Useful Advices - Business

India has been edge for the offshore outsourcing of the IT, financial services, business process outsourcing (BPO), because l

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

ow cost manpower with higher education, neutral accent English speaking capability. In spite of these the India is emerging

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

Examples of combination products may in

as new hub for KPO (knowledge process outsourcing), having large pool of knowledge workers in various sector. The India has b

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

een ranked the most preferred KPO destination.

KPO deals with executing standardized processes, involves higher-end services

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

which require advanced analytical and technical skills. knowledge process outsourcing involves Legal works carried out at la

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

Combination pro

w firms like patent document writing, global filing, search, trademark search, trademark registration, prior art searches, le

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

gal advise on infringements, invalidation search, freedom of use search, etc. The prior art search for a patent, drafting and

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

filing of patent in the US is very expensive. According to a recent study by researchers at the University of California at

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

Berkeley, legal assistants and paralegals working in India on behalf of U.S. law firms earn, on average, between $6 and $8 pe

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

r hour. That's about one-third of what their counterparts in the United States are paid.

According to a report by GlobalSour

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

cingNow, the Global Knowledge Process Outsourcing industry (KPO) is expected to reach USD 17 billion by 2010, of which USD 12

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

Following aspects would a

billion would be outsourced to India. In addition, the Indian KPO sector is also expected to employ more than 250,000 KPO pr

dd to the challenges in developing combination products:

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

ofessionals by 2010, compared with the current figure of 25,000 employees. A report by Evalueserve predicts that India will c

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

apture more than 70 percent of the KPO sector by 2010. Apart from India, countries such as Russia, China, the Czech Republic,

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

Ireland, and Israel are also expected to join the KPO industry.

The competitiveness of the market demands that trailblazing

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

entrepreneurs protect their innovations in order to profit from them, the KPO is becoming the high valuable interests of com

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

Professional from academic institutions, pharmaceutical industries, health care indust

panies for their business strategies and protection of intellectual property rights. Some of the challenges involved in KPO w

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

ill be maintaining higher quality standards, investment in KPO infrastructure, the lack of talent pool, requirement of higher

.

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

level of control, confidentiality and enhanced risk management.

More than half a dozen companies in India have also set up

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

Companies that provide selfless information through particip

facilities to provide IPR-related services. These include SciTech Patent Art Services, IP Matrix, Patent Matrix, Evalueserve.

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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