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Outsourcing is not new for the country like India. It was started dates back during 1960s. Business Process Outsourcing (BPO) is the long-ter

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

m contracting out of non-core business processes to an outside provider to help achieve increased shareholder value. BPO saves precious manag

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

Examples of combination products may in

ement time and resources and allows focus while building upon core competencies. After BPO, India has now set its sights on becoming a global

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

hub for knowledge process outsourcing (KPO). Knowledge Process Outsourcing (KPO), a new terminology is evolved for the business related to t

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

e patents and intellectual property.

As India has the second largest English speaking scientific manpower pool in the world after the U.S. m

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

Combination pro

ost of the Global competitors are looking forward to India to outsource their IPR needs related to patent searching, prior art search, infrin

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

gement and validity search etc,. In a survey it was found that Indian graduates cost 50%+ lower than the U.S. and initial setup cost are half

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

those in U.S. According to the Rick Wills, CEO, of Tektronix Inc.

"In India, free-market reforms are creating the world's largest back offi

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

e, transforming the country into a major force in IT, outsourcing, and critical service application delivery."

Confederation of Indian Indus

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

try (CII) study saying that KPO would grow at 46 per cent to become $17 billion sector by 2010. The BPO industry, only 26%. Global KPO pie in

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

2010 will be around $17 billion of which $12 billion (70%) will be outsourced to India.” Thus KPO is going to be global hub for the country

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

Following aspects would a

like India. Areas with significant potential for KPO include pharmaceuticals, biotechnology, and ICT, besides legal support, intellectual pro

dd to the challenges in developing combination products:

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

erty research and design and development for automotive and aerospace industries, CII stated.

KPO involves high-end processes like valuation

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

research, investment research, patent filing, legal and insurance claims processing, patents and prior-art search, etc. India with its knowl

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

edge base and lower costs will be leading the pack in the race for KPO businesses.

The economy of an industry is fueled by its innovation an

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

d thus there is a need to protect your innovations in order to make money from them. The firm protection of intellectual property requires a

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

Professional from academic institutions, pharmaceutical industries, health care indust

lanned investment of both time and money. There are many ways by which you can protect your invention to avoid others making money from your

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

efforts. When a company starts of thinking of a new project or going to file a patent for a newly developed product, it is suggested to condu

.

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

ct a state-of-art search or prior art search. This service is provided by many KPO firms in India at reasonable cost and better quality.

Thu

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

Companies that provide selfless information through particip

s it is assumed that KPO will be a global hub among the student in Indian in near future, with more demand for the people expert in this area

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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