Main Subject - Business

IT (Internet Technology) companies from advanced countries are increasingly outsourcing their work t

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

o developing countries in Latin America, Africa, Asia and the Middle East. The main motive behind th

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

Examples of combination products may in

is outsourcing of IT work is to reduce the costs to the company. An estimated 50% can be reduced by

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

outsourcing IT jobs to offshore countries with lower economies.

Most companies that undertake outso

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

urced work, such as BPOs (Business Process Outsourcing), can handle many aspects of IT works. These

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

Combination pro

aspects may range from software developing and testing, help desk support and data entry and process

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

ing. Offshore IT companies usually hire proficient professionals to develop software such as .NET, J

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

ava/J2EE, wireless/mobile application developments, database solutions and smartcard solutions among

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

others. These professionals may be permanent employees of the offshore BPO, or they may be hired fr

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

om time to time on a contractual basis.

Outsourcing IT to other countries does not always mean huge

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

projects outsourced by big companies. Even individual work is sometimes outsourced. India is indispu

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

Following aspects would a

tably the hub of outsourced IT work -- mostly from America. In Bangalore, India alone, there are 110

dd to the challenges in developing combination products:

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

,000 employees who perform jobs like building software, designing chips, reading MRIs, running compu

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

ter systems, etc. These people are IT professionals who may work at a rate of less than $7 an hour.

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

This certainly saves the American company a lot of money; while, at the same time, adds fuel to 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

foreign economy.

Offshore IT companies need to be dynamic. Outsourcing companies prefer their offsh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ore counterparts to keep in tune with rapidly the ever-changing information technology. Hence, compa

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

nies that undertake IT outsourced jobs continually upgrade their employees sending them for training

.

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

in the country of the parent company. BPOs hire their employees from time to time from among a pool

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

Companies that provide selfless information through particip

of qualified people who have extensive IT knowledge, as well as proficiency in the English language

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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