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

r a business enterprise, outsourcing will be definitely beneficial as their savin

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

on labor will be tremendous. Besides saving on labor cost, outsourcing can help

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

n time-saving for the enterprises. Less important or labor intensive jobs can be

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

asily outsourced and the management will be free to concentrate on other aspects

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

f business to explore.

Cost saving is, of course, inevitable factor in outsourci

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

Following aspects would a

ng. As we all know that labor is expensive in US and Europe compared to Asian cou

dd to the challenges in developing combination products:

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

tries, outsourcing jobs will bring huge saving on labor for them. But saving is n

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

t only the criteria. You must also look for quality output you desired. If you ar

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

offered cheap labor with the same standard of quality results or even better 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

what would be your answer? Of course, you would say yes and here comes the need

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

Professional from academic institutions, pharmaceutical industries, health care indust

for outsourcing.

India is producing millions of educated workforce every year. M

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

st of them speak good English, sometimes better than English people. This young w

.

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

rkforce is intelligent, enthusiastic, hardworking and ambitious to succeed. They

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

Companies that provide selfless information through particip

ven do not mind night shifts to keep the working pace with their fellow Americans

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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