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Debts incurred if not managed effectively go on accumulating and this can lead to the debtor ultimately turning bankrupt. Nonpayment o

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

f the debts can also be severely frustrating and stressful to the lender. These problems are more significant in the corporate and bus

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

Examples of combination products may in

iness sector. Thus businessmen and lenders arm themselves with the following strategies to recover debts:

Firstly, the lender may cal

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

the debtor, negotiate and set up a deadline by which the debt should be paid off. The debtor usually tries to portray an intimidating

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

attitude. If the calls are left unanswered or the debtor fails to meet the deadline the lender can go to the court.

The court employ

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

Combination pro

s three methods to recover debts. They are Small Claim Process (SCP), Warrant of Execution (WoE) and Section 65 proceedings. The court

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

determines the method to be used depending on the money owed.

Small Claim Process (SCP):

The SCP being straight forward and cheap is

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

the most widely accepted method. The disputes can be settled using the fast-track process or the multiple track process. Generally am

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

ounts above ?5,000 are dealt with the fast-track process while those in excess of ?15,000 are dealt with using the multiple track proc

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

ss. In the instances where the creditor may be given a default judgment with respect to the debtor the creditor has two options. He ma

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

y appeal to the court to issue a WoE to the debtor or his property. The other remedy is to refer to Section 65 of the Magistrate's Cou

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

Following aspects would a

rt Act.

Warrant of Execution (WoE):

Here, the court places the responsibility of auctioning off the debtor’s assets and property wit

dd to the challenges in developing combination products:

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

the sheriff. The debtor is supposed to surrender his real estate documents as collateral. First the movable assets like vehicles or f

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

urniture are auctioned followed by the immovable assets like real estate. The public is invited to such auctions and the assets are so

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

ld to the highest bidder. The money raised is then given to the creditor. If that money does not successfully recover the loan the deb

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

or is asked to make some other arrangements to get the additional money.

Section 65 Proceedings:

If the debtor and the creditor have

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

Professional from academic institutions, pharmaceutical industries, health care indust

reached a conclusion to settle the debt in smaller installments, the court is sanctioned to make this a court order. Now, in accordan

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

ce with section 65 (A), if the debtor fails to pay the amount, the creditor can summon him to court. A particular day is decided for t

.

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

e court hearing where both the debtor and creditor should be present to defend themselves. If the debtor stays absent on the predeterm

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

Companies that provide selfless information through particip

ined day, he can be charged with contempt and even imprisoned.

These are the ways in which a lender can effectively recover his money

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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