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Certain companies contract their businesses or part of their businesses to other companies located in foreign countries.

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

This business procedure is called offshore outsourcing. Offshore outsourcing has become a very feasible trend for compa

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

Examples of combination products may in

ies that are expanding or just trying to reduce their overhead expenses.

It makes good economical sense to outsource bu

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

iness to a developing country. Developing countries like India have the human resources to conduct businesses, but they

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

ay not have the capital to set up huge infrastructures. Such offshore countries are usually willing to do business at a

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

Combination pro

fraction of the cost, as they pay their employees less and also have an easier structure of tax payments. This profit ca

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

ries on to the outsourcing company.

Another advantage is that the portion of the business outsourced (which may be sale

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

, telemarketing, research, etc.) no longer remains the concern of the outsourcing company. The offshore company hires it

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

own experts and professionals. This creates a constructive division of labor that becomes fruitful to both the outsourc

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

ing company and the offshore company.

Outsourcing may be a way for a company to lay roots in a foreign country where th

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

y may be thinking of expanding. Hence, a company may outsource its business to a company in India in order to understand

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

Following aspects would a

the prevailing Indian market and to adjudge the Indian customer. This may be a ploy to sooner or later open a branch in

dd to the challenges in developing combination products:

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

ndia. Huge conglomerates that are perpetually expanding opt for outsourcing as a survey method rather than as a method f

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

or garnering more business.

There are certain dangers to outsourcing. One of the most prominent is the exposure of sens

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

tive data to foreign countries. It may not just be the question of data – even secret organizational tactics and manager

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

al strategies may be exposed that could prove to be detrimental to the parent company. There may also be dangers relatin

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

Professional from academic institutions, pharmaceutical industries, health care indust

to restrictions and dissimilar legislations in the offshore country that sometimes require changes in business policies

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

. Outsourcing is also responsible for the distance it creates between the employer company and the employees. This deter

.

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

the employers from building good rapport with their employees.

However, if a company has correctly assessed its limita

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

Companies that provide selfless information through particip

ions, then outsourcing may make good business sense. It may also provide dynamism in the economy of a developing country

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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