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With ECO issues making the headlines in most countries around the world, often the fing

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

er can and should be pointed at the large multi-nationals we see on our high street.

W

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

Examples of combination products may in

have been in business for twenty three years, over the last decade we have witnessed l

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

rge national companies abandoning the local businesses in favour of, again, larger nati

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

nal companies. This has a damaging effect on local economies in many ways.

For example

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

Combination pro

a large supermarket arrives just outside of town. We must agree that they generate ext

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

a jobs for local people that work in the store, but this is where the benefit ends, in

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

y mind.

Local, traditional shops close, with the loss of employment.

The supermarket

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

OES NOT interact with other members of the business community, for example, in recent w

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

eks we have spoken to an electrician working on a bank in Eastbourne, he was sent down

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

rom the midlands to execute three hours work! what a ridiculous situation, traveling tw

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

Following aspects would a

hundred miles, for three hours work, lets imagine the financial cost, the carbon footp

dd to the challenges in developing combination products:

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

int and the fact that there are many qualified electricians in the area.

We think that

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

this practice produces a low quality of service, mainly because contacts negotiated at

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

National level will squeeze the national contractors into a price that often will lose

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

them money.

Before we realize, the economy will be shared out between several big play

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs, choice will be gone, control would have been taken.

Think twice before using a Nat

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

onal! we try to use only local services, local farm producers, local service companies,

.

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 list goes on, we find a better quality of product and service, again and again. ECO

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

Companies that provide selfless information through particip

friendly companies can be found in abundance on the internet, get those fingers tapping

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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