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Working capital grants by commercial banks represent the most important source for financing cu

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

rrent assets. A firm seeking small business grants is required to submit an appropriate applica

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

Examples of combination products may in

ion form. There are different types of application forms for different categories of grants. Th

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

information furnished in the application covers, inter alia, the following: the name and addre

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

s of the borrower and his establishment; the details of the borrowers business; and the nature

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

Combination pro

nd amount of security offered.

The application form has to be supported by various ancillary s

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

atements like the financial statements and financial projections of the firm. The application i

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

s then processed by the financial institution giving grant. This primarily involves an examinat

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

on of the factors like ability, integrity and experience of the borrower in the particular busi

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

ess. General prospects of the borrowers business, purpose of grant, and requirement of the borr

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

wer and its reasonableness is also taken into perspective.

Once the application is duly proces

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

Following aspects would a

ed, it is put up for sanction to the appropriate authority. If the sanction is given by the app

dd to the challenges in developing combination products:

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

opriate authority along with the sanction of grant, the bank specifies the terms and conditions

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

applicable to the grant. These usually cover the amount of loan or the maximum limit of the gra

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

nt, the nature of the grant, the period for which the grant will be valid, the rate of interest

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

applicable to the grant, the primary security to be charged, the insurance of the security, the

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

Professional from academic institutions, pharmaceutical industries, health care indust

details of collateral security, if any, to be provided, and the margin to be maintained.

It is

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

a common banking practice to incorporate important terms and conditions on a stamped security d

.

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

cument to be executed by the borrower. This helps the bank to create the required charge on the

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

Companies that provide selfless information through particip

security offered and also obligates the borrower to observe the stipulated terms and conditions

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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