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Bankruptcy is a phrase heard and used by many. Individuals tend to have pre-conceived notions about bankrupts that they are individua

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

ls who are totally broke. But bankruptcy information can be a real eye opener for debtors who are contemplating bankruptcy and indivi

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

Examples of combination products may in

duals who are seeking information about bankruptcy. It helps debunk all the myths attached to bankruptcy.

1)What is bankruptcy?

Ban

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

kruptcy is a legal term to formally identify an individual as bankrupt. It refers to the inability of any debtor or organization to p

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 their creditors. In majority of the cases, bankruptcy is initiated by debtors or organization themselves. The main purpose of bank

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

Combination pro

ruptcy law is to provide any honest debtor a chance to start afresh and to help a debtor repay his/her creditor/s in an orderly manne

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

r to the best extent possible by the debtor. Debtors are discharged of most of their financial obligations after their non-exempt ass

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

ets have been distributed. Creditors can no longer harass debtors or continue any lawsuits once the debtor has opted for bankruptcy.

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

2)Implications of bankruptcy:

Filing bankruptcy is one of the hardest financial decisions. Debtors must carefully examine the impli

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

cations of bankruptcy and choose it as a last resort to deal with financial troubles. Following are the implications of bankruptcy:

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

•Lose control over your assets (except items/equipment required for work/household purposes)

•Cannot act as director of a company/pr

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

Following aspects would a

actice as a lawyer/chartered accountant

•Negative publicity as a bankruptcy is advertised in ‘London Gazette’ and a local newspaper

dd to the challenges in developing combination products:

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

•Bankruptcy remains on record with credit agencies, land registry and other organizations

3)Common terms to understand bankruptcy

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

•Bankruptcy petition: Individuals who opt for bankruptcy need to formally request protection of the federal bankruptcy laws. It invol

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

ves filling of two important forms-The petition (Insolvency Rules 1986 form 6.27) and the statement of affairs (Insolvency Rules 1986

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

form 6.28).

•Chapter 7 bankruptcy: This chapter of the bankruptcy code provides for ‘liquidation’. The debtor’s non-exempt property

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

Professional from academic institutions, pharmaceutical industries, health care indust

will be sold and the proceeds will be distributed among his/her creditors.

•Chapter 13 bankruptcy: This chapter of bankruptcy provi

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

des a reorganization plan for individuals with regular income. It allows a debtor to retain his/her property and pay back his/her deb

.

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

t within 3-5 years.

Debtors could also consider various alternatives to bankruptcy before filing for bankruptcy. IVA, debt consolida

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

Companies that provide selfless information through particip

tion loan, debt management etc are proven alternatives to bankruptcy which the debtor can consider before he/she files for bankruptcy

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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