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All firms need finance to pay for running costs or to buy new premises and equipm

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

ent, to develop new products and for working capital.

The cash flow is what come

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

Examples of combination products may in

s from the business’ revenue/turnover after paying expenses, interests and taxes

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

and after amortization/depreciation as well. The net profit at the end of the yea

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

is what the firm has earned; it can be retained in reserves, reinvested and/or p

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

Combination pro

aid as dividends to the owners or shareholders.

External finance comes from outs

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

ide sources such as through borrowing (usually from banks), from private investor

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 (owners of the firm, venture capitalists etc) or government subsidies or by iss

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

ing shares on the Stock Exchange.

Bookkeeping is an essential part of auditing a

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

nd accountancy running and control. It consists of keeping records of all transac

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

tions and entries, invoices/bills, payroll, bank drafts etc. thus an account/fina

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

Following aspects would a

nce manager is provided with the information about financial matters (with a ‘Cas

dd to the challenges in developing combination products:

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

Flow statement’ and a ‘Source and application of funds’) and for preparing the f

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

irm’s annual financial reports with the ‘Balance Sheet’ and a “profit and loss ac

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

count’. These accounts are presented according to various accounting standards/pr

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

inciples/plans which may be changing from time to time.

The balance sheet gives

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

Professional from academic institutions, pharmaceutical industries, health care indust

he present picture of the business, its assets (items owned by the firm) and liab

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

ilities (items owed by the firm).

The profit and loss account reflects operation

.

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

s and performance of the company during the past fiscal year. If operating costs

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

Companies that provide selfless information through particip

and other expenses exceed revenue the balance shows a deficit instead of a profit

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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