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Bankruptcy in the UK is on the increase. The most recent figures from the DTI show that in the th

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

ird quarter of 2005 personal bankruptcies rose by 32% and as many as 12,256 people were declared

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

Examples of combination products may in

bankrupt.

One of the reasons for this rise is that a growing number of people with serious debt

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

roblems see bankruptcy as an easy way out following the Enterprise Act of 2002 that made it possi

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

ble for a bankrupt to be discharged after less than a year.

However, anyone who thinks bankruptc

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

Combination pro

is easy is mistaken – unless their definition of ‘easy’ covers the prospect of lost assets, the

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

return of hired and leased goods, press notices of the bankruptcy and severe restrictions placed

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

n the bankrupt.

These restrictions make it impossible to get credit of ?250 or more without lett

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

ing the lender know you are bankrupt. Also you cannot start, manage, promote or become a director

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

of a company without the court’s consent or informing everyone with whom you do business of your

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

situation.

However, those in the unfortunate situation of chronic debt will be happy to discover

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

Following aspects would a

that there is an alternative that could save them much of the heartache inherent of bankruptcy:

dd to the challenges in developing combination products:

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

he IVA.

IVA is short for Individual Voluntary Arrangement. An IVA can be arranged by an i

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

nsolvency practitioner for people with unsecured debts of ?15,000 or more.

A creditors’ meeting

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

s organised where the people to whom you owe money agree the terms of your IVA. If a majority of

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

75% vote in favour then the IVA can go ahead.

An IVA can wipe off a significant proportion of yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r debt instantly – often as much as 60%.

For the remaining debt, a payment programme is worked o

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

ut according to how much you can afford and you can be debt-free within five years.

And of cours

.

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

this all happens without the restrictions and asset-loss associated with bankruptcy.

Chronic de

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

Companies that provide selfless information through particip

bt is a bad situation no matter how you look at it, but an IVA is often the least painful way out

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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